```

[House Hearing, 111 Congress]
[From the U.S. Government Publishing Office]

 
                          21ST CENTURY BIOLOGY

=======================================================================

                                HEARING

                               BEFORE THE

             SUBCOMMITTEE ON RESEARCH AND SCIENCE EDUCATION

                  COMMITTEE ON SCIENCE AND TECHNOLOGY
                        HOUSE OF REPRESENTATIVES

                     ONE HUNDRED ELEVENTH CONGRESS

                             SECOND SESSION

                               __________

                             JUNE 29, 2010

                               __________

                           Serial No. 111-103

                               __________

     Printed for the use of the Committee on Science and Technology

     Available via the World Wide Web: http://www.science.house.gov

                  U.S. GOVERNMENT PRINTING OFFICE
57-601                    WASHINGTON : 2010
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                  COMMITTEE ON SCIENCE AND TECHNOLOGY

                   HON. BART GORDON, Tennessee, Chair
JERRY F. COSTELLO, Illinois          RALPH M. HALL, Texas
EDDIE BERNICE JOHNSON, Texas         F. JAMES SENSENBRENNER JR., 
LYNN C. WOOLSEY, California              Wisconsin
DAVID WU, Oregon                     LAMAR S. SMITH, Texas
BRIAN BAIRD, Washington              DANA ROHRABACHER, California
BRAD MILLER, North Carolina          ROSCOE G. BARTLETT, Maryland
DANIEL LIPINSKI, Illinois            VERNON J. EHLERS, Michigan
GABRIELLE GIFFORDS, Arizona          FRANK D. LUCAS, Oklahoma
DONNA F. EDWARDS, Maryland           JUDY BIGGERT, Illinois
MARCIA L. FUDGE, Ohio                W. TODD AKIN, Missouri
BEN R. LUJAN, New Mexico             RANDY NEUGEBAUER, Texas
PAUL D. TONKO, New York              BOB INGLIS, South Carolina
STEVEN R. ROTHMAN, New Jersey        MICHAEL T. McCAUL, Texas
JIM MATHESON, Utah                   MARIO DIAZ-BALART, Florida
LINCOLN DAVIS, Tennessee             BRIAN P. BILBRAY, California
BEN CHANDLER, Kentucky               ADRIAN SMITH, Nebraska
RUSS CARNAHAN, Missouri              PAUL C. BROUN, Georgia
BARON P. HILL, Indiana               PETE OLSON, Texas
HARRY E. MITCHELL, Arizona
CHARLES A. WILSON, Ohio
KATHLEEN DAHLKEMPER, Pennsylvania
ALAN GRAYSON, Florida
SUZANNE M. KOSMAS, Florida
GARY C. PETERS, Michigan
JOHN GARAMENDI, California
VACANCY
                                 ------                                

             Subcommittee on Research and Science Education

                 HON. DANIEL LIPINSKI, Illinois, Chair
EDDIE BERNICE JOHNSON, Texas         VERNON J. EHLERS, Michigan
BRIAN BAIRD, Washington              RANDY NEUGEBAUER, Texas
MARCIA L. FUDGE, Ohio                BOB INGLIS, South Carolina
PAUL D. TONKO, New York              BRIAN P. BILBRAY, California
RUSS CARNAHAN, Missouri                  
VACANCY                                  
BART GORDON, Tennessee               RALPH M. HALL, Texas
               DAHLIA SOKOLOV Subcommittee Staff Director
            MARCY GALLO Democratic Professional Staff Member
           BESS CAUGHRAN Democratic Professional Staff Member
           MELE WILLIAMS Republican Professional Staff Member
                   MOLLY O'ROURKE Research Assistant

                            C O N T E N T S

                             June 29, 2010

                                                                   Page
Witness List.....................................................     2

Hearing Charter..................................................     3

                           Opening Statements

Statement by Representative Daniel Lipinski, Chairman, 
  Subcommittee on Research and Science Education, Committee on 
  Science and Technology, U.S. House of Representatives..........     9
    Written Statement............................................    10

Statement by Representative Vernon J. Ehlers, Minority Ranking 
  Member, Subcommittee on Research and Science Education, 
  Committee on Science and Technology, U.S. House of 
  Representatives................................................    10
    Written Statement............................................    11

                               Witnesses:

Dr. Keith Yamamoto, Chair, National Academy of Sciences' Board on 
  Life Sciences, and Professor, Cellular and Molecular 
  Pharmacology, University of California, San Francisco
    Oral Statement...............................................    12
    Written Statement............................................    15
    Biography....................................................    18

Dr. James Collins, Virginia M. Ullman Professor of Natural 
  History and the Environment, Department of Ecology, Evolution 
  and Environmental Science, Arizona State University
    Oral Statement...............................................    18
    Written Statement............................................    20
    Biography....................................................    28

Dr. Reinhard Laubenbacher, Professor, Virginia Bioinformatics 
  Institute, Department of Mathematics, Virginia Tech
    Oral Statement...............................................    28
    Written Statement............................................    30
    Biography....................................................    41

Dr. Joshua N. Leonard, Assistant Professor, Department of 
  Chemical and Biological Engineering, Northwestern University
    Oral Statement...............................................    41
    Written Statement............................................    43
    Biography....................................................    49

Dr. Karl Sanford, Vice President, Technology Development, 
  Genencor
    Oral Statement...............................................    50
    Written Statement............................................    52
    Biography....................................................    55

             Appendix 1: Answers to Post-Hearing Questions

Dr. Keith Yamamoto, Chair, National Academy of Sciences' Board on 
  Life Sciences, and Professor, Cellular and Molecular 
  Pharmacology, University of California, San Francisco..........    64

Dr. Karl Sanford, Vice President, Technology Development, 
  Genencor.......................................................    66

             Appendix 2: Additional Material for the Record

Statement of Dr. James Sullivan, Vice President for 
  Pharmaceutical Discovery, Abbott Laboratories..................    70

                          21ST CENTURY BIOLOGY

                              ----------                              

                         TUESDAY, JUNE 29, 2010

                  House of Representatives,
     Subcommittee on Research and Science Education
                        Committee on Science and Technology
                                                    Washington, DC.

    The Subcommittee met, pursuant to call, at 2:07 p.m., in 
Room 2318 of the Rayburn House Office Building, Hon. Daniel 
Lipinski [Chairman of the Subcommittee] presiding.

                            hearing charter

                  COMMITTEE ON SCIENCE AND TECHNOLOGY

             SUBCOMMITTEE ON RESEARCH AND SCIENCE EDUCATION

                     U.S. HOUSE OF REPRESENTATIVES

                             june 29, 2010
                          2:00 p.m.-4:00 p.m.
                   2318 rayburn house office building

1. Purpose:

    The purpose of the hearing is to examine the future of the 
biological sciences, including research occurring at the intersection 
of the physical sciences, engineering, and biological sciences, and to 
examine the potential these emerging fields of interdisciplinary 
research hold for addressing grand challenges in energy, the 
environment, agriculture, materials, and manufacturing.

2. Witnesses:

          Dr. Keith Yamamoto, Chair, National Academy of 
        Sciences, Board on Life Sciences and Professor, Cellular and 
        Molecular Pharmacology, University of California, San Francisco

          Dr. James Collins, Virginia M. Ullman Professor of 
        Natural History and the Environment, Department of Ecology, 
        Evolution, & Environmental Science, Arizona State University

          Dr. Reinhard Laubenbacher, Professor, Virginia 
        Bioinformatics Institute and Department of Mathematics, 
        Virginia Tech

          Dr. Joshua N. Leonard, Assistant Professor, 
        Department of Chemical and Biological Engineering, Northwestern 
        University

          Dr. Karl Sanford, Vice President, Technology 
        Development, Genencor

3. Overarching Questions:

          What is the future of research in the biological 
        sciences? What potential does research at the intersection of 
        the biological sciences, physical sciences, and engineering 
        hold for addressing grand research challenges in energy, the 
        environment, agriculture, materials, and manufacturing? What 
        new technologies and methodologies, including computational 
        tools, are enabling advances in biological research? Are there 
        promising research opportunities that are not being adequately 
        addressed?

          What is the nature of the interactions and 
        collaborations between physical scientists, engineers, and 
        biological scientists? How might these disparate research 
        communities be better integrated? Is the National Science 
        Foundation playing an effective role in fostering research at 
        the intersection of the physical sciences, engineering, and the 
        biological sciences? Is research in the biological sciences, 
        including research at the intersection of the biological 
        sciences, the physical sciences, and engineering being 
        effectively coordinated across the Federal agencies? If not, 
        what changes are needed?

          What changes, if any, are needed in the education and 
        training of undergraduate and graduate students to enable them 
        to work effectively across the boundaries of the physical 
        sciences, engineering, and the biological sciences without 
        compromising core disciplinary depth and understanding? How do 
        you achieve that balance?

          How are advances in the biological sciences affecting 
        the biotechnology industry? What are the research needs of the 
        biotechnology sector and are they being adequately addressed? 
        Are science and engineering students being adequately trained 
        by colleges and universities to be successful in the 
        biotechnology industry? Is the National Science Foundation 
        playing an effective role in fostering university-industry 
        collaborations?

4. Background:

    Research in the biological sciences is the largest area of research 
supported by the Federal Government, representing 27 percent of Federal 
research obligations in 2007. Currently over 20 Federal agencies 
support biological sciences research ranging from bioterrorism-related 
research at the Department of Homeland Security to stream ecology at 
the National Science Foundation. Over the last 30 years there have been 
rapid advances in DNA sequencing technologies, the real-time imaging of 
cells and organisms, and computational power. These technical advances, 
among others, have enabled significant accomplishments in biological 
research, including the sequencing of the human genome in 2003 and more 
recently, the creation of a synthesized genome by the J. Craig Venter 
Institute \1\. Many believe biological research is on the verge of a 
revolution, moving from a field that has focused primarily on 
``identifying parts'' (i.e. plant species, cells, genes, and proteins) 
and defining complex systems to one that can design, manipulate, and 
predict the function of biological systems at all levels of 
organization from the individual cell to an entire ecosystem. Many 
experts predict that just as the 20th century was the golden era for 
physics the 21st century will be the ``age of biology'', and advances 
and discoveries in the biological sciences will transform society.
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    \1\ http://www.sciencemag.org/cgi/rapidpdf/science.1190719v1.pdf
---------------------------------------------------------------------------
    A deeper understanding of biological systems and the ability to 
address biology-based societal problems such as the production of a 
sufficient amount food to sustain the growing human population or the 
generation of clean energy are increasingly being tackled through 
interdisciplinary research. The trend toward interdisciplinary 
research, specifically, research at the intersection of the biological 
sciences, engineering, mathematics, and the physical sciences has been 
termed the ``new biology'' \2\. Within the ``new biology'' three areas 
are emerging as foundational fields: computational biology, systems 
biology, and synthetic biology. Computational biology is the use of 
mathematical tools and techniques in the examination of biological 
processes and systems; for example the use of math to describe and 
understand heart physiology. Systems biology is the study and 
predictive modeling of biological processes through a holistic 
examination of the dynamic interaction of the individual components of 
a system; for example the study of an organism, viewed as an integrated 
and interacting network of genes, proteins and biochemical reactions. 
Synthetic biology is an emerging field that applies the principles of 
engineering to the basic components of biology. The aim of synthetic 
biology is to make predictable and easy to use genetically-engineered 
cells, organisms, or biologically-inspired systems for industrial 
applications like the production of biofuels or therapeutic 
applications to treat disease.
---------------------------------------------------------------------------
    \2\ http://www.nap.edu/catalog.php?record-id=12764
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    A number of issues need to be considered as these new trends in 
biological sciences research develop. Specifically, the type of 
education and training necessary for undergraduate and graduate 
students to work effectively across traditional disciplines, the 
effectiveness of Federal support for interdisciplinary research and 
education, and the increasing need for interagency coordination of 
biological sciences research.

The Role of NSF in Biological Sciences Research
    The Directorate for Biological Sciences (BIO) at the National 
Science Foundation supports 68 percent of the non-medical, basic 
biological sciences research performed at academic institutions, 
including plant biology, environmental biology and biodiversity 
research. The fiscal year 2011 budget request for BIO is $767.8 
million, an increase of 7.5 percent over fiscal year 2010 (see table 
below). BIO is separated into 5 divisions and supports research to 
advance understanding of the underlying principles and mechanisms 
governing life. Research supported by BIO ranges from the examination 
of the structure and dynamics of biological molecules to more complex 
systems and scales, including organisms, communities, ecosystems, and 
the global biosphere.

    The Division of Molecular and Cellular Biosciences (MCB) supports 
research to understand the dynamics and complexity of living systems at 
the molecular, biochemical and cellular levels. Projects funded through 
MCB often focus on the regulation of genes and genomes, properties of 
biomolecules, and the structure of subcellular systems. Activities 
supported by MCB are increasingly interdisciplinary with the use of 
tools and technologies developed in the physical sciences, mathematics, 
and engineering becoming routine.
    The Division of Integrative Organismal Systems (IOS) supports a 
systems-level approach to the understanding of plants, animals, and 
microorganism; this holistic approach includes the study of an 
organism's development, function, behavior, and evolution. The Plant 
Genome Research Program (PGRP), which is part of the National Plant 
Genome Initiative, is supported through IOS. The PGRP, with a budget 
request of $105.4 million in fiscal year 2011, supports basic research 
to improve crop production, and to identify and develop new sources for 
bio-based fuels and materials.
    The Division of Environmental Biology (DEB) supports fundamental 
research on the origins, functions, relationships, interactions, and 
evolutionary history of populations, species, communities, and 
ecosystems. Research on the complexity and dynamics of ecosystems and 
evolution are essential to improving our ability to understand and 
mitigate environmental change.
    The Division of Biological Infrastructure (DBI) supports a variety 
of activities from the development of instruments, software, and 
databases to the improvement and maintenance of biological research 
collections and field stations to the transformation of undergraduate 
biology education. DBI provides the infrastructure, including the human 
capital, necessary for contemporary research in biology. DBI oversees 
BIO's participation in cross-cutting programs at NSF including, the 
Graduate Research Fellowships program, the Integrative Graduate 
Education and Research Traineeship (IGERT) program (described in detail 
later) and the Major Research Instrumentation program.
    Developing programs and priority areas often start in the Emerging 
Frontiers (EF) Division and then are integrated into BIO's core 
programs. EF supports novel partnerships across disciplines and enables 
the development of new conceptual frameworks. Additionally, EF develops 
and implements new forms of merit review and mechanisms to support 
high-risk, high-reward research.
    In addition to the research and education activities supported by 
BIO, the National Ecological Observatory Network (NEON) was included in 
NSF's fiscal year 2011 budget request for the Major Research Equipment 
and Facilities Construction (MREFC) account. NEON, a continental-scale 
research platform for discovering and understanding the impacts of 
climate change, land-use change, and invasive species on ecosystems, is 
the first biological sciences related project funded through the MREFC 
process.

The Role of NSF in Interdisciplinary Education and Training
    NSF supports interdisciplinary education primarily through the 
IGERT program. Since 1998 the IGERT program has made 215 awards to over 
100 universities and has provided funding for nearly 5,000 doctoral-
level graduate students. IGERT awards average $3.0 million over five 
years with the major portion of the funds being used for graduate 
student stipends and training expenses. While each IGERT award is 
unique, the overall goal of the program is to develop scientists and 
engineers who will pursue careers in research and education from a 
strong interdisciplinary background and catalyze a cultural change in 
graduate education, for students, faculty, and institutions, by 
establishing innovative models that transcend traditional disciplinary 
boundaries. For example, there are currently 15 IGERT awards in the 
area of bioinformatics all seeking to create professionals who can 
translate scientific problems in biology into mathematics and 
computations.
    NSF also supports a number of research centers that are 
interdisciplinary in nature and undergraduate and graduate students 
working in the context of those research centers are exposed to 
interdisciplinary research, education, and training. For example, 
through the Centers for Analysis and Synthesis Program, the iPlant 
Center led by the University of Arizona integrates biologists, computer 
scientists, and engineers to address grand challenges in the plant 
sciences, and through the Engineering Research Centers program, the 
Center for Biorenewable Chemicals led by Iowa State University seeks to 
transform the chemical industry by integrating biologists and chemists 
to produce sustainable biochemicals. However, centers are not required 
to be interdisciplinary and the degree of formal graduate and 
undergraduate education programs associated with the centers varies.

Interagency Biological Sciences Research Programs
    The National Plant Genome Initiative (NGPI) was established in 1998 
and includes the U.S. Department of Agriculture (USDA), the Department 
of Energy (DOE), the National Institutes of Health (NIH), and NSF. 
According the initiative's strategic plan \3\, the goal of the 
initiative is translate basic research and understanding of 
economically important plants and plant processes, including a deeper 
understanding of the structures and functions of plant genomes into the 
enhanced management of agriculture, natural resources, and the 
environment to meet societal needs.
---------------------------------------------------------------------------
    \3\ http://www.csrees.usda.gov/business/reporting/stakeholder/pdfs/
pl-iwg-plant-genome
-yearPlan.pdf
---------------------------------------------------------------------------
    The U.S. Global Change Research Program (USGCRP), which began as a 
presidential initiative in 1989 and includes 13 Federal agencies, was 
formally established by Congress through the Global Change Research Act 
of 1990 (P.L. 101-606). The USGCRP coordinates and integrates Federal 
research on global climate change. While the USGCRP extends beyond 
biological sciences research one of the program's strategic goals is to 
``understand the sensitivity and adaptability of different natural and 
managed ecosystems and human systems to climate and related global 
changes.'' \4\
---------------------------------------------------------------------------
    \4\ http://www.climatescience.gov/Library/stratplan2008/CCSP-RRP-
FINAL.pdf
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    On a smaller scale, NSF and NIH are jointly funding grants in 
mathematical biology and the ecology of infectious diseases. 
Specifically, NSF and NIH sponsor a collaborative research program in 
computational neuroscience that could lead to significant advances in 
the understanding of nervous system function and the underlying 
mechanisms of nervous system disorders such as Alzheimer's disease.

5. Questions for Witnesses:

Dr. Keith Yamamoto

          Please summarize the findings and recommendations of 
        the National Research Council's report, A New Biology for the 
        21st Century.

          Are there promising research opportunities at the 
        intersection of the biological sciences, the physical sciences, 
        and engineering that are not being adequately addressed? Are 
        Federal agencies, in particularly NSF, playing an effective 
        role in fostering research at this intersection? If not, what 
        recommendations would you offer?

          Is research in the biological sciences, including 
        research at the intersection of the biological sciences, the 
        physical sciences, and engineering being effectively 
        coordinated across the Federal agencies? If not, what changes 
        are needed?

          What changes, if any, are needed in the education and 
        training of undergraduate and graduate students to enable them 
        to work effectively across the boundaries of the physical 
        sciences, engineering, and the biological sciences without 
        compromising core disciplinary depth and understanding? 
        Specifically, what recommendations or changes, if any, would 
        you offer regarding the portfolio of education and training 
        programs supported by NSF?

Dr. James Collins

          In your opinion, what is the future of research in 
        the biological sciences and what potential does research at the 
        intersection of the biological sciences, the physical sciences, 
        and engineering hold for addressing grand challenges in the 
        environment? What tools and methodologies need to be developed 
        and what are the most promising research opportunities?

          As the most recent Assistant Director for Biological 
        Sciences at the National Science Foundation,

                  How is NSF fostering research at the intersection of 
                the biological sciences, the physical sciences, and 
                engineering? What recommendations, if any, would you 
                offer regarding NSF's current portfolio of programs 
                supporting research at this intersection?

                  What education and training programs at NSF provide 
                undergraduate students, graduate students, and postdocs 
                with the skills necessary to work at the intersection 
                of the biological sciences, the physical sciences, and 
                engineering? What recommendations, if any, would you 
                offer regarding NSF's education and training programs?

                  How is NSF fostering university-industry research 
                collaborations in the biological sciences? What 
                recommendations, if any, would you offer regarding 
                NSF's university-industry programs?

          Is research in the biological sciences, including 
        research at the intersection of the biological sciences, the 
        physical sciences, and engineering being effectively 
        coordinated across the Federal agencies? If not, what changes 
        are needed?

Dr. Reinhard Laubenbacher

          In your opinion, what is the future of research in 
        the biological sciences and what role does research at the 
        intersection of biology and mathematics hold for addressing 
        grand challenges in energy, the environment, agriculture, 
        materials, and manufacturing? What computational tools still 
        need to be developed? Are there promising research 
        opportunities that are not being adequately addressed? Is the 
        National Science Foundation playing an effective role in 
        fostering research at the intersection of the physical 
        sciences, engineering, and the biological sciences? If not, 
        what recommendations would you offer?

          What is the nature of the interactions and 
        collaborations between mathematicians and biological scientists 
        at the Virginia Bioinformatics Institute (VBI)? How is VBI 
        facilitating these interdisciplinary collaborations and what 
        lessons can we learn from VBI? Is research at the intersection 
        of the biological sciences, the physical sciences, and 
        engineering being effectively coordinated across the Federal 
        agencies? If not, what changes are needed?

          What changes, if any, are needed in the education and 
        training of undergraduate and graduate students to enable them 
        to work effectively across the boundaries of the physical 
        sciences, engineering, and the biological sciences without 
        compromising core disciplinary depth and understanding? 
        Specifically, what recommendations or changes, if any, would 
        you offer regarding the portfolio of education and training 
        programs supported by NSF?

Dr. Joshua N. Leonard

          In your opinion, what role does research at the 
        intersection of biology and engineering hold for addressing 
        grand challenges in energy, the environment, agriculture, 
        materials, and manufacturing? Specifically, describe the 
        emerging field of synthetic biology, including the work of your 
        research group and your involvement in the recent NSF sponsored 
        ``sandpit'' and National Academies Keck Futures Initiative on 
        synthetic biology. Is the National Science Foundation playing 
        an effective role in fostering research in synthetic biology? 
        If not, what recommendations would you offer?

          Is research in the biological sciences, including 
        research at the intersection of the biological sciences, the 
        physical sciences, and engineering being effectively 
        coordinated across the Federal agencies? If not, what changes 
        are needed?

          What changes, if any, are needed in the education and 
        training of undergraduate and graduate students to enable them 
        to work effectively across the boundaries of the physical 
        sciences, engineering, and the biological sciences without 
        compromising core disciplinary depth and understanding? 
        Specifically, describe the ongoing efforts of Northwestern 
        University and the Department of Chemical and Biological 
        Engineering to improve interdisciplinary graduate education. 
        What recommendations or changes, if any, would you offer 
        regarding the portfolio of education and training programs 
        supported by NSF?

Dr. Karl Sanford

          Please provide a brief overview of Genencor, 
        including a description of the development of new products and 
        processes in the areas of bioenergy and biomaterials.

          In your opinion, what is the future of research in 
        the biological sciences? How are research advances in the 
        biological sciences driving industrial biotechnology? Does the 
        current range of federally supported research adequately 
        address the needs of the biotechnology industry? If not, what 
        are the research gaps?

          Are science and engineering students being adequately 
        trained by colleges and universities to be successful in the 
        biotechnology industry? If not, what kind of education and 
        training is needed and at what levels of education?

          What is the nature of Genencor's partnerships with 
        U.S. universities, including Genencor's involvement in the 
        Synthetic Biology Engineering Research Center at the University 
        of California-Berkeley? Are the Federal agencies, including the 
        National Science Foundation playing, an effective role in 
        fostering university-industry collaboration? Are these research 
        partnerships effective in the transfer of knowledge and 
        technology from U.S. universities to industry? If not, are 
        there best practices, training, or policies that should be put 
        in place to facilitate the commercialization of federally 
        funded research in the biological sciences?
    Chairman Lipinski. The hearing will now come to order.
    Good afternoon, and welcome to today's Research and Science 
Education Subcommittee hearing on 21st century biology.
    There are an increasing number of reports showing how cheap 
DNA sequencing and computing power, together with our growing 
ability to control molecules at the smallest scales, are 
driving us toward a revolution in biology. Some believe that if 
we can combine vastly increased amounts of data with increased 
collaborations between biologists, computer scientists, 
mathematicians and engineers, we might be able to understand, 
manipulate, predict or even design the most complex system 
there is: a living organism.
    Although biology was not my favorite subject in high 
school--although that may be because it was first semester 
freshman year and we had to dissect the fetal pig, and I can 
still remember the smell of the formaldehyde--the new, 21st 
century biology has me much more interested. I was trained as a 
mechanical engineer, and when I hear people talking about cells 
as a systems design problem, I understand the important role of 
engineers and physicists working in biology, and how ``new 
biology'' may be able to deliver on promises to solve critical 
problems in fields like energy, the environment, manufacturing 
and agriculture.
    This afternoon we are going to take a closer look at the 
promise of 21st century biology by exploring research happening 
at the intersection of the biological sciences, the physical 
sciences, engineering and mathematics, and its potential to 
address real-world problems. We will also look at how these 
potential advances can be translated into technologies that 
benefit society, and what we need to do to train researchers 
who can thrive in an area that doesn't fit into any one 
department.
    For example, research at the intersection of biology and 
engineering, known as synthetic biology, which we will learn 
more about today from Dr. Leonard, could lead to the 
development of bacteria that could help clean up the oil spill 
in the Gulf of Mexico, produce cellulosic biofuels, or even 
lead to an organism that can detect and destroy cancer cells. 
The current market for synthetic biology-based products is 
estimated at $600 million and it is expected to grow to over 
$3.5 billion within the next decade. This trend highlights the 
importance of today's hearing: the need to link research 
outcomes to American companies and American jobs.
    As a former university professor, I have seen firsthand the 
difficulty of overcoming cultural and institutional barriers 
between academic departments and schools. Even within a single 
discipline like political science, researchers often stay 
safely within their subspecialties. But the potential successes 
that can be realized by having interdisciplinary teams working 
on biological problems mean that we need to ensure these 
collaborations continue to grow.
    I am interested in hearing recommendations from today's 
witnesses about how the National Science Foundation can foster 
interdisciplinary research and how it can improve education and 
training for students who want to work at the intersection of 
the biological sciences, engineering, and the physical 
sciences. Finally, I would like to hear the panel's thoughts on 
the need to increase research coordination and collaboration in 
the biological sciences across the Federal agencies.
    I thank the witnesses for being here this afternoon and 
look forward to their testimony.
    [The prepared statement of Chairman Lipinski follows:]
             Prepared Statement of Chairman Daniel Lipinski
    Good afternoon and welcome to today's Research and Science 
Education Subcommittee hearing on 21st century biology. There are an 
increasing number of reports showing how cheap DNA sequencing and 
computing power, together with our growing ability to control molecules 
at the smallest scales are driving us toward a revolution in biology. 
Some believe that if we can combine vastly increased amounts of data 
with increased collaborations between biologists, computer scientists, 
mathematicians, and engineers, we might be able to understand, 
manipulate, predict, or even design the most complex system there is--a 
living organism.
    Although biology was not my favorite subject in high school--
although that may be because it was first semester freshman year and we 
had to dissect the fetal pig--the new, 21st century biology has me much 
more interested. I was trained as a mechanical engineer, and when I 
hear people talking about cells as a systems design problem, I 
understand the important role of engineers and physicists working in 
biology, and how ``New Biology'' may be able to deliver on promises to 
solve critical problems in fields like energy, the environment, 
manufacturing, and agriculture.
    This afternoon we're going to take a closer look at the promise of 
21st century biology by exploring research happening at the 
intersection of the biological sciences, the physical sciences, 
engineering, and mathematics, and its potential to address real-world 
problems. We'll also look at how these potential advances can be 
translated into technologies that benefit society, and what we need to 
do to train researchers who can thrive in an area that doesn't fit into 
any one department.
    For example, research at the intersection of biology and 
engineering, known as synthetic biology, which we will learn more about 
today from Dr. Leonard, could lead to the development of bacteria that 
could help clean up the oil spill in the Gulf of Mexico, produce 
cellulosic biofuels, or even lead to an organism that can detect and 
destroy cancer cells. The current market for synthetic biology-based 
products is estimated at $600 million dollars and it is expected to 
grow to over $3.5 billion within the next decade. This trend highlights 
the importance of today's hearing the need to link research outcomes to 
American companies and American jobs.
    As a former university professor, I've seen firsthand the 
difficulty of overcoming cultural and institutional barriers between 
academic departments and schools. Even within a single discipline like 
political science researchers often stay safely within their 
subspecialties. But the potential successes that can be realized by 
having interdisciplinary teams working on biological problems mean that 
we need to ensure these collaborations continue to grow. I'm interested 
in hearing recommendations from today's witnesses about how the 
National Science Foundation can foster interdisciplinary research and 
how it can improve education and training for students who want to work 
at the intersection of the biological sciences, engineering, and the 
physical sciences. Finally, I'd like to hear the panel's thoughts on 
the need to increase research coordination and collaboration in the 
biological sciences across the Federal agencies.
    I thank the witnesses for being here this afternoon and look 
forward to their testimony.

    Chairman Lipinski. The Chair now recognizes Dr. Ehlers for 
his opening statement.
    Mr. Ehlers. Thank you, Mr. Chairman. I thank you for having 
this hearing. This is a very important topic, and frankly a 
very difficult topic, and I will get into some details of that 
in just a moment. Let me also mention that I have, as often 
happens here, something else going on simultaneously, so I may 
be dashing in and out, but I will always be in earshot of what 
is going on here so I will keep track.
    The collaborations between the biological sciences, 
physical sciences and engineering are becoming much more common 
at our major research institutions. Young investigators have 
discovered that to remain on the cutting edge of their 
research, they need to be partnering with various departments 
to solve challenges that are much larger than a single 
discipline. This type of research arrangement will inevitably 
benefit students by preparing them for today's workforce much 
more than an education bound by a single discipline. At the 
same time, we need to ensure that our graduate students do not 
become overly broad instead of gaining a great level of 
expertise in a disciplinary area.
    I can emphasize from some personal observations the 
difficulty of doing first-class, high-quality research in two 
different fields. I have a friend who has a Nobel Prize, not in 
biology, but decided some years ago that the future was in 
biology and related fields and so transferred over, and even 
though he earned a Nobel Prize in one area of science, he has 
never, to the best of my knowledge, contributed significantly 
to the area that he entered into involving biological sciences. 
So I think it is very important for us to respect that fact, 
particularly as we discuss funding for the future, and it is 
not at all clear that funding decisions up to this point at the 
various funding institutions in fact show recognition of that 
and how difficult it is, particularly for the older 
researchers, to switch from one field to another or try to 
combine two fields. I think this is clearly a case where we 
have to make certain that the young scientists coming along 
are, early on, recognized and given grants so that they can 
grow equally in both fields at the same time instead of first 
mastering one and then attempting to master another. So I think 
that is probably the most important thing we can learn here in 
this committee, and that relates to the funding and how to fund 
appropriately to ensure that the good scientists do have the 
money they need to accomplish success in two, maybe even three 
fields simultaneously.
    As this committee determines how to foster new models for 
science and engineering research, today's witnesses will 
provide valuable insights on both conducting research in the 
new biology and integrating with other disciplines. I certainly 
look forward to hearing about this topic from our witnesses. I 
thank you for putting together a good panel, Mr. Chairman, and 
I am sure we can learn a lot about the issues that I raised a 
moment ago from this distinguished panel we have before us 
today.
    With that, I yield back.
    [The prepared statement of Mr. Ehlers follows:]
         Prepared Statement of Representative Vernon J. Ehlers
    Thank you, Chairman Lipinski. I am pleased that the Committee is 
holding this important hearing today.
    Collaborations between the biological sciences, physical sciences 
and engineering are becoming much more common at our major research 
institutions. Young investigators have discovered that to remain on the 
cutting edge of their research they need to be partnering with various 
departments to solve challenges that are much larger than a single 
discipline. This type of research arrangement will inevitably benefit 
students by preparing them for today's workforce much more than an 
education bound by a single discipline. At the same time, we need to 
ensure that our graduate students do not become overly broad instead of 
gaining some level of expertise in a disciplinary area.
    As this Committee determines how to foster new models for science 
and engineering research, today's witnesses will provide valuable 
insights on both conducting research in the ``new biology'' and 
integrating it with other disciplines.
    I look forward to hearing about this topic from our witnesses.

    Chairman Lipinski. Thank you, Dr. Ehlers, and I know this 
is a very busy time. I actually have two other hearings going 
on with subcommittees I am on, so hopefully if you do have to 
go, we will----
    Mr. Ehlers. I will be in and out, so----
    Chairman Lipinski. We will carry on without you.
    I wanted to point out an article in the New York Times 
yesterday that calls attention to why we are holding this 
hearing today. The issue of new biology, or 21st century 
biology--obviously our witnesses all understand it very well. 
The general public certainly does not have that great of an 
understanding of what all this means. I can't say that I have--
certainly I don't come close to what our witnesses know, the 
knowledge that they have. But this article in the New York 
Times provides an example of some of the exciting research that 
is happening at the intersection of biology and material 
sciences. An interdisciplinary team is converting methane to 
ethylene using genetically engineered viruses. Now, ethylene is 
used widely in industrial products and processes such as 
manufacturing of solvents, but the process of producing 
ethylene hasn't changed since the 19th century. The work of 
this group is a significant step toward a more sustainable and 
less expensive process, so clearly there are many things going 
on right now in the new biology that will allow us to make 
great advances, and it is one of the reasons why we are holding 
this hearing here today.
    So at this point, if there are Members who wish to submit 
additional opening statements, your statements will be added to 
the record at this point of the record.
    So right now I want to start by introducing our witnesses. 
First we have Dr. Keith Yamamoto, who is Chair of the National 
Academy of Sciences' Board on Life Sciences as well as 
Professor of Cellular and Molecular Pharmacology at the 
University of California, San Francisco. Dr. James Collins is 
the Virginia M. Ullman Professor of Natural History and the 
Environment in the Department of Ecology, Evolution and 
Environmental Science at Arizona State University. Dr. Reinhard 
Laubenbacher is Professor in both the Virginia Bioinformatics 
Institute and the Department of Mathematics at Virginia Tech. 
Dr. Joshua N. Leonard is an Assistant Professor in the 
Department of Chemical and Biological Engineering at 
Northwestern University. And Dr. Karl Sanford is the Vice 
President for Technology Development at Genencor.
    As our witnesses should know, you will each have five 
minutes for your spoken testimony. Your written testimony will 
be included in the record for the hearing. When you have all 
completed your spoken testimony, we will begin with questions. 
Each Member will have five minutes to question the panel.
    So we will start here with Dr. Yamamoto.

    STATEMENT OF KEITH YAMAMOTO, CHAIR, NATIONAL ACADEMY OF 
 SCIENCES' BOARD ON LIFE SCIENCES, AND PROFESSOR, CELLULAR AND 
MOLECULAR PHARMACOLOGY, UNIVERSITY OF CALIFORNIA, SAN FRANCISCO

    Dr. Yamamoto. Thank you. Good afternoon, Chairman Lipinski 
and Members of the Subcommittee. I am Keith Yamamoto, a 
Researcher, Professor, Executive Vice Dean of the School of 
Medicine at the University of California, San Francisco, and 
Chairman of the Board on Life Sciences of the National Research 
Council. Thank you for the invitation to discuss with you today 
this report, the report from that board on the National 
Research Council called ``A New Biology for the 21st Century.'' 
The report was sponsored by the NSF [National Science 
Foundation], the NIH [National Institutes of Health], the 
Department of Energy, and was co-chaired by MIT professor and 
Nobel laureate Phillip Sharp and Dupont Senior Vice President 
Thomas Connelly. I also served as a member on that study 
committee.
    To begin to describe the New Biology report, allow me to 
weave an imaginary scenario of research and science education 
for you in the biology 101 classroom of a college or university 
in your district. So here is the professor. I am good at this 
part. ``In this course, we are going to dig into the 
fundamental principles of biology, and you will see that there 
are exciting mysteries waiting to be solved and within your 
reach. You will also learn that more than ever before, 
deepening our basic knowledge could help solve major societal 
problems. For example, discoveries in biology could allow us to 
breed new food crops that thrive under terrible growth 
conditions and give each region of the United States a thriving 
biofuel industry with transportation fuels produced from 
locally and sustainably grown biomass. To achieve this, you 
will need to team up with your classmates in physics, 
chemistry, engineering, math, and computer science to crack the 
deepest secrets of how living organisms obtain energy, grow, 
resist stress, combat disease and dispose of waste. Getting 
there will require a focused effort to apply that understanding 
to invent new technologies, and of course, getting there will 
require your curiosity and excitement about biological 
discovery and its potential for profound social impact.''
    The New Biology committee proposed that this scenario 
become reality, that our current biological research 
enterprise, that remarkable discovery engine spread across more 
than 20 Federal agencies, be augmented with a small number of 
ten-year challenges that are urgent and inspiring but 
unreachable without a coordinated approach that aligns the 
separate strengths of multiple agencies.
    Why this approach and why now? Because many of the pieces 
are in place to make it work. The unity of biology means that 
knowledge gained about one genome, one cell, organism, 
ecosystem is useful in understanding many others. Physical 
scientists, mathematicians and engineers are already entering 
this field and contributing unique approaches to biological 
puzzles. Scientists are exploiting the benefits of the Human 
Genome Project, new information and imaging technologies and 
whole new fields such as synthetic biology. Nevertheless, the 
committee found that we are missing critical synergies and 
leveraging opportunities because the new biology is currently 
poorly recognized, inadequately supported and delivering only a 
fraction of its potential.
    The committee recommended that the United States can better 
capitalize on emerging knowledge in the life sciences by 
coordinating efforts toward urgent societal challenges in four 
broad areas: food, energy, the environment and health.
    Why go after these huge sweeping issues? First, because we 
are in crisis mode with each. We must find ways to provide food 
and energy to a growing population without destroying our 
ecosystems. We must reduce the burden of chronic disease in our 
society and of malnutrition and infectious disease in the 
developing world. Second, because big goals like putting a man 
on the moon or sequencing the human genome can inspire both 
scientists and the public. Big goals can focus the imagination, 
creating the technological breakthroughs essential for 
achieving those goals. Finally, big goals provide 
accountability, a commitment to concrete measurable results in 
return for sustained investments. The committee called for 
visionary scientists and engineers from the various focus areas 
to meet to identify some big goals, some great challenges.
    In March, New Biology committee members briefed Department 
of Energy Secretary Steven Chu, Department of Agriculture 
Secretary Tom Vilsack and Howard Hughes Medical Institute 
President Robert Tjian, who then agreed to sponsor an early 
June workshop to generate challenge ideas that could provoke 
quantum leaps toward sustainable production of food and 
biofuels. The workshop brought together 30 extraordinary 
scientists and engineers who converged on a common overall 
goal: to sharply increase productivity in agriculture and 
biofuel production while simultaneously making both of those 
sectors carbon neutral.
    Clearly, neither USDA [United States Department of 
Agriculture] nor DOE [Department of Energy] alone can achieve 
this goal. Rather, a coordinated effort will be required, a 
National New Biology Initiative that harnesses the capabilities 
of these and other agencies: NSF to stimulate necessary 
advances in fundamental knowledge of plants and ecosystems, 
NASA [National Aeronautics and Space Administration], NOAA 
[National Oceanic and Atmospheric Administration], USGS [U.S. 
Geological Survey] and NIST [National Institute of Standards 
and Technology] to work with DOE's AmeriFlux program and NSF's 
NEON [National Ecological Observatory Network] program to 
develop the ability to monitor carbon flows, NIH to contribute 
its expertise in genomics, basic cellular, molecular and 
microbial biology and bioengineering.
    Finally, to return to the college classroom scenario that 
opened my testimony, a new biology initiative would demand 
reassessment of biology education. The committee strongly 
endorsed three major recommendations from the 2003 NRC report, 
``Bio 2010.'' First, ensure that biology students are well 
grounded in math, physical sciences and engineering; second, 
offer interdisciplinary independent lab research experience as 
early as possible; and third, provide faculty development time 
to embrace the integration of biology with the physical 
sciences, math and engineering, and to revise courses 
accordingly.
    The New Biology Initiative adds a new layer to the 
traditional strategies, marshalling basic science purposefully 
toward solving urgent societal dilemmas, focusing teams of 
researchers, technologies and foundational sciences across 
agency boundaries. The initiative is a daring maneuver with 
great potential benefits: a more productive life sciences 
community, a better educated citizenry, a broad range of new 
bio-based industries, and most importantly, a science-based 
strategy to produce food and biofuels sustainably, monitor and 
restore ecosystems and improve human health.
    [The prepared statement of Dr. Yamamoto follows:]

                Prepared Statement of Keith R. Yamamoto

    Good afternoon, Chairman Lipinski and Members of the Subcommittee. 
Thank you for the invitation to present a statement before you today. I 
am Keith R. Yamamoto, Professor of Cellular and Molecular Pharmacology 
and Executive Vice Dean of the School of Medicine at the University of 
California, San Francisco, and Chairman of the Board on Life Sciences 
of the National Research Council. The National Research Council is the 
operating arm of the National Academy of Sciences, National Academy of 
Engineering, and the Institute of Medicine, chartered by Congress in 
1863 to advise the government on matters of science and technology. In 
2008, the Board on Life Sciences established the Committee on A New 
Biology for the 21st Century: Ensuring the United States Leads the 
Coming Biology Revolution, whose report I am very pleased to discuss 
with you today. The report ``A New Biology for the 21st Century,'' 
which was released in August 2009, was sponsored by the National 
Science Foundation, the National Institutes of Health, and the 
Department of Energy. The study committee was co-chaired by MIT 
Professor and Nobel Laureate Philip Sharp and Dupont Senior Vice 
President and Chief Innovation Officer Thomas Connelly. I also served 
as a member of the study committee.
    To begin to describe the New Biology report, allow me to weave for 
you an imaginary scenario, a scenario of research and science 
education, in the classroom or lecture hall of the introductory biology 
course this September in a college or university in your district. 
Listen in with me to the professor:

         ``Thirty years from now, farmers in the United States and 
        around the world could be producing sufficient food locally to 
        nourish people in their regions, with no net increase in arable 
        land and fresh water use, and a decrease in use of fertilizer, 
        pesticides and fossil fuels. Furthermore, each region of the 
        United States could have a thriving and sustainable biofuel 
        industry, with liquid transportation fuels produced from 
        locally grown biomass. Importantly, these advances in food and 
        biofuel production could be carbon neutral, in other words, 
        releasing no more greenhouse gases than they consume. And 
        carbon flows into and out of the environment could be monitored 
        by sensors that also assess ecosystem health, and provide 
        immediate warning and simple restitution of environmental 
        stress.

         How will we achieve this? We must find ways to quickly and 
        safely breed new and different food crops to achieve maximum 
        production under any growing condition. We must find ways to 
        adapt biomass crops to capture solar energy efficiently and 
        convert it into easily processed biomolecules. We must find 
        ways to detect early signs of stress to our ecosystems, and 
        ways to restore them when they've been damaged. These are all 
        challenges that demand aggressive and substantial advances in 
        our knowledge and understanding of biology. Getting there will 
        demand your best efforts should you become a biologist. But 
        getting there will also require that some of your classmates 
        who become physicists, chemists, engineers, mathematicians and 
        computer scientists apply their skills to biological problems. 
        It will take all of you, working together, to crack the deepest 
        secrets of how living organisms obtain energy, grow, interact, 
        resist stress, combat disease, reproduce, and dispose of waste. 
        And it will take all of you to apply that understanding, and 
        invent the technologies to advance our knowledge and achieve 
        these goals.

         The United States has determined that it must and will lead 
        the world in achieving carbon neutral and sustainable 
        agriculture and biofuel production. A national New Biology 
        effort has been undertaken jointly by the National Science 
        Foundation, the Departments of Agriculture, Energy, Interior 
        and Education, the National Institutes of Health, and many 
        other partners both public and private. The scope and scale of 
        this challenge are such that no individual, no university, no 
        company, no Federal agency could possibly solve it alone. Today 
        you begin the process of learning how biology--the New 
        Biology--can enable the United States to meet these 
        challenges.''

    The Committee on a New Biology for the 21st Century recommended 
that just such an imaginary scenario become reality--perhaps not by 
this September, but very soon. The scientists and engineers on the 
committee agreed that biology is at an inflection point - poised on the 
brink of major advances that could address urgent societal problems. 
Importantly, these problems demand bold action--they cannot be solved 
by a `business as usual' approach. The United States has invested 
wisely to make us the world leader in life science discovery by 
promoting and supporting the curiosity and creativity of individual 
scientists. It is crucial that this investment continues and expands. 
But in addition, the committee recommended that now is the time to 
recognize some profound challenges, and to address those challenges by 
undertaking a bold experiment--to augment current life sciences 
research, which is spread across more than 20 Federal agencies, with a 
small number of ten-year challenges that are urgent and inspiring, but 
unreachable without a coordinated approach that draws from and aligns 
the separate strengths of multiple agencies.
    Why did the committee decide that a new approach is needed? For two 
reasons: first, the science is ready. And second, it is clear that we 
are missing important synergies and opportunities to leverage advances 
being made across the life sciences.
    The report details five reasons why biology is ready to take on 
major challenges:

          First, the fundamental unity of biology has never 
        been clearer or more applicable. Knowledge gained about one 
        genome, cell, organism, or ecosystem is useful in understanding 
        many others. The same technologies that allow us to survey 
        human genomes for disease-associated genes also power high-
        throughput approaches to screening millions of plant seeds for 
        desired genetic characteristics. It no longer makes sense to 
        talk about biomedical research as if it is unrelated to biofuel 
        or agricultural research; advances made in any of these areas 
        are directly applicable in the others and all rely on the same 
        foundational technologies and sciences.

          Second, new players are entering the field, bringing 
        new skills and ideas. Physicists, chemists, mathematicians and 
        engineers are increasingly attracted to the field of biology 
        because of the fascinating questions it poses--questions that 
        they can uniquely contribute to answering.

          Third, a strong foundation has already been built. 
        Life science research has been amazingly productive for the 
        last fifty years. The effort to construct the ``parts list'' 
        for living systems has been a tremendously exciting 
        intellectual adventure in its own right, and has had 
        revolutionary outcomes in agriculture, health and industry.

          Fourth, past investments are paying big dividends. 
        The Human Genome Project and subsequent advances in other high-
        throughput approaches and computational analysis have 
        dramatically increased the productivity of life sciences 
        researchers no matter what organism they study. Being able to 
        collect and analyze comprehensive data sets allows researchers 
        to study biological phenomena at the level of systems. The 
        explosion of unanticipated benefits of the Human Genome Project 
        demonstrates how biology can benefit from large-scale 
        interdisciplinary efforts.

          Finally, new tools and emerging sciences are 
        expanding what is possible. In addition to high-throughput 
        approaches, information and imaging technologies have 
        dramatically expanded the kinds of questions biologists can ask 
        and answer. Systems, computational and synthetic biology are 
        contributing to advances across the field of biology, from 
        biomedicine to bioremediation.

    The report gives many examples of advances that have been made 
possible by interdisciplinary teams integrating past discoveries and 
new technologies to produce major advances. The committee called this 
new approach the `New Biology' and examples of the new approach are 
already emerging in many universities. But the committee's discussions 
with scientists and supporting agencies made it clear that the New 
Biology is as yet poorly recognized, inadequately supported, and--
critically--delivering only a fraction of its potential.
    The committee concluded that the United States has an unprecedented 
opportunity to capitalize on the new capabilities emerging in the life 
sciences by mounting a multi-agency initiative to marshal resources and 
provide coordination to empower and enable the academic, public, and 
private sectors to address major societal challenges.

Why major challenges?

    First, because the problems are urgent. We must find ways to 
provide food and energy to a growing population without destruction of 
our ecosystems; we must find solutions to the increasing burden of 
chronic disease in our society, and to malnutrition and infectious 
disease in the developing world.
    Secondly, because big goals--like putting a man on the moon, or 
sequencing the human genome--can inspire both scientists and the 
public. Big goals can attract the efforts of scientists and engineers 
who currently may not see how they could contribute their expertise to 
solving these urgent problems. Big goals can focus the imagination, 
creating the technological breakthroughs essential for achieving the 
goals. Finally, big goals provide explicit accountability: in 
enunciating a major challenge, the New Biologists and the public sector 
make a compact--a commitment to a sustained investment that will 
produce concrete, measurable results.
    In the report, the committee described four broad areas of urgent 
need--food, energy, the environment, and health--and gave examples of 
the kinds of challenges that the New Biology could take on. In the area 
of food, for example, the committee suggested that the New Biology 
might develop ways to quickly, inexpensively, and safely adapt any crop 
plant to any growing condition. Success could enable local production 
of sufficient food, even on land that is considered non-arable today.
    But the committee avoided prescribing specific projects or action 
plans. Instead, they called for visionary scientists and engineers from 
each area to identify great challenges for the New Biology that seem 
impossible now, but within reach if attacked in a coordinated way. A 
recent workshop demonstrated that the scientific community is more than 
up to the task.
    The starting point was a March 16th meeting, where Department of 
Energy Secretary Stephen Chu, Department of Agriculture Secretary Tom 
Vilsack and HHMI President Robert Tjian agreed after a briefing from 
members of the New Biology committee to sponsor a workshop to generate 
challenge ideas at the scope and scale envisioned in the report. 
Secretaries Chu and Vilsack, and President Tjian all recognized the 
interconnections among their missions--human health depends on 
achieving sustainable production of food and energy in the face of 
multiple environmental stressors, including climate change. Clearly, 
none of these challenges can be addressed in isolation, but equally 
clearly, all four challenges are critically dependent on rapid advances 
in biological understanding and application.
    The resulting June 3-4 workshop sought to develop broad ideas and 
project areas that could provoke quantum leaps of progress toward 
sustainable production of both food and biofuels. (Subsequent workshops 
will focus on other combinations of the four areas of need identified 
by the committee.) The workshop brought together an extraordinary group 
of scientists and engineers that spanned the scales, from molecules to 
ecosystems, and spectrum, from viruses to microbes to plants to 
animals, of modern biology. Each participant arrived at the workshop 
armed with a transformative idea to be presented in a three-minute talk 
during the first session. After hearing these short talks, the group 
broke into small subgroups to separately mold this collection of thirty 
bold ideas into a few decadal challenges, map out strategies for 
reaching them, and identify knowledge and technology gaps.
    Upon reconvening, the subgroups swiftly converged on a common 
overall goal: to sharply increase productivity in agriculture and 
biofuel production while simultaneously making both of these sectors 
carbon neutral. All agreed that reaching this goal would require major 
advances in our fundamental understanding of plants and microbial 
communities, substantial investment in computational theory and 
infrastructure, and development of a quantitative and biologically-
informed system for measuring the flow of carbon and other greenhouse 
gas constituents. It became very clear that not only could neither USDA 
nor DOE achieve this goal alone, but that a coordinated effort would be 
required--a National New Biology Initiative that harnesses the 
capabilities of these and other agencies: NSF to stimulate necessary 
advances in fundamental knowledge of plants and ecosystems; NASA, NOAA, 
USGS and NIST to work with DOE's Ameriflux program and NSF's NEON 
program to develop the ability to monitor carbon flows; NIH to 
contribute its expertise in genomics, basic cellular, molecular and 
microbial biology, and bioengineering.
    I would be remiss if I failed to return to the vision that opened 
my testimony--college students being challenged from the first day of 
class to consider how life science research is relevant, indeed 
essential, to the solution of serious societal problems. A New Biology 
Initiative would give students interested in real-world problems an 
incentive to learn fundamental principles of science, mathematics and 
engineering, and to acquire an integrated view of those disciplines.
    At the same time, the Initiative would provide the opportunity to 
establish and evaluate new educational and training opportunities. Many 
reports have appeared that recommend ways to improve science education 
in the United States; few of the recommendations have been implemented. 
To promote and enable the New Biology Initiative, the committee 
strongly endorsed three major recommendations from the 2003 NRC report, 
Bio2010: First, design curricula to ensure that biology students are 
well grounded in mathematics, physical and chemical sciences, and 
engineering; conversely, biological concepts and examples should 
included in all science courses. Second, laboratory courses should be 
interdisciplinary, and independent research experience should be 
offered as early as possible. Finally, development time should be 
provided to enable faculty to appreciate fully the integration of 
biology with the physical sciences, math and engineering, and to revise 
their courses accordingly.
    The New Biology committee issued a call to devote a modest portion 
of the life sciences research enterprise to empowering this new 
approach--to adding a new layer to the traditional strategies, a New 
Biology Initiative that marshals basic science purposefully toward 
solving urgent societal dilemmas, that focuses teams of researchers, 
technologies and foundational sciences required for the task and 
coordinates efforts across agency boundaries to ensure that gaps are 
filled, problems addressed, and resources brought to bear at the right 
time. Close interaction between these problem-oriented efforts and the 
more decentralized basic research enterprise will be critical--and 
mutually beneficial--as the traditional approaches will make relevant 
unanticipated discoveries, and advances that benefit all researchers 
will spin out from problem-based projects. A New Biology Initiative to 
address major challenges would represent a daring addition to the 
nation's research portfolio, with remarkable and far-reaching potential 
benefits: a more productive life sciences research community; a 
citizenry better informed about the logic and potential impact of 
biological research; a broad range of new bio-based industries; and, 
most importantly, a science-based strategy to produce food and biofuels 
sustainably, monitor and restore ecosystems, and improve human health.
    This concludes my testimony. I would be pleased to answer your 
questions or address your comments. Thank you again for the opportunity 
to discuss this important matter with you.

                    Biography for Keith R. Yamamoto

    Dr. Keith Yamamoto, Ph.D., is Professor of Cellular and Molecular 
Pharmacology and Executive Vice Dean of the School of Medicine at the 
University of California, San Francisco. He has been a member of the 
UCSF faculty since 1976, serving as Director of the PIBS Graduate 
Program in Biochemistry and Molecular Biology (1988-2003), Vice Chair 
of the Department of Biochemistry and Biophysics (1985-1994), Chair of 
the Department of Cellular and Molecular Pharmacology (1994-2003), and 
Vice Dean for Research, School of Medicine (2002-2003). Dr. Yamamoto's 
research is focused on signaling and transcriptional regulation by 
intracellular receptors, which mediate the actions of several classes 
of essential hormones and cellular signals; he uses both mechanistic 
and systems approaches to pursue these problems in pure molecules, 
cells and whole organisms. Dr. Yamamoto was a founding editor of 
Molecular Biology of the Cell, and serves on numerous editorial boards 
and scientific advisory boards, and national committees focused on 
public and scientific policy, public understanding and support of 
biological research, and science education; he chairs the Coalition for 
the Life Sciences (formerly the Joint Steering Committee for Public 
Policy) and for the National Academy of Sciences, he chairs the Board 
on Life Sciences. Dr. Yamamoto has long been involved in the process of 
peer review and the policies that govern it at the National Institutes 
of Health, serving as Chair of the Molecular Biology Study Section, 
member of the NIH Director's Working Group on the Division of Research 
Grants, Chair of the Advisory Committee to the NIH Center for 
Scientific Review (CSR), member of the NIH Director's Peer Review 
Oversight Group, member of the CSR Panel on Scientific Boundaries for 
Review, member of the Advisory Committee to the NIH Director, Co-Chair 
of the Working Group to Enhance NIH Peer Review, and Co-Chair of the 
Review Committee for the Transformational R01 Award. Dr. Yamamoto was 
elected as a member of the American Academy of Arts and Sciences in 
1988, the National Academy of Sciences in 1989, the Institute of 
Medicine in 2003, and as a fellow of the American Association for the 
Advancement of Sciences in 2002.

    Chairman Lipinski. Thank you, Dr. Yamamoto.
    Dr. Collins.

  STATEMENT OF JAMES COLLINS, VIRGINIA M. ULLMAN PROFESSOR OF 
  NATURAL HISTORY AND THE ENVIRONMENT, DEPARTMENT OF ECOLOGY, 
 EVOLUTION AND ENVIRONMENTAL SCIENCE, ARIZONA STATE UNIVERSITY

    Dr. Collins. Thank you very much, Chairman Lipinski, 
Ranking Member Ehlers and Committee members. I appreciate the 
opportunity to testify before you today on 21st century 
biology. It is a topic of vital importance to sustaining 
America's leadership in science and technology.
    The biological sciences will flourish in the 21st century 
by sustaining strength in its core disciplines while 
simultaneously supporting research at the intersection of the 
natural, physical and social sciences as well as engineering. 
Interdisciplinary methods cut across disciplines to combine, in 
powerful ways, basic research with solving real-world problems.
    Biology itself emerged as an interdisciplinary science late 
in the 19th century when researchers studying physiology, 
natural history, anatomy and other sciences argued for uniting 
them as the new discipline of biology focused on the study of 
life. Some late 19th and early 20th century life scientists 
also conceived of their research more within the realm of 
engineering. They thought that their studies should be focused 
on controlling life. They envisioned manipulating, transforming 
and even replicating living systems in order to understand 
nature and also to help solve human problems. It is a 19th 
century perspective reminiscent of modern synthetic biology. 
Throughout the 20th century, the two great themes of 
understanding and controlling life wove together even as 
biology divided itself into the basic subdisciplines of 
genetics, cell biology, ecology and evolution.
    Two things stand out as we look to biology's 21st century 
future. First, more and more research questions require 
reintegrating biology subdisciplines, and the fields are making 
progress in carrying out that integration. The second thing we 
see is the biological sciences as a growing source of 
inspiration for and collaboration with engineering and the 
physical and social sciences. Computational biology, systems 
biology and sustainability science are products of this merger. 
However, even as we imagine biology's role in addressing 
today's challenges, we cannot forget that these will change 
over time. This means that U.S. institutions that fund and 
conduct research must be innovative and adaptable. Reinforcing 
this need is the fact that many of the challenges ahead will 
not be solved by business as usual. Innovation must be the 
hallmark of research and education if ``A New Biology,'' 
envisioned in the recent NRC report, is to be realized.
    Creating and sustaining an innovation ecosystem in the life 
sciences means that all of the pieces must function as a 
system, which generally means lowering the barriers that block 
the ready flow of knowledge and ideas between, for example, 
academic departments, funding agencies, or the public and 
private sector.
    As we look at the history of science, it is also clear that 
the process of discovery changes. In an obvious sense, new 
tools and methods are developed and that remains true today. 
But modern research also joins individuals into larger and 
larger teams. New methods like crowdsourcing and prediction 
markets are linking experts across the globe, effectively 
lowering those barriers I mentioned earlier. Funding agencies 
can also use these innovative methods to help fund the very 
best research, and NSF, for example, is already using some of 
these methods.
    In a rapidly changing world, the process of discovery 
itself is also changing, and our students must learn how to 
keep up. Modern biology curricula should expose students to 
this sort of thinking and more. Because today's students are 
tomorrow's problem solvers, we must integrate research and 
education to prepare the next generation to address 21st 
century challenges.
    I urge this subcommittee and Congress to support innovative 
agency efforts to catalyze transformative research and 
education at levels that sustain reasonable success rates; 
disciplinary and interdisciplinary programs that drive the 
ready exchange of knowledge and ideas; efforts to advance 
curriculum reform in biology; and establishing appropriate 
metrics to judge programs.
    The Subcommittee asked me to comment on university and 
industry collaborations and coordination across U.S. Federal 
agencies. These topics are related. Knowledge creation and use 
along with the best ideas to identify and fund research and 
education should not start or stop at the borders of one 
organization. In the best cases, the relationship between a 
university and an industry partner, or either of these with a 
Federal funding agency, should be a two-way process of learning 
best practices from each other. Coordination across Federal 
agencies builds coalitions and lowers barriers while leveraging 
the innovative ideas of several institutions. At its best, this 
really creates an open-source environment for innovation.
    One last thought. In the NRC's ``A New Biology'' report, we 
see the central themes of biology's origins--understanding 
life, controlling life, and a call for broad engagement with 
other disciplines--recast in new forms around contemporary 
problems. Modern science, engineering and technology are full 
of breathtaking discoveries. It would be wrong, however, to 
conclude that scientists and engineers can solve all the 
problems of food, health, energy and the environment. Social 
scientists call questions in these areas `wicked problems' for 
a reason. They are full of complex interdependent parts, and 
solving one aspect of a problem often reveals or even creates 
other problems. Simply put, so-called `wicked problems' will 
not yield to only scientific or technological fixes. America's 
best researchers and their students must engage in a process of 
discovery that transforms the way in which research is 
conducted and students are educated. If the changes needed are 
to occur at a sufficiently fundamental level, it will also mean 
transforming our research institutions.
    I have envisioned a future for biology that has three 
elements: first, sustaining disciplines while blurring their 
boundaries; second, innovation as a central feature of life 
science research and education; and third, building coalitions 
among institutions. In combination, these three elements are a 
vision for how the life sciences will play a key role in 
addressing the great intellectual and social challenges of the 
21st century. At the same time, we will sustain America's 
leadership in science, engineering and technology innovation 
during the years ahead.
    Once again, thank you, Mr. Chairman, for giving me the 
opportunity to testify on this very important subject. I will 
be pleased to answer any questions that you have.
    [The prepared statement of Dr. Collins follows:]

                 Prepared Statement of James P. Collins

    Chairman Lipinski, Ranking Member Ehlers, and committee members: I 
am James P. Collins, Virginia M. Ullman Professor in the School of Life 
Sciences at Arizona State University (ASU). I am also an Affiliated 
Scholar in the Consortium for Science and Policy Outcomes at ASU. Prior 
to returning to Arizona State University, I served in the Federal 
Government during the George W. Bush and Barack H. Obama 
Administrations as Assistant Director for Biological Sciences at the 
National Science Foundation (NSF) from October 2005 to October 2009. I 
am currently a consultant at NSF.
    The biological sciences will flourish in the 21st century by 
sustaining strength in its core disciplines while simultaneously 
supporting research at the intersection of the natural, physical, and 
social sciences as well as engineering. Research at these disciplinary 
edges holds great promise for addressing problems in energy, the 
environment, agriculture, materials, and manufacturing. 
Interdisciplinary methods cut across disciplines to combine in powerful 
ways basic research with solving real world problems. Because today's 
students are tomorrow's problem solvers we must also integrate research 
and education to prepare the next generation to address 21st century 
challenges. But the problems confronting us are complex and will not be 
solved by business as usual: innovation must be a hallmark of both 
research and education in 21st Century Biology.

Sustaining disciplines while blurring their boundaries

    Biology itself emerged as an interdisciplinary science late in the 
19th century. At that time researchers from diverse areas such as 
physiology, natural history, and anatomy realized their research had a 
common theme and argued for uniting these largely separate areas of 
scholarship into the new discipline of biology focused on the study of 
life: How did life originate? Why are there so many species? How does 
heredity influence development of individuals? What organizes living 
systems from the complexity of a cell to the complexity of a forest?
    Some late 19th and early 20th century life scientists also 
conceived of their research more within the realm of engineering. As 
the historian of science Dr. Philip Pauly argued, they thought that 
their research should be focused on controlling life. They envisioned 
manipulating, transforming, and even replicating living systems, in 
order to understand nature and also to help solve human problems. 
``Nature was raw material to be transformed by the power of the 
biologist'' wrote Dr. Pauly (Pauly, P.J. 1987. Controlling Life. 
Jacques Loeb and the engineering ideal in biology. Oxford University 
Press, Oxford). Straight from the first decade of the 20th century this 
is a perspective that we can easily imagine finding in a 21st century 
discussion of synthetic biology or nanotechnology.
    Throughout the 20th century the two great themes of understanding 
and controlling life wove together even as biology itself divided into 
sub-disciplines such as genetics, cell biology, ecology, and evolution. 
Discoveries such as the molecular structure of DNA advanced our basic 
understanding of genetics, and this knowledge was then applied through 
biotechnology to control living organisms such as genetically modified 
crops. Discoveries in embryology led to fertility treatments, while 
discoveries in ecology led to improved environmental quality. Yet until 
recently, the subdisciplines have not worked together as effectively as 
they might.
    Two things stand out as we look to biology's 21st century future:

          First, more and more research questions require 
        reintegrating biology's sub-disciplines, and the fields are 
        making progress in carrying out that integration.

    For example, systems biology seeks a deep quantitative 
understanding of the emergent properties of complex biological 
systems--properties such as resilience, adaptability and 
sustainability--through the dynamic interaction of components that may 
include multiple molecular, cellular, organismal, population, 
community, and ecosystem functions (after A New Biology. 2009. National 
Academies Press, Washington, DC: p. 61).

          The second thing we see is the biological sciences as 
        a growing source of inspiration for and collaboration with 
        engineering and the physical and social sciences.

    A recent National Research Council report, Inspired by Biology: 
from molecules to materials to machines (2008. National Academies 
Press, Washington, DC), calls for three research strategies: biomimicry 
or learning how a living system's mechanistic principles achieve a 
function and then replicating that function in a synthetic material; 
bioinspiration where a task achieved by a living system inspires making 
a synthetic system; and bioderivation which involves hybridizing a 
biological and artificial material. Developing these biologically 
inspired materials advances basic science, improves U.S. 
competitiveness, and addresses national challenges in materials and 
manufacturing. This sort of visionary research at disciplinary edges is 
transforming and selectively dissolving the boundaries of the life and 
physical sciences as well as engineering.
    Biology in the 21st century is rapidly changing before our eyes as 
life scientists engage in innovative ways with many other areas of 
scholarship. Today's biologists conduct research in areas that did not 
exist as recently as ten or even five years ago: computational biology, 
systems biology, and sustainability science are examples. These 
interdisciplinary fields are emerging as a result of new questions, new 
tools such as sensors, new methods such as computational thinking, and 
new ways of conducting research especially in large group 
collaborations supported by new cyberinfrastructure.
    At the Subcommittee's request I'll comment on the environmental 
sciences, which offer many promising research opportunities. 
Interdisciplinary research is advancing our basic understanding of 
challenges such as global change and global loss of biodiversity and 
suggesting ways in which we might mitigate these changes. NSF-supported 
sensing systems in the Long Term Ecological Research Network (LTER) and 
in the proposed National Ecological Observatory Network (NEON) are 
designed to gather enormous quantities of data continuously. These 
networks of sensors, computers, and people promise to transform how we 
test basic ecological theory and apply the results to environmental 
problem solving. Molecular methods are accelerating the description of 
new species, including the discovery of novel microbes that add to our 
basic understanding of the biosphere while serving as ``bio-inspiring'' 
sources of novel energy technologies. At NSF the new Dimensions of 
Biodiversity initiative is supporting just this sort of grand challenge 
research in which new knowledge is developed.
    As this research matures, researchers will need new tools such as 
sensors that run on small, very long life power sources. New methods 
must include fast, highly accurate molecular techniques for identifying 
species and efficient computer algorithms for analyzing, visualizing, 
and storing large quantities of data. Students entering these fields 
must be skilled in quantitative and computational methods, understand 
how to draw on multiple disciplines to address problems, and learn to 
do science in nationally and globally connected communities.
    We must remember, however, that even as we envision biology as a 
way to address today's problems we cannot forget that today's ``grand 
challenges'' eventually will change. Our research institutions must 
remain agile and capable of responding to new and evolving problems 
that we cannot yet imagine. Part of the agility and capability needed 
must come from supporting researchers conducting basic research that 
generates new knowledge. In addition, the agility and capability needed 
must come from educating students and ourselves in innovative ways. 
Failing to do both of these things would cause the U.S. to lose out in 
two ways: first, we would not have the basic knowledge needed to 
respond to a future challenge and second, in the near term we fail to 
sustain ourselves as science and technology leaders. Research agencies 
and universities must be innovative and adaptable if ``a new biology'' 
envisioned in the recent NRC report by the same name is to be realized.

Innovation as a central feature of life science research and education

    When I testified before this Subcommittee in October 2009, I 
observed that NSF was first and foremost an innovation agency with a 
long history of success in supporting research with far-reaching 
impacts on the U.S. economy and the well-being of all Americans 
(Investing in high-risk, high-reward research; available at: http://
frwebgate.access.gpo.gov/cgi-bin/
getdoc.cgi?dbname=111-house-hearings&docid
=f:52484.pdf).
    In particular I argued that, ``The challenge for agencies like NSF 
that fund research done by other organizations is to create and sustain 
a culture of innovation in which the flow of information among its 
members creates an institutional culture and framework that stimulates, 
reinforces, and rewards creativity, and pervades the agency and guides 
its decision-making process.'' That remains true today for NSF, and in 
general creating and sustaining an innovation ecosystem is a wider 
challenge for our funding agencies, America's universities, and 
industry.
    At the heart of this ecosystem is what we can call the process of 
discovery, which begins with an idea that is tested and developed by 
one or a few individuals. Increasingly, however, the testing is done by 
large groups that may or may not be in one place. Networks of computers 
unite investigators in problem solving efforts using what is called 
``the wisdom of the crowd.'' It is an approach that can be very 
effective in bringing together widely separated experts for solving 
problems rapidly. Crowd sourcing models, prediction markets, and prizes 
are modern components of the process of discovery (Collins, J.P., 
Investing in high-risk, high-reward research).
    Innovation is not just an idea, but it is a process that links a 
few to many individuals. In a rapidly changing world the process of 
discovery itself is also changing rapidly, and our students must learn 
how to keep up. Modern biology curricula should expose students to this 
sort of thinking and more. Learning is the creative process by which 
new knowledge is discovered; learning is not memorization of facts as 
an end in itself. Too often students imagine biology as the latter, 
perhaps because it is commonly taught that way, but no characterization 
of the biological sciences could be further from the truth.
    One innovative reform effort in biology curricula is called Vision 
and Change in Undergraduate Biology which is a joint effort of NSF and 
the American Association for the Advancement of Science or AAAS (http:/
/visionandchange.org/). A second international effort focused on 
undergraduate curricula in general is emerging from an international 
consortium at the Wissenschaftskolleg zu Berlin/Institute for Advanced 
Study (Appendix I). Both are opportunities for the U.S. to assume a 
leadership role in shaping student learning and problem solving in the 
21st century.
    But as the saying goes, a vision (or idea) without resources is a 
mirage. Funding is needed for developing innovative ideas and here is 
where researchers/entrepreneurs turn to public and private sources for 
help.
    NSF is one choice for U.S. researchers and educators. The 
Directorate for Biological Sciences advances transformative science by 
building on fundamental disciplinary strengths and also by encouraging 
high risk/high reward research. The directorate is experimenting with 
new methods of review such as crowd sourcing and prediction markets to 
support transformative science and learning at the interface of biology 
and many other disciplines. Experimenting with innovative methods for 
finding the best ideas to fund in research and education must be a 
central feature of NSF and other Federal agencies.
    Especially as budgets tighten it is easy for any institution to be 
satisfied with sustaining what it does well. But the magnitude of some 
of the challenges and the need to respond quickly means that business 
as usual is not good enough. Agencies like NSF should be bold and adopt 
policies that foster innovation as they seek to fund high risk, high 
reward research--and education.
    A central value at NSF is the integration of research and 
education. In response to a question from the Subcommittee I'll note 
that the NSF supports a wide range of programs from undergraduate REUs 
(Research Experiences for Undergraduates), to graduate IGERTs 
(Integrated Graduate Research and Training), and postdoctoral 
fellowships.
    As contributors to the U.S. scientific enterprise students also 
need an understanding of the historical, philosophical, and ethical 
context within which research questions are asked and answered. 
Students must understand that knowledge is not a static set of facts 
but is always evolving within a historical and cultural context. We 
must instill in students an interest in and a healthy respect for the 
societal implications of their research because the best of them will 
make discoveries that will have huge implications for society.
    The radical transformations enabled by modern technologies for 
generating and disseminating knowledge quickly and widely can be a 
great help in enabling the basic discoveries needed for understanding 
life and addressing real world problems. Much of the future will be 
about networks of investigators and networks of institutions.

Building coalitions among institutions

    The Subcommittee asked me to comment on university-industry 
collaborations and coordination across U.S. Federal agencies. These 
topics are related: knowledge creation and use along with the best 
ideas to identify and fund research and education should not start or 
stop at the borders of one organization.
    University-industry partnerships are increasingly a feature of the 
modern educational landscape. NSF funds major Science and Technology 
Centers that connect universities and colleges to private sector 
technology development. At the Subcommittee's request I have appended 
to this testimony examples of NSF activities at the intersection of 
federally funded basic research, the private sector, and universities 
(Appendix II).
    In the best cases the relationship between a university and 
industry partner, or either of these with a Federal funding agency, 
should be a two-way process of learning. For example, the process of 
discovering marketable ideas within industry can be very innovative. In 
my last discussion with the Subcommittee I described how ``The recent 
Netflix million-dollar prize competition is a compelling example of the 
successful use of crowd sourcing for technological discovery while also 
contributing to a culture of innovation.'' A recent New York Times 
(June 27, 2010: B1-B8) report described ``proof-of-concept centers'' to 
bridge university researchers studying basic problems to the business 
world. The report noted that ``Rather than offering seed money to 
businesses that already have a product and a staff, as incubators 
usually do, the universities are harvesting great ideas and then trying 
to find investors and businesspeople interested in developing them 
further and exploring their commercial viability.'' Universities are 
acting as very early risk takers to help bridge the so-called ``valley 
of death'' separating people with ideas from people willing to invest 
in them.
    As NSF fosters university-industry collaborations in biology the 
Foundation can learn best practices from this process. Institutions 
should be open to using great ideas wherever they are found.
    Coordination across Federal agencies is another way to build 
coalitions while also serving as a way to leverage the innovative ideas 
of several institutions. For example, the National Institute for 
Mathematical and Biological Synthesis is jointly supported by NSF's 
Directorate for Biological Sciences, Directorate for Mathematics and 
Physical Sciences, U.S. Department of Agriculture (USDA), and 
Department of Homeland Security. Two Nanotechnology Centers are 
supported by NSF's Directorate for Biological Sciences and the 
Environmental Protection Agency. The Plant Genome Research Program 
(PGRP) is an excellent example of coordination across Federal agencies. 
NSF, USDA, Department of Energy, National Institutes of Heath, and the 
U.S. Agency for International Development collaborate to support PGRP, 
which is an exceptionally effective National Science and Technology 
Council collaboration for fostering basic plant research and its 
translation to agriculture.
    Institutional coalitions are not the answer to every challenge, but 
in selected cases they can be very effective ways to leverage resources 
and facilitate innovation.

Modern problem solving requires more than science and technology

    In the U.S. National Research Council's New Biology report we see 
the central themes of biology's origins--understanding life, 
controlling life and a call for broad engagement with other 
disciplines--recast in new forms around contemporary problems. Modern 
science, engineering, and technology are full of breathtaking 
discoveries. It would be wrong, however, to conclude that scientists 
and engineers can solve all of the problems of food, health, energy, 
and the environment. Social scientists call questions in these areas 
``wicked problems'' for a reason: they are full of complex, 
interdependent parts and solving one aspect of a problem often reveals 
or even creates other problems. Simply put, so-called wicked problems 
will not yield to only scientific or technological fixes.
    America's best researchers and their students must engage in a 
process of discovery that transforms the way in which research is 
conducted and students are educated. If the changes needed are to occur 
at a sufficiently fundamental level it will also mean transforming our 
research institutions. Solving problems must not be limited by 
disciplinary or institutional borders. Global change and the global 
loss of biodiversity are part of a litany of important and pressing 
problems. Challenges such as these have the quality that the longer we 
delay addressing them the worse they become. The process of discovering 
solutions must include students as partners with our senior 
researchers. Because they are young, students have great energy to 
invest in realizing a future in which they have the greatest stake as 
planetary stewards. Agility and adaptability, which are available in 
great quantities in young people, will be indispensable qualities for 
problem solvers in a rapidly changing world.
    I have envisioned a future for biology that has three elements: 
sustaining disciplines while blurring their boundaries; innovation as a 
central feature of life science research and education; and building 
coalitions among institutions. In combination these three elements are 
a vision for understanding how the life sciences will play a key role 
in addressing the great intellectual and social challenges of the 21st 
century. At the same time, we will sustain America's leadership in 
science, engineering, and technology innovation during the years ahead.
    Once again Mr. Chairman, thank you very much for giving me the 
opportunity to testify on this very important subject. I would be 
pleased to answer any questions that you have.
Appendix I. Principles for Rethinking Undergraduate Curricula for the 
21st Century: A Manifesto (From: Principles of curricular reform 
developed by a Wissenschaftskolleg zu Berlin/Institute for Advanced 
Study 2009-2010 working group and revised at the Workshop on ``The 
University of the 21st Century,'' Wissenschaftskolleg zu Berlin/
Institute for Advanced Study, June 5-6, 2010.)

    The current crisis of the university is intellectual. It is a 
crisis of purpose, focus and content, rooted in fundamental confusion 
about all three. As a consequence, curricula are largely separate from 
research, subjects are taught in disciplinary isolation, knowledge is 
conflated with information and is more often than not presented as 
static rather than dynamic. Furthermore, universities are largely 
reactive rather than providing clear forward-looking visions and 
critical perspectives. The crisis is all the more visible today, as the 
pace of social, intellectual and technological change inside and 
outside the universities is increasingly out of step. While 
universities worldwide are undergoing many, often radical, structural 
transformations, ranging from the Bologna Process in Europe and the 
Exzellenzinitiative in Germany to the rapid expansion of universities 
in India and China, the accelerating decline of public investments in 
universities in the United States and elsewhere and an ever growing 
demand for university access everywhere, much less attention has been 
paid to university curricula. But for the university as a community of 
scholars and students, that is its central function and the key to its 
internal renewal. Universities are embedded in multiple institutional, 
economic, financial, political, and research networks. All of these 
generate pressures and constraints as well as opportunities. The 
curriculum, however, is the core domain of the university itself.
    Here we present a set of eleven overlapping principles designed to 
inform an international dialogue and to guide an experimental process 
of redesigning university undergraduate curricula worldwide. There can 
be no standard formula for implementation of these principles given the 
huge diversity of institutional structures and cultural differences 
amongst universities but these principles, we believe, provide the 
foundational concepts for what needs to be done.

        1.  As a central guideline teach disciplines rigorously in 
        introductory courses together with a set of parallel seminars 
        devoted to complex real life problems that transcend 
        disciplinary boundaries.

        2.  Teach knowledge in its social, cultural and political 
        contexts. Teach not just the factual subject matter, but 
        highlight the challenges, open questions and uncertainties of 
        each discipline.

        3.  Create awareness of the great problems humanity is facing 
        (hunger, poverty, public health, sustainability, climate 
        change, water resources, security, etc.) and show that no 
        single discipline can adequately address any of them.

        4.  Use these challenges to demonstrate and rigorously practice 
        interdisciplinarity avoiding the dangers of interdisciplinary 
        dilettantism.

        5.  Treat knowledge historically and examine critically how it 
        is generated, acquired, and used. Emphasize that different 
        cultures have their own traditions and different ways of 
        knowing. Do not treat knowledge as static and embedded in a 
        fixed canon.

        6.  Provide all students with a fundamental understanding of 
        the basics of the natural and the social sciences, and the 
        humanities. Emphasize and illustrate the connections between 
        these traditions of knowledge.

        7.  Engage with the world's complexity and messiness. This 
        applies to the sciences as much as to the social political and 
        cultural dimensions of the world. This will contribute to the 
        education of concerned citizens.

        8.  Emphasize a broad and inclusive evolutionary mode of 
        thinking in all areas of the curriculum.

        9.  Familiarize students with non-linear phenomena in all areas 
        of knowledge.

        10.  Fuse theory and analytic rigor with practice and the 
        application of knowledge to real-world problems.

        11.  Rethink the implications of modern communication and 
        information technologies for education and the architecture of 
        the university.

    Curricular changes of this magnitude and significance both require 
and produce changes in the structural arrangements and institutional 
profiles of universities. This is true for matters of governance, 
leadership, and finance as well as for systems of institutional 
rewards, assessment, and incentives; it is bound to have implications 
for the recruitment and evaluation of both professors and students as 
well as for the allocation of resources and the institutional practice 
of accountability. The experimental process of curriculum reform we 
hope to stimulate by offering these guiding principles will thus 
require the collaboration of scholars and educators willing to 
transform their scholarly and educational practices and of 
administrators willing to support experimentation and to provide the 
necessary structural conditions for it to succeed.
    These principles are the conclusion of deliberations by a working 
group of scholars that met at the Wissenschaftskolleg zu Berlin during 
the academic year 2009/10. Participants represented diverse disciplines 
(from the natural and social sciences and the humanities), geographical 
origins (Europe, North America, and India) as well as career stages 
(from former university presidents to students). They invite their 
colleagues around the world to join in this effort of re-thinking and 
re-shaping teaching and learning for the university of the future.
Appendix II: Examples of NSF activities at the intersection of 
federally funded basic research and the private sector and 
universities. (from Collins, J.P. 2009. Investing in high-risk, high-
reward research. available at: http://frwebgate.access.gpo.gov/cgi-bin/
getdoc.cgi?dbname=111-house-hearings&docid=
f:52484.pdf).

    NSF-funded Centers are designed from the outset with built-in 
flexibility so that investigators can pursue innovative ideas within 
the context of a defined program of research. Examples are legion, and 
include the Mosaic web browser developed at NSF's National Center for 
Supercomputing Applications at the University of Illinois. NSF's 
creation of two Centers for the Environmental Implications of 
Nanotechnology (CEIN) in 2008 exemplify innovative networks that are 
connected to other research organizations, industry, and government 
agencies to strengthen our nation's commitment to understanding the 
potential environmental hazards of nanomaterials and to provide basic 
information leading to the safe environmentally responsible design of 
future nanomaterials.
    The Industry/University Cooperative Research Centers (I/UCRC) 
program develops long-term partnerships among industry, academe, and 
government. Each I/UCRC contributes to the Nation's research 
infrastructure, enhances the intellectual capacity of the STEM 
workforce by integrating research with education, and encourages and 
fosters international cooperation and collaborative projects. For 
example, the NSF Industry/University Collaborative Research Center (I/
UCRC) known as the Berkeley Sensor and Actuator Center conducts 
industry-relevant, interdisciplinary research on micro- and nano-scale 
sensors, moving mechanical elements, microfluidics, materials, and 
processes that take advantage of progress made in integrated-circuit, 
bio, and polymer technologies. This I/UCRC has developed and 
demonstrated a handheld device that allows verified diagnostic assays 
for several infectious diseases currently presenting significant 
threats to public health, including dengue, malaria, and HIV. The 
device uses a dramatically simplified testing protocol that makes it 
suitable for use by moderately-trained personnel in a point-of-care or 
home setting. The center has also created many spin-off ventures 
including companies in the areas of wireless sensor networks for 
intelligent buildings; MEMS mirror arrays for adaptive optics; and 
optical flow sensors for industrial, commercial, and medical 
applications.
    The objective of the NSF Small Business Innovation Research (SBIR) 
program is to increase the incentive and opportunity for small firms to 
undertake cutting-edge research that would have a high potential 
economic payoff if successful. For example, in 1985, Andrew Viterbi and 
six colleagues formed ``QUALity COMMunications.'' In 1987-1988 NSF SBIR 
provided $265,000 (Phase I 8660104 and Phase II 8801254) for single 
chip implementation of the Viterbi decoder algorithm. Qualcomm 
introduced CDMA (code division multiple access) which replaced TDMA 
(time division multiple access) as a cellular communications standard 
in 1989. This advance led to high-speed data transmission via wireless 
and satellite. Now the $78B company holds more than 10,100 U.S. 
patents, licensed to more than 165 companies. Another example--Machine 
Intelligence Corp. was supported by SBIR Phase I and Phase II awards to 
develop desktop computer software that could alphabetize words, a feat 
that previously had been accomplished only on supercomputers. When 
Machine Intelligence went bankrupt, principal investigator Gary Hendrix 
founded Symantec and continued the project. The line of research 
resulted in the first personal computer software that understood 
English, marketed as ``Q&A Software.'' Q&A quickly became an extremely 
successful commercial product and remains a widespread commercial 
application of natural language processing. Symantec research supported 
by NSF SBIR eventually led to six other commercial products and 
contributed to 20 others. Now, Symantec is a leading anti-virus and PC-
utilities Software Company valued at $12B with more than 17500 
employees worldwide.
    NSF launched the Integrative Graduate Education and Traineeship 
Program (IGERT) in 1997 to encourage innovative models for graduate 
education at colleges and universities across the Nation that would 
catalyze a cultural change in graduate education--for students, faculty 
and institutions. IGERT was designed to challenge narrow disciplinary 
structures, to facilitate greater diversity in student participation 
and preparation, and to contribute to the development of a diverse, 
globally-engaged science and engineering workforce. The result has been 
a cadre of imaginative and creative young researchers. For example, an 
NSF-funded IGERT award to the Scripps Institute of Oceanography (NSF 
#0333444) supported a doctoral student who successfully modeled the 
extinction of the Caribbean monk seal and demonstrated the magnitude of 
the impact of over-fishing on Caribbean coral reefs. This research 
developed improved ecological models, which may influence environmental 
policy and ultimately lead to the preservation of species and 
ecosystems for future generations.

                     Biography for James P. Collins

    Dr. James Collins received his B.S. from Manhattan College in 1969 
and his Ph.D. from The University of Michigan in 1975. He then moved to 
Arizona State University where he is currently Virginia M. Ullman 
Professor of Natural History and the Environment in the School of Life 
Sciences. From 1989 to 2002 he was Chairman of the Zoology, then 
Biology Department. At the National Science Foundation (NSF) Dr. 
Collins was Director of the Population Biology and Physiological 
Ecology program from 1985 to 1986. He joined NSF's senior management in 
2005 serving as Assistant Director for Biological Sciences from 2005 to 
2009. NSF is the U.S. government's only agency dedicated to supporting 
basic research and education in all fields of science and engineering 
at all levels. Collins oversaw a research and education portfolio that 
spanned molecular and cellular biosciences to global change as well as 
biological infrastructure. He coordinated collaborations between NSF 
and other Federal agencies though the President's National Science and 
Technology Council where he chaired the Biotechnology Subcommittee and 
co-chaired the Interagency Working Group on Plant Genomics. He was also 
NSF's liaison to NIH.
    Dr. Collins's research has centered on the causes of intraspecific 
variation. Amphibians are model organisms for field and laboratory 
studies of the ecological and evolutionary forces shaping this 
variation and its affect on population dynamics. A recent research 
focus is host-pathogen biology as a driver of population dynamics and 
even species extinctions. The role of pathogens in the global decline 
of amphibians is the model system for this research.
    The intellectual and institutional factors that have shaped 
Ecology's development as a science are also a focus of Dr. Collins's 
research, as is the emerging research area of ecological ethics. 
Federal, state, and private institutions have supported his research.
    Dr. Collins teaches graduate and undergraduate courses in ecology, 
evolutionary biology, statistics, introductory biology, evolutionary 
ecology, and professional values in science; he has directed 33 
graduate students to completion of doctoral or Masters degrees. Collins 
was founding director of ASU's Undergraduate Biology Enrichment 
Program, and served as co-director of ASU's Undergraduate Mentoring in 
Environmental Biology and Minority Access to Research Careers programs.
    Honors include the Pettingill Lecture in Natural History at The 
University of Michigan Biological Station; the Thomas Hall Lecture at 
Washington University, St. Louis; Distinguished Lecturer in Life 
Science, Penn State University, and serving as Kaeser Visiting Scholar 
at the University of Wisconsin-Madison. ASU's College of Liberal Arts 
and Sciences awarded him its Distinguished Faculty Award. He is a 
Fellow of the American Association for the Advancement of Science, a 
Fellow of the Association for Women in Science, and President Elect of 
the American Institute of Biological Sciences (AIBS).
    Dr. Collins has served on the editorial board of Ecology and 
Ecological Monographs as well as Evolution. He is the author of over 
100 peer reviewed papers and book chapters, co-editor of three special 
journal issues, and co-author with Dr. Martha Crump of Extinction in 
Our Times. Global Amphibian Decline (Oxford University Press, 2009).

    Chairman Lipinski. Thank you, Dr. Collins.
    Dr. Laubenbacher.

    STATEMENT OF REINHARD LAUBENBACHER, PROFESSOR, VIRGINIA 
 BIOINFORMATICS INSTITUTE, DEPARTMENT OF MATHEMATICS, VIRGINIA 
                              TECH

    Dr. Laubenbacher. Good afternoon, Chairman Lipinski, 
Ranking Member Ehlers and Members of the Committee. Thank you 
for the invitation to testify today on 21st century biology. My 
name is Reinhard Laubenbacher and I am a Professor at the 
Virginia Bioinformatics Institute at Virginia Tech. I am also 
the Vice President for Science Policy for the Society for 
Industrial and Applied Mathematics, an organization with 
approximately 13,000 members who work in academia, government 
and industry. While our members come from many different 
disciplines, we have a common interest in applying mathematics 
and computational science toward solving real-world problems. I 
will speak to three areas in my testimony today: first, 
research to address grand challenges; second, fostering 
interdisciplinary collaborations and cross-agency coordination; 
and third, workforce development, education and training.
    The first area I want to discuss is research to address the 
grand challenges. A central finding of the National Research 
Council report is that new information, technologies and 
sciences will be essential to achieving the new biology for the 
21st century and meeting challenges in health, food, energy and 
environment. Two examples of how mathematics can contribute to 
the new biology are, first, through modeling. The ability to 
describe the essence of complex biological systems with 
mathematical equations will allow researchers to test their 
understanding of a system and make predictions about how whole 
organisms and ecosystems behave. And secondly, through ways to 
deal with data. Mathematics provides techniques to access, 
analyze, visualize and understand the ever-growing amounts of 
data generated in the life sciences, be it DNA sequence data or 
satellite surveillance data. My written testimony goes into 
more detail on specific research areas in mathematics that 
should be supported as part of the new biology. To support this 
research, an array of complementary Federal programs will be 
needed from those that focus on building expertise, or enabling 
research networks in a single topic area, often at a single 
agency, to application-driven programs that cross agencies.
    The second area I want to address is fostering 
interdisciplinary collaborations and cross-agency coordination. 
The Virginia Bioinformatics Institute where I work is part of 
Virginia Tech's response to the challenge of fostering 
interdisciplinary research on its campus. I am a mathematician 
by training, and at the Institute, my office neighbors are a 
statistical geneticist on one side and a biochemist on the 
other side. From our experience, it is clear to me that 
locating researchers with different areas of expertise under 
one roof can serve as an important accelerator of 
interdisciplinary research. Co-location allows researchers to 
develop a common culture and allows multiple disciplines to 
merge and organically develop together. The Federal Government 
should support this type of collaboration with programs that 
allow for co-location of disciplines by enabling new biological 
and new mathematical and computational research to be carried 
out within the same project. This way, the computational 
scientists developing algorithms, the engineers developing new 
technologies, and the biologists asking questions about the 
fundamental principles of life can advance the science in 
tandem. So this sort of interdisciplinary activity, the Federal 
programs that pool agency resources to allow the funding of 
larger-scale projects, are needed.
    The third and final area that I want to discuss is 
workforce training at several levels. In graduate education, 
both departmental and interdisciplinary Ph.D. programs can be 
very effective in preparing students to conduct new biology 
research, with the key issues being an integration of 
curricula, the need for a balance between diversity and depth 
and training, as you mentioned, Mr. Chairman, and the 
opportunity to develop a common culture across disciplines. 
Federal support for efforts to align graduate education with 
these goals is needed, as creating and maintaining such 
programs requires a major investment of time and resources.
    At the undergraduate level, the two most important elements 
for preparing students to work in the areas of new biology are, 
again, an integrated curriculum and research experiences. Close 
partnerships between teaching and research institutions can 
help in both areas. In addition, improved opportunities for 
faculty professional development, such as workshops that bring 
together faculty from diverse disciplines, will be critical.
    Finally, realizing the potential of the new biology will 
depend on future generations of scientists still to be 
nurtured. At Virginia Bioinformatics Institute, we conduct 
outreach programs that involve hundreds of children every year. 
I have seen the excitement on the face of a nine-year-old who 
in a lecture hall with 400 other children stands up and asks an 
insightful question after listening to a scientist talk about 
nanotechnology--a nine-year-old. Experiences such as this 
convince me that science in this country has a bright future. 
However, to get there, we all must engage in a joint effort to 
inspire and mentor the children who are the future of science.
    Again, thank you for giving me the opportunity to testify 
today. I have provided additional detail and recommendations in 
my written testimony and I am happy to answer any questions. 
Thank you.
    [The prepared statement of Dr. Laubenbacher follows:]

              Prepared Statement of Reinhard Laubenbacher

    My name is Reinhard Laubenbacher and I am a professor at the 
Virginia Bioinformatics Institute, where I lead the Applied Discrete 
Mathematics Group and am the Director for Education and Outreach. I am 
also a professor of mathematics at the Virginia Polytechnic Institute 
and State University and an adjunct professor in the Cancer Biology 
Department at the Wake Forest University School of Medicine.
    Since 2009 I have served as Vice President for Science Policy for 
the Society for Industrial and Applied Mathematics (SIAM). SIAM is a 
community of approximately 13,000 applied and computational 
mathematicians, computer scientists, numerical analysts, engineers, 
statisticians, and mathematics educators who work in academia, 
government, and industry. While SIAM members come from many different 
disciplines, we have a common interest in applying mathematics in 
partnership with computational science towards solving real-world 
problems.
    In my invitation to testify on the New Biology, the Subcommittee 
raised questions in three areas, and I have organized my testimony 
accordingly into three sections:

          Research to Address Grand Challenges and Areas of 
        Scientific Opportunity

          Interdisciplinary Collaborations--Culture and Cross-
        Agency Coordination

          Workforce--Education and Training

    In each of these sections, I offer observations from my experiences 
at the interface of mathematics and biology and specific comments and 
recommendations about National Science Foundation (NSF) programs. 
Specifically, the testimony highlights

          ways in which mathematical and computational research 
        will contribute to New Biology research to tackle societal 
        challenges in food, energy, the environment, and health;

          mechanisms for support of research at the interface 
        between mathematical and life sciences, and examples of 
        successful programs in this area;

          lessons learned on the integration of cultures to 
        enable interdisciplinary research; and

          recommendations for ways to enhance graduate and 
        undergraduate education to prepare students to conduct research 
        in the New Biology.

    I note that many of the descriptions of research opportunities and 
the recommendations in this testimony reflect discussion within SIAM on 
the opportunities interface between the mathematical and computational 
sciences and the life sciences, as reflected in a white paper SIAM has 
produced in this area.\1\
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    \1\ The SIAM white paper on ``Mathematics: An Enabling Technology 
for the New Biology'' is available online at http://www.siam.org/about/
science/pdf/math-bioloev.pdf.

RESEARCH TO ADDRESS GRAND CHALLENGES, AREAS OF SCIENTIFIC OPPORTUNITY

    First Set of Questions from the Committee. In your opinion, what is 
the future of research in the biological sciences and what role does 
research at the intersection of biology and mathematics hold for 
addressing grand challenges in energy, the environment, agriculture, 
materials, and manufacturing? What computational tools still need to be 
developed? Are there promising research opportunities that are not 
being adequately addressed? Is the National Science Foundation playing 
an effective role in fostering research at the intersection of the 
physical sciences, engineering, and the biological sciences? If not, 
what recommendations would you offer?
    The 2009 National Research Council report ``A New Biology for the 
21st Century: Ensuring the United States Leads the Coming Biology 
Revolution'' \2\ proposes a national initiative to promote the New 
Biology that focuses on problem-centric, interdisciplinary research in 
the life sciences to solve societal challenges in Health, Food, Energy, 
and Environment. A central finding of the report is that new 
information technologies and sciences will be essential to achieving 
the New Biology and meeting these challenges. Biology has become a 
highly technology driven, fast moving science. New technologies 
typically produce new data types and larger volumes of data, and allow 
that data to be generated more cheaply. At the same time, the 
expertise, tools, and time needed to analyze that data, to turn it from 
numbers into knowledge and understanding, is becoming more complex and 
more expensive. For example, while the cost of sequencing a person's 
genome is moving toward the $100 level, the cost of extracting 
information from the sequence that is meaningful for that person's 
health is likely in the $1 million range. So the real bottleneck in 
biology is already shifting toward data analysis. Breakthroughs in 
mathematics, statistics, and the computational sciences will be 
necessary to assure that data analysis can keep up with data 
generation.
---------------------------------------------------------------------------
    \2\ National Research Council, A New Biology for the 21st Century: 
Ensuring the United States Leads the Coming Biology Revolution (2009), 
http://dels.nas.edu/Report/Biology-21st/12764.
---------------------------------------------------------------------------
    For each challenge area, the report outlines how biology can 
contribute directly and which research and technological needs must be 
met in order to do so. In each area, new approaches to information 
analysis, data, and modeling will be needed to advance our 
understanding of the natural world, as biology develops as a predictive 
science.
    Food: In order to help ensure a sustainable and responsibly grown 
food supply, particularly in light of the changing global climate, one 
of the challenges is to understand and quantify how plants grow and 
interact with their environment. This involves characterizing the 
relationship between the genotype and phenotype of organisms, a 
fundamental problem in biology. At the genome level biology is 
essentially digital, and genetic sequence information is translated 
into dazzlingly complex interacting networks of genes, proteins, and 
metabolites, making up cellular function. Cells organize into tissues, 
which, in turn form the whole plant.
    Functioning of the cellular networks is directly influenced by 
features of the environment the plant finds itself in, such as climate, 
resource availability, and microbial communities.
    Environment: In order to sustain ecosystem functions in the face of 
rapid change, we need to be able to monitor multiple heterogeneous 
variables spanning a range of temporal and spatial scales. The vast 
amount of data so collected needs to be integrated and used to 
construct unifying mathematical models that help guide environmental 
policy, and have the predictive capability to assess consequences of 
informed intervention. Here too, the models need to integrate 
interconnected networks and systems of complex systems at vastly 
different scales, all affected by a common environment.
    Energy: In order to expand sustainable alternatives to fossil 
fuels, new approaches beyond ethanol derived from corn must be 
developed. Microbial biocatalysis, for example, is a promising 
direction. In order to make it a reality, solving the genotype-
phenotype problem will lead to the capability to engineer microbes from 
standard DNA modules that perform a specified metabolic function. 
Another promising approach is to engineer plants with molecular 
networks that produce more leaves and fruit without using additional 
fertilizer, thereby increasing energy production through 
photosynthesis. With predictive models of the intertwined gene, 
protein, and metabolic networks, it becomes feasible to engineer and 
optimize the organism for efficient biofuel production.
    Health: To make a transformational contribution to human health, 
solution of the genotype-phenotype problem will contribute to 
integrating genomics information with complex genetic, protein, and 
metabolic networks, on up to the tissue and organism levels, all of 
which react to the external environment. In fact, environmental 
influences are known to play a very important role in several important 
diseases, such as cancer and neurological disorders.
    The importance of developing better modeling, computational, 
statistical, and analytical tools to enable a better understanding of 
biological systems and detailed discussion of the potential impact and 
key problems are also described in the 2005 National Research Council 
report ``Mathematics and 21st Century Biology.'' \3\ We are approaching 
a time when gathering the data necessary to truly begin to comprehend 
complex life as a whole system will be possible. This will be done 
through consolidating the ever-increasing amounts and types of 
available information at an ever-increasing level of completeness and 
granularity. The development of mathematical and computational tools to 
use this information in sophisticated models should be a priority. To 
date, exploiting modeling in biology has led to progress on 
understanding small pieces of large complex systems. But for the 
biological sciences to bring their full potential to bear on solving 
the most challenging problems humankind faces in the 21st century, we 
must now turn our attention to the comprehension of whole systems, and 
the mathematical and computational sciences are a key enabling 
technology in this quest.
---------------------------------------------------------------------------
    \3\ Mathematics and 21st Century Biology (2005) is available at 
http://www.nap.edu/catalog.php?record-id=11315.

Common Themes from Challenges in New Biology Report

    Three common themes emerge from the challenges described in the 
report.

        1.  All four challenges require the construction and analysis 
        of predictive mathematical models of large, nonlinear dynamic 
        networks that span several spatial and temporal scales. 
        Understanding and manipulating these systems will require 
        large, multi-scale, nonlinear, and hybrid models. Existing 
        simulation and analysis tools for such models are in their 
        infancy, or nonexistent in some cases. For instance, an 
        increasingly popular modeling paradigm for complex networks in 
        fields ranging from molecular biology to ecology is agent-based 
        modeling, which captures the important feature of many complex 
        systems that global behavior emerges from local interactions. 
        Very few analysis tools exist for such models. For many 
        applications it is desirable to use models to predict how 
        interventions on one level will impact biological systems on 
        other levels, such as in the development of therapeutics. This 
        process requires control approaches, but for the systems at the 
        heart of the New Biology challenge areas, it is sometimes 
        difficult or impossible to apply existing control theoretic 
        approaches.

        2.  In all problem areas high performance computation will play 
        a crucial role, from simulating complex multi-scale models to 
        analyzing sequence data, e.g., multiple sequence alignment. 
        This will require new breakthroughs in algorithm development, 
        since we cannot expect significant increases in clock speed due 
        to silicon technology. Performance improvements in computation 
        will come from more cores on a chip. This means significant 
        changes in algorithms to take advantage of parallelism on the 
        chip as well as parallelism between computational nodes 
        comprised of multiple chips. In order to achieve high rates of 
        performance, algorithms that minimize data movement, possibly 
        at the expense of doing additional computations, will be the 
        most efficient. Algorithm developers will need to take these 
        facts into account as they develop multi-scale, multi-physics 
        algorithms.

           It is also important to mention that the speedup in 
        scientific computation achieved over the last four or five 
        decades owes more to the development of new numerical 
        algorithms than to hardware improvements. Several reports have 
        documented the ways in which the contribution of algorithms has 
        surpassed the improvements due to better technology (Moore's 
        Law),\4\ but the impact from both has been critical. Together, 
        hardware and mathematical improvements account for an increase 
        in the speed at which we are able to perform the calculations 
        to model important systems, such as in numerical weather 
        prediction, by a factor of roughly 10,000,000 in the period 
        between the 1960s and the 1990s.
---------------------------------------------------------------------------
    \4\ See, for example, Figure 5, page 53 of Computational Science: 
Ensuring America's Competitiveness, a 2005 report to the President of 
the United States from the President's Information Technology Advisory 
Committee (PITAC). See also Figure 13, page 32 of the DOE Office of 
Science report A science-based case for large-scale simulation, 2003.

        3.  In all four challenge areas we face ever-growing data 
        volumes, from DNA sequence data to satellite surveillance data. 
        As an example, the amount of DNA sequence data stored in 
        GenBank, a data repository maintained by the NIH, has grown by 
        a factor of 100,000 over the past 25 years. Currently, there 
        are over 150 million genetic sequences stored in this publicly-
        available database. Genetic data like this, and the many other 
        types of data generated by the application of new imaging tools 
        and other technologies to biological systems, need to be stored 
        in databases that are easily accessible, organized, and 
        searchable, requiring increasingly sophisticated and scalable 
        data mining algorithms. In addition, the data from 
        heterogeneous sources need to be integrated, within databases 
        as well as within models. Once accessible in databases, the 
        typically high dimensional data sets need to be analyzed using 
        statistical methods. In order to meet these challenges, new 
        tools from multivariate statistics and discrete mathematics are 
---------------------------------------------------------------------------
        needed, in particular graph theory and combinatorics.

Biology to Inform Mathematical Research

    As happened with physics in the last century, we can expect that an 
increasingly strong feedback loop will develop between biology and the 
computational disciplines that now serve as tools, such as mathematics, 
statistics, computer science, and engineering. For instance, the 
National Science Foundation is already capitalizing on this feedback 
with its program ``Quantum and Biologically Inspired Computing.'' We 
mention here two more examples.
    It is well appreciated that the human immune system has important 
lessons to teach us about computer security. But the immune system is 
also a vast distributed information-processing network that adapts to 
ever-changing tasks. Once we understand its design principles well 
enough to build mathematical models capturing its key capabilities we 
will be able to transfer these principles to engineered networks. The 
immune system's complexity and the multiple spatial and temporal scales 
involved offer several mathematical and computational challenges that 
can only be overcome by fundamental breakthroughs in these fields.
    As another example, it is observed frequently by experimentalists 
that after engineering an organism with a gene deletion, even an 
apparently essential one, its phenotype remains unchanged. That is, the 
organism is robust to many such changes and can remodel its molecular 
networks after a change in its genome to maintain function. The 
underlying fundamental problem of understanding the genotype-phenotype 
relationship is mirrored by the analogous mathematical problem, namely 
understanding the relationship between the structure of a dynamical 
system and its resulting dynamics. This problem is still largely 
unsolved and poorly understood. Biological insights about the sources 
of this robustness in organisms can help generate hypotheses about 
solutions to the corresponding mathematical problem in dynamical 
systems. In turn, these solutions can be applied to better understand 
and control other complex systems such as the power grid and computer 
networks.

Recommendations--Research Areas

    This analysis makes clear that mathematics is indeed an important 
enabling technology for the New Biology. We recommend that any funding 
programs related to the New Biology initiative provide support for 
mathematical research related to the problems identified above in the 
following areas:

        1.  Complex networks, both in the graph-theoretic sense and in 
        the dynamical systems sense.

        2.  Multi-scale modeling and simulation, including 
        computational science research to enable new approaches.

        3.  Systems of partial differential equations.

        4.  Algorithms for high performance computation.

        5.  Algorithms for new multi-core computer architectures.

        6.  Multivariate statistics.

        7.  Dynamical systems.

        8.  Hybrid models.

        9.  Control theory.

        10.  Combinatorics and graph theory.

        11.  Data mining algorithms.

        12.  New methodologies for modeling complex stochastic 
        biological systems.

        13.  Quantification of model uncertainty.

    In addition to research in these areas, it is becoming increasingly 
clear that there is much untapped potential in mathematical fields that 
are not traditionally considered as applied. Good examples are recent 
applications of algebraic geometry to biological problems and the use 
of methods from algebraic topology for high dimensional data analysis. 
(Within SIAM, recognition of these emerging opportunities has led to 
the establishment of a new SIAM Activity Group in Algebraic Geometry.)

Recommendations--Research Support Mechanisms, Examples of Successful 
                    Programs

    To support the research areas outlined above, programs at 
individual agencies and interagency initiatives will be needed. 
Specifically, an array of complementary approaches will be needed--from 
those that focus on building expertise in a single topic area, often at 
a single agency, to application-driven programs that combine mission 
agency's user communities and discipline-organized research programs. 
Agencies likely to have relevant expertise, communities, programs, and 
missions include: the National Science Foundation (NSF), the National 
Institutes of Health (NIH), the Department of Energy (DOE), the U.S. 
Department of Agriculture (USDA), the Department of Defense (DOD), the 
Environmental Protection Agency (EPA), the Department of Homeland 
Security (DHS), and others.
    The National Science Foundation has been a leader in the 
development of models for stimulating and funding interdisciplinary 
research in general and as it relates to biology in particular. There 
are several existing programs that effectively support research at the 
interface of the life sciences on the one hand and mathematics, the 
computational sciences, and statistics on the other. These programs 
could be expanded or used as models for the establishment of new 
programs at NSF or other agencies.
    One particular inter-agency program has been very successful and 
enormously valuable to research at the interface of mathematics and 
biology. The Joint DMS/NIGMS Initiative to Support Research in the Area 
of Mathematical Biology is a collaborative program between NSF and NIH, 
originally established in 2001 and is now in its second five-year 
cycle. (A recent meeting of investigators supported by the program over 
the course of its existence, organized jointly by NSF and NIH, 
showcased some of the projects that have been funded and demonstrated 
the truly innovative nature of the program.) The key characteristic of 
this program is that it is one of the very few existing programs at any 
of the Federal funding agencies that allows for new biological AND new 
mathematical research to be conducted at the same time within the same 
project proposal. (While the program has been very successful, an 
ongoing concern is that award sizes are too small to tackle larger-
scale ambitious projects.)
    This dual approach is critically important because, for many of the 
new technologies being developed to generate biological data (such as 
next-generation sequencing or in vivo imaging), we still lack the 
mathematical and statistical tools needed to analyze and interpret 
these data so that they can be used to increase our understanding of 
biological systems and provide input for the construction of predictive 
models. To fully and efficiently tap the expertise of all the different 
kinds of researchers in this equation--e.g. the mathematicians 
developing data analysis algorithms, the engineers developing imaging 
technologies, and the life scientists defining the questions about 
biological system functioning--the Federal Government should be looking 
for ways to support the development of all elements of a research 
problem (the tools, models, and experiments) in tandem. (I will discuss 
this point more in the section below on the Virginia Bioinformatics 
Institute and effective environments for interdisciplinary research).
    In a related, but broader area, NIH and NSF announced a new program 
this spring, New Biomedical Frontiers at the Interface of the Life and 
Physical Sciences. While no projects have been selected and funded yet 
by this new program, the emphasis in the solicitation on supporting 
efforts that involve multiple investigators who represent the physical, 
computational or engineering and life or behavioral sciences is to be 
lauded.
    Other examples of exemplary NSF programs include:

          Cyber-enabled Discovery and Innovation (CDI) is an 
        NSF-wide initiative established in 2007 and designed to fund 
        projects that use innovation in computational thinking to make 
        advances in any discipline supported by the agency. (At NSF, 
        computational thinking is defined as encompassing computational 
        concepts, methods, models, algorithms, and tools.) This program 
        encourages researchers to think boldly about challenges in 
        data, complexity, and collaboration across multiple disciplines 
        without being constrained by disciplinary cultures and 
        programs.

          Frontiers in Integrative Biological Research, a 
        program, phased out in 2008, was designed to support integrated 
        teams of researchers from different scientific fields, focused 
        on biological problems that transcend traditional disciplinary 
        boundaries.

          Algorithms for Threat Detection, a joint program 
        between the NSF Division of Mathematical Sciences and the 
        Defense Threat Reduction Agency in DOD, is intended to support 
        the development of the next generation of mathematical and 
        statistical algorithms and methodologies in sensor systems for 
        the detection of chemical and biological materials.

    Mechanisms should be available to support a variety of sizes of 
research projects, from individual investigators to center-scale 
collaborations. Examples of multi-agency and single-agency center-scale 
initiatives in this area include:

          The National Institute for Mathematical and 
        Biological Synthesis (NIMBioS), jointly supported by the NSF 
        Biological Sciences Directorate and DMS, together with USDA and 
        DHS.

          NSF DMS supports the Mathematical Biosciences 
        Institute (MBI) at the Ohio State University.

    Both institutes focus on research at the interface between the 
mathematical and computational sciences and biology and foster 
interactions between mathematical scientists and bioscientists.
    Thus, NSF has developed and tested successful models to foster 
interdisciplinary research at the interface of biology and computation, 
both within the agency and in collaboration with other Federal funding 
agencies. These can serve as models for the broader cross agency 
funding structure advocated by the New Biology report.
    In addition to programs that support research activities, Federal 
agencies should focus on raising awareness in the biological and 
mathematical communities about science at the interface and 
facilitating cross-disciplinary collaborations, as creating research 
teams and partnerships across disciplines takes more time and 
conversation than building teams of people who are within a discipline 
and share a common culture (this point is discussed in more depth later 
in my testimony). In addition, outreach within each community about 
interesting results in one discipline that may potentially be relevant 
to problems in the other discipline could have a significant impact 
(i.e. the discovery of applications of algebraic geometry to biological 
problems mentioned above). Such unexpected linkages can bring very high 
returns, and their development should be systematically fostered and 
supported.
    To accomplish the above goals, programs that support network 
creation, workshops, travel, and summer programs, would be useful. 
``Sabbatical'' cross-disciplinary opportunities for researchers, post-
doctoral students, and graduate students also might be effective in 
creating a new community of researchers more alert to and equipped to 
conduct interdisciplinary research.
    An example of a Federal effort focused on enabling the creation and 
sustaining of connections between researchers with common interests is 
the NSF Research Coordination Networks program, which in 2010 is 
expanding to include a special track supporting networks of researchers 
focused on problems at the interface of the biological and mathematical 
or physical sciences.

INTERDISCIPLINARY COLLABORATIONS--CULTURE AND CROSS-AGENCY COORDINATION

    Second Set of Questions from the Committee: What is the nature of 
the interactions and collaborations between mathematicians and 
biological scientists at the Virginia Bioinformatics Institute (VBI)? 
How is VBI facilitating these interdisciplinary collaborations and what 
lessons can we learn from VBI? Is research at the intersection of the 
biological sciences, the physical sciences, and engineering being 
effectively coordinated across the Federal agencies? If not, what 
changes are needed?
    Much of the scientific research in biology and related disciplines 
happens at universities. By and large, the nature of the interactions 
among scientists from different disciplines is constrained by existing 
academic administrative structures, which generally do not encourage 
interdisciplinary research. This has been well documented in the 2004 
National Research Council report ``Facilitating Interdisciplinary 
Research,'' \5\ which also puts forward solutions to this part of the 
problem. Many universities are addressing the issue of 
interdisciplinary research by creating research centers that are more 
flexible administratively and are sometimes organized in a problem-
centric rather than discipline-centric way. Some of these centers are 
``virtual,'' in the sense that the researchers all have primary 
appointments in academic departments, with some shared research 
infrastructure. Other centers have dedicated buildings that provide 
primary laboratory space. The institute I work in is part of Virginia 
Tech's response to the challenge of fostering interdisciplinary 
research on its campus.
---------------------------------------------------------------------------
    \5\ Facilitating Interdisciplinary Research (2004) is available at 
http://www.nap.edu/catalog.php?record-id=11153.
---------------------------------------------------------------------------
    The Virginia Bioinformatics Institute (VBI) was established on the 
campus of Virginia Tech in 2000 and is focused on research at the 
interface of the experimental and computational sciences. The institute 
currently has a staff of approximately 230, including approximately 150 
scientific personnel and a dedicated 130,000 square foot. building, 
completed in 2004, with in-house computational and data generation 
cores. Researchers at VBI are engaged in a wide range of 
interdisciplinary research projects that bring together diverse 
disciplines such as mathematics, computer science, biology, plant 
pathology, biochemistry, systems biology, statistics, economics, 
medicine, and synthetic biology.
    My own research is focused on systems biology, in particular the 
development of mathematical algorithms related to the modeling of 
molecular networks. My research group has worked on applications to 
understanding gene regulatory networks, infectious diseases, and, more 
recently, cancer. During my eight years at VBI I have collaborated with 
experimental biologists, biochemists, and computer scientists, both at 
VBI and elsewhere. Based on my experience, the single most important 
factor for making VBI an excellent environment for interdisciplinary 
research is the fact that a wide range of disciplines are brought 
together under one physical roof. I am trained as a mathematician and 
most of my research group consists of mathematicians. But a statistical 
geneticist occupies the office on one side of me, and my neighbor on 
the other side is a biochemist. Similarly, my Ph.D. students might 
share office space with experimental biologists or computer scientists. 
The two most important benefits of such an arrangement are that, 
firstly, it becomes very easy to share information. Even in this age of 
instant electronic access to information and video chats with 
colleagues around the world nothing can replace a face-to-face 
conversation or chance encounter at the proverbial water cooler. 
Secondly, sharing physical space on a daily basis allows for the 
merging of different scientific cultures. In my opinion, the most 
important and difficult challenge in fostering interdisciplinary 
research is the creation of a common culture and a common language, 
even at the most basic level. In a mathematician or a physicist, the 
word ``vector'' might elicit the image of an arrow depicting the 
direction and velocity of a moving object, whereas in a biologist the 
same word might bring to mind the image of a disease-carrying mosquito 
or a rat.
    A common obstacle in applying quantitative data analysis methods 
effectively in life sciences research is that biological experiments 
are often designed without the involvement of a modeler or 
bioinformatician or statistician. Once the data from these experiments 
are generated, often at considerable cost, they sometimes turn out to 
be unsuitable for the desired data analysis or modeling method. It is 
important, therefore, to assemble the entire team for a project ahead 
of time, so that everybody can contribute to all phases of the project. 
The laboratory of one of my collaborators, for instance, is just across 
the hall from me and I can easily provide input, suggestions, and 
answers to questions, as I visit frequently. In fact, computational 
modeling and analysis will become an increasingly important component 
of the experiments themselves and their design. An integrated 
environment such as VBI makes the transition to ``computer aided 
design'' of experiments easier. It also facilitates biologists' input 
into the subsequent generation of biological hypotheses through 
computational methods.
    A thorny problem in creating an interdisciplinary environment, one 
that we have struggled with for a long time, is performance evaluation. 
In a scientifically more homogeneous academic department it is easier 
to evaluate the quality of someone's research, since colleagues are 
more familiar with the different scientific journals in the field and 
their quality. A common and problematic practice is to replace this 
domain knowledge with metrics such as the impact factor of a journal. 
It is well known that it is possible for a journal to influence its 
impact factor in ways that do not reflect its actual scientific 
importance. Also, cultural factors in different scientific communities 
affect this metric. For instance, while Science and Nature, two of the 
very best journals in the physical and life sciences, have very high 
impact factors, the top rated mathematics journals, such as Annals of 
Mathematics, have impact factors that are an order of magnitude 
smaller. So the impact factor of journals can be only one of several 
measures to be used. Extramural funding through grants and contracts is 
another factor that is commonly taken into consideration in academic 
institutions. Preparing grant applications for interdisciplinary 
research tends to take considerably more time and effort than single 
investigator grants, and budgets typically need to be larger. Since 
there are fewer funding programs available for interdisciplinary 
research than for research within a single discipline, success rates 
tend to be lower. It is important to provide incentives for scientists 
to nonetheless embrace interdisciplinary research.
    At VBI we are continually working to refine our evaluation process 
that takes these and other factors into account. For instance, the 
institute also wants to encourage its scientists to engage in 
entrepreneurial activities to ensure that their scientific discoveries 
translate into tangible products that benefit society. So 
entrepreneurial activity is another criterion in our evaluation 
process.
    The most important lesson I can draw from VBI's experience is that 
integration of different areas of expertise into one physical and 
administrative structure that is problem centric rather than discipline 
centric can serve as an important accelerator of interdisciplinary 
research. While this is common practice in industry, it is less so in 
academe. But it resonates well with the central theme of integration in 
the New Biology report.
    I frequently serve on grant review panels for several agencies, 
including the NSF, NIH, the postdoctoral program for Federal research 
laboratories run by the National Academy of Sciences, and a variety of 
foreign funding agencies. Panels I have served on have focused on a 
wide range of disciplines, including mathematics, biology, engineering, 
computer science, oncology, and several interdisciplinary panels. In 
addition to these agencies, the Office of Science within the Department 
of Energy, and the U.S. Department of Agriculture also support research 
at the interface of biology and the computational sciences. In my 
experience as a reviewer, I have come to realize, that such research 
takes place in a large variety of settings, including academic 
departments such as biology, computational biology, biochemistry, 
physics, bio- and biomedical engineering, electrical engineering, 
systems engineering, computer science, mathematics, to name the most 
common ones, as well as a variety of academic and nonacademic research 
centers, medical schools, government laboratories, and companies. My 
experience shows me that the scientific community is already mobilizing 
on a broad scale to meet the challenges outlined in the New Biology 
report.
    While this diversity of computational biology research is a very 
encouraging sign, it also represents a challenge to funding agencies 
that need to tailor programs to the different communities. I have 
described earlier some examples of funding programs that cross 
disciplines within agencies or span across agencies. The agencies are 
tapping into a broad and partly overlapping pool of reviewers. It 
happens to me frequently, that I meet somebody at an NSF review panel, 
who I had met a few months before at an NIH study section, for 
instance. And program officers from different funding agencies 
communicate with each other regularly, in my experience. However, there 
are still many opportunities for the agencies to coordinate programs, 
and a particular need is to pool resources for funding larger-scale 
projects. We now have some good case studies we can draw on of programs 
that create synergy between agencies' expertise, such as the DMS/NIGMS 
program I mentioned earlier, and can, as discussed in the previous 
section, be a model for larger-scale cross-agency activities.

Lessons Learned about Interdisciplinary Collaboration and Cross-Agency 
                    Coordination

          From our experience at VBI, it is clear to me that 
        integration of different areas of expertise into one physical 
        and administrative structure that is problem centric rather 
        than discipline centric can serve as an important accelerator 
        of interdisciplinary research. The value of colocation is at 
        least two-fold: (1) It allows researchers to develop a common 
        culture and learn each other's language; and (2) It allows 
        multiple disciplines to contribute to the development of 
        hypotheses, the methods for making predictions, and the design 
        of experiments from the beginning of a project.

          One of the major challenges facing interdisciplinary 
        research is that of performance evaluation. One growing problem 
        is how those in a discipline can assess the quality of research 
        of someone publishing outside that field. Another problem is 
        the greater time for preparing proposals to support large 
        interdisciplinary teams and the lower success rate for such 
        large grants.

          Finally, from my experience with multiple Federal 
        agencies as a grantee and a reviewer, I am pleased to report 
        that I see good individual collaborations among these 
        agencies--the program officers communicate regularly with each 
        other, the expertise of reviewers are tapped and shared across 
        agencies, and a number of joint programs have been established 
        (as highlighted in the previous section). However, there are 
        still many opportunities for the agencies to coordinate 
        programs, and a particular need is ways to pool agency 
        resources to allow the funding of larger-scale projects.

WORKFORCE--EDUCATION AND TRAINING

    Third Set of Questions from the Committee: What changes, if any, 
are needed in the education and training of undergraduate and graduate 
students to enable them to work effectively across the boundaries of 
the physical sciences, engineering, and the biological sciences without 
compromising core disciplinary depth and understanding? Specifically, 
what recommendations or changes, if any, would you offer regarding the 
portfolio of education and training programs supported by NSF?
    As Director of the VBI Education and Outreach Program I devote part 
of my time to education and training in computational biology from the 
K-12 to postgraduate levels, in formal and informal settings. The 
program has four full-time staff members, in addition to myself, 
including one at the Ph.D. level.

Graduate Education

    I will first address education at the graduate level. As the New 
Biology report states: ``Certain institutions have recognized these 
limitations of traditional departments for establishing the New 
Biology, and have responded not by eliminating departmental structures, 
but rather by supplementing or overlaying them with interdisciplinary 
programs or institutes that have both research and educational 
objectives. Virginia Tech is one of those institutions. In 2003, we 
created a Ph.D. program with the name ``Genetics, Bioinformatics, and 
Computational Biology (GBCB)'' that was designed to train students at 
the interface of experiment and computation in the life sciences. The 
program is administered by the Graduate School and draws on faculty 
from several departments and institutes, including VBI. While the 
program was one of a handful at the time, there are now a number of 
such Ph.D. programs at other institutions in the U.S. and worldwide. 
The structure of the program is fairly typical, with each student 
choosing a major area of expertise, such as computer science or one of 
the life sciences, together with topics from other minor areas of 
expertise, and a dissertation research project that involves more than 
one area. In designing the program, we tried to strike a balance 
between the need for diversity and depth of training. Other programs 
may strike this balance in more or less different ways, with varying 
administrative structures. Our graduates are sought after in both 
academic institutions and industry and have no difficulties finding 
attractive employment opportunities.
    Most of the research in my group is such that it typically requires 
fairly deep training in mathematics, so that most of my Ph.D. students 
are enrolled in the mathematics Ph.D. program. (In fact, I have had 
excellent experiences also with postdoctoral mathematicians with no 
prior background in biology, who have acquired significant biology 
skills in a short period of time and have made important research 
contributions.) In order to learn the requisite biology they take 
courses designed for the GBCB program and, in effect, their course of 
study could qualify for the GBCB program as well. Most departmental 
Ph.D. programs are flexible enough to allow students such a diverse 
plan of study. So both departmental and interdisciplinary Ph.D. 
programs can be very effective in training students for New Biology 
research. An important prerequisite for the success of departmental 
programs in this endeavor is, again, integration. In addition to 
integration of curricula, students need to have an opportunity to 
develop a common culture with other disciplines.
    While Virginia Tech has had great success with the GBCB program and 
other interdisciplinary graduate programs, creating and maintaining 
such programs is a major investment of time and resources on the part 
of the institution and its faculty. To date, the NSF Integrative 
Graduate Education and Research Traineeship Program (IGERT) program has 
played an important role in creating integrated graduate programs 
across the scientific spectrum at universities across the U.S. For 
example, Virginia Tech currently has four IGERT awards, and their 
cumulative effect is beginning to transform the institution.
    To educate the future scientists who will be critical in realizing 
the New Biology, universities will have to transform graduate education 
in many areas, some interdisciplinary, some not. While the IGERT 
program is excellent at supporting the creation of programs at newly 
established interdisciplinary boundaries, academic institutions and 
departments will also have to revisit existing disciplinary programs 
and established interdisciplinary areas (e.g. the intersection of 
biology and mathematics). Support from NSF for these efforts--such as 
for the design of the structure and curricula associated with such 
programs, faculty development and training, and the development, 
coordination, and execution of related activities such as internships, 
laboratory rotations, fieldwork, and seminars--would enable 
universities to create integrated, flexible programs, as described 
above, that will prepare the next generation of researchers for the New 
Biology and other emerging opportunities. The graduate experiences 
developed by this sort of Federal program will benefit multiple 
disciplines and application areas, and hence such a program may be 
appropriate for cross-agency partnerships and collaborations.

Undergraduate Education

    At the undergraduate level the two most important factors, in my 
experience, for New Biology training, are an integrated curriculum and 
research experiences. In order to create an integrated curriculum there 
is a tremendous need for faculty professional development, especially 
at the many undergraduate institutions. For instance, a few weeks ago I 
lectured at a week-long workshop for college faculty, entitled 
``Mathematical Biology: Beyond Calculus,'' which was supported by the 
Mathematical Association of America and was held at Sweet Briar College 
in Virginia. The participants came from undergraduate teaching 
institutions around the country, and some came in teams of two: a 
biologist and a mathematician. The goal was to develop integrated 
teaching modules that faculty could use in both mathematics and biology 
classes, and to plan curricula for integrated courses. In my opinion, 
many more workshops of this type across all the disciplines 
contributing to the New Biology are needed to allow faculty to develop 
and teach courses that will interest students in this area and prepare 
them for interdisciplinary graduate study and research.
    Beyond such professional development workshops, teaching 
institutions could benefit additionally from close partnerships with 
research institutions that incorporate professional development, 
expertise in curriculum development, and research opportunities for 
faculty and students. This will enable faculty at these institutions to 
keep their curriculum up to date, both within and across disciplines, 
and will allow them to train their students in ways that make them 
competitive for cutting edge graduate programs. For instance, we are 
working with three minority-serving undergraduate institutions to set 
up such partnerships. For the second summer now we are hosting their 
faculty at VBI where they engage in research and professional 
development, and we are hosting their students for research 
experiences. I have found this to be an effective way to help 
undergraduate institutions keep pace with scientific developments and 
training needs. It is not clear to me whether there are any funding 
programs that are particularly targeted at or well-suited to support 
such partnerships.
    The NSF has established the program Interdisciplinary Training for 
Undergraduates in Biological and Mathematical Sciences, that addresses 
curriculum integration and research experiences. The program is very 
successful, in my opinion, and should be expanded. It can also serve as 
a model for similar programs involving other New Biology disciplines. 
And its scope could be modified to include partnerships of the kind 
mentioned above.
    Genuine research experiences play a tremendously important role in 
getting undergraduate students interested in the sciences and in 
preparing them for graduate programs. The NSF's Research Experiences 
for Undergraduates (REU) program has played an important role in 
attracting students to science and engineering careers and in preparing 
them to begin research earlier in their training. For admission to many 
of the best Ph.D. programs an REU or similar experience has become an 
important criterion. As I am talking to you here, we have over 30 
undergraduates from all over the country at VBI who are doing research 
with our scientists during the summer, including students from half a 
dozen states with Representatives on this committee. The students are 
supported by grants from NSF and NIH. In addition, we have a dozen 
undergraduates from foreign countries at the institute for the summer. 
I can see every day what a powerful effect this experience has on the 
students, and e-mails and letters from past participants make clear 
that such programs have a lasting impact on them and their career 
choices.

Recommendations--Graduate and Undergraduate Education

    In graduate education, both departmental and interdisciplinary 
Ph.D. programs can be very effective in preparing students to conduct 
research in the New Biology, with the key issues being an integration 
of curricula, the flexibility to strike a balance between the need for 
diversity and depth of training, and the opportunity to develop a 
common culture across disciplines. Creating and maintaining graduate 
programs with these characteristics is a major investment of time and 
resources on the part of institutions and faculty. Federal support for 
university efforts to transform graduate education would greatly help 
prepare the next generation of researchers for the New Biology and 
other emerging opportunities.
    At the undergraduate level the two most important elements for 
preparing students to work in the areas of the New Biology are an 
integrated curriculum and research experiences. In order to create an 
integrated curriculum there is a tremendous need for faculty 
professional development, especially at the many predominantly 
undergraduate institutions in the U.S. This could be enabled by 
programs that support professional development workshops that, for 
example, bring together faculty from mathematics and biology. In 
addition, teaching institutions could benefit from close partnerships 
with research institutions, in which the partnerships provide 
professional development, expertise in curriculum development, and 
research opportunities for faculty and students. The NSF programs 
Interdisciplinary Training for Undergraduates in Biological and 
Mathematical Sciences and Research Experiences for Undergraduates have 
been successful in supporting enhancements in undergraduate education 
and improving access to critical research experiences, and these 
programs should be expanded.

Researchers of the Future--K-12 Education and the Perception of 
                    Mathematics and Science

    Realizing the potential of the New Biology is a long-term effort. 
It will depend strongly on the generations that are now in the K-12 
educational system, their parents who influence their career choices, 
and their teachers who prepare them for those careers. There is a 
tremendous need for teacher training and for providing children with 
opportunities to experience practitioners of science, engineering, 
technology, and mathematics (STEM) as what they are: explorers of 
fascinating mysteries on the most important frontiers of knowledge. 
Without changing the image of the STEM disciplines in the minds of the 
public and our children, we will not succeed in reversing the trend of 
ever smaller numbers of students choosing STEM careers.
    During the last year we hosted over 5000 K-12 students at VBI and 
we are carrying out programs that involve hundreds of children, their 
parents, and teachers, in partnership with other organizations, such as 
Virginia 4H. In my experience, engagement with science and technology 
at this level can have a huge payoff in the future. Seeing the 
excitement and genuine interest on the face of a 9-year-old who, in a 
lecture hall with 400 other children, stands up and asks an insightful 
question after listening to a scientist talk about nanotechnology 
convinces me that the number of students electing to study STEM in 
higher education can be increased, if all stakeholders work together to 
affect the needed cultural change. There are wonderful examples of such 
efforts. The U.S. Science Festival later this year will be a signature 
event for shining the public spotlight on science, and VBI will do its 
share in our booth to showcase New Biology research. And there are many 
other smaller events and programs of this type taking place across the 
country. But given the size of the challenge and the large potential 
benefit to the U.S. economy and well being, a national effort may be 
required to affect the needed cultural change. An example of such a 
larger-scale program is the 2007-2008 ``Year of Mathematics,'' a 
massive effort by the German mathematical community to help the public 
experience mathematics. (The program was funded through a public-
private partnership with approximately 11 million Euros.)

CONCLUSION

    Enabling and exploiting the intersection between the life sciences 
and the mathematical and information sciences will have great benefits 
for society, in health, food, energy, and the environment, as noted in 
the New Biology report. This alone is a reason for the U.S. to explore 
and invest in this area. However, like in many other fields, such as 
information technology, medicine, and security, the work in New Biology 
also has the potential for significant economic benefit to the Nation 
that makes the discoveries and is first to turn them into products and 
services. The U.S. is not the only nation to see the potential of this 
area,\6\ and the investments of other countries in their research and 
education infrastructures to produce 21st century innovations lend 
urgency to our efforts to improve our own research and training 
capabilities.
---------------------------------------------------------------------------
    \6\ For a discussion of international efforts, see the WTEC 
International Assessment of Research and Development in Simulation-
Based Engineering and Science, which includes a chapter on Life 
Sciences and Medicine, available at http://www.wtec.orc/sbes/SBES-
GlobalFinalReport-BW.pdf.

                  Biography for Reinhard Laubenbacher
    Dr. Reinhard Laubenbacher is a professor at the Virginia 
Bioinformatics Institute, where he leads the Applied Discrete 
Mathematics Group and is the Director for Education and Outreach. He is 
also a professor of mathematics at the Virginia Polytechnic Institute 
and State University and an adjunct professor in the Cancer Biology 
Department at the Wake Forest University School of Medicine. He holds a 
Ph.D. in mathematics from Northwestern University.
    Since 2009 he has served as Vice President for Science Policy for 
the Society for Industrial and Applied Mathematics (SIAM). SIAM is a 
community of approximately 13,000 applied and computational 
mathematicians, computer scientists, numerical analysts, engineers, 
statisticians, and mathematics educators who work in academia, 
government, and industry.
    Dr. Laubenbacher's research focuses on the development of cutting 
edge mathematical tools to allow for a comprehensive understanding of 
biological systems. Specifically, his group develops mathematical 
algorithms related to the modeling of molecular networks with 
applications to yeast, infectious diseases, and cancer. Dr. 
Laubenbacher's research has been supported by grants from the National 
Science Foundation, the National Institutes of Health, and the 
Department of Defense. He has authored or coauthored over 80 
publications and co-authored or edited 5 books. His work as an educator 
has also been supported by grants from the National Science Foundation.

    Chairman Lipinski. Thank you, Dr. Laubenbacher.
    Dr. Leonard.

STATEMENT OF JOSHUA N. LEONARD, ASSISTANT PROFESSOR, DEPARTMENT 
OF CHEMICAL AND BIOLOGICAL ENGINEERING, NORTHWESTERN UNIVERSITY

    Dr. Leonard. Mr. Chairman, thank you for this opportunity 
to discuss these important issues related to the transformative 
shifts now occurring in research and education at the interface 
of biology, engineering and the physical sciences.
    I am an Assistant Professor of Chemical and Biological 
Engineering at Northwestern University and my expertise and 
research interests center on engineering biological systems for 
applications in biotechnology and medicine using synthetic 
biology, a field that I will describe today. I am honored to be 
here today and speak with you and this subcommittee about these 
topics.
    Over the last three decades, molecular biology has 
revolutionized our ability to explore the living world, and we 
now stand at another transformative moment in the biological 
sciences. Through technological advances, it is possible to 
collect a wealth of biological data, and we now need new 
conceptual, computational and experimental tools to transform 
this information into useful understanding and practical 
applications. Already, it is clear that by developing these 
capabilities, we may use the richness of biology to meet 
pressing needs in areas including energy, through the sustained 
production of advanced biofuels; in the environment, including 
cleanup, remediation and ecosystem management; in agriculture, 
including crops that withstand harsh conditions or changing 
environmental conditions; materials, including the production 
of industrially useful materials, like polymers from renewable 
biomass instead of from petroleum; in manufacturing, by 
carrying out chemical synthesis inside microorganisms to 
transform cheap biological feedstocks into high-value products 
like pharmaceuticals; and in health, by harnessing our own 
biology to treat cancer, to generate vaccines on demand and to 
extend the quality of life.
    At the leading edge of these efforts is synthetic biology, 
a nascent technical discipline whose central goal is to 
transform biology into a system that can be engineered as we 
engineer mechanical and electrical systems today. Synthetic 
biology seeks a new paradigm of biology by design in which one 
can conceive a desired biological function, design a biological 
system to perform this function, build the system and have it 
work as predicted. We are still some distance from realizing 
this goal, but synthetic biology provides a framework for 
proceeding. In this model, basic biological parts such as genes 
are constructed and characterized such that they can be 
interconnected and assembled into novel configurations to 
generate new functions, which are designed with the assistance 
of computational tools and rigorous quantitative methods.
    As in all areas of applied science, construction and 
understanding are connected. First, we build to learn how to 
design. Understanding the principles of aeronautics did not 
directly provide the Wright Brothers with the ability to 
achieve controlled flight. This was achieved only through an 
ongoing cycle of design, construction, testing and refinement, 
and the same is true for engineering biological systems. We 
also build to understand. Sometimes understanding comes through 
failure. For example, through unsuccessful attempts to engineer 
bacterium to perform a simple task--for example, turning a gene 
on and off in a regular fashion--we learned that cells do not 
function as well-oiled machines, but rather, their inner 
workings proceed through bursts of activity. In these ways, 
synthetic biology is intrinsically part of the new biology of 
the 21st century as described by the National Research Council. 
Synthetic biology is not a change within biology, engineering 
or the physical sciences, but rather it is an effort that must 
span traditional disciplinary boundaries and integrate these 
strengths. Work in synthetic biology also spans the funding and 
oversight priorities of our Federal agencies.
    At this stage, the basic challenges, technologies and 
frontiers are largely independent of whether the eventual 
application is in energy, health or the environment. For 
example, my research group works to engineer cell-based devices 
and networks, approaches that have applications in both 
biotechnology and medicine. Interagency cooperation is 
therefore required to make the best use of our collective 
capabilities and resources.
    The NSF has supported early synthetic biology efforts 
through the multi-institutional center SynBERC [Synthetic 
Biology Engineering Research Center]. Now, we must also develop 
interdisciplinary centers throughout our research 
infrastructure to build a national synthetic biology community 
that is integrated with other facets of 21st century biology. 
Given the early state of synthetic biology and its vast 
potential for benefiting society, investing in high-risk, high-
reward projects should form a major part of our national 
strategy. In 2008, the NSF conducted such an experiment, along 
with partners in the United Kingdom, by running a sandpit event 
that brought together a multinational group of researchers to 
foster innovation in synthetic biology and develop competitive 
projects targeted at grand challenges. For example, our team is 
building a technology inspired by the evolution of bacterial 
ecosystems that could transform our ability to construct 
complex functions in bacteria, such as the challenging 
biochemical synthesis of the anticancer drug Taxol.
    The National Academy's Keck Futures Initiative also held a 
synthetic biology conference in 2009, using interdisciplinary 
teams to develop field-wide perspectives on major scientific 
and ethical issues. These findings also generated several 
innovative projects. For example, our team is developing a 
technology to enable engineered symbiotic bacteria which might 
patrol the colon for signs of cancer, for example, to 
communicate this information to their hosts.
    Finally, addressing challenges in 21st biology requires 
training a new generation of students prepared to integrate 
diverse areas of expertise. At the graduate level in 
particular, we need to engage a broad pool of students and move 
towards models in which training is an interdepartmental 
effort, a strategy that we are developing and implementing at 
Northwestern. Nationwide, our students are already eager to 
apply their capabilities to meet today's pressing challenges. 
With the United States' adaptable and entrepreneurial cultures 
in both research institutions and the private sector, we are 
positioned to continue to lead this revolution in biology and 
biotechnology. By fostering a national synthetic biology 
community and investing in high-risk, high-reward research, we 
can capitalize upon our capabilities to realize the benefits of 
biology by design.
    Mr. Chairman, thank you again for this opportunity to share 
my perspective on this important topic, and I would be happy to 
address any questions you may have.
    [The prepared statement of Dr. Leonard follows:]
                Prepared Statement of Joshua N. Leonard

    Mr. Chairman, thank you for this opportunity to discuss these 
important issues related to the transformative shifts now occurring in 
research and education at the interface of biology, engineering, and 
the physical sciences. I am an Assistant Professor of Chemical and 
Biological Engineering in the McCormick School of Engineering and 
Applied Science and member of the Robert H. Lurie Comprehensive Cancer 
Center at Northwestern University, in Evanston, Illinois. My expertise 
and research interests center on engineering biological systems for 
applications in biotechnology and health through ``synthetic biology'', 
a nascent technical discipline that holds immense promise for helping 
to meet our most pressing societal needs. I am honored to be here today 
and to speak with you and the members of this subcommittee about these 
topics.

Why are new approaches for engineering and understanding biological 
                    systems needed?

    Over the last three decades, molecular biology has revolutionized 
our ability to investigate and utilize the diversity of the living 
world in unprecedented ways. We now stand at another transformative 
moment in the biological sciences. Technological advances such as high-
throughput DNA sequencing have made it possible to collect massive 
amounts of biological data, and what is needed now are new conceptual, 
computational, and experimental tools to transform this wealth of 
information into useful understanding and practical applications. 
Already, is clear that by developing these capabilities, the 
versatility of biology may be harnessed to meet our most pressing 
societal needs, including:

          Energy--through the sustainable and affordable 
        production of advanced biofuels

          The Environment--including cleanup and remediation as 
        well as ecosystem management

          Agriculture--including the production of food crops 
        that grow in water and resource-poor areas and can tolerate 
        changing climactic conditions

          Materials--both by taking inspiration from natural 
        innovations, like spider's silk whose strength exceeds that of 
        steel, and by producing substances that are outside the 
        existing realm of biology, such as industrially-useful 
        polymers, from renewable feedstocks like sugar or biomass

          Manufacturing--for example, by carrying out 
        customized and complex chemical synthesis reactions inside 
        microscopic yeast or bacteria to transform cheap biological 
        feedstocks to high value specialty products

          Health--for example, to harness our own biology to 
        treat cancer, to generate vaccines on demand, to resolve 
        chronic infections and autoimmune disease, and to extend 
        quality of life to meet the needs of our changing population 
        demographics

    Our research infrastructure is already making headway towards these 
goals, with notable and early successes in biotechnology (e.g., the 
production of specialty products in microorganisms) and energy 
(especially in the realm of biofuels). This is a transformative moment 
in both the basic and applied biological sciences, and the steps we 
take to act on this opportunity will guide our ability to lead the 
development of this central technological and scientific capacity 
through the 21st century.

How will ``synthetic biology'' help to achieve these goals?

    At the leading edge of these efforts is a nascent technical and 
scientific discipline called synthetic biology. The central goal of 
this field is to transform biology into a system that can be engineered 
just as we design and engineer mechanical and electronic systems today. 
In this way, synthetic biology seeks to enable a new paradigm of 
biology by design, which can be summarized as follows:

          Conceive a given desired biological function

          Design an engineered biological system to perform 
        this function

          Build the system

          The system works as predicted

    We are still some way from realizing this ambitious goal, but 
synthetic biology provides a framework for addressing each of these 
steps. A central part of this concept is constructing and 
characterizing basic biological parts (such as a genes that encode 
enzymes or other proteins), which can be interconnected and assembled 
into novel configurations. Also important is the use of computational 
tools and rigorous quantitative methods to help design a configuration 
that will perform a given function. New technological advances are also 
required to provide reliable, affordable, and accessible assembly of 
large biological components (especially large pieces of DNA that may 
compose many genes, or other DNA-based ``parts ''). Together, this is 
more than a technological advance; it is a conceptual shift. Synthetic 
biology will enable us to move from what does exist, to what can exist.
    Synthetic biology is also intrinsically linked to fundamental 
biological sciences, including systems and computational biology, and 
as such, it is a central component of the New Biology described in the 
recent report on this topic from the National Research Council. As in 
all areas of applied science, construction and understanding are 
connected through these general approaches:

          Build to learn how to design. We know that 
        understanding the principles of aeronautics did not directly 
        provide the Wright Brothers with the ability to achieve 
        controlled flight. This was achieved only through the ongoing 
        cycle of designing, constructing, testing, and refining the 
        design. The same is proving true for engineering biological 
        systems to performed in desirable and predictable ways.

          Build to understand. Since its inception, synthetic 
        biology has provided new biological understanding through 
        failure. For example, through unsuccessful attempts to 
        genetically engineer a bacterium to perform a simple task (for 
        example, turning a gene on, off, and then back on in a regular 
        fashion), we learned that cells do not function as stable and 
        well-oiled machines, but rather their inner workings proceed 
        through bursts of activity mixed with stretches of inactivity. 
        Thus, attempting to engineer biology reveals new fundamental 
        biological insights, perhaps especially when it fails.

What types of research infrastructure and support are required?

    Synthetic biology, like other areas of 21St century biology, 
requires an inherently interdisciplinary approach. It is not just a 
change within biology, engineering, or the physical sciences, but 
rather it is an effort that must continue to span traditional 
disciplinary boundaries. Consequently, this field is not a replacement 
for existing core competencies--it is a new meeting place.
    The fundamental work required to develop synthetic biology 
capabilities spans the funding and oversight priorities of our Federal 
agencies. At this stage, the basic challenges, technologies, and 
frontiers are largely independent of whether the eventual application 
is in energy, health, or the environment. For example, my group works 
to engineer multicellular networks and build cellular devices, 
approaches that have applications in both biotechnology and medicine. 
Various component disciplines (including biology, engineering, physics, 
chemistry, computer science, and medicine) are already involved in 
these efforts, but what are needed are mechanisms for supporting the 
integration of these diverse strengths. Thus, interagency cooperation 
is required to maximize the progress that can be achieved.
    The NSF is taking early action to support the development of 
synthetic biology. SynBERC (the Synthetic Biology Engineering Research 
Center) is an NSF Engineering Research Center, which serves as a multi-
institutional home for foundational research in this field. The NSF is 
also supporting the new International Open Facility Advancing 
Biotechnology (Biofab) project, which will work to scale up the 
manufacturing and dissemination of technologies developed through 
SynBERC. These models established a foundation for synthetic biology 
research and have helped to coordinate activities between member 
institutions. To continue the development of this field and capitalize 
upon diverse types of core competencies, we must also develop 
interdisciplinary centers throughout our research infrastructure to 
build a national synthetic biology community, which must be closely 
integrated with other facets of 21st century biology.
    Building this community may be achieved through establishing 
regional centers, or in other cases an institution-level organization 
may be successful. In any implementation, it is essential that the 
program be sufficiently flexible to allow for innovative models that 
can integrate different institutional cultures and organizational 
structures. Furthermore, a key goal of this program should be to foster 
the growth of this nascent field, rather than to merely reinforce 
existing efforts, so a substantial component of any support should go 
towards activities that build new interactions. Particularly effective 
approaches may include pilot projects, multi-year graduate student and 
postdoctoral training fellowships tied to interdisciplinary advising, 
and activities that promote communication and dissemination such as 
seminars, local scientific meetings, and internet-based media.
    Given the rapidly expanding scope of synthetic biology as a 
discipline, as well as its potential for transformative contributions 
to society, it is essential that we invest in high-risk, high-reward 
projects. In November 2008, The NSF conducted an experiment in this 
area by running a so-called ``Sandpit'' event dedicated to fostering 
innovation and identifying new directions in the field of synthetic 
biology.\1\ This event was run in conjunction with the U.K.'s 
counterpart organization--the Engineering and Physical Sciences 
Research Council (EPSRC). I had the opportunity to attend this 
competitive event that brought together 15 researchers from the U.S. 
and 15 from the U.K. The EPSRC has run a number of such events since 
2004, but this was the first event to be held in the U.S. or by the 
NSF. The aim was to address basic questions, identify challenges and 
opportunities, and create novel research directions that wouldn't be 
supported through existing mechanisms, and moreover, wouldn't be 
proposed without this unique opportunity for collaborative 
interactions. By design, the resulting projects were targeted at grand 
challenges that both drive basic scientific capabilities and could 
enable transformative applications.
---------------------------------------------------------------------------
    \1\ Profiled in ``Digging for fresh ideas in the sandpit'' (2009) 
Science. Vol. 324. no. 5931, pp. 1128-9.
---------------------------------------------------------------------------
    To provide an example of the projects that were generated through 
this event, my group, along with Jay Keasling at the University of 
California, Berkeley and four other collaborators across the U.K., is 
developing a technology that could transform the way we engineer 
microorganisms for biotechnology. Existing approaches to engineering a 
microbe to carry out a useful function, for example to synthesize a 
valuable small molecule through modifying the organism's metabolism, 
require substantial investments of resources, time, and labor. Much of 
the difficulty arises from the extensive work required to tweak and 
optimize the system. In this project, we are building a new engineering 
technology inspired by a set of natural mechanisms by which communities 
of bacteria modify and optimize their own biology. This capability 
should eventually enable researchers to carry out the optimization of 
engineered biological functions with great savings in time, resources, 
and labor. Other projects addressed similarly ambitious and potentially 
transformative challenges.
    This Sandpit was an experiment and perhaps a model for driving 
innovation in other nascent areas of research. Importantly, the NSF has 
also followed this event with calls to develop networks for 
coordinating research efforts in this area. This emphasis on driving 
high-impact, high-reward research while developing our collective 
capacity to carry out work in synthetic biology reflect two effective 
strategies for leveraging and enhancing our existing research 
infrastructure.
    The NSF/EPSRC sandpit also dovetails with other national-level 
efforts including the National Academies Keck Futures Initiative's 
conference on ``Synthetic Biology: Building on Nature's Inspiration'', 
which was held in November 2009.\2\ This conference invited some 150 
researchers to work in interdisciplinary teams to address some of the 
major questions facing the field. This process was structured to assess 
and develop field-wide perspectives on major scientific and ethical 
topics related to synthetic biology. The resulting findings were 
disseminated to the public in several forms, including a series of 
summaries written by graduate students in science journalism, one of 
whom was part of each interdisciplinary team.
---------------------------------------------------------------------------
    \2\ http://www.keckfutures.org/conferences/synthetic-biology.html 
(accessed June 25, 2010).
---------------------------------------------------------------------------
    In comparison to the Sandpit event, the emphasis of the NAKFI 
conference was more on community and field development than on directly 
driving innovation at the meeting. However, NAKFI also recognizes the 
need to foster high-risk, high-impact research in synthetic biology 
and, accordingly, supported 13 pilot projects developed by attendees 
after the completion of the meeting. Most of these projects targeted 
problems identified as major challenges and opportunities at the event.
    For example, my group and our collaborators are working on a 
project to address the need for new systems for engineering 
communication between cells. Specifically, we are seeking to develop a 
synthetic molecular communication system that can send information 
between bacteria and human cells. This is a fundamental technical 
challenge, and it could also eventually result in applications. As a 
hypothetical example, one could engineer a symbiotic bacteria 
``probiotic'' to patrol within the colon for pathogenic microbes or 
signs of emerging colon cancer and respond by directing the immune 
system to respond appropriately.
    Continued investment to foster the growth of a national synthetic 
biology community and provide mechanisms to drive high-risk, high-
reward research as an essential part of our national research strategy 
will enable the development of this new scientific enterprise and 
catalyze the development of transformative technologies and 
applications in areas including energy, agriculture, the environment, 
materials, and health.

What educational strategies will prepare students and trainees to 
                    pursue these challenges?

    Addressing challenges in synthetic biology, and 21st century 
biology more generally, requires training a new generation of 
undergraduates, graduate students, and postdoctoral fellows who will be 
uniquely prepared to integrate diverse areas of expertise. Working 
effectively on interdisciplinary teams requires the development of a 
common language. Combining rigorous quantitative methods with open-
ended biological design challenges requires balanced development of 
both analytical and creative capacities--we need to train whole-brain 
thinkers.
    At the graduate level, we must move beyond current models in which 
training in synthetic biology often occurs as an outgrowth of training 
within a single existing department. To engage a broad pool of students 
and develop the interdisciplinary capacities they require, we must move 
towards models in which training occurs as part of a broader 
interdepartmental effort. An especially important mechanism for 
promoting these changes would be to provide faculty with support to 
develop and teach new courses designed for this new training model. 
This might be particularly important to implement in institutions where 
there currently exist barriers to interdisciplinary training and co-
advising across departmental boundaries. For such reasons, it is 
imperative that efforts to promote interdisciplinary training be 
flexible enough to allow for innovative models that can thrive within 
different institutional cultures and organizational structures.
    As an example of what such a model might entail, I can describe how 
we are approaching these challenges at Northwestern University. Our 
highly interdisciplinary biological sciences Ph.D. program is an 
excellent model for how graduate education may support 21st century 
biology. It is a life sciences training program that includes a high 
concentration of training faculty drawn from engineering, chemistry, 
and the physical and quantitative sciences. Students benefit from broad 
interdisciplinary training that challenges them to become fluent in the 
languages of multiple disciplines, and to bridge those disciplines in 
order to carry out cutting-edge innovative research projects that move 
life sciences research in exciting new directions.
    We are currently implementing a new innovation in which graduate 
biology education is structured around thematic clusters designed to 
balance depth in certain competencies with flexibility to cross 
disciplinary boundaries. Over the past year, I have led an effort, 
along with Prof. Michael Jewett and other colleagues, to create an 
interdepartmental organization for integrating systems and synthetic 
biology efforts across the university. This organization will include 
training activities including boot camps, to build basic competencies 
and facilitate the development of a common language, ongoing research 
interactions, and new course offerings. Our goal is that such training 
activities will eventually be integrated into the graduate education of 
students with primary homes in biology, engineering, and physical and 
quantitative science departments. Training a new generation of 
scientists and engineers that can fluidly cross traditional 
disciplinary boundaries is critical to achieving the goals of a new 
biology for the 21st century.
    Interdisciplinary training in synthetic biology at the 
undergraduate level is already an active area, driven in large part 
through the International Genetically Engineered Machines (iGEM) 
experience originally developed at MIT.\3\ Each year over the summer, 
teams of undergraduates work on synthetic biology projects of their own 
design, which culminate in gathering to share their results and 
experiences at a ``Jamboree'' held at MIT in Cambridge, MA. By 2009, 
only the fifth year of this event, participation had swelled to include 
112 teams from 26 countries, comprising over 1000 participants.
---------------------------------------------------------------------------
    \3\ Smolke, Christina D. ``Building outside of the box: iGEM and 
the BioBricks Foundation'' (2009) Nature Biotechnology. Vol. 27. no. 
12, pp. 1099-1102.
---------------------------------------------------------------------------
    An examination of student-selected project topics suggests that the 
enthusiasm for iGEM is partly explained by the fact that it builds upon 
the existing desire of our students to apply their capabilities to 
solving real problems and meeting pressing societal needs. Recurrent 
themes include global health, environmental stewardship, and community-
based technology development. Importantly, iGEM also requires that 
teams consider and discuss possible secondary uses of any technologies 
they may develop. By facing these security and ethical issues head-on 
in a tangible context, this experience should help these students to 
carry these considerations forward, to their careers in industry and 
academia, and as informed members of society. Perhaps most importantly, 
this competition promotes innovation, creativity, and self-reliance, 
all of which translate to fostering an entrepreneurial spirit.
    Ongoing challenges in undergraduate education are to incorporate 
interdisciplinary training, and perhaps some elements of an iGEM-like 
experience, into existing discipline-based undergraduate curricula. One 
option is to create interdisciplinary courses that supplement, or serve 
as electives, within multiple existing undergraduate programs. For 
example, an undergraduate synthetic biology elective may bring together 
engineers, biologists, and computer scientists to work in teams to 
tackle problems that involve both computational modeling and wet 
laboratory experiments and insights. I have personally implemented such 
a model of team-based ``cooperative learning'' using synthetic biology 
in my teaching of a core chemical engineering course. Although this 
course focuses on strategies for predicting and controlling the 
dynamics of chemical processes, I regularly use examples drawn from the 
context of biology to build an appreciation for the general 
applicability of these methods. The course culminates in a team-based 
project in which students apply process dynamics and control principles 
to understand and ultimately redesign engineered synthetic biological 
systems. This shift in context helps students to develop their 
abilities to apply their core competencies to new challenges and 
unfamiliar disciplines. Similar strategies may be incorporated 
throughout the various core disciplines that contribute to 21ST century 
biology, since developing student capacities to work on 
interdisciplinary challenges will benefit them in any career they 
eventually pursue.

How will synthetic biology serve the United States' national interests?

    Synthetic biology taps into a vast potential to grow the industries 
that will lead 215t century economies and meet societal needs in 
energy, biotechnology, high-value manufacturing, environmental 
technologies and services, and health. Our international partners and 
competitors in Europe and elsewhere are also investing heavily in this 
sector. However, the U.S. already possesses the essential ingredients 
required to build a competitive advantage and lead the growth of this 
sector. Our adaptable and entrepreneurial culture, in both the private 
sector and in our academic research institutions, positions the U.S. to 
continue to lead this next revolution in biological technology. Through 
capitalizing upon our intellectual resources and rededicating ourselves 
to training the next generation of biologists, engineers, and 
scientists to take on these challenges, we can realize the benefits of 
achieving biology by design.

Summary

    We stand at a transformative moment in the biological sciences, 
where we can collect massive amounts of biological data, and what is 
needed now are new conceptual, computational, and experimental tools to 
transform this information into useful understanding and practical 
applications.
    Developing these capabilities will allow us harness this knowledge 
to meet pressing societal needs in energy (e.g., renewable fuels), the 
environment (e.g., cleanup and ecosystem management), agriculture 
(e.g., climactically robust food crops), materials (e.g., to achieve 
special properties and utilize renewable feedstocks), manufacturing 
(e.g., microbial factories), and health (e.g., advanced vaccines and 
biological therapies).
    At the leading edge of these efforts is a nascent technical and 
scientific discipline called synthetic biology, the central goal of 
which is to transform biology into a system that can be engineered. 
Synthetic biology seeks to enable a new paradigm of biology by design:

          Conceive a given desired biological function

          Design an engineered biological system to perform 
        this function

          Build the system

          The system works as predicted

    Synthetic biology is intrinsically linked to the fundamental 
biological sciences as part of the New Biology of the 21st century. It 
is not a change within biology, engineering, or the physical sciences, 
but rather it is an effort that must span traditional disciplinary 
boundaries. Mechanisms for supporting the integration of these diverse 
strengths are needed.
    The fundamental work required to develop synthetic biology 
capabilities spans the funding and oversight priorities of our Federal 
agencies. Thus, interagency cooperation is also required to maximize 
the progress that can be achieved.
    NSF has supported early synthetic biology efforts through projects 
such as SynBERC. Now, we must also develop interdisciplinary centers 
throughout our research infrastructure and build a national synthetic 
biology community that is integrated with other facets of New Biology.
    Given the early but rapidly expanding scope of synthetic biology as 
a discipline, as well as its potential for transformative contributions 
to society, it is essential that we invest in high-risk, high reward 
projects as a major portion of our national research investment 
strategy.
    Addressing challenges in synthetic biology, and 21st century 
biology more generally, requires training a new generation of 
undergraduates, graduate students, and postdoctoral trainees who will 
be uniquely prepared to integrate diverse areas of expertise.
    The U.S. is positioned to continue to lead this next revolution in 
biological technology and fundamental science, and through capitalizing 
upon our public and private sector capabilities, we can realize the 
benefits of achieving biology by design.
    Mr. Chairman, thank you again for this opportunity to share my 
perspective on this important topic, and I will be happy to address any 
questions you may have.

                    Biography for Joshua N. Leonard

    Joshua N. Leonard, Ph.D. is an Assistant Professor of Chemical and 
Biological Engineering in the McCormick School of Engineering and 
Applied Science and is a member of the Robert H. Lurie Comprehensive 
Cancer Center at Northwestern University in Evanston, IL. Leonard's 
research interests center on using engineering principles to build 
synthetic multicellular networks for applications in biotechnology and 
medicine. Ongoing projects in his research group include developing 
programmable cellular devices, with applications in cancer 
immunotherapy and regenerative medicine, and developing foundational 
synthetic biology technologies for engineering complex functions in 
microbial systems.
    Leonard received a B.S. in chemical engineering from Stanford 
University in 2000, and a Ph.D. in chemical engineering from the 
University of California, Berkeley in 2006. For his doctoral thesis, 
Leonard employed computational and experimental approaches to develop 
novel gene therapies for treating HIV infections in such a way that the 
therapy suppresses the emergence of treatment-resistant viruses. 
Leonard and collaborators also patented a technology for enhancing the 
production of certain gene therapy vehicles. While at Berkeley, Leonard 
also studied entrepreneurship in biotechnology at the Haas School of 
Business and received a certificate in the Management of Technology in 
2005. From 2006-2008, Leonard trained in immunology as a postdoctoral 
fellow at the National Cancer Institute, Experimental Immunology 
Branch, at the National Institutes of Health intramural campus in 
Bethesda, MD. While at the NIH, Leonard led a project that elucidated a 
central mechanism by which the immune system recognizes viral 
infections and initiates an appropriate antiviral response. This 
knowledge led to the development of a family of novel and targeted 
vaccine adjuvants that should be useful in vaccines against viruses and 
cancer. In 2008, he was recruited to his current position as an 
Assistant Professor of Chemical and Biological Engineering at 
Northwestern University. In addition to leading his research group and 
teaching, Leonard serves as faculty mentor for Northwestern's 
international Genetically Engineered Machines (iGEM) team, which will 
participate in this undergraduate synthetic biology experience for the 
first time this year.

    Chairman Lipinski. Thank you, Dr. Leonard.
    Dr. Sanford.

     STATEMENT OF KARL SANFORD, VICE PRESIDENT, TECHNOLOGY 
                     DEVELOPMENT, GENENCOR

    Dr. Sanford. Good afternoon. My name is Karl Sanford. I am 
Vice President of Technology Development for Genencor, and I am 
honored to present this testimony to your Committee.
    Genencor, a division of Danisco, is a leader in industrial 
biotechnology innovation and manufacturing on a global scale. 
We have multiple manufacturing, R&D and sales locations 
throughout the world with a central location in Palo Alto, 
California, and offices and manufacturing plants in Cedar 
Rapids, Iowa, Beloit, Wisconsin, and Rochester, New York. Our 
goal is to push the boundaries of what is achievable in the 
realm of biotechnology and accelerate development of the bio-
based economy.
    This opportunity for my testimony comes at an exciting time 
for Genencor. Recently, we have made some exciting new advances 
in making isoprene from renewable feedstocks that promises to 
help our Nation increase its technological competitiveness and 
decrease its dependency on imported foreign oil, while also 
protecting the environment.
    Genencor started in 1982 as a spin-out company from 
pharmaceutical biotechnology pioneer Genentech, with an 
aspiration of bringing to industrial and everyday customers the 
benefits of recombinant DNA technology to new product features 
and manufacturing efficiencies. Over the past 28 years, we have 
roughly doubled our revenues every five years such that our 
business now approaches $1 billion annually. Our manufacturing 
processes are based on the conversion of biorenewable 
feedstocks, like corn and soy, into bioproducts like enzymes, 
using efficient, large-scale fermentation processes. Every day, 
you eat, use or wear something made with Genencor enzymes.
    Collaboration is a key for success. The rate of improvement 
in the seminal technologies of DNA synthesis, DNA sequencing 
and synthetic biology is continuing to provide accelerating 
innovation opportunities. No single enterprise can go it alone, 
and hence the need for developing effective networks that 
connect the players. As an example, we are an industrial member 
of SynBERC, the Synthetic Biology Engineering Research Center, 
which is an NSF-funded multi-institution research effort 
establishing a foundation for the emerging field of synthetic 
biology. SynBERC's vision is to catalyze biology as an 
engineering discipline by developing foundational understanding 
and technologies, to allow researchers to design and build 
standardized, integrated biological systems to accomplish many 
particular tasks. In essence, SynBERC is making biology easier 
to engineer. It is also engaged in training students who can 
leverage the investments and training as they go forward into 
industry. Powerful new technologies such as synthetic biology 
must also include governance and oversight to fully understand 
any potential unintended consequences. Hence, centers such as 
SynBERC also provide initiatives in which ethics and biosafety 
approaches are purposely incorporated into synthetic biology 
research and development. The collaborative human practices 
model within the NSF-funded SynBERC project was the first 
initiative in which social scientists were explicitly 
integrated into a synthetic biology research program.
    Increasing the science and technology acumen of our society 
and engaging young minds in science and engineering are key 
success factors for improving our innovation potential and 
social receptivity for technology-based solutions. Science 
Bound, Iowa State University's premier pre-college program, 
prepares and empowers Iowan ethnic minority students to earn 
college degrees and pursue careers in science. In its 20th 
year, SCIENCE BOUND has worked with more than 800 middle and 
high school students and offered college scholarships to 200 
program graduates. The program asks 12- and 13-year-olds to 
make a five-year commitment. Working in tandem with expert 
teachers, students can emerge academically equipped as well as 
socially and culturally empowered to earn a college degree in 
science or engineering. We need to further support and expand 
this concept of making science fun and exciting and the 
learning process friendly enough to encourage commitment to a 
career in technology.
    Biotechnology and technology in general are played on an 
international stage. U.S. centricity is insufficient in 
providing the education and training necessary to be among the 
best, brightest and most successful. Language skills, cultural 
perceptivity and global perspective are requirements for 
biotechnology players of the future. International awareness is 
an area for improvement in U.S. education and training.
    The President's Innovation and Technology Advisory 
Committee, PITAC, has identified a technological congruence 
that is called the ``Golden Triangle''. Each side of the Golden 
Triangle represents one of the three areas of research that 
together are transforming the technology landscape today: 
information technology, biotechnology and nanotechnology. Each 
of these research fields has the potential to enable a wealth 
of innovative advances in medicine, energy production, national 
security, agriculture, manufacturing, and sustainable 
environments--advances that in turn help to create jobs and 
increase the Nation's gross domestic product.
    In combination, these fields have an even greater potential 
to transform society. It is this interplay of technologies, 
along with the ever more demanding societal needs, which 
creates grand challenges. Industrial biotechnology is one of 
the tributary themes to this Golden Triangle. Continued 
investment in research, education, business and legal 
developments is necessary to achieve our collective aspiration 
of meeting the needs of the present without compromising the 
ability of future generations to meet their needs. 
Interdisciplinary collaborations that work the Golden Triangle 
in different patterns of innovation may offer routes to 
success, provided the membership, results and ownership 
outcomes are based on transparency, trust and data-based 
decision making.
    Mr. Baird. [Presiding] Dr. Sanford, I am going to ask you 
to conclude as quickly as you can.
    Dr. Sanford. I thank the Committee for the opportunity to 
present these views and welcome any questions and comments.
    [The prepared statement of Dr. Sanford follows:]

                 Prepared Statement of Karl J. Sanford

Introduction

    Good afternoon--My name is Karl Sanford. I am Vice President of 
Technology Development for Genencor, and I am honored to present this 
testimony to your Committee.
    This opportunity for my testimony comes at an exciting time for 
Genencor. Recently, we have made some exciting new advances in making 
isoprene from renewable feedstocks that promises to help our Nation 
increase its technological competitiveness and decrease its dependency 
on imported foreign oil while also protecting the environment.

Genencor Background: A Pioneer in Industrial Biotechnology

    Genencor, a division of Danisco A/S, is a leader in industrial 
biotechnology innovation and manufacturing on a global scale. We have 
multiple manufacturing, R&D and sales locations throughout the world 
with a central location in Palo Alto, California and offices and 
manufacturing plants in Cedar Rapids, Iowa, Beloit, Wisconsin and 
Rochester, New York. Our goal is to push the boundaries of what is 
achievable in the realm of biotechnology and accelerate development of 
the bio-based economy.
    Genencor started in 1982 as a spin-out company from pharmaceutical 
biotechnology pioneer, Genentech, with an aspiration of bringing to 
industrial and everyday customers the benefits of recombinant DNA 
technology through new product features and manufacturing efficiencies. 
Over the past 28 years we have roughly doubled our revenues every five 
years such that our business now approaches about one billion dollars 
annually. Our manufacturing processes are based on the conversion of 
bio-renewable feedstocks like corn and soy into enzymes using efficient 
large scale fermentation processes. Every day you eat, use or wear 
something made with Genencor enzymes. We discover, produce and market 
enzymes to large industrial manufacturers. Our products touch people's 
lives in many ways--getting dirty clothes cleaner while using less 
energy and water doing it; getting clothes to feel better, softer, 
nicer to wear with dramatic reductions to water, energy usage and 
backed by the first textile industry LCA; improving the nutritional 
efficiency of livestock while reducing environmental impact by using 
less chemicals; improving quality, nutrition and safety of human foods; 
converting biomass into sugars, a critical step in the production of 
cellulosic ethanol, other advanced biofuels and biochemicals; creating 
a suite of enzymes for biorefiners who convert grain into higher value 
products such as sweeteners and bioethanol; developing microbial cell 
factories that convert sugars to biochemicals, such as the 
BioIsopreneTM product we are developing with The Goodyear 
Rubber and Tire Company. Our manufacturing processes include innovative 
processes to convert bio-renewable feedstocks like corn into enzymes 
using efficient large-scale fermentation processes.

Networks and Partnerships make a Difference

    Partnerships play an important role in getting the right products 
to the right customer segments in a timely manner. We have teamed with 
the Departments of Energy, Commerce and Defense, and some of the 
largest consumer, food product and chemical companies in the world. For 
example, we partnered with DuPont in the mid 1990s to design and 
develop the bioprocess for making BioPDOTM monomer from 
corn. That project took almost ten years before the first commercial 
sale was realized in 2006. We teamed with DuPont again in 2008 to form 
the joint venture company, Dupont Danisco Cellulosic Ethanol LLC 
(DDCE), to commercialize the technology for conversion of biomass to 
ethanol. DC. aims to be the world's leading cellulosic ethanol company 
and a key player in facilitating global energy independence and 
sustainable fuel supply. At present, we are working with The Goodyear 
Rubber and Tire Company to commercialize a bioprocess for making 
isoprene, a key ingredient for synthetic rubber, from renewable 
feedstocks. Our technology allows for the bio-based production of 
isoprene and represents a significant move away from the use of and 
reliance on petroleum-derived isoprene. A concept tire made with our 
BioIsopreneTM product was on display at the United Nations 
Climate Change Conference in Copenhagen (the COP 15 meeting) in 
December, 2009.

Sustainability is Good Business

    Genencor has made sustainability a centerpiece of its business 
strategy. The goal of sustainable development is to meet the needs of 
the present without compromising the ability of future generations to 
meet their needs. This means that we pursue the long-term viability and 
progress of our business while taking responsibility for improving the 
environmental, economic, and social conditions resulting from our work. 
Examples of our commitment and leadership in business practice include 
winning the 2003 Presidential Green Chemistry Award for the microbial 
production of 1,3-propanediol along with DuPont and in 2009 winning the 
national Sustainable Energy Award from the American Institute of 
Chemical Engineers (AIChE) for our Accellerase family of enzymes for 
cellulosic ethanol. The AIChE Sustainable Energy Award recognizes the 
critical impact of chemistry and biochemistry innovations in developing 
sustainable energy solutions. In addition, we recently introduced our 
PrimaGreen EcoWhite product, which is a unique and first-to-market 
enzyme. This enzyme powers the system that will be sold by Huntsman 
Textile under the name Gentle Power BleachTM. This novel 
bio-bleaching technology significantly reduces energy and water 
consumption in wet textile processing, while improving fabric quality. 
Our commitment to sustainable and environmentally responsive innovative 
solutions is also demonstrated by our work on biologically based 
methods for producing isoprene. Our BioIsopreneTM research 
and development collaborator, The Goodyear Rubber and Tire Company, won 
the Environmental Achievement of the Year Award in 2010 for the concept 
tire made with our BioIsopreneTM product--a breakthrough 
alternative to petrochemically produced tires.

Collaboration boosts Innovation

    Genencor is a leader in industrial biotechnology and a participant 
along with university, business and government laboratories in further 
developing the underlying technologies that propel this platform of 
innovation forward. Collaboration is a key theme for success. The rate 
of improvement in the seminal technologies of DNA synthesis, DNA 
sequencing and synthetic biology is continuing to provide accelerating 
innovation opportunities. No single enterprise can to go it alone and 
hence the need for developing effective networks that connect the 
players. As an example, we are industrial members of SynBERC, The 
Synthetic Biology Engineering Research Center, which is an NSF funded 
multi-institution research effort establishing a foundation for the 
emerging field of synthetic biology. SynBERC's vision is to catalyze 
biology as an engineering discipline by developing the foundational 
understanding and technologies to allow researchers to design and build 
standardized, integrated biological systems to accomplish many 
particular tasks. In essence, SynBERC is making biology easier to 
engineer. It is also engaged in training students who can leverage the 
investments and training as they go forward into industry. Powerful new 
technologies such as synthetic biology must also include governance and 
oversight to fully understand any potential unintended consequences. 
Hence, centers such as SynBERC also provide initiatives in which ethics 
and biosafety approaches are purposely incorporated into synthetic 
biology research and development. The collaborative Human Practices 
model within the NSF-funded SynBERC project was the first initiative in 
which social scientists were explicitly integrated into a synthetic 
biology research program. The Woodrow Wilson International Center for 
Scholars also provides new opportunities for collaboration emerging 
between scientists and social scientists working on synthetic biology.

Making Biotechnology Interesting Enough to Learn About

    Increasing the science and technology acumen of our society and 
engaging young minds in science and engineering are key success factors 
for improving our innovation potential and social receptivity for 
technology based solutions. Science Bound, Iowa State University's 
premier pre-college program, prepares and empowers Iowan ethnic 
minority students to earn college degrees and pursue careers in 
science. In its 20th year, Science Bound has worked with more than 800 
middle and high school student and offered college scholarships to 200 
program graduates. The program asks 12 and 13 year olds to make a five-
year commitment. Working in tandem with expert teachers, students can 
emerge academically equipped as well as socially and culturally 
empowered to earn a college degree in science or engineering. We need 
to further support and expand this concept of making science fun and 
exciting and a learning process friendly enough to encourage commitment 
to a career in technology. To this end, we have a very active summer 
intern program that brings undergraduate and graduate level college 
students to Genencor to work on a variety of biotechnology projects 
over the summer months. In addition, we have representatives engaged 
with various community and local industry boards to help educate and 
foster public awareness and policy. We are also active members in 
industry groups such as the Biotechnology Industry Organization (BIO), 
Europabio and BayBio, an association serving the life science industry 
in Northern California.

International Awareness

    Biotechnology and technology in general are played on an 
international stage. U.S. centricity is insufficient in providing the 
education and training necessary to be among the best, brightest and 
most successful. Language skills, cultural perceptivity and a global 
perspective are requirements for biotechnology players of the future. 
International awareness is an area for improvement in U.S. education 
and training.

The Golden Triangle

    The President's Innovation and Technology Advisory Committee 
(PITAC), has identified a technological congruence that is called the 
``Golden Triangle.'' Each side of the Golden Triangle represents one of 
three areas of research that together are transforming the technology 
landscape today: ``information technology, biotechnology, and 
nanotechnology. Information technology (IT) encompasses all 
technologies used to create, exchange, store, mine, analyze, and 
evaluate data in multiple forms. Biotechnology uses the basic 
components of life (such as cells and DNA) to create new products and 
new manufacturing methods. Nanotechnology is the science of 
manipulating and characterizing matter at the atomic and molecular 
levels. Each of these research fields has the potential to enable a 
wealth of innovative advances in medicine, energy production, national 
security, agriculture, manufacturing, and sustainable environments--
advances that can in turn help to create jobs, increase the nation's 
gross domestic product (GDP), and enhance quality of life.'' In 
combination, these fields have an even greater potential to transform 
society. It is this interplay of technologies along with ever more 
demanding societal needs, which creates grand challenges. Industrial 
biotechnology is one of the tributary themes to this Golden Triangle. 
Continued investment in research, education, business and legal 
developments is necessary to achieve our collective aspiration of 
meeting the needs of the present without compromising the ability of 
future generations to meet their needs. Interdisciplinary 
collaborations that work the Golden Triangle in different patterns of 
innovation may offer routes to success provided the membership, results 
and ownership to outcomes are based on transparency, trust and data-
based decision making.
    A recent study by the National Research Council, ``A New Biology 
for the 21st Century'', recommends the integration of the many sub-
disciplines of biology, and the integration into biology of physicists, 
chemists, computer scientists, engineers, and mathematicians. The most 
effective leveraging of investments would come from a coordinated, 
interagency effort to encourage an integrated approach to biological 
research focused on key problem solving areas. This study provides a 
roadmap to `21st Century Biology'.

Fostering University--Industry Collaboration

    The Bayh-Dole Act provides the process through which technology 
transfer from university laboratories to industry happens. University 
patents and start-up companies based on these intellectual assets have 
provided a significant boost to U.S. economic growth over several 
decades. There is opportunity to do more and a process to assess 
current barriers and potential new incentives should be undertaken. 
Examples are the following: current procedures do not allow companies 
that fund work in universities to own the IP; legal processes are 
cumbersome and the opportunity exists to slim-line these processes so 
that investments are largely for the technology development not the 
legal negotiation.
    I thank the Committee for the opportunity to present these views 
and welcome any questions or comments.

                     Biography for Karl J. Sanford
    In reference to the invitation from Chairman Lipinski to testify 
before the Subcommittee on Research and Science Education on June 29, 
2010 with respect to 21st Century Biology, I (Karl J. Sanford) provide 
the following biographical information. I am currently Vice President 
of Technology Development at Genencor, a Division of Danisco and have a 
substantial track record of success as an industry leader in 
establishing the industrial biotechnology industry as we know it today.
    Specific examples of my track record pertinent today's testimony 
are the following: 1) member of founding management team for Genencor 
International which has grown from nothing to over $800 M in industrial 
product sales 2) 25 years of continuous technology and research 
activities in bringing many industrial enzymes to the market place 
addressing customer needs in detergent, grain processing, textile 
manufacturing, animal feed and human nutrition, biomass hydrolysis, 
bio-bleaching, silicon biotechnology and metabolic pathway engineering/
synthetic biology. 3) leader in developing productive collaborations 
which include ADM/amino acid processes, Eastman Chemical/ascorbic acid 
continuous bio-catalysis, DuPont/BioPDO pathway engineering, Dow 
Corning/Silicon Biotechnology development and The Goodyear Rubber and 
Tire Co/BioIsoprene synthetic biology development. The commercial 
contribution in terms of annual product sales that derive from these 
and other related activities in the biotechnology sector exceed $3 
billion USD. 4) Advisor to various government led initiatives that were 
seminal in laying the foundation for the current industrial 
biotechnology and biofuels sectors. Highlights include: a) Compact 
signing for the Plant/Crop-Based Renewables at the Commodity Classic, 
Long Beach, CA., February, 1998 b) Plant/Crop-Based Renewables 2020 
Vision and Road Map. c) Congressional testimony to House Committee on 
Science Subcommittee on Technology on Industrial Biotechnology National 
Competitiveness, February 1998 d) Testimony to Senate Committee on 
Agriculture, Nutrition and Forestry Hearing on The New Petroleum: S. 
935, the National Sustainable Fuels and Chemicals Act of 1999 May 27, 
1999 on importance of industrial biotechnology and bioenergy e) Thought 
leader and participant for Global Energy Technology Strategy Program 
(GTSP) in generating Applications of Biotechnology to the Mitigation of 
Greenhouse Warming, 2003.
    I believe that my record demonstrates a substantial contribution to 
the industrial biotechnology sector. Genencor has established itself as 
a world leader in this sector which includes enzymes for corn 
bioethanol processing, enzymes for biomass hydrolysis, total solution 
for cellulosic ethanol production through our joint venture with 
DuPont, the DC. Company, and production of hydrocarbon biofuels from 
our BioIsopreneTM platform. I believe this combination of 
pioneer and thought leadership in anticipating what the technology and 
customer needs could be and the persistence and tenacity to design and 
build the products and processes to meet them distinguishes my record.

    Mr. Baird. Great. Thank you, Dr. Sanford. I apologize for 
the interruption. Those beeps or noises you heard are a call to 
a vote. We have about 15 minutes. We are Pavlovian here. We 
begin to salivate when we hear those.
    Thank you to all the witnesses for the testimony. Dr. 
Lipinski departed so that he can vote and then come back, and 
our goal will be to try to keep the hearing going rather than 
have a prolonged interruption while we go and congratulate 
sports teams and name post offices.
    I want to thank the witnesses, believe it or not, for their 
expertise and their input. I will recognize myself for five 
minutes, followed by Dr. Ehlers.
    I am intrigued by this concept and excited by it. As I get 
it, basically the idea is that we are going to--the new biology 
refers to the integration, sort of cross-disciplinary 
integration of lots of other fields--physics, chemistry, 
computational technologies, engineering--and the report 
suggests that one of the ways we develop this cross-
disciplinary new biology is to apply it to kind of `grand 
challenges,' and that all makes good sense to me. So my 
question is, NRC makes this report. Distinguished folks like 
you folks seem to be behind it. The biological section of NSF 
already receives a lot of money, a $767 million request for the 
next year. What is going to happen? Do you think--and maybe Dr. 
Collins, this is appropriate to ask you. Dr. Laubenbacher, you 
seem to be working in an area where, actually, you are applying 
this, as many of you do. But what happens to NSF now? Do they 
look at this NRC report and say, by golly, these folks are 
right, let us start focusing our research funding on this, or 
do they keep in the same kind of channels they may have been 
in?
    Dr. Collins. Congressman, NSF played a role, actually, in 
calling for the report. We were one of the agencies that were 
involved in it, and in fact, we have already started to marshal 
resources. I shouldn't say ``we'' since I am no longer with 
NSF. But the Foundation has already started to marshal 
resources along these lines--some of the things I referred to, 
actually, in terms of these new ways to look at 
interdisciplinarity. NSF has hired program officers jointly 
between directorates, for example. The sandpit process that Dr. 
Leonard referred to was one that we called for.
    Mr. Baird. Give us a 15-second summary of a sandpit other 
than children playing in sand. With five-year-olds, my mind 
goes there.
    Dr. Collins. So the sandpit is in fact the sandbox but it 
is out of the United Kingdom. That is where we got it. So your 
image is exactly the right image. We posted a question in 
synthetic biology: give us your best ideas. A hundred and 
seventy two-page applications came in, front page, what is your 
idea, back page, a series of questions prepared by an 
industrial psychologist--how well do you play in groups, for 
example, interest in interdisciplinarity. A committee chose 30 
of those individuals and they were all brought here, just 
outside Washington, D.C., for a week, put together with program 
offices for real-time review of their questions, and groups 
were put together and matched within that week-long period. And 
at the end of it, we got five to eight exciting proposals, some 
funded by the United Kingdom, some funded by the NSF.
    Mr. Baird. So get some really bright people who work well 
together, get them together and set them loose?
    Dr. Collins. Set them loose.
    Mr. Baird. Neat.
    Dr. Collins. And it was a really creative way, the sandpit, 
sandbox, however you want to think about it. And we picked this 
edgy, innovative area with emerging stuff that is rough, that 
is right at the edges, and synthetic biology was the first 
place that we went to, for all the reasons that are in the 
report.
    Mr. Baird. Got you. So NSF is already working on this. As 
they are selecting their new person to replace your position, 
that person presumably will be savvy to this integrated issue. 
The other directors of other NSF programs are also on board?
    Dr. Collins. They are, so when we decided to do this area 
of synthetic biology in the sandpit, engineering came on board 
very quickly, and then as the other directorates heard about 
it, all of a sudden we had the social sciences in, we had 
education and human resources, math and physical sciences. At 
the end of the day, all the groups had a piece of it.
    Mr. Baird. Great. How will this affect grant applications 
and then how does it affect your training? You know, when I 
used to chair at a psychology department, I had this fun idea 
that we would just put all these disciplines and faculty 
members in a hat and we would draw another discipline out, so I 
might draw nursing faculty or chemistry faculty or PE and all 
kinds of neat things would come. All the other faculty freaked 
out. They said oh, we can't do that. It seemed to me pretty 
exciting. But how is it affecting your educational enterprise 
in preparing the students who will feed this new biology 
effort?
    Dr. Collins. So look, I think the real challenge is to get 
students to be comfortable going into that sort of arena. 
Faculty members, as I suggested in here, have to get much more 
comfortable with lowering the barriers, much the way they are 
often lowered in industry where folks can move around much more 
easily.
    Mr. Baird. Any others wish to comment on that? I have only 
got about 40 seconds left, so Dr. Laubenbacher?
    Dr. Laubenbacher. Yes. I think in terms of training, it 
reminds me a little bit of the 1990s when we introduced 
calculators into teaching calculus. It is difficult to teach an 
old dog new tricks, as they say, and the students were far 
ahead of the professors at that time, and I think similar 
things will happen here, that students, as they grow up, if 
they are provided with the right environment, they will be way 
ahead in terms of interdisciplinary thinking.
    Mr. Baird. Thank you.
    I am going to recognize--thanks to all your answers. I have 
to be brief, so I recognize Dr. Ehlers for five minutes.
    Mr. Ehlers. Your questions were so brilliant, Dr. Baird, 
that they leave me wordless, so if you wish to pursue yours any 
further, go ahead. I just want to say I found this very 
enlightening, and I have got to wrap my mind around it a bit 
more. But I really--what you are doing is wonderful and it is 
what I would love to do if I could return to science today. It 
is just so exciting to hear this again. It brings back the 
memories of how exciting science was when I first encountered 
it, and I would love to join you.
    Mr. Baird. I do have a follow-up, and both Dr. Ehlers and I 
are going to retire. Maybe, Vern, we should go back in and both 
of us sign up and take this coursework if our aging brains 
could--but, see, they will come up with a device that will 
allow our aging brains to comprehend what they are doing.
    Mr. Ehlers. Speak for yourself.
    Mr. Baird. Oh, okay. Sorry.
    On a more serious note, though, so I am very intrigued by 
this issue of how we train people for this, because it is 
already a pretty challenging thing to get a Ph.D. in biology. 
Now you have got to somehow be able to interface with physics, 
chemistry. I mean, there is already a certain base level of 
awareness, et cetera, but are we going to need a longer amount 
of time in the training process, or is there just a new way of 
sort of wrapping one's head around the multidisciplinary 
approach? And I open that to everybody but Dr. Yamamoto and 
maybe Dr. Sanford, you can talk about how you are doing this in 
your applied realm.
    Dr. Yamamoto. Well, let me begin and say that I am hopeful 
that not only will we not require more time for the training, 
but we will require less. The training periods in biology have 
gotten to be very extended to the point that investigators 
don't really begin their independent work until in their 40s 
and may have passed or at least lost some of the kind of age in 
which they are doing their boldest thinking and their boldest 
research. So hopefully the amount of time can come down. So the 
question then, of course, is a very good one, and that is, how 
can this happen? And I would say that there are two ways to 
think about this. One is that we need increasingly to be 
thinking about working in teams, that increasingly we will have 
scientific endeavors that are carried out by groups of people 
who don't share the same expertise but have enough familiarity 
that they know the kinds of tools that are needed, the kinds of 
experiments that need to be done, even though they themselves 
may not know how to do them.
    Mr. Baird. So it seems to me that needs to--not to pat 
myself on the back, but that model I had of working at a very 
early undergraduate age where you are just really used to 
saying, okay, so I am a social science major, but this semester 
I am taking a course with physics students--that needs to 
happen very, very early on, so it is integrated into who you 
are.
    Dr. Yamamoto. Your model is exactly right, and so that in 
the teaching of biology we need to be integrating some of these 
physical principles that weren't really needed before. We have 
passed through an era in which biology was mostly descriptive. 
We were trying to identify all the characters, see what they 
look like in the microscope, for example, and we have now 
advanced to a point where we really need to understand in a 
quantitative way how these things interact. And we are moving 
on to being able to require the physical principles, 
mathematical manipulations to be able to understand what these 
things are. And students can comprehend that and understand it 
early on and be able to integrate that learning. So it will be 
teams, and a broader education from the outset, exactly as you 
said.
    Mr. Baird. I have got to run and vote, as probably does Dr. 
Ehlers. Dr. Lipinski will resume the Chair. I apologize, I 
won't be here to hear the answer. Any quick comment before I 
go?
    Dr. Sanford. Yes, I would emphasize the word ``teams,'' 
building interdisciplinary teams where the team has a 
composition of the expertise required to solve the problem and 
the problem is very important to help focus the attention of 
the team members on working together.
    Mr. Baird. Thank you.
    Chairman Lipinski. The Chair will now recognize himself. I 
will have the opportunity now to ask my questions and conclude 
the hearing. I ran out there to vote to make sure that we could 
have this time to conclude the hearing rather than have you sit 
here probably waiting 45 minutes at least for us to finish with 
our votes and give the opportunity for those members to ask 
questions.
    A couple things that I wanted to ask, and I will keep 
watching. As soon as this vote ends, I am going to have to run 
out of here quickly, finish up here, dismiss you and run out. 
But a couple questions. First, a broad question, mainly for Dr. 
Sanford and Dr. Leonard but for anyone else who has any--wants 
to offer any views on this. How does the U.S. position in 
synthetic biology compare to other nations? If we have an edge, 
what are our primary obstacles to keeping that edge? Dr. 
Sanford, why don't you start?
    Dr. Sanford. Yes. My view is that the United States is 
number one in the world in terms of leading this thrust around 
synthetic biology, even defining the term and integrating the 
disciplines that are required to make synthetic biology work. 
Having said that, I think there is broad participation around 
the world, and frankly there is much more eagerness that I see 
on the part of students and numbers of students in other parts 
of the world, that I think the United States needs to really 
make the science and engineering, math and technology a number 
one agenda for bringing students into this field versus 
transaction specialists.
    Chairman Lipinski. Dr. Leonard?
    Dr. Leonard. I guess I can comment on an aspect that is 
related to sort of the previous question as well, which has to 
do with the undergraduate synthetic biology competition called 
iGEM [international Genetically Engineered Machine], so this is 
an international competition, and over the five years that it 
has been around it has seen increasing international 
participation. And the teams that participate from outside of 
the United States are strong in taking the top prize several 
years now going so there is a groundswell outside the United 
States as well in interest in this area. So I would just second 
Dr. Sanford's comment--that in my experience, it is still a 
hotbed of activity and probably the majority of the driving 
laboratories are currently in the United States, although there 
is potential for competition and growth all over the world.
    Chairman Lipinski. Do any other witnesses have any comments 
on this?
    Dr. Collins. Well, I think in terms of sustaining our edge, 
it really does go to the comments that were made by all of us, 
and that is, whatever can be done to facilitate the open 
sharing of knowledge between different groups, whether it is 
within departments in terms of universities or across our 
Federal funding agencies, this openness is really going to be 
important as far as powering something like synthetic biology 
where you do need the basic biological information reinforced 
by physicists, by engineers, mathematicians. And it is that 
culture, that environment of innovation that--however we can 
continue fostering that is going to be central to keeping the 
edge in terms of synthetic biology.
    Chairman Lipinski. Dr. Yamamoto.
    Dr. Yamamoto. The New Biology report would suggest that by 
enunciating these major challenge areas, that it will generate 
the technologies that we need to be able to answer the 
questions, and this was really the case when the decision was 
made to put a man on the moon, the decision was made to 
sequence the human genome. In neither of those cases, at the 
time that the challenges were enunciated, were the technologies 
available to actually achieve the goals, and it was by 
enunciating the challenge and capturing the imagination of 
scientists about the ways that they could contribute to these 
challenges that those technologies became generated. And the 
impact of being able to achieve those challenges has been 
immeasurable.
    There is an article in Nature magazine today about the 
impact of sequencing the human genome that goes well beyond 
being able to simply know the order of the nucleotides and the 
genome, and so that is a long way of saying that I think that 
the capacity for the United States to maintain a lead in 
synthetic biology and these other areas could actually hinge on 
the decision by our government, or by ourselves, to enunciate 
these kinds of challenges, capture the imagination of 
scientists as well as the public at large, in ways that they 
can contribute. And that will certainly include this new, 
exciting field of synthetic biology that really has a place, as 
we heard, in each of these areas.
    Chairman Lipinski. Following up a little bit on that, if a 
new biology research initiative were created by the Federal 
Government, what should be done to ensure that the private 
sector is actively engaged and that the resulting research 
discoveries are translated to the marketplace? Whoever wants to 
start. Dr. Sanford?
    Dr. Sanford. One of the very important elements of working 
with universities, from a Genencor standpoint, is access and a 
window into new technologies. And I would use SynBERC as an 
example of such a consortium of not only universities, but 
companies that can participate and exchange ideas and learn 
together, also offer students training in the companies where 
we use internships, for instance, in the summer to host some of 
the SynBERC students, and this is a great way to get dialog and 
the exchange of information of developers of the technology and 
the users of the technology. Second, I think we have an 
opportunity to make the legal system a little bit more 
responsive and easier to negotiate in terms of licensing 
technologies from the universities into companies.
    Chairman Lipinski. Dr. Yamamoto, do you want to add 
something?
    Dr. Yamamoto. I think that one of the other key elements of 
the New Biology report was the whole notion of cooperation 
between agencies that are supporting life sciences research, 
and we have entered an exciting--one of the ways to think about 
the exciting area of biology that we have now entered is that 
we have in place kind of--we have all the cards on the table. 
You can play a different card game when you know that all the 
cards are on the table, and that is really where we are now, 
and having reached that, we can enunciate challenges that go 
from the most fundamental sort of question to the capacity to 
apply them. And I think the role that the government could play 
in being able to contribute to this is to be able to make funds 
available that will bring together these sectors. So one of the 
things that the New Biology report talks about in particular is 
different agencies within the Federal Government, over 20 of 
them, as you know, that are supporting life sciences research, 
being motivated by funding to be able to be working together--
funds available, for example, only for projects that require 
the expertise of two or more Federal agencies. Exactly the same 
sort of scheme could be used for bringing together the public 
and private sector, and putting together exciting new decadal-
level challenge ideas that can be accomplished only through 
application of fundamental research that takes place within 
academia, and its development and application in the private 
sector.
    Chairman Lipinski. Dr. Collins.
    Dr. Collins. In my written testimony, I alluded to an 
article in Sunday's New York Times on these proof-of-concept 
centers that are being tried at a variety of universities now 
that have to do with funding ideas very early in the stream, as 
far as getting them transferred into technology. Our funding 
agencies could play a role there. That is a policy decision as 
far as the government is concerned--where Federal money should 
be used in crossing this so-called `valley of death' between an 
idea and getting it into technology. But there is also a place, 
as far as basic research organizations like the NSF is 
concerned, for funding individuals who want to study this 
entire process of moving from idea into technology. Upstream, 
how do you get it started, and downstream, what are the 
conditions under which it is successful or not successful, and 
what can we learn from both of those sorts of things? So it 
seems to me there are a variety of places where this could be 
thought through, both in terms of injecting funds, but also 
studying the process itself and how it works.
    Chairman Lipinski. Dr. Laubenbacher.
    Dr. Laubenbacher. I think synthetic biology is a real 
poster child for the kind of research that the National 
Academies' report advocates, and I think everything that the 
members of this witness panel have talked about apply to it, 
and in particular as Dr. Leonard mentioned, the iGEM 
competition is an incredibly good tool to get students excited. 
We have one of those. We field a team at our institute, and it 
has been terrific to watch.
    In terms of making sure that the fruits of basic research 
get turned into products that actually help society, I think 
that, again, synthetic biology in other areas--for example, I 
am a bit familiar with research done by pharmaceutical 
companies. As basic research becomes very important, I think 
there will be more opportunities for research collaborations 
between companies and academics that do not involve IP issues, 
and intellectual property is, in many cases, the stumbling 
block between successful--for successful collaborations.
    Chairman Lipinski. Thank you.
    One very quick, and if I can get an answer quickly from Dr. 
Sanford and maybe you want to follow up in a written form, how 
well do you think the current regulatory guidelines apply to 
synthetic genomics? Do we need a different set of guidelines 
for synthetic genomics relative to natural genomics?
    Dr. Sanford. Yes, I do. I think that is true. We do need 
additional guidelines with regard to synthetic biology. One 
example is that in the regulatory terminology there is no such 
thing as a chassis. What is used as a host strain would be 
another terminology. So when a synthetic biology company brings 
forward to their regulatory experts terminologies that they are 
not familiar with and that really don't have a track record, 
probably at the very least, the regulatory trail is now 
complicated and lengthened. So I think there is an opportunity 
here to get ahead of the wave, so to speak, and do some 
definitions and some exchange of information with regulatory 
experts to get advice on how to do this without undue problems.
    Chairman Lipinski. Thank you for being quick there. 
Anything else you want to add, I would appreciate a follow-up 
in writing if there is anything else you want to add to that 
answer. But I want to thank all the witnesses today for their 
testimony. The record will remain open for two weeks for 
additional statements from the Members and for answers to any 
follow-up questions the Committee may ask of the witnesses. It 
was a very good hearing and we had--despite all the 
competition, we had a good turnout of Members and I expect 
there will be some follow-up questions to this, and with that, 
the witnesses are excused and the hearing is now adjourned.
    [Whereupon, at 3:12 p.m., the Subcommittee was adjourned.]

                              Appendix 1:

                              ----------                              

                   Answers to Post-Hearing Questions

Responses by Dr. Keith Yamamoto, Chair, National Academy of Sciences' 
        Board on Life Sciences, and Professor, Cellular and Molecular 
        Pharmacology, University of California, San Francisco

Questions submitted by Representative Brian P. Bilbray

Q1.  Assuming a national Electronic Medical Records (EMR) 
infrastructure is eventually developed, what are the existing 
impediments to the future utilization of EMR data for research?

A1. We are very far from a national EMR, but it is an important and 
worthy goal that could have enormous impact for both health and 
research. A range of potential impediments to utilization of EMR data 
for research would need to be recognized and addressed:

        a.  Privacy/Security. Robust, broad-based but stratified 
        consenting for collection, archiving, accessing different 
        categories of information, tissues, etc. coupled with assurance 
        of appropriate protection of information.

        b.  Access. Standardization of identifiers for medical care 
        purposes; mechanisms for removal of identifiers for many 
        research purposes; firewall separation of different categories 
        of information for access by different stakeholders and 
        interested parties: the individual subject of record, emergency 
        medical personnel, clinical caretakers (primary and 
        subspecialists), insurers, researchers.

        c.  Standardization. Information fields; nomenclature; 
        preservation, fixation, storage, recovery and distribution 
        protocols for tissues/fluids/images/molecules

        d.  Scope. Range of information and materials to be included; 
        ongoing updating of information and materials for longitudinal 
        analysis.

        e.  Integration. Systems and network computational 
        methodologies for organization and analysis of multiple classes 
        of information--pathophysiological, epidemiological, 
        behavioral, histological/imaging, molecular.

Q2.  Unfortunately, the capacity to quickly generate enormous amounts 
of data has grown far more rapidly than our investments in mid-level 
cyber-infrastructure--e.g. high-performance computers, mass storage, 
and database development and support. Are there opportunities to 
promote increased efficiency regarding our investments in cyber-
infrastructure, especially as the capacity to generate data continues 
to soar?

A2. The two largest barriers to efficient utilization of research data, 
databases and material repositories are lack of standards and enforced 
access/sharing of information/materials at appropriate times/levels. 
The Federal Government, via the power of funding, could potentially 
address both problems, but setting of missions, standards and funding 
are currently fragmented (e.g., life sciences research is supported by 
>20 Federal agencies with separate budgets, overlapping but commonly 
competing missions) across agencies that often themselves host multiple 
noninteractive information systems. If project funding was made 
conditional, dependent upon agreements to share information and 
materials, and to provide information access through a common data 
platform, these barriers could be significantly ameliorated.

Q3.  How do you envision the ``new biology'' approach achieving a 
reasonable balance between funding fundamental basic science and 
applied research?

A3. President Obama has established clearly the rationale for sustained 
commitment of public support of basic science: ``An investigation . . . 
might not pay off for a year, or a decade, or at all. And when it does, 
the rewards are . . . enjoyed by those who bore its costs, but also by 
those who did not. That's why the private sector under-invests in basic 
science--and why the public sector must invest in this kind of 
research.'' Hence, while the opportunities for translation and 
application of fundamental discoveries clearly deserve attention and 
require focus, Federal funding must also maintain a central focus on 
basic research; the NIH, for example, has long maintained a ratio of 
approximately 60:25:15 for basic:translational:clinical research. The 
New Biology report describes three strategies to help ensure that the 
funding balance effectively promotes and achieves applications of 
fundamental discoveries:

        a.  Enunciate and adopt decadal challenges to inspire and focus 
        efforts extending from discovery to application on urgent 
        societal needs in the areas of health, energy, food and the 
        environment.

        b.  Better recognize the unity of biology, and thus the 
        potential for basic science advances or applications in one 
        area to contribute to others, by developing programs that 
        facilitate and drive cooperative research programs across two 
        or more agencies that address questions not otherwise 
        accessible by a single agency.

        c.  Establish new models for public-private research ventures 
        that reduce barriers in the continuum from basic discovery in 
        academia to development and application in industry.
                   Answers to Post-Hearing Questions
Responses by Dr. Karl Sanford, Vice President, Technology Development, 
        Genencor

Questions submitted by Chairman Daniel Lipinski

Q1.  How well do you think the current regulatory guidelines apply to 
synthetic genomics? Do we need a different set of guidelines for 
synthetic genomics relative to natural genomics?

A1. At the conclusion of the oral testimonies of the invited witnesses 
at the U.S. House of Representatives Committee on Science and 
Technology Subcommittee on Research and Science Education on 21st 
Century Biology, on June 29, 2010, Subcommittee Chairman Daniel 
Lipinski (D-IL) invited additional input regarding regulatory 
implications on this subject matter. Specifically, Mr. Lipinski asked 
how the current regulatory guidelines apply to synthetic genomics, and 
whether we need a different set of guidelines for synthetic genomics 
relative to natural genomics. We respectfully submit this additional 
perspective.
    The new biology for the 21st century builds upon the existing 
regulatory framework that has provided for the safe and effective 
development, manufacture and use of many bio-products that are in 
commerce today across the health, food, agricultural and industrial 
sectors. We anticipate continued rapid advancement in this field due to 
many factors; the ongoing development of DNA synthesis and sequencing 
technologies, more efficient molecular and microbiology methods and 
continued integration of nano- and information technologies. In 
addition, synthetic biology will catalyze the transformation of biology 
to an engineering discipline through design and construction of 
standardized, integrated biological parts, components and systems 
broadening the potential for private sector applications. All of these 
advances will shorten product development times and accelerate the pace 
of innovation, improving economic outcomes for the private sector 
thereby improving our nation's ability to compete in the global economy 
based on a `faster, better and cheaper' model.
    As Synthetic Biology is an emerging field, it is still too early to 
know precisely what will be required to ensure that the science is 
conducted in a safe and ethical manner and that any products resulting 
from it are also safe. However, past models offer insight into how we 
should move forward in a collaborative, productive manner to ensure our 
dual goals of safety and continued innovation. To guide the regulatory 
process of 21st Century Biology, we submit three major points for 
consideration:

          The Golden Triangle of information technology, 
        biotechnology and nanotechnology, described by the President's 
        Innovation and Technology Advisory Committee (PITAC) can be 
        used as a guide to identify agencies and individuals who 
        understand the science behind innovations as well as its 
        ramifications with regard to safety and ethics.

          Government can also utilize the model of study and 
        policy formation that was carried out for biotechnology in the 
        early 1980s by the FDA, USDA, OSHA and EPA. The proposed 
        policies published by the Office of Science and Technology 
        Policy, Coordinated Framework for Regulation of Biotechnology, 
        FR 51 (123): 23302-23393, June 26, 1986, allowed industry and 
        interested persons to comment and resulted in the final 
        biotechnology regulatory policies and rules which proved vital 
        in helping guide the science and industry forward.

          In addition, the NIH Guidelines for Research 
        Involving Recombinant DNA molecules, instituted to assure safe 
        use of rDNA technology in research, may need to be modified to 
        include the new concepts of synthetic biology. (Please see: 
        http://oba.od.nih.gov/oba/rac/guidelines-02/
        NIH-Guidelines-Apr
        -02.htm) Also, EPA's TSCA biotechnology regulation 
        is based on the concept that intergeneric microorganisms are 
        new. It is therefore a specific regulation which will also need 
        revision to include the concepts of synthetic biology. (Please 
        see: http://www.epa.gov/biotech-rule/index.htm)

    Due to the above described existing framework, we do not recommend 
the formation of a new agency or regulation at this time, but strongly 
suggest that key individuals from the existing agencies are involved in 
the process of identifying risks and safeguards in order to arrive at 
well-informed decisions on modifications of existing guidelines.
    In summary, given the number of unknowns and the many facets of New 
Biology, close collaboration between industry, academia and regulators 
is required to ensure all decisions made are from a well-informed 
position, are based on sound science, and with international 
coordination (e.g., the EU has ongoing discussions on synthetic 
biology: link http://ec.europa.eu/research/biotechnology/ec-us/
workshop-on-standards-in-synthetic-biology-2009-en.cfm) as 
this new field of science is emerging quickly in many regions of the 
world. This close collaboration will ensure that together we can 
explore the science involved, anticipate new technologies or 
combinations of technologies, discuss potential outcomes, identify any 
new ethical and safety issues that require guidance and begin to craft 
any new regulatory modifications that are identified. As the committee 
heard during the testimony on June 29th, this new frontier offers many 
promising developments for a more sustainable future. We look forward 
to working with regulators and our colleagues in academia to ensure 
that the appropriate safeguards are in place so synthetic biology can 
flourish in the 21st century and bring forth the many promising 
advancements it holds to the people of the United States and the world.

                              Appendix 2:

                              ----------                              

                   Additional Material for the Record

  Statement of Dr. James Sullivan, Vice President for Pharmaceutical 
                     Discovery, Abbott Laboratories

    I am pleased to submit this statement for the record for the 
hearing entitled, ``21st Century Biology.'' The purpose of this 
statement is to highlight the importance of a new trend of 
interdisciplinary research--what we call ``new biology''--and state my 
support for the National Research Council's call for a multi agency, 
multidisciplinary new biology initiative, so we can more fully explore 
the potential of this field.
    ``New biology'' lies at the intersection of the fields of 
biological sciences, engineering, mathematics, and the physical 
sciences--and its utility is apparent in the novel tools that are now 
available to the biotechnology industry. These ``new biology'' tools 
are driving medical innovation in not only the discovery of the 
pathways that underlie complex diseases, but also in the creation of 
new and better therapies.
    As a pharmaceutical scientist at Abbott, I have firsthand knowledge 
of the importance of ``new biology.'' I work to create treatments that 
address significant medical problems. It is a goal that is easy to 
articulate, and vastly more difficult to achieve. Additionally, the way 
we meet this goal has evolved over time as our understanding of 
biological processes grows.
    Over the past century, the pharmaceutical industry has been able to 
create breakthrough treatments for some of the world's most devastating 
diseases. In the past 40 years alone, for example, new drugs that help 
control blood pressure and normalize lipid levels have helped cut in 
half the number of deaths from heart disease, and reduce by 70 percent 
the incidence of stroke. Scientific discoveries from Abbott's own 
laboratories have been key elements in the transformation of HIV 
infection from a death sentence to a more manageable chronic disease.
    Over the years, as scientists have gained a more comprehensive 
understanding of the molecular interactions that underlie biologic 
processes, we in the pharmaceutical industry have been focused on 
discovering medicines that treat disease by interacting with a single 
protein, or target, involved in the disease process. We've developed 
complex technologies to help us identify appropriate targets, built 
chemical compounds designed to interact with those targets, and then 
rapidly screened hundreds of thousands of potential compounds in an 
effort to identify likely candidates for further study. We've developed 
incredibly detailed computer models to help us better predict the way 
these compounds will behave in the body. We have more ways than ever 
before to generate data and more experts than ever before to analyze 
that data to drive the creation of new drug molecules. The process of 
creating new medicines is now the ultimate team sport. It requires 
coordinated efforts from experts in multiple disciplines, from 
biochemists and pharmacologists, to MDs and engineers.
    A current ongoing program at Abbott provides a useful example. We 
are one of many companies working to develop more effective treatments 
for Hepatitis C infection, a condition that impacts more than 70 
million people worldwide. Abbott is developing a compound that blocks 
the activity of a key enzyme involved in the replication of the 
hepatitis C virus (HCV). The challenge here is that some molecules that 
are most effective at blocking this enzyme, (HCV polymerase) can 
exhibit a high degree of adverse events. Our task was to design a 
molecule that was effective against HCV without causing those adverse 
events. We started with thousands of possibilities that needed to be 
evaluated. This required the use of high-throughput screening 
technologies; nuclear magnetic resonance and x-ray crystallography to 
better understand the protein structures we were dealing with; and 
sophisticated molecular modeling techniques to design a series of 
molecules that blocked the polymerase. But we weren't finished. That 
series was then screened using another multi-disciplinary approach that 
draws on cellular biology and systems engineering to rapidly eliminate 
compounds that may cause cardiac adverse events. This process 
represents a multi-year effort that brought us to the point where we 
could advance a compound into the clinic (treating patients)--where we 
have an industry average 1-in-10 chance of creating a viable medicine 
for patients.
    And the process is only getting more complex. Diseases like cancer, 
schizophrenia and Alzheimer's disease have proven difficult to treat 
because they involve the interactions of multiple, interdependent 
proteins designed to interact with multiple targets, increasing the 
complexity of the discovery process exponentially. Without putting the 
necessary resources into fields like ``new biology,'' we will not have 
the tools or the scientists capable of generating treatments for these 
complex, devastating diseases.
    At Abbott, our research program has established a strong paradigm 
for multidisciplinary research, one that relies on the coordination and 
integration of expertise from a variety of fields. But finding 
solutions to the increasingly complex problems we face today is beyond 
the scope of any single institution's efforts. We need to ensure that 
we have an integrated systems approach to biologic science that spans 
academia, biotechnology and the pharmaceutical industry. This is why, 
as a scientist deeply interested in the next generation of medical 
research, I believe we need to support the National Research Council's 
proposal for a multi agency, multidisciplinary new biology initiative.

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