DEPARTMENT OF HEALTH AND HUMAN SERVICES

NATIONAL INSTITUTES OF HEALTH

NATIONAL CANCER INSTITUTE

Fiscal Year 2006 Budget Request

Witness appearing before the\
House Subcommittee on Labor-HHS-Education Appropriations

Andrew C. von Eschenbach, M.D.\
Director, National Cancer Institute

William Beldon\
Deputy Assistant Secretary, Budget

March 9, 2005

Mr. Chairman and Members of the Committee:

I am pleased to present the President's budget request for the National
Cancer Institute (NCI) for Fiscal Year (FY) 2006. The FY 2006 budget
includes \$4,841,774,000, an increase of \$16,516,000 over the FY 2005
enacted level of \$4,825,258,000 comparable for transfers proposed in
the President\'s request.

LONG TERM GOAL

The accelerating progress that the National Cancer Institute (NCI) and
its partners in the cancer community have made over the past three
decades in understanding the molecular mysteries of cancer is now
extending the years and enhancing the quality of patients' lives. Now we
are closer to the reality of eliminating the suffering and death due to
cancer---the goal that NCI set to be achieved by 2015. The FY 2006
budget continues to accelerate the discovery, development, and delivery
of the interventions that will transform our traditional view of cancer
as a death sentence into a disease that we can prevent, eliminate, or
control. Accomplishing this goal is the legacy we strive to leave our
children.

Our increased knowledge in several clinical approaches has led to new
treatments approved for use. For example, our understanding of the
molecular mechanisms required for tumors to develop the blood supply
necessary for their growth led to the Food and Drug Administration's
(FDA) approval of the [monoclonal
antibody](http://www.cancer.gov/dictionary/db_alpha.aspx?expand=m#monoclonal antibody)
Avastin® as a [first-line
treatment](http://www.cancer.gov/dictionary/db_alpha.aspx?expand=f#first-line therapy)
for patients with metastatic colorectal cancer. Similarly, knowledge of
the growth factors necessary to stimulate cancer cell proliferation led
to development and approval of another targeted monoclonal antibody
Erbitux® for the treatment of metastatic colorectal carcinoma and to the
accelerated approval of Alimta® for locally advanced or metastatic
non-small cell lung cancer. These are just a few of the new drugs
offering fresh hope for patients with advanced cancer.

We have made progress in preventing cancer from ever developing in the
first place, especially in people at high risk. An example is the
creation of a vaccine that has prevented women from becoming
persistently infected with human papilloma viruses (HPV), an infection
that is responsible for half of all cervical cancers.

Now we must quicken the pace of progress because the trajectory is
clear: discovery of cancer's genetic and molecular mechanisms leads to
development of innovative interventions that---when delivered to
patients---save lives. Building on this knowledge, the promise of
tomorrow's advances is just over the horizon. This hopeful prospect will
be realized by investing in strategic research areas, including: cancer
genomics, biomarkers, molecular imaging, nanotechnology, and
bioinformatics.

ADVANCED TECHNOLOGY INITIATIVES

The technology revolution is speeding up and enabling the discovery
process. Recent advances in molecularly-targeted imaging will allow us
to locate very small tumors and interrogate their features.
Nanotechnology has emerged as a key strategy for imaging molecular
features of cancer that are notoriously difficult to detect. In one
case, a team of NCI-supported scientists has crafted a nano-sized
device---less than 1/80,000 the width of a human hair---to identify
areas of new blood vessel growth, which is characteristic of growing
tumors. Further, drugs attached to agents that seek out the proteins on
cancer cells will target therapy to exactly where it is needed without
damage to healthy cells.

The development, integration, and coordination of advanced technologies
are pivotal to enabling the biomedical and cancer research advances that
are necessary to achieve NCI's 2015 goal. The Institute has played a
crucial role in charting the path and collaborating in efforts to
support bold new programs in this crucial arena.

For instance, the National Advanced Technologies Initiative for cancer
(NATIc) is a plan to create a nationwide "virtual" laboratory for
cancer. The NATIc plan envisions a network of state and regional
technology "hubs" focused on several strategic areas, including advanced
computing, nanotechnology, and biorepositories.

NCI has already begun development of the cancer Biomedical Informatics
Grid (caBIG) to create a "world-wide web" for cancer research. The goal
is to create a network of interconnected data, applications,
individuals, and institutions that will redefine how cancer research is
conducted and care is provided. During its initial year, the caBIG
enterprise began bearing its first fruits with the release of NCI's
caArray, a prototype software application that is made freely available
to facilitate the sharing and analysis of microarray data by the medical
research community. NCI and its partners in academia and industry are
also developing an online information infrastructure to support clinical
trials management and electronic drug approval submissions to the FDA.
The first system module---the Federal Investigator Registry
(Firebird)---starts pilot testing this spring.

In addition, NCI has for the first time adopted a modern business model
approach to our research and development program for cancer-imaging
technologies. This entailed creation of an Imaging
Integration/Implementation (I ^2^) Team that recently submitted a
proposed business plan for a new entity to be called I ^2^ Imaging, Inc.
The goal is to create distinct product lines to organize NCI's imaging
program and clearly define measurable goals for each of the product
lines. The plan includes four R&D programs encompassing imaging
technologies for: a) understanding of cancer biology and
microenvironments; b) cancer prevention and preemption; c) development
and preclinical validation of therapies; and d) tools for clinical trial
support.

STRATEGIC RESEARCH INITIATIVES

Exponential advances in cancer research are defining, with ever
increasing specificity, the many genetic, molecular, and cellular events
that influence the cancer process. We now understand cancer as an
ongoing process that can be interrupted at many stages---from
susceptibility to initiation to disease progression. We are translating
this new knowledge into innovative strategies to prevent cancer from
developing, eliminate it early when it does occur, and modulate its
devastating effects. This involves NCI making strategic investments in
several research areas.

[Cancer prevention, early detection, and prediction]{.underline} New
evidence-based interventions encourage lifestyle improvements in diet
and physical activity, discourage tobacco use, and promote safe and
fully-tested chemoprevention approaches for people at risk. Pioneering
proteomic and biomarker advances, and the promise of nanotechnology,
give us new hope for the early detection of cancer and prediction of
patient responses to treatment.

[Development of strategic cancer interventions]{.underline} One of NCI's
key strategies is to optimize the development and speed delivery of
targeted cancer diagnostics, therapies, and preventives to patients.
This is evidenced by NCI's investments into the Cancer Genome Anatomy
Project, Academic Public-Private Partnership programs, and Rapid Access
to Intervention Development (RAID).

[An integrated clinical trials system]{.underline} NCI provides
leadership, resources, and expertise for clinical trials programs that
span the discovery of novel molecules to the evaluation of new agents
and interventions. To make clinical trials more efficient and to
accelerate and improve the regulatory approval process, NCI is enhancing
its working relationship with the FDA and the Department of Health and
Human Services' (DHHS) Office of Human Research Protections to develop
more streamlined policies and procedures for the conduct of clinical
trials.

[Integrative cancer biology]{.underline} Integrative cancer biology is
the study of cancer as a complex biological system. NCI's initiatives in
this cutting-edge area include creating computational models of the
complex networks within and among cancer cells, building our
understanding of the tumor microenvironment, and studying the role of
the tumor macroenvironment in cancer development.

[Molecular epidemiology]{.underline} NCI is developing novel ways to
unravel the complexities of inherited and environmental contributions to
cancer causation. Future investments will help scientists uncover risk
factors, identify genetically susceptible individuals, and generate
individual and public health strategies to avoid or mitigate adverse
genetic exposures.

INTERAGENCY COLLABORATIONS

Cancer is a large and complex problem with scientific, medical, social,
cultural, and economic dimensions. Addressing this problem requires that
NCI work across institutional and sector boundaries, share knowledge,
and bring together the diverse members of the DHHS family of agencies,
as well as other Federal offices, that can help develop systems-based
solutions to the cancer problem. Just within the National Institutes of
Health (NIH), NCI collaborates with virtually all of the 27 Institutes
and Centers. Likewise, NCI also has many ongoing collaborations with
several DHHS agencies. The ultimate beneficiaries of this continued
cooperative effort will be cancer patients and their families.

NCI and FDA created an Interagency Oncology Task Force (IOTF) to remove
bottlenecks in the process of developing and approving safe, more
effective cancer interventions. IOTF, which is comprised of senior
representatives from both agencies, has been meeting regularly to define
key areas of mutual interest and concern. As a result, the NCI-FDA
Cancer Training Fellowship Program was launched in 2005. The program
will train a cadre of scientists in research and research-related
regulatory review so that they can develop skill sets that bridge the
two distinct processes.

NCI is also an active participant in the Medical Innovation Task Force
established last year by DHHS. The group---which also includes the FDA,
the Centers for Disease Control and Prevention, the Centers for Medicare
& Medicaid Services, and the NIH---is weighing new ideas and solutions
to encourage innovation in health care. The interagency panel seeks to
speed the delivery to market of effective new medical technologies, such
as drugs, biological products, and medical devices.

NIH ROADMAP

NCI's contributions to NIH Roadmap initiatives will increase NCI's
ability to support the collaborative research critical to cancer
studies. Cooperation across the cancer continuum is vital for continued
progress. The NIH Roadmap mechanisms support research in cancer biology
that will also enhance continued interdisciplinary research to address
vital questions related to cancer and the immune system, the interface
of aging and cancer, and the role of microbial agents in the etiology of
human cancers. By encouraging interdisciplinary teams to evolve in both
directed and serendipitous ways, these new funding mechanisms complement
and enlarge NCI's efforts toward the integration and cross-fertilization
of research efforts that span the cancer spectrum.

CHALLENGES AND OPPORTUNITIES

In the coming years, we will face a number of critical challenges and
opportunities. We stand on the brink of a new age of "personalized
oncology"---delivering the right treatment to the right patient at the
right time to halt cancer-causing processes in the body before they
cascade into advanced disease states. NCI is driven to meet the 2015
challenge goal. Cancer is a public health and financial challenge for
the United States. NIH estimates that in 2003, the total cost of cancer
was over \$189 billion: \$64 billion in direct medical costs (much of it
paid by Medicare) and \$125 billion from lost productivity due to
illness and premature death. More telling, 570,000 Americans lost their
lives to the disease last year, according to the American Cancer
Society. Furthermore, the fact that cancer occurs primarily in
individuals over the age of 50 means that more of our citizens will
suffer the terrible burden of this disease in the future due to the
aging and changing demographics of our population. NCI and its partners
are committed to making progress toward the goal of eliminating
suffering and death due to cancer in the next 10 years.

Thank you, Mr. Chairman. I would be pleased to answer any question that
the Committee may have.

**CURRICULUM VITAE**

**NAME:** **Andrew C. von Eschenbach, M.D.**

**Present Title Director, National Cancer Institute**

**and Affiliation: 31 Center Drive, MSC 2590**

**Building 3l, Room 11A48**

**Bethesda, MD 20892-2590**

Phone: 301-496-5615

FAX: 301-402-0338

**Birth Date and Place:** October 30, 1941; Philadelphia, Pennsylvania

**Education:**

1963 -- 1967 M.D. Georgetown University, Washington, D.C.

1959 -- 1963 B.S. St. Joseph's College, Philadelphia, PA

**Postgraduate Training:**

1967 -- 1968 Internship: Surgery/Medicine, University of Pennsylvania
Division Philadelphia General Hospital, Philadelphia, PA

1971 -- 1972 Residency: General Surgery, Pennsylvania Hospital,
Philadelphia, PA

1972 -- 1975 Residency: Urology, Pennsylvania Hospital, Philadelphia, PA

1976 -- 1977 Fellowship: Urologic Oncology, The University of Texas M.
D. Anderson Cancer Center, Houston, TX 77030

**Post Graduate Continuing Education:**

Stanford Executive Program in Organization Change, 1991

Stanford University Graduate School of Business, June 23 - July 5, 1991

Executive Development Program in conjunction with Rice University, 1991

University Jesse H. Jones Graduate School of Administration, 1991

**Specialty Boards:**

American Board of Urology - February 8, 1978

**Military or Government Service:**

1968 -- 1971 Lieutenant Commander, U. S. Navy Medical Corps

**Academic and Professional Appointments:**

1975 -- 1976 Instructor in Urology, The University of Pennsylvania
School of Medicine, Department of Surgery, Philadelphia, PA

1975 -- 1976 Staff Physician, Pennsylvania Hospital, Philadelphia, PA

1975 -- 1976 Staff Physician, St. Agnes Hospital, Philadelphia, PA

1977 -- 1980 Assistant Professor of Urology, Department of Urology, The
University of Texas M. D. Anderson Cancer Center, Houston, TX

1978 -- 1980 Assistant Professor, Department of Surgery, The University
of Texas Medical School at Houston, Houston, TX

1980 -- 1985 Associate Professor of Urology, Department of Urology, The
University of Texas M.D. Anderson Cancer Center, Houston, TX

1980 -- 1994 Professor, Graduate School of Biomedical Sciences, The
University of Texas Health Science Center at Houston, Houston, TX

1981 -- 1986 Associate Professor, Department of Surgery, The University
of Texas Medical School at Houston, Houston, TX

1985 -- Jan. 2002 Professor of Urology, The University of Texas M. D.
Anderson Cancer Center, Houston, TX

1985 -- Jan. 2002 Consulting Professor of Cell Biology, The University
of Texas M. D. Anderson Cancer Center, Houston, TX

1986 -- Jan. 2002 Professor, The University of Texas Medical School,
Houston, TX

1988 -- Jan. 2002 Adjunct Clinical Fellow, The Institute of Religion,
Houston, TX

1990 -- Oct. 1994 Irving and Nadine Mansfield and Robert David Levitt
Cancer Research Chair

1994 -- Jan. 2002 Roy M. & Phyllis Gough Huffington Distinguished Chair
in Urologic Oncology

2003 -- Present Distinguished Professor of Surgery, Department of
Surgery, F. Edward Hebert School of Medicine, Uniformed Services
University of the Health Sciences, Bethesda, MD

**Administrative Responsibilities:**

Sept. 1979 -- Sept. 1983 Deputy Head, Department of Urology, The
University of Texas M.D. Anderson Cancer Center, Houston, TX

Sept. 1981 -- 1986 Chief, Section of Sexual Rehabilitation, The
University of Texas M.D. Anderson Cancer Center, Houston, TX

Sept. 1983 -- Nov. 1996 Chairman, Department of Urology, The University
of Texas M. D. Anderson Cancer Center, Houston, TX

Sept. 1990 -- Aug. 1993 Administrative Director of Laser Program, The
University of Texas M.D. Anderson Cancer Center, Houston, TX

1996 -- 2002 Director, Prostate Cancer Research Program, The University
of Texas M. D. Anderson Cancer Center, Houston, TX

Feb. 1997 -- Sept. 1997 Vice President for Academic Affairs (*ad
interim),* The University of Texas M. D. Anderson Cancer Center,
Houston, TX

Oct. 1997 -- Dec. 1997 Executive Vice President/Chief Academic Officer
(*ad interim),* The University of Texas M. D. Anderson Cancer Center,
Houston, TX

Jan. 1998 -- Jan. 1999 Executive Vice President/Chief Academic Officer,
The University of Texas M. D. Anderson Cancer Center, Houston, TX

Jan. 1999 -- Jan. 2002 Director, Genitourinary Cancer Center, Special
Assistant for External Affairs, The University of Texas M. D. Anderson
Cancer Center, Houston, TX

Department of Health and Human Services

Office of Budget

William R. Beldon

Mr. Beldon is currently serving as Deputy Assistant Secretary, Budget in
the Department of Health and Human Services. He has been a Division
Director in the Budget Office for sixteen years, most recently as
Director of the Division of Discretionary Programs. Mr. Beldon started
in federal service as an auditor in the Health, Education and Welfare
Financial Management Intern program. Over the course of more than 30
years in the Budget Office, Mr. Beldon has held Program Analyst, Branch
Chief and Division Director positions. Mr. Beldon received a Bachelor's
Degree in History and Political Science from Marshall University and
attended the University of Pittsburgh where he studied Public
Administration. He resides in Fort Washington, Maryland.