DEPARTMENT OF HEALTH & HUMAN SERVICES

**Public Health Service**

**Food and Drug Administration**

**Office of Science Coordination & Communication**

**FDA Science Board Meeting**

**November 16, 2001**

**Executive Summary**

# Administration

The agenda and meeting arrangements of the Science Board to the Food and
Drug Administration (FDA) were administered by FDA's Office of Science
Coordination and Communication (OSCC). On Friday, November 16, 2001, a
meeting was convened at 5630 Fishers Lane, Conference room 1066,
Rockville, MD. The public meeting was called to order at 9:00 a.m. by
the FDA Science Board Chair, Robert S. Langer, Sc.D.

**[Members in Attendance]{.underline}** *(names in alphabetical order,
affiliation information attached)*

Marion W. Anders, D.V.M., Ph.D.

Michael P. Doyle, Ph.D.

Owen Fennema, Ph.D.

Robert S. Langer, Sc.D., Chair

Robert M. Nerem, Ph.D.

Cecil M. Pickett, Ph.D.

José Principe, Ph.D.

**[FDA Participants]{.underline}** *(alphabetical order)*

Norris E. Alderson, Ph.D., Acting Senior Advisor for Science, FDA

Dennis Baker, Associate Commissioner for Regulatory Affairs, FDA

Celeste F. Bové, CCC-A, Acting Executive Secretary, Office of
Coordination & Communication

David W. Feigal, Jr., M.D., M.P.H., Director, Center for Devices &
Radiological Health (CDRH)

Ajaz Hussain, Ph.D., Deputy Director, Office of Pharmaceutical Science,
CDER

David Lepay, M.D., Senior Advisor for Clinical Science, FDA

Joe Levitt, Director, Center for Food Safety and Nutrition (CFSAN)

Murray Lumpkin, M.D., Acting Deputy Commissioner, FDA

Bernard A. Schwetz, D.V.M., Ph.D., Acting Principal Deputy Commissioner,
FDA

Steven Sundlof, Director, Center for Veterinary Medicine (CVM)

Linda Suydam, D.P.A., Sr. Assoc. Commissioner for Communications &
Constituent Relations

Janet Woodcock, M.D., Director, Center for Drug Evaluation & Research
(CDER)

Kathryn Zoon, Ph.D., Director, Center for Biologics Evaluation &
Research (CBER)

**[Invited Guests and Speakers]{.underline}** *(alphabetical order)*

Frances Bruttin, PricewaterhouseCoopers, Pharmaceutical Sector Team

Alexa I. Canady, M.D., Co-Chair, CDRH External Science Review Committee

Doug Dean, Ph.D., PricewaterhouseCoopers, Pharmaceutical Sector Team

Steve Hammond, Manager, Process Analytical Group, Pfizer

G.K. Raju, Ph.D., Executive Director, MIT Pharmaceutical Manufacturing
Initiative

Norman Winskill, Ph.D., Vice President, Manufacturing, Pfizer, Inc.

**[Public Comment Speakers]{.underline}** *(alphabetical order)*

# 

Robert Chisholm, International Technology Manager, AstraZeneca

Mats Josefson, AstraZeneca (AZ) Sweden (with Umetrics group)

Gideon Kantor, Ph.D, personal statement.

# Nouna Kettaneh-Wold, Umetrics

# Gabi Levin, Ph.D., Brimrose Corporation of America

# John Parsons, Umetrics (alternate) 

Scott C. Ratzan, MD, MPA, MA, Editor, Journal of Health Communication

# Svante Wold, Ph.D., Umetrics

**[Major Topics:]{.underline}**

The Science Board convened to consider the following scientific topics:

-   Emerging Science Issues: Pharmaceutical Manufacturing

-   The Center for Devices and Radiological Health's External Science
    Review

-   Emerging Issues in FDA's Oversight of Clinical Research

## **Introductory Remarks**

## After brief introductions from the participants, Bernard A. Schwetz, D.V.M., Ph.D., Acting Principal Deputy Commissioner, began the session by introducing Norris E. Alderson, the Acting FDA Senior Advisor for Science, who is new to the position since the last FDA Science Board meeting. Dr. Schwetz also announced another staff change and introduced Dr. Mac Lumpkin, M.D., as the new Acting Deputy Commissioner. Next Dr. Schwetz welcomed the two new FDA Science Board members, Dr. Cecil Pickett and Dr. José Principe. 

## 

Dr. Schwetz updated the group on recent activities of the agency
including counter-terrorism, the review of emergency preparedness plans,
the review of product security, and the review of food security. In
addition, he discussed the recent anthrax events at the agency, the five
presumptive positives findings in the mail rooms and the final confirmed
negatives. Dr. Schwetz further related that at a time when everyone
wants to be protected, the agency has developed a new Crisis Management
Center. Janet Woodcock, M.D. has taken the lead to develop this new
center that will help us communicate and sort out the more routine
variety of emergencies from those that the whole agency needs to address
and to be prepared to work with other agencies such as the Centers for
Disease Control, the United States Department of Agriculture, and the
Environmental Protection Agency.

## 

Regarding a peer review update, Dr. Schwetz indicated that the Center
for Devices and Radiological Health (CDRH) has been completed and Drs.
Nerem and Canady will report today along with comments from Dr. Feigal,
Director of CDRH. The science within the field operation, Office of
Regulatory Affairs (ORA), is scheduled for the next peer review. In
addition, Dr. Schwetz gave brief comments on the 2002 budget regarding
coverage for the pay increase and a supplemental request.

Lastly, Dr. Schwetz thanked two board members that are here for the last
time because their term is expiring the end of this year, Drs. Anders
and Nestle. Dr. Schwetz stated that over the course of the next year,
FDA will need five new Science Board members as current terms expire and
he asked members to send recommendations for replacements.

# 

# Update On Action Items From April 2001 Meeting

Norris E. Alderson, Ph.D., Acting Senior Advisor for Science, FDA,
related that the FDA has established a list of ethicists in response to
the Science Board's suggestion for FDA to have an Ethics Advisory
Committee. This list of ethicists will be maintained in the Office of
Science Coordination and Communication for FDA's use. At the last
meeting, Dr. Scolnick recommended that FDA consider institutionalizing
its peer review system. Because Dr. Scolnick could not join us today, we
will defer this topic to a future meeting.

Dr. Alderson reported that the Science Board members will soon be
receiving the nominations for FDA's 2002 Scientific Achievement Awards.
The Board members vote and is the final recommending body in determining
these important recognition awards. Based on earlier correspondence,
arrangements have been made for the Science Board members to tour FDA
laboratories this Spring to learn about how we establish research
priorities at the agency.

#### Emerging Science Issues: Pharmaceutical Manufacturing 

Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research
(CDER), FDA,

explained that this topic relates to science issues in the regulation of
pharmaceutical quality.

She reported that at FDA we are seeing an increasing trend toward
manufacturing-related

problems which are a real health care issue because a lack of efficiency
contributes to the cost

of drugs. Dr. Woodcock related that it's a huge challenge for FDA to
enable the introduction of

new technologies while maintaining quality standards. The speakers from
industry and

academia (refer to list above) presented a broad view of the problem and
some of the various

approaches that may be used to facilitate the introduction of modern
process analytical

technologies and pharmaceutical engineering principles into practice.
Dr. Ajaz Hussain, CDER,

related that this issue has been discussed at the FDA's Advisory
Committee for Pharmaceutical

Science and the committee recommended FDA form a subcommittee on Process
Analytical

Technology (PAT). The Federal Register notice has been published and the
end of November

is the deadline to apply. He encouraged attendees from industry to
consider being part of the

PAT subcommittee. The Science Board agreed by consensus that the FDA
should move

forward to act on this issue and supported CDER's approach to start with
some pilots on small

pieces.

# Open Public Comment

The FDA received five requests to speak during the open comment period
(refer to above list of public comment speakers). The speakers commented
on topics to include: real-time quality control, enhancement of
regulatory science animal research, risk communication, rel-time process
control, and Total Quality Management Strategy.

**Note:** Copies of the public comment presentations are available on
the FDA Advisory Committee website,
<http://www.fda.gov/oc/advisory/sciboard111601.html>

# Update on CDRH External Science Review 

######### Robert M. Nerem, Ph.D., Science Board Member was Chair for the CDRH External Science Review Committee. Dr. Nerem reported for the committee and also introduced Dr. Alexa Canady, the co-chair, who was present as an invited guest. The objective of the External Science Review was to assess the quality of science across the organization and its relevance to the organization's regulatory mission. 

######### 

######### This internal review process was initiated in February 2001 with the field of electrostimulation devices chosen as a representative technology. The review was not an evaluation of individual decisions, but rather an evaluation of the overall role of science. The external review process built on the foundation of knowledge provided by the internal review. The findings addressed: science and the regulatory decision-making process; the present level of scientific expertise in the CDRH; the increasing complexity of applications; science and the long-term regulatory role; the leveraging of external and internal expertise for the Office of Device Evaluation; metrics for quantity, timeliness, and the quality of decision making; and, scientific expertise for the newer, breakthrough technologies. Finally, the subcommittee appreciates the fact that these recommendations, if accepted, cannot be put into place overnight; the subcommittee suggests that these recommendations be incorporated as explicit components of the CDRH strategic plan.

In response to the external review findings, David W. Feigal, Jr., M.D.,
M.P.H., Director of CDRH, discussed a "Top 10 list" of the greatest
challenges and problems for science-based regulation at CDRH and a "Top
10 list" of recommendations for science-based regulation at CDRH**.**
For next steps, the center has established a CDRH Recommendations
Committee to go over the review and make recommendations to the senior
management and division directors. The final report is posted at
[p://http://www.fda.gov/cdrh/science/science-work-CDRH.html](http://www.fda.gov/cdrh/science/science-work-CDRH.html)

The Science Board members unanimously accepted the CDRH external science
review report as presented. Overall, comments emphasized that the
internal review was the most beneficial part of the process, with the
external review being an additive benefit for the center.

**Note:** These presentations are available on the FDA Advisory
Committee website, <http://www.fda.gov/oc/advisory/sciboard111601.html>

####### [Emerging Issues in FDA's Oversight of Clinical Research]{.underline}

David A. Lepay, M.D., Senior Advisor for Clinical Science, Office for
Good Clinical Practice (OGCP) in the Office of Science Coordination and
Communication. Dr. Lepay talked about clinical trials, the conduct of
clinical trials, the oversight of clinical trials, and some of the
events taking place in this arena. First he presented a brief history to
the underpinnings of our current models. He explained that FDA's mission
in clinical research is broad and includes: ensuring the implementation
of Good Clinical Practice (GCP) standards with human subject protection
is one facet of GCP. Dr. Lepay also described OGCP operations and
functions as well as its challenges. Additional information is available
online, p<http://www.fda.gov/oc/gcp/default.htm>

**Note:** This presentation is available on the FDA Advisory Committee
website, <http://www.fda.gov/oc/advisory/sciboard111601.html>

**[Recommendations/Action Items]{.underline}**

1.  In response to Dr. Anders request, FDA will provide information on
    the magnitude of the drug recall problem, i.e., the relationship of
    recall to manufacturing problems.

2\. Dr. Langer will work with Dr. Raju on presenting seminars at
universities and chemical engineering schools to help address the lack
of available scientific expertise in the newer technologies as
opportunities may arise.

**[Adjournment]{.underline}** - The meeting was adjourned at
approximately 4:00 p.m.

**Note:** Refer to the complete official transcript for additional
information:
<http://www.fda.gov/ohrms/dockets/ac/01/transcripts/3799t1.htm>

**Science Board Member Affiliations**

**FDA Science Board Meeting**

### November 16, 2001

**Marion W. Anders, D.V.M., Ph.D.**

Professor and Chair Department of Pharmacology

University of Rochester

601 Elmwood Avenue

Rochester, NY 14642

**Michael P. Doyle, Ph.D.**

Professor and Director Center for Food Safety

Department of Food Science and Technology

University of Georgia

1109 Experiment Street

Griffin, GA 30223

**Owen Fennema, Ph.D.**

Professor Emeritus, Department of Food Science

University of Wisconsin

1605 Linden Drive

Madison, WI 53706

**Robert S. Langer, ScD., Chair**

Massachusetts Institute of Technology

45 Carlton Street

Building E25, Room 342

Cambridge, Massachusetts 02139

**Robert M. Nerem, Ph.D.**

Professor and Director Institute of Bioengineering and Bioscience

Georgia Institute of Technology

315 Ferst Drive, N.W.

Atlanta, GA 30332-0363

**Cecil B. Pickett, Ph.D.**

Executive Vice President, Discovery Research

Schering-Plough Research Institute

2015 Galloping Hill Road

Kenilworth, NJ 07033

**Jose C. Principe, Ph.D.**

Professor of Electrical Engineering

University of Florida

Department of Electrical & Computer Engineering

451 EB, Bldg. 33

Gainesville, FL 32611-6130