Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter.
Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.
Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.
OCR for page 117
APPENDIX B
Agendas for Information-Gathering Meetings
MEETING I
DECEMBER 1617, 2002
The National Academy of Sciences Building
2101 Constitution Avenue, N.W.
Washington, DC
Monday, December 16, 2002
1:15 p.m. Introductory Remarks
Leslie Benet, Ph.D., Chair, Committee on Accelerating the
Research, Development, and Acquisition of Medical
Countermeasures Against Biological Warfare Agents
Introductions by Committee Members and Meeting
Attendees
1:30 Sponsor Presentation on the Study Charge
Carol Linden, Ph.D., Director, Medical Chemical and
Biological Defense Research Program, U.S. Army Medical
Research and Materiel Command
Congressional Comment on the Study Charge
Mr. Jean Reed, Professional Staff Member, House Armed
Services Committee
Discussion
117
OCR for page 118
118 GIVING FULL MEASURE TO COUNTERMEASURES
2:30 Status of Department of Defense Effort on Accelerating
Research, Development, and Acquisition of Medical
Countermeasures
Anna Johnson-Winegar, Ph.D., Deputy Assistant to the
Secretary of Defense for Chemical and Biological Defense
Discussion
3:15 Break
3:30 CBER Perspective on Opportunities for Accelerating
Licensure of Medical Countermeasures for Biowarfare
Agents
Kathryn Zoon, Ph.D., Director, Center for Biologics
Evaluation and Research, Food and Drug Administration
Discussion
4:15 CDER Perspective on Opportunities for Accelerating
Licensure of Medical Countermeasures for Biowarfare
Agents
Janet Woodcock, M.D., Director, Center for Drug Evaluation
and Research, Food and Drug Administration
Discussion
5:00 Adjourn
Tuesday, December 17, 2002
8:00 a.m. Breakfast
8:30 IOM Report, September 2002: Protecting Our Forces:
Improving Vaccine Acquisition and Availability
in the U.S. Military
Stanley Lemon, M.D., Chair, IOM Committee on a Strategy
for Minimizing the Impact of Naturally Occurring
Infectious Diseases of Military Importance: Vaccine Issues
in the U.S. Military
Discussion
OCR for page 119
APPENDIX B 119
9:15 DoD Acquisition of Vaccine Production
Report to the Deputy Secretary of Defense, December
2000
Gerald V. Quinnan, Jr., M.D., Professor and Chair of
Preventive Medicine, Uniformed Services University of
the Health Sciences
Discussion
10:00 Adjourn
MEETING II
JANUARY 1415, 2003
The National Academies Keck Center
500 Fifth Street, N.W.
Washington, DC
Tuesday, January 14, 2003
9:00 a.m. Breakfast
9:30 Introductory Remarks
Leslie Benet, Ph.D., Chair, Committee on Accelerating the
Research, Development, and Acquisition of Medical
Countermeasures Against Biological Warfare Agents
9:45 Medical Countermeasures for Biological Warfare
Agents
Research Carried out at/through the U.S. Army Medical
Research and Materiel Command (USAMRMC)
Carol Linden, Ph.D., Director, Medical Chemical and
Biological Defense Research Program, USAMRMC
10:30 Break
10:45 Chemical Biological Medical Systems (CBMS) (formerly
Joint Vaccine Acquisition Program)
COL David Danley, Ph.D., Director, CBMS
11:30 DynPort Vaccine Company LLC
Michael J. Langford, D.V.M., Ph.D., Senior Vice President
and Chief Scientific Officer, DynPort Vaccine Company
LLC
OCR for page 120
120 GIVING FULL MEASURE TO COUNTERMEASURES
12:00 p.m. Working Lunch
12:45 Defense Threat Reduction Agency (DTRA)
LTC Keith R. Vesely, D.V.M., Ph.D., Chief, Medical Science
and Technology Division, Chemical and Biological Defense
Directorate
1:15 Defense Advanced Research Projects Agency (DARPA)
John Carney, Ph.D., Unconventional Pathogen
Countermeasures Program
1:45 Joint Program Executive Office for Chemical and
Biological Defense (JPEO-CBD)
BG Stephen Reeves, Program Executive Officer, Chemical
and Biological Defense
2:15 Joint Requirements Office for Chemical, Biological,
Radiological, and Nuclear (JRO-CBRN) Defense
MAJ Ronald Fizer, Joint Requirements Integrator,
JRO-CBRN Defense
2:45 Break
3:00 Directed Roundtable Discussion: Representatives of
Involved Government and Other Organizations
3:00 I Basic Research
Early Development
3:45 II Transition to Advanced Development
4:30 III Advanced Development
Licensure
5:30 Summary and General Discussion
6:00 Adjourn
OCR for page 121
APPENDIX B 121
MEETING III
MARCH 1718, 2003
The National Academies Keck Center
500 Fifth Street, N.W.
Washington, DC
Monday, March 17, 2003
9:00 a.m. Breakfast
9:30 Introductory Remarks
Leslie Z. Benet, Ph.D., Chair, Committee on Accelerating the
Research, Development, and Acquisition of Medical
Countermeasures Against Biological Warfare Agents
9:45 Current and Planned Activities of the National Institute
of Allergy and Infectious Diseases (NIAID) in Research
and Development of Medical Countermeasures Against
Biological Warfare Agents
Anthony S. Fauci, M.D., Director, NIAID
Discussion
11:30 Break
11:45 Working Lunch
12:30 p.m. Opportunities for the Food and Drug Administration
(FDA) to Contribute to Accelerating the Development
and Licensure of Medical Countermeasures Against
Biological Warfare Agents
Mark B. McClellan, M.D., Ph.D., Commissioner, FDA
Discussion
2:00 Break
2:15 Roundtable Discussion: Issues Related to the FDA Role
in Development and Licensure of Medical
Countermeasures Against Biological Warfare Agents
OCR for page 122
122 GIVING FULL MEASURE TO COUNTERMEASURES
Maria Bernwinkler, Director, Clinical Research, PPD
LTC Robert Borowski, Ph.D., Senior Medical Advisor, Office
of the Deputy to the Assistant to the Secretary of Defense
for Chemical and Biological Defense, DoD
COL David Danley, Ph.D., Director, Chemical and Biological
Medical Systems, DoD
Karen Goldenthal, M.D., Director, Division of Vaccines and
Related Products Applications, Center for Biologics
Evaluation and Research, FDA
Carole Heilman, Ph.D., Director, Division of Microbiology
and Infectious Diseases, NIAID, NIH
COL Charles Hoke, Jr., M.D., U.S. Army Medical Research
and Materiel Command (USAMRMC), DoD
Virginia Johnson, Ph.D., Deputy Product Development
Manager, DynPort Vaccine Company LLC
Carol Linden, Ph.D., Director, Medical Chemical and
Biological Defense Research Program, USAMRMC, DoD
John McCormick, M.D., Orphan Products Development,
FDA
Andrea Meyerhoff, M.D., Director, Counterterrorism
Programs, Office of the Commissioner, FDA
Dianne Murphy, M.D., Director, Office of Counterterrorism
and Pediatric Drug Development, Center for Drug
Evaluation and Research, FDA
Jerald Sadoff, M.D., Washington, DC
4:30 Adjourn Open Session
Tuesday, March 18, 2003
8:00 a.m. Breakfast
8:30 Roundtable Discussion:
I. Industry Approaches to Basic Research, Transition to
Advanced Development, Advanced Development,
and Licensure for Vaccines and Therapeutic Drugs
II. Challenges or Barriers to Additional Industry
Involvement in Research and Development of
Medical Countermeasures Against Biological
Warfare Agents
OCR for page 123
APPENDIX B 123
Maria Bernwinkler, Director, Clinical Research, PPD
LTC Robert Borowski, Ph.D., Senior Medical Advisor, Office
of the Deputy to the Assistant to the Secretary of Defense
for Chemical and Biological Defense, DoD
COL David Danley, Ph.D., Director, Chemical and Biological
Medical Systems, DoD
Joan Fusco, Ph.D., Vice President, Technical Affairs, Baxter
Vaccines
Karen Goldenthal, M.D., Director, Division of Vaccine and
Related Products Applications, Center for Biologics
Evaluation and Research, FDA
Christine Grant, J.D., M.B.A., Vice President, Public Policy
and Government Relations, Aventis Pasteur
Carole Heilman, Ph.D., Director, Division of Microbiology
and Infectious Diseases, NIAID, NIH
COL Charles Hoke, Jr., M.D., U.S. Army Medical Research
and Materiel Command (USAMRMC), DoD
Raymond Keifer, Ph.D., Senior Director Manufacturing,
BioReliance Corporation
Michael Langford, D.V.M., Ph.D., Senior Vice President and
Chief Scientific Officer, DynPort Vaccine Company, LLC
Frank Lee, Ph.D., President and CEO, engeneOS
Brad Leissa, M.D., Office of Counterterrorism and Pediatric
Drug Development, Center for Drug Evaluation and
Research, FDA
John McCormick, M.D., Orphan Products Development,
FDA
Dennis Panicali, Ph.D., Chief Scientific Officer, Therion
Biologics
Jerald Sadoff, M.D., Washington, DC
Peter Young, M.B.A., President and CEO, AlphaVax
Philip Youngman, Ph.D., Vice President of Discovery
Biology, Elitra Pharmaceuticals
11:45 Adjourn Open Session
OCR for page 124
124 GIVING FULL MEASURE TO COUNTERMEASURES
MEETING IV
APRIL 22, 2003
The National Academy of Sciences Building
2101 Constitution Avenue, N.W.
Washington, DC
Tuesday, April 22, 2003
9:00 a.m. Breakfast
9:30 Introductory Remarks
Leslie Z. Benet, Ph.D., Chair, Committee on Accelerating the
Research, Development, and Acquisition of Medical
Countermeasures Against Biological Warfare Agents
9:45 Availability of Biocontainment Facilities Needed to
Support Research and Development of Medical
Countermeasures to Biological Warfare Agents
Gerald Parker, M.S., D.V.M., Ph.D., Colonel, Veterinary
Corps, Assistant Deputy for Research and Development,
USAMRMC
Discussion
11:15 Break
11:30 Role of the Assistant Secretary of Defense for Health
Affairs in DoD Efforts Toward Accelerating the
Development and Licensure of Medical
Countermeasures Against Biological Warfare Agents
William Winkenwerder, Jr., M.D., M.B.A., Assistant
Secretary of Defense for Health Affairs
Discussion
12:30 p.m. Working Lunch
1:15 The Role That New Technologies (Genomics,
Proteomics) Might Play in the Acceleration of Drug and
Vaccine Research and Development
Stephen Hoffman, M.D., Sanaria
OCR for page 125
APPENDIX B 125
1:45 Rapid Development of a Medical Countermeasure to
Protect Against Anthrax
Vivian Albert, Ph.D., Human Genome Sciences
2:15 Discussion
3:00 Adjourn Open Session
MEETING V
JUNE 2, 2003
The National Academies Keck Center
500 Fifth Street, N.W.
Washington, DC
Monday, June 2, 2003
1:45 p.m. Introductory Remarks
Leslie Z. Benet, Ph.D., Chair, Committee on Accelerating the
Research, Development, and Acquisition of Medical
Countermeasures Against Biological Warfare Agents
2:00 Perspectives on Liability Issues Related to Biowarfare
Countermeasures
Mr. Alan B. Morrison, LL.B., Public Citizen Litigation
Group
Discussion
3:00 Intellectual Property Concerns of the Pharmaceutical
Industry
Mr. Jeffrey Kushan, J.D., Sidley Austin Brown and Wood
Discussion, Including Government Contracts
Perspective
Mr. Jay Winchester (by phone), U.S. Army Medical Research
and Materiel Command
4:30 Attributes of the LiebermanHatch Proposed
Legislation
Mr. Chuck Ludlam, J.D., Office of Senator Joseph Lieberman
5:30 Adjourn Open Session
OCR for page 126
Representative terms from entire chapter:
biological warfare
