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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

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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

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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

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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

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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

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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

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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

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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

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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

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