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Suggested Citation:"Appendix B: Agendas for Information-Gathering Meetings." Institute of Medicine and National Research Council. 2004. Giving Full Measure to Countermeasures: Addressing Problems in the DoD Program to Develop Medical Countermeasures Against Biological Warfare Agents. Washington, DC: The National Academies Press. doi: 10.17226/10908.
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Suggested Citation:"Appendix B: Agendas for Information-Gathering Meetings." Institute of Medicine and National Research Council. 2004. Giving Full Measure to Countermeasures: Addressing Problems in the DoD Program to Develop Medical Countermeasures Against Biological Warfare Agents. Washington, DC: The National Academies Press. doi: 10.17226/10908.
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Page 118
Suggested Citation:"Appendix B: Agendas for Information-Gathering Meetings." Institute of Medicine and National Research Council. 2004. Giving Full Measure to Countermeasures: Addressing Problems in the DoD Program to Develop Medical Countermeasures Against Biological Warfare Agents. Washington, DC: The National Academies Press. doi: 10.17226/10908.
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Page 119
Suggested Citation:"Appendix B: Agendas for Information-Gathering Meetings." Institute of Medicine and National Research Council. 2004. Giving Full Measure to Countermeasures: Addressing Problems in the DoD Program to Develop Medical Countermeasures Against Biological Warfare Agents. Washington, DC: The National Academies Press. doi: 10.17226/10908.
×
Page 120
Suggested Citation:"Appendix B: Agendas for Information-Gathering Meetings." Institute of Medicine and National Research Council. 2004. Giving Full Measure to Countermeasures: Addressing Problems in the DoD Program to Develop Medical Countermeasures Against Biological Warfare Agents. Washington, DC: The National Academies Press. doi: 10.17226/10908.
×
Page 121
Suggested Citation:"Appendix B: Agendas for Information-Gathering Meetings." Institute of Medicine and National Research Council. 2004. Giving Full Measure to Countermeasures: Addressing Problems in the DoD Program to Develop Medical Countermeasures Against Biological Warfare Agents. Washington, DC: The National Academies Press. doi: 10.17226/10908.
×
Page 122
Suggested Citation:"Appendix B: Agendas for Information-Gathering Meetings." Institute of Medicine and National Research Council. 2004. Giving Full Measure to Countermeasures: Addressing Problems in the DoD Program to Develop Medical Countermeasures Against Biological Warfare Agents. Washington, DC: The National Academies Press. doi: 10.17226/10908.
×
Page 123
Suggested Citation:"Appendix B: Agendas for Information-Gathering Meetings." Institute of Medicine and National Research Council. 2004. Giving Full Measure to Countermeasures: Addressing Problems in the DoD Program to Develop Medical Countermeasures Against Biological Warfare Agents. Washington, DC: The National Academies Press. doi: 10.17226/10908.
×
Page 124
Suggested Citation:"Appendix B: Agendas for Information-Gathering Meetings." Institute of Medicine and National Research Council. 2004. Giving Full Measure to Countermeasures: Addressing Problems in the DoD Program to Develop Medical Countermeasures Against Biological Warfare Agents. Washington, DC: The National Academies Press. doi: 10.17226/10908.
×
Page 125
Suggested Citation:"Appendix B: Agendas for Information-Gathering Meetings." Institute of Medicine and National Research Council. 2004. Giving Full Measure to Countermeasures: Addressing Problems in the DoD Program to Develop Medical Countermeasures Against Biological Warfare Agents. Washington, DC: The National Academies Press. doi: 10.17226/10908.
×
Page 126

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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

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

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

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

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

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

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

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

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

Next: Appendix C: Acknowledgements »
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In recent years, substantial efforts have been initiated to develop new drugs, vaccines, and other medical interventions against biological agents that could be used in bioterrorist attacks against civilian populations. According to a new congressionally mandated report from the Institute of Medicine and National Research Council of the National Academies, to successfully develop these drugs, vaccines, and other medical interventions against biowarfare agents, Congress should authorize the creation of a new agency within the Office of the Secretary of the U.S. Department of Defense. The committee recommended that Congress should improve liability protections for those who develop and manufacture these products, to stimulate willingness to invest in new research and development for biowarfare protection. Giving Full Measure to Countermeasures also identifies other challenges—such as the need for appropriate animal models and laboratories equipped with high-level biosafety protections—that will require attention if DoD efforts to develop new medical countermeasures are to be successful.

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