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APPENDIX B
Workshop Agenda

NATIONAL ACADEMY OF SCIENCES INSTITUTE OF MEDICINE

FORUM ON EMERGING INFECTIONS

2nd Meeting: 10–11 February 1997

Monday, February 10th

9:30 MEETING BEGINS

ELEMENT 1: THE EMERGING INFECTIOUS DISEASE R&D AGENDA AND INDUSTRY'S RESPONSE

1. What are the public-sector health agendas, priorities, and/or particular concerns in connection with R&D related to emerging infectious diseases?

2. What components of these are shared and which are specific to individual public-sector entities?

Thumbnail Reports—Priorities/Relevant Activities:

John LaMontagne (NIAID)

James Hughes/Joseph McDade (CDC)

Michael Hughes (VA)

Stephen Morse (DARPA)

Nancy Carter-Foster (State)

Veerle Coignez Sterling (World Bank)

3. In which of the areas indicated in the public health agenda and priorities list is industry already working, who is doing so, and what are they doing?

Overview:

John Siegfried (PhRMA)

Additional Comments:

Individual industry representatives who are members of the Forum



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--> APPENDIX B Workshop Agenda NATIONAL ACADEMY OF SCIENCES INSTITUTE OF MEDICINE FORUM ON EMERGING INFECTIONS 2nd Meeting: 10–11 February 1997 Monday, February 10th 9:30 MEETING BEGINS ELEMENT 1: THE EMERGING INFECTIOUS DISEASE R&D AGENDA AND INDUSTRY'S RESPONSE 1. What are the public-sector health agendas, priorities, and/or particular concerns in connection with R&D related to emerging infectious diseases? 2. What components of these are shared and which are specific to individual public-sector entities? Thumbnail Reports—Priorities/Relevant Activities: John LaMontagne (NIAID) James Hughes/Joseph McDade (CDC) Michael Hughes (VA) Stephen Morse (DARPA) Nancy Carter-Foster (State) Veerle Coignez Sterling (World Bank) 3. In which of the areas indicated in the public health agenda and priorities list is industry already working, who is doing so, and what are they doing? Overview: John Siegfried (PhRMA) Additional Comments: Individual industry representatives who are members of the Forum

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--> 4. Where are the gaps between what the public sector needs and what industry is already doing? Gap Analysis and Discussion 1:30 RECONVENE ELEMENT 2: A LEARNING CASE—THE CHILDREN'S VACCINE INITIATIVE 5. What have we learned? (NOTE: While particular topics are indicated for some individuals, all are highly knowledgeable about this activity and can speak to a range of relevant points.) Panel Presentation and Discussion—Attempts to Modify the Structure of Incentives for Industry to Produce ''Social Products": The Illuminating Case of the Children's Vaccine Initiative William Hausdorff (Wyeth-Lederle) Pamela Johnson (United Nations) Amie Batson (Vaccine Supply and Quality Unit, WHO Global Programme for Vaccines and Immunization) William Muraskin (Department of History, Queens College) Jack Melling (Salk Institute, Swiftwater) Roy Widdus (WHO/Children's Vaccine Initiative) Patents: Protection and Problems Charles Caruso (Merck and Company, Inc.) ELEMENT 3: OTHER MODELS AND MECHANISMS Special Disease-Focused Initiatives: Malaria Vaccine Development Board Phillip Russell (Johns Hopkins School of Hygiene and Public Health) International AIDS Vaccine Initiative (IAVI) Seth Berkley (Rockefeller Foundation) Legislative Mechanisms Orphan Drug Act Anne Marie Finley (Committee on Government Reform and Oversight, Subcommittee on Human Resources, U.S. House of Representatives)

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--> 6. Contemplating what we have heard today, what do we think we know about what works and what does not, and what would be the most useful things that could/should happen next? GENERAL DISCUSSION and CHAIRMAN'S SUMMARY 5:30 ADJOURN Tuesday, February 11th 8:30 MEETING RESUMES ELEMENT 4: Discussion Panel, FDA and Industry Representatives 7. Current Legal/Regulatory Issues Around Development of Drugs and Vaccines for Emerging Infections Antimicrobial Resistance and Labeling Combination Products: Vaccines and Pharmaceuticals Special Mechanisms to Expedite Approval (e.g., fast-track mechanisms) Use of Foreign Data/ICH Activities Product Availability From the Food and Drug Administration: Elaine Esber Mark Goldberger Jeffrey Murray Stuart Nightingale From the Forum on Emerging Infections: Member Representatives from Industry 10:30 ADJOURN