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Suggested Citation:"Appendix B." Institute of Medicine. 1997. Orphans and Incentives: Developing Technology to Address Emerging Infections. Washington, DC: The National Academies Press. doi: 10.17226/5948.
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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

Suggested Citation:"Appendix B." Institute of Medicine. 1997. Orphans and Incentives: Developing Technology to Address Emerging Infections. Washington, DC: The National Academies Press. doi: 10.17226/5948.
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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)

Suggested Citation:"Appendix B." Institute of Medicine. 1997. Orphans and Incentives: Developing Technology to Address Emerging Infections. Washington, DC: The National Academies Press. doi: 10.17226/5948.
×

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

Suggested Citation:"Appendix B." Institute of Medicine. 1997. Orphans and Incentives: Developing Technology to Address Emerging Infections. Washington, DC: The National Academies Press. doi: 10.17226/5948.
×
Page 60
Suggested Citation:"Appendix B." Institute of Medicine. 1997. Orphans and Incentives: Developing Technology to Address Emerging Infections. Washington, DC: The National Academies Press. doi: 10.17226/5948.
×
Page 61
Suggested Citation:"Appendix B." Institute of Medicine. 1997. Orphans and Incentives: Developing Technology to Address Emerging Infections. Washington, DC: The National Academies Press. doi: 10.17226/5948.
×
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Infectious diseases remain a leading cause of prolonged illness, premature mortality, and soaring health costs. In the United States in 1995, infectious diseases were the third leading cause of death, right behind heart disease and cancer. Mortality is mounting over time, owing to HIV/AIDS, pneumonia, and septicemia, with drug resistance playing an ever-increasing role in each of these disease categories. This book, a report from a Forum on Emerging Infections workshop, focuses on product areas where returns from the market might be perceived as being too small or too complicated by other factors to compete in industrial portfolios with other demands for investment. Vaccines are quintessential examples of such products. The lessons learned fall into four areas, including what makes intersectoral collaboration a reality, the notion of a product life cycle, the implications of divergent sectoral mandates and concepts of risk, and the roles of advocacy and public education. The summary contains an examination of the Children's Vaccine Initiative and other models, an industry perspective on the emerging infections agenda, and legal and regulatory issues.

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