Global Health Risk Framework Research and Development of Medical Products: Workshop Summary (2016) / Chapter Skim
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Appendix C: Workshop Agenda
Appendix C: Workshop Agenda
Pages 91-100
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From page 91... ...
of the National Academies of Sciences, Engineering, and Medicine will serve as the secretariat for an independent global commission that will conduct a study to recommend an effective global architecture for recognizing and mitigating the threat of epidemic infectious diseases. The Commission will receive input from four IOM workshops on governance for global health, financing response to pandemic threats, resilient health systems, and research and development of medical products, which will be coordinated.
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From page 92... ...
SESSION 1: INCENTIVES AND DEVELOPMENT MODELS Objectives: • Review existing incentives, business models, and partnership approaches that support the research and development of medical products for emerging infectious diseases. • Identify shortcomings in existing regulatory and financial incentives, and highlight promising ideas for improvements that can help advance the development of medical products for emerging infectious diseases.
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From page 93... ...
B: Sustainable and Effective Business Models Segment and Public–Private Partnerships Keynote lectures: 40 min David Reddy, Medicines for Malaria Venture (MMV) Krishna Ella, Bharat Biotech International Limited Panel discussion: 50 min Mel Spigelman, TB Alliance Graeme Bilbe, Drugs for Neglected Diseases initiative Peter Dull, The Bill & Melinda Gates Foundation 12:30p.m.
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From page 94... ...
• Discuss whether and how discordant regulatory specifications hinder efficient development and evaluation of medical products, and possible approaches for convergence. • Characterize the critical needs of country regulatory authorities in times of public health emergency and discuss potential strategies regulators and international organizations can take to help address these needs.
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From page 95... ...
B: Sharing of Data and Reagents, Intellectual Segment Property, and Liability Keynote lecture: 20 min Anthony So, Duke University Panel Discussion: 60 min Michelle Mulder, South African Medical Research Council Lynn Marks, GlaxoSmithKline Reid Adler, Practical Innovation Strategy 4:20p.m. Break 4:30p.m.
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From page 96... ...
• Describe responsible and adaptive clinical trial designs that could be developed for use in times of public health emergencies and discuss ethical considerations associated with the possible options. • Consider ethical and methodological standards that may be used to determine optimal trial designs for assessing the readiness of investigational medical products prior to broader deployment during public health emergency.
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Centers for Disease Control and Prevention Fred Binka, University of Health and Allied Sciences, Ghana 12:30p.m. Lunch SESSION 4: MANUFACTURING, STOCKPILING, AND DEPLOYMENT Objectives: • Characterize the needs and gaps in current manufacturing, stockpiling, and supply chain mechanisms for medical product development and deployment during public health emergencies.
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Adjourn Session 4 DAY 3 (HALF DAY) SESSION 5: TOP PRIORITIES FOR FACILITATING MEDICAL PRODUCT RESEARCH AND DEVELOPMENT Objectives: • Examine the ethical and practical considerations for setting priorities to facilitate medical product research, development, and availability.
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Peter Kilmarx, Fogarty International Center, NIH Paul Stoffels, Johnson & Johnson Glenda Gray, South African Medical Research Council 11:20a.m. Adjourn Session 5 11:20a.m.
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