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Suggested Citation:"Appendix C: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2016. Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.
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C

Workshop Agenda

August 19-21, 2015
Cheung Kung Hai Conference Centre, G/F,
William MW Mong Block, 21 Sassoon Road
Lecture Theatre 4
Hong Kong

The U.S. Institute of Medicine (IOM) 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.

This workshop will inform the Commission prior to the final release of its report by providing a forum for relevant stakeholders to describe and provide input on the core needs and strategies to facilitate development of medical products to prevent, diagnose, treat, and protect from emerging global infectious diseases. Speakers and workshop participants will be invited to describe and examine systems and approaches to discover and develop medical products to address emerging threats. The focus of the workshop will be on global systems and policy needs to foster communication, partnerships, and other strategies to advance medical product development.

The workshop will feature invited presentations and discussions that will describe and examine

  • the current state of approaches and infrastructure,
  • barriers to effective and efficient research and development, and
  • potential strategies to address impediments to the research or development processes.
Suggested Citation:"Appendix C: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2016. Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.
×

The workshop will focus on strategies to facilitate the development of medical products, including therapeutics, vaccines, diagnostics, and personal protective equipment. Key areas for consideration include product development, clinical development, optimization for development, regulatory review standards and systems, manufacturing, legal issues, and indicators relevant to medical product research and development.

The workshop is co-hosted by The University of Hong Kong and will be held on August 19-21, 2015. Participants will be invited from around the world to engage in dialogue and identify potential avenues for collaboration.

DAY 1

8:40a.m. Meeting begins
Welcome—Gabriel Leung, Dean, Li Ka Shing Faculty of Medicine, The University of Hong Kong
Welcome—Victor Dzau, President, National Academy of Medicine
Opening Keynote Lecture—Margaret Chan, World Health Organization (WHO)

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.
  • Discuss challenges to building and sustaining more effective business models and public–private partnerships; explore promising approaches and identify key attributes of a well-working collaborative approach.

Moderator: Tachi Yamada, Frazier Life Sciences

Suggested Citation:"Appendix C: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2016. Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.
×
9:30a.m. Segment A: Existing and Promising Incentives
Keynote lectures:20 min
BT Slingsby, Global Health Innovative Technologies (GHIT) Fund
Panel discussion:60 min
Lynn Marks, GlaxoSmithKline
Rajeev Venkayya, Takeda Pharmaceuticals
Kevin Outterson, Boston University
10:50a.m. Break
11:00a.m. Segment B: Sustainable and Effective Business Models 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. Lunch
Suggested Citation:"Appendix C: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2016. Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.
×

SESSION 2: SCIENCE AND REGULATORY CONVERGENCE AND CAPACITY

Objectives:

  • Review and characterize the needs and gaps in current scientific tools, technologies, and capacities to develop and evaluate products.
  • Highlight promising common platforms to enable nimble and rapid development and evaluation of products.
  • 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.
  • Discuss potential strategies for encouraging the sharing of knowledge, clinical, and clinical trial data to speed clinical assessment of investigational products for emerging infectious disease.

Moderator: Maria Freire, Foundation for the National Institutes of Health (NIH)

1:30p.m. Segment A: State of the Science
Keynote lectures:40 min
Michael Pfleiderer, Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines
Trevor Mundel, The Bill & Melinda Gates Foundation
Panel discussion:50 min
Margaret Hamburg, National Academy of Medicine (NAM)
Rudi Pauwels, BioCartis NV
Charles Goldstein, Becton Dickinson (BD)
Suggested Citation:"Appendix C: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2016. Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.
×
Adel Mahmoud, Princeton University
Craig E. Colton, 3M Personal Safety Division
3:00p.m. Segment B: Sharing of Data and Reagents, Intellectual 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. Segment C: Global Regulatory Convergence and Capacity
Keynote lectures:40 min
Margaret Hamburg, NAM
Hans-Georg Eichler, European Medicines Agency (EMA)
Panel Discussion:50 min
Raymond Chua, Singapore Health Sciences Authority (HSA)
Mike Ward, WHO
6:00p.m. Adjourn Day 1
Suggested Citation:"Appendix C: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2016. Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.
×

DAY 2

SESSION 3: CLINICAL ASSESSMENT

Objectives:

  • Examine barriers to the clinical assessment of the safety and efficacy of investigational medical products in communities experiencing a public health emergency from an emerging infectious disease.
  • Discuss a framework for determining when investigational products should be subjected to controlled clinical assessment and when they should be used more broadly under other mechanisms.
  • 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.
  • Highlight strategies for engaging communities during times of public health emergency to determine how and when to undertake controlled clinical assessment and, where trials are used, to facilitate rapid and fair enrollment in trials for investigational products.

Moderator: Maria Freire, Foundation for the NIH

9:00a.m. Segment A: Ethical Principles and Methodological Framework for Clinical Trial Designs
Keynote Lectures:40 min
Andre Kalil, University of Nebraska Medical Center
Fred Binka, University of Health and Allied Sciences, Ghana
Panel Discussion:80 min
Luciana Borio, U.S. Food and Drug Administration (FDA) (via video conference)
Suggested Citation:"Appendix C: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2016. Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.
×
Paul Stoffels, Johnson & Johnson
Mike Levine, University of Maryland School of Medicine
Peter Kilmarx, Fogarty International Center, NIH
Rob Califf, U.S. FDA (via video conference)
11:00a.m. Break
11:10a.m. Segment B: Practical Considerations and Community Engagement
Keynote Lecture:20 min
Samba Sow, Center for Vaccine Development, Mali
Panel Discussion:60 min
Joan Awunyo-Akaba, Future Generations International (FUGI), Ghana
Beth Bell, U.S. 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.
  • Highlight promising approaches for delivery and deployment of products that are manufactured outside of an affected region during public health emergencies.
Suggested Citation:"Appendix C: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2016. Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.
×
  • Discuss the ethical considerations of different manufacturing approaches and deployment capabilities.

Moderator: Tachi Yamada, Frazier Life Sciences

1:30p.m. Segment A: Manufacturing and Stockpiling
Keynote Lecture:20 min
Rajeev Venkayya, Takeda Pharmaceuticals
Discussion Panel:60 min
Krishna Ella, Bharat Biotech International Limited
Shanelle Hall, United Nations Children’s Fund (UNICEF)
2:50p.m. Break
3:00p.m. Segment B: Supply Chain Mechanisms and Deployment
Keynote Lecture:20 min
David Ripin, Clinton Health Access Initiative (CHAI)
Discussion Panel:60 min
Shanelle Hall, UNICEF
Rajeev Venkayya, Takeda Pharmaceuticals
4:00p.m. 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.
Suggested Citation:"Appendix C: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2016. Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.
×
  • Discuss potential strategies for developing a structure and process to select priorities for medical product research, development, and availability.
  • Discuss potential strategies for encouraging collaboration and information sharing among private companies to speed research and development for top priorities.
  • Explore how to align regulatory considerations, development milestones, and financing models for designated top priorities.

Moderators: Maria Freire, Foundation for the NIH, and Tachi Yamada, Frazier Life Sciences

9:00a.m. Summary Lecture:20 min
Tachi Yamada, Frazier Life Sciences
Panel Discussion:120 min
Robin Robinson, Biomedical Advanced Research and Development Authority, U.S. Department of Health and Human Services (via video conference)
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. Closing Remarks—Ceci Mundaca-Shah, National Academies of Sciences, Engineering, and Medicine
11:30a.m. Adjourn Public Workshop
Suggested Citation:"Appendix C: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2016. Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.
×

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Suggested Citation:"Appendix C: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2016. Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.
×
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Suggested Citation:"Appendix C: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2016. Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.
×
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Suggested Citation:"Appendix C: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2016. Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.
×
Page 93
Suggested Citation:"Appendix C: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2016. Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.
×
Page 94
Suggested Citation:"Appendix C: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2016. Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.
×
Page 95
Suggested Citation:"Appendix C: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2016. Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.
×
Page 96
Suggested Citation:"Appendix C: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2016. Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.
×
Page 97
Suggested Citation:"Appendix C: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2016. Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.
×
Page 98
Suggested Citation:"Appendix C: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2016. Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.
×
Page 99
Suggested Citation:"Appendix C: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2016. Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.
×
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Since the 2014 Ebola outbreak many public- and private-sector leaders have seen a need for improved management of global public health emergencies. The effects of the Ebola epidemic go well beyond the three hardest-hit countries and beyond the health sector. Education, child protection, commerce, transportation, and human rights have all suffered. The consequences and lethality of Ebola have increased interest in coordinated global response to infectious threats, many of which could disrupt global health and commerce far more than the recent outbreak.

In order to explore the potential for improving international management and response to outbreaks the National Academy of Medicine agreed to manage an international, independent, evidence-based, authoritative, multistakeholder expert commission. As part of this effort, the Institute of Medicine convened four workshops in summer of 2015 to inform the commission report. The presentations and discussions from the Workshop on Research and Development of Medical Products are summarized in this report.

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