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Global Health Risk Framework Research and Development of Medical Products: Workshop Summary (2016) / Chapter Skim
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7 Critical Considerations for Facilitating Medical Product Research and Development
Pages 75-82

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From page 75...
... . Insights from panelists Kilmarx; Stoffels; Glenda Gray, President and CEO of the South Africa Medical Research Council; and Robin Robinson, Director of the Biomedical Advanced Research and Development Authority (BARDA)
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From page 76...
... , distribution, and compliance; sociological and anthropological research can help identify approaches to engaging communities • Ethical and Legal Framework: agreed upon IP/data sharing and liability standards • Leadership: strategies will differ in routine versus emergency operations. In an emergency, the designated global leadership group should establish priorities for products to develop, test, manufacture, and distribute, to ensure efficient use of limited time/resources • Communication: accurate information about the emerging disease threat, diagnosis, prevention and control, and available treatments including ongoing clinical trials and how they work.
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From page 77...
... Centers for Disease Control and Prevention; GHIT = Global Health Innovative Technology Fund; GSK = GlaxoSmithKline; IP = intellectual property; MMV = Medicines for Malaria Venture; MRC = Medical Research Council; NGO = nongovernmental organization; NIH = U.S. National Institutes of Health; PPE = personal protective equipment; R&D = research and development; TB = tuberculosis.
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From page 78...
... . Public–private partnerships and product development partnerships were discussed as approaches to foster discovery and development, and the Japanese Global Health Innovative Technology Fund (GHIT)
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From page 79...
... Marks pointed out the need to align academic grant awards and government contracts with national and global health risk priorities. Many workshop participants discussed vaccine platforms that could potentially be U.S.
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From page 80...
... REGULATIONS The workshop discussions highlighted the ongoing advantages that harmonization of regulatory processes and regulatory science offer. The concept of preapproved clinical trial designs and protocols was raised and discussed by Yamada and Hamburg, as well as the possibility of preapproval of vaccine platforms.
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From page 81...
... In times of crisis, a broad base of support is needed, and additional assistance can come from the military, community, nongovernmental organizations, and other industries with last-mile delivery capabilities and expertise (Yamada suggested Amazon, Coca Cola, and FedEx as examples)
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Key Terms

  • clinical trials
  • global health
  • medical products
  • medical product
  • discussed included

  • workshop discussions
  • capacity building
  • vaccine platforms
  • protective equipment
  • analysis map

  • barda list
  • strategic analysis
  • personal protective
  • product discovery
  • regulatory science

  • health innovative
  • controlled trial
  • trial designs
  • biomedical advanced
  • randomized controlled

  • trial data
  • platforms discussed
  • identifies potential
  • innovative technology
  • technology fund

  • biopreparedness organization
  • spare capacity
  • guide ongoing
  • participants discussed
  • creatively structured


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