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Suggested Citation:"Message from the Co-Chairs." National Academies of Sciences, Engineering, and Medicine. 2020. Forum on Drug Discovery, Development, and Translation: 2019 Annual Report. Washington, DC: The National Academies Press. doi: 10.17226/26109.
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Page 2
Suggested Citation:"Message from the Co-Chairs." National Academies of Sciences, Engineering, and Medicine. 2020. Forum on Drug Discovery, Development, and Translation: 2019 Annual Report. Washington, DC: The National Academies Press. doi: 10.17226/26109.
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Page 3
Suggested Citation:"Message from the Co-Chairs." National Academies of Sciences, Engineering, and Medicine. 2020. Forum on Drug Discovery, Development, and Translation: 2019 Annual Report. Washington, DC: The National Academies Press. doi: 10.17226/26109.
×
Page 4
Suggested Citation:"Message from the Co-Chairs." National Academies of Sciences, Engineering, and Medicine. 2020. Forum on Drug Discovery, Development, and Translation: 2019 Annual Report. Washington, DC: The National Academies Press. doi: 10.17226/26109.
×
Page 5

Below is the uncorrected machine-read text of this chapter, intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text of each book. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

Message from the Co- hairs  C Robert Califf and Gregory Simon Clinical trials remain a cornerstone of medical product development by providing the scientific evidence that proves or disproves concepts during earlier stages of The Forum serves as a hub development about the safety and efficacy of medical products and by informing clinical care. At the same time, the clinical research enterprise faces continued and a catalyst for nurturing and mounting pressures, strained from all sides by rising costs, an evolving new ideas and partnerships regulatory and economic landscape, increasing clinical trial complexity, difficulties and offers a neutral space in the recruitment and retention of research participants, and a clinical research for stakeholders to advance workforce that is under tremendous stress. These challenges cannot be overcome in isolation and will require collaboration among patients, providers, academia, critical policy discussions on industry, federal agencies, payers, nonprofit organizations, and funders. biopharmaceutical innovation Consider the past when health records were all on paper. Today, health systems nationally and globally. serve millions of people and new technologies help improve our understanding of treatment and disease through the analysis of information from electronic health records and other data sources. We have entered an exciting time in biomedical research when clinical research and health care are at a critical juncture and the biological, physical, and digital spheres are merging. These opportunities hold great promise for advancing our understanding of health maintenance and prevention, disease progression, and for developing new therapies for patients. The Forum on Drug Discovery, Development, and Translation (the Forum) of the National Academies of Sciences, Engineering, and Medicine (the National Academies) was created in 2005 by the National Academies’ Board on Health Sciences Policy to foster communication, collaboration, and action in a neutral setting on issues of mutual interest across the drug research and development (R&D) lifecycle. The Forum membership includes leaders from the National Institutes of Health (NIH), the U.S. Food and Drug Administration (FDA), the biopharmaceutical industry, academia, consortia, foundations, journals, and patient-focused and disease advocacy organizations. In 2019, the Forum, in collaboration with the National Academies’ National Cancer Policy Forum, hosted a meeting on Updating Labels for Generic Oncology Drugs, which provided a venue to examine the challenges and opportunities for

updating labeling for generic oncology drugs. In collaboration with the National Academies’ Forum on Neuroscience and Nervous System Disorders, National Cancer Policy Forum, and Roundtable on Genomics and Precision Health, the Forum hosted two workshops. One on Enhancing Scientific Reproducibility Through Transparent Reporting, which explored issues related to transparent reporting (e.g., the disclosure of the availability and location of data, materials, analysis, and methodology) to improve rigor and reproducibility in biomedical research. And one Robert Califf on Sharing Clinical Trial Data: Challenges and a Way Forward, which examined Co-Chair progress, lessons learned, and remaining gaps in clinical trial data sharing and reuse following the publication of the 2015 Institute of Medicine report Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. In 2020, more work is needed to spur biomedical innovation in a responsible manner and ensure that research is adequately powered to answer real questions about the safety and effectiveness of medical products. While we can point to important breakthroughs in understanding disease biology and the development of precision treatments, broader innovation is needed to address the major causes of disability and premature mortality. The executive and legislative branches of the federal government have continued to show bipartisan support for biomedical research, including ongoing funding for programs such as the BRAIN Initiative, the Precision Medicine Initiative, and the 21st Century Cures Act. Government funders Gregory Simon and regulators of biomedical research, such as NIH and FDA, stand to receive Co-Chair continued infusions of funding and support for relevant programmatic priorities. The Forum serves as a hub and a catalyst for nurturing new ideas and partnerships and offers a neutral space for stakeholders to advance critical policy discussions on biopharmaceutical innovation nationally and globally. Looking ahead to 2020, the Forum plans to focus on important issues such as examining the role of digital health technologies in drug development, improving drug innovation for older adult populations, and accelerating progress toward a clinical trials enterprise that is more efficient, effective, patient-centered, and integrated into the health delivery system. We look forward to another groundbreaking and productive year for the Forum in 2020.

Forum members at the 42nd Forum meeting held in March 2019.

Contents Reflecting Back: Forum Activities in 2019 6 Looking Forward: Forum Activities in 2020 10 Action Collaboratives 14 Forum Themes and Priorities 18 Forum Sponsorship and Membership 22 Timeline 24

Next: Reflecting Back: Forum Activities in 2019 »
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In 2019, the National Academies’ Forum on Drug Discovery, Development, and Translation (the Forum), in collaboration with the National Academies’ National Cancer Policy Forum, hosted a meeting on Updating Labels for Generic Oncology Drugs, which provided a venue to examine the challenges and opportunities for updating labeling for generic oncology drugs. In collaboration with the National Academies’ Forum on Neuroscience and Nervous System Disorders, National Cancer Policy Forum, and Roundtable on Genomics and Precision Health, the Forum hosted two workshops:

  • Enhancing Scientific Reproducibility Through Transparent Reporting, which explored issues related to transparent reporting (e.g., the disclosure of the availability and location of data, materials, analysis, and methodology) to improve rigor and reproducibility in biomedical research.
  • Sharing Clinical Trial Data: Challenges and a Way Forward, which examined progress, lessons learned, and remaining gaps in clinical trial data sharing and reuse following the publication of the 2015 Institute of Medicine report Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk.
For more information, please see https://www.nationalacademies.org/our-work/forum-on-drug-discovery-development-and-translation.
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