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Forum on Drug Discovery, Development, and Translation Board on Health Sciences Policy 2021 Annual Review
Message from the Co-Chairsâ Robert Califf and Gregory Simon Real progress in health and health care requires continuous innovation at every stage of the treatment lifecycle: discovery of new disease mechanisms The Forum will continue and treatment targets, translation of those discoveries into effective and safe treatments, and delivery of those treatments to maximize public health benefit. to serve as a hub and a Clinical trials remain a cornerstone of medical product development by providing catalyst for nurturing new the scientific evidence that proves or disproves concepts developed during earlier ideas and partnerships and stages of development about the safety and efficacy of medical products and by will offer a neutral space informing clinical care. At the same time, the clinical research enterprise faces continued and mounting pressures, strained from all sides by rising costs, an for stakeholders to advance evolving regulatory and economic landscape, increasing clinical trial complexity, critical policy discussions on difficulties in the recruitment and retention of research participants, and a clinical biopharmaceutical innovation research workforce that is under tremendous stress. These challenges cannot be overcome in isolation and will require collaboration among patients, providers, nationally and globally. academia, industry, federal agencies, payers, nonprofit organizations, and funders. Consider the past when health records were all on paper. Today, health systems serve millions of people and new technologies help improve understanding of treatment and disease through the analysis of information from electronic health records (EHRs) and other data sources. The clinical trials enterprise has 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 understanding of health maintenance and prevention, disease progression, and 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 Academiesâ 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 and digital technology industries, academia, consortia,
foundations, journals, and patient-focused and disease advocacy organizations. Through the forumâs activities, participants have been better able to bring attention and visibility to important issues, explore new approaches for resolving problem areas, share information and find common ground, and work together to develop ideas into concrete actions and new collaborations. Over the past decade, the forum has supported a variety of activities that have Robert Califf engaged key stakeholders from across the biomedical research lifecycle. Co-Chair These activities have fostered discussion and collaboration toward a clinical trials enterprise that is more efficient, effective, patient-centered, and integrated into the health delivery system. Looking ahead to the coming decade, more work is needed to spur biomedical innovation in a responsible and equitable manner and to ensure that research is adequately powered to answer practical questions about the safety and effectiveness of medical products. While there have been 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 Gregory Simon Co-Chair to show bipartisan support for biomedical research, including ongoing funding for programs such as the NIH Brain Research Through Advancing Innovative Neurotechnologies® (BRAIN) Initiative, the Precision Medicine Initiative, the 21st Century Cures Act, and a proposed new entity, the Advanced Research Projects Agency for Health (ARPA-H). Government funders and regulators of biomedical research, such as NIH and FDA, stand to receive continued infusions of funding and support for relevant programmatic priorities. In 2022, the forum will continue to serve as a hub and a catalyst for nurturing new ideas and partnerships and will offer a neutral space for stakeholders to advance critical policy discussions on biopharmaceutical innovation nationally and globally.
Forum members at the 42nd Forum meeting held in March 2019.
Contents Reflecting Back: Forum Activities in 2021 6 Looking Forward: Forum Activities in 2022 10 Action Collaboratives 14 Forum Themes and Priorities 18 Forum Sponsorship and Membership 22 Timeline 24
