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Forum on Drug Discovery, year Development, Review and Translation 2011â2020 Board on Health Sciences Policy
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 Over the coming decade, the and treatment targets, translation of those discoveries into effective and safe treatments, and delivery of those treatments to maximize public health benefit. forum will continue to serve as Clinical trials remain a cornerstone of medical product development by providing a hub and catalyst for nurturing the scientific evidence that proves or disproves concepts developed during earlier new ideas and partnerships. stages of 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 mounting pressures, strained from all sides by rising costs, an evolving regulatory and economic landscape, increasing clinical trial complexity, difficulties in the recruitment and retention of research participants, and a clinical research workforce that is under tremendous stress. These challenges cannot be overcome in isolation and will require collaboration among patients, providers, academia, industry, federal agencies, payers, nonprofit organizations, and funders. Consider the pastâwhen health records were all on paper. Today, health systems serve millions of people and new technologies help improve our understanding of treatment and disease through analysis of information from electronic health records (EHRs) 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 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. These Co-Chair 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 we can point to important breakthroughs in understanding disease biology and the development of precision treatments, broader innovation is needed to address 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. Over the coming decade, the forum will continue to serve as a hub and catalyst for nurturing new ideas and partnerships and offer a neutral space for stakeholders to advance critical policy discussions on biopharmaceutical innovation nationally and globally.
The forum is supported by dedicated members and staff who have contributed to the immense body of work that the forum has produced over the past 10 years. 10
Contents YEARS Forum Themes and Priorities Reflecting Back: Forum Activities 2011â2020 6 8 Special Topics 24 Looking Forward: Forum Activities in 2021 and Beyond 26 Forum Sponsorship and Membership 34 Timeline 36
