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-Chairs Russ Altman and Steven Galson The Forum on Drug Discovery, Development, and Translation of the National Academies of Sciences, Engineering, and Medicine (the Academies) was created in 2005 by the Academiesâ Board on Health Sciences Policy to foster communication, collaboration, and action in a neutral setting on issues of mutual interest relating to drug discovery, development, and translation. The Forum brings attention and visibility to important issues; explores new approaches for resolving problem areas; helps define the scope of the field and thus sets the stage for future policy action; provides a catalyst for collabora- tion on topics where there is synergy among potential partners; and elevates the general understand- ing of drug discovery, development, and translation among the research, public policy, and broader communities. The Forum membership includes leaders from the Food and Drug Administration and the National Institutes of Health, the pharmaceutical and biotech industries, academia, foundations, and patient and disease advocacy organizations. The group is self-governing, with Forum members convening several times each year to identify and prioritize the topics they wish to address. The Forum recognizes that although breakthroughs in biomedical research have led to an increased understanding of human disease, the translation of these discoveries into therapies for patients has not kept pace with medical need. The pharmaceutical innovation enterprise faces continued and mounting pressures, strained from all sides by increasing costs, suboptimal productivity, regulatory and economic uncertainties, and accelerating complexity. As diseases become increasingly complex and our knowledge about them becomes more comprehensive, the time is ripe for an increased investment in innovation and commitment to effective collaborative models and partnerships. When patients, industry, federal agencies, academia, and funders come together, their efforts can create results that would be impossible alone. The Forum views challenges as opportunities and has used its convening to address a variety of extraordinarily complex issues. In 2015, the Forum provided a focused and neutral venue for stake- holders to identify and characterize the needs and priorities in the drug discovery and development âecosystemâ and to encourage meaningful information sharing and collaboration across sectors. The Forum contributed to broad conversations on drug development research and policy, including con- vening a workshop to explore a forward-looking agenda for bolstering the field of innovative regula- tory science. The Forum membership also continued its focused effort to address challenges in the drug discovery and development process by facilitating an action-oriented collaborative that identified rate-limiting steps in the drug development enterprise and facilitated dialogue for potential process improvement efforts in the biomedical innovation ecosystem.
In 2016, a broad and deep policy conversation continues about how we can advance biomedical product innovation nationally and globally. Congressional discussions and federal agency initiatives have begun to address some key issues, including advancing the development of precision medicine, championing treat- ments for rare diseases, building a workforce prepared to address arising chal- lenges in biomedical research, and facilitating clinical data sharing. The Executive Branch has launched the Cancer âMoonshotâ initiativeâa coordinated effort to enhance cooperation among researchers, regulators, and patients to accelerate the development of new cancer therapies. Informed deliberation is still necessary, however, to make progress and advance our system for developing promising dis- coveries into therapies for patients. The Forum will continue to convene its inno- vative action collaborative to establish a vocabulary and identify key bottlenecks in the biomedical innovation ecosystem. The Forum will also convene a workshop exploring approaches to maximize the utility of large genomic data banks to facilitate more productive drug discovery. Through these and other working group discussions and workshops, solicited and original qualitative research and collab- orative writing, and broad outreach, the Forum will serve as a hub and a catalyst for new ideas and directions. As a neutral convening venue for stakeholders and collaborators, the Forum pro- vides a unique setting in which complex issues of health science policy can be tack- led collegially, and in which partnerships may be formed and nurtured. We look forward to another groundbreaking and productive year for the Forum in 2016. Russ Altman Steven Galson Co-Chair Co-Chair
