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 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 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 collaboration on topics where there is synergy among potential partners; and elevates the general understanding of drug discovery, development, and translation among the research, public policy, and broader communities. The Forum mem- bership includes leaders from the Food and Drug Administration (FDA) and the National Institutes of Health (NIH), the biopharmaceutical industry, academia, foundations, and patient-focused and disease advocacy organizations. The group is self-governing, with Forum members convening several times each year to iden- tify and prioritize the topics they wish to address. The Forum recognizes that although breakthroughs in biomedical research have led to an increased under- standing of human disease, the translation of these discoveries into therapies for patients has not kept pace with medical need. The biopharmaceutical innovation enterprise faces continued and mounting pressures, strained from all sides by increasing costs, suboptimal productivity, regulatory and economic uncertain- ties, 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 these and a variety of extraordinarily complex issues. In 2016, the Forum provided a focused and neutral venue for stakeholders 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 convening a workshop to explore a forward-looking agenda for generating and incorporating real-world evidence into the development of therapeutics. 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 and facilitated dialogue for potential process improvement efforts in the biomedical innova- tion ecosystem. The Forum also supported and fostered cross-disciplinary dialogue through workshops focusing on genetic bioresources for drug discovery and seamless cancer-focused drug development.
In 2017, a broad and deep policy conversation continues about how we can advance biomedical product innovation nationally and globally. The executive and legislative branches of the federal government have shown initiative in marshalling bipartisan support for biomedical research, including developing and supporting new programs such as the BRAIN Initiative, the Precision Medicine Initiative, the Cancer Moonshot, and the 21st Century Cures Act. As a result, government funders and regulators of biomedical research such as FDA and NIH stand to receive an infusion of funding and support for relevant programmatic priorities. The Forum is well-positioned to participate in policy discussions to help promote the goals and sustain the momentum spurred by these initiatives as they grow in 2017 and beyond. In addition to continuing action collaborative work on responsible shar- ing of clinical trial data and harmonization of clinical trial site standards, the Forum will launch new action collaboratives in 2017 focused on addressing the barriers and opportunities to improving the drug development process and on furthering the science of patient input. The Forum will also convene a workshop exploring enabling precision medicine through genetics in clinical drug development. The group will also serve as a center for thought, dialogue, and action to advance the use of real-world evidence in developing and evaluating medical products by convening a workshop and venue for the development of discussion papers on the issue. Through these and other working group discussions and workshops, solicited and original qualitative research and collaborative writing, and broad outreach, the Forum will serve as a hub and catalyst for new ideas and directions. As a neutral convening venue for stakeholders and collaborators, the Forum provides a unique setting in which complex issues of health science policy can be tackled col- legially, and in which partnerships may be formed and nurtured. We look forward to another groundbreaking and productive year for the Forum in 2017. Russ Altman Steven Galson Co-Chair Co-Chair
