Forum on Drug Discovery, Development, and Translation: 2013 Annual Report (2014)

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Message from the Co-Chairs Jeffrey Drazen and Steven Galson The Institute of Medicine’s (IOM’s) Forum on Drug Discovery, Development, and Translation was created in 2005 by the IOM’s Board on Health Sciences Policy to foster communication and collaboration and to provide ongoing opportunities to discuss and act on issues of mutual interest in a neutral setting. The Forum brings attention and visibility to important issues in drug development; 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 col- laboration 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 membership includes leaders from the pharma- ceutical and biotech industries, academia, federal agencies, foundations, and patient groups. 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 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, reducing produc- tivity, regulatory and economic uncertainties, and accelerating complexity. The Forum views such great challenges as opportunities and has used collaborative approaches to address these complex issues. In 2013, the Forum provided a focused venue for stakeholders to take stock of the needs and pri- orities in the drug discovery and development “ecosystem” and to encourage meaningful infor- mation sharing and collaboration across sectors and stakeholder groups. The Forum contributed to broad conversations on biomedical research and policy, including convening a workshop with multi-national participants from the regulatory and pharmaceutical development sectors to help foster more harmonized regulatory standards for pharmaceutical product development. The Forum membership also continued its focused effort to address challenges in the U.S. clinical tri- als enterprise, facilitating an action-oriented, collaborative dialogue to advance development of a national accreditation system for clinical trial sites. 

In this pivotal time of enormous change and opportunity for pharmaceuti- cal innovation, sustaining and growing the biomedical research enterprise requires a renewed intellectual, business, scientific, and public policy climate in which effective collaboration in research and translation can flourish. The Forum has proposed new paradigms for discovering and developing drugs that bridge the ever-widening gap between scientific discoveries and translation of those discoveries into life-changing medi- cations. Worldwide, patients, industry, federal agencies, academia, and foundations bring a broad array of new tools and approaches in response to this challenge with the understanding that thoughtful partnership and collaboration can create results that would be impossible alone. In 2014, the Forum will foster innovative efforts to identify and highlight potentially breakthrough ideas and visionary approaches to the “drug development and translational science enterprise of the future.” Through working group discussions and workshops, solicited and original qualita- tive 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 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 2014. Jeffrey Drazen Steven Galson Co-Chair Co-Chair