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Message from the Co-Chairs Jeffrey Drazen and Steven Galson The Institute of Medicineâs (IOMâs) Forum on Drug Discovery, Development, and Translation was created in 2005 by the IOMâs Board on Health Sciences Policy to foster dialogue among stakeholders and provide ongoing opportunities to discuss issues of mutual interest in a neutral set- ting. The Forum provides a venue for dialogue and collaboration among its membership, which includes leaders from the pharmaceutical and biotech industries, academia, federal agencies, foundations, and patient groups. The Forum brings ongoing 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 collaboration 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 is self-governing, with Forum membership convening several times each year to identify and prioritize the topics they wish to address. The need for venues such as the Forum to provide a neutral convening ground for stakeholders to address complex issues of health science policy has never been greater. The drug development science, regulatory, and economic landscape is fraught with uncertainty and risk. Despite signifi- cant recent scientific advances in areas such as nanotechnology, genomics, and synthetic biology, there remains large unmet medical need, particu- larly for patients experiencing rare or neglected diseases. Radically new approaches to the discovery and development of therapies may be neces- sary to break the bottlenecks and bridge the âvalley of deathâ between preclinical and clinical efficacy. The year 2011 saw the continued emergence throughout the biomedical science, policy, and business sectors of a focus on the need for innovation. The Forum contributed to this conversation in a variety of ways, includ-
ing envisioning a framework for a transformed clinical trials enterprise to facilitate the development of new therapies or indications, and advance- ment of regulatory science as a discipline to support the evaluation and regulation of therapies. The Forum membership dedicated activities to global health concerns and neglected diseases such as multidrug-resistant tuberculosis (MDR TB), and undertook concerted efforts to better engage the public in the drug discovery and development enterprise. In 2012, the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) will continue to carry out key aspects of their expressed commitment to innovation in regulatory science and transla- tional medicine, including the establishment of the new National Center for Advancing Translational Sciences (NCATS) at NIH. Collaboration and dialogue among the federal agencies, academia, and industry will be essen- tial to ensuring the success of these efforts to promote innovation in drug discovery and development. We look forward to another groundbreaking and productive year for the Forum in 2012. Jeffrey Drazen Steven Galson Co-Chair Co-Chair