Forum on Drug Discovery, Development, and Translation: 2018 Annual Report (2019)

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Forum Themes and Priorities The Forum seeks to address the key challenges and opportunities in the discovery, development, and translation of new therapeutics for patients, covering the full continuum from basic discovery to the approval and adoption of new therapies into The Forum fosters innovative clinical practice. As an overarching and cross-cutting theme, the Forum fosters efforts to identify and highlight innovative efforts to identify and highlight potentially breakthrough ideas and visionary approaches to the drug development and translational science enterprise potentially breakthrough ideas of the future. The Forum identified four core components across the R&D lifecycle, and visionary approaches to which serve as thematic pillars to frame the Forum’s focus areas and activities: the drug development and (1) Innovation and the Drug Research and Development Enterprise; (2) Science Across the Biomedical Research Lifecycle (Basic, Translational, and Regulatory translational science enterprise Sciences); (3) Clinical Trials and Medical Product Development; and (4) Infrastructure of the future. and Workforce for Advancing Drug Discovery, Development, and Translation. Innovation and the Drug Research and Development Enterprise Despite exciting scientific advances, the path from basic science to new therapeutics faces challenges on many fronts. Innovative paradigms are needed to bridge the ever-widening gap between scientific discoveries and the translation of those discoveries into life-changing medications. There is increasing recognition of the need for new models and methodologies to advance drug discovery, development, and translational science. The Forum serves as a hub and a catalyst for nurturing new ideas, collaborations, and partnerships and offers a neutral space for stakeholders to help chart a course through the turbulent forces of disruptive innovation and advance critical policy discussions on biopharmaceutical R&D nationally and globally. 18 

Forum Themes and Priorities Science Across the Biomedical Research Lifecycle Revolutionary advances in biomedical research and technology applications present new and exciting opportunities for the discovery and development of new therapies for patients. At the same time, key gaps remain in our knowledge about the science, technology, and methodologies needed to support the research that underpins drug discovery and development. The Forum provides a neutral venue to focus attention on key scientific issues across the biomedical research lifecycle and facilitate the exploration of new and more patient-centric approaches to spur innovation. The Forum continues to support activities that contribute toward the defining, establishment, and refinement of biomedical and regulatory science and other critical aspects of drug discovery and medical product development. Clinical Trials and Medical Product Development Clinical research provides a critical link between the laboratory bench and patients’ bedside when it comes to developing new therapeutics and advancing understanding of health maintenance and prevention and disease progression. However, 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. Collaborative, cross-sector approaches that engage patients, providers, academia, industry, federal agencies, payers, nonprofit organizations, and funders are needed to effectively address the key challenges and to develop systems-based solutions. Infrastructure and Workforce for Advancing Drug Discovery, Development, and Translation Considerable opportunities remain for the improvement and enhancement of the infrastructure—the organizational framework, systems, workforce, and other resources—that supports the drug discovery and development enterprise. The fields of drug discovery and development, clinical research, and clinical practice are intersecting, cross-cutting, and multidisciplinary. However, career paths in 19 

these fields are difficult to pursue, training may be lacking, and career opportunities may be limited. The Forum has considered workforce needs as foundational for the advancement of drug discovery, development, and translation and has focused substantial attention on these issues and fostered the development of strategies to improve the discipline of innovative regulatory science through the development of a robust workforce. 20 

Forum Themes and Priorities Strategies Topics addressed by the Forum span a broad range of issues in drug discovery, development, policy, and practice. In providing a venue for independent, STR ATEGIES systematic discussions of these issues, the Forum employs the following strategies. . MEMBERS Facilitate visibility and continuous discussion on important issues Foster collaboration on topics where there is synergy among potential partners Explore innovative and transformative approaches for resolving problem areas Educate and elevate understanding of issues Acade Exp Patient- & Disease- Clarify and expand areas of Focused Organizations agreement Biopharma Com Foundations & Nonprofit Funders Set the stage for future Federal ü ü policy action Consortia & Regulator ü Associations 21 Topics addressed by the Forum span a broad range The Forum has approximately 30-35 me