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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 clinical practice. As an overarching and cross-cutting theme, the forum fosters innovative efforts to identify and highlight potentially breakthrough ideas and visionary approaches to the drug development and translational science enterprise of the future. The forum identified four core components across the R&D lifecycle, which serve as thematic pillars to frame The forum seeks to address the the forumâs focus areas and activities: (1) Innovation and the Drug Research key challenges and opportunities and Development Enterprise; (2) Science Across the Biomedical Research Lifecycle (Basic, Translational, and Regulatory Sciences); (3) Clinical Trials in the discovery, development, and Medical Product Development; and (4) Infrastructure and Workforce for and translation of new Advancing Drug Discovery, Development, and Translation. therapeutics for patients. Innovation and the Drug Research and Development Enterprise Innovative paradigms and new methodologies are needed to bridge the ever- widening gap between scientific discoveries and the translation of those discoveries into life-changing medications. The forum offers a neutral space for stakeholders to advance critical policy discussions on biopharmaceutical research and development nationally and globally. 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. The forum highlights critical issues across the biomedical research lifecycle and facilitates the exploration of more person-centric approaches to spur innovation. 6
Forum Themes and Priorities Clinical Trials and Medical Product Development The clinical trials enterprise faces challenges on all sidesârising costs, an evolving regulatory and economic landscape, increasing clinical trial complexity, difficulties in engaging research participants, and a strained workforce. The forum brings together patients, providers, academia, industry, federal agencies, payers, nonprofit organizations, and funders to help overcome these challenges. Infrastructure and Workforce for Advancing Drug Discovery, Development, and Translation Considerable opportunities remain to improve and enhance the infrastructure supporting the clinical trials enterprise. The forum has fostered the development of strategies to improve the discipline of innovative regulatory science and continues to focus attention on critical infrastructure and workforce issues. 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, systematic discussions of these issues, the forum employs the strategies outlined in the image to the right. 7
