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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. Four thematic priorities frame the forumâs focus areas and activities: (1) Spurring Innovation and Implementation, (2) Increasing Person-Centeredness and Equity, (3) Promoting Collaboration and Harmonization, and (4) Enhancing the Workforce and Infrastructure. Spurring INNOVATION and IMPLEMENTATION Revolutionary advances in biomedical research and technology present new and exciting opportunities for the discovery and development of new therapies for patients. The evolution of health care is expanding the possibilities for integration of clinical research into the continuum of clinical care; new approaches are enabling the collection of data in real-world settings. New modalities, such as digital health technologies and artificial intelligence applications, can be leveraged to overcome challenges and advance clinical research. The forum brings together stakeholders to identify opportunities, address bottlenecks, and spur innovation in drug discovery, development, and translation. Increasing PERSON-CENTEREDNESS and EQUITY There is increasing recognition of the need for more person-centered and inclusive approaches that prioritize lived experience, equity, and justice in the discovery, development, and translation of new treatments. The forum seeks to center the priorities of people living with disease and those who have been traditionally under-represented or excluded from the clinical trials enterprise, advance the science of patient input, and help bring to fruition innovations that address the needs of patients. Promoting COLLABORATION and HARMONIZATION The forum provides a neutral platform for communication and collaboration across sectors and disciplines to better harmonize efforts throughout the drug R&D life cycle. The forum convenes a broad and evolving set of stakeholders to help integrate patients, caregivers, researchers, trialists, community practitioners, sponsors, regulators, payers, patient and disease advocacy groups, and others into the continuum of research and clinical care, enable shared decision making, and ensure that patients have input on research questions, researchers have insight into clinical practice, and practitioners are engaged in the clinical trials enterprise. Enhancing the WORKFORCE and INFRASTRUCTURE The forum has fostered the development of strategies to improve the discipline of innovative regulatory science and continues to focus attention on building a workforce that is diverse, adaptable, and resilient. Considerable opportunities remain to improve and expand the evolving clinical trials workforce and infrastructure, integrate community-based practices, and engage early-career scientists and clinicians in drug discovery, development, and translation. The forum will continue to anticipate and promote adaptation to changes in the infrastructure of health care delivery. Annual Report 2022â |â 9
