Forum on Drug Discovery, Development, and Translation: 2019 Annual Report (2020)

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T I M E LI NE 2019 | March 6–7 Forum Meeting #42 | March 26 Meeting: with the Roundtable on Genomics and Precision Health) Updating Labels for Generic Oncology Drugs (in collaboration | March 9 Forum Meeting #36 | July 10–11 Forum Meeting #37 with the National Cancer Policy Forum) | July 30–31 Forum | September 19–20 Workshop Series: Examining the Impact Meeting #43 | September 25–26 Workshop: Enhancing Scientific of Real-World Evidence on Medical Product Development— Reproducibility Through Transparent Reporting (in collaboration Workshop 1: Incentives | October 24–25 Forum Meeting #38 with the Forum on Neuroscience and Nervous System Disorders, the National Cancer Policy Forum, and the Roundtable on 2016 | March 12 Workshop: Deriving Drug Discovery Value from Genomics and Precision Health) | October 23–24 Forum Meeting Large-Scale Genetic Bioresources (in collaboration with the #44 | November 18–19 Workshop: Sharing Clinical Trial Data: Roundtable on Genomics and Precision Health) | March 23 Forum Challenges and a Way Forward (in collaboration with the Forum Meeting #33 | July 19–20 Forum Meeting #34 | October 18 Forum on Neuroscience and Nervous System Disorders, the National Meeting #35 | October 19 Workshop: Real-World Evidence Cancer Policy Forum, and the Roundtable on Genomics and Generation and Evaluation of Therapeutics | December 12–13 Precision Health) Workshop: The Drug Development Paradigm in Oncology (in collaboration with the National Cancer Policy Forum) 2018 | March 6–7 Workshop Series: Examining the Impact of Real-World Evidence on Medical Product Development— 2015 | January 20–21 Workshop: Financial Incentives to Workshop 2: Practical Approaches | March 19–20 Forum Support Unmet Medical Needs for Nervous System Disorders Meeting #39 | May 9 Workshop: Advancing the Science of Patient (in collaboration with the Forum on Neuroscience and Nervous Input in Medical Product R&D: Towards a Research Agenda | System Disorders) | March 17–18 Forum Meeting #30 | March July 17–18 Workshop Series: Examining the Impact of Real- 26–27 Workshop: Rapid Medical Countermeasure Response to World Evidence on Medical Product Development—Workshop 3: Infectious Diseases: Enabling Sustainable Capabilities Through Application | July 18 Forum Meeting #40 | October 3–4 Forum Ongoing Public- and Private-Sector Partnerships (in collaboration Meeting #41 | November 28–29 Workshop: Virtual Clinical Trials: with the Forum on Medical and Public Health Preparedness for Challenges and Opportunities Disasters and Emergencies) | June 23–24 Forum Meeting #31 | October 20 Workshop: Advancing the Discipline of Regulatory 2017 | March 8 Workshop: Enabling Precision Medicine: The Science for Medical Product Development: An Update on Role of Genetics in Clinical Drug Development (in collaboration Progress and a Forward-Looking Agenda | October 21 Forum Meeting #32 24 

2014 | February 12 Workshop: Characterizing and Roundtable on Genomics and Precision Health) | October 23–24 Communicating Uncertainty in the Assessment of Benefits Forum Meeting #23 | November 26–27 Workshop: Large Simple and Risks of Pharmaceutical Products (Day 1) | March 3–4 Trials and Knowledge Generation in a Learning Health System Forum Meeting #27 | May 12 Workshop: Characterizing and (in collaboration with the Leadership Consortium for a Value & Communicating Uncertainty in the Assessment of Benefits and Science-Driven Health System) Risks of Pharmaceutical Products (Day 2) | June 10–11 Forum Meeting #28 | October 7–8 Forum Meeting #29 2011 | March 28 Forum Meeting #18 | March 29–30 Workshop: Advancing Regulatory Science for Medical Countermeasure 2013 | January 15 Workshop Summary Release: Developing and Development (in collaboration with the Forum on Medical and Strengthening the Global Supply Chain for Second-Line Drugs for Public Health Preparedness for Disasters and Emergencies) | Multidrug-Resistant Tuberculosis | January 16–18 Workshop: The April 18–19 and 21 Workshop: Facing the Reality of Multidrug- Global Crisis of Drug-Resistant Tuberculosis and Leadership of Resistant Tuberculosis: Challenges and Potential Solutions the BRIGS Countries (Beijing, China) | February 12 Forum (New Delhi, India) | June 27–28 Workshop: Public Engagement Meeting #24 | February 13–14 Workshop: International Regulatory and Clinical Trials: New Models and Disruptive Technologies Harmonization Amid Globalization of Biomedical Research and (in collaboration with the Mount Sinai School of Medicine) | June Medical Product Development | June 3 Forum Meeting #25 | 28–29 Forum Meeting #19 | July 12 Workshop Summary Release: October 28–29 Forum Meeting #26 The Emerging Threat of Multidrug-Resistant Tuberculosis: Global and Local Challenges and Solutions (Durban, South Africa) | 2012 | March 13–14 Forum Meeting #21 | June 4–5 Workshop: September 20–21 Workshop: Strengthening a Workforce for Maximizing the Goals of the Cures Acceleration Network to Innovative Regulatory Science in Therapeutics Development | Accelerate the Development of New Drugs and Diagnostics October 4–5 Forum Meeting #20 | November 7–8 Workshop: | June 5 Forum Meeting #22 | July 31–August 1 Workshop: Envisioning a Transformed Clinical Trials Enterprise in the Developing and Strengthening the Global Supply Chain for United States: Establishing an Agenda for 2020 | November 15 Second-Line Drugs for Multidrug-Resistant Tuberculosis | Workshop Summary Release: The New Profile of Drug-Resistant October 4–5 Workshop: Sharing Clinical Research Data (in Tuberculosis: A Global and Local Perspective (Moscow, Russia) collaboration with the Forum on Neuroscience and Nervous System Disorders, the National Cancer Policy Forum, and the 25 

T I M E LI NE 2010 | February 23–24 Workshop: The Public Health | June 23 Workshop: Breakthrough Business Models: Drug Emergency Medical Countermeasures Enterprise (in Development for Rare and Neglected Diseases and Individualized collaboration with the Forum on Medical and Public Health Therapies | June 24 Forum Meeting #10 | October 24 Workshop: Preparedness for Disasters and Emergencies) | February 26 Assessing and Accelerating Development of Biomarkers for Workshop: Building a National Framework for the Establishment Drug Safety | November 2–3 Forum Meeting #11 | November 5 of Regulatory Science for Drug Development | March 3–4 Workshop: Addressing the Threat of Drug-Resistant Tuberculosis: Workshop: The Emerging Threat of Multidrug-Resistant A Realistic Assessment of the Challenge Tuberculosis (Pretoria, South Africa) | April 29–30 Forum Meeting #15 | May 26–27 Workshop: The New Profile of Drug-Resistant 2007 | March 12 Symposium: The Future of Drug Safety: Tuberculosis (Moscow, Russia) | August 5 Forum Meeting Challenges for the FDA | April 23–24 Workshop: Emerging Safety #16: Conflict of Interest | October 29 Forum Meeting #17: Science | April 24 Forum Meeting #7 | September 14 Discussion Administrative and Regulatory Inefficiencies in Clinical Trials Series: From Patient Needs to New Drug Therapies: Can We Improve the Pathway? | October 15–16 Forum Meeting #8 | 2009 | February 23 Capitol Hill Briefing: Growing Threat of November 30 Discussion Series: A Conversation with Tony Fauci Drug-Resistant Tuberculosis | March 13 Discussion Series: FDA Community Update on Personalized Medicine and the Genetic 2006 | March 28–29 Forum Meeting #4 | May 30–31 Workshop: Basis of Adverse Events | April 27 Workshop: Streamlining Understanding the Benefits and Risks of Pharmaceuticals | Clinical Trial and Material Transfer Negotiations | April 27–28 June 13 Workshop: Addressing the Barriers to Pediatric Drug Forum Meeting #12 | July 10 Symposium: Drug Regulation with Development | June 27–28 Forum Meeting #5 | October 24–25 FDA Commissioner Peggy Hamburg and Forum Meeting #13 Forum Meeting #6 | September 2 Discussion Series: FDA Community Update: Improving the Science of Drug Safety | October 7–8 Workshop: 2005 | March 28–29 Forum Meeting #4 | May 30–31 Workshop: Transforming Clinical Research in the United States | October Understanding the Benefits and Risks of Pharmaceuticals | 15–16 Forum Meeting #14 June 13 Workshop: Addressing the Barriers to Pediatric Drug Development | June 27–28 Forum Meeting #5 | October 24–25 2008 | February 20 Discussion Series: Comparative Forum Meeting #6 Effectiveness | February 20–21 Forum Meeting #9 | April 21 Discussion Series: Science at FDA: Challenges and Opportunities 2002–2004 | Clinical Research Roundtable, predecessor to the Forum 26 

FORUM STAFF Carolyn K. Shore, Ph.D. Senior Program Officer and Forum Director Amanda Wagner Gee, M.S. Program Officer Jennifer Hinners, M.D., M.P.H. Program Officer Eeshan Khandekar, M.Sc. Associate Program Officer Sylvia Ncha, M.P.H. Associate Program Officer Melvin Joppy Senior Program Assistant National Academies staff supporting the Forum in 2019 (from left to right): Jeanay BOARD ON HEALTH SCIENCES POLICY Butler, Sylvia Ncha, Anna I. Camilo Javier, Bettina Seliber, Carolyn Shore, Eeshan Andrew M. Pope, Ph.D. Khandekar, Jennifer Hinners, Melvin Joppy, Director Amanda Wagner Gee, Taryn Young, and Robert (“Skip”) Day. 3 

ABOUT THE FORUM ABOUT THE NATIONAL ACADEMIES OF SCIENCES, ENGINEERING, AND MEDICINE The Forum on Drug Discovery, Development, and Translation of the National Academies of Sciences, The National Academy of Sciences was established in 1863 by an Act of Engineering, and Medicine was created in 2005 by the Congress, signed by President Lincoln, as a private, nongovernmental institution National Academies’ Board on Health Sciences Policy to to advise the nation on issues related to science and technology. Members are provide a unique platform for dialogue and collaboration elected by their peers for outstanding contributions to research. Dr. Marcia McNutt among thought leaders and stakeholders in government, is president. academia, industry, foundations, and patient advocacy The National Academy of Engineering was established in 1964 under the with an interest in improving the system of drug discovery, charter of the National Academy of Sciences to bring the practices of engineering development, and translation. The Forum brings together to advising the nation. Members are elected by their peers for extraordinary leaders from private-sector sponsors of biomedical contributions to engineering. Dr. John L. Anderson is president. and clinical research, federal agencies sponsoring and regulating biomedical and clinical research, the academic The National Academy of Medicine (formerly the Institute of Medicine) was community, and patients, and in doing so serves to educate established in 1970 under the charter of the National Academy of Sciences to the policy community about issues where science and advise the nation on medical and health issues. Members are elected by their policy intersect. peers for distinguished contributions to medicine and health. Dr. Victor J. Dzau is president. The Forum convenes a few times each year to identify and discuss key problems and strategies in the discovery, The three Academies work together as the National Academies of Sciences, development, and translation of drugs. To supplement the Engineering, and Medicine to provide independent, objective analysis and perspectives and expertise of its members, the Forum also advice to the nation and conduct other activities to solve complex problems and holds public workshops to engage a wide range of experts, inform public policy decisions. The National Academies also encourage education members of the public, and the policy community. The and research, recognize outstanding contributions to knowledge, and increase Forum also fosters collaborations among its members and public understanding in matters of science, engineering, and medicine. constituencies. For more information about the Forum on Drug Discovery, Development, and Translation, Learn more about the National Academies of Sciences, Engineering, and please visit our website at http://www.nationalacademies. Medicine at www.nationalacademies.org. org/DrugForum.