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

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T I M E LI NE 2002–2004 | Clinical Research Roundtable, predecessor to Opportunities | June 23 Workshop: Breakthrough Business the Forum Models: Drug Development for Rare and Neglected Diseases and Individualized Therapies | June 24 Forum Meeting #10 | October 24 Workshop: Assessing and Accelerating 2005 | Forum on Drug Discovery, Development, and Translation Development of Biomarkers for Drug Safety | November 2–3 founded | March 23–24 Forum Meeting #1 | June 29–30 Forum Forum Meeting #11 | November 5 Workshop: Addressing the Meeting #2 | September 8–9 Forum Meeting #3 | November Threat of Drug-Resistant Tuberculosis: A Realistic Assessment 3–4 Workshop: Adverse Drug Event Reporting: The Roles of of the Challenge Consumers and Health-Care Professionals 2009 | February 23 Capitol Hill Briefing: Growing Threat of 2006 | March 28–29 Forum Meeting #4 | May 30–31 Workshop: Drug-Resistant Tuberculosis | March 13 Discussion Series: FDA Understanding the Benefits and Risks of Pharmaceuticals | Community Update on Personalized Medicine and the Genetic June 13 Workshop: Addressing the Barriers to Pediatric Drug Basis of Adverse Events | April 27 Workshop: Streamlining Development | June 27–28 Forum Meeting #5 | October 24–25 Clinical Trial and Material Transfer Negotiations | April 27–28 Forum Meeting #6 Forum Meeting #12 | July 10 Symposium: Drug Regulation with FDA Commissioner Peggy Hamburg and Forum Meeting #13 | 2007 | March 12 Symposium: The Future of Drug Safety: September 2 Discussion Series: FDA Community Update: Challenges for the FDA | April 23–24 Workshop: Emerging Improving the Science of Drug Safety | October 7–8 Workshop: Safety Science | April 24 Forum Meeting #7 | September 14 Transforming Clinical Research in the United States | October Discussion Series: From Patient Needs to New Drug Therapies: 15–16 Forum Meeting #14 Can We Improve the Pathway? | October 15–16 Forum Meeting #8 | November 30 Discussion Series: A Conversation with 2010 | February 23–24 Workshop: The Public Health Emergency Tony Fauci Medical Countermeasures Enterprise (in collaboration with the Medical Preparedness Forum) | February 26 Workshop: Building 2008 | February 20–21 Forum Meeting #9 | February a National Framework for the Establishment of Regulatory Science 20 Discussion Series: Comparative Effectiveness | for Drug Development | March 3–4 Workshop: The Emerging April 21 Discussion Series: Science at FDA: Challenges and Threat of Multidrug-Resistant Tuberculosis (Pretoria, South 24 

Africa) | April 29–30 Forum Meeting #15 | May 26–27 Workshop: 2012 | March 13–14 Forum Meeting #21 | June 4–5 Workshop: The New Profile of Drug-Resistant Tuberculosis (Moscow, Maximizing the Goals of the Cures Acceleration Network to Russia) | August 5 Forum Meeting #16 | October 29 Forum Accelerate the Development of New Drugs and Diagnostics | Meeting #17 June 5 Forum Meeting #22 | July 31–August 1 Workshop: Developing and Strengthening the Global Supply Chain for Second-Line Drugs for Multidrug-Resistant Tuberculosis | 2011 | March 28 Forum Meeting #18 | March 29–30 Workshop: October 4–5 Workshop: Sharing Clinical Research Data (in Advancing Regulatory Science for Medical Countermeasure collaboration with the Neuroscience Forum, National Cancer Development (in collaboration with the Medical Preparedness Policy Forum, and Genomics Roundtable) | October 23–24 Forum) | April 18–19 and 21 Workshop: Facing the Reality of Forum Meeting #23 | November 26–27 Workshop: Large Simple Multidrug-Resistant Tuberculosis: Challenges and Potential Trials and Knowledge Generation in a Learning Health System Solutions (New Delhi, India) | June 27–28 Workshop: Public (in collaboration with the Leadership Consortium for a Value & Engagement and Clinical Trials: New Models and Disruptive Science-Driven Health System) Technologies (in collaboration with the Mount Sinai School of Medicine) | June 28–29 Forum Meeting #19 | July 12 Workshop Summary Report Release: The Emerging Threat of Multidrug- 2013 | January 15 Workshop Summary Report Release: Resistant Tuberculosis: Global and Local Challenges and Developing and Strengthening the Global Supply Chain for Solutions (Durban, South Africa) | September 20–21 Workshop: Second-Line Drugs for Multidrug-Resistant Tuberculosis | Strengthening a Workforce for Innovative Regulatory Science in January 16–18 Workshop: The Global Crisis of Drug-Resistant Therapeutics Development | October 4–5 Forum Meeting #20 | Tuberculosis and Leadership of the BRICS Countries (Beijing, November 7–8 Workshop: Envisioning a Transformed Clinical China) | February 12 Forum Meeting #24 | February 13–14 Trials Enterprise in the United States: Establishing an Agenda for Workshop: International Regulatory Harmonization Amid 2020 | November 15 Workshop Summary Report Release: The Globalization of Biomedical Research and Medical Product New Profile of Drug-Resistant Tuberculosis: A Global and Local Development | June 3 Forum Meeting #25 | October 28–29 Perspective (Moscow, Russia) Forum Meeting #26 25 

T I M E LI NE 2014 | February 12 Workshop: Characterizing and October 19 Workshop: Real-World Evidence Generation and Communicating Uncertainty in the Assessment of Benefits Evaluation of Therapeutics | December 12–13 Workshop: The and Risks of Pharmaceutical Products (Day 1) | March 3–4 Drug Development Paradigm in Oncology (in collaboration with Forum Meeting #27 | May 12 Workshop: Characterizing and the National Cancer Policy Forum) Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products (Day 2) | June 10–11 Forum 2017 | March 8 Workshop: Enabling Precision Medicine: Meeting #28 | October 7–8 Forum Meeting #29 The Role of Genetics in Clinical Drug Development (in collaboration with the Genomics Roundtable) | March 9 Forum 2015 | January 20–21 Workshop: Financial Incentives to Meeting #36 | July 10–11 Forum Meeting #37 | September 19–20 Support Unmet Medical Needs for Nervous System Disorders Workshop Series: Examining the Impact of Real-World Evidence (in collaboration with the Neuroscience Forum) | March 17–18 on Medical Product Development—Workshop 1: Incentives | Forum Meeting #30 | March 26–27 Workshop: Rapid Medical October 24–25 Forum Meeting #38 Countermeasure Response to Infectious Diseases: Enabling Sustainable Capabilities Through Ongoing Public- and 2018 | March 6–7 Workshop Series: Examining the Impact Private-Sector Partnerships (in collaboration with the Medical of Real-World Evidence on Medical Product Development— Preparedness Forum) | June 23–24 Forum Meeting #31 | October Workshop 2: Practical Approaches | March 19–20 Forum 20 Workshop: Advancing the Discipline of Regulatory Science Meeting #39 | May 9 Workshop: Advancing the Science of Patient for Medical Product Development: An Update on Progress and a Input in Medical Product R&D—Towards a Research Agenda | Forward-Looking Agenda | October 21 Forum Meeting #32 July 17–18 Workshop Series: Examining the Impact of Real-World Evidence on Medical Product Development—Workshop 3: 2016 | March 22 Workshop: Deriving Drug Discovery Value Application | July 18 Forum Meeting #40 | October 3–4 Forum from Large-Scale Genetic Bioresources (in collaboration with Meeting #41 | November 28–29 Workshop: Virtual Clinical the Genomics Roundtable) | March 23 Forum Meeting #33 | July Trials—Challenges and Opportunities 19–20 Forum Meeting #34 | October 18 Forum Meeting #35 | 26 

FORUM STAFF Carolyn K. Shore, Ph.D. Senior Program Officer and Forum Director Rebecca A. English, M.P.H. Program Officer Amanda Wagner Gee, M.S. Program Officer Morgan L. Boname, M.S. Associate Program Officer (until May 2018) Sylvia Ncha, M.P.H. Associate Program Officer (as of August 2018) Eeshan Khandekar, M.Sc. Research Associate (as of September 2018) Melvin Joppy Senior Program Assistant BOARD ON HEALTH SCIENCES POLICY Andrew M. Pope, Ph.D. Director 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 provide a unique platform for dialogue and collaboration are elected by their peers for outstanding contributions to research. Dr. Marcia among thought leaders and stakeholders in government, McNutt 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. C. D. Mote, Jr., 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 Learn more about the National Academies of Sciences, Engineering, and Drug Discovery, Development, and Translation, please visit Medicine at www.nationalacademies.org. our website at http://www.nationalacademies.org/DrugForum.