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Appendix B Workshop Agenda WEDNESDAY, JULY 24, 2019 8:00 am Registration 8:45 am Welcome and Workshop Overview Jeff Bingaman, J.D., Planning Committee Chair 9:00 am SESSION 1: Keynote Address Moderator: Jeff Bingaman, J.D., Former U.S. Senator, New Mexico Overview of the Translational Research Landscape Christopher Austin, M.D., National Center for Advancing Translational Sciences, National Institutes of Health (NIH) Open Discussion 10:00 am Break 10:15 am SESSION 2: Federal Funding for Biomedical Research and Its Contributions to New Drug Development and Commercialization Moderator: Amitabh Chandra, Ph.D., Harvard University Session Objective: To discuss the impacts of publicly funded biomedical research and ways to better track, quantify, and document NIH investments that lead up to drug commercialization Food and Drug Administration Initiatives to Advance Drug Development Innovation Janet Woodcock, M.D., Center for Drug Evaluation and Research, U.S. Food and Drug Administration (FDA) The Public Sector Role in Drug Development Bhaven Sampat, Ph.D., Columbia University Gauging the Returns on Federally Funded Basic Research Danielle Li, Ph.D., Massachusetts Institute of Technology Sloan School of Management PREPUBLICATION COPY: UNCORRECTED PROOFS 59
60 ROLE OF NIH IN DRUG DEVELOPMENT INNOVATION Quantifying the Impact of NIH Funding on Pharmaceutical Innovation Margaret Blume Kohout, Ph.D., Gettysburg College Panel Discussion 12:00 pm Lunch Break 1:00 pm SESSION 3: Patent and Technology Transfer Policies in Promoting the Development and Commercialization of NIH-Conducted and Funded Medical Research Moderator: Stephen Merrill, Ph.D., Senior Fellow and former executive director, Center for Innovation Policy at Duke Law School Session Objective: To discuss the current state of technology transfer agreements and licensing, and models for spurring drug innovation Uncertainty About Patentable Subject Matter: Implications for Biomedical Research Arti Rai, J.D., Duke Law School Technology Transfer at U.S. Academic Institutions Today Ashley Stevens, Ph.D., Focus IP Group, LLC Reforming March-In Rights John Thomas, J.D., Georgetown University Improving the Technology Transfer Process Chuck Na, M.S., National Institute of Standards and Technology Panel Discussion 2:45 pm Break 3:00 pm SESSION 4: Strategies and Policies to Facilitate the Translation of Federally Funded Biomedical Research into Drug Development and Commercialization Moderator: Jennifer Moore, Ph.D., R.N., Institute for Medicaid Innovation and University of Michigan Medical School Session Objective: To examine ways to improve efficiency and lower the cost of clinical drug trials or other costly phases of drug development, and ways to incentivize translation of federally funded research discoveries into drug innovation Clinical Trials: Risks and Costs in Drug Development Steven Galson, M.D., M.P.H., Amgen PREPUBLICATION COPY: UNCORRECTED PROOFS
61 APPENDIX B Initiatives by the U.S. Department of Defense to Advance Drug Development Innovation Terry Rauch, Ph.D., M.P.H., M.B.A., U.S. Department of Defense Collaborating to Accelerate Medical Product Development Lynn Hudson, Ph.D., Critical Path Institute Strategies to Aid Repurposing of Compounds for Secondary Uses Christine Colvis, Ph.D., National Center for Advancing Translational Sciences, NIH Infrastructure in Drug Development Innovation David Dilts, Ph.D., M.B.A., Vanderbilt University and Oregon Health & Science University Panel Discussion 5:00 pm Wrap-Up and Open Discussion Ameet Sarpatwari, Ph.D., J.D., Harvard Medical School and Brigham and Womenâs Hospital 5:30 pm Adjourn Day 1 THURSDAY, JULY 25, 2019 8:00 am Registration 8:30 am SESSION 5: Drug Pricing and Innovative Financing and Business Models Moderator: Patricia Danzon, Ph.D., University of Pennsylvania Session Objective: To discuss the economic implications of escalating drug costs and explore new ideas and opportunities, potential business models and financing structures to accelerate drug discovery and development Drug Pricing: The Components Patricia Danzon, Ph.D., University of Pennsylvania Consumer Perspective on Recent Prescription Drug Price Trends Leigh Purvis, M.P.A., AARP Public Policy Institute Innovative Drugs: Access to Medicaid Beneficiaries Doug Wirth, M.S.W., Amida Care PREPUBLICATION COPY: UNCORRECTED PROOFS
62 ROLE OF NIH IN DRUG DEVELOPMENT INNOVATION Innovative Financial and Business Models to Accelerate Drug Discovery and Development Kevin Outterson, LL.M., Boston University School of Law Panel Discussion 10:15am Break 10:30 am SESSION 6: Strategies and Policies to Ensure Affordable Access to Innovative Drugs That Have Benefited from Federal Investments Moderator: Reed Tuckson, M.D., Tuckson Health Connections, LLC Session Objective: To discuss new ideas and opportunities, and to explore potential public policies that should be implemented to ensure that the public has affordable access to innovative drugs that have benefited from federal investments Taxpayer Funded Drugs and a Pricing Crisis David Mitchell, Patients for Affordable Drugs New Ideas and Opportunities to Ensure That the Public Has Affordable Access to Innovative Drugs Tanisha Carino, Ph.D., FasterCures, Milken Institute Potential Ways to Reform the Patent System to Ensure That Patients Have Affordable Access to Innovative Drugs Tahir Amin, LL.B., Dip. LP., Initiative for Medicines, Access & Knowledge (I- MAK), Inc. Strategies and Policies Available to Bring About Transformative Reductions in the Increasing Prices of Drugs Aaron Kesselheim, M.D., J.D., M.P.H., Harvard Medical School and Brigham and Womenâs Hospital Panel Discussion 12:30 pm Wrap-Up and Adjourn PREPUBLICATION COPY: UNCORRECTED PROOFS