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
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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 (FDA) Initiatives to Advance Drug Development Innovation
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The Public-Sector Role in Drug Development
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Gauging the Returns on Federally Funded Basic Research
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Quantifying the Impact of NIH Funding on Pharmaceutical Innovation
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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 |
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
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Technology Transfer at U.S. Academic Institutions Today
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Reforming March-In Rights
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Improving the Technology Transfer Process
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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
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Initiatives by the U.S. Department of Defense (DoD) to Advance Drug Development Innovation
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Collaborating to Accelerate Medical Product Development
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Strategies to Aid Repurposing of Compounds for Secondary Uses
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Infrastructure in Drug Development Innovation
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Panel Discussion | |
5:00 pm | Wrap-Up and Open Discussion Ameet Sarpatwari, Ph.D., J.D., Harvard Medical School and Brigham and Women’s 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
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Consumer Perspective on Recent Prescription Drug Price Trends
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Innovative Drugs: Access to Medicaid Beneficiaries
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Innovative Financial and Business Models to Accelerate Drug Discovery and Development
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Panel Discussion | |
10:15 am | 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
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New Ideas and Opportunities to Ensure That the Public Has Affordable Access to Innovative Drugs
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Potential Ways to Reform the Patent System to Ensure That Patients Have Affordable Access to Innovative Drugs
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Strategies and Policies Available to Bring About Transformative Reductions in the Increasing Prices of Drugs
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Panel Discussion | |
12:30 pm | Wrap-Up and Adjourn |
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