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Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2020. The Role of NIH in Drug Development Innovation and Its Impact on Patient Access: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25591.
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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
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2020. The Role of NIH in Drug Development Innovation and Its Impact on Patient Access: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25591.
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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
  • Janet Woodcock, M.D., Center for Drug Evaluation and Research, 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
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
Session Objective: To discuss the current state of technology transfer agreements and licensing, and models for spurring drug innovation
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2020. The Role of NIH in Drug Development Innovation and Its Impact on Patient Access: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25591.
×
Uncertainty About Patentable Subject Matter: Implications for Biomedical Research
  • Arti Rai, J.D., Center for Innovation Policy at Duke Law
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
Initiatives by the U.S. Department of Defense (DoD) to Advance Drug Development Innovation
  • Terry Rauch, Ph.D., M.P.H., M.B.A., DoD
Collaborating to Accelerate Medical Product Development
  • Lynn Hudson, Ph.D., Critical Path Institute
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2020. The Role of NIH in Drug Development Innovation and Its Impact on Patient Access: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25591.
×
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 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
  • 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
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2020. The Role of NIH in Drug Development Innovation and Its Impact on Patient Access: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25591.
×
Innovative Financial and Business Models to Accelerate Drug Discovery and Development
  • Kevin Outterson, LL.M., Boston University School of Law
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
  • 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, 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 Women’s Hospital
Panel Discussion
12:30 pm Wrap-Up and Adjourn
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2020. The Role of NIH in Drug Development Innovation and Its Impact on Patient Access: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25591.
×

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Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2020. The Role of NIH in Drug Development Innovation and Its Impact on Patient Access: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25591.
×
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Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2020. The Role of NIH in Drug Development Innovation and Its Impact on Patient Access: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25591.
×
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Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2020. The Role of NIH in Drug Development Innovation and Its Impact on Patient Access: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25591.
×
Page 83
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2020. The Role of NIH in Drug Development Innovation and Its Impact on Patient Access: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25591.
×
Page 84
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2020. The Role of NIH in Drug Development Innovation and Its Impact on Patient Access: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25591.
×
Page 85
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2020. The Role of NIH in Drug Development Innovation and Its Impact on Patient Access: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25591.
×
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To explore the role of the National Institutes of Health (NIH) in innovative drug development and its impact on patient access, the Board on Health Care Services and the Board on Health Sciences Policy of the National Academies jointly hosted a public workshop on July 24–25, 2019, in Washington, DC. Workshop speakers and participants discussed the ways in which federal investments in biomedical research are translated into innovative therapies and considered approaches to ensure that the public has affordable access to the resulting new drugs. This publication summarizes the presentations and discussions from the workshop.

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