Innovation in Drug Research and Development for Prevalent Chronic Diseases Proceedings of a Workshop (2021) / Chapter Skim
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Appendix A: Workshop Agenda
Appendix A: Workshop Agenda
Pages 73-84
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will discuss key opportuni ties and challenges for increasing investment, broadening biospecimen collection and registry use, and supporting innovative discovery and preclinical research in prevalent chronic diseases.
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For additional information on this virtual workshop, please visit the main project page.1 Part One: February 22, 2021 Opportunities in Discovery and Preclinical Research for Prevalent Chronic Diseases 11:00 am–3:00 pm ET 11:00 am Welcome and Opening Remarks Carlos Garner, Workshop Co-Chair Vice President, Global Regulatory Affairs Eli Lilly and Company Anantha Shekhar, Workshop Co-Chair Senior Vice Chancellor for Health Sciences and Dean of the School of Medicine University of Pittsburgh SESSION I OVERVIEW OF R&D FOR PREVALENT CHRONIC DISEASES Session Objectives: • Discuss the unique cross-cutting challenges facing preclinical research for prevalent chronic diseases; and • Highlight opportunities to overcome those challenges and mobilize the R&D innovation engine. 1 For more information, see https://www.nationalacademies.org/our-work/innovation-in drug-research-and-development-for-prevalent-chronic-diseases-a-workshop (accessed October 29, 2021)
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11:25 am Response and Overview Susan Schaeffer, Moderator President and Chief Executive Officer Patients' Academy for Research Advocacy 11:35 am Funder Perspective Jason Mellad Chief Executive Officer and Founder Start Codon 11:50 am Public–Private Partnership Investor Perspective Joseph Menetski Associate Vice President of Research Partnerships Foundation for the National Institutes of Health 12:05 pm Moderated Panel Discussion and Audience Q&A 12:30 pm BREAK (30 minutes)
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Rosen, Moderator Managing Director, BonVelo Ventures Lecturer, Stanford University 1:10 pm Academic Perspective Erica Woodahl Professor, Department of Biomedical and Pharmaceutical Sciences University of Montana SESSION IV NEW TECHNOLOGIES ENABLING DISCOVERY RESEARCH Session Objectives: • Discuss the unique cross-cutting challenges in preclinical research for prevalent chronic diseases and consider how new technologies could help researchers overcome these challenges; and • Consider lessons learned from other disease areas for which new technologies have been a key driver of progress. 1:25 pm Academic Discovery Science–Technology Perspective John Ngai Director BRAIN Initiative, National Institutes of Health 1:40 pm Artificial Intelligence for Discovery Science Andrew A
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APPENDIX A 77 1:55 pm Regulator Perspective Qi Liu Senior Science Advisor, Office of Clinical Pharmacology & Translational Sciences U.S. Food and Drug Administration 2:10 pm Moderated Panel Discussion and Audience Q&A 2:50 pm Closing Remarks Carlos Garner, Workshop Co-Chair Vice President, Global Regulatory Affairs Eli Lilly and Company Anantha Shekhar, Workshop Co-Chair Senior Vice Chancellor for Health Sciences and Dean of the School of Medicine University of Pittsburgh 3:00 pm ADJOURN Part Two: March 1, 2021 Opportunities in Clinical Research for Prevalent Chronic Diseases 11:00 am–3:00 pm ET 11:00 am Welcome and Opening Remarks Carlos Garner, Workshop Co-Chair Vice President, Global Regulatory Affairs Eli Lilly and Company Anantha Shekhar, Workshop Co-Chair Senior Vice Chancellor for Health Sciences and Dean of the School of Medicine University of Pittsburgh SESSION I OVERVIEW OF R&D FOR PREVALENT CHRONIC DISEASES Session Objectives: • Discuss the unique cross-cutting challenges facing clinical research for prevalent chronic diseases; and • Highlight opportunities to overcome those challenges and mobilize the R&D innovation engine.
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11:35 am Economics Perspective Kirsten Axelsen Visiting Fellow American Enterprise Institute 11:50 am A Payer's Perspective: Pricing and Health Economic Drivers That Incentivize Development Investments Ken Ehlert Chief Scientific Officer UnitedHealth Group 12:05 pm Moderated Panel Discussion and Audience Q&A 12:25 pm BREAK (30 minutes) SESSION III INNOVATIVE APPROACHES TO EFFICIENT CLINICAL DEVELOPMENT Session Objectives: • Discuss the unique cross-cutting challenges in clinical trials for prevalent chronic diseases (e.g., are the regulatory requirements predictable?
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Food and Drug Administration SESSION IV NEW TECHNOLOGIES ENABLING INNOVATIVE CLINICAL RESEARCH Session Objectives: • Discuss the unique cross-cutting challenges in clinical research for prevalent chronic diseases and consider how new technologies could help researchers overcome these challenges; and • Consider lessons learned from other disease areas where new technologies have been a key driver of progress. 1:50 pm Biotech Perspective Grace Colón Chief Executive Officer InCarda Therapeutics
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80 DRUG R&D FOR PREVALENT CHRONIC DISEASES 2:05 pm Regulatory Perspective Elizabeth Kunkoski Clinical Methodology Team, Office of Medical Policy U.S. Food and Drug Administration 2:20 pm Moderated Panel Discussion and Audience Q&A 2:50 pm Closing Remarks Carlos Garner, Workshop Co-Chair Vice President, Global Regulatory Affairs Eli Lilly and Company Anantha Shekhar, Workshop Co-Chair Senior Vice Chancellor for Health Sciences and Dean of the School of Medicine University of Pittsburgh 3:00 pm ADJOURN Part Three: March 8, 2021 Case Studies in Prevalent Chronic Disease Research 11:00 am–3:00 pm ET 11:00 am Welcome and Opening Remarks Carlos Garner, Workshop Co-Chair Vice President, Global Regulatory Affairs Eli Lilly and Company Anantha Shekhar, Workshop Co-Chair Senior Vice Chancellor for Health Sciences and Dean of the School of Medicine University of Pittsburgh
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11:10 am Introduction and Overview Grace Colón, Moderator Chief Executive Officer InCarda Therapeutics 11:20 am Success Story from Cystic Fibrosis Robert K Coughlin Managing Director, Life Sciences, JLL Former President and Chief Executive Officer, MassBio 11:35 am Digital Innovation for Treating Prevalent Chronic Diseases Raolat Abdulai Global Clinical Lead, Immunology & Inflammation Sanofi 11:50 am Investing in One Treatment, Applying to Multiple Diseases Robert Heine Distinguished Eli Lilly Scholar Eli Lilly and Company 12:05 pm Moderated Panel Discussion and Audience Q&A Discussion Questions: • How can patient advocacy affect drug research and development?
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Grace Colón Chief Executive Officer InCarda Therapeutics Bettina Drake Professor, Washington School of Medicine Associate Director of Community Outreach and Engagement Alvin J Siteman Cancer Center Howard B
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• How might overall risk for stakeholders innovating in prevalent chronic disease treatments be lowered, with an eye toward integrating policy with stimulus? 2:50 pm Closing Remarks Carlos Garner, Workshop Co-Chair Vice President, Global Regulatory Affairs Eli Lilly and Company Anantha Shekhar, Workshop Co-Chair Senior Vice Chancellor for Health Sciences and Dean of the School of Medicine University of Pittsburgh 3:00 pm ADJOURN
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