Advancing Clinical Research with Pregnant and Lactating Populations Overcoming Real and Perceived Liability Risks (2024) / Chapter Skim
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Appendix A: Public Meeting Agendas
Appendix A: Public Meeting Agendas
Pages 207-216
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Sponsor Perspective and Charge to the Committee Camille Fabiyi Program Officer, NICHD National Institutes of Health Aaron Pawlyk Chief, Obstetric and Pediatric Pharmacology and Therapeutics Branch, NICHD National Institutes of Health 207 PREPUBLICATION COPY -- Uncorrected Proofs A02260_Advancing_Clinical_Research_AppA.indd 207 3/27/24 10:17 AM
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208 ADVANCING CLINICAL RESEARCH Nahida Chakhtoura Branch Chief, Pregnancy and Perinatology Branch, NICHD National Institutes of Health 12:10–12:45 Discussion with Committee 12:45 ADJOURN OPEN SESSION 12:45–1:45 Break 1:45–4:30 CLOSED SESSION -- COMMITTEE MEMBERS ONLY 4:30 END OF MEETING Meeting 2 Agenda Thursday, March 23, 2023 CLOSED SESSION -- COMMITTEE MEMBERS ONLY 9:30–10:00 a.m. Closed Session Deliberations OPEN SESSION -- PUBLIC WORKSHOP Welcome and Introduction 10:00–10:10 Opening Remarks Mimi Foster Riley, Committee Chair Professor of Law University of Virginia SESSION I – product liability Considerations Session Objectives • Discuss the role of product liability considerations in creating incentives and/or disincentives for medical product companies to generate evidence for the safety and efficacy of their products in pregnant and lactating populations; and • Consider what incentives and accountability measures may be effective in generating evidence for pregnant and lactating populations.
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10:45–11:10 Panel Discussion Patricia Danzon, Moderator Celia Moh Professor of Healthcare Management University of Pennsylvania Trial Insurance Perspective Sara Dyson Vice President of Underwriting Operations and Risk Management Medmarc Academic Medical Center Perspective Hillary Noll Kalay Principal Counsel University of California PREPUBLICATION COPY -- Uncorrected Proofs A02260_Advancing_Clinical_Research_AppA.indd 209 3/27/24 10:17 AM
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210 ADVANCING CLINICAL RESEARCH Institutional Review Board Perspective Elisa Hurley Executive Director Public Responsibility in Medicine and Research 11:10–11:45 Discussion with Committee 11:45–12:45 LUNCH BREAK SESSION III -- EQUITY CONSIDERATIONS FOR INJURY COMPENSATION Session Objectives • Understand how research participants view and make decisions regarding participation in clinical research while pregnant or lactating; • Consider various perspectives on what constitutes fair and just compensation for participants harmed in the course of clinical research; • Examine the benefits and drawbacks to different injury compensation schemes in the context of promoting fairness and justice; and • Discuss opportunities to improve upon existing compensation schemes to make them more equitable. 12:45–1:00 Presentation Jason Malone Director of the Human Subjects Division University of Washington 1:00–1:45 Panel Discussion Anne CC Lee, Moderator Director of Global Newborn Health Brigham and Women's Hospital Harvard Medical School Research Participant Perspective Yvette Raphael Executive Director Advocacy for Prevention of HIV and AIDS in South Africa Marcela Smid Research Participant Jillian Brown Research Participant PREPUBLICATION COPY -- Uncorrected Proofs A02260_Advancing_Clinical_Research_AppA.indd 210 3/27/24 10:17 AM
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Gentry Tort Perspective Michelle Mello Professor of Law and Health Policy Stanford University 1:45–2:30 Discussion with Committee 2:30–3:00 BREAK SESSION IV -- CASE STUDIES IN RISK MITIGATION Session Objectives • Consider approaches that various institutions have adopted to mitigate risk and liability in clinical research that includes pregnant or lactating persons; • Discuss challenges and successes of adopting and implementing risk and liability mitigation strategies for research involving pregnant or lactating persons; and • Discuss opportunities to scale risk and liability mitigation strategies to other clinical research studies that could include pregnant or lactating persons. 3:00–3:20 Panel Discussion Anna Mastroianni, Moderator Research Professor Johns Hopkins University Nonprofit Perspective Metin Gülmezoglu Executive Director Concept Foundation PREPUBLICATION COPY -- Uncorrected Proofs A02260_Advancing_Clinical_Research_AppA.indd 211 3/27/24 10:17 AM
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212 ADVANCING CLINICAL RESEARCH Niranjan Bhat Senior Medical Officer PATH Industry Perspective Lorien Urban Senior Medical Director, Clinical Development Ferring Pharmaceuticals 3:20–4:00 Discussion with Committee WORKSHOP ADJOURNS CLOSED SESSION -- COMMITTEE MEMBERS ONLY 4:15–4:30 Closed Session Deliberations 4:30 ADJOURN DAY 1 Friday, March 24, 2023 CLOSED SESSION -- COMMITTEE MEMBERS ONLY 9:30–4:00 Closed Session Deliberations Meeting 3 Agenda Thursday, June 15, 2023 CLOSED SESSION -- COMMITTEE MEMBERS ONLY OPEN SESSION 10:15–11:15 Real-World Data and Real-World Evidence: Challenges and Opportunities Panel Discussion Ahizechukwu Eke, Moderator Director of Research, Division of Maternal-Fetal Medicine Johns Hopkins University Industry Registry Perspective Kristin Veley Executive Director, Research Science Epidemiology and Scientific Affairs, PPAS & RWE PPD PREPUBLICATION COPY -- Uncorrected Proofs A02260_Advancing_Clinical_Research_AppA.indd 212 3/27/24 10:17 AM
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12:15–1:15 LUNCH BREAK 1:15–2:15 Presentation on FDA Commissioned Paper Julie Tibbets Partner Goodwin Procter LLP Sarah Wicks Associate Goodwin Procter LLP 2:15–2:30 BREAK PREPUBLICATION COPY -- Uncorrected Proofs A02260_Advancing_Clinical_Research_AppA.indd 213 3/27/24 10:17 AM
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214 ADVANCING CLINICAL RESEARCH CLOSED SESSION -- COMMITTEE MEMBERS ONLY 2:30–4:30 Closed Session Deliberations 4:30 ADJOURN DAY 1 Friday, June 16, 2023 CLOSED SESSION -- COMMITTEE MEMBERS ONLY OPEN SESSION 11:30–12:00 Product Liability Discussion Bruce Kuhlik, Moderator Former General Counsel Merck & Co. Kirke Weaver General Counsel Organon CLOSED SESSION -- COMMITTEE MEMBERS ONLY 12:45–4:00 Closed Session Deliberations 4:00 ADJOURN DAY 1 Meeting 4 Agenda Thursday, July 13, 2023 10:30–3:00 CLOSED SESSION -- COMMITTEE MEMBERS ONLY 12:15–1:00 Lunch Break Friday, July 14, 2023 10:00–3:00 CLOSED SESSION -- COMMITTEE MEMBERS ONLY 12:00–1:00 Lunch Break PREPUBLICATION COPY -- Uncorrected Proofs A02260_Advancing_Clinical_Research_AppA.indd 214 3/27/24 10:17 AM
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APPENDIX A 215 Meeting 5 Agenda Wednesday, September 27, 2023 10:30–1:00 CLOSED SESSION -- COMMITTEE MEMBERS ONLY OPEN SESSION 1:00–2:00 Drug Development Incentive Programs: Experience with BPCA & PREA FDA Perspective Prabha Viswanathan Deputy Director Office of Pediatric Therapeutics, Officer of the Commissioner, FDA NIH Perspective Perdita Taylor-Zapata Program Lead, BPCA Clinical Program NICHD Public Policy Perspective Florence Bourgeois Codirector, Harvard–MIT Center for Regulatory Science Associate Professor of Pediatrics and Emergency Medicine Harvard Medical School 2:00–2:15 Coffee Break 2:15–5:00 CLOSED SESSION -- COMMITTEE MEMBERS ONLY Thursday, September 28, 2023 10:00–3:00 CLOSED SESSION -- COMMITTEE MEMBERS ONLY Meeting 6 Agenda Friday, October 20, 2023 10:00–5:00 CLOSED SESSION -- COMMITTEE MEMBERS ONLY PREPUBLICATION COPY -- Uncorrected Proofs A02260_Advancing_Clinical_Research_AppA.indd 215 3/27/24 10:17 AM
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