Suggested Citation:"Appendix A: Public Meeting Agendas." National Academies of Sciences, Engineering, and Medicine. 2024. Advancing Clinical Research with Pregnant and Lactating Populations: Overcoming Real and Perceived Liability Risks. Washington, DC: The National Academies Press. doi: 10.17226/27595.
×
A
Public Meeting Agendas
Meeting 1 Agenda
Thursday, January 26, 2023
| 10:30–11:30 a.m. | CLOSED SESSION—COMMITTEE MEMBERS ONLY |
| 11:30–11:50 | Break |
OPEN SESSION
| 11:50–11:55 | Welcome and Introductions |
| Mimi Foster Riley, Committee Chair | |
| Professor of Law | |
| University of Virginia | |
| 11:55–12:10 p.m. | 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 |
Suggested Citation:"Appendix A: Public Meeting Agendas." National Academies of Sciences, Engineering, and Medicine. 2024. Advancing Clinical Research with Pregnant and Lactating Populations: Overcoming Real and Perceived Liability Risks. Washington, DC: The National Academies Press. doi: 10.17226/27595.
×
| 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.
Suggested Citation:"Appendix A: Public Meeting Agendas." National Academies of Sciences, Engineering, and Medicine. 2024. Advancing Clinical Research with Pregnant and Lactating Populations: Overcoming Real and Perceived Liability Risks. Washington, DC: The National Academies Press. doi: 10.17226/27595.
×
| 10:10–10:25 | Fireside Chat |
| Bruce Kuhlik, Moderator | |
| Former General Counsel | |
| Merck & Co. | |
| Defense Attorney Perspective | |
| John Beisner | |
| Partner | |
| Skadden, Arps, Slate, Meagher & Flom LLP and Affiliates | |
| 10:25–10:45 | Discussion with Committee |
SESSION II—THE ROLE OF RISK MANAGEMENT AND TRIAL INSURANCE
Session Objectives
- Understand what factors or considerations influence decisions to include or exclude pregnant and lactating populations from clinical research;
- Discuss how risk and benefit are assessed for populations that are being considered for inclusion in a clinical research study, as well as for the institutions conducting, funding, or insuring the study; and
- Examine opportunities to apply risk mitigation strategies to clinical research that includes pregnant and lactating populations.
| 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 |
Suggested Citation:"Appendix A: Public Meeting Agendas." National Academies of Sciences, Engineering, and Medicine. 2024. Advancing Clinical Research with Pregnant and Lactating Populations: Overcoming Real and Perceived Liability Risks. Washington, DC: The National Academies Press. doi: 10.17226/27595.
×
| 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 C.C. Lee, Moderator | |
| Director of Global Newborn Health | |
| Brigham and Women’s Hospital | |
| Harvard Medical School | |
| Research Participant Perspective | |
| Marcela Smid | |
| Research Participant | |
| Jillian Brown | |
| Research Participant |
Suggested Citation:"Appendix A: Public Meeting Agendas." National Academies of Sciences, Engineering, and Medicine. 2024. Advancing Clinical Research with Pregnant and Lactating Populations: Overcoming Real and Perceived Liability Risks. Washington, DC: The National Academies Press. doi: 10.17226/27595.
×
| No Fault Compensation Perspective | |
| Efthimios Parasidis | |
| Chief Justice Thomas J. Moyer Professorship for the Administration of Justice and Rule of Law Ohio State University |
|
| Renée Gentry | |
| Principal Partner | |
| The Law Office of Renée J. 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 C. Mastroianni, Moderator | |
| Research Professor in Bioethics and Law | |
| John Hopkins Berman Institute of Bioethics | |
| Charles I Stone Professor of Law Emeritus | |
| University of Washington | |
| Nonprofit Perspective | |
| Metin Gülmezoglu | |
| Executive Director | |
| Concept Foundation |
Suggested Citation:"Appendix A: Public Meeting Agendas." National Academies of Sciences, Engineering, and Medicine. 2024. Advancing Clinical Research with Pregnant and Lactating Populations: Overcoming Real and Perceived Liability Risks. Washington, DC: The National Academies Press. doi: 10.17226/27595.
×
| 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 & RW PPD |
Suggested Citation:"Appendix A: Public Meeting Agendas." National Academies of Sciences, Engineering, and Medicine. 2024. Advancing Clinical Research with Pregnant and Lactating Populations: Overcoming Real and Perceived Liability Risks. Washington, DC: The National Academies Press. doi: 10.17226/27595.
×
| Human Milk Biorepositories Perspective | |
| Tina Chambers | |
| Professor of Pediatrics | |
| University of California San Diego | |
| FDA Perspective | |
| Tamara Johnson | |
| Lead Medical Officer | |
| Division of Pediatric and Maternal Health | |
| FDA | |
| Clinical Researcher Perspective | |
| Jonathan Watanabe | |
| Associate Dean of Pharmacy Assessment and Quality | |
| University of California Irvine | |
| 11:15–11:30 | Coffee Break |
| 11:30–12:15 | Discussion: Liability for Pregnant and Lactating Persons Exclusion |
| Leslie Meltzer-Henry, Moderator | |
| Professor of Law | |
| University of Maryland | |
| Alan C. Milstein | |
| Shareholder & Chairman, Department of Litigation | |
| Sherman, Silverstein, Kohl, Rose & Podolsky, P.A. | |
| 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 |
Suggested Citation:"Appendix A: Public Meeting Agendas." National Academies of Sciences, Engineering, and Medicine. 2024. Advancing Clinical Research with Pregnant and Lactating Populations: Overcoming Real and Perceived Liability Risks. Washington, DC: The National Academies Press. doi: 10.17226/27595.
×
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 |
Suggested Citation:"Appendix A: Public Meeting Agendas." National Academies of Sciences, Engineering, and Medicine. 2024. Advancing Clinical Research with Pregnant and Lactating Populations: Overcoming Real and Perceived Liability Risks. Washington, DC: The National Academies Press. doi: 10.17226/27595.
×
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 |
Suggested Citation:"Appendix A: Public Meeting Agendas." National Academies of Sciences, Engineering, and Medicine. 2024. Advancing Clinical Research with Pregnant and Lactating Populations: Overcoming Real and Perceived Liability Risks. Washington, DC: The National Academies Press. doi: 10.17226/27595.
×
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Suggested Citation:"Appendix A: Public Meeting Agendas." National Academies of Sciences, Engineering, and Medicine. 2024. Advancing Clinical Research with Pregnant and Lactating Populations: Overcoming Real and Perceived Liability Risks. Washington, DC: The National Academies Press. doi: 10.17226/27595.
×
Suggested Citation:"Appendix A: Public Meeting Agendas." National Academies of Sciences, Engineering, and Medicine. 2024. Advancing Clinical Research with Pregnant and Lactating Populations: Overcoming Real and Perceived Liability Risks. Washington, DC: The National Academies Press. doi: 10.17226/27595.
×
Suggested Citation:"Appendix A: Public Meeting Agendas." National Academies of Sciences, Engineering, and Medicine. 2024. Advancing Clinical Research with Pregnant and Lactating Populations: Overcoming Real and Perceived Liability Risks. Washington, DC: The National Academies Press. doi: 10.17226/27595.
×
Suggested Citation:"Appendix A: Public Meeting Agendas." National Academies of Sciences, Engineering, and Medicine. 2024. Advancing Clinical Research with Pregnant and Lactating Populations: Overcoming Real and Perceived Liability Risks. Washington, DC: The National Academies Press. doi: 10.17226/27595.
×
Suggested Citation:"Appendix A: Public Meeting Agendas." National Academies of Sciences, Engineering, and Medicine. 2024. Advancing Clinical Research with Pregnant and Lactating Populations: Overcoming Real and Perceived Liability Risks. Washington, DC: The National Academies Press. doi: 10.17226/27595.
×
Suggested Citation:"Appendix A: Public Meeting Agendas." National Academies of Sciences, Engineering, and Medicine. 2024. Advancing Clinical Research with Pregnant and Lactating Populations: Overcoming Real and Perceived Liability Risks. Washington, DC: The National Academies Press. doi: 10.17226/27595.
×
Suggested Citation:"Appendix A: Public Meeting Agendas." National Academies of Sciences, Engineering, and Medicine. 2024. Advancing Clinical Research with Pregnant and Lactating Populations: Overcoming Real and Perceived Liability Risks. Washington, DC: The National Academies Press. doi: 10.17226/27595.
×
Suggested Citation:"Appendix A: Public Meeting Agendas." National Academies of Sciences, Engineering, and Medicine. 2024. Advancing Clinical Research with Pregnant and Lactating Populations: Overcoming Real and Perceived Liability Risks. Washington, DC: The National Academies Press. doi: 10.17226/27595.
×
Suggested Citation:"Appendix A: Public Meeting Agendas." National Academies of Sciences, Engineering, and Medicine. 2024. Advancing Clinical Research with Pregnant and Lactating Populations: Overcoming Real and Perceived Liability Risks. Washington, DC: The National Academies Press. doi: 10.17226/27595.
×
Suggested Citation:"Appendix A: Public Meeting Agendas." National Academies of Sciences, Engineering, and Medicine. 2024. Advancing Clinical Research with Pregnant and Lactating Populations: Overcoming Real and Perceived Liability Risks. Washington, DC: The National Academies Press. doi: 10.17226/27595.
×
