Page 93 Cite

Suggested Citation: "Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2023. Inclusion of Pregnant and Lactating Persons in Clinical Trials: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26790.

B

Workshop Agenda

DAY 1: THURSDAY, JUNE 16, 2022

8:30 am	Welcome and Opening Remarks
	Ruth R. Faden, Workshop Cochair
	Founder, Johns Hopkins Berman Institute of Bioethics
	Philip Franklin Wagley Professor
	Johns Hopkins University
	Shirley Sylvester, Workshop Cochair
	Senior Medical Director, Women’s Health
	Johnson & Johnson
8:50 am	SESSION I – Making the Case: The Need for Evidence Generation to Support Safety and Efficacy of Drugs Used during Pregnancy and Lactation
8:50 am	Purpose:
Highlight knowledge gaps on drug product use during pregnancy and lactation; Consider the clinical, ethical, public health, and personal implications of excluding pregnant and lactating persons from participation in clinical trials or otherwise failing to collect data on safety and efficacy in pregnancy and lactation; and

Page 94 Cite

Suggested Citation: "Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2023. Inclusion of Pregnant and Lactating Persons in Clinical Trials: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26790.

	Discuss outputs from the Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC Task Force).
	Discussion Questions:
	How has the exclusion of pregnant and lactating persons from clinical trials and the general lack of evidence for these population groups affected maternal health on an individual and societal level? How does the lack of evidence for treating pregnant and lactating persons with drug therapies and vaccines affect decision-making for patients, clinicians, and public health authorities? What are the potential trade-offs of not taking a prescribed drug during pregnancy and lactation versus taking a prescribed drug during pregnancy and lactation, when there is no or limited evidence for safety and efficacy? What information about the relative absence of evidence specific to these populations should be shared with pregnant and lactating persons and their care providers in order to make informed decisions? What information should they have?
8:50 am	Fireside Chat
	Maggie Little, Keynote speaker
	Senior Research Scholar, Professor of Philosophy, and Director of Ethics Lab
	Georgetown University Kennedy Institute of Ethics
	Leyla Sahin, Moderator
	Acting Deputy Director for Safety
	Division of Pediatrics and Maternal Health
	FDA
9:20 am	Panel Discussion
	Leyla Sahin, Moderator
	Acting Deputy Director for Safety
	Division of Pediatrics and Maternal Health
	FDA

Page 95 Cite

Suggested Citation: "Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2023. Inclusion of Pregnant and Lactating Persons in Clinical Trials: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26790.

	Physiological Differences in Response to Drugs during Pregnancy & Lactation
	Thomas Hale
	University Distinguished Professor of Pediatrics and Associate Dean of Research
	Texas Tech University
	Pregnant & Lactating Person Perspective
	Sarah Mancoll
	Mother and Advocate
	Gaps in Evidence for Clinical Care of Persons Prescribed Drugs during Pregnancy & Lactation
	David Haas
	Robert A. Munsick Professor of Obstetrics and Gynecology
	Indiana University
	Gaps in Evidence for Public Health Policy Affecting Pregnant & Lactating Persons
	Ajoke Sobanjo-ter Meulen
	Vice President, Medical Affairs & Policy, Icosavax
	Affiliate Associate Professor in Global Health, University of Washington
9:50 am	Q&A/Audience Discussion
10:10 am	Coffee Break (30 minutes)
10:40 am	SESSION II – Practical Challenges and Opportunities for Including Pregnant and Lactating Persons in Clinical Trials
	Purpose:
	Explore the social and cultural contexts for conducting clinical trials that include pregnant and lactating persons; Consider the barriers to and opportunities afforded by participation in clinical trials for pregnant and lactating persons; and Discuss practical short- and long-term opportunities and/or actions to improve access to clinical trials for pregnant and lactating persons.

Page 96 Cite

Suggested Citation: "Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2023. Inclusion of Pregnant and Lactating Persons in Clinical Trials: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26790.

	Discussion Questions:
	What are the challenges that you or your institution face when considering including pregnant and lactating persons in clinical trials? How should these challenges be addressed to ultimately improve inclusion of these populations in clinical trials? What are specific challenges and opportunities to ensuring diversity in research participants and equity in science dissemination in regards to research involving pregnant and lactating persons? What should clinicians and researchers know about recruiting pregnant and lactating persons for participation in clinical research? What approaches can be used to decrease the burden on clinical trial participants who are pregnant or lactating?
10:40 am	Panel Discussion
	Ebony Boyce Carter, Moderator
	Chief of Clinical Research in Obstetrics and Gynecology
	Washington University School of Medicine in St. Louis
	Advocating for Pregnant & Lactating Persons in Clinical Trials
	Zsakeba Henderson
	Senior Vice President of Maternal Child Health Impact and Interim Chief Medical Officer
	March of Dimes
	Equity and Diversity Considerations for Including Pregnant & Lactating Persons in Clinical Trials
	Veronica Gillispie-Bell
	Associate Professor, Senior Site Lead and Section Head of Obstetrics and Gynecology, and Director of Quality for Women’s Services, Ochsner Health System
	Medical Director, Louisiana Department of Health
	Recruitment and Retention of Pregnant & Lactating Persons in Chronic Disease Trials
	Brittany Bettendorf
	Clinical Assistant Professor
	University of Iowa
11:10 am	Q&A/Audience Discussion

Page 97 Cite

Suggested Citation: "Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2023. Inclusion of Pregnant and Lactating Persons in Clinical Trials: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26790.

11:45 am	Lunch Break (1 hour)
12:45 pm	SESSION III – Legal Considerations: Regulatory Pathways
	Purpose:
	Discuss the laws and regulations governing drug research and development for pregnant and lactating persons, including human subject regulation, institutional review boards, and drug approval; and Discuss practical short- and long-term opportunities and/or actions to make regulatory pathways more supportive of including pregnant and lactating persons in clinical trials.
	Discussion Questions:
	What are the most easily addressable legal and regulatory barriers that have prevented the inclusion of pregnant and lactating persons in clinical trials for both therapeutics and preventatives? How can these barriers be addressed? What are the more persistent legal and regulatory barriers to inclusion, and how could government, industry, patients, clinicians, and researchers collaborate to address them? What might that look like? How can researchers and institutional review boards address barriers to the inclusion of pregnant and lactating persons in clinical trials?
12:45 pm	Presentation
	Legal Landscape
	Leslie Meltzer Henry, Moderator
	Professor of Law
	University of Maryland
1:05 pm	Panel Discussion
	Human Subjects Research Regulation Perspective
	Anna Mastroianni
	Charles I. Stone Professor of Law
	University of Washington

Page 98 Cite

Suggested Citation: "Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2023. Inclusion of Pregnant and Lactating Persons in Clinical Trials: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26790.

	FDA Perspective
	Catherine Sewell
	Acting Deputy Director and Deputy Director for Safety
	Division of Urology, Obstetrics, and Gynecology
	FDA
	Vaccine Regulation Perspective
	Jeff Roberts
	Associate Vice President, Vaccine Clinical Development
	Merck Research Laboratories
1:30 pm	SESSION IV – Addressing Real and Perceived Liability Concerns
	Purpose:
	Discuss real and perceived liability concerns with including pregnant and lactating persons in drug research and development on the part of private and public sponsors of clinical trials; Discuss the real and perceived liability concerns associated with the use of drug products and vaccines in these populations on the part of practicing clinicians, researchers, and other key stakeholders; and Discuss practical short- and long-term opportunities and/or actions to address liability concerns.
	Discussion Questions:
	What are the most common sources of risks that are more perceived than real (e.g. knowledge deficits, incorrect information presented to stakeholders, augmented risk aversion based on perspective as a clinician, researcher, or industry, other)? What are ways that clinicians, researchers, and industry stakeholders could partner or support each other in addressing real liability concerns? Are these roles for other stakeholders in also addressing real liability concerns? In considering strategies to address liability concerns, is there a logical order in which the solutions should be pursued? Are there any that are low hanging fruit, and which will be the most challenging to address? Looking to the next 3-5 years, is there a realistic path toward mitigation of actual or perceived liability risks? What is the best-case forecast for where the field could be at the end of 3-5 years?

Page 99 Cite

Suggested Citation: "Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2023. Inclusion of Pregnant and Lactating Persons in Clinical Trials: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26790.

1:30 pm	Panel Discussion
	William Cooper, Moderator
	Professor of Pediatrics and Health Policy
	Vanderbilt University
	Clinician Perspective
	Carmen Zorrilla
	Professor of Obstetrics and Gynecology
	University of Puerto Rico
	Industry Perspective
	Aviva Wein
	Assistant General Counsel
	Johnson & Johnson
	Research Perspective
	Jessica Cohen
	Director, Office of Research Affairs
	PATH
2:05 pm	Q&A/Audience Discussion
2:40 pm	Coffee Break (30 minutes)
3:10 pm	SESSION V – Breakout Groups
	Purpose:
	Discuss opportunities to address liability concerns in the inclusion of pregnant and lactating persons in clinical trials; and Consider strategies to advance evidence generation for the clinical care of pregnant and lactating persons.
3:10 pm	Charge to Breakout Groups
	Ruth R. Faden, Workshop Cochair
	Founder, Johns Hopkins Berman Institute of Bioethics
	Philip Franklin Wagley Professor
	Johns Hopkins University

Page 100 Cite

Suggested Citation: "Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2023. Inclusion of Pregnant and Lactating Persons in Clinical Trials: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26790.

3:15 pm	Breakout Group Discussions
	Workshop participants can select one of the following breakout group topics:
	Group 1: Opportunities to address liability concerns on the part of clinical investigators Group 2: Opportunities to address liability concerns on the part of trial sponsors Group 3: Opportunities to improve evidence generation for persons during pregnancy Group 4: Opportunities to improve evidence generation for persons during lactation
4:15 pm	Breakout Group Report-outs
5:00 pm	ADJOURN WORKSHOP DAY 1

DAY 2: FRIDAY, JUNE 17, 2022

8:30 am	SESSION VI – Fireside Chat: Progress toward Including Pregnant and Lactating Persons in Trials
	Purpose:
	Discuss progress toward implementing the PRGLAC Task Force recommendations and improving the inclusion of pregnant and lactating persons in clinical trials; and Consider next step opportunities to improve the inclusion of pregnant and lactating persons in clinical trials.
	Discussion Questions:
	How are the finding and recommendations of the PRGLAC Task Force advancing the inclusion of pregnant and lactating persons in clinical trials? What are the short- and long-term opportunities to execute the PRGLAC Task Force recommendations? Following the publication of the PRGLAC Task Force recommendations, are there any success stories from their implementation that can inform ongoing efforts to improve the inclusion of pregnant lactating persons in clinical trials?

Page 101 Cite

Suggested Citation: "Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2023. Inclusion of Pregnant and Lactating Persons in Clinical Trials: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26790.

	Are there areas that the PRGLAC Task Force did not address that still require additional study? What opportunities exist to better understand and begin to resolve these issues?
	Diana Bianchi, Keynote speaker
	Director
	Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH
	Shirley Sylvester, Workshop Cochair, Moderator
	Senior Medical Director, Women’s Health
	Johnson & Johnson
9:00 am	SESSION VII – Case Studies: Lessons Learned in Trials in Mental Health and COVID-19
	Purpose:
	Examine lessons learned from case studies for improving the inclusion of pregnant and lactating persons; and Consider opportunities to apply and/or scale-up approaches for including pregnant and lactating persons in clinical trials across therapeutic areas.
	Discussion Questions:
	How can the lessons from research with pregnant and lactating persons in the cases of mental health and COVID-19 inform future clinical trials in other therapeutic and public health areas? How can stakeholders in this area continue to share lessons learned from clinical trials that include pregnant and lactating persons to build on previous successes? What are the opportunities for researchers, trial sponsors, and regulators to expand access to clinical trials to pregnant and lactating persons? Are there ways to prioritize clinical research in different therapeutic and public health areas that would provide the greatest benefit to pregnant and lactating persons?

Page 102 Cite

Suggested Citation: "Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2023. Inclusion of Pregnant and Lactating Persons in Clinical Trials: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26790.

9:00 am	Case Study 1: Lessons Learned from Drug Trials for Mood Disorders
	Katherine Wisner
	Norman and Helen Asher Professor of Psychiatry and Behavioral Sciences, and Obstetrics and Gynecology
	Director, Asher Center for Research and Treatment of Depressive Disorders
	Northwestern University Feinberg School of Medicine
9:15 am	Case Study 2: Lessons Learned from COVID-19 Vaccine Trials
	Ruth Karron
	Professor of International Health
	Johns Hopkins University Bloomberg School of Public Health
9:30 am	Panel Discussion: Opportunities to Scale-up Evidence Generation across Health Concerns
	Kavita Shah Arora, Moderator
	Associate Professor and Division Director of General Obstetrics and Gynecology
	University of North Carolina at Chapel Hill
	Research Perspective
	Geeta Swamy
	Associate Vice President for Research and Vice Dean for Scientific Integrity
	Professor of Obstetrics and Gynecology
	Duke University
	Industry Perspective
	Iona Munjal
	Director, Clinical Research and Development, Pfizer Vaccines
	Assistant Professor of Pediatrics, Albert Einstein College of Medicine and Montefiore Medical Center
	Regulatory Perspective
	Lynne Yao
	Director, Division of Pediatric and Maternal Health
	FDA
	Advocating for Pregnant & Lactating Persons in Clinical Trials
	Kathryn Schubert
	President and CEO
	Society for Women’s Health Research

Page 103 Cite

Suggested Citation: "Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2023. Inclusion of Pregnant and Lactating Persons in Clinical Trials: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26790.

10:05 am	Q&A/Audience Discussion
10:30 am	Coffee Break (30 minutes)
11:00 am	SESSION VIII – New Approaches to Generate Evidence for Treating Pregnant and Lactating Persons
	Purpose:
	Consider different approaches to generate evidence on the safety and effectiveness of drug products for pregnant and lactating persons, in addition to randomized control trials; and Discuss practical short- and long-term opportunities and/or actions to increase the use of these approaches to evidence generation in both product development and oversight, and clinical and public health practice.
	Discussion Questions:
	What methods and approaches are most amenable to generating quality evidence on the short- and long-term safety as well as effectiveness of drugs for use in pregnant and lactating persons? What are opportunities for pregnant and lactating persons to be better engaged in designing clinical trials? How can evidence generated outside of randomized control trials best inform drug research and development for pregnant and lactating persons? For what kinds of questions and for what kinds of drugs can new approaches approximate the quality of evidence generated in RCTs or be an appropriate source of adequate data? What are the short- and long-term opportunities to advance the use of new approaches for evidence generation on the safety and effectiveness of drugs for use in pregnant and lactating persons?
11:00 am	Panel Discussion
	Steven Kern, Moderator
	Deputy Director, Quantitative Sciences
	Bill & Melinda Gates Foundation
	Real World Evidence Perspective
	Christina Chambers
	Professor of Pediatrics
	University of California, San Diego School of Medicine

Page 104 Cite

Suggested Citation: "Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2023. Inclusion of Pregnant and Lactating Persons in Clinical Trials: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26790.

	Pharmacology Perspective
	Raman Venkataramanan
	Professor of Pharmaceutical Sciences and Pathology
	University of Pittsburgh
	Novel Approaches to Engage Pregnant & Lactating Persons in Real World Evidence Studies
	Tolúwalàṣé Ajayi
	Director of Clinical Research and Diversity Initiatives, Scripps Research Translational Institute
	Assistant Professor, Scripps Research
	Regulatory Perspective
	Wei Hua
	Acting Deputy Director, Division of Epidemiology
	Office of Surveillance and Epidemiology
	FDA
11:30 am	Q&A/Audience Discussion
11:50 am	Wrap Up Discussion and Closing Remarks
	Ruth R. Faden, Workshop Cochair
	Founder, Johns Hopkins Berman Institute of Bioethics
	Philip Franklin Wagley Professor
	Johns Hopkins University
	Shirley Sylvester, Workshop Cochair
	Senior Medical Director, Women’s Health
	Johnson & Johnson
12:00 pm	ADJOURN DAY 2