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Appendix B: Workshop Agenda
Pages 93-104

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From page 93...
... 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 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 93
From page 94...
... 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
From page 95...
... 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.
From page 96...
... 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
From page 97...
... • 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
From page 98...
... 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?
From page 99...
... 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
From page 100...
... • 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?
From page 101...
... 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?
From page 102...
... 102 INCLUSION OF PREGNANT AND LACTATING PERSONS IN CLINICAL TRIALS 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
From page 103...
... • 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
From page 104...
... 104 INCLUSION OF PREGNANT AND LACTATING PERSONS IN CLINICAL TRIALS 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


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