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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 |
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Discussion Questions: | |
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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 |
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 |
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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 |
11:45 am | Lunch Break (1 hour) |
12:45 pm | SESSION III – Legal Considerations: Regulatory Pathways |
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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 |
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 |
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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 |
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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 |
3:15 pm | Breakout Group Discussions |
Workshop participants can select one of the following breakout group topics: | |
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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 |
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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 |
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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 |
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 |
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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 |
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 |