Optimizing Pregnancy Registries
Thursday, May 7 and Friday, May 8, 2026
A block of rooms is available for those traveling to attend this workshop at the Courtyard by Marriott Silver Spring Downtown hotel, located at 8506 Fenton Street, Silver Spring, MD, 20910. To utilize this block, reservations must be confirmed by April 17.
Agenda & Speakers
Day 1: 8:30 a.m.-4:15 p.m.
Welcome & Introduction
8:30-9 a.m.
Registration
9-9:10 a.m.
Welcome and Introduction
Leyla Sahin, M.D.
Division of Pediatrics and Maternal Health (DPMH)
Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine (ORPURM)
Office of New Drugs (OND)
Center for Drug Evaluation and Research (CDER)
U.S. Food and Drug Administation (FDA)
9:10-9:20 a.m.
Opening Remarks
Kaveeta Vasisht, M.D., Pharm.D.
Associate Commissioner for Women’s Health
Director, Office of Women’s Health
Office of the Commissioner, FDA
Session 1: Current State of Pregnancy Registries
9:20-9:40 a.m.
Pregnancy Registries: Current Status and FDA Observations
Wenjie Sun, M.D.
DPMH, ORPURM, OND, CDER, FDA
9:40-10 a.m.
Update on FDA PDUFA VII Activities
Youjin Wang, Ph.D.
Office of Surveillance and Epidemiology (OSE), CDER, FDA
10-10:20 a.m.
Healthcare Provider Perspective
Megan E. B. Clowse, M.D., MPH
Duke University School of Medicine
10:20-10:40 a.m.
Academic Perspective
Lee S. Cohen, M.D.
Harvard Medical School
10:40-11 a.m.
Break
11-11:20 a.m.
Industry Perspective
Keele Wurst, Ph.D., M.S., RPh
GlaxoSmithKline
11:20-11:40 a.m.
Introduction to Multi-Product Pregnancy Registries: Antiretroviral Pregnancy Registry
Jessica Albano, Ph.D., MPH
EPIphany Real-World Research
11:40 a.m.-12:40 p.m.
Session 1 Panel Discussion and Q&A
Moderated by the FDA
Panelists:
Jessica Albano, Ph.D., MPH
EPIphany Real-World Research
Keele Wurst, Ph.D., M.S., RPh
GlaxoSmithKline
Megan E. B. Clowse, M.D., MPH
Duke University School of Medicine
Kayla Stomack
Christopher M. Zahn, M.D.
ACOG
12:40-1:40 p.m.
Lunch Break (on your own)
Session 2: Optimizing Design of Pregnancy Registries in Context of Totality of Evidence
1:40-2:40 p.m.
Pregnancy Registry Patient Perspectives
Kayla Stomack
Lisa Feret
Database and Pregnancy Registries
Sonia Hernandez-Diaz, M.D., DrPH
Harvard T. Chan School of Public Health
Industry Perspectives on Integration of Evidence from Non-Registry Sources
Marie Teil, M.D.
UCB Biopharma SRL
2:40-3 p.m.
Break
3-4 p.m.
Session 2 Panel Discussion and Q&A
Moderated by Lynne Yao, M.D.
DPMH, ORPURM, OND, CDER, FDA
Panelists:
Sonia Hernandez-Diaz, M.D., DrPH
Harvard T. Chan School of Public Health
Marie Teil, M.D.
UCB Biopharma SRL
Lee S. Cohen, M.D.
Harvard Medical School
Lisa Feret
4-4:15 p.m.
Closing Remarks
Lynne Yao, M.D.
DPMH, ORPURM, OND, CDER, FDA
Day 2: 9 a.m.-12:40 p.m.
Welcome
9-9:05 a.m.
Welcome
Leyla Sahin, M.D.
DPMH, ORPURM, OND, CDER, FDA
Session 3: Partnerships and Future Directions
9:05-9:25 a.m.
Introduction to Strategically Coordinated Registry Networks
Danica Marinac-Dabic, M.D., Ph.D., MMSc, FISPE
Office of Clinical Evidence and Analysis
Office of Product Evaluation and Quality
Center for Devices and Radiological Health (CDRH)
FDA
9:25-9:45 a.m.
Lessons Learned from Coordinated Registry Networks via Public-Private Partnerships
Gregory Pappas, M.D., Ph.D.
Office of Biostatistics and Pharmacovigilance (OBPV)
Center for Biologics Evaluation and Research (CBER)
FDA
9:45-10:05 a.m.
Lessons Learned from Public-Private Partnerships
Kourtney Davis, Ph.D., MSPH
Johnson & Johnson
10:05-10:25 a.m.
FNIH Partnership Models for Accelerating Pregnancy Health
Tania Kamphaus, Ph.D.
Foundation for NIH, Bethesda, MD
10:25-10:40 a.m.
Break
10:40-11 a.m.
Experience with Multi-Sponsored Consortiums and Public-Private Partnerships to Develop Coordinated Population Cohorts and Registries
Carla Rodriguez, Ph.D., MPH
Reagan-Udall Foundation for the FDA
11-11:20 a.m.
Beyond Multi-Product Registries and Registry Networks: Can a Single, National Pregnancy Registry Fill Knowledge Gaps More Efficiently and Quickly?
Christina Chambers, Ph.D., MPH
University of California San Diego
11:20 a.m.-12:20 p.m.
Session 3 Future Directions Panel Discussion and Q&A
Moderated by the FDA
Panelists:
Christina Chambers, Ph.D., MPH
University of California San Diego
Kourtney Davis, Ph.D., MSPH
Johnson & Johnson
Aaron Pawlyk, Ph.D.
NICHD, NIH
Gregory Pappas, M.D., Ph.D.
OPBV, CBER, FDA
Kavita Shah Arora, M.D., MBE, M.S.
ACOG
12:20-12:40 p.m.
Closing Remarks
Leyla Sahin, M.D.
DPMH, ORPURM, OND, CDER, FDA
