Leveraging Real-World Data to Study Medication Use in Pregnancy and Lactation: A 3-Part Virtual Public Workshop
Session #1: Understanding the impact of data gaps for medication use during pregnancy and lactation
10:00 - 11:25 AM ET
View a recording of this webinar: [recording link to be added here after the event]
Session #2: Regulatory perspective on the collection and use of real-world data to evaluate medications during pregnancy and lactation
11:25 - 12:20 PM ET
View a recording of this webinar: [recording link to be added here after the event]
Session #3: Novel application of real-world data to evaluate medication use in pregnancy and lactation
1:00 - 2:30 PM ET
View a recording of this webinar: [recording link to be added here after the event]
Hosted by Johns Hopkins Center of Excellence in Regulatory Science and Innovation (JH-CERSI) and the Food and Drug Administration Office of Women's Health
Overview
Many chronic and/or pregnancy-related health conditions require the use of medication during pregnancy and lactation. However, few clinical trials enroll pregnant or lactating participants, thus, there is a lack of data on medication safety and efficacy in this population. Through a 3-session virtual workshop, we will highlight the potential role of real-world data to help address these gaps in our knowledge, the opportunities and challenges of collecting real-world data, and current regulatory perspectives on the collection and potential use of real-world data.
Agenda & Speakers
Kaveeta Vasisht, MD, PharmD
Associate Commissioner for Women's Health
Director, Office of Women's Health
Food and Drug Administration
Xiaobin Wang, MD, ScD, MPH
Johns Hopkins University
Session #1: Understanding the impact of data gaps for medication use during pregnancy and lactation
This 90-minute session will present patient and clinician perspectives on the challenges of navigating mediation use with the current lack of clinical trial data in pregnant and lactating people. The speakers will discuss recent findings related to behaviors and attitudes towards medication use in during pregnancy and present real-world data on national trends in medication use before, during, and after pregnancy.
Catherine Sewell, MD, MPH
Food and Drug Administration
Kristin Darwin, MD
Johns Hopkins University
Irina Burd, MD, PhD
Johns Hopkins University
Sara Head, PhD, MPH
Food and Drug Administration
Christine Ladd-Acosta, PhD
Johns Hopkins University
Session #2: Regulatory perspective on the collection and use of real-world data to evaluate medications during pregnancy and lactation
This 60-minute session will focus on regulatory perspectives on the collection and use of real-world data to help understand the potential risks and benefits of medicines in people who are pregnant or lactating.
Susan Bersoff-Matcha, MD
Food and Drug Administration
LCDR Kenneth Quinto, MD, MPH
Food and Drug Administration
Leyla Sahin, MD
Food and Drug Administration
Kira Leishear, PhD, MS
Food and Drug Administration
LCDR Danijela Stojanovic, PharmD, PhD
Food and Drug Administration
Session #3: Novel application of real-world data to evaluate medication use in pregnancy and lactation
This 90-minute session will discuss innovative ways to collect real-world data to inform medication use, safety and effectiveness during pregnancy and lactation.
Ahizechukwu Eke, MBChB, PhD, MPH
Johns Hopkins University
Mili Duggal, PhD
Food and Drug Administration
Sonia Hernandez-Diaz, MD, DrPH
Harvard University
Teresa Baker, MD
Texas Tech University Health Sciences Center
Tina Chambers, PhD, MPH
University of California at San Diego
This project is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award U01FD005942-06 with 100 percent funded by FDA/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.
Work presented by Christine Ladd-Acosta, PhD, Johns Hopkins University is funded by 3U01FD005942-04S1 through the FDA Office of Women's Health.
Contact
For questions and concerns, please email Jill Curran at jcurra14@jhmi.edu.