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About this Virtual Workshop:

The U.S. Food and Drug Administration (FDA) in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) will host a two-day virtual public workshop entitled “Pharmacokinetic Evaluation in Pregnancy” on May 16-17, 2022. The purpose of this workshop is to engage with stakeholders to assess available science and data gaps to advance the conduct of pharmacokinetic (PK) studies in pregnant individuals.

Most pregnant individuals use prescribed or over-the-counter medications during pregnancy; however, this population has historically been excluded from clinical trials. Therefore, there are important gaps in knowledge about the appropriate dosing for most medications used during pregnancy at the time of approval. In the absence of data, the approved adult dose is typically prescribed to a pregnant individual. However, because of the physiologic changes in pregnancy, under dosing or excessive dosing may occur, with potential adverse impacts on safety and efficacy. Further pharmacologic research and collection of PK data during pregnancy are needed to ensure that the appropriate dosing information is available for pregnant individuals. Advancing this field requires identifying key knowledge gaps, barriers to data collection, and potential innovative solutions to improve data generation and analysis.

Workshop Objectives:

• Review the general landscape of existing regulatory, scientific, and ethical considerations for drug development in pregnant individuals
• Describe study design considerations for trials collecting PK data in pregnant individuals
• Discuss key aspects of utilizing modeling and simulation to inform study design and dosing considerations for pregnant individuals
• Explore innovative approaches to data generation and analysis in pregnant individuals

Meeting Information and Registration:

This workshop is open to the public with no cost to attend and is intended for clinicians, academicians, and drug developers, but registration is required. This virtual public workshop will be available to view via webcast. Registrants will receive the link to access the live workshop several weeks prior to the meeting.

For more information, visit the MCERSI Webpage at: https://cersi.umd.edu/event/17326/fdam-cersi-workshop-pharmacokinetic-evaluation-in-pregnancy

To register, visit: https://bioeumd.wufoo.com/forms/modi0au1wjs8as/

Contact:

For questions regarding this event, please contact:

Daphne Guinn
Office of Clinical Pharmacology
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
[email protected]

Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.

Event Materials

• PK Evaluation in Pregnancy Workshop Agenda (PDF - 251 KB)
• PK Evaluation in Pregnancy Workshop Bio Book (PDF - 1,174 KB)

Workshop Presentations

Session 1

• General landscape of existing regulatory guidance and drug labeling in pregnancy - Leyla Sahin, FDA (PDF – 1,246 KB)
• Ethical considerations for enrolling pregnant individuals in clinical studies - Anne Lyerly, University of North Carolina (PDF – 2,871 KB)
• Physiologic changes during pregnancy and impact on drug disposition and response - Ahizechukwu Eke, John Hopkins University (PDF – 4,134 KB)
• PK studies in pregnancy – Regulatory experience - Su-Young Choi, FDA (PDF - 844 KB)
• Public health perspective on PK studies in pregnancy - Martina Penazzato, WHO-IMPAACT (PDF – 2,710 KB)
• The conundrum of clinical studies in pregnancy: Industry view - Michael Fossler, Cytel (PDF – 222 KB)
• Design considerations for pharmacokinetic studies in pregnant individuals - Mary Hebert, University of Washington (PDF – 1,519 KB)
• Designing PK Studies in Pregnancy – Part II - Catherine Stika, Northwestern University (PDF – 1,815 KB)
• Importance of achieving racial and ethnic equity in pregnancy clinical research - Adetola Louis-Jacques, University of Florida (PDF – 3,225 KB)

Session 2:

• Overview of current modeling approaches to support studies in pregnancy - Jeff Barrett, Critical Path (PDF – 2,368 KB)
• The role of modelling and trial design considerations – regulatory perspective - Susan Cole, MHRA (PDF – 823 KB)
• Industry perspective on role of PBPK modeling in pregnancy - Amy Cheung, Certara (PDF – 3,757 KB)
• Predicting maternal-fetal exposure to drugs using a mechanistic PBPK model - Jashvant Unadkat, University of Washington (PDF – 1,979 KB)

Session 3:

• Innovative data analytics to inform pharmacokinetics and dosing of drugs in pregnancy- Mathangi Gopalakrishnan, University of Maryland (PDF – 1,430 KB)
• Translating data into dosing recommendations in pregnancy - Brookie Best, University of California San Diego (PDF – 1,156 KB)