What are the key takeaways from this The Life Science Rundown episode?

Key insights include: **Historical exclusion drivers:** Two catastrophic drug events — thalidomide (1957–1961), prescribed for morning sickness and causing birth defects, and DES (1940s–1970s), linked to vaginal cancers and reproductive abnormalities in offspring — established the 1964 Helsinki Declaration protections that defaulted sponsors and IRBs toward excluding pregnant women from all subsequent clinical research.; **Pregnancy ADME changes:** Drug absorption, distribution, metabolism, and excretion differ significantly from non-pregnant adults, vary by trimester, and may not normalize until six to twelve months postpartum. Without pregnancy-specific data, clinicians extrapolate adult doses, risking either dangerous accumulation or underdosing — the latter carrying consequences like spina bifida from untreated fever.; **E21 early engagement strategy:** Sponsors should initiate Type C or INTERACT meetings with FDA before IND submission to agree on inclusion triggers, pharmacokinetic parameters, required specialists such as maternal-fetal medicine, IRB safety criteria, lactation strategy, and post-marketing commitments — converting regulatory compliance into a collaborative, derisking partnership rather than a reactive submission process.

What did Regina Atim discuss on The Life Science Rundown?

Pharmacist and maternal health expert Regina Atim examines FDA's July 2025 E21 draft guidance, which establishes a framework for proactively including pregnant and breastfeeding women in clinical trials, addressing decades of exclusion rooted in the thalidomide and DES disasters of the mid-twentieth century. Key topics include: **Historical exclusion drivers:** Two catastrophic drug events — thalidomide (1957–1961), prescribed for morning sickness and causing birth defects, and DES (1940s–1970s), linked to vaginal cancers and reproductive abnormalities in offspring — established the 1964 Helsinki Declaration protections that defaulted sponsors and IRBs toward excluding pregnant women from all subsequent clinical research.; **Pregnancy ADME changes:** Drug absorption, distribution, metabolism, and excretion differ significantly from non-pregnant adults, vary by trimester, and may not normalize until six to twelve months postpartum. Without pregnancy-specific data, clinicians extrapolate adult doses, risking either dangerous accumulation or underdosing — the latter carrying consequences like spina bifida from untreated fever..

How long is this episode of The Life Science Rundown?

This episode is 28 minutes long. SignalCast provides an AI-generated summary so you can get the key insights in about 3 minutes.

The Life Science Rundown

Breaking Down FDA’s E21 Draft Guidance: Including Pregnant and Breastfeeding Women in Clinical Trials with Regina Atim

September 29, 2025

28 min episode · 2 min read

Regina Atim

Episode

28 min

Read time

2 min

Topics

Productivity, Health & Wellness, Relationships

AI-Generated Summary

Published Mar 16, 2026

Key Takeaways

✓Historical exclusion drivers: Two catastrophic drug events — thalidomide (1957–1961), prescribed for morning sickness and causing birth defects, and DES (1940s–1970s), linked to vaginal cancers and reproductive abnormalities in offspring — established the 1964 Helsinki Declaration protections that defaulted sponsors and IRBs toward excluding pregnant women from all subsequent clinical research.
✓Pregnancy ADME changes: Drug absorption, distribution, metabolism, and excretion differ significantly from non-pregnant adults, vary by trimester, and may not normalize until six to twelve months postpartum. Without pregnancy-specific data, clinicians extrapolate adult doses, risking either dangerous accumulation or underdosing — the latter carrying consequences like spina bifida from untreated fever.
✓E21 early engagement strategy: Sponsors should initiate Type C or INTERACT meetings with FDA before IND submission to agree on inclusion triggers, pharmacokinetic parameters, required specialists such as maternal-fetal medicine, IRB safety criteria, lactation strategy, and post-marketing commitments — converting regulatory compliance into a collaborative, derisking partnership rather than a reactive submission process.
✓Real-world evidence gap: Systematic collection of real-world data from pregnant patients taking existing drugs would resolve many current safety debates. The ongoing acetaminophen controversy — despite seventy years of use and its 1960s adoption in pregnancy — exists precisely because structured observational data was never collected, leaving only empirical clinical experience rather than documented evidence.
✓Sponsor competitive advantage: Including pregnant and breastfeeding women early in clinical development enables early signal detection, more informative labeling with trimester-specific dosing, and smoother FDA review cycles. Sponsors who proactively disclose safety signals avoid regulatory restrictions that apply when agencies determine a sponsor "should have known" — making inclusion a risk management strategy, not just an ethical obligation.

What It Covers

Pharmacist and maternal health expert Regina Atim examines FDA's July 2025 E21 draft guidance, which establishes a framework for proactively including pregnant and breastfeeding women in clinical trials, addressing decades of exclusion rooted in the thalidomide and DES disasters of the mid-twentieth century.

Key Questions Answered

•Historical exclusion drivers: Two catastrophic drug events — thalidomide (1957–1961), prescribed for morning sickness and causing birth defects, and DES (1940s–1970s), linked to vaginal cancers and reproductive abnormalities in offspring — established the 1964 Helsinki Declaration protections that defaulted sponsors and IRBs toward excluding pregnant women from all subsequent clinical research.
•Pregnancy ADME changes: Drug absorption, distribution, metabolism, and excretion differ significantly from non-pregnant adults, vary by trimester, and may not normalize until six to twelve months postpartum. Without pregnancy-specific data, clinicians extrapolate adult doses, risking either dangerous accumulation or underdosing — the latter carrying consequences like spina bifida from untreated fever.
•E21 early engagement strategy: Sponsors should initiate Type C or INTERACT meetings with FDA before IND submission to agree on inclusion triggers, pharmacokinetic parameters, required specialists such as maternal-fetal medicine, IRB safety criteria, lactation strategy, and post-marketing commitments — converting regulatory compliance into a collaborative, derisking partnership rather than a reactive submission process.
•Real-world evidence gap: Systematic collection of real-world data from pregnant patients taking existing drugs would resolve many current safety debates. The ongoing acetaminophen controversy — despite seventy years of use and its 1960s adoption in pregnancy — exists precisely because structured observational data was never collected, leaving only empirical clinical experience rather than documented evidence.
•Sponsor competitive advantage: Including pregnant and breastfeeding women early in clinical development enables early signal detection, more informative labeling with trimester-specific dosing, and smoother FDA review cycles. Sponsors who proactively disclose safety signals avoid regulatory restrictions that apply when agencies determine a sponsor "should have known" — making inclusion a risk management strategy, not just an ethical obligation.

Notable Moment

Atim points out that the largest evidence gaps exist in seizure disorders and HIV — conditions that are actually worsened or more frequent during pregnancy — meaning the populations most likely to need these drugs are precisely the ones for whom no dosing data exists.

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Episode Transcript

Hello, everyone. Welcome to the Life Science Rundown. This is Nicholas Chapman with the FDA Group. Before we jump into our discussion for today, just a little bit about the FDA Group. We help life science companies in the areas of quality assurance, regulatory affairs, clinical operations, commissioning, qualification, and validation, as well as pharmacovigilance. We offer three different engagement models, which are consulting, staff augmentation, and full time employer recruitment. So if you ever find yourself in need, just head over to the fdfdagroup.com to check us out and get in touch. So today, I'm speaking with Regina Atim. Hey, Regina. How are you? Hi, Nick. How are you? I'm doing great. You? Likewise. Thank you for joining. So before we jump into our discussion for today, would you kindly introduce yourself? Absolutely. So I am Regina Atem, and I'm a pharmacist by trade. I bring a unique 360 degree perspective to maternal and perinatal health, and this has been shaped by my career, which spans clinical practice, regulatory and industry leadership. I have also served as as an advisory board member with the Institute for Safe Medication Practices, where I have worked to help shape some of our national strategies around medication safety. At my company, Clinician Such Healthcare Solutions, I collaborate with biotech and pharmaceutical companies to develop some strategies that advance their therapies through regulatory framework, including inspection readiness, human factors engineering, and, post market studies. So I'm also the founder of a maternal health, company, which is developing a technology to detect cardiovascular disease that is acquired during pregnancy. And this is in our effort to try to decrease some of the mortality and, morbidity that is associated with cardiovascular disease. Okay. Fantastic. Thank you for that. So today, we are gonna be talking about how can the persistent exclusion of pregnant and breastfeeding women from clinical trials despite the physiological changes that significantly affect drug metabolism be addressed to ensure evidence based, safe, and effective treatment decisions in light of the FDA's July 2025 guidance draft guidance e 20 '1 promoting proactive inclusion and data generation for for this population. So that's that's a mouthful, but there's a lot there, and, obviously, it's very relevant in today's day and time. So let's let's start by understanding the problem. So my first question is, what historical, ethical, and regulatory factors have contributed to the exclusion of pregnant and breastfeeding women from clinical trials? Oh, absolutely. So, typically, sponsors and IRBs, have defaulted to exclusion of pregnant women. And re really, the reason behind this is, having to do with the 1964 declaration of of Helsinki, which had to do with the protections of pregnant women and children, that should supersede any other benefits that might occur. And what led up to this is actually two catastrophic events. One of them being the thalidomide, event that, that we experienced from 1957 to 1961. And in these four years, there was a sedatives that was actually prescribed …

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