Pregnant women, long excluded from drug trials, are back in the spotlight

In a recent PharmaVoice feature, Karen Yeo, Senior Vice President of Client and Regulatory Strategy at Certara, discusses the FDA’s new draft guidance encouraging the inclusion of pregnant and breastfeeding women in clinical trials of investigational drugs.

Dr. Yeo highlights how this long-overdue shift can improve women’s health data and help sponsors make safer, evidence-based dosing decisions. She explains how Certara’s pregnancy modeling platform, developed with 37 pharma partners, can simulate pregnant women’s physiological changes across trimesters to predict safe and effective dosing.

The interview underscores both the regulatory momentum and operational hurdles ahead — from liability concerns to the need for early study planning. Yeo calls the FDA’s move a critical “starting point” in rethinking how drug development supports maternal health.