On October 23, the Coalition to Advance Maternal Therapeutics (CAMT) convened its annual all-member meeting. This gathering brought together experts, advocates, and stakeholders dedicated to enhancing maternal health through improved therapeutic research and regulatory frameworks. The meeting featured special presentations by Dr. Camille Fabiyi from the National Institute of Child Health and Human Development (NICHD) and Dr. Leyla Sahin of the Food and Drug Administration (FDA).
Insights from the NICHD and the FDA
In her presentation, Dr. Fabiyi, Program Officer at the NICHD, discussed the National Institutes of Health’s (NIH) research prioritization process, focusing on the critical health needs of pregnant, postpartum, and lactating individuals. Her talk highlighted key takeaways from the July 2024 inaugural stakeholder meeting for the prioritization of therapeutic research needs for pregnant, postpartum, and lactating persons. During the NICHD meeting, stakeholder experts came together to review current research gaps and establish a framework for prioritizing nominations for future studies. A major topic of discussion was refining study designs to address the unique therapeutic needs of maternal health.
Dr. Fabiyi’s presentation to the CAMT underscored the importance of continued collaboration to ensure that research better supports the health of pregnant and lactating individuals. To learn more about the meeting outcomes and next steps, read the full Report on Implementation Progress here.
Dr. Leyla Sahin, Deputy Director for Safety in the Division of Pediatrics and Maternal Health at the FDA, shared insights on the ICH E21 Guideline, which focuses on improving the inclusion of pregnant and lactating populations in clinical trials. With 3.6 million births annually in the United States, the historical exclusion of these groups from drug development research has created significant gaps in our understanding of medication safety and efficacy for this demographic.
Dr. Sahin emphasized the importance of advancing clinical research to better protect pregnant and lactating individuals through research, not from it. Drawing on the National Academies report, Advancing Clinical Research with Pregnant and Lactating Populations, she outlined the challenges and the urgent need for collaboration among stakeholders to improve data collection and inclusion in clinical trials.
Dr. Sahin stressed the FDA’s commitment to improving the inclusion of pregnant and lactating populations in future studies, ultimately ensuring that medications are safe and effective for all individuals. To learn more about advancing research in this area, read the full report from the National Academies here. Hear more from Dr. Sahin by watching her presentation from the previous CAMT webinar, Addressing Concerns and Considerations Surrounding the Inclusion of Pregnant and Lactating Populations in Research Addressing Concerns and Considerations Surrounding the Inclusion of Pregnant and Lactating Populations in Research.
Coalition Updates
Rebecca Abbott from the Society for Fetal and Maternal Medicine and the chair of the CAMT, shared updates on coalition activities, including the addition of new rotating members from esteemed organizations, the Epilepsy Foundation, the Elizabeth Glaser Pediatric AIDS Foundation, and the Preeclampsia Foundation. Looking ahead to 2025, the Society for Women’s Health Research will assume the chair role while also continuing its administrative support.
In terms of FY 2024 appropriations activities, the Coalition’s advocacy efforts resulted in maintaining funding for the Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC) Advisory Committee and the inclusion of report language for the FDA to finalize regulations regarding the inclusion of pregnant and lactating women in research.
Looking Ahead
Looking ahead in the field of PRGLAC research, members discussed predictions for the upcoming congressional sessions and the significant implications for maternal health initiatives that may be at play. The Coalition is actively working on bipartisan support for the Advancing Safe Medications for Moms and Babies Act, aiming to secure champions in the Senate and leverage the momentum from past successes to drive future legislation.
The CAMT annual meeting served as a vital platform for collaboration and discussion on the future of maternal health research. As we enter a new administration and Congress, the Coalition remains committed to its mission of advocating for the implementation of PRGLAC recommendations and the prioritization of the inclusion of pregnant and lactating individuals in clinical trials, while addressing the unique challenges they face through robust, evidence-based solutions.
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