Overview:
Excluding pregnant and breastfeeding persons from clinical research has resulted in a significant deficiency of crucial dosing and safety data, leading to incomplete or non-existing information for health care professionals and patients at the time of drug approval. Women are entitled to explicit, evidence-based guidance to manage their diseases and chronic conditions during pregnancy and lactation, ensuring the best possible outcomes for both their health and that of their newborn.
Explanations on the ethical considerations supporting the inclusion of pregnant individuals in clinical research brought attention to the removal of the outdated classification of pregnant individuals as a vulnerable population. Several institutions and regulatory agencies have responded to recent developments with initiatives to enhance the participation of pregnant and lactating individuals in clinical studies.
This presentation will cover recent and ongoing efforts to increase the inclusion of pregnant and lactating individuals in clinical trials. It will examine new guidance under development, existing and proposed guidances, and the FDA's PDUFA VII commitments to establish a framework for pregnancy safety studies.
Speakers:
Martine Dehlinger-Kremer, PhD, MS
Dr. Dehlinger-Kremer brings over 30 years of experience in the research industry, including 30 years with a particular focus on global regulatory affairs, medical affairs, and pediatric leadership. At ICON’s Centre for Pediatric Clinical Development, she supports pediatric developments and advances in pediatric research. Additionally, as Co-Chair of ICON’s Maternal-Foetal Medicine Unit, Dr. Dehlinger-Kremer contributes to the search for innovative solutions in maternal-foetal health.
Prior to joining ICON, Dr. Dehlinger-Kremer served in several executive leadership roles at global CROs, and has experience in global drug development in more than 40 countries. She has contributed to the global development of numerous products, including medicines for children, drugs for orphan diseases and biosimilars. Her vision and leadership extend to service with a number of professional organisations – she is an observer member of the Coordinating Group of the European Network of Pediatric Research (Enpr-EMA) at the European Medicines Agency, chair of the Pediatric Working Group and also President of the European CRO Federation (EUCROF), serves as chair of the European Forum for Good Clinical Practice (EFGCP) Children’s Medicines Working Party and Board Member of the association, and is active in the International Children’s Advisory Network (iCAN).
In 2015, Dr. Dehlinger-Kremer was named one of PharmaVOICE’s 100 Most Inspiring People in Life Sciences.
Dr. Dehlinger-Kremer earned a Doctorate in Sciences from the J. W. Goethe University in Francfort on the Main, Germany; a Diploma of Advanced Study in Neurophysiology from the University Louis-Pasteur, Strasbourg, France; and a Master of Sciences degree from University Moulin de la Housse in Reims, France.
Mark Sorrentino, MD, MS
Dr. Sorrentino has over 20 years of experience in the pharmaceutical and biotech industries and currently leads ICON’s global Centre for Pediatric Clinical Development and Maternal Foetal Medicine unit. Prior to joining ICON, Dr. Sorrentino spent 5 years as the global chair and founder of the pediatric practice area at a leading CRO, overseeing all aspects of strategy and pediatric clinical development, as well as the global therapeutic head of critical care and the interim head of infectious diseases. Dr. Sorrentino served as the global chief medical officer at ADMA Biologics, where he oversaw all clinical development operations, and as director of medical science at MedImmune, where he was responsible for development and oversight of numerous phase 4/post-marketing studies across several therapeutic areas, including infectious diseases, respiratory diseases, and transplant medicine. As a former consultant to biotechnology firms, Dr. Sorrentino has overseen implementation of medical information systems. Having earned his medical degree and master's degree in clinical nutrition from the Chicago Medical School, Dr. Sorrentino completed both a residency in pediatrics and a fellowship in pediatric critical care at Children's National Medical Center (CNMC) in Washington, DC. Currently, Dr. Sorrentino holds an appointment as an assistant clinical professor at the George Washington University School of Medicine.
Prior to joining the industry, Dr. Sorrentino was an attending physician in the CNMC pediatric intensive care unit for 8 years and participated in numerous industry-sponsored critical care trials. He holds active medical licenses in California and Maryland and has an interest in disaster management and special operations/tactical medicine. Dr. Sorrentino is an active medical team member of Team Rubicon, and the California Medical Reserve Corps. He has deployed to disasters in the US and has also volunteered on several international medical missions. In addition, he is on the advisory board of several companies including Mejo, A Little Better Company, and Bezyl and sits on an Enpr-EMA workstream. Dr. Sorrentino also holds a position on the AAP Council on Children and Disasters writing and editing committee.
Monica Lee, MD
Dr. Lee is a board-certified Obstetrician Gynecologist with over 16 years of clinical experience. She graduated from Stanford University with honors and went on to obtain her MD at University of California San Francisco. Subsequently, Dr. Lee finished her residency training in obstetrics and gynecology at University of California Los Angeles. Dr. Lee enjoys teaching and has been involved with Cedars Sinai, UCLA and USC residency training as well as Stanford Bioengineering student mentorship. Dr. Lee subsequently has had experience as a Phase 2-4 clinical trial investigator, consultant for pharmaceutical protocol development on the sponsor side, Medical Director at a Digital Health startup and advisor to a venture capital firm. Dr. Lee joined ICON as a Medical Director of Women’s Health in 2021 and has contributed to studies as both a medical monitor and as a therapeutic expert.
Heather Peterson, RN, BSN
Ms Peterson has a diverse background in clinical research, both as a registered nurse (RN) and in clinical operations. She applies her expertise in pediatric populations to assist in strategic review of protocol development, ensuring critical pediatric content is thoughtfully measured and consistent with governing bodies while incorporating patient-family centric considerations. She previously served as the lead clinical research coordinator at Renown Regional Medical Center, a non-profit hospital in Reno, Nevada, where she coordinated and managed clinical trials of varied phases and indications. She worked across several therapeutic specialties to streamline scientific review committees and institutional review boards (IRB) submission processes. She brings a site and patient perspective that is valuable in developmental aspects of patient recruitment, enrollment, and retention.