Addressing Concerns and Considerations Surrounding the Inclusion of Pregnant and Lactating Populations in Research

Drew Hatter currently serves as Federal Affairs Strategist at the American College of Obstetricians and Gynecologists (ACOG). As a member of ACOG’s Government Affairs team, Drew advocates to federal legislators and government officials for legislation and policy critical to improving women’s health, such as those pertaining to the physician workforce, federal appropriations, health information technology, and the inclusion of pregnant and lactating populations in research.

Prior to ACOG, Drew worked at the U.S. House of Representatives as a Legislative Assistant in the office of former Congressman Steve Stivers, where he advised the Congressman and served as primary point of contact on health-related policy and legislation.

Drew attended The Ohio State University where he received a BA degree from the Glenn College of Public Affairs in Public Management, Leadership, and Policy.

Catherine Spong, MD, serves as the Professor and Chair, Department of Obstetrics and Gynecology; Chief, Division of Maternal Fetal Medicine; Paul C. MacDonald Distinguished Chair in Obstetrics and Gynecology at the University of Texas Southwestern Medical Center. Dr. Spong received her MD from the University of Missouri-Kansas City in 1991. After serving as Chief Resident in Obstetrics and Gynecology at the Harbor-UCLA Medical Center, she began her career at National Institute of Child Health and Human Development (NICHD) as a Maternal-Fetal Medicine Fellow, including clinical work at Georgetown University. Then, she became a Clinical Associate and Senior Staff Fellow at the National Institutes of Health and the NICHD’s intramural research program, where she directed a lab, the Unit on Perinatal and Developmental Neurobiology, focusing on neuroprotective peptides and fetal development utilizing models of fetal alcohol syndrome and Down syndrome.

In 2000, she joined NICHD’s extramural program and had a 23-year career where she served in many capacities including as Deputy Director, Acting Director, Associate Director for Extramural Research, Director of the Division of Extramural Research, and Chief of the Pregnancy and Perinatology Branch.

Among Dr. Spong’s areas of expertise are maternal and child health, emphasizing prematurity, fetal complications, and improving child outcomes. One of her major research interests has been the developing fetus. She holds several patents for neuroprotective agents that help prevent fetal injury. Other research interests include improving the understanding of stillbirth, fetal surgery for myelomeningocele, zika in pregnancy, and the human placenta. During her tenure at NICHD, she launched the Human Placenta Project. She is a passionate advocate for inclusion in research for underrepresented groups.

She has received numerous teaching and professional awards including the Society for Maternal-Fetal Medicine Lifetime Achievement Award, the UMKC Alumnus of the Year Award, numerous National Institutes of Health Director’s Awards, the American College of Obstetricians and Gynecologists Distinguished Service Award, and a Surgeon General’s Certificate of Appreciation for her work on prematurity.

Dr. Spong has served on a number of professional and federal boards including the Society for Maternal Fetal Medicine, the Reproductive Scientist Development Program, The Federal Interagency Task Force on Environmental Health Risks and Safety Risks to Children, the Muscular Dystrophy Coordinating Committee, the Interagency Autism Coordinating Committee, the Advisory Committee on Heritable Disorders in Newborns and Children, The Federal Interagency Forum on Child and Family Statistics, the Health and Human Services Working Group on health Weight in Pregnancy, and the Russian G-8 Infant Mortality Initiative. She was a member of the HHS Delegation to Brazil to coordinate efforts to combat zika, led by Ambassador Jimmy Kolker. She was the Chair of the Department of Health and Human Services Federal Task Force on Research Specific to Pregnant Women and Lactating Women.

Dr. Spong is board-certified in maternal-fetal medicine and obstetrics and gynecology. She is an Editor of William’s Obstetrics, Management of High Risk Pregnancy, Protocols of High Risk Pregnancy, and Stillbirth: Prediction, Prevention and Management. She is Editor-in-Chief of Contemporary ObGyn, the most widely disseminated and read publication by practitioners. She has published more than 300 peer-reviewed papers, has an h-index of 71, with over 24,490 citations, and been featured on national television and radio, including The CBS Early Show, the Diane Rehm Show, NPR’s All Things Considered, CNN, and Voice of America, discussing women’s health and pregnancy topics.

Dr. Bucci-Rechtweg graduated with a MD from the University of Rochester School of Medicine & Dentistry and was Residency trained in Pediatrics and Fellowship trained in Pediatric Critical Care Medicine at the State University of New York at Buffalo. She has over 20 years of pharmaceutical industry experience with roles in Clinical Development & Medical Affairs as well as Regulatory and Development Policy, where she was responsible for the oversight and registration of global clinical development programs.

In her career she has developed and implemented clinical programs as a Global Medical Director for pediatric and women’s health in phase II and III, including those with pediatric regulatory obligations in the EU and the United States, and is widely regarded for her negotiating skills in adult and pediatric drug development, as well as health policy and international regulatory consensus building.

Dr. Bucci-Rechtweg is actively involved in numerous external organizations advancing the regulatory and development environment for pediatric and maternal health globally, including the U.S. National Advisory Council for Child Health and Human Development, ICH Pediatric Standing Advisory Committee, ICH E11A Pediatric Extrapolation Expert Working Group, Critical Path Institute’s International Neonatal Consortium, EFGCP Children’s Medicines Working Party, the IQ Consortia’s Pediatric Clinical Pharmacology Leadership Group, HHS Task Force on Research in Pregnant Women & Lactating Women, as well as numerous professional societies and the trades. Christina is currently the Global Head for Pediatric and Maternal Health Policy at Novartis Pharmaceuticals Corporation.

Aaron C. Pawlyk, Ph.D., is Chief of the Obstetric and Pediatric Pharmacology and Therapeutics Branch (OPPTB) in the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)’s Division of Extramural Research. OPPTB supports research and training to advance thesafe and effective development and use of therapeutics for pregnant women, lactating women, and children, with an emphasis on clinical pharmacology to improve dosing, safety, and effectiveness.

Since joining NICHD as Branch Chief in August 2019, Dr. Pawlyk has led OPPTB’s national extramural portfolio. He established a five-year strategic plan, expanded intra-NIH and cross-agency collaboration, and advanced data-driven recommendations to strengthen NICHD’s research direction. Heoversees funding mechanisms—including grants, cooperative agreements, contracts, and OTAs—and leads work at the science–policy interface, supporting activities under the Best Pharmaceuticals for Children Act (BPCA) and guiding PRGLAC follow-up and implementation, including a National Academies study on legal, ethical, and regulatory policy issues for research involving pregnant and lactating women.

Dr. Pawlyk has prioritized strengthening quantitative clinical pharmacology to close evidence gaps. Under his leadership, OPPTB envisioned the Maternal and Pediatric pRecisioN in Therapeutics (MPRINT) Hub, a national resourcespanning quantitative systems pharmacology, pharmacometrics, and tool development. He also developed initiatives focused on mechanisms driving maternal–fetal and pediatric exposure and response across organ systems. In his role as the NIH point of contact for pediatric medical devices, he led OPPTB in launching a design-phase public–private partnership in pediatric medical device innovation via the Foundation for the NIH, in coordination with FDA and BARDA.

Dr. Pawlyk earned a BA in Biochemistry and Biology at the University of Pennsylvania and a PhD in Biochemistry at Texas A&M University, with training in enzymology and allosteric regulation. Prior to NIH, he built expertisein women’s health and biomarker-informed product development at Wyeth and gained experience at Redpoint Bio in how excipients and palatability can affect use in children. Earlier NIH leadership at NIDDK strengthened his focus on data and knowledge resources and translational programs, including coordination of the Common Fund’s Illuminating the Druggable Genome (IDG) program and stewardship of large-scale initiatives coupling multi-omics data and phenotypes to accelerate target discovery and therapeutic translation. Hehas authored 37 peer-reviewed publications and is recognized for building multidisciplinary teams and national-scale resources that connect mechanism, modeling, biomarkers, and implementation.

Leyla Sahin, MD, is an obstetrician-gynecologist. She is the Deputy Director for Safety in the Division of Pediatrics and Maternal Health in the Office of New Drugs, Center for Drug Evaluation and Research at the U.S. Food and Drug Administration (FDA). She oversees pregnancy and lactation safety activities and leads various maternal health related scientific and regulatory/policy initiatives.