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Addressing Concerns and Considerations Surrounding the Inclusion of Pregnant and Lactating Populations in Research
December 6, 2022 @ 2:00 pm - 3:00 pm EST
Pregnant and lactating women have historically been excluded from clinical trials. Federal policies from the 1970s that excluded “women of childbearing age” from research led research to use male participants, limiting our knowledge base. Although a 1994 report from the Institute of Medicine recommended that pregnant women be presumed to be eligible to participate in clinical studies and that lactating women not be excluded from clinical studies, concerns remain about including pregnant and lactating populations in research.
During this virtual congressional briefing and national webinar, panelists reviewed ethical considerations surrounding inclusion of pregnant and lactating women in research, how to ensure the appropriate inclusion of these populations, and the current state of this type of inclusion in research, both within the federal government and the corporate sector.
Follow the conversation on Twitter at @SWHR.
This event is free and open to the public.
This event is part of a series about the inclusion of pregnant and lactating peoples in research. The full series includes:
- Addressing Concerns and Considerations Surrounding the Inclusion of Pregnant and Lactating Populations in Research (December 6, 2022)
- Pregnant and Lactating Populations in Research: How Leaving These Populations Out Leaves Them Behind (January 26, 2023)
- PRGLAC Then and Now: Where We Are and Where We’re Going (February 14, 2023)
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 Bachelor of Art degree from the Glenn College of Public Affairs in Public Management, Leadership, and Policy.
Catherine Spong, MD
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.
Christina Bucci-Rechtweg, MD
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 Pawlyk, PhD
Aaron C. Pawlyk, PhD, joined the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) as its OPPTB chief in 2019. His long-term research interests and experience include drug discovery and pre-clinical development, pharmacogenomics, and mathematical modeling, especially how these approaches can be applied across multiple therapeutic areas.
Prior to joining NICHD, Dr. Pawlyk served at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) as a program director and senior advisor in the Division of Diabetes, Endocrinology, and Metabolic Diseases. At NIDDK, his portfolio included drug discovery, pharmacogenomics, and drug response research. He directed the Type 1 Diabetes-Rapid Access to Interventional Development program, which offered preclinical development contract services to outside researchers. As a program official, he managed cooperative agreement components of the Accelerating Medicines Partnership for Type 2 Diabetes and initiated and directed a trans-NIDDK program on therapeutics translation. He continues to serve as a coordinator of the NIH Common Fund program, Illuminating the Druggable Genome.
Dr. Pawlyk received his bachelor’s degree from the University of Pennsylvania, where he studied biology and biochemistry. He completed his Ph.D. in biochemistry at Texas A&M University, followed by postdoctoral studies at the University of Pennsylvania. Before joining NIH, he held multiple positions in the pharmaceutical sector.
Leyla Sahin, MD
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.