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PRGLAC Then and Now: Where We Are and Where We’re Going

February 14 @ 1:00 pm - 2:00 pm EST

The 21st Century Cures Act established the Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC) to advise the Secretary of the U.S. Department of Health and Human Services regarding gaps in knowledge and research on safe and effective therapies for pregnant women and lactating women. The Task Force’s work culminated in a set of recommendations based on information gleaned during four open meetings and a public comment period. The central theme of those recommendations was “the need to alter cultural assumptions that have significantly limited scientific knowledge of therapeutic product safety, effectiveness, and dosing for pregnant and lactating women.”

During this congressional briefing and national webinar, designed specifically for—but not limited to—members of the 118th Congress, panelists will review the state of PRGLAC, the PRGLAC recommendations and their implementation status, the current legislative and regulatory landscape, and review actions that can be taken at the federal level to increase representation of these populations in clinical trials.

*This event is widely attended and relevant to official duties.

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)

REGISTER

Details

Date:
February 14
Time:
1:00 pm - 2:00 pm EST
Event Categories:
,
Website:
https://swhr-org.zoom.us/webinar/register/WN_Uem0jHu_R6at5FiP080mfw

Organizer

SWHR

Panelists

Diana W. Bianchi, MD
Director, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health
Diana W. Bianchi, MD
Director, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health

Dr. Bianchi is director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, where she oversees an annual budget of about $1.5 billion in support of NICHD’s mission to lead research and training to understand human development, improve reproductive health, enhance the lives of children and adolescents, and optimize abilities for all. Dr. Bianchi was the Health Public Service Visionary Award Winner during SWHR’s 2020 Annual Awards event.

Dr. Bianchi received her MD from Stanford University School of Medicine and her postgraduate training in pediatrics, medical genetics and neonatal-perinatal medicine at Boston Children’s Hospital and Harvard Medical School. Dr. Bianchi’s research focuses on prenatal genomics with the goal of advancing noninvasive prenatal DNA screening and diagnosis to develop new therapies for genetic disorders that can be administered prenatally.

She is a member of the National Academy of Medicine and a past president of the Perinatal Research Society and the International Society for Prenatal Diagnosis. She has served on the Board of Directors of the American Society of Human Genetics and on the Councils of the American Pediatric Society and Society for Pediatric Research. Dr. Bianchi has received multiple awards, including the 2015 Neonatal Landmark Award from the American Academy of Pediatrics, the 2016 Maureen Andrew Award for Mentorship from the Society for Pediatric Research, and the 2017 Colonel Harland Sanders Award for lifetime achievement in Medical Genetics from the March of Dimes. She received an honorary doctorate from the University of Amsterdam in 2020.

Jennita Reefhuis, PhD
Branch Chief, Birth Defects Monitoring and Research Branch, Centers for Disease Control and Prevention Division of Birth Defects and Infant Disorders
Jennita Reefhuis, PhD
Branch Chief, Birth Defects Monitoring and Research Branch, Centers for Disease Control and Prevention Division of Birth Defects and Infant Disorders

Jennita Reefhuis, PhD, is the Branch Chief for the Birth Defects Monitoring and Research Branch in CDC’s Division of Birth Defects and Infant Disorders. In this role, Dr. Reefhuis oversees birth defects surveillance and research activities to identify causes of birth defects, find opportunities to prevent them, and improve the health of those living with birth defects.

Dr. Reefhuis received her PhD in Epidemiology from the University of Groningen in the Netherlands in 2000 while working at the EUROCAT Birth Defects Registry. In 2001, she joined CDC as an Epidemic Intelligence (EIS) officer in the Birth Defects Branch. From 2006 to January 2019, Dr. Reefhuis led CDC’s National Birth Defects Prevention Study (NBDPS), a case-control study of birth defects. Dr. Reefhuis has published numerous scientific papers on birth defects and medications such as fertility treatments, antidepressants, antibiotics, ADHD medications; maternal diseases such as diabetes, Zika, and HIV; and other factors such as maternal age, genetics, and environmental exposures.

Kaveeta Vasisht, MD, PharmD
Associate Commissioner for Women’s Health, U.S. Food and Drug Administration
Kaveeta Vasisht, MD, PharmD
Associate Commissioner for Women’s Health, U.S. Food and Drug Administration

Dr. Kaveeta Vasisht is the Associate Commissioner for Women’s Health at the U.S. Food and Drug Administration (FDA). She is responsible for directing the Office of Women’s Health at the FDA. Under her leadership, the Office works to advance the health of women through scientific programs, policy development, research, education and outreach.

Prior to joining the Office of Women’s Health, Dr. Vasisht served as the Deputy Director for the Division of Clinical Trial Quality in the Office of Medical Policy in the Center for Drug Evaluation and Research. She has led multi-stakeholder international collaborations and policy development that are critical to the Agency’s approach to improving clinical trial quality and methodologies. She has worked to promote the inclusion of diverse populations in clinical trials. Dr. Vasisht began her career at the FDA in the Division of Metabolism and Endocrine Products, Office of New Drugs, where she served as the clinical expert on multidisciplinary teams in the review and evaluation of scientific data to make regulatory decisions regarding risk-benefit assessments on the safety and effectiveness of therapeutics to treat endocrine conditions for the U.S. population.

Dr. Vasisht is board certified in both internal medicine and adult endocrinology and holds a Doctor of Pharmacy degree. She completed her internal medicine training as well as her fellowship training in adult endocrinology, diabetes and metabolism at the University of Chicago Hospitals, where she also served as a clinical instructor of medicine. She has completed a hospital pharmacy practice residency. Dr. Vasisht continues to practice endocrinology in a volunteer clinic. She obtained her medical degree from the University of Medicine and Dentistry of New Jersey, Robert Wood Johnson Medical School. Dr. Vasisht combines her clinical experience and academic training with her diverse regulatory background to further advance FDA’s mission to protect, promote and advance the health of women.

This webinar series is an initiative of the Coalition to Advance Maternal Therapeutics, administered by the Society for Women’s Health Research.