National Institutes of Health – Office of Research on Women’s Health
U.S. Food & Drug Administration – Office of Women’s Health

25th Anniversary Congress on Women’s Health
 2017 Pre-conference Symposium

Working Together to Address Women's Health in Research and Drug Development: Challenges and Opportunities

Thursday, April 27, 2017
2:30 – 5:00pm



Welcome and Opening Remarks

Janine Austin Clayton, MD
NIH Associate Director for Research on Women’s Health
Director, Office of Research on Women's Health (ORWH), NIH

Marsha Henderson, MCRP
FDA Assistant Commissioner for Women’s Health
Director, Office of Women’s Health (OWH), FDA

Past Accomplishments:  2:30 – 3:20pm


Women's Health Initiative

Michael S. Lauer, MD
NIH Deputy Director for Extramural Research


Progress in Including Women in Clinical Trials for FDA-Approved Products

Pam Scott, PhD, MA
Deputy Director and Director of Research and Development, Office of Women’s Health, FDA

Present Endeavors:  3:20 – 4:00pm


NICHD Clinical Trials in Pregnant Women: Illuminating, Path-breaking, and Humbling (No Kidding!)

Tonse N. K. Raju, MD, DCH
Chief, Pregnancy and Perinatology Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH


FDA Pregnancy Updates: Drug Labeling, Registries, and Clinical Trials

Tamara Johnson, MD, MS
Team Leader, Maternal Health Team, Division of Pediatric and Maternal Health, Center for Drug Evaluation and Research, FDA

Future Directions:  4:00 – 4:40pm


All of Us - The Precision Medicine Initiative, The Future of Health Begins with You

Stephanie Devaney, PhD
Deputy Director, All of Us Research Program, NIH


Expanding FDA Transparency and Communications: What Every Provider Should Know

Milena Lolic, MD, MS
Medical Officer, Professional Affairs and Stakeholder Engagement, Center for Drug Evaluation and Research, FDA



Discussion, Questions, and Answers


Closing Remarks

Marjorie Jenkins, MD, MEdHP, FACP
Director of Medical Initiatives and Scientific Engagement, Office of Women’s Health, FDA