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
 

Opening

2:30-2:40pm    

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

2:40-3:00pm     

Women's Health Initiative

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

3:00-3:20pm

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

3:20-3:40pm      

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

3:40-4:00pm    

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

4:00-4:20pm      

Precision Medicine Initiative: Precision for Women

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

4:20-4:40pm   

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  

Closing

4:40-4:55pm     

Discussion, Questions, and Answers

4:55-5:00pm

Closing Remarks

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

Terri L. Cornelison, MD, PhD, FACOG
Associate Director for Clinical Research
Office of Research on Women’s Health, National Institutes of Health