Menopause: Potential Impact on Clinical Pharmacology and Opportunities for Future Research October 11, 2023

Workshop | Virtual

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• Date: October 11, 2023
• Time: 10:00 AM - 2:00 PM ET

• Organized By: Office of Women's Health

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The FDA Office of Women’s Health (OWH), in collaboration with the Center for Drug Evaluation and Research (CDER) Office of Clinical Pharmacology (OCP), will host a free virtual public workshop to discuss the current understanding of the impact of menopause on drug pharmacology and highlight the areas with the greatest need for further research and exploration. OWH works to protect, promote and advance the health of women through research, education, and outreach. 

This workshop will include presentations and session discussions by experts in the fields of clinical pharmacology, obstetrics and gynecology, endocrinology, and clinical care. Each session will include a Q&A to respond to questions from attendees. 

Speakers will discuss the current understanding of the impact of menopause on the pharmacokinetics (PK), pharmacodynamics (PD), and exposure-response relationships of FDA-regulated drugs and biologics used by menopausal women for non-menopause-related indications. The discussion is intended to identify the research and data gaps regarding the potential impact of menopause on PK/PD. 

The workshop will be held virtually on the Zoom platform and registrants will receive a link to attend the workshop after completing their registration. Live closed captioning will be available during the workshop. If you require additional accommodations, please request them when completing your registration. 

A video recording of this workshop will be available on the OWH website a few weeks after the workshop ends.  

For questions about this event please email OWHmeetings@fda.hhs.gov. 

View workshop recording here

Meeting objectives 

• Examine the biological and physiological changes that occur during menopause.

• Discuss the current understanding of the impact of menopause on the pharmacokinetics (PK), pharmacodynamics (PD), and exposure-response relationships of FDA-regulated products used by menopausal women for non-menopause-related indications.

• Discuss whether the changes in drug absorption, distribution, metabolism, and elimination, if any, are specifically due to hormonal changes of menopause (independent of age), or other non-hormonal influences (including age-related renal and hepatic changes).

• Identify the research and data gaps regarding the impact of menopause on PK/PD, highlighting areas with the greatest need for further research and exploration.

Menopause: Potential Impact on Clinical Pharmacology and Opportunities for Future Research; Public Workshop (Federal Register Notice 9/21/23)

Agenda

10:00 a.m.	Opening remarks Welcome and housekeeping remarks - Susan Bersoff-Matcha, MD, Deputy Director, Office of Women’s Health (OWH), Food and Drug Administration
10:03 a.m.	OWH opening remarks - Kaveeta Vasisht, MD, PharmD, Associate Commissioner for Women’s Health and Director of the Office of Women’s Health, Food and Drug Administration
10:05 a.m.	Keynote – Janet Woodcock, MD, Principal Deputy Commissioner, Food and Drug Administration
	Session I: Overview of biological changes of menopause Objectives: Provide an overview of the biological and physiological changes that occur during the menopause transition and the resulting impact on health outcomes. Discuss perimenopause, surgical vs. natural menopause, and the impact of age, race, and ethnicity on menopause. Moderator: Christina Chang, MD, MPH, Division of Urology, Obstetrics, and Gynecology, Food and Drug Administration.
10:10 a.m.	Nanette Santoro, MD, Professor and E. Stewart Taylor Chair, Department of Obstetrics and Gynecology, University of Colorado School of Medicine
10:30 a.m.	Gloria Richard-Davis, MD, MBA, NCMP, FACOG, Reproductive Endocrinology Obstetrician/Gynecologist; Executive Director, Division for Diversity, Equity & Inclusion, Department of Obstetrics and Gynecology, University of Arkansas for Medical Sciences (UAMS)
10:50 a.m.	Cynthia A. Stuenkel, MD, Clinical Professor of Medicine, Endocrinology and Metabolism, University of California San Diego School of Medicine
11:10 a.m.	Q & A
11:25 a.m.	Break
	Session II: Menopause and PK/PD Objectives: The effects of menopause on the PK/PD of drugs are largely unknown. Sex hormone changes during menopause may affect the metabolic pathways of drugs by affecting drug metabolizing enzymes. Hormone changes may also affect other pathways that play an important role for drug disposition and excretion. In addition, many women experience weight gain at menopause. These changes have the potential to result in changes to drug PK. Furthermore, the physiological changes in menopause may result in altered sensitivity to drug response independent of changes in PK. This panel will discuss whether and how these variables could be considered during medical product development and the challenges and opportunities for addressing knowledge gaps. Moderator: Rajanikanth (Raj) Madabushi, PhD, Associate Director, Guidance and Scientific Policy, Office of Clinical Pharmacology, Food and Drug Administration
11:35 a.m.	Leslie Z. Benet, PhD, Professor and Former Chair, Department of Bioengineering & Therapeutic Sciences, Schools of Pharmacy and Medicine, University of California San Francisco
11:55 a.m.	Virginia Miller, MBA, PhD, Professor Emerita, Surgery and Physiology, Mayo Clinic
12:15 p.m.	Break
12:25 p.m.	Audrey Gassman, MD, Deputy Director, Division of Urology, Obstetrics, and Gynecology, Food and Drug Administration
12:45 p.m.	Yanhui Lu, PhD, Office of Clinical Pharmacology, Food and Drug Administration
1:05 p.m.	Q & A
1:25 p.m.	Closing Remarks

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Event Materials

Title	File Type/Size
Workshop Speaker and Moderator Bios	pdf (850.67 KB)

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