HEALTH OF WOMEN CENTER FOR DEVICES & RADIOLOGICAL

HEALTH OF WOMEN CENTER FOR DEVICES & RADIOLOGICAL

HEALTH OF WOMEN CENTER FOR DEVICES & RADIOLOGICAL HEALTH September 07, 2018 WOMENS HEALTH TECHNOLOGIES CRN ANNUAL MEETING Terri L. Cornelison, MD, PhD Assistant Director for the Health of Women 1

CDRH Health of Women Program Origin - 2011 Visionary CDRH has long been interested in a It is human health Health of Women framework Health of Women extends far beyond reproductive health to explore the unique issues related to the

performance of medical devices in women But conditions where course and outcome are different in women Health of Women encompasses not only health conditions specific to women 2 CDRH Health of Women Program Origin The CDRH Health of Women Program is charged to:

Because of the steadily growing importance ofexplore sex- and gender-specific issues in unique issues related to arising the regards to performance ofmedical medicaltechnology, devices in women design and development, improve analysis and communication clinical

trial design, and other of sex/gender-specific data formatters, the safe and medical device-related effective use of medical devices CDRH formalized the creation of the develop and implement major health Health of Women Program science and medical programs, strategies and initiatives across CDRH www.fda.gov 3 CDRH Health of Women Program PROTECT AND PROMOTE THE HEALTH OF WOMEN

SEX/ GENDERSPECIFIC ANALYSIS & REPORTING INTEGRATE D APPROACH FOR CURRENT & EMERGING ISSUES RESEARCH ROADMAP 4 1

SEX/GENDERSPECIFIC ANALYSIS & REPORTING 5 More and more, we are learning that sex and gender Every Cell is Sexed | Every Person is Gendered differences play significant roles in the course and outcome of conditions that affect all organ systems in the human body. What implication does this have for the performance of every medical device and diagnostic in the health care for both women and for men? Sex and Gender: Definitions XXXY Sex Gender

classification derived from the chromosomal complement a persons self-representation as male or female Biological Construct Cultural Concept IOM Report , 2001 7 Our Vision .

Collect . Analyze . Report Data Disaggregated by Sex/Gender 8 Global Patterns of Gene Expression Differ in Males and Females 50-75% of genes are sex-biased Mean difference of 8-9% This magnitude in majority of genes may reflect fundamental sex differences

Which individual sex-biased factors are responsible for physiologic sex differences Yang et al. Genome Res 2006 9 Sex-Biased Genes Reside where in genome? Chromosome or hormone effect? Although all sex differences stem from X and Y genes Almost all sex differences in liver gene expression abolished by gonadectomy Most important factors caused by ovarian versus testicular hormones

Sex hormones cause sexual bias in gene expression by acting directly on genes throughout the genome 10 FDA Center for Devices and Radiologic Health Ventricular Assist Devices (VADs) Cardiac Resynchronization Therapy Defibrillators (CRT-D) Drug-Eluting Coronary Stents Endovascular Grafts Breast Implants Sterilization Devices Pelvic Mesh www.fda.gov 11

Simply This Does sex and/or gender affect your observation? If no, why not? If yes, how? www.fda.gov 12 2 INTEGRATED APPROACH FOR CURRENT & EMERGING ISSUES 13 Integrated Approach

DEVELOP AND IMPLEMENT MAJOR HEALTH SCIENCE AND MEDICAL PROGRAMS AND INITIATIVES Develop an integrated approach to address emerging issues related to the health of women Collaborative Responsive Counciland with Proactive stakeholders Develop Core Systematic

Community Scientific ofexternal Practice Approach Decisional Leadership Steering Committee 14 Integrated Approach Responsive and Proactive Comprehensive & Product Specific sex-specific trends or differences safety signals in sex-specific devices

ACROSS ENTIRE PRODUCT LIFE CYCLE post-market pre-market compliance real world evidence 15 Integrated Approach Systematic Scientific Approach Survey Identify Scientifically Evaluate Track

Prioritize Address Report 16 Integrated Approach Decisional Leadership Steering Committee C O N S C I E N C E & C O M PA S S Decision making on behalf of the Center Oversight body of the integrated approach for emerging issues Address emerging issues in real time 17

Integrated Approach Core Community of Practice CDRH Community that Provides Perspectives, Input, Feedback Working Groups integrated within Steering Committee Extremely knowledgeable about: Clinical trial design Devices specifically targeted to

women Sex/Gender research in specific organ systems Help with Benefit/Risk Help with Study Design Build resource that gets pulled into surveillance team 18 Integrated Approach Collaborative Council Build coalitions of clinicians, researchers, academia, government agencies, industry, patient/ advocacy groups to develop devices that best meet the needs of women

Stakeholder engagement Professional societies FDA product centers, OWH HHS agencies 19 Integrated Approach Develop innovative strategies, technologies, and device-specific clinical study paradigms Devise Center-wide policies and outreach activities

20 3 RESEARCH Develop research roadmap ROADMAP for the device health of women ecosystem 21 Research Roadmap Portfolio of Women-Specific Devices Strategize around gap areas Think about device heavy issues Where can we break news?

Sex/Gender-Specific Partner: Office Science/Engineering Labs Data: premarket, post-market, registries Analysis Communicate sex-specific information on device use to inform decisions HW Patient Preference Initiative Partner: Science of Patient Input Develop Women Device Registries Partner: Division of Epidemiology Clinical Trial Design Perspectives of women who have benefited Make informed and sound decisions around patient preference

Strengthen post-market surveillance Make better use of real world data Partner: Clinical Trials Program Clinical trial design for sex/gender-specific outcomes Clinical trial enrollment address unique challenges of device studies 22 CDRH Health of Women Program PROTECT AND PROMOTE THE HEALTH OF WOMEN SEX/ GENDERSPECIFIC ANALYSIS & REPORTING INTEGRATE D APPROACH

FOR CURRENT & EMERGING ISSUES RESEARCH ROADMAP 23 THANK YOU HEALTH OF WOMEN CENTER FOR DEVICES & RADIOLOGICAL HEALTH 24

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