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The Society for Womens Health Research (SWHR) is pleased that the new agenda for womens health

research at the Office of Research on Womens Health (ORWH) at the National Institutes of Health (NIH) places sex differences research at the top of its priorities. SWHR fought to create ORWH in 1990 and since its establishment has tirelessly advocated for women's health research and in particular sex differences research over the past 20 years, believing that such differences need to be incorporated into the design and application of new technologies, medical and therapeutic devices. SWHR looks forward to continue working with ORWH to bring sex and gender differences research to the forefront of the medical and research community and helping them achieve their goals to further women's health research. Below are the six goals ORWH has laid out for the next decade, and examples of work SWHR has done in these specific areas to date: ORWH Goal #1 - Increase the study of sex and gender differences in basic biomedical behavioral research. Advancing the field of women health research and sex and gender differences research has been an integral part of SWHR's mission since its founding in 1990, and it is our belief that sex as a biological variable should be considered in all research, from pre-clinical animal models to post-marketing analysis of approved therapies. In 2006, SWHR established the Organization for the Study of Sex Differences (OSSD) to enhance the knowledge of sex and gender differences by facilitating interdisciplinary communication and collaboration among scientists and clinicians of diverse backgrounds. SWHR has pressed FDA and NIH to expand the mandate on inclusion of women in clinical trials beyond Phase III research and to require sex-based analysis for each research grant application and for each new approved product, where appropriate. Representation of sex in basic animal models, as well as Phase I and II research may help identify unique attributes of medication safety, effectiveness, and appropriate dosing in women sooner. Goal #2 - Incorporate findings of sex and gender differences into the design and application of new technologies, medical devices, and therapeutic drugs. SWHR's mission to integrate sex and gender differences into all areas of research is particularly true in the arena of new innovative technologies, drugs, devices, and biologics. Since the issuing of the GAO report Drug Safety: Most Drugs Withdrawn

in Recent Years Had Greater Health Risks for Women (GAO-01-286R) in 2001, SWHR regularly petitions the FDA for the need for deliberate and statistically significant sex based analysis during the approval process of all new drugs, biologics and devices indicated for use in both men and women. Despite numerous known physiological differences between men and women, there are no FDA approved drugs that distinguish appropriate doses for women versus men, even where the drug studies leading to approval found differences. In 2010, the IOM released the report Womens Health Research: Progress, Pitfalls, and Promise, which stated that womens health research must be mainstreamed in such a way that the differences between men and women and differences between subgroups of men and women are routinely assessed in all health research. SWHR is an active member of the Alliance for a Stronger FDA, which works to increase FDA's federal appropriations in order that the Agency can fulfill its mission of ensuring the safety, efficacy, and security of human drugs, biological products, and medical devices, which should include the reporting of clinical trial data by sex and analysis of all data by sex. Goal #3 - Actualize personalized prevention, diagnostics, and therapeutics for women and girls. SWHR believes that with the proper resources and training at the federal health agencies, the science of sex-based biology can promote a personalized approach to medicine, moving away from a one-size-fits-all model. By advancing sex differences research, these agencies can develop more defined research topics, studied in and adaptive to representative groups of subjects, with focused analysis of results and application, both before and after marketing. SWHR consistently urges federal health agencies to collaborate to bring about the changes needed to produce targeted, personalized, sex-based, effective, and clinically meaningful results from their funded research for women and girls. Goal #4 - Create strategic alliances and partnerships to maximize the domestic and global impact of women's health research. SWHR supports the new FDA/NIH strategic alliance to improve the area of regulatory science and research translation. SWHR believes that these types of partnerships and alliances are long past due and will exponentially increase the quality of research and results while streamlining the approval process for new drugs, devices, and biologics. SWHR submitted the following comments to the newly created body in 2010: that statistically significant and appropriate representation of both sex be mandated in all phases of NIH-sponsored research, and that the FDA the enforce its requirement of reporting of sex-based analysis in the approval documentation and post-marketing analysis of each new diagnostic, treatment, or device approved for both men and women.

Further, SWHR supports and is a member of many powerful coalitions and strong strategic alliances, and, as such, understands their influence and impact in the political and policy debates that occur in the area of womens health research. Goal #5 - Develop and implement new communication and social networking technologies to increase understanding and appreciation of women's health and wellness research. SWHR recognizes the importance of utilizing every available form of communication to help in the translation and understanding of the important advances being made in women's health research. While SWHR has a robust communications and social networking strategy pushing women's health research and information by utilizing Facebook, Twitter, SWHR blog, partnerships with major women's websites (Lifescript, Women's Health Today), and various online email campaigns. SWHR also seeks new opportunities and technologies to effectively disperse the latest information in womens health and womens health research to consumers, specifically women. Further, SWHR has a rich tradition of sponsoring public education campaigns aimed at diverse populations, in order to spread our message on womens health and womens health research to the public at large. Goal #6 - Employ innovative strategies to build a well-trained, diverse, and vigorous women's health research workforce. Advancing the career of those researchers who are working tirelessly in the area of women's health research and sex differences research has been a part of SWHR's work since its inception. SWHR has strongly advocated for the funding by Congress of ORWH's Building Interdisciplinary Research Careers in Womens Health (BIRCWH) and Specialized Centers of Research on Sex and Gender Factors Affecting Womens Health (SCOR) programs. These two highly successful programs are critical to the advancement of womens health research. SWHRs Recognition of the Achievements of Women in Science, Engineering, Mathematics and Medicine (RAISE) Project was designed to increase the status of professional women through enhanced recognition. Current components of the RAISE Project include an interactive website with a listing of available awards categorized by discipline, career level and eligibility by gender. When available, all award recipients are listed since 1981. More recently, SWHR has awarded the annual $75,000 Society for Women's Health Research Medtronic Prize for Scientific Contributions to Women's Health, to a distinguished mid-career female scientist or engineer for her contributions to women's health.