The Society for Women’s Health Research (SWHR) is pleased that the new agenda

for women’s health research at the Office of Research on Women’s 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 Since the issuing of the GAO report “Drug Safety: Most Drugs Withdrawn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 “Women’s Health Research: Progress, Pitfalls, and Promise,”
which stated that women’s 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 women’s 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 women’s health and women’s 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 women’s health and women’s 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 Women’s Health
(BIRCWH) and Specialized Centers of Research on Sex and Gender Factors
Affecting Women’s Health (SCOR) programs. These two highly successful programs
are critical to the advancement of women’s health research.

SWHR’s 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.