According to the World Health Organization, both biological and gender-related differences can significantly impact women’s health. This is true from the perspective of direct care but also extends to drug development for indications that are specific to women and indications where treatment in women may be different than in men.
A significant obstacle to advancing women’s health has been their persistent underrepresentation in clinical trials. In the past, women were often excluded due to misconceptions about menstrual cycles, hormonal fluctuations, use of oral contraceptives, hormonal therapy, pregnancy, and lactation.
The FDA’s Office of Women’s Health (OWH) was established in 1994 by a congressional mandate requiring the inclusion of women in clinical trials. Despite more than two decades of progress facilitated by OWH, women remain underrepresented in trials of certain medications.
To address this shortcoming, the OWH created a “Research Roadmap” to help guide the future of drug development in women’s health. The Roadmap outlines seven priority areas where more research is needed, creates strategic direction to maximize the OWH’s initiatives to promote optimal health for women, and identifies specific focus populations, including elderly, pregnant, lactating, pre-menopausal, and post-menopausal women.
The seven OWH priorities are:
- Advance Safety and Efficacy
- Improve Clinical Study Design and Analyses
- Novel Modeling and Simulation Approaches
- Advances in Biomarker Science
- Expand Data Sources and Analysis
- Improve Health Communications
- Emerging Technologies
Nuventra’s Women’s Health Experience
Nuventra has extensive experience in developing drugs to treat indications specific to women’s health. Our co-founder, Bill Wargin, Ph.D., served as a Pharmacokineticist for the clinical development of multiple compounds to treat breast cancer, vaginitis, and vulvovaginal conditions. In addition, Nuventra’s team of consultants has supported several marketing applications, performed various PK/TK analyses, and provided modeling and simulation for a variety of women’s health indications.
Nuventra can perform any of our wide range of services for drugs to treat women’s health issues. Visit our services page to see our full range of services and to learn more about what our drug development consultants can offer your program.
Women’s Health Indications
Nuventra has experience with several women’s health indications, including:
- Breast Cancer
- Interstitial Cystitis
- Paget’s Disease
- Preterm Labor