On October 23, 2024, Dr. Jill Biden, first lady of the United States,  announced the winners of $110 million in awards on behalf of the Advanced Research Projects Agency for Health (ARPA-H) to accelerate transformative research and development in women’s health.

“It’s time for investors, researchers, and business leaders to have [conversations about women’s health], not as an afterthought but as a first thought,” Dr. Biden said in her prepared remarks. “Those kinds of questions belong in your research proposals, in your laboratories, in your pitch decks.”

The awards will go to 23 teams from small startups to global innovators working to further developments in women’s health—with projects ranging from a non-invasive blood test to diagnose endometriosis to a revolutionary treatment for late-stage and metastatic ovarian cancer.

ARPA-H, a research and development funding agency within the U.S. Department of Health and Human Services, was established by the Administration in 2022 to generate high-impact biomedical and health breakthroughs. Its Sprint for Women’s Health initiative, created by Dr. Biden in February 2024, issued a call for “bold and transformative women’s health solutions” selected the winning teams based on their approaches to six critically important topics: 1) women’s health at home; 2) ovarian health; 3) enhanced models for investigating the influence of sex differences on health outcomes; 4) advancing women’s brain health via lymphatic targeting; 5) measurement of chronic pain in women; and 6) a “wild card” category, revolutionary breakthroughs in women’s health.

ARPA-H received an unprecedented response to this call for solutions for women’s health, with over 1,700 submissions across 45 states and D.C. as well as 34 countries. While the Sprint for Women’s Health initiative was meant to invest only in early-stage companies that private industry might be hesitant to fund, one quarter of the awardees chosen are what ARPA-H has deemed “launchpad” projects or projects that they expect to be ready for commercialization within two years. 

The announcement, made at the HLTH conference in Las Vegas, highlights the recent momentum around investment in women’s health in both government and industry. The awards further the White House Initiative on Women’s Health Research, launched by the Biden Administration in November 2023 to improve how the United States approaches and funds women’s health research. The Initiative aims to close gaps in research in order to improve prevention, diagnosis, and treatment of diseases and conditions that affect women uniquely, disproportionately, and differently.

It is important to note that this research and investment is not just limited to reproductive health.  These winning projects span the lifecycle of women and focus on some diseases—such as heart disease and Alzheimer’s—that disproportionally impact women but are not thought of as women’s health issues.

To quote Dr. Biden: “It seems like women’s bodies are considered miracles when we’re in our child-bearing years, and mysteries as we age…I knew this had to change.”

Dr. Biden noted that in addition to ARPA-H, the National Institutes of Health is investing millions of dollars in new interdisciplinary women’s health research and the Department of Defense is committing half a billion dollars each year to women’s health research.

As leaders in the health care and life sciences industry, we at Epstein Becker Green are at the forefront of understanding the regulatory implications for bringing these products to market successfully. We can help investors to better understand the legal and regulatory landscape of this new and exciting focus on women’s health innovation from government and industry. If you have questions or would like to discuss how EBG lawyers can assist, please contact the authors.

Ann W. Parks contributed to this post