Push for women's health R&D paying off

Biotech enters ‘the golden era of women’s health’

Years of advocacy urging more women’s health R&D appears to be paying off.

An ecosystem arises: Historically overlooked, women’s health is enjoying a more robust biotech ecosystem with increased investment, greater regulatory engagement, and growing attention to conditions that lacked research—let alone treatment options, BIO 2026 panelists said.

Why it matters: The ultimate goal is not to treat women’s health as a separate vertical, but to “bring women’s health back into overall health,” said panelist Juan Camilo Arjona Ferreira, M.D., Head of Research & Development and Chief Medical Officer at Organon, the largest biotech dedicated to women’s health.

Supporting women’s research: Organon boosts others working on women’s health through an accelerator giving emerging companies resources to reach their next milestone, with “no strings attached.” Daré Bioscience used a public offering allowing investments as low as $250 to let women help fund their own health research.

BIO’s backing: Panel moderator Michele Oshman, BIO’s Chief Patient Advocate and Head of the Patient Advocacy Center of Excellence, is also executive sponsor of BIO’s board-level Women’s Health Task Force, which encourages a robust pipeline of biopharmaceutical innovation for women’s health.

Signs of growth: We see growing interest from large pharmaceutical companies, government investment, and a broader focus beyond traditionally recognized women’s health categories into conditions including pregnancy and endometriosis, said panelist Julie Krop, M.D., of DiaMedica Therapeutics.

What they’re saying: “I think we’re entering the golden era of women’s health,” said Dr. Arjona Ferreira. “The momentum is real.”

Read more on Bio.News.

BIO Coffee Chat: Importance of patient perspectives on affordability and access

Patients are the best judges of drug affordability and access, and they are finding many barriers to getting treatments they need, advocates told BIO’s August Patient Advocacy Coffee Chat.

Barriers advocates mentioned include:

• Utilization management tactics like step therapy and prior authorization.
• The Inflation Reduction Act (IRA): The law’s Medicare Drug Price Negotiation Program (MDPNP) restricts access for patients.
• 340B:CancerCare partnered with the Pioneer Institute to produce a report that essentially found 340B hospitals are not providing charity care at greater levels than non-340B hospitals.
• Insurers are narrowing their formularies, covering fewer drugs or placing them on higher tiers with greater cost-sharing responsibilities.
• Defrayal: Under the Affordable Care Act (ACA), if states mandate that insurers in the ACA exchange cover additional benefits—beyond federally defined essential health benefits—those states are required by the original law to “defray” the added costs.

BIO’s view: “Context around patient-identified affordability and access challenges is really critical,” Karin Hoelzer, BIO Senior Director, Patient Advocacy, told the Coffee Chat. “Truly understanding the root causes of the challenges patients face—including a lot of the changes we’ve seen to insurance design, the increase in utilization management, etc.—is key.”

BIO promoting patients’ voice: BIO’s Patient Advocacy Changemakers Event (PACE) taking place in October will be an empowering and inspiring event focused on breaking barriers to access and ensuring that innovative medicines reach the patients who need them.

Read more on Bio.News.

What Else to Read

Nevada Gov. Joe Lombardo is named BIO’s Governor of the Year on Aug. 31. The award recognizes his leadership in growing the life sciences in Nevada and his commitment to biomedical innovation. "At a pivotal moment for biotechnology, Governor Lombardo has demonstrated a forward-looking approach to public policy and meaningful commitment to improving outcomes and access for patients in Nevada,” said BIO President & CEO John F. Crowley. “By championing workforce development, encouraging research and investment, and supporting policies that support biomedical discovery, Governor Lombardo is helping ensure that researchers, innovators, and companies can thrive in Nevada." Gov. Lombardo commented: “We are building a stronger Nevada by supporting innovation, expanding access to care, and creating an environment where researchers, entrepreneurs, and companies can succeed. I’m grateful to BIO for this award and for its partnership.” Read more here.

Robust IP ecosystems drive biotech R&D and investment, report shows. Stronger intellectual property protection statistically correlates with increased development of cutting-edge therapies and greater investment in life sciences research, according to the U.S. Chamber of Commerce International IP Index Statistical Annex, which was announced in August. Read more on Bio.News.

BIO leaders attend The Future of Public Health 2026 conference. Phyllis Arthur, BIO EVP and Chief of Global Health, joins a panel on “Vaccines in the 21st Century: Where Do We Go from Here?”; and Michele Oshman, BIO’s Chief Patient Advocate and Head of the Patient Advocacy Center of Excellence, joins a panel on “Prior Authorization” at the Sept. 9 event. Jay Bhattacharya, Director of the National Institutes of Health, is a keynote speaker. Presented by the Journal of the Academy of Public Health, in cooperation with RealClearHealth, the conference convenes senior policymakers, industry leaders, clinicians, and researchers for discussion on the forces reshaping American healthcare: trust, cost, and risk. Read more here.

mRNA gets a boost. "The mRNA technology that built Moderna and BioNTech's COVID-19 vaccines and is now being used to build cancer vaccines has been through political whiplash. But now, with clinical success from Moderna and Merck on using a personalized mRNA vaccine for melanoma, experts are hoping for a more stable future for the field," according to STAT news. Read more here.

Beltway Report

Congress voted Sept. 1 to extend the U.S. Patent and Trademark Office’s (USPTO) fee-setting authority through Dec. 11. At a hearing on USPTO charges—held the next day by the House Judiciary Subcommittee on Courts, Intellectual Property, Artificial Intelligence, and the Internet—Subcommittee Ranking Member Hank Johnson (D-GA) and Rep. Kevin Kiley (R-CA) asked about the importance of USPTO fees. Witness David Kappos, Board Chairman of the Council for Innovation Promotion and former USPTO Director, said a predictable budget is critical for innovators to present business plans to investors and enter the marketplace. He said USPTO needs income from fees to retain employees, invest in AI, and maintain world leadership in IP protection. Rep. Deborah Ross (D-NC) highlighted the importance of patents for small inventors who rely on IP to commercialize and raise capital.

The House and Senate are on District Work Periods this week.