The Root Causes of the Innovation Gap in Women’s Health

In this Pharmaceutical Executive video interview, Dr. Dina Radenkovic, CEO of Gameto, discusses the company's pioneering use of induced pluripotent stem cell (iPSC) technology in fertility treatments, particularly addressing ovarian aging. Its lead product, Fertilo, is an iPSC-derived ovarian support cell line in phase III clinical trials in the US with FDA clearance, and commercial availability in markets like Australia and Latin America. The company faces challenges including the scarcity of human eggs and regulatory hurdles. Radenkovic also highlights the need for better models to study female-specific conditions and the importance of political advocacy and funding to drive innovation in women's health.

Pharmaceutical Executive: In your experience, what are the root causes of the gap in innovation in women's health?
Dr. Dina Radenkovic: That’s a difficult question, especially for a brief interview. I participated in a panel at SXSW on International Women’s Day where I was joined by Olivia Walton (CEO of Ingeborg Investments), Chelsea Hirschorn (founder and CEO of Frida), and Maneesh Jain (CEO and co-founder of Mirvie), and we discussed this topic for about an hour.

I think it’s multifactorial, as are all big problems. There are numerous causes that contribute to it, and the first one stems from the fact that modern medicine was not necessarily designed with women in mind. We’ve started playing catch-up work by studying female specific conditions and including women in clinical trials. There was no mandate to include women in clinical trials until 1993 and NIH studies weren’t mandated to include female mice until around 2016, so these are recent developments.

It doesn’t all come from bad factors, some of it just comes from under appreciation. There is the fear of including women of child-bearing age and potentially causing danger when it comes to pregnancy development. We just studied women less, therefore we understand conditions that either predominantly effect women or affect them differently less.

When it comes to ovaries, we didn’t have good models to test things. Which means you don’t get good treatments. The way we would induce ovarian aging in animals in studies was by destroying their ovaries with a chemotherapy drug. That is not how most women experience infertility in menopause. It’s a slow loss of ovarian function over time.

Innovation comes mostly from biotechs, which are fueled by large biopharma companies. Even today, most large pharma companies do not have specific women’s health divisions. There are only a few players operating in the space. And some of the large companies that have women’s health portfolios have de-prioritized women’s health R&D. There are not too many publicly traded biopharma companies in women’s health. It's a chicken-or-the-egg situation. It’s hard to secure funding and develop novel treatments.

Finally, there is the payer mechanism. IVF is an anomaly because it’s a large market. It’s very expensive, and while we hope to drop the cost of these treatments over time, there’s still a lot of money in it. In a lot of areas of women’s health, however, there isn’t. There is data to show that HCPs get paid more to perform a penile biopsy compared to a vaginal biopsy. This disincentivizes innovation in the space. HCPs and researchers are not going to get the same amount of payment for the clinical work.

Unfortunately, that is true for a lot of clinical areas in women’s health. Along with changing the payment structures, we need to see more wins and successful companies in this space. I’m sure we will because these are massive addressable markets. There’s a huge unmet need.

At Gameto, we’re seeing advocacy from women all over the world who are excited to see this come to life. They want to have a treatment that’s modern, has the patient at the heart of it, and isn’t as difficult on the body as current treatments that involve two weeks of injections.

There’s some good science coming out that will drive the change further down and start building out the control, infrastructure, and business models. It’s early, but I’m optimistic.