De-risking and Self Advocacy Key to Changing… Leave a comment

Diversity pledge_Organon

Courtesy of Organon 

According to a recent report by Emergen Research, the revenue opportunity in the women’s healthcare market is expected to hit $24.48 billion by 2027. Yet, in 2018, Forbes put the allocation of R&D funding directed toward women’s healthcare at just 4 percent and U.S. femtech startups received just 4.7% of that year’s total funding.

In 2019 and the first half of 2020, this number fell to 3.3 and 1.5 percent, noted in a recent report, and in 2020, McKinsey and Company reported that female-specific indications outside of oncology accounted for just one percent of all research and innovation.

This picture could be changing, however, as companies like Organon, Femasys, Agile Therapeutics and Ascend Therapeutics make progress in the space.

Sandy Milligan_OrganonDr. Sandy Milligan, M.D., head of research and development at Organon told BioSpace the company was formed to take this challenge head-on.    

Since Organon spun off from Merck a little over a year ago, it has invested resources to make what Milligan called “a significant impact in women’s health.”

Organon began with a portfolio of 60 products and medicines across a wide therapeutic range. “What’s really important to us is that those brands are the jet fuel to allow us to further invest in the area of women’s health research and development,” Milligan said.

With a diverse pipeline of existing products and others in development, Organon is focused on four primary cornerstones: contraception, fertility, maternal and peripartum conditions and conditions that are predominantly unique to women.

The company has a long list of contraceptive products, including Nexplanon and NuvaRing. It is also interested in male contraception.

“We have a portfolio of established fertility products and are interested in new innovation around either the practice of helping patients with their fertility journey or innovative science and technology in that area,” Milligan shared.

Last year, Organon acquired Alydia Health and its proprietary Jada System, which is designed to reduce postpartum hemorrhage. It is also building a pipeline of assets that treat conditions such as endometriosis and pica.

Listening to Women

In order to fill the research and data vacuum across women’s health, Milligan said the first step is listening. “At Organon, we found that women are speaking out about their healthcare needs, but only a few companies are listening and taking action.” She shared that one of the company’s first steps was to launch “a listening effort where we heard from women on the challenges related to unintended pregnancy infertility, maternal health, sexual health and more.”

This research culminated in the Wall of Voices report which highlighted emerging themes including self-care, women’s mental health, respectful maternity care and specific non-communicable diseases.

Organon used the responses to guide its approach with the goal of turning “listening into action.” Milligan highlighted an interesting takeaway: when women are willing to come forward and speak up about their healthcare needs, it empowers other women to discuss their personal experiences, too.

Beyond Fertility and Contraception 

On an industry-wide level, accelerating innovation in products specific to women is not a single-step process. While many products are available to women in the area of contraception, other areas offer little to no choice at all.

Milligan brought up menopause as an example. “We need to recognize that just because a woman has never died of a hot flash, it doesn’t mean that menopause isn’t miserable for a large proportion of women,” she said. “The condition needs to have a more balanced approach to treatment so that women going through menopause can have a balanced lifestyle.”

In its second annual State of Menopause Survey, Bonifide Health gathered responses from over 2,000 women in various menopausal stages. Respondents listed several perimenopausal symptoms they felt unprepared for, including hot flashes, sleep problems, night sweats, anxiety and depression, brain fog and memory issues and weight gain.

“We know that menopause is impacting women pretty significantly,” Milligan said. “Even though it’s a condition, we need to fund more research. We need to help women going through menopause manage their symptoms.”

De-risking Research and Partnering for Success

Preterm labor and preeclampsia, a pregnancy-related blood pressure condition, are additional areas of focus for Organon. “I love being part of this organization because I feel like Organon has been very brave in taking a look at those two areas of unmet medical need. Ordinarily, companies try to shy away from what could be considered more risky clinical research.”

To get products all the way through to the women who need them most, Milligan listed de-risking clinical research and partnering with both governmental and non-governmental agencies as necessities.

She said that when well-developed drugs fail in the marketplace, it creates a shadow on women’s research overall. “The ecosystem really is not just the innovators or the large developers like Organon, but it’s also that partnership with the government, health agencies and the payers that pull it all the way through.”

Organon is focused on four different areas to make a difference in women’s health: innovation, information, choice and access.

“I think information is critical,” Milligan shared. “It’s really the fundamental factor that’s required to move women’s health forward toward solutions that are more personalized.”

Information covers everything from data generated in clinical studies to how healthcare providers and women are then able to use that knowledge to treat conditions.

In the area of choice, Milligan highlighted concerns that have few or no treatment options at all, such as preventing prenatal birth. To close these gaps, Organon is “bringing in some really great technology and science that we’ve seen on the innovator side and pulling it through into a company like ours where we can develop it and hopefully eventually get it to patients,” she said.

In terms of access, Milligan pointed to the relationship between the government and the payers. “We need to…make sure that there’s a receptive market on the other end so you can continue that virtuous cycle of investment in research and development and patient access and payer support on the other end.”

Organon hopes to raise health literacy levels, helping women to open dialogues with their own providers. “We’re focused on how we can unravel some of these stigmas, bust the taboos and empower women to take charge of their own health.”


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