Guest Column | September 9, 2021

What Can Clinical Leaders Do To Tackle The Global Women's Health Gap?

By Sandra Milligan, MD, JD, head of research and development at Organon

Group of Women Socialize Teamwork Happiness Concept-iStock-811116180

We are living through a time of great revolution in health innovation. Between 2010 and 2019, the number of drug approvals increased 60% over the previous decade, with a peak of 59 new therapies approved in 2018. Those approvals included important advances and treatments in areas such as oncology, which makes up 27% of all new drug approvals in the U.S. since 2010. We’re transforming therapeutics for many, but now it’s time to apply that same energy and innovation to women’s health.

More innovation in women’s health is needed to address the staggering global burden of disease. Nearly 300,000 women die every year from preventable causes related to pregnancy and childbirth; approximately 95% of them are from low- and middle-income countries. Postpartum hemorrhage (PPH), a significant complication during childbirth, is the leading cause of maternal death globally — and in the United States, PPH is on the rise. An estimated 75% of reproductive-age women have uterine fibroids, with many suffering pelvic pain, heavy menstrual bleeding, pregnancy loss, and infertility. Uterine fibroids disproportionately impact Black women and are a leading cause of hysterectomies, but less than 20% of affected women are diagnosed and treated.

To meet this immense need, we must drive a concerted, ecosystem-wide effort that builds on the new momentum in innovation seen in other diseases and continues to scale up clinical research for women. No single organization can do this alone. Instead, this has to be a team effort, employing collaboration across disciplines and even bringing together players who might, in the past, have been considered competitors.

This kind of global effort should harness resources and expertise, wherever they can be found, in order to foster and drive innovation among academics, biotech, and healthcare venture firms, as well as other potential partners. And, more than focusing only on drug development, the effort must take a broad view, including how to accelerate innovation, education, choice, and access to bring tomorrow’s much-needed solutions to all women, faster.

New Therapies Are Starting To Meet Women’s Unmet Needs

For the research pipeline, science is evolving and there is new excitement in terms of availability of potential solutions that address areas of significant unmet need. An analysis showed that there are more than 140 compounds in various stages of development around the world for diseases that disproportionately impact women. Two recent acquisitions by Organon underline the promise. Created by Alydia Health, the Jada System is a medical device focused on preventing maternal morbidity and mortality caused by PPH or abnormal postpartum uterine bleeding. Ebopiprant, an investigational agent currently in development from ObsEva, has the potential to be a first-in-class innovation addressing acute treatment of preterm labor, a condition for which there are no currently FDA approved treatments or solutions. However, we can’t stop there.

Access to innovative new therapeutics is the critical lynchpin between innovation and practically meeting women’s health needs. For example, we don’t just need new contraception tools—we need to scale existing solutions to improve access for every woman who needs them. A range of treatments are available, but women aren’t getting them.

For some years, the unintended pregnancy rate has remained 50% globally and, during the pandemic, resources have been diverted from sexual and reproductive health services. One study finds that a 10% decline in coverage of pregnancy-related and newborn health resulting from COVID-19 could result in an additional 28,000 maternal deaths and 168,000 newborn deaths in developing countries annually.

Greater Innovation Needed In Clinical Trials

Yet as we prepare for a next wave of women’s health research, we must make sure we are conducting clinical trials and local and regional studies to unequivocally provide the evidence that allows greater access and more rapid uptake of innovations across the globe to benefit women wherever they are. We should continue to consider more innovative designs in clinical research for women’s health, like what has worked in trials for oncology, where we have seen the approval and success of transformative therapies. And we need to ensure women at all stages of life can benefit from innovations—a need that has been recognized by the European Medicines Agency (EMA), the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA), and the FDA’s Office of Global Policy and Strategy’s Europe office, which put forth a united call to action for researchers to include pregnant and breastfeeding women when conducting clinical trials.

We also need to increase diversity of participation in clinical research by ethnicity, race, and location, in order to ensure we develop safe and effective therapies for all patients who need them. Despite the pain it has caused, COVID-19 provided opportunities to reimagine trials, driving broad adoption of decentralized and virtual research out of necessity. These new approaches can allow us to accelerate processes that have limited us in the past. Such approaches also create the opportunity to further choice and access because the heterogenous, rich data set has the potential to enable precision medicine to truly become more precise.

New Attitudes, More Collaboration Are Key

Today, when it comes to women’s health, the science and data are advancing rapidly, and in many cases therapies and tools are emerging, but also our attitudes need to change. When it comes to evaluating risk/benefit of new treatments for women, we’re too often making our determination of who accepts risk and how by looking at populations rather than allowing a personalized approach that empowers individual women impacted by diseases and medical conditions to accept informed risk.

Those of us working in women’s health see the gap, but we also see the energy and excitement from those working in this area. And in taking a new approach, one that recognizes the urgency of the need, we’re stronger together. We must enlist:

  • innovators in drug, device, and technology research, especially academics and small start-ups;
  • larger life sciences companies with the manufacturing capabilities, distribution infrastructures, and drug development resources to scale up efforts and create expanded opportunities for access worldwide;
  • regulatory authorities and governments; engaging them with clinical trial data can accelerate approvals for urgently needed drugs, devices, diagnostics, and other modalities of care; and
  • Nonprofits and foundations, which have the ability to work with governments and agencies globally to identify pressing needs, coordinate efforts, and help direct treatments to where they are most needed.

It’s becoming more widely recognized that broad collaboration is an essential component of making progress quickly in women’s health, and in order to succeed in this effort, we need to be better listeners. By listening to women and doctors, we begin to holistically understand the full extent of their needs and how we can adapt our processes and our thinking. Our task also demands that we become better at listening to each other across disciplines and sectors to better advance the health and well-being of women worldwide; it’s a global challenge that requires collaboration on a global scale.

We are living in a special time for innovation; we need to also make it count more for women and their health. That requires increasing new effort and new partnerships across all aspects of the healthcare ecosystem. Only by working together can we realize our ability to revolutionize women’s health and ensure women can benefit from the treatments they need.

About The Author:

As the head of research and development for Organon, Sandra Milligan, MD, JD, is leading the advancement of medicines and solutions to help women and all patients live better and healthier every day. In her role, Milligan oversees Organon’s scientific, medical, and regulatory capabilities in support of its diverse portfolio and long-term vision. She encourages women and their providers to share what areas of women’s healthcare they believe are overlooked at