Blog | September 4, 2025

Women’s Health: Innovations and Therapeutics

By Karen Lackey, CEO

Redefining women’s health with data-driven innovation, hormone-aware therapeutics, and precision medicine powered by chemomics

Women’s biology is distinct from men’s, down to the cellular level, yet this difference is still largely overlooked in how we design, test and deliver care. Consider Alzheimer’s disease: women represent 75% of the 5.4 million Americans affected, yet clinical trials remain male-dominated. If treatments aren’t tested in the population they’re meant to serve, are we truly capturing their therapeutic potential?

As personalized medicine evolves, so must our approach to women’s health. Women are not only patients; they are also key decision-makers, driving 80% of the healthcare spending as caregivers and advocates. Yet in 2023, just 2% of $41.2B in venture funding went toward women’s health. The science is clear. The need is urgent. Progress demands not just advocacy, but active participation, and a system built for the realities of female biology.

Expand the vision beyond FemTech

Historically defined by reproductive and fertility products, “FemTech” has barely scratched the surface. Women’s health encompasses so much more: autoimmune diseases, cardiovascular health, neurodegenerative disorder and the unique ways common diseases present in women.

With the market projected to reach $58.1 billion by 2030, the opportunity is clear. But tapping into it requires a broader vision. Hormone-aware drug delivery systems, AI-powered diagnostics, menstrual and menopausal biomarker tracking and personalized medicine that incorporates genetic profiles are just the beginning.

To build this future, we need to fund the entrepreneurs leading the way. The return on investment isn’t speculative. It’s grounded in unmet need and real clinical demand.

Apply the oncology playbook to women’s health

Misconceptions about exit potential and risk continue to stall funding in women’s health. But if venture capital is about value creation, then the life sciences industry must deliver de-risked, investable opportunities. When that happens, women’s health won’t be seen as niche, but a high-growth domain.

We’ve done this before. Oncology evolved from blunt-force chemotherapy to targeted therapies . It wasn’t easy, and many doubted it could be done, but science prevailed and the field transformed. Women’s health is at a similar inflection point. With rigorous science and strategic investment, we can reshape it, just as we did with cancer.

Prioritize equity in research models and disease understanding

Nearly 78% of autoimmune disease patients in America are women. Cardiovascular disease is the number one killer of women. Non-smoking women die from lung cancer at rates exceeding those of all female reproductive cancers combined.

And yet, research models remain outdated. The NIH only required female animal inclusion in research in 2016. Today, male animals still dominate female 5:1 in pharmacology studies. In Alzheimer’s disease models, 66% of animals are either male or sex-uncategorized. Brain disorder models show a 5.5:1 male-to-female ratio. Mice, which don’t menstruate,  fail to replicate key hormonal cycles, limiting the translational value of these studies for women.

To move forward, pharma and biotech must adopt models that reflect the complexity of female biology, such as organ-on-a-chip systems, organoids, and cellular mechanisms designed for hormone responsiveness. But this is more than a biology upgrade. It’s also a data challenge.

Use Chemomics to turn complexity into precision

Chemomics, the large-scale application of chemistry-centered data to answer biological and pharmacological questions, offers a breakthrough path forward. By combining ultra-high throughput screening, machine learning, and phenotypic data across diverse, sex-aware systems, researchers can detect nuanced, hormone-specific drug responses.

I see chemomics not as a supplement, but as a foundational strategy. Applied across a gender-aware portfolio, it brings data from pharmacology, hormones and genetics into a continuous loop of discovery. With today’s data tools, we can convert biological complexity into precision innovation.

Design drugs with Hormones in Mind

Hormonal shifts across the menstrual cycle, pregnancy and menopause dramatically affect drug absorption, metabolism and distribution. But most drug development still ignores this.

Liver enzymes like the CYP family, which metabolize most medications, are regulated by estrogen, progesterone and testosterone. For example, a bronchodilator, theophylline, is metabolized faster during low-estrogen phase and slower when hormone levels peak, raising the risk of toxicity.

Pregnancy introduces another layer of complexity. Estrogen increases antibody production, while progesterone modulates inflammation and immune response. These changes affect both maternal and fetal responses to treatment.

Postmenopausal women often experience slower drug clearance rates, leading to higher drug accumulation and side effects, especially with lipophilic drugs. Depression, which affects twice as many women as men in the US, illustrates this point: antidepressants often require hormone-aware dosing.

By studying drug metabolism (DMPK) in both male and female tissue systems and GI tract, we can design therapies and delivery systems that actually perform across the hormonal spectrum.

Lead with science. Invest with intention.

With intention, focus and strategic investments, drug discovery advancements within women’s health are highly achievable and poised for acceleration. Conditions fall into three categories: those exclusive to women, those that disproportionately affect them, and those that affect them differently. Only about 5% of women’s health conditions are truly exclusive. The real opportunity lies in understanding how common diseases present and progress differently in women.

With chemomics, AI and modern biological models, we are better equipped to turn biological variability into biomedical breakthroughs. What’s long been seen as complexity is actually the clearest path for transformation. Now is the time to lead.  

This blog was originally published as a guest blog on MassBio’s website.

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