Welcome back to Healthy Innovations! 👋
This week marks International Women's Day, and I am dedicating the Deep Dive to a story that's overdue for the spotlight.
For decades drug trials, dosage guidelines, disease models were all built on male data, then applied to everyone. The consequences for women's health have been significant, and they're still playing out today in conditions like endometriosis and PCOS, where diagnosis can take nearly a decade.
The correction is finally underway, so let’s take a look!
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When medicine's default setting was male
For most of the 20th century, medical science had a default setting: male.
Drug trials, dosage guidelines, disease models, reference ranges – all calibrated on male bodies, then applied to everyone. Following the thalidomide tragedy of the 1960s, regulators worldwide grew cautious about including women of childbearing potential in clinical trials. In the US, an FDA guideline formalised that exclusion in 1977; similar caution prevailed across Europe.
The prevailing assumption, as one European medicines policy review later described it, was that "women did not differ from men except where their reproductive organs were concerned and data obtained from clinical research involving men could simply be extrapolated to women."
It was wrong.
The US NIH Revitalization Act of 1993 mandated female inclusion in federally funded research. The EU's Clinical Trials Regulation of 2014 added requirements for representative populations and sex-disaggregated data reporting. The intention behind the original exclusions was protective.
The effect was something else.
The consequences were global
When sex-specific data wasn't collected or reported, the effects on patients were real.
Women were 1.5 to 1.7 times more likely to experience adverse drug reactions than men, a disparity researchers have partly attributed to the absence of female-specific dosing and pharmacokinetic data
Eight of ten prescription drugs withdrawn from the US market between 1997 and 2001 posed greater health risks for women.
The 1% problem
A 2024 report from the World Economic Forum and McKinsey Health Institute found that women spend 25% more of their lives in poor health than men. A separate McKinsey analysis found that just 1% of healthcare research and innovation funding goes to female-specific conditions beyond oncology.
Conditions affecting hundreds of millions of women – including heavy menstrual bleeding, preeclampsia, and menopause – remain deeply under-researched relative to their scale. The gap is very visible in endometriosis and PCOS, which together affect an estimated 380 million women globally, yet both remain chronically under-diagnosed.
Endometriosis: A decade lost to diagnosis
Endometriosis affects around 190 million women worldwide – approximately 10% of women of reproductive age. Tissue similar to the uterine lining grows outside the uterus, causing chronic pain, heavy bleeding, and in many cases infertility.
For most women who have it, the road to diagnosis is long:
Average global diagnostic delay: 6.8 years
A 2025 systematic review reported delays ranging from under a year to 12 years depending on country
In the UK, some studies have recorded delays of up to 27 years.
The current gold standard for diagnosis is laparoscopy – surgery. Without a reliable non-invasive alternative, women move through years of GP visits and misdiagnoses before reaching a specialist. A large European multicenter study estimated the total annual cost per woman with endometriosis at around 9,500 Euros, most of it lost productivity rather than treatment.
Several companies are now developing non-invasive diagnostics:
Ziwig (saliva-based test) – sold in 30 countries, fully covered by France's national health insurance
Proteomics International – secured its first patent for a blood-based biomarker test in Japan, June 2025
Yale School of Medicine – identified a microRNA blood signature in January 2026 that can detect endometriosis in adolescents and young adults, years earlier than current methods allow.
PCOS: The most common hormonal disorder most people have never heard of
Polycystic ovary syndrome affects an estimated 10–13% of women of reproductive age globally – similar to endometriosis at around 190 million people according to the WHO. It is a leading cause of infertility and raises long-term risk of type 2 diabetes, cardiovascular disease, and endometrial cancer.
Up to 70% of women who have it have never been diagnosed.
Symptoms like irregular periods, acne, and weight changes are common and non-specific, and many women wait years before anyone connects the dots. A 2025 analysis of Global Burden of Disease data found that PCOS cases among women aged 10–24 rose 56% between 1990 and 2021, with the sharpest increases in Southeast Asia, East Asia, and Oceania.
A 2025 study in Scientific Reports found that machine learning models for non-invasive PCOS diagnosis showed strong potential for clinical use – particularly in settings where specialist access is limited.
The correction is underway
In August 2025, the Gates Foundation announced a major multi-year commitment through 2030 to accelerate R&D focused exclusively on women's health – the largest single investment it has made in this area. The funding targets five chronically under-resourced areas: obstetric care, maternal health and nutrition, gynecological and menstrual health, contraceptive innovation, and sexually transmitted infections.
"For too long, women have suffered from health conditions that are misunderstood or ignored," said Dr. Anita Zaidi, president of the Gates Foundation's Gender Equality Division. "We want this investment to spark a new era of women-centered innovation."
Progress is coming from multiple directions.
The NHS approved linzagolix (brand name Yselty), a new oral endometriosis treatment, following trials showing significant reductions in pelvic pain.
UK-based Cyclana Bio secured seed funding in late 2024 to accelerate endometriosis drug discovery.
A 2025 European Parliament question flagged a stark disparity: of 145,983 EU research projects funded since inception, just 27 related to endometriosis, while depression attracted 735. The EU Parliament has called on the European Commission to bring investment in line with the disease's substantial annual cost to EU productivity.
A step backward in the US
Not all developments point in the right direction.
In January 2025, the Trump administration signed an executive order that replaced references to "gender" with "sex" in federal policy and instructed agencies to ensure that research grants did not promote what it termed "gender ideology."
Within days, the FDA quietly removed its draft clinical trial diversity guidance from its public website – a change first flagged by regulatory lawyers and health-policy reporters, made without prior notice or explanation. More than 1,700 NIH grants were subsequently terminated, including projects that had already cleared scientific review, a figure cited in federal court proceedings.
Updated FDA guidance on clinical trial diversity, published in January 2026, dropped earlier language on gender and health equity, narrowing the agency's stated commitments to representative enrollment. The reversal has prompted researchers and funders outside the US to accelerate their own commitments – a shift already visible in the European and global progress detailed above.
Hope remains on IWD
This International Women's Day, the data debt is impossible to ignore. For the first time, the science, the funding, and the political will are moving in the same direction – even if that direction varies by country.
For the hundreds of millions of women waiting on better diagnostics, faster answers, and treatments built for their biology, that matters more than any headline.
Innovation highlights
🎯 AI bullseyes cancer vaccines. Yale researchers built Immunostruct, a machine learning model that could supercharge personalized cancer vaccines. Unlike older models that read peptides as flat text sequences, Immunostruct adds 3D structural and biochemical data to better identify immune targets – leading to more accurate results. The goal: help scientists find the right epitopes for each patient's unique tumor, potentially delivering a more effective, less toxic alternative to chemotherapy. The model is open source on GitHub.
🧬 One shot, lifetime relief. Researchers at the University of Basel have developed a gene therapy that could transform LAMA2-related muscular dystrophy from a fatal childhood disease into a treatable condition. A single treatment stabilized muscles and nerves in animal models, with mice developing almost normally when treated at birth. Even at advanced disease stages, muscle strength improved. The therapy is ready for clinical trials, though funding remains a significant hurdle given the small patient population.
🪨 Anxiety hides in hand. LUMA is a concept device shaped like a smooth asymmetric pebble that fits entirely inside a closed fist. Designed by Vedant Kulkarni, it combines haptic vibration to pace breathing and gentle warmth to counter the cold-hands response that spikes during anxiety. No screen, no audio, no second hand needed. At a networking event or meeting, nobody around you sees a thing. On a bedside table, it doubles as a glowing ambient object.
🧬 Stem cells fix spinal defect. For the first time, researchers at UC Davis treated spina bifida in the womb using placenta-derived stem cells applied directly to the exposed spinal cord during fetal surgery. In a Phase I trial published in The Lancet, all six babies were born with intact spinal repairs, no infections, and brain abnormalities reversed in every child. A Phase I/IIa trial is now underway to assess long-term safety and effectiveness.
Company to watch
🧬 Tamarind Bio is building the software layer that makes AI actually usable for drug discovery. Founded two years ago by Stanford researchers Sherry Liu and Deniz Kavi, the platform lets scientists run multiple machine learning models, program workflows, train models on their own data, and connect experiments to validate findings – without needing deep machine learning expertise.
The company started as an internal lab tool and spread entirely by word of mouth. Today, pharma and biotech companies including Boehringer Ingelheim, Bayer, Mammoth Biosciences, and Adimab are using it. Revenue growth hit 700% last year – with zero sales staff.
With 12 employees and plans to double headcount, Tamarind's goal is to become the single platform for all computational work in drug development before human trials.
Weird and wonderful
🚀 Houston, we have a blood problem. Space travel has a new issue: your blood doesn't clot properly up there. University of Florida Health scientists found that after just five days in microgravity, platelets – the components that stop bleeding – become significantly slower to activate. In space, platelet membranes get softer and more fluid, which disrupts the protein "doorways" that trigger clotting. Fewer doorways open, creating a bottleneck. Platelets still activate, but they're late to the party.
On Earth, a few extra minutes barely matters for a paper cut. Mid-spacewalk with a head injury? That delay gets dangerous fast. As senior author Abdel Alli put it: "It's not as if you can visit an emergency room." Researchers are now hunting for drug therapies to fix the glitch before Mars comes calling.
Thank you for reading the Healthy Innovations newsletter!
Keep an eye out for next week’s issue, where I will highlight the healthcare innovations you need to know about.
Have a great week!
Alison ✨
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