NAMs for Women's Health
Addressing the gender gap in drug development—using human-relevant models to understand sex-based differences and develop treatments that work for women
Historical Exclusion
Women were excluded from clinical trials until 1993 in the US. Much medical knowledge is based primarily on male subjects.
Male-Biased Preclinical Research
Most animal studies use male animals to avoid hormonal "variability"—missing critical sex-based differences.
Drug Dosing Problems
Dosing is often based on male physiology. Women may metabolize drugs differently, leading to overdosing.
Underdiagnosed Conditions
Conditions that primarily affect women (endometriosis, PCOS) are understudied with limited treatments.
Drug Metabolism
Women have different CYP450 enzyme activity levels, affecting how drugs are processed. Ambien (zolpidem) dosing was halved for women after adverse effects.
Cardiac Differences
Women have longer baseline QT intervals and are more susceptible to drug-induced arrhythmias—8 of 10 drugs withdrawn for QT prolongation affected women more.
Immune Response
Women have stronger immune responses, affecting vaccine efficacy and autoimmune disease susceptibility (80% of autoimmune patients are women).
Pain Processing
Women process pain differently at molecular, neural, and hormonal levels—yet most pain research uses male subjects.
NAMs for Women's Health Research
Human-relevant models using female cells and tissues
Female iPSC-Derived Cells
Human cells derived from female donors, retaining XX chromosomes and female-specific gene expression patterns.
- ✓ XX chromosome expression
- ✓ Female hormone receptors
- ✓ Sex-specific metabolism
- ✓ Available as cardiac, liver, neural cells
Endometrium-on-Chip
Microfluidic models of the uterine lining that respond to hormonal cycles for studying menstrual disorders.
- ✓ Hormone-responsive cycling
- ✓ Endometriosis modeling
- ✓ Implantation studies
- ✓ Contraceptive testing
Placenta-on-Chip
Models of the maternal-fetal barrier to test drug transfer and safety during pregnancy.
- ✓ Drug transfer studies
- ✓ Fetal toxicity prediction
- ✓ Preeclampsia modeling
- ✓ Human placental cells
Breast Tissue Organoids
3D breast tissue models for studying breast cancer, lactation, and hormone response.
- ✓ Normal and tumor tissue
- ✓ Hormone receptor expression
- ✓ Drug screening
- ✓ Patient-derived options
Conditions Being Studied
Women's health research using NAMs
Endometriosis
Affects 10% of women with average 7-year diagnosis delay. Organ chips model lesion development and test treatments.
Polycystic Ovary Syndrome
Metabolic and reproductive condition affecting 1 in 10 women. Ovarian organoids help understand mechanisms.
Pregnancy Drug Safety
Pregnant women excluded from most trials. Placenta models predict fetal drug exposure without human risk.
Breast Cancer
Patient-derived organoids test which treatments will work for individual tumors, improving outcomes.
Ovarian Cancer
Often diagnosed late with poor prognosis. Organoids from patient tumors enable drug sensitivity testing.
Menstrual Disorders
Heavy bleeding, pain, and irregularity affect millions. Endometrium models test new therapeutic approaches.
Use female cells by default — Include XX cells in all preclinical testing, not just male cells
Model hormone effects — Test drugs across hormonal cycles using responsive tissue models
Study pregnancy safely — Use placenta models to test drugs without exposing pregnant women
Create female-specific organs — Develop uterus, ovary, and breast models for understudied conditions
Detect sex-specific toxicity — Use female cardiac cells to predict QT prolongation risk in women
Personalize treatment — Patient-derived models enable treatment selection based on individual response