The National Institutes of Health is awarding $21 million to launch a research program developing computer-based models that simulate how sex hormones regulate body functions and affect drug response.
Hormone activity varies widely between men and women, resulting in different reactions to drug therapy, including varying outcomes to dosing, treatment response, and drug toxicity, according to the NIH. The program, called the Computational Modeling of Hormone Homeostasis Initiative, will use advanced computational techniques to create models tailored to individual physiology rather than relying on mathematical formulas or animal studies.
Sex hormones interact with multiple tissues and organ systems beyond reproductive function, including the lungs, bones, and immune system. Changes in hormone levels during puberty, the menstrual cycle, pregnancy, and menopause trigger systemic responses and long-term changes throughout the body, according to the NIH. "Current mathematical and animal models do not sufficiently capture variations between men and women," said Nicole Kleinstreuer, NIH Deputy Director for Program Coordination. "By leveraging advanced computer-based models that use human biological data to simulate hormone activity across the lifespan, we can help researchers improve the evaluation of new treatments."
The initiative is supporting projects focused on developing sex-specific models to test drugs and therapeutics for effectiveness and toxicity. Funded techniques include interactive machine learning, multi-scale models, AI-enhanced multi-scale models, physics-informed models, and digital twins—virtual replicas of biological systems.
Janine Clayton, NIH Associate Director for Research on Women's Health, said accounting for sex as a biological variable in drug testing "holds promise for streamlining drug and biologics testing and propelling bench-to-bedside translation."