Michigan State University researchers are launching a novel project to transform how medications are developed and prescribed for women
A US$4.6m award will fund computer models designed to predict how hormonal changes affect the way medicines move through and act in women’s bodies
The funding is the first instalment of an award worth up to US$12.8m over three years, supporting work intended to account for hormonal changes throughout women’s lives
Researchers plan to examine factors including menstrual cycles, pregnancy, contraceptive use, menopause and hormone replacement therapy, which can affect responses to medicines
Teresa K. Woodruff, lead investigator on the project, said: “Because female hormone levels are constantly shifting, precision medicine allows us to map out these complex interactions
“This NIH-backed initiative will create the first computationally driven clinical tool designed to guide medical care across every stage of a woman’s life.”
The project is led by researchers at Michigan State University and funded by the National Institutes of Health, with collaborators from Rutgers, Emory, Tulane, the University of Colorado Anschutz, the University of Michigan and the University of Utah
Thirteen researchers will develop computational models to predict how changes in female hormones influence the way medicines move through and act within the body
The work is part of the NIH Computational Modeling of Hormone Homeostasis Initiative, which is awarding US$21m nationally to support research into sex-specific hormonal biology
The team plans to use artificial intelligence to digitise and organise more than 40 years of hormone research data in a publicly accessible database
Researchers will also develop a standard computer model of a 28-day menstrual cycle, alongside models of how hormones regulate organs and tissues involved in processing nutrients, including the liver, muscle and fat
Real-world patient data will then be used to expand the models to represent groups including women going through menopause or taking birth control, as well as women with conditions such as diabetes and obesity
The project will also use three-dimensional human tissue models and lab-grown organoids, including liver, muscle and ovarian tissue, to test and refine the computer predictions
Researchers plan to examine medicines including metformin, insulin and GLP-1 drugs, with the aim of developing tools that could help clinicians tailor doses and avoid harmful side effects
Qiang Zhang, associate professor at Emory University, said: “Empowered by AI, novel assays and legacy human data, we will develop mechanistically based computational models of female physiology that can make translational, quantitative predictions for women’s responses to metabolic therapies.”
The researchers said the work could help address differences in how women respond to treatments for metabolic conditions including obesity, type 2 diabetes, cholesterol imbalances and thyroid disorders
Nanette Santoro, professor at the University of Colorado Anschutz and president of the Endocrine Society, said: “Women experience large shifts in reproductive hormones at several points in their lifespan: puberty, pregnancy and menopause
“During reproductive years, women also undergo profound day-to-day changes in reproductive hormone levels, giving them a markedly different endocrine backdrop than men
“Using state-of-the-art computational technology to examine how these changes interact with commonly used medications is a critical pathway toward supporting life-course women’s health.”
The project team said its computer models and data will be made freely available to researchers and healthcare professionals when the work is completed
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