NEW JERSEY — Rutgers researchers are joining a multi-university project aimed at better understanding how changes in female hormone levels affect the way medications are processed by and act within the body.
The project, led by Michigan State University, is backed by a new $4.6 million award from the National Institutes of Health, the first installment of an award worth up to $12.8 million over three years. Researchers from Emory University, Tulane University, the University of Colorado, the University of Michigan and the University of Utah are also collaborating on the project.
Researchers said clinical trials often do not account for hormonal changes that occur during menstrual cycles, pregnancy, birth control use, menopause and hormone replacement therapy. That can result in treatments being less effective or causing more severe side effects in women than in men.
A team of 13 researchers will develop advanced computer models designed to predict how natural hormonal changes affect how medicines move through and act within the body.
“Developing computational models that provide insights into women’s health — including the consequences of disease, efficacy and side effects of medicines — and integrate age and reproductive cycle stage is a moon shot,” said Teresa K. Woodruff, the project’s lead investigator, president emerita of Michigan State University and an MSU Research Foundation Distinguished Professor.
Rutgers researchers involved in the project include Shuo Xiao, associate professor in the Department of Pharmacology and Toxicology at the Ernest Mario School of Pharmacy, and Jiyang Zhang, a research assistant professor at the school.
“We’ll supplement the project’s computer models with lab-grown biological models, known as new approach methodologies, or NAMs, that mimic hormone levels in multiple organs during key moments in women, like ovulation, menstruation, pregnancy, menopause or the onset of a hormone-altering disease. We’ll expose each of these wet-lab NAM models to common metabolic drugs and measure responses to inform the development of computer models that can help improve women’s medication use,” Xiao said.
The research is part of the NIH’s Computational Modeling of Hormone Homeostasis Initiative, a joint effort by the NIH Office of Research on Women’s Health and the Division of Program Coordination, Planning and Strategic Initiatives. A total of $21 million is being awarded through the national program.
The Rutgers-led work will include lab-grown biological models designed to mimic hormone levels in multiple organs at different stages, including ovulation, menstruation, pregnancy and menopause.
Researchers will focus in part on metabolic conditions such as obesity, type 2 diabetes, cholesterol imbalances and thyroid disorders. The project will examine how hormone levels can affect responses to commonly prescribed medications, including insulin and GLP-1 weight-loss and diabetes drugs.
The team plans to use artificial intelligence to organize more than 40 years of hormone research data into a free public database. Researchers will also develop a computer model of a typical 28-day menstrual cycle and use patient data to account for factors including menopause, birth control use, diabetes and obesity.
Human-relevant three-dimensional tissue models and lab-grown organoids, including liver, muscle and ovarian tissue, will be used to test the computer predictions.
Researchers also plan to develop personalized treatment tools for medications including metformin, insulin and GLP-1 drugs to help health care providers determine appropriate doses and reduce harmful side effects.
The final computer platform and data produced through the NIH initiative are expected to be made freely available to researchers and health care professionals worldwide.
