University Initiative Backing First-of-its-Kind Pharmacogenetics Research Project

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Associate Professor Dan Hertz and Clinical Assistant Professor Amy Pasternak are among a group of five university faculty members teaming up to perform potentially lifesaving research around pharmacogenetics. The funding and infrastructure for this project are provided by the Bold Challenges Initiative through the University of Michigan Office of the Vice President for Research (OVPR).

This initiative awarded eight teams across ten schools, colleges and units this funding in its mission to help teams in the early stage of research solve real-world problems.

The real-world problem Dr. Hertz, Dr. Pasternak and their team are attempting to solve is a lack of published data that pharmacogenetics testing can improve treatment outcomes in hundreds of cancer patients receiving chemotherapy.

Some patients carry genetic variants that can lead to dangerous and sometimes fatal toxic respons

es to common drugs used in cancer treatments. Champions of pharmacogenetic testing, like Hertz and Pasternak, push doctors to test for these genetic variants prior to administering these drugs, but it is not common practice to do so in the United States at this time.

This project will evaluate the use of 5-fluorouracil, a common chemotherapy drug used in patients across dozens of sites in the United States. The team will pool this real-life data to see if pharmacogenetic testing reduces the toxicity of this drug in patients without reducing the efficacy.

“It’s not very feasible to get clinical trials approved to prove the importance of pharmacogenetics, so our ability to pool real-world outcomes and data on this testing will hopefully help us move the needle forward,” Hertz explained. “The Bold Challenges Initiative allows us to build a database and coordinate all of the agreements with these healthcare sites to collect this real-world data and do this analysis.”

Working alongside Dr. Donglin Zeng, a Professor of Biostatistics in the School of Public Health, Dr. John C. Krauss, a Clinical Associate Professor of Internal Medicine in the Medical School and Dr. Norah Lynn Henry, a Breast Cancer Research Professor and Professor of Internal Medicine in the Medical School, Dr. Hertz and Dr. Pasternak are eager to bring everyone’s expertise to the table.

“Dr. Hertz brings expertise on this specific gene and drug pairing, while my background is in the implementation of pharmacogenetics testing,” explained Dr. Pasternak.

“It’s also important to have the background of a biostatistician who understands the complexity of real-life data and our colleagues in the Medical School who have experience with patients and the outcomes people care about,” said Hertz.

Although this specific research focuses on 5-fluorouracil, Hertz hopes that the research infrastructure pu

t in place in this project will allow for easier data collection in other therapeutic areas in the future.

“Once we create this process, it will be much more efficient to repeat this data collection beyond oncology in areas like cardiology and psychology to show the benefit of pharmacogenetic testing for other drugs,” Hertz explained.

“Studies like this that demonstrate the benefit of pharmacogenetic testing will help reduce barriers to implementing this testing more routinely in patient care,” said Pasternak.

This project is a prime example of the lifesaving work performed by researchers in the College of Pharmacy’s Clinical Pharmacy and Translational Sciences department, and another way the College is leading at pharmacy’s edge.

You can read in-depth about Dr. Hertz’s background in pharmacogenetics testing research and advocacy in this piece.