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URMC / Clinical & Translational Science Institute / Stories / January 2024 / Students Tackle FDA Focus Areas in America’s Got Regulatory Science Talent Competition

Students Tackle FDA Focus Areas in America’s Got Regulatory Science Talent Competition

John Miller, presenting Stopping Runaway CAR-T CellsGraduate students from across the University of Rochester presented their proposals to improve regulatory science as participants in the America’s Got Regulatory Science Talent Student Competition held by UR CTSI this past December. Individuals and teams developed their proposals to address a current area of focus of the Food and Drug Administration (FDA).

John Miller, a PhD candidate in Microbiology & Immunology, won first place with his presentation “Stopping Runaway CAR-T Cells.” Miller earned the opportunity to present directly to FDA representatives this spring.

“CAR-T cells are an incredible therapy that highlights the importance of individualized medicine,” Miller said. “However, there are still improvements that can be made to increase the safety of these treatments, which led me to learn about one of the current mechanisms being investigated to improve the benefit/risk profile of these treatments, and how this could be incorporated into the current regulatory guidelines to make the review process more efficient.”

Miller took the initiative to reach out directly to FDA advisors prior to competing. He leveraged their knowledge on current regulations and research regarding CAR-T cell therapies to inform his project.

I am very excited to present at the FDA and discuss in further detail the challenges and improvements that can be made in regulating CAR-T cell therapies and individualized therapies in general,” Miller said. “It will be a great experience and I’m grateful to everyone that put this competition and opportunity together.”

Hossein Abolhassani and Chiao Yun Chen, PhD candidates in Biomedical Engineering, took second place for their presentation, “3D Organoid-On-A-Chip.”

“Two-dimensional monolayer cell cultures and in vivo animal models are being extensively used for drug screening and development,” Abolhassani said. “However, they cannot adequately recapitulate human tissues. More than 90% of drugs have been reported to fail to gain FDA approval in clinical trials mainly due to inadequacy of screening models. The tissue chip model can be employed as a novel technology to provide a proper microenvironment for three-dimensional disease modeling and high-throughput drug screening. The model can replace, reduce, and refine reliance on animal testing.”

Chen has been working on a salivary gland tissue chip project in the Delouise and Benoit labs since 2021 in an effort to reduce or replace animal testing.

“We successfully identified potential radioprotective drugs that protect against radiation-induced salivary gland damage using these chips,” Chen said. “In addition to drug discovery, we anticipate utilizing salivary gland tissue chips for various biomedical applications.”

Abolhassani and Chen believe that tissue chips can be integrated into microfluidic devices and provide organoid-on-a-chip microphysiological systems for individualized therapies and precision medicine purposes.

Rana Alabdali and Ryan Owens took third place for “AI Detecting Infant Seizures.” Alabdali is a PhD candidate in the Department of Pharmacology and Physiology and Owens is a PhD candidate in the Department of Environmental Medicine.

“Rana's inspiration for this groundbreaking idea is deeply personal,” they said in a joint email. “Three beloved family members have endured the challenges of chronic seizures since childhood, and witnessing their pain has fueled her determination to make a difference. Instead of merely empathizing, Rana saw an opportunity to transform her observations of seizure symptoms, repeatedly witnessed within her family, into a revolutionary diagnostic tool.”

Alabdali and Owens share the hope that their idea will evolve into a product that can serve and relieve individuals experiencing epilepsy and the uncertainty of seizures.

“This is not just a project; it's a mission to transform a personal idea into a source of hope for those in need,” they said.

The participants’ proposals were evaluated by Jean-Philippe Couderc, PhD, MBA, professor of Electrical and Computer Engineering; Scott Steele, PhD, senior advisor for translational science at the Center for Biologics Evaluation and Research, FDA; and Yue Zhao, MS, senior data scientist at the Goergen Institute of Data Science at the Department of Mechanical Engineering.

As the winner of this competition, John Miller will travel to the FDA this spring to compete against representatives from the University of Maryland, who will present their own ideas to improve regulatory science. In addition to the competition, Miller and the other students will spend time networking with the experts from the Office of Regulatory Science and Innovation and others at the FDA.

This was the 11th iteration of the America’s Got Regulatory Science Talent Student Competition at the University of Rochester, which is organized by Joan Adamo, PhD, director of the Office of Regulatory Support, UR CTSI.

Michael Hazard | 1/4/2024

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