Where the Puck is Going: Non-Animal Models for Disease Modeling and Drug Development

Shifting priorities in federal research funding, evolving FDA guidance for drug development, and broader societal expectations are accelerating the transition toward non-animal models in biomedical research. In this Translational Science Grand Rounds presentation, James McGrath, PhD, William R. Kenan Jr. Professor of Biomedical Engineering, and Joan Adamo, PhD, director of the Office of Regulatory Support, will describe the rapidly evolving landscape of non-animal model adoption, highlight recent work from the Translational Center for Barrier Microphysiological Systems (TraCe-bMPS), and offer practical guidance for laboratories seeking to integrate tissue-on-chip and other human-relevant models into their research portfolios.

Speaker Bios:

Professor McGrath holds degrees in Mechanical Engineering from Arizona State University and the Massachusetts Institute of Technology, and earned his PhD in Biological Engineering from the Harvard/MIT Division of Health Sciences and Technology. He completed postdoctoral training as a Distinguished Fellow in the Department of Biomedical Engineering at Johns Hopkins University before joining the Biomedical Engineering faculty at the University of Rochester in 2001. Professor McGrath leads several interdisciplinary and multi-institutional teams focused on the development and application of ultrathin, silicon-based porous membrane technologies for a wide range of biomedical applications. He has co-founded three companies to advance the commercial use of nanomembranes: SiMPore (2007), Parverio (2020), and SiObex (2024). His contributions have been recognized with the Edmund A. Hajim Outstanding Faculty Award (2019), the University’s Goergen Award for Excellence in Undergraduate Teaching (2023), and appointment as the William R. Kenan, Jr. Professor of Biomedical Engineering (2023). He is the founding director of the University of Rochester’s Translational Center for Barrier Microphysiological Systems. Professor McGrath holds 16 issued and pending patents and has authored more than 115 scientific publications.

Joan E. Adamo, PhD, is the director of the Office of Regulatory Support at the University of Rochester Clinical and Translational Science Institute. There she provides guidance on clinical and basic research projects and serves as an FDA liaison for University investigators working on industry-sponsored and sponsor-investigator clinical studies. This includes supporting researchers in IDE- and IND-governed clinical studies, managing a framework for preclinical GLP compliance within the University and at external University collaborators, and leading the University efforts to foster a culture of quality by establishing elements of quality systems in basic and translational research. As part of the Regulatory Science program at the University of Rochester, Joan leads the America’s Got Regulatory Science Talent student competition, mentors students, and teaches two courses focused on FDA regulation of and intellectual property issues for medical devices and therapeutics. Prior to joining the University, Adamo served as a researcher and regulator at the Center for Biologics Evaluation and Research in the FDA. Her work in the Division of Viral Products at the FDA was focused on the research and approval of viral vaccines such as Influenza, Smallpox and West Nile Virus. Dr. Adamo received her BS in Biochemistry from Cornell University and her PhD in molecular genetics from Cornell Medical College.

Accreditation

The University of Rochester School of Medicine and Dentistry is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

Certification

The University of Rochester School of Medicine and Dentistry designates this live activity for a maximum of 1.00 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.