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Food and Drug Administration (FDA) Academia Kent Johnson, MD University of Michigan Medical School, Department of Pathology Mitchell McGill, PhD University of Arkansas for Medical Sciences Roscoe Warner, PhD University of Michigan Medical School, Department of Pathology Paul Watkins, MD University of North Carolina, Eshelman School of Pharmacy, Institute for Drug Safety Sciences Consortium Members Roche Genentech Merck Sarepta Johnson and Johnson Associate Members American Association of Kidney Patients (AAKP) Translational Safety Biomarker Pipeline (TransBioLine) Consortium Foundation for the National Institutes of Health Kidney Health Initiative The 3Rs Collaborative IQ Microphysiological Systems Affiliate Team Graham Marsh, PhD Scientific Director Katrina Peron , MS Associate Director Andrew Poalillo, MEd Data Manager II Samantha Wilkins, PhD Project Manager Laura Lummus , BFA, PACE Senior Project Coordinator Claire Bassetti , MPH Communications and Patient Engagement Manager Industry Co-Directors Tanja Zabka, DVM, DACVP Genentech/Roche Warren Glaab, PhD Merck

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