Journal of Molecular Biomarkers & Diagnosis

J. Eric McDuffie

Biography

Dr. James (Eric) McDuffie is a native of Aiken, South Carolina. He graduated from Benedict College with a B.S. degree in Biology and Meharry Medical College with a Ph.D. in Pharmacology. Following the completion of postdoctoral studiesin Pathology at The University of Michigan Medical School, he served as a Senior Scientist in the Toxicologic Pathology Section within the Drug Safety Evaluation Department at Pfizer Global Research & Development, Inc. where he managed the Histology & Necropsy Laboratory Core groups in both Ann Arbor, Michigan and Mississauga, Canada. He later functioned as a Principal Scientist/Manager of the Investigative Pathology Laboratory groups at Pfizer in Ann Arbor, Michigan and subsequently at Esperion Therapeutics, a Pfizer Inc. Company in Plymouth, Michigan. Eric first joined JanssenPharmaceuticals Companies of Johnson & Johnsonas a Principal Scientist in the Investigative Toxicology group. Currently, he serves as Scientific Director of Investigative Toxicology/Discovery Toxicology and Laboratory Animal Medicine within the within the Preclinical Development & Safety Department at Janssen Pharmaceutical Research & Development, L.L.C. located in San Diego, California; and he directly manages the scientists/staff members within these areas of expertise.Eric is a Preclinical Co-Chair to the Nephrotoxicity Working Group (NWG) of the Predictive Safety Testing Consortium(PSTC). The PSTC was created by the Critical Path Institute (C‑Path) as a neutral ground where scientists from pharmaceutical companies and academia can ultimately develop sufficient evidence to qualify new predictive safety tests for regulatory use that may improve the safety of new drugs that reach the market. Eric contributed to the studies which were conducted to support the first sets of biomarkers that were submitted by PSTC to the FDA, EMA and PMDA and were qualified for use in testing for renal safety in rodents to detect drug-induced kidney injury. Eric co-leads the NWG’s efforts to evaluate the expanded preclinical (non‑rodent) and clinical utility of the previously qualified urinary proteinbiomarkers (cystatin C, β2‑microglobulin, total protein, urinary clusterin, kidney injury molecule 1, trefoil factor 3, and albumin) and otheradditional biomarkers in human clinical research sponsored by the Foundation for the NIH and/or the Innovative Medicines Initiative (IMI) Project - Safer And Faster Evidenceâ€Ã‚based Translation(SAFE-T, an European consortiumapproach to renal safetybiomarkers). He also plays a leading role in the cross-consortia collaboration between the PSTC and Health and Environmental Sciences Institute (HESI) to explore the potential utility of microRNAs as novel renal safety biomarkers in non-rodents.Based on this research, Eric has received several awards; and he has a myriad of publications including peer-reviewed manuscripts and book chapters. He also serves as an expert Reviewer for several journals and is a member of both the Society of Toxicology and the American Society for Investigative Pathology.

Research Interest

Potential utility of microRNAs as novel renal safety biomarkers in non-rodents