Head, Clinical Biomarkers
Sun Pharma Advanced Research
Princeton, New Jersey
Dr. Steven P. Piccoli, Ph.D., came to SPARC in April 2020 as Head of Clinical Biomarkers. He came from GSK, where he was Senior Director of Precision Medicine and Head of Clinical Biomarkers. Prior to that, as a recognized expert in clinical biomarkers and precision medicine with extensive contributions to in vitro diagnostics and clinical chemistry, he led clinical and analytical teams in the pharmaceutical, biotechnology, and medical/companion diagnostics industries, including at Novartis, Johnson & Johnson and Bristol-Myers Squibb. Earlier entrepreneurial efforts included founding a contract research organization to conduct medical device trials and accelerate in vitro diagnostic device (IVD) submissions in oncology to the FDA, and directing the CLIA regulated patient testing reference laboratory of the CRO. In addition, he has served on the Medical Devices Panel in Immunology of the FDA (CDRH) and is engaged in public/private partnerships (Critical Path Institute, Predictive Safety Testing Consortium, Foundation of the National Institutes of Health, Biomarkers Consortium) with whom he is co-leading an initiative to advance and harmonize scientific and regulatory aspects of bioanalytical and biomarker qualification for regulatory submissions. He obtained degrees in chemistry, biochemistry and molecular biology from Carnegie Mellon University, Washington University in St. Louis, and Princeton University.
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Hot Topic: FDA Laboratory Developed Test Proposed Rule and Biomarker Testing
Monday, October 21, 2024
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