Dr. Itay Perlstein, Ph.D. graduated from the Hebrew University in Pharmaceutical Sciences in 2000 and perused his postdoc in the University of Pennsylvania/The Children Hospital of Philadelphia in the development of novel gene delivery systems. He then moved to the Pharma industry where he served in the Clinical Pharmacology & Pharmacometrics departments of GSK (2004-2007), Merck (2007-2011), and BMS (2011-2015) with growing responsibilities as a Sr.PK/PD Scientist, a Study Director, and a Clinical Pharmacology Lead. He has an extensive experience in all clinical phases of drug development, from first-in-human to the successful global filing of blockbuster drugs: COREG CR ® (CHF, 2006), Benlysta® (Lupus, 2011), Belsomra® (insomnia, 2014), Eliquis® (anticoagulant, 2015), Uzedy® (Schizophrenia, 2023). Throughout the years he gained broad experience in interactions with the FDA, EMA, and major Health Authorities in the world. He has an established record of preparation and maintenance of regulatory documents and development plans. Dr. Perlstein is now providing independent consulting services for Pharma, Biotech, and Medical Device companies (directly or through CROs).
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