Chief Technical Officer and Senior Vice President, Chemistry, Manufacturing and Controls, Regulatory CMC and Quality
Suketu D. Desai, Ph.D. has 25+ years of experience in the Biologics and Pharmaceutical Industry. Suketu is Chief Technical Officer and Senior Vice President, Chemistry, Manufacturing and Controls, Regulatory CMC and Quality at Semnur Pharmaceuticals (acquired by Scilex Pharmaceuticals), Inc., (2015-current). Prior to Semnur, Suketu was Vice President of Biologics Development and Manufacturing for biologics drug substance and drug product, technical due diligence and commercial technical operations at Allergan, Inc. (2014-2015), which was acquired by Actavis, plc. Before Allergan, Suketu was a CMC consultant in 2013. Suketu was Vice President, Biotechnology Technical Operations for biologics drug substance and drug product, analytical, manufacturing and technical due diligence at Cephalon, Inc. (2010-2012), which was acquired by Teva Pharmaceuticals. During 2007-2010, Suketu was Ception Therapeutics, Inc., Vice President, Chemistry, Manufacturing and Controls (CMC) and Quality responsible for biologics drug substance and drug product development, analytical, manufacturing, quality, regulatory CMC and technical due diligence for business development. Ception was acquired by Cephalon (2010).
Earlier, Suketu was Principal Scientist, Process Sciences/Technical Operations for late-stage and commercial biologics drug substance and drug product at Centocor, Inc., a Johnson & Johnson subsidiary (2003-2006); Assoc. Director, Pharmaceutical and Biologic Formulations Development at AAI Pharma Development Services (2001-2003); Director/Sr. Manager at Aronex Pharmaceuticals, Inc. (1996-2001); and Senior Scientist II/I at Novartis Pharmaceuticals, formerly Alcon Labs, Inc., (1992-1996).
Suketu has contributed to several commercial biologic products (Botox, Cinquair, Simponi, Remicade, ReoPro, Retavase, Eprex) and pharmaceutical products (Azopt and Volfenol) and late-stage products including SP-102 and abicipar pegol.
Suketu has experience in biologics development, pharmaceutical development, internal and contract manufacturing, process validation, methods development and validation, quality, CMC regulatory and pre-approval inspection, clinical and commercial supply chain, CMC outsourcing, contract manufacturing organization (CMO) management and technical due diligence. He has managed CMOs in US, Europe and Asia for biologics and pharmaceutical drug substance and drug products.
Dr. Desai received his Ph.D. in Pharmaceutical Sciences from the University of Arizona, Tucson, AZ and Master’s in Pharmacology and Bachelor’s in Pharmacy from the University of Mumbai, Mumbai, India.