Chief Technical Officer and Senior Vice President, Chemistry, Manufacturing and Controls
Suketu D. Desai, Ph.D., currently serves as Chief Technical Officer and Senior Vice President, Chemistry, Manufacturing and Controls (CMC) at Semnur Pharmaceuticals, Inc. Prior to Semnur during 2014-2015, Suketu was Vice President of Biologics Development and Manufacturing responsible for biologics drug substance and drug product, technical due diligence and commercial technical operations at Allergan, Inc. which was acquired by Actavis, plc. for $66B. Prior to Allergan, Suketu was a CMC consultant in 2013 for the Biotech and Pharma companies and Finance Industry. From 2010-2012, Suketu was Vice President, Biotechnology Technical Operations for biologics drug substance and drug product development, analytical, manufacturing and technical due diligence at Cephalon, Inc. which was acquired by Teva Pharmaceuticals for $6.8B. During 2007-2010, Suketu was Vice President, Chemistry, Manufacturing & Controls and Quality responsible for biologics drug substance and drug product development, analytical, manufacturing, quality, regulatory CMC strategies and technical due diligence for business development at Ception Therapeutics, Inc., which was acquired by Cephalon, Inc. for $350M.
Earlier, Suketu was Principal Scientist, Process Sciences and Technical Operations for late-stage and commercial biologics at Johnson & Johnson subsidiary Centocor, Inc. (2003-2006); Assoc. Director, Pharmaceutical and Biotech Formulations Development at AAI Pharma Development Services (2001-2003); Director/Sr. Manager, Pharmaceutical Development and Operations accountable for product development, manufacturing, quality control and regulatory CMC strategies at Aronex Pharmaceuticals, Inc. (1996-2001); and Senior Scientist at Novartis Pharmaceuticals, formerly Alcon Labs, Inc., (1992-1996).
Suketu has extensive background in biotechnology process and product development, pharmaceutical formulations and drug product development, internal manufacturing, contract manufacturing, process validation, analytical development and validation, quality, CMC regulatory, supply chain, CMC outsourcing, contract manufacturing organization (CMO) management, CMO contract negotiations and technical due diligence for business development.
Suketu has contributed to several INDs, IMPDs, NDAs, BLAs, MAAs and regulatory submissions to USFDA, KFDA, SFDA, PMDA, EMA, TGA, HC and commercial biologics and pharmaceutical products including Botox, Simponi, Remicade, ReoPro, Retavase, Eprex, Azopt and Volfenol and late-stage products including reslizumab and abicipar pegol. He has extensively managed CMC related outsourcing to 3rd-Party/CMOs in US, Europe and Asia for biotechnology 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 and Bachelor’s in Pharmacy from the University of Mumbai, Mumbai, India.