Thomas Alessi

Vice President, Development and Manufacturing at Intarcia Therapeutics

Dr. Tom Alessi joined Intarcia in December 1997 as Executive Director, Regulatory Affairs and Drug Development and was promoted to Vice President, Development and Manufacturing in February 2002 with responsibility for the areas of product development, project management, chemistry and manufacturing. Prior to joining Intarcia, Tom served as the Senior Director, Regulatory Affairs, Quality Assurance and Project Management at Ansan Pharmaceuticals where he was responsible for successful IND filings and for managing five drug development programs with oversight of vendors for preclinical and clinical studies and manufacturing clinical supplies. Before joining Ansan, Tom was Director of Regulatory Affairs and Quality Assurance at Glycomed, Inc. where his duties included oversight and compliance of clinical manufacturing. His previous experience includes regulatory affairs and drug discovery experience in large pharmaceutical companies. Tom was Senior Manager of Regulatory Affairs for Schering-Plough working in the Anti-infectives, Allergy Products and Chemisty, Manufacturing, & Controls groups. While at Schering-Plough, he had regulatory responsibilities for approval and launch of Intron® for hepatitis C as well as for hepatitis B. In his CMC role, he served on separate committees for process development and production of solid oral dosage forms, inhaled products, creams and semisolid products and sterile dosage forms, in addition to regulatory review of the CMC sections of Schering-Plough INDs and NDAs. Prior to joining Schering-Plough, he invented and patented several new families of anti-diabetic drugs while working as a Senior Scientist in the drug discovery group at Wyeth-Ayerst.

Timeline

  • Vice President, Development and Manufacturing

    Current role

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