Cowden

About Cowden

Scientific leader with over 25 years’ experience in the Pharmaceutical industry. Recently responsible for the successful NDA filing and commercialization of deuruxolitinib (LeqselviTM) which was given FDA approval on 25 July, 2024. Passionate about new drug development and the critical role that process chemists, formulation scientists, analysts and chemical engineers play in all stages of development through to successful approval of an NDA. Specializing in all aspects of CMC from candidate selection through to NDA filing and commercialization. Extensive expertise in IND/NDA filings, process validation, analytical method development/validation, technical operations (supply chain), process characterization, GMP phase-appropriate quality systems and quality assurance. Various contributions to approved and late stage programs such as deuruxolitinib, deutivacaftor, aprepitant, suvorexant, talcagepant, grazoprevir, elbasvir, vaniprevir, letermovir and doravirine. Currently leader of Pharmaceutical Development at Sun Pharmaceutical following their acquisition of Concert Pharmaceuticals.

Experience

1. Vice President Cmc at Elion Therapeutics

   Elion Therapeutics

   Feb 2025 — Present

Education

• University of Melbourne

  Doctor of Philosophy (PhD)

• University of Melbourne

  BSc

Skills

• Technology Transfer
• Drug Development
• Chromatography
• Organic Chemistry
• Clinical Development
• Gmp
• Validation
• Medicinal Chemistry
• Biotechnology
• Pharmaceutical Industry
• Chemistry
• Hplc
• Drug Discovery
• Organic Synthesis
• Glp