With over 28 years of experience in the biotechnology and pharmaceutical industries, I have demonstrated my expertise as a skilled leader of technical and project teams. My extensive international consulting experience encompasses chemical development and CMC with biotechnology companies in the United States, South Korea, and China. I possess comprehensive knowledge in CMC, chemical development, and product development, spanning GLP to phase 3 clinical development. This encompasses chemical and process development, scale-up, technology transfer, production, and API cost-reduction strategies across various therapeutic areas, including ophthalmology, dermatology, central nervous system, gastrointestinal, fatty liver, oncology, radiotherapy, antibody drug conjugate (ADC), and psychedelics. My regulatory CMC experience is extensive, including the authorship of sections of regulatory submissions and the establishment of RSM and DS specification strategies. I am knowledgeable in drug discovery and chemical development, having managed full-time employees at a contract research organization (CRO) and transitioned technology transfer from a CRO to a contract manufacturing organization (CMO). Notably, I am a co-inventor of three drug candidates in phases 1, 2, and 3, and hold over 60 U.S. issued patents.

Professional Experience

• Drug Development Advisor, N-Zyme Biomedical LLC, 2026-Present
• Principal consultant, TDD Consulting LLC, 2020-present
• Director, Chemistry Development, Allergan LLC - Abbvie, 2015-2020
• Sr. Manager, Process Chemistry, CMC Team Leader, Allergan LLC, 2012-2015
• Manager, Process Chemistry, Allergan LLC, 2008-2012
• Scientist, Process Chemistry, Allergan LLC, 2005-2008
• Scientist, Medicinal Chemistry, Allergan LLC, 2001-2005
• Assoc. Scientist, Medicinal Chemistry, Idun Pharmaceutical (Pfizer), 1998-2001
• Research Chemist, Medicinal Chemistry, Tularik (Amgen), 1998

Representative Accomplishments

• IND submissions (Oncology (asset in South Korea), hair growth in dermatology (asset in CA) currently in Phase 2, radio-oncology (asset in CA) partnered with Lilly, CTN submission for a psychedelic asset for migraine in Australia, preparing a submission in Germany, preparing another CTN submission in Australia (TDD Consulting LLC)
• Co-inventors of Aganepag isopropyl and Simenepag isopropyl advanced to Phase I and II, respectively, for the treatment of glaucoma (next generation of Lumigan)
• CMC team leader for program completed Phase 2 (Allergan)
• Authored chemistry CMC section over 25 INDs (Allergan)
• Chemical development leads to development projects in a broad range of therapeutic areas such as ophthalmology, aesthetics & dermatology, CNS, liver diseases, etc. (Allergan)
• Allergan’s Best Inventor Award for Basic Science 2008 and Applied Science 2010
• Co-inventor of Caspase 1 inhibitor which entered Phase 1 for alcoholic hepatitis indication (Idun)