Possessing over 30 years in the pharmaceutical and biotech industries, this expert offers deep proficiency in drug development, CMC, and drug delivery systems. Key experience includes executive roles reporting to CEOs in public companies, supporting successful product launches and an IPO. The expert specializes in authoring and reviewing CMC sections (Module 3) for global regulatory submissions (IND, IMPD, NDA, BLA), contributing to the market approval of several drugs in oncology, infectious disease, pain management, and ophthalmology. Expertise covers small molecules and biologics (proteins, peptides, vaccines), encompassing formulation (sterile products, lyophilization, injectables, sustained release), analytical/process development, tech transfer, scale-up, and cGMP manufacturing management (including CMOs). Strong experience with combination products (PFS, autoinjectors, large volume injectors), due diligence, IP management, and expert witness consulting on formulation/manufacturing matters. Proven ability managing large budgets and complex development programs.
✓ Depositions