Beth Brown, Ph.D.

Dr. Brown has over 30 years’ experience in pharmaceutical product, process, and analytical development and commercialization of 40+ diverse product lines. She has led programs for small organic molecules, oligonucleotides, peptides, mAbs, cell and gene therapy, microbial restoration therapy, adenovector and protein/adjuvant vaccines, and drug/device combination products. She has been the primary author of Module 1, 2 and 3 CMC global regulatory documents (FDA, HC, EMA, MHRA, TGA, Medsafe, PMDA) including leadership of IND, ANDA, NDA, BLA, EUA, MAA and PMA submissions, briefing packages, change control regulatory assessments, and RFI rapid response teams. Beth has performed CTO activities including due diligence library design, regulatory pathway strategy, patent assessments, creation of target product profiles and business plans, including pitch decks and documents to support investor funding. She has led CDMO/OTL selection, created procedures for supplier identification/selection and managed outsourced technical transfer programs. She holds a Ph.D. in Pharmaceutics from University of Michigan, Ann Arbor and a B.S. in Pharmacy (Pharmacist) from Purdue University, West Lafayette.