A resourceful pharmaceutical development leader who leverages broad based drug development experience and technical formulation expertise to optimize product development and delivery for clinical phases and commercialization.

Anh Nguyen

Delivered numerous clinical formulations/supplies and 7 marketed products.

Anh is a Principal Consultant with 25+ years of delivering pharmaceutical products to market with global manufacturing leaders such as GlaxoSmithKline.

Anh’s broad development experience includes developability of drug candidates, drug delivery design for early clinical phase through marketed product, clinical supply manufacture, process development, scale-up, technology transfer, research alliances, development and manufacturing through CMOs, due diligence evaluations, and leadership/management of projects from candidate selection through commercial launch.

Anh has delivered 12+ early clinical formulations/supplies and 7 marketed products including sterile lyophilized product, oral solution, and oral solids. Anh has led multiple CMC matrix teams and New Product Supply teams.

Anh completed her bachelor degree in Chemistry at the University of Michigan and her doctorate degree in Pharmaceutical Sciences at the Ohio State University. She has published in peer reviewed research papers, presented at national conferences, and served as reviewer for research journals. She holds a patent on oral formulation and patent applications for controlled release and lyophilized formulation.

Anh is a member of the American Association of Pharmaceutical Scientists (AAPS) and Project Management International (PMI). She held leadership positions (membership and section chairs) in AAPS Pharmaceutical Technology section. She serves as Guardian ad Litem for abused and neglected children and meal provider/server for the homeless in the community.

Anh lives in Raleigh, NC USA with her husband and one dog. She enjoys singing, hiking, taking care of orchids, and photography.

Examples of projects completed:

  • Successfully delivered a new capability (sterile nanomilled suspension) to support long acting parenteral development for breakthrough HIV treatment & prevention (one injection every 1-3 months).
  • Led CMC project team on a fast paced HIV program to develop and deliver filing & approval of a pediatric oral solution at the same time as adult oral solid program.
  • Led and delivered an accelerated program, complexed by an active Alliance partner, using multiple compounds (3) in FTIH at the same time for best PK profile with QD dosing potential, followed by tablets in phase 2a/b within 2 months using an adaptive clinical design.
  • Performed due diligence reviews on in-licensing opportunities (10+) for sterile products and oral dose forms saving money for the company with “No Go” recommendation on two assets.
  • Led 4 late stage projects (CMC space) successfully through major milestones (pivotal manufacture, file, and transfer to production)
  • Provided effective integrated project planning, risk management, and leadership during preparation for launch of a breakthrough product.
  • Contributed and/or reviewed numerous CMC sections of IND, IMPD, NDA, MAA, and JNDA
  • Provided CMC consultancy and project management for product development and manufacture of registration batches for drug + device combination product.