Dr. Nguyen has over 25+ years of experience in the pharmaceutical industry working in pharmaceutical product development, from Candidate Selection, IND, Clinical Studies, through market registration. Prior to founding Ascent Pharma Consulting, LLC, she held the positions of Medicine Process Delivery Leader and Early/Late Phase Pharmaceutical Development Manager at GlaxoSmithKline where she contributed to multiple selection of candidates, delivery of clinical supplies for First Time in Human studies, optimization of formulation for commercialization, technology transfer, and provided leadership of these development activities through Phase 2b (as CMC Project Leader) and from Phase2b through commercial product launch (as Medicine & Process Delivery Leader)
Her broad development experience includes developability of drug candidates, drug delivery design for early clinical phase through commercial 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.
She has demonstrated excellence in sterile solution/suspension/lyophilized products, oral liquids, and oral solid dose. She has a track record of successful submissions from initial INDs to support FITH studies to NDAs to support commercial products. Her understanding of the drug development process, requirements, adept integration/planning of development activities, excellent communication skills, and relationship building led to successful team leadership/management experiences.
Dr. Nguyen 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. She has taken business and professional courses for team effectiveness, matrix team leadership, project management, and process improvement. She 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 also serves as Guardian ad Litem for abused and neglected children in Wake County, NC, tutor for at risk students, and meal provider/server for the homeless in the community (Helen Wright Women’s Center and Wake Interfaith Hospitability Network)