Associate, Regulatory Affairs
Dr Lucie Hwang is a Regulatory Professional with two years’ experience of working in regulatory agencies (EMA and ANSM), Merck Sharp & Dohme Co. France (MSD France), and four years’ experience in the AP-HP Public Hospital Pharmacy and Community Pharmacies in Paris.
Lucie began her pharmaceutical career with an internship in the Cell and Gene Therapy Clinical Trial Evaluation Department at ANSM before moving to MSD France, where she supported monoclonal antibody and small molecule CTA submissions.
Lucie obtained a one year Scientific Officer Traineeship in the Orphan Medicines Office of Scientific Evidence Generation Department at the EMA where she evaluated sponsor oncology and other rare disease indications data and wrote the associated reports for COMP members for Orphan Drug Designation (ODD). During the traineeship, Lucie supported the statistical analysis of the EMAs ODD outcomes data. Lucie also supported the COMP-CAT Working Group on activities related to naming convention for Cell-Based ATMPs.
Lucie has specialised in the Pharmaceutical Development of Biologics and ATMPs and has an M.Sc. (with honors) in Bio-Medical Engineering in Cellular and Molecular Biotherapies and a Pharmaceutical Doctorate (Pharm.D) of the Paris Descartes University.
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