Regulatory professional Dr Lucie Hwang has joined Boyds as associate in our award-winning regulatory affairs team, based in Cambridge.
Lucie is a specialist in the pharmaceutical development of biologics and advanced therapy medicinal products (ATMPs), orphan drug designations, clinical trial applications (CTAs), cell and gene therapies, and monoclonal antibodies. As part of the Boyds’ team, Lucie will be involved in producing submissions for CTAs, orphan drug designations and scientific advice requests for small molecules.
Her regulatory advice will contribute to our support for clients throughout the full product lifecycle and across a range of therapeutic areas for biological and new chemical entities.
Lucie has an MSc in Bio-Medical Engineering in Cellular and Molecular Biotherapies and a Pharmaceutical Doctorate (PharmD) from the Paris Descartes University. She began her pharmaceutical career with an internship in the Cell and Gene Therapy Clinical Trial Evaluation Department at regulatory agency ANSM. She then moved to Merck Sharpe & Dohme, where she supported monoclonal antibody and small molecule CTA submissions.
Prior to joining Boyds, she was a Registered Pharmacist with the Paris Community Pharmacies in France. In 2017, she secured a 12-month 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. Other roles include Regulatory Clinical Operations Manager in the Global Clinical Trial Operation of Merck Sharp & Dohme Co. France.
Of joining Boyds’ regulatory affairs team, Dr Hwang says: “When I graduated with a PharmD last year, I wanted to pursue my interest in strategic regulatory and regulatory science, ideally working in the development of pharmaceutical innovations in rare diseases therapeutics.
In so many ways, Boyds is the organisation and the role that enables me to realise this professional ambition. It has an impressive team of experts with long-standing, trusted relationships with the regulatory bodies, and I am looking forward to the range of rewarding regulatory experiences from being part of such a talented and accomplished team.”
Professor Alan Boyd, President and CEO of Boyds, adds: “Our regulatory affairs team has an enviable track record and works across a number of advanced therapeutic areas. As well as strategic input, Boyds can assist with the preparation of regulatory documentation and guide clients through the various procedures to bring their product to market.
He adds: “The consultancy’s eight-strong regulatory affairs team, which last year won the Futures category in the coveted TOPRA Awards for its work in cell and gene therapies, has grown steadily – Dr Victoria Marsh, Director of Regulatory Affairs and Dr Kim Champion, Regulatory Affairs Manager, joined Boyds in April this year.
“Lucie’s impressive scientific knowledge, qualifications and experience make her a great addition to the regulatory affairs team, and her specialist knowledge complements the whole team at Boyds and our services for clients.”