Ka-Wai Wan

Company: Medicines & Healthcare products Regulatory Agency

Job title: Senior Pharmaceutical Assessor

Bio:

Dr Ka-Wai Wan is a pharmacist by training and graduated from The School of Pharmacy (University of London). She was trained as a hospital pharmacist before completing her PhD in nanomedicine at the Welsh School of Pharmacy (Cardiff, UK). Her research interests lie in the field of nano-based drug delivery systems for targeted therapy and delivery of macromolecules such as nucleotides and proteins, particularly for cancer and antimicrobial applications. Ka-Wai worked as a research academic for over a decade, and she was a Principal Lecturer in Pharmaceutics and Course Leader for the MSc Industrial Pharmaceutics Programme prior to her transition to the MHRA as a pharmaceutical assessor in 2016. What was meant to be a sabbatical has ultimately changed her career. She is now working as an Expert Quality Assessor at the MHRA, leading on the assessment of nano-based medicinal products, and providing scientific and regulatory advice on innovative medicines, particularly on nanomaterials used for both small and macromolecules delivery. This includes nano-based drug delivery systems using polymers, liposomes and various types of lipid nanoparticles (LNPs) for a wide variety of medical applications, including mRNA/LNP products for vaccines and cancer immunotherapies. She is an invited expert for various national and international regulatory and scientific committees, specifically in relation to nanomedicines and mRNA technologies.

Seminars:

Quality, Safety & Efficacy: Building a Phase-Appropriate Foundation for Regulatory Success in LNP Development 9:00 am

Understanding how quality, safety, and efficacy data requirements evolve from early clinical trials to marketing authorization, and why foundational thinking should start early for safety and approval Reframing regulatory frameworks as protective tools for both patients and developers, mitigating legal risk while guiding better science Identifying and addressing data gaps early on to ensure a…Read more

day: Conference Agenda

Q&A Session 9:50 am

Join our speakers for an interactive Q&A session, where they’ll come together to answer your questions, share further insights, and expand on key themes from their presentations.Read more

day: Conference Agenda