Valerie Ng

Company: Kite, a Gilead Company

Job title: Associate Director - Regulatory Affairs, Chemistry, Manufacturing & Controls

Seminars:

Navigating Regulatory Challenges in Viral Vector Process Development with Insights from Commercialized Products 9:30 am

As viral vector-based therapies move from development to commercialization, regulatory challenges become increasingly critical. This session will focus on overcoming key regulatory hurdles in viral vector process development and manufacturing, including maintaining product consistency, standardizing assays, and ensuring safety across large-scale operations. This workshop will provide practical strategies and insights on achieving regulatory compliance while…Read more

day: Pre-Conference Workshop Day

CMC Strategies for Ensuring AAV Vector Potency and Infectivity in Gene Therapy 2:30 pm

Potency Assays for AAV Vectors: Discuss the development and validation of reliable potency assays to ensure that AAV vectors retain their ability to effectively transduce target cells and deliver the therapeutic gene Balancing Yield and Infectivity: Address the challenges of maximizing viral yield without compromising infectivity, focusing on process optimization, transfection efficiency, and the importance…Read more

day: Conference Day Two