Wendy Larson

Company: Astellas Innovation Management LLC

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

Bio:

Wendy holds a Bachelor of Science Degree in Pharmacology, and Master of Science in Regulatory Affairs and Health Policy from Massachusetts Colleges of Pharmacy and Health Sciences. Wendy has a demonstrated scientific expertise (16+ years) from preclinical research through late-stage commercialization activities focused on biologics and cell and gene therapies.

She is a Regulatory Chemistry Manufacturing and Control (CMC) lead with practical scientific understanding of analytics, manufacturing processes, and quality systems to ensure compliance with applicable regulations and guidelines. She has supported/led both development activities as well as commercial filings for the cell and gene therapy products such as ABECMA (US), SKYSONA (US), and ZYNTEGLO (US and EU). Additionally, Wendy has both supported/led development and Regulatory CMC strategies to support early and late-stage clinical trial applications as well as health authority interactions. Wendy strives to partner cross-functionally both internally and externally to identify and action solutions to the unique challenges we face in the advanced therapies space.

Seminars:

TACKLING THE MOST PRESSING REGULATORY CMC CHALLENGES 9:00 am

Navigating regulatory expectations after process changes, including technical regulatory strategies for successful comparability assessments Taking advantage of all channels available for drug sponsors to interact with the regulators Identifying the commonly observed CMC-related issues that have potential to lead to a clinical hold Identifying common pitfalls related to product characterization and manufacturing process controls Leveraging…Read more

day: Workshop Day - track c