Scott Burger

Scott Burger

Company: Advanced Cell & Gene Therapy

Job title: Principal & Founder


Workshop: Beginning with the End in Mind: Establishing a Clear Quality Target Product Profile Prior to R&D can Prevent Roadblocks in Process Development 2:00 pm

This session will act as a platform to allow attendees to re-evaluate their approach to upstream design by looking at strategies to look forward to commercialization & manufacturing prior to R&D & Upstream Development. This will allow you to gain key insights to help with your future development strategies. Join this session to learn: Addressing…Read more

day: Day One PM

Regulatory Expectations for Comparability in Gene Therapy 3:00 pm

Overview of the July 2023 FDA Draft Guidance on Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products Practical considerations for comparability studies – determining when comparability is needed, appropriate analytical methods and study design, and effective data analysis strategies Recommendations for productive interactions with FDA when planning comparabilityRead more

day: Conference Day Two