Implement Effective CMC & Analytical Comparability Studies to Maintain Therapy Manufacturing from Phase 1 to Commercialization
March 28-30 |Boston
Welcome to the 3rd Annual Gene Therapy Comparability Summit
Providing Practical Insights to Optimize Your Gene Therapy Comparability Approach
In the context of ever-important gene therapy scale-up to achieve commercial goals and mounting regulatory scrutiny, the 3rd Annual Gene Therapy Comparability Summit is the only event focused on comparability of gene therapy. Join 150+ Quality Assurance, CMC, Regulatory, Analytical and Process Development experts from pharma and biotechs to provide you with hands-on, practical insights into exactly what it takes to ensure you can maintain safety, quality, consistency, and efficacy while adapting manufacturing processes, methods and platforms, to adhere to regulatory demands and avoid costly delays to clinical programs.
With two recent approvals there has been a resurgence surrounding gene therapy, so comparability continues to be of upmost importance, and is at the forefront of the communities minds due to push-back from regulators.
This is your exclusive opportunity to join likeminded individuals from across the Gene Therapy space to gain a hands-on and practical insight into methods to improve your comparability assessments
World-class Speaker Faculty Includes:
Senior Director - Analytical Development & Product Lead
Sr. Director Quality Control
Ultragenyx Pharmaceutical Inc
Director - Chemistry, Manufacturing, Controls & Project Management
Tmunity Therapeutics Inc.
Principal Scientist and Group Leader
Roche Diagnostics GmbH
Director & Team Lead - Analytical Development, Late Stage, Chemistry, Manufacturing & Controls Analytical
Quality Evaluator for Cell & Gene Therapy Products
Director - Regulatory Affairs, Chemistry, Manufacturing & Controls
Astellas Innovation Management
Executive Director - Analytical Development
Ultragenyx Gene Therapy