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:

Ilya Shestopalov

Senior Director - Analytical Development & Product Lead

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Joshua Kidder

Sr. Director Quality Control

Ultragenyx Pharmaceutical Inc

Julia Sable

Director - Chemistry, Manufacturing, Controls & Project Management

Tmunity Therapeutics Inc.

Marco Thomann

Principal Scientist and Group Leader

Roche Diagnostics GmbH

Santoshkumar Khatwani

Director & Team Lead - Analytical Development, Late Stage, Chemistry, Manufacturing & Controls Analytical

Sangamo Therapeutics

Sarah Wassmer

Quality Evaluator for Cell & Gene Therapy Products

Health Canada

Tayler Renshaw

Director - Regulatory Affairs, Chemistry, Manufacturing & Controls

Astellas Innovation Management

Xiaohui Lu

Executive Director - Analytical Development

Ultragenyx Gene Therapy

Snapshot of Attending Organizations from Last Year:

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