Implement Effective CMC & Analytical Comparability Studies to Maintain Safety, Consistency and Efficacy at Every Stage of Gene Therapy Manufacturing from Phase 1 to Commercialization

The Gene Therapy Comparability Summit returns for the second year providing you with all the practical insights to optimize your gene therapy comparability approach.

In the context of scaling up gene therapy development to achieve commercial goals and mounting regulatory scrutiny, the 2nd Annual Gene Therapy Comparability Summit will unite large pharma and innovative biotechs to ensure you can establish comparability at every stage of development, supporting a seamless transition to the larger scales required for commercialization.

Focused specifically on enhancing your gene therapy comparability approach, this event will ensure you can maintain safety, quality, consistency and efficacy while adapting manufacturing processes, methods and platforms, to satisfy regulatory demands and avoid costly delays to clinical programs.

Across four days of curated content, incorporating detailed case studies from leading CMC, Regulatory, Analytical and Process Development experts, this is your opportunity to gain a hands-on, practical insight into exactly what it takes to execute successful comparability studies.

Health & Safety

The health, safety and well-being of our community remains our highest priority. Therefore, all attendees will be required to complete a health declaration prior to attending the event. As part of this, attendees must declare that they are either fully vaccinated and /or have completed a negative Lateral Flow Test or PCR Test within 48 hours the event*.

For further information around Health and Safety onsite, please visit our FAQ here.

*Please note, this is subject to change at any time without prior notice.

Top Speakers

Janet Glassford

Quality Assessor

MHRA

Joshua Kidder

Director of Quality Control

Ultragenyx

Van Hoang

Head of Analytical & Quality Control

Spark Therapeutics

Ilya Shestopalov

Director & Analytical Product Lead

Bluebird Bio

Cynthia N. Brysch

Head of CQA

Vertex Pharmaceuticals

Kyle Grant

Director of Vector Production

Voyager Therapeutics

Markus Haindl

Head Gene Therapy Technical Development

Roche

William Werner

Sr. Director Analytical Assay development

Astellas Gene Therapies

Who Attended in 2021?

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