Implement Effective Comparability Studies to Overcome

Strategic & Technical Hurdles & Expedite More Gene Therapy Approvals

This Event Has Now Run.

Thank you to our speakers, sponsors, and delegates who joined us in Boston for the summit! If you are interested in the 2025 event, please get in touch at info@hansonwade.com

Welcome to the 4th Gene Therapy Comparability Summit!

The late-stage gene therapy pipeline is rapidly evolving, with five FDA approvals in the past year and several more BLA filings expected by 2024. As momentum builds towards significantly higher numbers of active later-stage clinical trials, the importance of comparability for drug developers and regulators is increasing.

That’s why the 4th Gene Therapy Comparability Summit will be back in February 2024, hot on the heels of 2023 approvals, this summit will ensure that you can establish comparability in your clinical phase of development and prove to regulators that your products are comparable when scaling up for commercialization and navigating process changes.

Join us in February to design and implement an effective comparability study, significantly de-risk costly delays to clinical programs and ultimately increase the chances of approval.

3

DEEP DIVE WORKSHOPS

20

EXPERT SPEAKERS

15+

case studies with insights

6+

HOURS OF NETWORKING

World-Class Speaker Faculty Includes:

Shibu Poulose

Senior Scientist - QCAT Gene Therapy

CSL Behring

Megan Chartier

Associate Engineer - Gene Therapy Downstream Process Development

Sarepta Therapeutics

Wendy Larson

Director - Regulatory Affairs Chemistry, Manufacturing & Controls

Astellas

Blair McNeill

Senior Vice President & Head of CMC

Sumitovant Biopharma

Elben Guimaraes

Senior Manager - Manufacturing - Gene Therapy

Ultragenyx

Previously Attending Companies Include:

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many more!

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"The quality of presentations, discussions and questions; and the experience shared at the conference was excellent’’

A previous Gene Therapy Comparability attendee, IVERIC Bio

‘’The conference topic was very focused, and the audience and speakers all had direct experience with comparability. Lots of great audience engagement in each presentation’’

A previous Gene Therapy Comparability attendee, Abeona Therapeutics

abeona therapeutics