Conference Description:

The late-stage gene therapy pipeline is rapidly evolving, with 10+ approvals across the FDA and EMA in the past year and several more BLA filings and decisions expected by the beginning of 2024.

As momentum builds towards significantly higher numbers of active later-stage clinical trials, the importance drug developers and regulators are placing on comparability is increasing too. That's why the 4th Gene Therapy Comparability Summit will be back in February 2024, hot on the heels of 2023 approvals, to share the lessons learnt by biopharma directly dealing with comparability for their clinical-stage assets.

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.

Tickets: https://go.evvnt.com/2017303-2?pid=154
Prices:
Drug Developer - Conference + Workshop Day Pricing: USD 4197.00,
Drug Developer - Conference Only Pricing: USD 2999.00,
Service Provider Developer - Conference + Workshop Day Pricing: USD 5097.00,
Service Provider Developer - Conference Only Pricing: USD 3699.00

Speakers: Anubhav Arora, Director - Chemistry, Manufacturing and Controls, Apellis Pharmaceuticals, Blair McNeill, Senior Vice President and Head of Chemistry, Manufacturing and Controls, Sumitovant Biopharma, Chen Zhou, Principal Research Scientist, Abbvie, Elben Guimaraes, Senior Manager - Manufacturing - Gene Therapy, Ultragenyx, Isaac Hutchinson, Tech Transfer Specalist, Johnson and Johnson Services, Inc, Massoud Motamed, Vice President of Quality and Analytics, Nanoscope Therapeutics Inc, Megan Chartier, Associate Engineer Gene Therapy Downstream Process Development, Sarepta Therapeutics, Meghan Brown, Vice President - Regulatory, Chemistry, Manufacturing and Control, Sarepta Therapeutics, Melody Dai, Executive Director, Regulatory Affairs, Adverum, Mia Wang, Executive Director - Cell Therapy Process Development, Novartis AG, Nesredin Mussa, Vice President and Global Head of Chemistry Manufacturing, Control, Analytical Development and Quality Control, Ultragenyx Pharmaceutical Inc, Rafal Garus, Associate Director MSAT BT Analytical Methods Eu, Bayer, Sam Mallonee, Senior Associate - Quality Control and Gene Therapy Analytical Technologies, BioMarin Pharmaceutical, Sarang Brahma, Vice President, Analytical Development and Quality Control, AskBio, Scott Burger, Principal Consultant, Advanced Cell and Gene Therapy, Shibu Poulose, Senior Scientist - Control, Quality Assurance and Testing Gene Therapy, CSL Behring, Sreeti Choudhury, Head of Analytical Sciences, Quality Control and Competitive Generic Therapy, Spark Therapeutics, Wendy Larson, Director - Regulatory Affairs Chemistry, Manufacturing, and Controls, Astellas Gene Therapy, Yong-Syu (Aaron) Lee, Senior Scientist - Analytical Process Development, Abbvie

Time: 09:00 to 15:00