About The 2024 Event
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!
Comparability can turn into a significant bottleneck in filing for approval with regulators if drug developers aren’t prepared for it. If your company is at any stage from filing for IND through to running a pivotal clinical trial, the Gene Therapy Comparability Summit needs to be a priority.
Who Will You Meet?
Uniting the key stakeholders tackling comparability across regulatory, process development, CMC, and analytics departments, 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 Your Peers To:
Join CSL Behring, Bayer, Ultragenyx, and other industry leaders to gain insights on transitioning to in-house production, effectively managing variability and scalability challenges, and ensuring consistency across multiple sites
Heard about the challenges associated with cell therapy comparability and the lessons that can be shared between
Explore global regulatory requirements with Novartis and uncover Sarepta's regulatory considerations both before and after approval
Hear from Abbvie and Spark Therapeutics on process development innovations designed to enhance the characterization and analysis of AAV-gene therapies, reducing the need for extensive process changes
Elevate your gene therapy analytical toolbox for more effective comparability studies. Dive into case studies and learn strategies to minimize variability from experts at AskBio, Ultragenyx, and BioMarin
Learn from the experiences of Novartis and Sumitovant Biopharma to discover strategic insights derived from cell therapy study design, novel analytical methods, and regulatory expertise to better inform your gene therapy comparability protocols
What Your Peers Have to Say:
‘’The knowledge of the speakers, especially those with prior/current regulatory experience, was very insightful’’
A previous Gene Therapy Comparability attendee, CRISPR Therapeutics