Navigate Regulatory Challenges Across Non-Clinical, Clinical, & CMC Functions from Pre-IND Through to Approval to Ensure Compliance & Satisfy Regulatory Requirements for Cell & Gene Therapies

October 28-30, 2024 | Washington, D.C.

Save up to $1,100 - Offer Ends this Friday, July 12!

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Welcome to the Cell & Gene Therapy Regulatory Affairs Summit!

Understand Guidance, Streamline Submissions, & Obtain Approval

With over 5,000 cell and gene therapies in pre-clinical and clinical development worldwide, regulatory clarity is crucial for developers striving for efficient and seamless approvals in their first regulatory submissions. Leading innovators are pioneering new approaches, like in vivo gene editing, rapidly pushing products from the clinic to commercialization. This rapidly evolving field is now on a mission to learn from case studies and glean insights from the forefront to optimize regulatory processes from pre-IND to approval.

Introducing the inaugural Cell & Gene Therapy Regulatory Affairs Summit in Washington D.C. This event will unite biopharma experts across non-clinical, clinical, and CMC regulatory domains in the cell and gene therapy sector. This is a uniquely positioned platform for the community to crystallize regulations, learn from the experiences of trailblazers, and engage in conversations to unravel regulatory bottlenecks.

Don’t miss this opportunity to gain exclusive insights from industry giants such as Orchard Therapeutics, AstraZeneca, Century Therapeutics, Bristol Myers Squibb, CytoImmune Therapeutics, Prime Medicine, Verve Therapeutics, and more, as they work collaboratively to tackle the regulatory challenges facing the cell and gene therapy community.

 

 

Cell & Gene Therapy Regulatory Affairs Summit - Full Agenda

"Cell and gene therapy is advancing at an extremely fast pace. It is the perfect time for a unique forum dedicated to the regulations around this space to be established"
2024 Speaker, Vice President, Regulatory Affairs, CytoImmune Therapeutics

Key Agenda Highlights

Cell & Gene Therapy Regulatory Affairs Summit

Navigating the development of novel endpoints from planning to validation to negotiations with regulatory bodies, to facilitate effective endpoint strategies and conversations

Cell & Gene Therapy Regulatory Affairs Summit

Delving into international regulation to gain a broad understanding of differences in expectations from regulatory bodies globally, enabling you to bring your therapies to a worldwide market

Cell & Gene Therapy Regulatory Affairs Summit

Understanding lessons learned from other companies who have recently gone through the IND and BLA application processes, allowing you to apply their feedback to your own work

Download the Full Agenda for More Information on:

                • 8+ Hours of Industry Networking
                • 20+ Regulatory Expert Speakers
                • 2 Interactive Deep-Dive Workshops
                • & Much More!

               

               

           

           

       

       

 

 

           

           

       

       

 

 

           

           

           

       

       

 

 

 

Cell & Gene Therapy Regulatory Affairs Summit - Full Agenda

World-Class Speaker Faculty Includes

"Intimate group setting allowing for greater information exchange"
Previous Cell Therapy Series Attendee, Director, Regulatory Affairs, 4D Molecular Therapeutics