Troubleshoot Potency Assay Development, Determine Required Reference Standard Material & Implement Potency Assurance to Meet New Regulatory Requirements for Cell Therapies
Troubleshoot Potency Assay Development, Determine Required Reference Standard Material & Implement Potency Assurance to Meet New Regulatory Requirements for Cell Therapies
Welcome to the 4th Cell Therapy Potency Assay Summit
Establish Mechanism of Action, Quality Control & Regulatory Compliance
In the ever-evolving cell therapy landscape, the challenge of potency assay development remains critical. With the field anticipating finalized regulatory guidelines from the FDA, the need to link mechanisms of action to potency assays scientifically has never been more urgent.
At the 4th Cell Therapy Potency Assay Summit, we unite analytical development, quality control, and regulatory experts to tackle these pressing issues. Our goal is to collaboratively design robust potency assays that not only conform to changing guidelines but also streamline patient access to the next generation of cell therapies.
Whether you are preparing for your first IND or gearing up for BLA submission, this summit offers an unparalleled opportunity to gain insights from leading organizations like Arsenal Biosciences, BlueRock Therapeutics, the NIST and Vertex Pharmaceuticals.
Join us this March to equip your team with the industry and academic insights needed to develop practical and reproducible assays, providing a deeper understanding of your cell therapy products for autologous and allogeneic therapies across various cell types and indications.
VIEW THE NEW 2025 AGENDA
“Just having a space where AD, QC, and regulatory professionals can come together, discuss and shared experiences (negative and positive) on cell therapy potency assays is huge"
~ Associate Director, Quality Assurance, Fate Therapeutics, 2024 Attendee
The World-Class Speaker Faculty Includes
Previously Attending Companies Include
“What made the experience enjoyable and memorable was the opportunity to interact with professionals from various companies, ranging from big pharma to small biotech firms"
~ Senior Scientist, Arsenal Bio, 2024 Attendee
Our Partners
EXHIBITION PARTNERS
HOSTING PARTNER
“It was a great learning experience for me - with amazing talks, posters and networking”
~ Scientist, Immatics, 2024 Attendee
Other Events in the Series
Dec 3-5, 2024
Boston, MA
Develop Robust Analytical Methods & Tools in a Phase-Appropriate & Cost-Efficient Manner, to Improve Cell Characterization, Expedite Product Release & Gain Regulatory Approval
Returning in 2025
Ensure Therapeutic Efficacy, Meet Regulatory Standards & Elucidate Mechanism of Action of Complex Gene Therapies with Robust, Validated Potency Assays
Returning in 2025
Harness the Expanding Analytical Toolbox & Ensure Process Quality at Every Phase to Demonstrate Safety, Efficacy & Consistency of Gene Therapies to Regulators
“The audience and speakers, it great that they are all willing to have the open discussion to move us forward to bringing the product to the patient”
~ Senior Director, Analytical Development, IN8Bio, 2024 Speaker