About Event

The 6th Cell Therapy Analytical Development Summit was dedicated to enhancing analytical methods to accelerate product progression through IND and clinical trials, securing regulatory approval more efficiently.  

Unlike other events including the CAR TCR Summit, this meeting focused on the critical role of analytical departments and quality control in reducing turnaround times and meeting regulatory standards. 

We were joined by industry leaders and 40+ expert speakers from companies like Bristol Myers Squibb, Takeda, and Kite Pharma to explore advances in immunophenotype, cell-based, and molecular assays. Attendees discussed phase-appropriate development, assay matrices, and specifications.

They engaged in 8+ hours of networking, data-driven case studies, and discussions to tackle challenges from product characterization to scale-up. Attendees left with actionable insights to expedite their analytical package and product release.

This Was Your Chance To:

1

Learn to navigate analytical development guidelines and method validation with KSQ Therapeutics, focusing on controversial aspects and early regulatory engagement

2

Discover how liquid handling robots, scheduling software, and organs-on-a-chip improve assay workflows with insights from Prime Medicine, Arsenal Biosciences, and Vertex Pharmaceuticals

3

Explore analytical development challenges from early trials to post-approval with Bristol Myers Squibb and the University of Minnesota, and discuss adapting methodologies to meet evolving needs

4

Address immunotherapy characterization challenges such as antigen specificity and T-cell functionality with Verismo, IN8bio, and Century Therapeutics, focusing on autologous vs. allogeneic therapies

5

Redefine potency assays with TR1X Bio and Vertex Pharmaceuticals, developing functional assays for engineered immune system evasion while balancing robustness with clinical trial needs

Who Would You Have Met?

This meeting united technical leads and decision-makers across cell therapy analytical development and quality control with expertise spanning across all assay types and technology focus working on early and late-stage cell therapy development to support learning across the analytical department.

Cell Therapy Analytical Development
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What Your Peers Have to Say:

"This summit highlights the need for continued conversations on analytical assay design for cell therapies. In 2024, I look forward to discussing major changes ushered into CGT development via the novel platform technology designation and potency assurance.”
Manager, Science & Industry Affairs, Alliance for Regenerative Medicine (2024 Speaker)

"With constantly evolving therapies and their regulations, it is important to have a space like this for the stakeholders to come together and share their knowledge and experiences.”
Senior Scientist, Process Development Drug Substance, Satellite Bio (2024 Speaker)

"I have been a regular attendee at this conference and it's always been a spot to meet new cell therapy SMEs and reconnect with some others.”
Head of Analytical Development, Takeda (2024 Speaker)

"The 6th Cell Therapy Analytical Development Summit is a pivotal event for advancing the field of cell therapy. It provides an unparalleled platform for sharing cutting-edge research, fostering collaborations, and addressing the latest challenges in analytical development. I am eagerly looking forward to the 2024 meeting in Boston to engage with industry leaders and contribute to the discussions that will shape the future of cell therapy.”
Director, Quality Assurance & Regulatory Affairs, University of Minnesota (2024 Speaker)

"I enjoyed the well-organized conference and streamlined tracks of different focus. I learned what the key questions are that all are interested in and need to be addressed, which will guide us to better develop cell therapy drugs.”
Principal Scientist, Merck & Co. (Past Attendee)

"Cell therapy processes and assays are very complex. We are looking forward to hearing about new technologies and innovations in cell therapy development. We also would like to learn the regulatory perspective towards release assays.”
Vice President, Cell Therapy, Aisaer/IxCell Biotechnology (2024 Speaker)
2024 EVENT GUIDE
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