Welcome to the Inaugural Cell Therapy Potency Assay Summit

As cell therapy continues to grow at a mind-blowing rate, with constructs growing in complexity, the need to effectively define and standardize a qualitative potency assay is greater than ever.

Overcome the regulatory roadblocks halting clinical and commercial progression by uniting as a community to bench-mark next-generation assays and share regulatory experience to help fast-track the field to approval.

Hear from the likes of Bluebird Bio, Achilles Therapeutics, Bayer, IN8 Bio, Turnstone Biologics, Precision Biosciences and more across three days, with two unrivalled workshops, dedicated Q&A time, interactive panel discussions, and highly appraised networking opportunities to meet and learn from the leaders pioneering this field.

Tackle the top 5 priorities in the field, including:

  1. Create an Effective Regulatory Strategy
    Fast-track your clinical submissions by brainstorming with industry experts on how to align potency assays with ICH and USP guidelines, questioning absolute Vs relative potency, and clarifying current FDA expectations with Precision Biosciences & Affini–T Therapeutics

  2. Relating Potency to Clinical Efficacy
    Benefit from data-driven case studies on the development of phase-appropriate potency assays, and explore those correlated with clinical efficacy with Cabaletta Bio & Turnstone Biologics

  3. Overcoming Cryopreservation Impact on Potency
    Assess stability-indicating analytical methods for cryopreserved CAR-T cells to understand the impact of freezing and thawing on potency in autologous and allogeneic cell therapies with Bristol Myers Squibb

  4. Overcome Variability and Achieve Consistency in QC
    Appreciate lot-to-lot variability of allogeneic therapies, considering donor and assay variability, and develop consistent potency methods fit for a QC setting with Atara Biotherapeutics

  5. Commercial Application – Develop BLA-Ready Assays
    Prevent approval delays with commercially sound assays, outlining decision making for late-stage selection, discussing translational strategies from R&D through to commercial and production with Bluebird Bio

The Cell Therapy Analytical Development Meeting provided great content and exposure to the latest progress being made in the field
Director, Potency, Analytical, Cell Based Assay, Center Excellence & Biologics Bioprocess, Merck