Welcome to the 2nd CRISPR-Based Therapy Analytical Development Summit!

As genome editing therapies become ever-complex, drug developers urgently need to innovate the analytical tools available to effectively characterize the critical quality attributes of their drug substances and drug products. We are also witnessing increased regulatory scrutiny, with the FDA closely studying off-target analysis conducted ahead of the approval of Casgevy, before finalizing guidance for the field in January.

To meet the growing analytical demands you face, the 2nd CRISPR-Based Therapy Analytical Development Summit returned to unite 50+ key figures across Analytical Development, CMC & QC domains, all with the common goal of developing more precise, accurate, and sensitive analytical assays.

Delegates & speakers joined us in 2024 to discuss the most recent analytical innovations across both traditional and disruptive CRISPR-based therapies, and in vivo and ex vivo delivery; with expert discussions covering the following core themes:

• • Characterization of guides, nucleases, delivery modalities, and full drug products, with Editas Medicine, Beam Therapeutics & Nvelop Therapeutics

• • Robust non-clinical and CMC assay development, including biodistribution studies, potency assays, and on-/off- target sequencing detection, nomination, and prediction, with Tome Biosciences, Verve Therapeutics & Vertex Pharmaceuticals
  • Meeting regulatory expectations for analytical data to successfully support IND submissions, with NIST, Prime Medicine & Metagenomi

If you are working to develop, characterize, and validate more robust analytical tools to enable the progression of your early R&D work into a clinical therapy, this is the collaborative forum to equip you with the latest innovation, case studies, and actionable insights to boost your analytical panel and strategy. Returning in 2025, please register your interest to receive updates on the upcoming meeting.