Develop, Characterize, and Validate Robust Analytical Tools that Demonstrate Safety, Efficacy, and Regulatory Compliance of Genome Editing Therapies

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

As CRISPR-based therapies become ever complex, drug developers urgently need to innovate the analytical tools available to effectively characterize their safety and efficacy profiles and agree upon gold standards moving forward. We are also witnessing increased regulatory scrutiny, with the FDA closely studying off-target analysis conducted ahead of the approval of Casgevy, prior to finalizing guidance on genome editing therapies in January.

To keep up with these growing analytical demands, the 2nd CRISPR-Based Therapy Analytical Development Summit is returning 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.

Expert discussions will highlight analytical innovation with both traditional and disruptive CRISPR-based therapies, and span in vivo and ex vivo delivery, covering the following core themes:

  • Characterization of guides, nucleases, and full drug constructs
  • Robust non-clinical and CMC assay development, including biodistribution studies, potency assays, and on-/off- target sequencing detection,   nomination, and prediction
  • Meeting regulatory expectations for analytical data to successfully support IND submissions

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 your collaborative forum to equip you with the latest innovation, case studies, and actionable insights to level up your analytical efforts.

2024 EXPERT SPEAKERS:

Zak Zhang, Beam Therapeutics - CRISPR Based Therapy Analytical Development Summit

“With a broad representation from industry, academia, and regulators, I look forward to attending this year’s CRISPR-Based Therapy Analytical Development Summit and exchange ideas with peer researchers and developers.”

- Zack Zhang, Director, Analytical Development at Takeda Pharmaceuticals

Andrew Kernytsky - CRISPR Based Therapy Analytical Development Summit

“It’s a great opportunity to talk about the trials and tribulations (and occasional glory) of getting CRISPR therapies to patients!” 

- Andrew Kernytsky, Principal Consultant at Next Gen Editing

Daniel O'Connell, Tome Biosciences - CRISPR Based Therapy Analytical Development Summit

“The 2024 CRISPR-Based Therapy Analytical Development Summit is an exciting conference because it brings together industry and academic leaders that are breaking new ground in genome editing to drive community consensus on standards for non-clinical and CMC assay development.” 

- Daniel O'Connell, Senior Director at Tome Biosciences

Who Attended in 2023?

CRISPR Based Therapy Analytical Development Summit
CRISPR Based Therapy Analytical Development Summit
CRISPR Based Therapy Analytical Development Summit
CRISPR Based Therapy Analytical Development Summit
CRISPR Based Therapy Analytical Development Summit
CRISPR Based Therapy Analytical Development Summit
CRISPR Based Therapy Analytical Development Summit

2024 Partner:

Aldveron - CRISPR-Based Therapy Analytical Development Summit

Next in the Gene Therapy Series for 2024