CRISPR cell and gene therapies allow clinicians to address the root cause of genetic disease. However, taking these complex biologics from discovery to delivery requires both scientific and regulatory expertise. This eBook explores the CRISPR regulatory space, from clinical trials to regulatory frameworks, and Synthego’s regulatory support for your CRISPR-based therapeutic journey.

Recent years have seen unprecedented growth in the CRISPR cell and gene therapy field, especially with the landmark approval of the first-ever CRISPR-based therapeutic in 2023, CASGEVY®. However, many scientists developing CRISPR-based medicines have experienced difficulties navigating the regulatory landscape, often impeding their progress into clinical trials.

Developing successful CRISPR therapies demands expert knowledge of regulatory affairs and clinical development. In this eBook, Synthego’s experts guide you through the evolving CRISPR regulatory space, exploring the following key concepts:

  • CRISPR clinical trials, understanding regulatory frameworks, causes of preclinical failure and potential solutions
  • Updated FDA guidances as they relate to CRISPR therapies, recent regulatory trends and initiatives
  • Synthego’s comprehensive regulatory support offerings, including CMC module preparation, expert regulatory strategy, and discovery to delivery support

Download the CRISPR Clinical Trials and Regulatory Approval of CRISPR Therapy Drugs eBook today!