Cell and gene therapies (CGT) are a sophisticated, highly promising and cutting-edge field of therapies. Drug developers’ level of interest in them, as well as in clinical trials including them, has significantly increased over the years. These complex biological products require an advanced level of understanding regarding pre-clinical and clinical development. Download the whitepaper to better understand these remarkable therapies and their impacts in clinical trials.

​Key Learnings:

• The growth and increasing interest in CGTs and related clinical trials
• How to demonstrate clinical success in both early phase and late phase clinical trials
• The importance of early engagement with regulatory agencies
• How to navigate the regulatory landscape and become familiar with critical guidance documentation and evolving regulations
• Clinical trial design guidance and planning, and understanding the factors that impact it
• Strategies for patient engagement
• How to keep abreast of developments and unique nuances in methodologies, applications, identification, and authorizations