This playbook will discuss how to navigate the regulatory and tech-transfer challenges that often arise throughout regulatory review for CGTs.
As technology advances, the demand for cell and gene therapies has surged: the global market for biologics is estimated to reach $201 billion in 2034. Delivering on the promise of CGTs in a complex and crowded landscape is forcing sponsors to find robust strategies for regulatory success and tech transfer. There are also unique complications for scaling manufacturing to reach patients across target global markets.
This playbook will discuss the regulatory and tech-transfer challenges that often arise throughout regulatory review for CGTs — and the steps sponsors can take with the right partners to streamline their path to market. Highlights include:
- Which regulatory and tech-transfer challenges most often affect CGTs developers.
- Strategies and best practices sponsors can adopt to develop a strong regulatory strategy and scalable manufacturing plan.
- How to find the right external partners for expertise and technical support for successful commercialization.
Offered Free by: BioPharma Dive’s Studio by Informa TechTarget and ProBio
See All Resources from: BioPharma Dive’s Studio by Informa TechTarget and ProBio
