CAR-T cells have entered the oncology therapeutic market as real game changers with the premise to provide one treatment to offer a curative effect. Two products have so far been approved and many more are in the pipeline to approval. The exponential growth of research by innovative companies has led to many other associated technologies and the overall cell-and gene-therapy market is the largest growth sector in the biopharmaceutical industry. Although these cell-based gene therapies provide major treatment opportunities, the innovative nature increases the residual risk which needs to be addressed by sufficient regulatory oversight. The complex chain from patient to manufacture back to patient for patient-specific products poses many challenges. Additionally, little is known about long-term safety at this stage.
The session brings together industry experts working in this fast-moving field to share their lessons learned and best practices. What are the technologies involved and regulatory requirements and standards currently available and how were they applied? What are the different regulatory considerations for patient-specific therapies versus off-the-shelf products? Are there any special ethical considerations? What opportunities for interactions with the regulators were taken? Was there any negotiation on specific requirements and/or to influence regulator to explore new ground?
Three industry experts will share their experience in developing a CAR-T cell therapy technology addressing pitfalls, hurdles, successes and lessons learned. The audience will have ample time to ask questions and support the session by providing responses to polls throughout the session, discussing their experience during the final panel discussion.
Describe the regulatory and development challenges associated with CAR-T cell technologies.
Discuss the specific regulatory considerations involved for successful development and approval.
Identify regulatory support options to optimize development plans for time and cost savings.