Navigating Regulatory Strategies for Cellular & Gene Therapies

This webinar explores key regulatory considerations for developing cellular and gene therapies and navigating the product development process.

While any drug development program can face regulatory hurdles, developing cellular and gene therapies often presents unique challenges. Small and mid-size biopharma companies developing cellular and gene therapies should begin to understand critical nuances for successful regulatory meetings and submissions and how they impact strategic decisions during the product development life cycle. Understanding these regulatory pathways early in development can help companies prepare more effective strategies for clinical trials and regulatory submissions.

Webinar Agenda

• Regulatory requirements to initiate clinical trials for cellular and gene therapy submissions in the US and EU
• Differences in product submissions for cellular and gene therapies vs. small molecule drugs
• How to apply the Target Product Profile to guide product development