This webinar covers key regulatory strategies important to first-in-human trials for cellular and gene therapies. While any drug development program can face regulatory hurdles, developing cellular and gene therapies often presents unique challenges.At the end of this webinar attendees should have a better understanding of:1. Regulatory requirements to initiate clinical trials for cellular and gene therapy submissions in the US and EU.2. Differences in product submissions for cellular and gene therapies vs. small molecule drugs.3. How to apply the Target Product Profile to guide product development.