The FDA has hired more than 50 new reviewers in anticipation of receiving 200 applications per year from companies hoping to start clinical trials of gene and cell therapies and issuing 10 to 20 new approvals a year by 2025. This represents both an opportunity and great challenge for gene and cell therapy developers, who will need to learn how to navigate the regulatory process effectively. In this webinar, we’ll review the latest developments in the regulatory review process for gene and cell therapies, offering advice that companies can use to streamline their interactions with regulators, both in the U.S. and overseas.

Topics include:

• Understanding the FDA’s new guidance documents covering product development, accelerated approval pathways and other topics specific to gene and cell therapies.
• How to apply the lessons learned from Biomarin’s setback and other approval delays to improving development strategies for future gene and cell therapies.
• Comparing and contrasting the FDA’s policies for gene and cell therapies to those of regulatory bodies in other large global markets.