Embedding Regulatory Strategy in Cell and Gene Therapy Development

For cell and gene therapy programs, early development decisions can have a significant impact on regulatory success, development timelines, and overall program risk. Embedding regulatory strategy from the outset helps developers identify critical challenges early, align development activities with product-specific requirements, and build a stronger foundation for future clinical and commercial milestones.

In this GEN webinar, experts from Rose BioSolutions, a CDMO and Cell Solutions organization formed from Charles River Laboratories’ businesses, will discuss how integrating regulatory strategy at the earliest stages of development can reduce overall risk and improve program outcomes. Attendees will learn how a well-defined Target Product Profile (TPP) can guide decision-making across the drug development lifecycle, and help teams prioritize activities, anticipate regulatory expectations, and develop a fit-for-purpose CGT manufacturing and testing strategy. Presenters will use real-world case studies to highlight common cell and gene therapy product development challenges and practical approaches to addressing issues such as sterility testing, interim product release, and device compatibility at patient infusion.

Key Takeaways

• How to implement a regulatory strategy during program scoping to align development activities with product-specific risks and compliance expectations
• Why a Target Product Profile (TPP) should be established at the beginning of development and how it guides strategy, critical quality requirements, and risk mitigation plans
• How early identification of product-specific challenges can help minimize unnecessary regulatory information requests, avoid manufacturing delays, and support timely patient treatment
• Practical strategies for developing a more efficient, inspection-ready path from early development through clinical manufacturing and commercialization

A live Q&A session will follow the presentation offering you a chance to pose questions to our expert panelists.

Produced with support from: