In a recent Pink Sheet roundtable experts from Lachman, Regenxbio, PPD and Etena Therapeutics discussed key considerations for designing and implementing successful CGT quality systems, including developing successful regulatory strategies, implementing effective quality systems that ensure CGT quality and compliance, and navigating manufacturing capacity and scalability challenges that may deter patient access.
Removing Roadblocks for Cell & Gene Therapies | PDF
Panelists included:
- Richard Dennett, Senior Director, CMC & Regulatory Strategy, PPD
- Keith Lamb, PhD, Executive Director, Lachman Consultant Services
- Susan McClatchey, Vice President, Quality, Eterna Therapeutics
- Sarah Thomas, Senior Vice President, Quality, REGENXBIO
- Shardha Millington, Consultant, Citeline (Moderator)
Key Takeaways:
- An effective CGT quality system depends on having the right people, following guidelines, and prioritizing flexibility
- To achieve a successful quality system, CGT manufacturers must be strategically selective, expect obstacles, and plan far in advance
- Engaging with regulators early is key to navigating roadblocks and addressing internal concerns
- Following in the footsteps of traditional pharma, the future of CGTs is likely to be platform based
