A challenge in #CGTdevelopment lies in the bespoke nature of these treatments, resulting in a multitude of proprietary solutions that demand extensive time and resources for both developers and regulators.
Traditional drug development timelines and regulatory frameworks may not adequately accommodate the unique characteristics of CGTs, leading to significant delays and costs, particularly for rare diseases where patients have limited time for treatment.
To ensure sustainability and broader access to CGTs, the industry must transition away from traditional approaches and streamline technological foundations to reduce costs and accelerate development timelines.
A recent initiative co-sponsored by the Alliance for Regenerative Medicine and NIIMBL | The National Institute for Innovation in Manufacturing Biopharmaceuticals aimed to identify building blocks and platform technologies to streamline CGT development and regulatory review, with this whitepaper offering an overview of sector challenges, regulatory paths, and proposed building block solutions.
Read more below!
h/t to Lindsay Gasch, PharmD, BCPS, BCACP
FDA
https://lnkd.in/eU5tQwFj
#cgt #fda #arm #NIIMBL #CDER #CBER #industrycollaboration #manufacturing #patientoutcomes #technologydevelopment
Vice President of Product Development @ Aurinia Pharmaceuticals Inc. | Medical Affairs
2moCongrats Sim. Exciting times ahead for you and the Dianthus team.