De-risking cell therapy product development: strategies for commercial success

Monday 08:00 PST / 11:00 EST / 16:00 GMT / 17:00 CET

Sponsor

De-risking cell therapy product development: strategies for commercial success

Cell and Gene-Modified Cell Therapies are revolutionizing the future of medicine. As the field continues to rapidly advance, it is paramount that sponsors de-risk manufacturing processes and analytics in development before entering the clinic to mitigate devastating technology transfer and clinical development setbacks. Thus, a scalable and robust framework for new products is critical in order to repeatably and reliably guide cross-functional teams throughout the product lifecycle.

It is important to implement effective commercial readiness risk management strategies right from the early stages of development. Identifying potential risks early on and proactively addressing them ensures a smoother and more efficient progression through the entire process. Implementing a standardized approach incorporating templated documentation that significantly streamlines batch record generation for GMP not only saves valuable time, but also enhances consistency and accuracy. During this webinar, we will discuss Charles River's new product introduction (NPI) framework and how we apply this approach to client programs to streamline the complex journey to the clinic and beyond.

Briefly review cell therapy and gene-modified cell therapy CMC challenges that impede commercialization
Explore critical elements that are required to de-risk preclinical lab scale process to achieve GMP standards
Examine a standardized, scalable, and robust framework for streamlining path to the clinic and beyond

Chad Andersen

Associate Director, MS&T at Charles River Laboratories

Chad is an Associate Director for the Manufacturing Sciences and Technology (MS&T) team which supports the cell therapy CDMO business. He obtained a Biological Sciences degree from the University of Nebraska and began his career in biopharmaceutical manufacturing in 2001. Since, he has held multiple roles in a wide range of biopharma organizations and has experience in early phase through commercial manufacturing operations. Chad is experienced in all aspects of biopharmaceutical production and has a complete understanding of FDA and EU regulations for biologics manufacturing.

Alex Sargent

Director, Process Development at Charles River Laboratories

Alex Sargent – better known as “Sarge” – is currently the Director of Process Development at Charles River Laboratories. He obtained his PhD from Case Western Reserve University in Cleveland Ohio, where he studied the challenges and promises of stem cell biology, neuroimmunology, and Cleveland sports teams. After a brief stint in academia at the Cleveland Clinic, he left Cleveland to pursue his industry career in cell therapy. During his many years in this industry, he has had the honor of working at several esteemed enterprises on new technologies and approaches for cell therapy scale up, automation, and gene editing. He is especially passionate about the challenge of curing cancer, working on CAR-T and CAR-NK cell therapy process and analytical development from discovery, through regulatory submission, manufacturing, and pivotal clinical trials. He wakes up each day excited to help advance cell and gene therapy to treat and cure disease, with the steadfast goal of improving human lives.