The Cell and Gene Therapy (CGT) clinical supply chain requires a higher level of logistic coordination, and communication while timelines must be shorter and transportation more agile to ensure cell viability. The temperature controlled aspect of it is even more complex as different legs of the journey require different temperatures for storage of the products. Come to this webinar to learn about the differences between the different Cell and Gene therapies, an overview of CGT development, transportation requirements and tips and techniques on how to ensure CGT products are well controlled from apheresis, to supercharging the cells all the way to patient infusion.
At the end of this webinar the attendee will be able to:
- Explain the difference between Autologous and Allogeneic sourced cells
- Describe the challenges of the supply chain for cell/ gene therapies
- Compare and contrast the logistics requirements of standard cold chain products versus cell and gene therapy products
- List at least two (2) concerns in the handling of cell and gene therapy clinical materials and how to mitigate those concerns
Steve is a successful trainer, business leader, consultant, executive coach and speaker. For the past 25 years he’s been heavily involved in clinical supply chain operations, IMPs, cGMPs, cGCPs, cGDPs, clinical development and quality (ICH Q8, Q9 & Q10) for pharmaceuticals, and biotech products.
He sits on the Board of Directors of the largest professional clinical supply organization in the world, the Global Clinical Supplies Group. His expertise also includes success in innovation, global cultural dynamics, organizational development, and high performing teams.
In the past he has been a CEO and COO, as well as the president and Global Chief Operating Officer, of a multinational clinical supply chain contract organization that served companies like Novartis, Eisai, Lilly and others in the pharmaceutical and biotech sector. Before that he was head of US clinical supply operations for Johnson & Johnson.
Steve was also a logistics and aviation officer, in the U.S. Army, where he rose to the rank of Major and was a maintenance test pilot, and pilot in command, for both helicopters and fixed wing aircraft.
His undergraduate degree is in Pharmacy from the University of the Sciences in Philadelphia and his MBA is from the University of Phoenix with a specialization in global management.