No room for error: preparing for inevitable variability in the cell and gene therapy supply chainPublished: September 30, 2019
Orchestrating cell and gene therapy logistics is complex and susceptible to variability at each point of the supply chain. When shipments are life-critical, delays and oversights can be fatal.
As operations scale from small populations in early-phase clinical trials to larger populations in late-stage trials and commercial launch, your supply chain complexity and risk increases. When issues arise, and a person’s life relies on your product being delivered intact and on time, you need established systems, processes and relationships in place to reroute, problem solve, and ultimately, deliver.
Watch this On Demand webinar for expert insights into navigating variability in the cell and gene therapy supply chain.
During this webinar our panelists explore:
- The complexity and variability of cell and gene therapy supply chains and potential impacts on manufacturing and therapy delivery deadlines
- How established relationships and well-designed, evidence-backed supply chain models can help ensure consistent, reliable product delivery
- The criticality of contingency planning and emergency preparedness to mitigate risk, minimize disruption and overcome the inevitable variability inherent to human-based therapy delivery supply chains
Jamie Margolis, PhD, Director, Cell and Gene Therapy Operations, Be The Match BioTherapies
Jamie Margolis is the Director of Product Development Operations for Be The Match BioTherapies, and has more than 9 years of experience managing the complexities of cellular therapies. Jamie and her team work closely with clients to understand their unique needs and determine how Be The Match BioTherapies can best support delivery of services based on client specifications. It is her team’s responsibility to ensure the smooth operational delivery of products and services to clients, such as supply chain management, development and management of collection networks, identifying and sourcing allogeneic donor cells, as well as regulatory compliance. She joined Be The Match BioTherapies’ parent organization, the National Marrow Donor Program/Be the Match, in 2009 and spent the first 6 years in patient case management supporting the operational needs of health care providers for stem cell transplant and troubleshooting unexpected disruptions that occur throughout the complex product delivery process. Jamie has worked for Be The Match BioTherapies since it was established in 2016. She holds her Ph.D. in Molecular Biology and Genetics from the University of Minnesota.
Lisa Fox, Co-Founder, Broken Lance Biotech Consulting
A cell and gene therapy professional with more than 25 years of experience in the development, cGMP manufacturing, and quality control for cell and gene therapy products. Lisa has successfully led development, manufacture and clinical delivery of ex vivo hematopoietic stem cells (HSCs), neural stem cells (NSCs), activated T cells, gene-modified T cell & HSC products as well as in vivo adeno-associated virus (AAV) products. Lisa has held leadership roles at Orchard Therapeutics, Sangamo BioSciences, StemCells Inc, and Xcyte Therapies and has experience preparing CMC regulatory submissions with for cell and gene therapy submissions in the US, Canada, Switzerland and Europe.
Ray Hornung, MBA, MBCI, CEM, CBCP, Manager, Logistics and Emergency Preparedness, Be The Match BioTherapies® and National Marrow Donor Program® (NMDP)/Be The Match®
Ray manages the Logistics and Emergency Preparedness team for Be The Match BioTherapies and its parent company, the NMDP/Be The Match. He and his team are responsible for managing the logistics for more than 22,000 cell and blood sample shipments a year. The NMDP/Be The Match has more than 30 years of supply chain and logistics experience in the first cell therapy, blood stem cell transplant with more than 92,000 cell therapies managed and delivered. Prior to joining the NMDP/Be The Match and Be The Match BioTherapies, Ray spent 23 years on active duty in the Army performing operations and logistics.
Robert Margolin, VP of Corporate Development and Strategy, TrakCel
Jason Krentz, Chief Technology Officer, Head of Technical Operations, Tmunity
Jason Krentz is currently Chief Technology Officer at Tmunity Therapeutics, a private clinical-stage T cell immunotherapy company. Jason has extensive technical leadershipexperience in the development and manufacturing of biologic and cell-based products atestablished and emerging pharmaceutical and biotech companies. He joined Tmunity from Endo Pharmaceuticals where he was Vice President of Endo’s biologics manufacturing and technical development organization. Prior to Endo, Jason was Vice President of Technical Operations and Head of CMC Project Management at Auxilium Pharmaceuticals, responsible for global manufacturing and supply chain, technical development and alliance management activities. Prior to joining Auxilium, Jason was Head of Technical Operations at Tengion, a clinical stage developer of autologous regenerative medicine therapies. Earlier in this career, he worked at Centocor / Johnson & Johnson where he held a variety of technical roles including head of upstream manufacturing operations at a large-scale mammalian cell culture facility. Jason holds an MBA from St. Joseph’s University and a BS in Materials Science and Engineering from the University of Michigan.