Standardized Techniques for Navigating the Cell and Gene Therapy Supply ChainPublished: July 30, 2018
Delivering solutions to the challenges of manufacturing gene and cell therapies has never been so significant, as more products move towards commercialization. The supply chain for these potentially transformative therapies is uniquely complex, making it essential to understand and optimize the various components including standardization and risk mitigation with your outsourcing partners.
In this webinar, our panelists explore standardization techniques for the cell and gene therapy supply chain, addressing issues such as:
- The feasibility of achieving standardization with so many elements to your supply chain logistics;
- How we as an industry can approach standardization;
- Advantages and disadvantages of outsourcing and managing your supplier relationships to minimize risk;
- Key considerations when assessing which elements of your supply chain could or should be outsourced.
Jamie Margolis, Director of Product Development Operations at Be The Match BioTherapies
Director of Product Development 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.
Dr. Mark Dudley, SVP Bioprocessing & Development CMC, Technical Operations at Adaptimmune Therapeutics
Dr. Mark Dudley is a Senior Vice President at Adaptimmune Therapeutics, a leader in genetically modified T cell therapies for solid cancers, where he is responsible for manufacturing and development. Dr. Dudley has been a pioneer in the field of immunotherapy manufacturing, and has developed and implemented innovative early process design with accompanying analytics for multiple therapies. Previously, as Director of New Cell Products in the Cell and Gene Therapies division of Novartis Pharmaceutical Corp, Dr Dudley was responsible for establishing scalable, GMP-compliant production strategies and facilitating globalization of CAR-T products and platforms. As Director of the Cell Manufacturing Facility at the Surgery Branch of the National Cancer Institute, NIH, in Bethesda, MD, Dr Dudley investigated tumor rejection antigens, T cell specificity and function, and methods for the generation and administration to patients of T cell therapies. His work has resulted in more than 100 peer-reviewed publications, and he is co-author on numerous seminal papers including early tumor-infiltrating lymphocytes studies demonstrating that adoptive T-cell transfer has tumor eradicating potential. Dr. Dudley earned a Ph.D. in Biological Sciences at Stanford University, and had post-doctoral fellowships at The University of Pennsylvania in Philadelphia, PA and at the Jackson Laboratory in Bar Harbor, ME.