The first autologous CAR-T therapy was approved in 2017, and the industry has since gained substantial operating experience, treating tens of thousands of patients globally. Some drug sponsors have developed in-house teams to manage, improve, and maintain the infrastructure needed for these complex therapies, while others have opted to outsource these responsibilities. The supply chain for autologous CAR-T therapies has been a focus of improvement since the early trials, especially the transport of cells. Significant investment have aimed to make the supply chain more predictable and reliable.
While outsourcing the supply chain to a single logistics supplier is now more feasible, active management of the supply chain remains crucial for maintaining quality and efficiency. Managing this task internally may lead to inefficiencies, especially when compared to using partners experienced in onboarding centers for multiple clients. However, some drug sponsors prefer to manage collection center qualification internally due to the specific protocols required for each autologous CAR-T therapy, ensuring tighter control over standards and processes.
Attend this webinar for insights from a panel of industry experts who will discuss these developments and how the industry can continue refining its process. They will review the successes and challenges of both in-house and outsourced models based on their extensive experiences, compare various approaches to building a collection center network. and consider potential inefficiencies when approaching the task individually compared to using a partner.
Attend this webinar to:
- Gain insights into the current state of the industry regarding outsourcing versus insourcing collection center onboarding and operations
- Explore the logistics of cell therapy logistics to support autologous cell and gene therapies
- Understand the financial, timing, and control challenges associated with each approach
- Discover the basic framework for evaluating whether or not outsourcing makes sense in their particular situation
Amy Hines
Vice President, Apheresis Strategy at Cryoport Systems
Amy Hines BSN, RN is the Vice President of Apheresis Strategy at Cryoport Systems, where she supports IntegriCell™ cryopreservation services. With a background in oncology and transplant nursing, Amy brings over 25 years of cellular therapy experience to her role. Before joining Cryoport Systems, Amy worked with NMDP and NMDP-BT where her responsibilities included oversight of apheresis and marrow collection network partner activities. She is mission-driven and known for her leadership, strategic thinking, and collaborative, innovative approach in tackling challenges. In her free time, Amy enjoys gardening, tending to her small farm, and enjoying the Northern Michigan outdoors.
Jeni Newman
Senior Director, Operations at NMDP BioTherapies
As Senior Director, Operations, Jeni leads the SupplyChain (logistics and case management), Donor (donor screening and workup),Network (onboarding and expertise associated with apheresis), ProcessDocumentation & Improvement and Vendor teams. She and her teams arededicated to the flawless delivery of services for cell and gene therapydevelopers.Prior to her current role, Jeni held leadershippositions in the NMDP parent organization as a leader in the Donor Contactteams, Director of Case Management and Senior Director of OperationalExcellence, where she most recently provided strategic direction and leadershipto a group that maintained relationships with over 140 domestic transplantcenters and led the relationship with 80 international partners. Growing thatteam to support increasing volumes while strategically changing how theysupported the NMDP vision, she delivered a 98% satisfaction rating withcustomers.During the COVID-19 pandemic, Jeni led manyoperational initiatives while maintaining global operations. Additionally, Jeniled the deployment of new functionality for our customers, increasing customersatisfaction with the application from 70% to 97% in 5 years.Jeni earned a bachelor’s degree in Biology from theUniversity of Minnesota Duluth.
Marcel van Houten
Director Global Supply Chain at Orchard Therapeutics
Seasoned professional serving the Cell and Gene Therapy Landscape for Clinical & Commercial Ultra Rare Diseases (i.e. MLD - Metachromatic Leukodystrophy) as Director Global Supply Chain & Distribution
as well as heading the Site Qualification Team for qualifying QTC / ATC (qualified / authorized treatment centres) globally for autologous treatments.
25+ years history as Supply Chain and Procurement Leader in Cell & Gene, Medical Devices, Aviation and Real Estate.