starting material Archives

Coordinating the collection and delivery of cells for cell and gene therapy developers begins long before the first patient or donor is collected. Our Be The Match BioTherapies® Collection Network Liaison team works with cell and gene therapy clients to understand their needs. Then, they use established, standardized approaches to onboard, audit and train the apheresis centers best suited for the specific cell harvest protocols. The team relies on the proven infrastructure and systems used to manage the National Marrow Donor Program® (NMDP)/Be The Match® network of more than 100 marrow and apheresis collection centers. They are also responsible for the ongoing support of centers. This helps collections run smoothly and efficiently for the collection of consistent, compliant and high-quality cells for each product. The team includes five collection network liaisons: Christine Barlow, RN; Lauren Ghazarian, RN; Carlos Ruiz; Erin Schaller; and Julie Tilbury, RN. Here the liaisons discuss the industry challenges they are seeing. They also explain Be The Match BioTherapies’ role in helping cell and gene therapy companies and apheresis centers overcome those challenges. The cell and gene therapy industry has experienced rapid growth in recent years. What are some of the challenges apheresis and collection centers and cell and gene therapy companies are facing? Julie: For cell and gene therapy companies, there are specific requirements that an apheresis or collection center must meet in terms of their capabilities. When a company is starting to build its network, it can be hard to know which centers meet the necessary requirements. Because we have longstanding relationships with many of these centers, we can help companies put those pieces of the puzzle together more efficiently to help expedite the time to onboard centers to the specific protocols. Carlos: With the rapid growth of cell and gene therapies in clinical trials, centers have experienced the challenges and opportunities that come with that growth. The field has grown so quickly that standardization, where possible, is important to be able to provide efficiencies for centers onboarding new clinical trials. That’s an area where Be The Match BioTherapies is trying to step in to help. Lauren: Seeing the amount of clinical trials that are out there, centers are really getting bombarded with all of them. The collection protocols are similar in a lot of ways, but there’s these little nuances that make them completely different, which can make the onboarding of multiple trials in a single center challenging. What is your role in helping centers and companies overcome those challenges? Erin: We listen to the apheresis centers, hear what they need, and share that information with the cell and gene therapy companies, as well as vice versa. Apheresis centers are able to adapt to the changing landscape. But they need to know why a change is needed and what specific protocol nuances need to be carefully managed. Because, at the end of the day, the safety of the patient or donor in front of them is their first priority, followed by the quality of the material they are collecting for further manufacturing. Julie: These collection sites all want to do everything they can. They see the great benefit of these therapies for patients in need. They all recognize there is so much more to be done for patients, and they want to be part of that. It truly comes down to support, communication and quality education for both the centers and the cell and gene therapy companies to try to overcome the barriers together and collect starting material that meets the needs of the manufacturer. Carlos: Every center is unique. I do my best to leverage the relationship with the collection center, as well as the cell and gene therapy company, and provide both of them what they need to have a successful collection and a successful product for the patient. Lauren: We have the opportunity to be on site and have communications face-to-face with centers. We are partners with the centers in delivering quality starting material. The fact that I can advocate for centers, I can advocate for patients, I can advocate for the cell and gene therapy companies, and that my voice can make a difference—that's a really exciting, unique opportunity. What are you most excited about when it comes to the cell and gene therapy field? Erin: The number of lives we can positively impact. It’s exciting to be able to make a difference, to make the process of cell harvest more efficient so that we can help as many patients as possible. That’s what it’s all about. Julie: I see the future of the cell and gene therapy industry as having the opportunity to make a great impact. To be part of this industry with an organization like Be The Match® that has so much history, so much experience, so much success –it is an incredible thing to me. Lauren: This is the future of medicine, and we are providing hope to patients and their families where previously they may have had none. Discover how our team can help your company onboard and train your collection center network for autologous cell and gene therapies.

starting material

Overcoming challenges to cellular starting material collection