In May, around 1,500 cell therapy developers, academics, clinicians and standardization body representatives gathered in Montreal, Quebec for one of the leading conferences on cell and gene therapies, the International Society for Cell and Gene Therapy (ISCT) Annual Meeting. “Now in its 26th year, the meeting has grown significantly since its early days and is now even more focused on supporting the delivery of commercial therapies,” says Mark Flower, Vice President of Business Development and Strategic Partnerships at Be The Match BioTherapies®.
The meeting’s evolving commercial focus was precisely where Chris McClain, Vice President of Sales and New Business Development at Be The Match BioTherapies, directed his remarks. Chris gave a presentation titled “Auditing, Onboarding, and Managing Apheresis and Marrow Collection Networks to Support Late-Stage Clinical Study and Commercial Launch of Cell and Gene Therapies” that addressed how leveraging Be The Match’s apheresis center network and apheresis network onboarding and management capabilities can help minimize burden on individual centers, reveal opportunities for standardization, and in turn, deliver cell therapies more efficiently and consistently.
Be The Match BioTherapies’ expertise in apheresis network management stems from our parent organization, the National Marrow Donor Program®/Be the Match®. Throughout the last 30 years, the organization has built and managed a national network of more than 80 apheresis centers, and established relationships with many more worldwide. “We know from experience that these networks can’t run themselves – they require a lot of ongoing training and management, and also rely very heavily on trust and relationships,” Chris said. “As commercialization grows, the industry is becoming aware that these seemingly small pieces of the puzzle, for example, creating and managing an expansive and highly efficient apheresis network, are not only extremely critical, but also very complicated,” added Julie Smolich, Vice President of Product Management.
Another conference highlight was a presentation by Steven Oh, Deputy Director of the Division of Cellular and Gene Therapies at the FDA. The presentation, titled “Manufacturing CAR-T cells for global market: U.S. regulatory perspective,” also reflected on the inevitable growth and expected global commercialization of cell and gene therapies. “It’s about much more than just products being approved, it’s about how they’re going to be delivered across multiple geographies into varied environments. As Director Oh pointed out, opportunities for standardization that facilitate this delivery will need to be addressed. It’s an important consideration that a growing number of cell therapy developers are now confronting head on,” Mark said.
“I think everyone’s anticipating that the volumes are going to increase significantly as therapies are approved for more and larger indications,” said Chris. “So, the industry as a whole is preparing for it, and we’re helping both our clients and the apheresis centers prepare by leveraging our already established relationships to develop apheresis networks specific to individual therapies.”