Snow has been something of a theme this conference season—and the inaugural CAR-T Congress USA in Boston was no exception. While the threat of yet another major storm may have kept attendance down, it did nothing to dampen the spirts of the more than 100 thought leaders from biotech, big pharma, academia and finance who gathered in Boston to address the challenges and opportunities of CAR-T therapies.
“The weather wasn’t a problem,” said Abby McDonald, PhD, senior business lead in product development operations for Be The Match BioTherapies®. “In fact, given the smaller crowd, there was a very focused, balanced approach to attending sessions and networking.”
CAR-T Congress USA follows the successful CAR-T Congress Europe, held earlier this year in Berlin. While the official focus of both “sessions” was the expansion of CAR-T therapies into other liquid and solid tumors, the buzzword that really dominated the three-day conference was standardization. In spite of CAR-T’s recent commercial splash, many are still expressing concern over how to regulate and manage the inherent variability in CAR-T products.
“We heard lots of questions from both the academic and industry attendees about how to balance variability and standardization,” said McDonald. “Patients, healthcare providers and physicians in particular are concerned with the variability they see across the different companies and the way the cell therapies are either ordered and manufactured or delivered.”
During a panel discussion on expanding CAR-T cell therapy to a global population, Vice President of Product Management, Julie Smolich, was asked how Be The Match BioTherapies manages to ensure that the manufacturing steps, including the apheresis collection, are performed in a standard and regulatory compliant manner. In her response, she outlined the detailed oversight process.
“Before initiating collection activities at any apheresis center, Be The Match BioTherapies manages a rigorous and comprehensive onboarding process. Centers are selected based on our knowledge of the site and the probability that the center has the capabilities required for the client. The center must meet our participation criteria, which includes accreditation by FACT and/or AABB, and host an on-site qualification audit. The Be The Match BioTherapies audit team reviews all pertinent SOPs, policies, and quality plans and inspects the center for compliance with applicable GMP/GTP requirements, FDA requirements and any specific client requirements. Once the center has been qualified and a signed Quality Agreement and Be The Match BioTherapies Agreement is in place, our network management team provides all training, SOP templates and other supporting materials to the center to ensure standardization and consistency of the collection activities. Our Network Liaisons oversee all Be The Match BioTherapies collection activities at their assigned centers, which can include refresher training when needed, and monitor key performance indicators (or KPIs). This real-time monitoring enables the Network Liaisons to identify any potential impacts to quality, uniformity and compliance.”
The discussion, which centered around managing the variability and disruptions that can happen with human-involved therapies, also included Gary C. Du Moulin, Ph.D., Professor of Regulatory Affairs at the Massachusetts College of Pharmacy and Health Sciences University, and Incysus co-founder Lawrence Lamb.
Following the panel, Julie went on to emphasize that although technology often gets the lion’s share of the attention, when it comes to standardization and supply chain management it’s only one piece of a broader solution.
“The piece that ties all of this together is dedicated patient and therapy case managers who are supported by a software platform and oversee the entire case progress, from referral to therapy infusion,” she said. “They draw on a reservoir of existing information and strong relationships to solve challenging problems and manage those inevitable disruptions.”