Be The Match BioTherapies®, an organization offering solutions for companies developing and commercializing cell and gene therapies, and the CIBMTR® (Center for International Blood and Marrow Transplant Research), a research partnership between the National Marrow Donor Program® (NMDP)/Be The Match® and the Medical College of Wisconsin that collaborates with the global scientific community to advance hematopoietic cell transplantation (HCT) and cellular therapy worldwide, today announced the outcomes of its second annual Standardization Summit (the Accellerate Summit), held May 29, 2019, in Minneapolis, Minn. The 2019 event convened distinguished stakeholders to discuss efforts to ensure accelerated and broadened patient access to the next generation of cell and gene therapies.
In panel discussions and small group sessions, more than 80 attendees from biopharma, health care, standards setting bodies and regulatory organizations discussed opportunities for increasing efficiency. Session topics centered around strategies for standardization in light of the rapidly growing demand for cell and gene therapy starting material and concomitant strains placed on those organizations collecting cells and delivering therapies. More than 800 cell and gene therapy clinical trials are registered with the FDA, and that number may double within five years. According to key stakeholders, including those in attendance, continued industry growth depends on standardization, particularly through the development of more streamlined processes for cell collection and transport, quality system audits and patient outcomes data tracking and accessibility.
The summit’s agenda centered on three overarching topics: the problems of divergent processes and requirements for cell collection; efficiencies enabled by standardized data capture for post-marketing studies; and opportunities to integrate the IT applications used to order therapies and track chain of custody throughout manufacture.
“It was incredibly productive for us to come together as a community to exchange ideas about how to ensure future access to safe, high-quality cell and gene therapies for all patients,” said Chris McClain, vice president, Sales and New Business Development at Be The Match BioTherapies. “Through our parent organization, NMDP/Be The Match, we have decades of experience guiding both the evolution of life-saving cellular therapies and the cell collection infrastructure that supports them, and we were proud to foster such an important discussion among our partners.”
“This is a truly thrilling time in the evolution of cell therapies,” said Dr. Steven Devine, senior vice president and senior medical director, Research, at the CIBMTR. “As a growing number of cell therapies enter the clinic and reach commercialization, it’s imperative for this group to work together to create common standards to make the production of these therapies more efficient — and, ultimately, to safeguard their future availability to patients.”
“From a clinical perspective, the Accellerate Summit provided a valuable forum for us to discuss with colleagues across all different industries ways to reduce the burden associated with running clinical trials for advanced cell therapies,” said summit attendee Kimberly Kasow, director of the Pediatric Bone Marrow Transplant Program at University of North Carolina. “At the heart of these efforts is patient safety: A streamlined approach will minimize errors, deliver medicines more quickly and ultimately save lives.”
“In the biotech industry, our work is very keenly focused on creating products that can improve patients’ lives, and cell and gene therapies have immense potential to do that,” said summit speaker Greg Whitehead, senior vice president of quality at Rubius Therapeutics. “However, biopharma, apheresis centers and health care providers must work together to ensure that the production and administration of these medicines are efficient and scalable as the field grows, so that drug makers are able to continue advancing breakthrough medicines to patients.”
Working groups are now being assembled to continue to advance initiatives in each of the summit’s three focus areas, and Be The Match BioTherapies and the CIBMTR expect to develop a white paper capturing the summit outcomes going forward.
About Be The Match BioTherapies
Be The Match BioTherapies is the only cell and gene therapy solutions provider with customizable services to support the end-to-end cell therapy supply chain. Backed by the industry-leading experience of the National Marrow Donor Program®/Be The Match®, and a research partnership with the CIBMTR® (Center for International Blood and Marrow Transplant Research®), the organization designs solutions that advance cell and gene therapies in any stage of development.
Be The Match BioTherapies is dedicated to providing high-quality cellular starting material consented for research, clinical and commercial use, developing and managing expansive cell collection networks, and navigating cell therapy regulatory compliance. Using proven infrastructure to successfully manage cell therapy supply chains, including MatchSource® Supply Chain Software, cell therapy supply chain case managers and logistics experts, the organization has a history of compliance managing the chain of identity. The collaboration with CIBMTR extends services to include long-term follow-up tracking for the first two FDA-approved CAR-T therapies.