By Louis GarguiloChief Editor, Outsourced Pharma
Follow Me On Twitter @Louis_Garguilo
Biotechs focused on cell and gene therapies say it can be difficult to find partners for advancing their programs and new drugs. They need support beyond the traditional outsourcing of development and manufacturing to CDMOs.
These elongated “support chains” should extend directly into hospitals and donor/transplant centers, because “raw materials” for new drugs aren’t sourced from traditional suppliers. Instead, they are cells taken from the patients they hope to treat, or from cell donors. Therefore, this atypical supply chain starts within the healthcare system, runs cells out to a CDMO (or the sponsor in some cases) for processing, and then circles back to the patient.
Particularly for smaller drug developers today, there’s a need to work with support partners with experience in the field, with supporting data – and as we’ll see at the end of our article, some nifty software.
Moreover, clinical trials for cell-based therapies and drugs need to be better optimized, or as Jason Gardner, co-founder, CEO and president of Magenta Therapeutics, often says, “operationalized.”
Despite all the needs above, Gardner, a former GSK executive, considers himself lucky. He’s found a partner organization to help Magenta achieve its goal of developing new drugs for bone marrow transplants.
Magenta Meets Its Match
Magenta’s partnership is with Be The Match BioTherapies, a cellular-therapy support organization with a parent company claiming some 30 years of experience, and a vast network within the healthcare system.
Be The Match BioTherapies President, Amy Ronneberg, describes the challenge this way: “Biotechs have these new cell and gene therapies, in clinical development or commercialized, which are delivered using a supply chain that is nearly identical to that of a stem cell transplant. They need help putting this all together.”
Gardner says both organizations share the mission of making bone marrow transplants a safer, more effective, and more widely used procedure for patients. “Today,” he says, “there remain certain elements to a transplant procedure that can be innovated. We are making drugs that can do that across the process.”
Bone marrow transplants have been practiced for some 60 years, with over a million patients having had a procedure. “A lot of medicine and science has already been developed around these procedures,” says Gardner, “and I want to emphasis that these transplants have always been considered as a one-time treatment with curative intent. The drugs Magenta is developing are intended to be transformative to that goal.”
Those potential drugs in Magenta’s portfolio currently include an antibody (toxin conjugate), and a number of other biologics and cell-based therapeutics, all of which are used at different points in the transplant process. So how does Be The Match BioTherapies aid in the development of these drugs?
“First, by assisting us in understanding the current practices across the different transplant centers in the world, they help us prove in clinical trials that our drugs are more effective than those standards,” replies Gardner. “We work together to understand how to operationalize trials. Their broad registry of data sets is important for understanding what’s currently done around the world.”
Gardner adds that Be The Match BioTherapies’ networks and relationships within transplant centers will be “powerful for us moving forward.” He says his partner “has been involved with or actually run many clinical trials in this field, through their research program, the Center for International Blood and Marrow Transplant Research [CIBMTR].”
Partners Can Invest, Too
Magenta maintains its own labs in Cambridge, Mass., and currently employs 44, including teams that work primarily with CDMOs on the manufacturing side, and trial centers on the clinical side. Gardner says while his company has a bold vision, “We are humble, and recognize we need to work with external groups, both in manufacturing and clinical development.”
He calls Be The Match BioTherapies a “force-multiplier,” because of that network of healthcare centers, and experienced transplant physicians, and says: “We were in discussions for a few months around what this partnership would look like. There was a lot of enthusiasm on our side, so we decided to raise more money to build our plans more aggressively.”
Apparently, the enthusiasm was shared. Be The Match BioTherapies was interested in participating, and it became their first equity investment in a company.
“We are in contact almost every day,” Gardner says. “This is an active collaboration, due in large part to the fact that we share the same goal.”
And There’s Software, Too
But what first caught this editor’s attention was the recent release of new software to help companies like Magenta help realize the elongated support chain. (Yes, software excites some of us, most recently displayed here: Unleash Blockchain Technologies On The Entire Supply Chain.)
Be The Match BioTherapies has designed MatchSource, a software application which appears to be the connectivity that strings together the sponsor, CDMOs, and clinical or transplant centers, for materials tracking and project management. Ronneberg describes it as “an implementation-ready technology platform for cell and gene therapies in clinical development or poised for commercialization.”
Interest duly piqued, I contacted Michael McCullough, Chief Information Officer for Be The Match BioTherapies. He further explained that MatchSource is a cloud-based application built to support integration with existing drug-sponsor systems, and enabling collaboration among all of the participants in the cellular therapy process. For Outsourced Pharma readers specifically, that translates into access and participation for drug sponsors’ contract manufacturing organizations. CDMOs can “actually operate as an agent of the Pharma/Bio provider, while also allowing the drug sponsor to control exactly what role the contract manufacturer plays in their process,” explains McCullough.
Biopharmaceutical companies have already made large investments in their manufacturing and supply chain systems – and continue to improve that segment of their business. McCullough says this new software now supports “the connectivity between those systems with the point-of-care providers, delivering an end-to-end cellular therapy platform.”
It appears the supply chain is in fact becoming the support chain for biopharma companies developing new cell and gene drugs and therapies.