From The Editor | July 9, 2021

Cell Therapy Production To Clinical Administration: Addressing The Gap

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By Matthew Pillar, Editor, BioProcess Online

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In his role as Sr. Clinical Development Manager, Cell Therapy Oncology at GSK, Michael Mehler is as close to the patient-level application of cell therapies as a biotech leader can get. His position serves a critical link between therapeutic development and patient centricity, and it gives him a unique vantage point to observe what’s working—and what’s not—in the translation of cellular therapeutics from manufacturing floor to administration.

Mehler has been on the front lines in clinical cell therapy since 2013, when he was with Adaptimmune. On a recent episode of the Business of Biotech podcast, Mehler told us just how far the clinical practice of cell therapy has come over the past 8 years. The rapid progress he’s seen has been driven by a resource that’s in increasingly short supply: a talented, research-driven, and scientifically curious talent pool capable of bridging the link between therapeutic development and clinical application.

It's a need that’s a long time in the making and overdue for a solution. When cell therapies leave the manufacturing site for the journey to clinical administration sites, therapeutic developers relinquish control and lose visibility into that critical last mile. But what happens during that last mile—from product handling and administration on the part of clinicians to the patient experience—is absolutely critical to the patient-centric advance of development and manufacturing approaches.

SOPs Have Advanced, But There’s Room For Improvement

Michael Mehler, Senior Clinical Development Manager, Cell Therapy Oncology, GSK
“Back in 2013, there was Juno and there was Kite but there were really no standard operating procedures for product development and clinical administration. We saw things occurring at clinical sites that surely aren’t occurring now,” says Mehler. From logistics to inspections to clinical administration, he tells us the process was prone to human error, “hiccups,” and hard learnings that have informed the development of today’s SOPs. He’s grateful for the exposure to those early stumbles, and how those experiences have informed and driven his passion for developing the next generation of skilled cell therapy developers and clinicians.

“We know that by 2025, there will be hundreds of cellular therapy INDs under FDA review. We’re going to need skilled manufacturing teams, which will require training opportunities that don’t currently exist,” says Mehler. “There’s also a strong need for clinical development talent that can sit cross-functionally and speak to each element of the process that occurs from vein-to-vein, or even allogeneic off-the-shelf products. Both manufacturing and clinical development need skilled experts in this space, and I think finding talent for that is certainly challenging.”

The Need For Earlier And Ongoing Cell Therapy Training

Mehler points to two opportunities to address the challenge: earlier training and ongoing training. He says earlier academic-level exposure to advance therapy manufacturing is necessary, and that specialized postgraduate degree programs must evolve quickly. More immediately, he sees opportunity to train and educate on the job. “We learn the most from the clinical sites that are administering these therapies. Whether it's a young emerging biotech or a global pharmaceutical company, the first thing to remember is that the people at the hospital, and of course the patients, are the ones that have the most insight into what's working and what's not working, even for commercially-approved products.” That starts, he says, with sponsors working closely with clinical sites to understand what's working, what's not working, and what can be done better. “The younger companies that are coming up need to get that information so they’re not repeating the same mistakes that have happened in the past. At GSK, we’re bringing that site-level information back to the company and leveraging it to implement additional training.”

Demand For A New Layer Of Cross-Functional Cell Therapy Talent

Mehler says he sees cell therapy companies, his own included, responding by building out what he dubs patient supply operations groups. “It's not supply chain necessarily, and it's not clinical development, but it's a patient supply group that is required to work very closely with clinical sites. It’s a cross-functioning team that works directly with clinical sites and commercial manufacturing, focused on what we need to do to get these patients treated more effectively, and it’s a challenge to find people who can execute on this role.”  

Learn much more about Michael Mehler, his role at GSK, and his opinions on how to bridge the gap between production and the clinic on episode 49 of the Business of Biotech.