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James is an accomplished life sciences executive with a distinguished track record of commercializing disruptive technologies and managing industry-leading global product portfolios. He currently serves as the VP of Cell Therapy Marketing at Berkeley Lights, where he leads the development and execution of the company’s marketing and product development strategy. Most recently, he served as the General Manager of Cell and Gene Therapy at Thermo Fisher Scientific. James holds a BS in Biology from the University of North Florida and an MBA from North Carolina State University.


James, what do you see as the main challenge facing cell therapy development today?

The first thing that comes to mind is patient access because there’s an inherent issue if a therapy is egregiously unaffordable. There are cell therapies that are known to be effective, yet they’re given as a last option and not a first, because of the cost. If we can change how cell therapies are manufactured—and how much it costs to make them —we can increase patient access.

Two manufacturing challenges underlie this core issue of patient access. The first is that the technology is relatively new; researchers are still learning how to direct a T cell into effective therapies. Once a therapy is found, the second challenge arises: how do we manufacture it in the most efficient way?


So, a challenge in discovery and a challenge in delivery.  How do they relate to each other?

T-cell profiles and functions are extremely diverse. Some of them grow and kill, and some of them don’t. Cells that proliferate well, secrete multiple cytokines, and kill multiple tumor cells—we know those are the cells worth replicating and getting to patients. But because T-cell discovery is limited by the inability to measure each of those characteristics on every single cell, therapeutic development relies on approximate data from heterogeneous cells. To be effective, therapeutics relying on that data require high doses of cells; high cell counts mean high production time and cost.

If researchers had the ability to fully characterize every T cell, they could ensure that only cells with desired behaviors made it out of the discovery phase. Less time and money would be spent on generating ineffective cells; therapeutic manufacturing would actually become more efficient.


Academic labs drive most of our understanding of T cells, but those institutions don’t have the capability to scale up for production. How does the benefit of fully characterized T cells get translated into the manufacturing improvements you mentioned?

In order to take a powerful T cell from a concept to something commercial, translational research institutions like Sloan Kettering or MD Anderson run clinical trials while also researching why trials succeed or fail. They have an important role to play because there’s already infrastructure which allows them to be at the front lines of scaling more efficacious cell therapies from the bench to the clinic.


Clearly, there are challenges across every step of development.  Is there a solution that can help address each one?

Absolutely. Find the right cells the first time.

That’s easier said than done; most single-cell analytical methods could find the perfect cell, but they’ll destroy it in the process and prevent the ability to sequence it, replicate it, or study it further. But that actually clarifies the goal for someone like me—if we can create a way to discover only the best cells and recover them, then we can introduce the opportunity to reduce production cost and timeline.

Making it possible to finding that right cell, the first time? That’s how we empower researchers seeking the next powerful, effective treatment. That’s how we can influence patient access.


Read the full conversation at berkeleylights.com/improving-access

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