Insights into regenerative medicine: Q&A with Kenneth Bertram
Kenneth Bertram, MD, PhD, FACP is the former commander of the Walter Reed Army Institute of Research, and Principal Assistant for Acquisition for the U.S. Army Medical Research and Materiel Command. He joined the BioBridge Global Regenerative Medicine Advisory Board in 2018.
In a question-and-answer session, he talked about the future of regenerative medicine, BioBridge Global’s potential in the field and how he developed an interest in regenerative medicine:
How do you think regenerative medicine fits into the future of medical care?
One way it will fit is in the concept of restoring function. As your kidney starts to wear out or your liver starts to wear out, I think there are going to be opportunities in regenerative medicine to help restore that function. In addition, it’s going to play a role in helping people who lose function of an organ because of cancer.
There also will be opportunities in trauma care, ranging from something simple, a scenario where you lose digits, but even beyond that. From a military standpoint, given the number of folks who have lost limbs in Afghanistan and Iraq, is it possible to restore that form and function through the use of regenerative medicine? There’s a lot of potential there. At the moment, we’re trying to learn how to take advantage of those capabilities.
One of the goals of GenCure Biomanufacturing is bridging the gap between concept and clinical trial. Is that a good area?
You have to look at BioBridge’s history in that it evolved out of a community blood center. With that comes lots of skills, capabilities, and ties to the community. A lot of regenerative medicine work requires abilities that already have been demonstrated in blood banking. You’ve got to be able to deal with quality and reproducibility. You’ve got to meet all kinds of accreditation standards. So I think BBG is in a good position to leverage its history and move forward into this new space of biomanufacturing.
What do you think is the organization’s biggest opportunity in this field?
To move potential products or products for clinical trials – and by that I mean various lines or various isolated cells – past a Phase 1 trial into a Phase 2 and beyond, you’ve got to have somebody to manufacture the cells. And it’s got to be done to where it meets human standards and where it’s going to pass the FDA. The FDA has put everyone on notice that they’re going to start enforcing the standards in 2020 and they’re just going to be like everything else that people are going to have to meet.
Besides experience in blood banking, what else has impressed you about the organization?
The skill sets being accumulated here. As you go around the table and you meet the folks that have experience doing other parts of this global entity, they all bring in 10, 20 years of experience. And I think that makes for a good solid track record to put your trust in and move forward.
Does the regenerative medicine focus by BBG and other entities in San Antonio have the potential to make this a center for regenerative medicine research?
There’s the simple answer that says ‘yes.’ But it’s a little more complicated. For example, take bone marrow transplants. The reality is there isn’t a standard set of bone marrow transplantation in the United States. Each of the major transplant centers has its own standard operating procedures, its own way of doing things. They’ve all gone through various reviews and accreditations, but how they do things is not necessarily identical to how things are done in Minneapolis at the University of Minnesota or at Johns Hopkins on the East Coast.
So a major question is going to be what’s the economy of scale? What’s the cost of goods? If there’s something I can do at my office, I’m going to do it there. If on the other hand I’ve got to scale up to treat 500 patients in a short period of time, or I demand that consistency of product to go to commercialization, that’s where I think you’re going to see contract manufacturing. For those folks, that’s going to be their sweet spot, and I think that’s an area BBG is well placed to do.
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