In this episode of the Ori Spotlight Podcast Jason C. Foster is joined by Jason Bock, CEO of the Cell Therapy Manufacturing Center. At the time of recording, Jason was the Vice President and Head of Biologics Product Development at MD Anderson. They talk about Jason’s unusual move from industry back into academia, how the relationship between academia and industry is evolving in the development of advanced therapies, and why failing is crucial to the progression of the cell and gene therapy industry.
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“Cell therapies have been the purview of academia for decades and have been percolating along over the last five years. Now they’ve reached an inflection point where it’s becoming more industrialized commercial products.”
Jason had the start-up experience that most biotech founders dream of. In 18 months from spinning off from Human Genome Sciences, they brought 3 completely novel biologics for unmet medical conditions into the clinic and were acquired by Teva. He achieved this by putting systems, processes and manufacturing capabilities in place that would enable them to be nimble in their approach. He then brought this expertise to the academic melting pot of innovation at MD Anderson, motivated by their very singular vision.
End cancer. That’s why we’re here. What that enables within this academic setting is that it’s extremely decentralized. There’s no central control… At MD Anderson, we can achieve both of those things. Allow the PIs to do what PIs do best – innovate, come up with new ideas, publish papers, go to conferences, come up with breakthrough ideas – and in parallel but in collaboration with them, we can be focused and deliberate about developing these as commercialized products. So I think it’s a great engineering concept of how to marry together innovation with disciplined therapeutics development.”– Jason Bock
Traditionally academic medical centres have been centers of innovation and initiators of clinical trials in the drug development process. But for cell therapies, Jason is seeing a shift in this model. Biotechs are turning to the experts in academia to help them tackle the challenges in commercialization, and investors are recognizing the benefits of partnering with these organizations.
“We’ve had quite a bit of success over the last 18 months in finding some very innovative biotech companies who are preclinical and have amazing products. We’ve partnered with them in creative collaborations where we can utilize the manufacturing capabilities in my group, the clinical capabilities to run data rich clinical studies, and enroll a lot of patients in the MD Anderson Clinic to solve that challenge for biotech. And that’s very different model than really has ever been used for other types of modalities… We’ve actually triggered a lot of collaborations through venture capitalists telling their biotechs who they sit on the board of like, ‘Hey, you guys should partner with these MD Anderson guys, they got something good going on. I, I really would rather spend our money with them than for you guys to build a whole infrastructure and bet the farm on one product’.”– Jason Bock
To maximize these capabilities MD Anderson has partnered with Resilience to create the Cell Therapy Manufacturing Center, which Jason now leads as CEO. The center aims to industrialize innovative cell therapies by bringing them to the clinic.
“It’s going to be phenomenal where we have the joint venture, with access to the amazing technology capabilities and reach of Resilience, and that science and clinical based understanding of oncology that is so deep at MD Anderson. Those two things are going to synergize in an amazing way, I’m sure of it.”– Jason Bock
Disrupting the status quo is crucial in the new age of cell and gene therapy manufacture. The existing drug development processes and systems are optimized for things like small molecules, but fall short for complex advanced therapies.
“There’s cell therapy where, I mean, I don’t know how many orders of magnitude a cell is more complicated than an antibody. How many zeros are added to that? Several. So it’s a really hard challenge… What we’re trying to push quite a bit on is characterization of these products not only during the manufacturing process, but the power of cell therapies is that they’re living drugs and that they change and divide and evolve in many ways after infusion… If we want to push the field forward, if we want to understand this relationship between attributes and clinical impact, we have to go way beyond that. So running data rich clinical trials is important… What I’m really excited about is not only developing novel therapies and have them reach patients but playing a role in influencing the field on how to do this. I think the important thing to achieve that goal is understanding our products.”– Jason Bock
Digitization of cell and gene therapies will allow all sorts of data to be captured to characterize cell therapies and achieve this deep understanding. But to provide real value and insights into the processes, this data needs to be captured in a structured way and interrogated.
“There’s a lot of focus on developing new tools and to generate lots of data. But if we don’t have ways of integrating and interrogating that data – whether it sits in the paper batch record, disintegrated on a shelf or on a shared drive somewhere – unless we have a way of pulling all this information together and assessing it, it doesn’t help us… So we have to make that data available, accessible, and in a way that’s digestible. I think focus on that is critically, critically important… We’re never going to be able to produce the exact same products of population of cells. There’s going to be heterogeneity, but somehow we need to be able to dissect the changes that are impactful on the safety and efficacy and those which don’t have an impact.”– Jason Bock
The goal of enabling widespread patient access to cell and gene therapies can’t happen without commercialization, and industrializing precisions medicines is far from easy. But both Jason Bock and Jason Foster realize the importance of failure and how they present opportunities for understanding that will propel the industry forward.
“Being able to learn from our failures and move those other ones that are higher quickly – they say fail fast and learn from it so you can do the next one better. Some of that thinking has to come in here too.”– Jason C. Foster
“If we just make a product, we don’t have control over it. We put it in a patient, we see only one complete response and, you know, 12 non-responders and we say, ‘okay, we failed, let’s move on’. Did we really learn from it? Was it the product? Was it how we manufacture the product? Was it the patient selection? Was it the conditioning treatment we used? Why did it fail? And so failing well, it’s really important that we can learn from it.”– Jason Bock