In this episode of the Ori Spotlight Podcast Jason C. Foster is joined by Elliot Menschik, Chief Digital Officer at Resilience, and Kevin Gordon, Chief Digital Officer at Ori. They talk about Elliot’s career leading up to his role at Resilience, how transformative digitization of cell and gene therapies could be for the industry, and why partnerships are crucial for the implementation of digital tools in cell and gene therapy developers and manufacturers, no matter the size.
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“Our perspective is it’s the early findings, earliest days for cell and gene. It’s still the Wild West. Everyone has a different process for what they’re trying to do. It’s the furthest away from standardization and that’s the biggest challenge.”– Elliot Menschik
For both Elliot and Kevin, their journeys into cell and gene therapy manufacturing were more a collection of opportunities than a pre-planned path. But the chance to help build the digital infrastructure that advanced therapy developers need to get precision medicines approved and delivered to patients was too good to pass up.
“I was approached by one of the early investors in Resilience when it was sort of still in stealth mode and basically asked, ‘Hey, would you like to go build the AWS of bio manufacturing?’ And got into it and it became a pretty compelling thing. It was going to be a once in a lifetime effort. So I left a little bit sad and bittersweet, but been here for the last 18 months.”– Elliot Menschik
“In three years at Tmunity we built a fully paperless manufacturing system, including a laboratory information management LIMS and a paperless certificate of analysis. That sort of cap stoned into a meeting with the FDA for a type C, where not only did they support everything we were doing, but literally said to us that we could run multiple lines of therapy in the same clean ballroom, where if we didn’t have such digital and granular control over our custody identity, they would have asked us to wash, clean, retool, recalibrate, to be able to switch CARs in that facility.”– Kevin Gordon
To enable widespread patient access to cell and gene therapies, Jonathan identifies that the industry needs to provide researchers with platforms that can give them insight into their experiments. Only then can they understand their technologies, reduce variables, and develop processes that can be scaled.Resilience believes that digitization of cell and gene therapy manufacture is the future. They want to remove the cost barrier in investments in digital tools that their customers face, allowing the focus to fall on making advanced therapies at scale.
“We always wanted to be a digital first company because the notion was that there are ton of bottlenecks, errors, costs, just pain in this industry tied up in things that are bespoke and manual error prone. If you’re going to be investing in what the future manufacturing is, then digital automation has to be a big part of that.”– Elliot Menschik
The uptake of digital platforms and tools is slower in the life science industry than other regulated industries. Many people are reluctant to adopt these systems because of the cost and concerns around quality. But Kevin has first-hand experience in turning people’s opinion.
“We knew that actually the way the CFA report was being generated was wrong when it was initially published to production, and the team working through that also knew. But our partners in quality were pretty convinced that it was set the right way. And so we built it the way we were requested to, but then we also had the version we believed to be correct. We ran it the first way, it came out wrong, and everybody in our partners in quality and compliance were feeling vindicated in that this would never work… When we handed them the correct one, the light bulb went on for all of those people and they not only became a believer in digital, but they also really understood the power of that platform.”– Kevin Gordon
Digital is a massive field, with many different tools that can be applied to cell and gene therapy manufacturing. Making data accessible to scientists and making processes transferrable are key things that Elliot views as vital to realizing high-throughput manufacturing in the future. From Kevin’s experience, automation and digitization are imperative to enabling tech transfer, but it doesn’t mean human operators are less valued.
“How do you give scientists who are not necessarily technically digitally facile the tools not to make common mistakes? How do you learn from the body of work that has happened in the past in developing these methods and processes?… I think there’s a lot of acceleration in process and analytical development that can happen through digital means, as well as in the tech transfer into the facilities. Having it in a digital format where you can use something like the batch to MML as a language to move it right from the pad lab into manufacturing execution system and shorten tech transfer times, we think is also going to be a big deal.”– Elliot Menschik
“What we learned was the people who do CAR-T development or people who build viral vectors are genius level folks who really hold a lot of that process and the grey matter between their ears. By digitizing each of those into an operation, you started to realize that it didn’t devalue any of them. It just meant that people could actually take vacations. Or if you did have a turnover in a facility, you could retrain somebody on a process.”– Kevin Gordon
Despite the incredible advances made in the last few decades, the cell and gene therapy industry is still relatively new. This means that democratized access to digital platform for the automation and scaling of advanced therapy manufacture doesn’t currently exist. Elliot believes that outsourcing digital infrastructure to specialists instead of building in-house is a better use of resources for early-stage developers.
“This is an industry that’s really bespoke and artisanal. It’s almost the province of only the privileged few who can afford to invest in their own facilities, their own CMC people. And it’s just it’s very costly. When you look at all the therapies that want to come to market, whether you’re a Tmunity or a Bluebird or any of the upstarts who want to bring these things to market faster, why are they investing in the equivalent of data centers?… Everything is being built by hand to do a task that should be given to a specialist who can do it in a scalable way.”– Elliot Menschik
Adopting digital platforms is an important piece of the puzzle that is industrializing precision medicines to enable widespread patient access to cell and gene therapies. Although it’s not an easy road, Elliot hopes that Resilience can provide the tools and expertise that developers need to realize the power of these incredible technologies.
“Trying to gain the COGs down is a critical piece. The supply chain, the end-to-end routing to patients, there’s a lot of complexity there and an explosion of types of cell therapies. As we move into not just cells but tissues, the potential is amazing, but there’s a ton of work to be done for sure.”– Elliot Menschik