The annual J.P. Morgan Healthcare Conference, held in San Francisco, California, is one of the premier healthcare investment conferences. This year, Endpoints News organized an engaging two days of candid fireside chats dubbed “Endpoints at #JPM25: Biopharma’s New Fundamentals.” Speakers discussed an array of topics, from AI-enabled R&D to outlooks for the healthcare industry under the incoming Trump administration.
On Tuesday morning, Ori Biotech CEO Jason C. Foster joined Endpoints founder Arsalan Arif onstage for a discussion around cell and gene therapies, which are, as Arif declared, “fundamentally different than the standard pharma play,” fitting nicely into Endpoints at #JPM25’s theme.
Arif jumped right in, highlighting the elephant in the room: the paucity of patients that actually access cell and gene therapies, and the trickle-down effects this has on the industry—including a cooling of venture funding.
Foster succinctly outlined the root cause of the accessibility problem: manufacturing bottlenecks resulting from the unique supply chain requirements of personalized, living medicines—something that, unfortunately, hasn’t received as much investment as safety, efficacy, and approvability—which are also critical.
“If you have a circular supply chain, starting with patient cells going through an ex vivo manufacturing process back to an individual patient, we need to think fundamentally differently,” explained Foster. The problem really is three-fold, Foster went on to say. Getting more therapies into the hands of more patients requires solutions to three problems. First, the throughput problem: we need to create more doses for more patients. Second and third are cost of goods and quality, which are intimately related.
Cell and gene therapy manufacturing processes—which leverage tedious, error-prone, and high-skill manual steps—largely rely on tools that are a decade old, says Foster, leading to a 20-40% out of spec rate (i.e., the therapeutics don’t meet quality standards and end up in the biological garbage bin). The associated costs are absorbed by the manufacturer; costs then naturally go up for payors and patients, and investors become less clear about the risk to reward ratio.
These three challenges—throughput, cost of goods, and quality—are exactly what Ori Biotech’s IRO instrument was developed to solve. About the size of your grandmother’s microwave oven, said Foster, the IRO instrument automates the core parts of the CGT manufacturing process, ultimately increasing throughput by 10 to 50 times over that achieved with traditional manual manufacturing processes.
“What does that mean?,” Foster provocatively asked, immediately answering, “If you look at a single clean room, we can get 1000 doses a year out of 1000 square feet of space—that’s about a 95% reduction in the amount of facility space you need, so a massive increase in throughput.”
According to Foster, the instrument also cuts cost of goods by up to 30-50% by reducing the need for highly skilled humans and by using expensive reagents more efficiently. Out of spec rates also drop from 20-40% to under 5%.
Playing devil’s advocate, Arif asked Foster about the traditional trade-offs made between biological quality and automation and whether Ori Biotech has been able to address this critical problem.
Foster’s short answer was yes: “We are able to deliver the best-in-class biology, but also the benefits of automation, higher throughput, lower costs, and better quality,” he said, citing the ability of the IRO instrument to turn out 12 billion therapeutic cells from 50 million starting patient cells. Foster then referenced collaborations that highlight some of IRO’s strengths that are particularly attractive to manufacturers: rapid, multi-site production of GMP-aligned products and significantly reduced tech transfer timelines.
Manufacturers are beginning to see the potential of automation in CGT manufacturing, particularly as increasingly bullish sponsors demand return on investment—leading to earlier consideration of commercial viability. These types of considerations, says Foster, really need to take place alongside preclinical safety and efficacy research—otherwise we run the risk of continuing to develop products that gain regulatory approval but ultimately don’t survive.
“That’s not good for anyone—that’s not good for patients, that’s not good for the regulator, that’s not good for the sponsor,” said Foster.
Bringing the conversation to a close, Arif asked one more thought-provoking question: “What will it take for investors to be interested in this space?”
According to Foster, the answer is simple: addressing commercial viability—which will be made more likely by using automation tools like the IRO instrument to tackle throughput, cost, and quality—early in the development cycle will bring in the venture capital the industry needs.
“The interest in the industry from big pharma, big biotech and venture investment has waned because they have a question: are these products commercially viable?,” said Foster. “For cell therapy to come into the next renaissance for the industry, we need to answer the commercial viability question. Can we get this product to market? Can we get the cost of goods in a place where we can make profits? Can we deliver enough doses to enough patients to deliver an ROI to our investors? If we can answer that question, I think the future of CGT is very bright.”