Warner Biddle: Building a commercial model for CAR-T in autoimmune care

In this episode of the Ori Spotlight Podcast, Jason C. Foster welcomes John Khoury, Founder of Project Farma, to unpack how the standards for advanced therapies are shifting.John reflects on why infrastructure planning, automation, and comparability studies can’t be left until late-stage development. They explore how CGT companies can reduce manufacturing risk by running development activities in parallel, why early investment in platform approaches matters, and how outdated assumptions about regulatory flexibility may be slowing progress. For developers aiming to compete at scale, these early decisions are quickly becoming non-negotiable.Connect with John: https://www.linkedin.com/in/john-khoury-017b592/

In this episode of the Ori Spotlight Podcast, Jason C. Foster welcomes Warner Biddle, CEO of Kyverna Therapeutics, to explore how autologous CAR-T therapies can be delivered safely, efficiently, and at scale in autoimmune disease.Warner shares Kyverna’s approach to designing a commercially viable treatment model — one that prioritizes outpatient care, streamlined manufacturing, and real-world practicality. They discuss what it means to bring complex therapies into community settings, how Kyverna is tailoring its rollout strategy by indication, and why the future of CAR-T in autoimmune disease depends as much on delivery as it does on data.Connect with Warner: https://www.linkedin.com/in/warnerbiddle/

In this episode of the Ori Spotlight Podcast, Jason C. Foster welcomes Lavakumar (Kumar) Karyampudi, Senior Director of Cell Therapies at Moffitt Cancer Center, to discuss how academic institutions are evolving to meet the demands of early-phase CGT trials.Kumar shares how Moffitt is building flexible, end-to-end infrastructure that supports the full development cycle – from translational research to GMP manufacturing. Together, they explore how tighter integration between scientists, clinicians, and operational teams can accelerate first-in-human trials, why academic centres play a crucial role in advancing CGTs, and how the right partnerships can extend institutional capabilities.Connect with Kumar: https://www.linkedin.com/in/lavakumar-karyampudi/

In this episode of the Ori Spotlight Podcast, Jason C. Foster welcomes Henrik Andersen, former SVP and Head of Cell Therapy Technology Development at Bristol Myers Squibb, to explore how early planning, automation, and economic discipline can help scale the impact of cell therapies.Henrik draws on his experience in both biologics and cell therapy to discuss how platform thinking, target product profiles, and cost-of-goods modelling can be applied earlier in development. Together, they reflect on the pitfalls of rushing to clinic without a viable manufacturing strategy, the shift in investor expectations, and why adapting lessons from biologics could help CGT companies avoid costly detours on the path to commercial success.Connect with Henrik

In this episode of the Ori Spotlight Podcast, Jason C. Foster welcomes Arsalan Arif, founder of Endpoints News, for a wide-ranging conversation on the business of biotech. From his early days bootstrapping a media company to Endpoints’ recent partnership with the Financial Times, Arsalan shares his journey and reflections on what it takes to build trust in an evolving industry.Together, they unpack today’s cell and gene therapy landscape, where clinical success alone isn’t enough. Arsalan offers his perspective on investor sentiment, why scaling remains the biggest challenge in CGT, and how economic models, not efficacy, will shape the next chapter of growth.Learn more about Arsalan: https://www.linkedin.com/in/arsalanarif/

In this episode of the Ori Spotlight Podcast, Jason C. Foster welcomes Dr. Julie Allickson, Chief Technology Officer for Mayo Clinic's Center for Regenerative Biotherapeutics. With over 30 years pioneering regenerative medicine - from early bone marrow transplant programs to today's cutting-edge cell and gene therapies - Julie shares her journey and insights on translating innovative therapies from discovery to clinical impact.Together, they explore how academic medical centers are evolving to bridge the gap between research and commercialization through integrated manufacturing capabilities, multi-site clinical trials, and strategic partnerships. Julie discusses Mayo Clinic's approach to managing 30+ clinical trials across three sites, the critical role of automation and AI in reducing costs and improving scalability, and why thinking about commercial viability early in development is essential widespread patient access.Learn more: https://www.linkedin.com/in/julie-g-allickson-phd-76129062/

In this episode of the Ori Spotlight Podcast, Jason C. Foster welcomes back Aaron Vernon, Chief Manufacturing Officer at Quell Therapeutics, for the second part of the discussion on building robust and scalable cell therapy manufacturing systems. Together, they explore how applying principles like the Theory of Constraints, designing smarter facility layouts, and implementing digital systems can reduce bottlenecks and improve throughput.Aaron brings over 20 years of experience leading manufacturing, engineering and supply chain operations across biologics and cell therapy. We’re grateful for his insights as the industry works to deliver more consistent, cost-effective therapies to patients at scale.Learn more: https://www.linkedin.com/in/aaronvernon/

In this episode of the Ori Spotlight Podcast, Jason C. Foster welcomes Aaron Vernon, Chief Manufacturing Officer at Quell Therapeutics, for a two-part discussion on building robust and scalable cell therapy manufacturing systems. Together they explore how applying principles like the Theory of Constraints, designing smarter facility layouts, and implementing digital systems can reduce bottlenecks and improve throughput.Aaron brings over 20 years of experience leading manufacturing, engineering and supply chain operations across biologics and cell therapy. We’re grateful for his insights as the industry works to deliver more consistent, cost-effective therapies to patients at scale.Learn more: https://www.linkedin.com/in/aaronvernon/

In this episode of the Ori Spotlight Podcast, Jason C. Foster welcomes Amritha Jaishankar, Executive Director of the Cell and Gene Therapy Center at IQVIA, to discuss how data integration and decentralized manufacturing are reshaping access to advanced therapies. Amritha shares her insights on how to overcome systemic challenges in cell and gene therapy, including data silos, workforce gaps, and manufacturing inefficiencies. Together, they explore the transformative potential of community sites, digital platforms and collaborative partnerships in driving scalability, improving affordability of CGTs, and expanding their access worldwide. Learn more: https://www.linkedin.com/in/amrithajaishankar/

In this episode of the Ori Spotlight Podcast, Jason C. Foster welcomes Boro Dropulić, CEO of Vector Biomed and Executive Director at Caring Cross. Boro shares his vision of how decentralized manufacturing, low-cost vector production, and open-source workflows can make cell and gene therapies more accessible worldwide. They also discuss the role of digital technologies, partnerships, and innovative processes in overcoming industry bottlenecks, driving down costs, and expanding this access. Learn more about Boro on LinkedIn