Michael Krajewski: How does the Theory of Constraints apply to CGT manufacturing?

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

In this episode of the Ori Spotlight Podcast, Jason Foster is joined by Michael Krajewski, Director at Stand Back and an expert in engineering and scaling operations. Michael, with his background in aeronautics, brings a unique perspective on the Theory of Constraints and its role in CGT manufacturing processes. Michael and Jason dive into the complex dynamics of bottlenecks and discuss how understanding constraints can pave the way for growth – without compromising efficiency. Together, they explore how manufacturing lessons from other industries can address the limitations faced by cell therapy today, and what it takes to streamline complex, regulated processes. Learn more about Michael: https://www.linkedin.com/in/michael-krajewski/

In this episode, Jason C. Foster welcomes Carl Schoellhammer, Principal & Advanced Therapies Practice Lead at DeciBio, to discuss the importance of considering viability alongside safety and efficacy in cell and gene therapies (CGTs). Schoellhammer highlights the need for scalable and decentralized manufacturing approaches to ensure the commercial viability of these advanced therapies, as well as the challenges of maintaining consistent quality in personalized medicines, and the role of enabling technologies in addressing these hurdles. Learn more about Carl: https://www.linkedin.com/in/carl-schoellhammer/

In this episode of the Ori Spotlight Podcast, Jason C. Foster welcomes Anshul Mangal, President at Project Farma, to discuss the hurdles to scalable CGT development, the importance of early strategic planning, and the role of digitalization in improving efficiency and reducing costs. Together they also highlight the potential of distributed manufacturing and the evolution of regulatory standards. Anshul Mangal is a biotech entrepreneur and executive, leading Project Farma and Precision for Medicine's Manufacturing Solutions. He has pioneered the industrialization of early cell and gene therapies. Anshul also serves on the boards of the Alliance for Regenerative Medicines, Alliance for mRNA Medicines, and IQHQ, driving advancements in next-generation medicines. Learn more about Anshul Mangal: https://www.linkedin.com/in/amangal/

In this episode, Omkar Kawalekar of Deloitte's NextGenTherapies practice joins Ori CEO Jason C. Foster, to explore the significance of technology and strategic collaborations in overcoming manufacturing challenges and developing advanced therapies at scale. Their conversation covers key industry hurdles like supply chain optimization and the strategic planning necessary for bringing innovative treatments to market – offering insights into how the industry can achieve commercial viability and widespread patient access to CGTs. Learn more about Omkar: https://www.linkedin.com/in/omkar-kawalekar-7406887/

In this episode of the Ori Spotlight Podcast, Jason C. Foster welcomes Joe DePinto, head of Cell and Gene Advanced Therapies at McKesson, to discuss challenges and innovations in cell and gene therapy manufacturing and supply chains. Together they also highlight the importance of collaborative partnerships and digital innovations to enhance access and streamline processes within the CGT sector. Joe DePinto is a strategic and operational leader at McKesson, focusing on establishing the company as a market leader in cell, gene, and advanced therapies. With an extensive background in biotech and pharmaceuticals, Joe has helped companies pioneer advanced solutions in speciality healthcare. Learn more about Joe DePinto: https://www.linkedin.com/in/joe-depinto-4a5b7b11/details/experience/

In this episode of the Ori Spotlight Podcast, Jason C. Foster welcomes Matthew Hewitt, Vice President and Technical Officer of Cell and Gene Therapy and Biologics at Charles River Laboratories, to discuss why industry collaboration is needed to experience the true impact of advanced therapies and develop them at a commercial scale. Together they also highlight the role of technology in closing, automating and scaling manufacturing processes. Matthew has over 10 years of experience in the CGT sector, contributing to the advancement of CGTs across research and commercialization. As a member of our Strategic Advisory Board we're grateful for Matthew's insights as we work towards enabling widespread patient access to CGTs. Learn more about Matthew Hewitt: https://www.linkedin.com/in/matthewmhewitt/

In this episode of the Ori Spotlight Podcast, host Jason C. Foster is joined by Jeff Holder and Adam Siebert from LEK Consulting, who offer an in-depth exploration of the evolving cell and gene therapy (CGT) industry. LEK Consulting, a global leader in strategic advisory, aims to address the critical challenges of scalability and commercial viability within the CGT sector. Jeff and Adam, with their extensive background in life sciences consulting, share their insights on the importance of early investment in manufacturing processes to ensure that groundbreaking therapies can be delivered to patients efficiently and on a large scale. Together they explore the intricacies of CGT production, the significance of early-stage manufacturing considerations, and their vision for making advanced therapies more accessible to those in need. Learn more about: Jeff Holder - https://www.linkedin.com/in/jeff-holder-ph-d-7a391087 Adam Siebert - https://www.linkedin.com/in/adam-siebert-8772b327/

In this episode of Ori Spotlight Podcast, we welcome Jim Faulkner, PhD, Independent Consultant at JDB BioConsulting and former SVP of Product Delivery at Autolus. Jim brings a wealth of experience from his remarkable career in biopharmaceutical development and his journey in the industry is marked by significant contributions, particularly in pioneering cell therapy at GSK. The episode offers a deep dive into the evolving challenges in CGT manufacturing – centering on the critical challenges of scalability and commercial viability in CGTs – and sheds light on the unique demands and opportunities in the sector. Learn more about Jim: https://www.linkedin.com/in/drjimfaulkner/