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

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/

In this episode of the Ori Spotlight Podcast, we're joined by Sanjay Srivastava, Managing Director of Accenture's Cell and Gene Therapy Practice. With his extensive background in consulting and a deep understanding of the biotechnology sector, Sanjay offers unique insights into the rapidly evolving world of cell and gene therapies. Sanjay and Jason C. Foster delve into the critical challenges facing the industry, particularly focusing on the scalability and efficiency of manufacturing processes. They discuss how these challenges impact the commercial viability of advanced therapies and the necessity of adapting our current healthcare systems to better accommodate innovative treatments. Learn more about Sanjay here: https://www.linkedin.com/in/nitreniumions/

We’re joined by Tim Hunt, CEO of Alliance for Regenerative Medicine (ARM). As an international advocacy organization, ARM is a global voice within the cell and gene therapy sector. They champion the benefits of engineered cell therapies and genetic medicines for patients, healthcare systems, and society as well as facilitating influential exchanges on policies and practices, and advances in narrative with data and analysis. In this episode, Tim and Jason C. Foster discuss why it is important to put the patient first and where we should be focusing our attention to reduce the cost of goods and improve the accessibility of cell and gene therapies. Tim also offers his advice for people and companies working in the CGT space. Learn more about Tim: https://www.linkedin.com/in/timhunt100/