Decentralizing Advanced Therapies: Are We Moving Closer to Bedside Therapeutics?
1:30pm Chair Introduction
Miguel Forte, President Elect, International Society for Cell & Gene Therapy
1:35pm Presentation: Improving Access of CAR-T Cell and Other Gene-Modified Cellular Therapies by Manufacturing the Final Product at the Place-of-Care
- Current pricing for CAR-T and other autologous gene modified cell products are unsustainable
- Place-of-care manufacturing offers a distribution model that is more economical
- How Caring Cross is enabling place-of-care manufacturing of autologous gene modified cell products
Boro Dropulic, Executive Director, Caring Cross
1:50pm Presentation: Enabling Decentralized Autologous Manufacturing by Artificial Intelligence, Metabolic Sensing, and Control
- Control and sensing as the base for decentralized GMP manufacturing
- Optimizing cell therapy with AI and metabolic readouts
- The Adva X3, next-gen manufacturing
Ohad Karnieli, Chief Executive Officer, Adva Biotechnology
2:05pm Presentation: Are There Models for Decentralized Advanced Therapy Manufacturing With Existing Infrastructure?
- What are the infrascture prerequisites for a safe, clinically effective, commercially viable decentralized advanced therapies manufacturing model?
- Are there pre-existing decentralized biological supply chain models we can mimic or adapt?
- Do alternatives exist for ‘bedside’ or ‘in-hospital’ manufacturing which still leverage the advantages of decentralization?
Lee Buckler, Senior Vice-President of Advanced Therapies and Business Development, Blood Centers of America
2:20pm Presentation: Challenges of Decentralized Manufacturing (DCM)
- Pros: shortening turnaround time, lowering costs, facilitating early clinical developments at the interface of academia and industry
- Cons: replicates the tough-to-harmonize organization seen in cell transplant activities, question mark on the sustainability of the implementation of industry standards for small-scale manufacturing, heterogeneity in national and international regulations, lack of economic model
- Potential solutions: innovations in process automation, central supervision of multiple sites
Christian Chabannon, Head of Center for Cell Therapy, Institut Paoli-Calmettes, Marseille, EBMT & GoCART
2:35pm Closing Panel with Q&A
With all session participants