Decentralizing Advanced Therapies: Are We Moving Closer to Bedside Therapeutics?

19 Jan 2023
Clinical and Patient Considerations Track
Adva Biotechnology

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


Boro Dropulic
Executive Director
Caring Cross
Lee Buckler
Senior Vice-President of Advanced Therapies and Business Development
Miguel Forte
President Elect
International Society for Cell & Gene Therapy
Ohad Karneili
Chief Executive Officer
Adva Biotechnology