Sessions

Building an Effective Supply Chain/Temperature-Controlled Therapeutics
Standardising Raw Materials to Reduce Outcome Variability
Arriving at your Cell & Gene Therapy Destination: Navigating the Many Journeys Within the Journey
Collection Centers of the Future: Standardisation and Optimising Apheresis for Quality Control
Patient-Centric Development – Supporting Improved Patient Outcomes

Building an Effective Supply Chain/Temperature-Controlled Therapeutics

26 Jan 2022
15:30
SPONSORED BY
AmerisourceBergen
Fujifilm Irvine Scientific

15:30 Chairperson’s Introduction
Maria Croyle, Professor of Molecular Pharmaceutics and Drug Delivery/Glaxo Wellcome Professor, University of Texas at Austin

15:35 Room Temperature Stable AAV To Enable Global Access To Gene Therapies 

  • AskBio works with rare/orphan diseases needed by patients worldwide
  • Current cold chain requirements do not allow for this; supply chain improvements are needed
  • Jurata Thin Film’s technology thermostabilizes gene therapies/AAV, expediting and simplifying advanced therapy supply chains
  • Data from AskBio/Jurata collaboration showing successful delivery of thermostabilized AAV

Maria Croyle, Professor of Molecular Pharmaceutics and Drug Delivery/Glaxo Wellcome Professor, University of Texas

15:50 Upcoming Data Management Transitions and Their Impact On Advanced Therapy Supply Chains

  • The current challenges related to data management in conjunction with supply chain distribution
  • Upcoming communication technology changes that will impact critical chain of custody, chain of condition and Chain of Compliance® data collection and management
  • Next generation technologies associated with more effective management of chain of custody and chain of condition in the field

Mark Sawicki, Chief Executive Officer, Cryoport

16:05 3 Key Factors in Cell Cryopreservation that Impact the Manufacturability of Cell & Gene Therapies

  • The principles of cryopreservation as learned from immune cells, stem cells, and embryos
  • Developing cryopreservation reagents and protocols for cell & gene therapy manufacturability
  • Criticality of source materials on the quality of the final product

Robert Newman, Chief Scientific Officer, FUJIFILM Irvine Scientific

16:20 Global Labelling Considerations for ATMPs (VIRTUAL)

  • Review of labelling requirements in comparison to USA
  • Examples of centers that have centralized apheresis centers
  • Compliance with COI/COC and what effectiveness checks should be in place

Sadaf Naz Khan, Regional CAR-T Site Liason, Janssen

16:35 Speaker Q&A and Panel Discussion

Joined by all session speakers

Speakers

Maria Croyle
Professor of Molecular Pharmaceutics and Drug Delivery/Glaxo Wellcome Professor
University of Texas at Austin
Robert Newman
Chief Scientific Officer
Fujifilm Irvine Scientific
Mark Sawicki
Chief Executive Officer
Cryoport Systems
Sadaf Naz Khan
Regional CAR T Site Liaision
Janssen