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
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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
