Welcome to the 2018 Supply Chain & Logistics Hub
Ever wondered what a fully integrated, end-to-end cell or gene therapy supply chain model actually looks like?
Take a journey through a cell & gene therapy supply chain of the future! Demystify every component, from cryopreservation to product tracking, and from initial sample collection to clinical site administration. You will leave with a clear vision of what YOUR product’s optimal supply chain management model should look like through scale up to the commercial setting.
You will visit seven hubs in total, representing the most important elements in the chain of custody:
|1.Supply Chain Planning|
|2. Registration & Workflow Management|
5. Temperature Management
|6. Point of Care Administration|
All event passes will give you free access to the supply chain hub, register for your pass here.
Each of the seven supply chain hub partners has written a never before seen case study detailing a customer challenge and how this was overcome, take a look at this week's featured case study...
Raw & Starting Materials: Tuesday, 23 January
Facing up to critical raw materials supply shortfalls – the single largest elephant in the commercial cell & gene therapy room?
- Where specifically do/will the greatest shortfalls current exist and just how significant are they in the context of expected clinical and commercial demand over the short- to mid-term? (Eg. plasmids, cell culture media)
- How to develop the innovation and infrastructure needed to overcome raw material supply shortages whilst minimizing Cost of Goods? (Eg. capitalizing on novel/emerging cell sources for the cell therapy industry)
Starting material optimization for autologous and allogeneic cell & gene therapies
- Viral safety considerations for cell- and gene-based therapies
- How to manage and standardize global/multi-site apheresis? Addressing quality and consistency challenges
- Defining best practice in allogeneic cell therapy donor supply and management
How to maximize efficiency in raw and starting materials quality control/characterization
- Optimizing quality of raw and starting materials – what exactly constitutes ‘good enough’?
- Identifying and overcoming key challenges in raw and starting materials management for decentralized/point of care manufacturing (eg. of a CAR T cell immunotherapy)?
Cold Chain & Data Integration/Management: Wednesday, 24 January
Supply chain data management and integration
- Integrated approach to management of CGT product supply chain
- How to identify the data that is really critical to collect, and how to integrate and utilize it to the benefit of the overall supply chain?
- Scaling up to commercial: how to automate the data management piece to allow the move from hundreds to thousands of patients?
- Track and trace and supply chain security – how to satisfy disparate regulatory requirements and standards on a multinational basis?
- Generic ‘off the shelf’ vs. tailored cell therapy supply chain management software – analysing the practical utility/applicability of both options
Tour of the Vein-to-Vein Supply Chain Hub
This session will be staged in our expanded Supply Chain hub – an experiential, circular journey along the entirety of the autologous cell-based therapy supply chain: from starting material obtainment/management through cold chain logistics, bioprocessing, quality control, fill-finish and management/ delivery to the patient back at the point of care.
- Delivering a strategic roadmap for supply chain development and validation for patient-specific cell & gene therapies
- How to identify/predict and minimize the potential variables in your supply chain to achieve true consistency in product quality and delivery?
- Leveraging supply chain strategies and technology to scale from clinical to commercial volumes
Supply chain scale up strategies and enabling technologies to minimize CoGs
- Sector leaders’ tips for designing and implementing efficient, scalable
- cell & gene supply chains
- Next generation cold chain technologies (including automated/closed solutions) – what real improvements are they delivering in practice? (Eg. cost, quality, configurability, flexibility and ease of integration)