After 2017’s successful launch, we and our partners are teaming up together to empower cell therapy developers to handle the complexities of a modern supply chain.
Raw & Starting Materials: Tuesday, January23RD
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, January 24TH
- 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)
- Director, Clinical Product Logistics, CRISPR Therapeutics
- Vice President of Sales & Account Management, TrakCel
- Executive Vice President, Technical Operations, Bellicum Pharmaceuticals
- Senior Manager, Apheresis & Collection Center Network Development, Be The Match Biotherapies
- Director, Quality Assurance, Nohla Therapeutics, Inc
- CEO, Akron Biotech
- Vice President, Manufacturing & Supply Chain, Adaptimmune
- Senior Vice President, Global Sales & Business Development, HemaCare Corporation
- Director, Regulatory Affairs/Quality Systems, Management Representative, Irvine Scientific
- Senior Director, Technical Operations, bluebird bio
- QA Director, Cell & Gene Therapies, GlaxoSmithKline
- Senior Vice President of Commercial Operations, Clinical Trial Logistics, QuickSTAT, A Quick Company
- Director, Regulatory Affairs, Cellectis
- Senior Manager, Advanced Therapies , Fisher BioServices
- Director of Operations & Business Development, Holding F.I.S.
- Associate Professor of Virolosgy, Head of Pathogen Safety, Shire
- Vice President, Science & Technology, AllCells
- Executive Vice President of Technical Operations, Kite - A Gilead Company