The ABPI (Association of British Pharmaceutical Industry) and AAC (Accelerated Access Collaborative) launched at the end of 2021 an ‘ATMP Roadmap’ that has been created on their behalf by Ernst & Young with input from organisations such as the Cell and Gene Therapy Catapult, The Medicines and Healthcare products Regulatory Agency (MHRA), NHS England (NHSE) and The National Institute for Health and Care Excellence (NICE). It is a very useful resource for anyone involved with these products.
This ATMP Roadmap is in the form of a downloadable interactive PDF and sets out the key steps and activities in the end-to-end pathway for Advanced Therapy Medicinal Products (ATMPs) in England from non-clinical research through to patient treatment. It also signposts where differences exist between devolved nations (Scotland, Wales and Northern Ireland) or different types of ATMPs.
There are general encouragements on best practices to Engage early, Seek advice and support, Minimise complexity and Patient centricity.
If you have any involvement in ATMPs, you would be well advised to spend some time working your way through this very useful resource.