Tools

ATMP & regenerative medicine in general

HelpdeskRM (Utrecht University, UMC Utrecht): helpdesk to answer any questions you may have related to regenerative medicine (in Dutch)

ATMP Sweden resources (ATMP Sweden): support resources published by ATMP Sweden such as a regulatory guide, commercial aspects and project reports

T2EVOLVE Stakeholder Ecosystem (T2Evolve): alliance to increase access to TCR or CAR immunotherapy; the stakeholder ccosystem is structured as a hub (bi-monthly meetings) and spokes (working groups). You can join at no cost to stay informed, access meetings and participate in projects

Manufacturing & training

Agora toolbox (ECA ATMP Working Group): a collection of documents assembled in the AGORA project on ATMP-related applications, protocols, templates, guidance, training and GMP – access requires registration for a free membership

ATTC resources (Advanced Therapy Treatment Centres, UK): information and resources from the UK ATMP network – from case studies to publications and tools to aid the delivery of advanced therapies to patients

Regulations

ECA tools (ECA foundation): information and interpretation of new or updated GMP guidances aimed to move towards a harmonised set of GMP and GDP guidelines

Regulatory and scientific support (EMA): The European Medicines Agency (EMA) provides regulatory and scientific support to foster development of new and innovative medicines, from the early phases in the laboratory all the way to the patient

Regulatory and scientific support for academia and SME (EMA): EMA provides incentives and support for academia and micro, small and medium-sized enterprises (SMEs) that are developing medicines for human or veterinary use, in order to promote innovation and the development of new medicines

Costs and lead times

Costing tool: A framework and methodology to facilitate academic and other small-scale cell therapy manufacturing costings. The publication includes a file to calculate costings, with essential background information in the article.

Dashboard doorlooptijd geneesmiddelen (ministry of Health, Welfare and Sport – VWS): an overview of the phase of reimbursement (submission, assessment or negotiation) of expensive new medicines and lead times per phase (in Dutch)

Infographic Early Acess (Hollandbio): overview of early access programmes and their characteristics

Clinical trials

Clinical research metadata repository (European Clinical Research Infrastructure Network): a searchable database of all registered clinical studies, together with related documents such as results, papers, protocols and data sets, whenever those objects are available