Advanced Therapies NHS Readiness Toolkit

Summary of workshop findings re: barriers to effective ATIMP trial set up, changes required to overcome them and key ATIMP trial metrics.

A proforma for submission to the Manchester Clinical Research Facility (Christie site), which outlines NHS Trust clinical and resource requirements, prior to study set up.

A template produced by The Christie NHS Trust to hold and update frequently asked questions and responses to cell therapy trial feasibility questionnaires.

Model Clinical Trials Agreement – This model agreement captures all the specific contractual requirements of ATMP commercial clinical trials for implementation in the NHS.

Advice produced by the Pan UK Pharmacy Working Group for ATMPs for Pharmacy sites on costings for clinical trials of ATMPs, using the NIHR interactive costing tool.

Advanced Therapy Medicinal Product (ATMP) Cost Model which supports NHS institutions to assess finance and resource implications arising from the adoption of an ATMP into clinical practice.

Micro costing analysis toolkit for Advanced Therapy Medicinal Products.

Cost Comparison of Tumour Collection Strategies for TIL Therapy.

Example business case for gene therapy cabinet in aseptic unit.

The Specialist Pharmacy Service produces a range of information to support managed entry of new drugs into the NHS, to assist organisations in developing medicines management policies and to inform prescribing decisions when a product has been launched. The service provides ways to track the development of drugs from when key trials start until they launch in the UK.

The AAC is bringing together industry, government, regulators, patients and the NHS to remove barriers and accelerate the introduction of ground-breaking new treatments and diagnostics which can transform care, including ATMPs

Focussing on four upcoming ATMPs in 2021, how they work, how patients might benefit, how they are given and other practical issues staff need to aware of.

A flow diagram showing the pathway a patient and treatment would follow for an autologous ATMP to be administered

A summary of activities across NA-ATTC hospitals geared towards patient centred, safe and efficient trial set-up, delivery and completion

Horizon Scanning is the systematic process of identifying new medicines or technologies in development. This information is useful to clinical trials sponsors, ATMP developers and manufacturers, organisations aspiring to hold ATMP marketing authorisations, as well as to NHS group members and beyond.

Key factors to consider to make the business cases for implementation of a new ATMP service

A flow chart showing the pathway a patient and treatment would follow for an allogeneic cell therapy to be administered

This guidance documents accompanies the ATMP model clinical trials agreement and can be use as a guide to allow the proper use of the model agreements.