"Cell or gene therapies show great potential in treating patients with conditions that cannot be cured with current treatments. These include arthritis, liver disease, several types of cancer, and diabetic ulcers. It is important to assess the impact of these new therapies on patient quality of life and symptoms, both at the point of receiving therapy and over the longer-term once out of hospital. The project will develop an electronic capture system to assess patient symptoms and quality of life when they receive these new therapies. Patients will be able to report how they feel on the treatment by using electronic devices. Any worrying symptoms will be flagged to the clinical team to help promote patient safety. These data will also be used to assess the effectiveness of treatment and be used as an evidence base for regulators and policy makers to support uptake in the NHS. Patients have been directly involved in development of the project and will provide direct input into the system development to ensure that it meets their needs. The Datatrial Nucleus database platform being rolled out across the Advanced Therapy Treatment Centres in the UK will collect data from multiple sources and will be important in allowing assessments of cost-effectiveness of these therapies. The project lead is the Midlands & Wales Advanced Therapy Treatment Centre (MW-ATTC) - a national centre of excellence in partnership with the Centre for Patient Reported Outcomes Research at The University of Birmingham, health technology companies Dignio and Datatrial. The project draws on expertise from stakeholders in the ATTC network, London's network of Advanced Therapy Centres (ATCs), the pharmaceutical industry including ATMP developers and producers such as Chiesi and Autolus, the Cell and Gene Therapy Catapult, UK regulators and payers."

"ATMPs, which can be _cell or gene therapies_, show great potential in treating patients with conditions that cannot be cured with current treatments. These include arthritis, liver disease, several types of cancer, and diabetic ulcers. ATMPs are just beginning to be available, with the UK playing a leading role. However, even when new ATMP therapies are developed and shown to be effective, there are **major challenges in rolling them out to patients**. The reasons for this include: complexities in transporting a 'living' product, and lack of familiarity with such products in most NHS hospitals. The project lead is the Birmingham Biomedical Research Centre, a national centre of excellence. The Welsh government has also made a major investment in cell therapy and is supportive of NHS Wales as the joint-lead on this project. We are a **team of industrialists, clinicians, academics and computer system experts** who have all the necessary skills to succeed in this project. Our group **covers the Midlands and Wales** giving us access to major teaching hospitals and almost 15 million people providing a unique opportunity to set cell therapy up to succeed. We will: -Set up a network of hospitals with medical staff trained to receive and administer ATMPs. -Build seamless supply chains that ensure that 'living medicines' remain healthy and effective as they are moved from the production laboratory to the bedside. -Put in place the IT systems to manage the end-to-end process. -Validate this new infrastructure using real ATMPs -Deliver a programme that uses this infrastructure to speed up the testing of ATMPs in clinical trials. -Set-up protocols to test whether the **cost of a new ATMP is justified by its clinical effectiveness.** The benefits of MW-ATTC are (a) Patients with challenging illnesses will get access to breakthrough medicines; (b) ATMP companies will get access to the clinical mainstream and market; (c) Investment in this important industry sector will increase, as we demonstrate that the UK is an excellent location for ATMP R&D. MW-ATTC will be one of three Advanced Therapy Treatment Centres in the UK, working together for patients and ATMP innovators, to reinforce the UK's position as a world leader in this important field."