The presentation focuses on the impact that the work of UK Advanced Therapies has had including a number of case studies.

The quality and safety of Advanced Therapy Medicinal Products (ATMPs) are contingent on that of their starting materials, particularly where these are substance of human origin such as mononuclear cells (MNCs) procured by apheresis. Across the UK there are over 50 Clinical Apheresis Units (CAUs) operating under a Human Tissue Authority (HTA) collecting starting material for ATMPs. The SAMPLE project brough together…

Involving patients in the development of ATMPs is a key part of improving outcomes for patients. This webinar explores the rationale around why patient and public engagement is essential in the development of new therapies, focusing on the specific challenges and needs for cell and gene therapy and the benefits to patient and clinical outcomes when this work is done…

Due to the unique nature of cell or tissue-based ATMPs, there may be occasions when the manufactured medicine is not in full compliance with the release specification, yet it may be in the patient’s best interest to allow administration of the out-of-specification (OOS) medicine.  Administration of OOS ATMPs is exceptionally permissible from a regulatory perspective. It, however, poses challenges to…

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Gene therapy shows great promise for treating many diseases and is a rapidly growing field. Several gene therapies are now licensed medicines and the number is steadily increasing. This webinar provides an introduction to gene therapy and is of interest to anyone involved in either treating patients with gene therapy or looking after patients that have received gene therapy.

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Patient-reported outcomes (PROs) are increasingly used in research and routine clinical care to provide evidence of the benefits and risks of therapy from a patient perspective.  This webinar will explore the potential use of PROs to evaluate the impact of advanced therapies on patient symptoms and quality of life.   Current challenges and opportunities for PRO assessment will be explored and the…

There is a very strong global optimism regarding the immediate future of cell and gene therapy and the UK Ecosystem generally is ‘punching above its weight’. Where will the UK feature over the next 10 years and what will be needed to optimise our contribution to transformative medical treatment and economic benefit? This webinar addresses critical success factors that will…

It is well known that there are substantial challenges for the development and clinical supply of Advanced Therapy Medicinal products (ATMP).  These  span many different themes: complex regulatory pathways; unfamiliar clinical procurement practices; novel biology; limited data to justify reimbursement; high cost of goods, to name just a few. As such it is important for developers of ATMPs to consider…

Advanced Therapy Medicinal Products (ATMPs) are complex medicines which offer ground-breaking new opportunities for the treatment of diseases previously considered intractable.  The Advanced Therapy Treatment Centre (ATTC) Network was established in 2018 to address the unique and complex challenges presented by the increasing number of ATMPs entering the UK. The ATTCs are working together to develop robust systems for the…

Do you want to learn effective ways to engage with patients and the public to support the successful translation of your ATMP to the clinic?