Case Studies

Accelerating access to ATMP clinical trials in Birmingham Children’s Hospital

The challenge

When the Birmingham Children’s Hospital (Birmingham Women’s and Children’s NHS Foundation Trust) were approached by a company to run a haematology ATMP clinical trial, the trust, seeing the promise of the treatment, were keen to support the trial. However, having no prior experience of advanced therapies, they needed support to enable the creation of the required governance structures and procedures to rapidly set up this clinical trial.

The solution

Through local networks, the team at BCH were made aware of the Midlands and Wales ATTC and introduced to Prof. Phil Newsome. The MW-ATTC have since been able to provide advice and support to the team around the complex regulatory framework. Pharmacists have been linked in to the MW-ATTC network and local individuals who have been able to provide specialist support, to ensure that the team has the required working knowledge in place to safely work with ATMP’s and that regulatory requirements are met.

The results

The introduction to the MW-ATTC galvanised the actions required, providing both a road map of the requisite next steps and access to necessary training and knowledge. The availability of multiple resources, including relevant policies and procedures which can be locally adapted has drastically compressed the time taken to progress from initial contact to trial set up.

Dr Fiona Reynolds, Medical Director of Birmingham Children’s Hospital, said “The MW-ATTC have really helped move things faster at BWC with access to their expertise and teaching materials”.

Making further impact

As a result of the introduction to MW-ATTC and facilitation to this essential knowledge regarding ATMP clinical trials, access to ATMP clinical trials in the Birmingham Children’s Hospital has been accelerated and BCH are now able to offer a new service. Although the timeframe for their first gene therapy trial was delayed by the COVID-19 pandemic, they plan to open a GMO trial in Spring 2021 and have already been approached by additional companies looking to partner on future ATMP trials.

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