An enlightening and informative presentation was recently made by Dr Sheila Waugh, a Consultant Virologist who chairs the Genetic Modification Safety Committee (GMSC) at The Newcastle upon Tyne Hospitals NHS Foundation Trust. This was hosted at the John Walton Muscular Dystrophy Research Centre (JWMDRC) based at Newcastle University’s Institute of Genetic Medicine in the International Centre for Life. The JWMDRC had previously consulted the expertise of Dr Waugh and the GMSC with regards to the set-up of a gene therapy trial, and with an increasing number of such trials under discussion, thought it opportune for Dr Waugh to present on the role of the GMSC.
The Newcastle Hospitals’ GMSC advises the Trust on the adequacy of any risk assessments undertaken relating to activities involving genetically modified (GM) microorganisms on its premises. Dr Waugh described the assessments that take place as part of the GMSC review including the assignment of the product to a group (1 to 4) depending on the level of risk to humans, with Group 1 being unlikely to cause human disease and Group 4 potentially causing severe human disease (eg. Ebola). This includes considerations of any modifications made to the vector backbone and the properties of any introduced genetic sequences. Risk assessment also covers the safety measures required for handling of the GM product prior to administration (receipt, storage and preparation), administration of the GM product to the patient, shedding, and waste.
Investigators are strongly advised to discuss potential projects with the GMSC Chair as early as possible and ideally obtain appropriate approvals (e.g. MHRA, ethics) prior to completing the risk assessment form, which is then submitted to the GMSC.
There are currently 9 licensed gene therapies (GM products) in the EU. With 3 of these – Kymriah (CAR-T), Yescarta (CAR-T) and Luxturna (inherited retina disease) having been licensed within the last 6 months, hospitals will increasingly be seeking the expert advice of the committees such as the GMSC to help facilitate the clinical testing and ultimately the adoption of these products by the NHS.