ESRC Biomodifying technologies: Organisation regulatory implications for the translation valuation of health research: Policy briefing Jan 2021
Michael Morrison, who leads the Biomodifying Technologies project, has recently published a third policy briefing titled "Trends in Customisation and Personalisation of Advanced Therapies". The policy briefing can be viewed on the Regenerative Medicine Journal website.

The Biomodifying Technologies project is led by the University of Oxford in collaboration with colleagues at the University of Sussex and the University of York, and funded by the UK Economic and Social Research Council. The project is aims to investigate the likely impact of such technology on human health, healthcare and medicine in the UK. Michael Morrison and Jane Kaye from HeLEX are both part of the project.

This is the third of four policy briefings. In this briefing, the team examines the options for customization and personalization in therapeutic applications of biomodifying technologies

This briefing looks at the potential for ‘customization’ and ‘personalization’ in the clinical translation of therapies based on gene editing, induced pluripotent stem cells (iPSCs) and 3D bioprinting. Customization and personalization involve tailoring some part of a product or process to a specific situation and context, which in medicine is often done to meet the requirements of an individual patient.

While scope for personalized ‘one-off’ therapies remains limited, a variety of forms of ‘mass customization’, at the level of both therapeutic products and manufacturing processes, could complement mass-produced cell and gene therapies.

Future policy developments need to evaluate whether to support one or several forms of manufacturing within the UK healthcare sector, as each requires different forms of support, skill sets from the workforce and logistical and regulatory hurdles to viability.