Decentralising precision medicine patient recruitment and clinical trial research to accelerate drug development

Traditionally outsourced to Contract research organisations ("CROs"), and run through in-person visits to the clinical trial sites, the clinical trial process has not changed since the 1980s.

Over the past ten years, there has been a monumental shift in our ability to collect and analyse genomic data due to continued innovation and reduced DNA sequencing costs. By the nature of personalised medicine, finding patients is complex, with very selective inclusion/exclusion criteria to enrol participants into trials. The CROs have a cost-plus model where they rely on bricks-and-mortar sites for patient recruitment, which often do not have adequate infrastructure or patient access. This is particularly hard given the fragmentation of genomic data across government, academia, consumer platforms and healthcare providers, many of which do not meet the high quality of information required for gene therapy trials. This combination results in significant time and cost inefficiencies and a high failure rate for patient enrolment.

Clinical trials in genetic neurodegenerative diseases, and other common complex diseases in particular take a significant amount of time, resources, and funding to recruit the right patients at the right stage of disease, with many failing due to poor recruitment and engagement. Taking up to 15 years and ~£119m to bring to market, potential therapies often show promise in Phase 2 trial results, then prove to be ineffective or face enrolment challenges in the subsequent, larger-scale Phase 3 trials.

The focus of this innovation is to develop a fully decentralised (at-home and digital first) genetic testing platform that combines:
Genetic counselling
Non-invasive sample collection
Bioinformatics
Return of results

In one platform, available in multiple languages across the UK and EU.

The output of the innovation will be an end-to-end platform for providing non-invasive sample collection, proprietary bioinformatics analysis, genetic counselling, and return of results that can be provisioned on independent cloud infrastructure in order to enable the operation of decentralised genetic testing studies across a range of jurisdictions with different data privacy regulations. The solution will address rare and common genetic diseases across three major customer segments: biopharma, biotechnology, and population genomics.