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Platform 5: Human Challenge
This platform provides single-point-access to an advanced clinical trials package that offers first-into-human testing across a full range of antimicrobial products and treatments – from hygiene and sanitation products, diagnostics, AI wearables and devices, to new therapeutics, and vaccines.
Leveraging the world-leading expertise of Liverpool School of Tropical Medicine (LSTM) and Liverpool University Hospitals NHS Foundation Trust’s MHRA Phase 1 Accredited Clinical Research Unit (CRU), this all-in-one solution covers each stage of the trial journey from study protocol design to downstream analysis. This removes the need for companies to call on the expertise of multiple partners or Contract Research Organisations.
iiCON’s platform provides access to the expert team at the Accelerator Research Clinic (ARC) led by Professor Daniela Ferreira. The state-of-the-art research facility has 18 beds co-located with adjacent laboratories allowing for high clinical and research standards and enabling rapid processing of samples due to clinic and laboratory proximity and the clinic’s expert and experienced team.
Companies undertaking clinical trials also benefit from access to facilities including the largest complement of containment level 3 (CL3) laboratories in the North West and access to a comprehensive BioBank.
Revolutionising Clinical Trials
The Human Challenge Model enables companies to carry out small scale clinical trials with between 100-300 participants to test the performance and efficacy of their product at a relatively early stage. This model provides companies with high-quality insight on their product’s performance and offers the opportunity to assess whether the product needs further development or is ready to advance to large- scale clinical trials. This allows for product testing and evaluation much more quickly and cost effectively than the ordinary product development pathway.
“This ability to provide single point access to expertise at every stage of the trial journey
has significant commercial impact for industry. Uniquely, we have the expertise and facilities available to shape the trial protocol design, secure ethical and regulatory approvals, deliver full clinical trials, and then conduct comprehensive downstream analysis of the trial results. We’re not aware of any other facility globally that is able to offer this range of capability and end-to-end expertise.”
Professor Daniela Ferreira
Testing the efficacy of a drug early in the development pipeline using human challenge models provides reassurance to developers and makes it less likely the product will fail in the later stages of development, particularly the large Phase III trials. This reduces overall costs in the product development phase and companies can test multiple candidates and combinations, conducting tests with a hundred participants at a fraction of the cost of larger Phase III trials.
Human Challenge trials are also an important tool in the context of anti-microbial resistance – where more targeted treatments are needed. Having access to rapid testing to refine and shape therapeutics to enhance precision and impact is crucial to combat resistance and avoid over-prescribing of antibiotics.
For more information or to learn how your business can engage with this platform.
Platform Lead
Professor Daniela Ferreira
Professor of Respiratory Infection and Vaccinology at Liverpool School of Tropical Medicine and the University of Oxford
Daniela is a global leader in Respiratory Infections and Controlled Human Infection Challenge(link is external) with experience in bacterial challenge, co-infection studies, mucosal immunity (nose and lungs) and vaccine testing and immune responses. She leads a Programme of work on respiratory infections and accelerated vaccine development with over £20million from various funders including BMGF, MRC, UKRI, NIHR and several industry partners.
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