Post Marketing & Clinical Diagnostics
Meeting the challenges in neurological disease
Despite significant advances in neuroscience, the variety and complexity of neurological disease continues to make long term treatment difficult. As new drugs arrive on the market, the use of imaging is increasingly being recognised as a way to assess how patients are responding to advanced treatments.
IXICO is pioneering the use of neuroimaging for post marketing assessment and clinical diagnostics. The Company has invested heavily in this new field to expand its clinical development expertise and AI imaging analytics technology to safely enable the prescription and optimal use of important drugs.
IXICO’s robust, secure and regulatory compliant end-to-end technology supports the biopharmaceutical industry as development pipelines approach and move beyond regulatory approval into the clinic. This provides a novel solution for regulatory bodies and biopharma to meet the challenge of managing important drugs in the clinic that have serious side effects, but where there is a lack of alternative medicines.
IXICO Services
Safety – supporting the monitoring and assessment of critical clinical safety factors and providing regulatory guidance for ongoing use in clinical practice. For example:
- The monitoring of Amyloid-related imaging abnormalities (ARIA) for Alzheimer’s Disease (AD) patients which is a recognised side effect and key safety assessment for novel AD drugs.
- The early and/or asymptomatic detection of Progressive Multifocal Leukoencephalopathy (PML) a rare infection caused by the John Cunningham virus.
Second Opinion – a centralised resource using IXICO’s sophisticated AI to facilitate second radiology opinions that provide additional guidance and assistance with final clinical judgements.
Efficacy – providing evidence for in-market drug effectiveness to support extended longitudinal clinical studies and reimbursement considerations that can assist payers in assessing efficacy.
Clinical diagnostics – Supporting the identification of patients that can benefit most from approved drugs. For example, imaging diagnostics to complement first-line blood based biomarkers that may be unclear or inconclusive.
Case Study
The early and/or asymptomatic detection of Progressive Multifocal Leukoencephalopathy (PML) a rare infection caused by the John Cunningham virus.