The Huntington’s Disease Regulatory Science Consortium (HD-RSC)
The HD-RSC, created through a partnership between CHDI Foundation and the Critical Path Institute (C-Path), is a global initiative aiming to improve the regulatory path for new HD therapies. It facilitates collaboration among biopharmaceutical industry partners, technology industry partners, academic institutions, government agencies, and patient-advocacy organizations. IXICO is committed to advancing HD science, contributing to reviewing current evidence, identifiying evidence gaps and planning targeted research with potential to increase the efficiency, safety, and speed of HD drug development.
By devising a regulatory science strategy for HD therapeutic development, the HD-RSC can incentivize drug developers and accelerate qualification or regulatory acceptance of drug development tools, biomarkers, and clinical assessments. It also provides an important forum for collaboration, bringing together the worldwide HD community for knowledge exchange, consensus and sharing of data. A better understanding of disease progression gained from leveraging an integrated database of patient-level data from observational studies and clinical trials will support model-informed drug development and could ultimately lead to regulatory approval of HD therapies.
European Prevention of Alzeimer's Disease (EPAD) and Amyloid Imaging to Prevent Alzeimer's Disease (AMYPAD)
EPAD and AMYPAD are international consortia where IXICO’s expertise and TrialTracker™ digital platform is being used to standardise the collection of MRI and PET imaging data from 6000 people recruited from clinical centres all over Europe.
EPAD project is pioneering a novel, more flexible approach to clinical trials of drugs designed to prevent Alzheimer’s disease, whilst AMYPAD aims to improve the understanding, diagnosis and management of Alzheimer’s disease through the utilisation of ß-amyloid PET imaging.
In both EPAD and AMYPAD projects, IXICO data analysis algorithms quantitatively analyse brain scans, to maximise the information extracted and increase chances of detecting therapy-induced changes in clinical trials. IXICO's artificial intelligence data analytics will be used to combine imaging with other data captured from patients, to predict the rate of disease progression in individual patients and identify those people who could benefit from enrolment in clinical trials aimed at preventing Alzheimer’s disease.
Critical Path against Alzheimer's Disease (CPAD)
Critical Path against Alzheimer's Disease (CPAD) is a public-private partnership aimed at creating new tools and methods that can be applied to increase the efficiency of the development process of new treatments for Alzheimer’s disease and related neurodegenerative disorders.
IXICO’s data management and regulatory scientists are enabling initiatives such as the qualification of low baseline hippocampal volume for use in Alzheimer’s disease clinical trials for selecting subjects as having a high probability of being in the prodromal stage of the disease; and to progress the regulatory landscape for the use of digital biomarker measures as endpoints in clinical trials to support regulatory approval of new medicines to treat people with Mild Cognitive Impairment.