Periodic Reporting for period 1 - PHIVIDIAS (Preclinical Human In Vitro Drug Immune Response Analysis Platform)
Reporting period: 2019-01-01 to 2019-06-30
Drug-induced tissue damage and the associated risk for developing auto-immune secondary disease is fully ignored in preclinical toxicity testing. As a consequence, there are currently 300 drugs on the market that cause drug-induced auto-immune-mediated interstitial lung disease. PHIVIDIAS is a unique and innovative platform for comprehensive preclinical analysis of drug-induced tissue damage and the immune response against molecules released from the damaged cells. PHIVIDIAS will consist of a combination of human cell lines, novel 3D tissue models and organoids and ultrasensitive analytical assays. The data generated from these biological and analytical assays are subsequently put into a state-of-the-art computational model to score the risk of developing auto-immune secondary disease. This predictive model includes biological pathways involved in the human immune response. PHIVIDIAS will be a first in the preclinical market and is globally unique. The overall objective is the development of an evidence-based and broadly applicable platform that enables the comprehensive analysis of drug-induced tissue damage, immune response against molecules released from the damaged cells and for assessing a patient's risk for developing auto-immune secondary disease as a result of a drug. Importantly the platform will be an entirely in vitro system, thus also reducing the waste in animals used during drug development.
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A bottleneck analysis was performed to nominate the most critical parts in the overall innovation project. This included the identification of technical and commercial risks and potential hurdles for the development of PHIVIDIAS. A market study was perfomed to identify potential to identify potential customers and competing technologies in order to validate the commercial potential and to be successful in exploitation of the project’s results. Also a strategy was outlined for IP management.
PHIVIDIAS will deliver new compelling information on the immunologic safety of drugs, thus boosting the development of safer drugs and helping the drug industry meet changing requirements by regulatory bodies for immunogenicity. PHIVIDIAS will enable to kill drug development projects early stage thus preventing financial loss and human health hazard. In addition, PHIVIDIAS enables to modify drug molecules to reduce immune response upstream thus preventing secondary pathology. Importantly the platform will be an entirely in vitro system, thus also reducing the waste in animals used during drug development. With this integrative novel approach,PHIVIDIAS aims to fill the gap in in vitro human immune response safety testing of drugs.