Project description
Improving drug safety
Harmful events associated with certain pharmaceutical drugs are known as adverse drug reactions (ADR) and could be related to the dose or the time of administration, or they could be a result of withdrawal from or failure of therapy. The EU-funded MEDIKURA project has developed a digital infrastructure for collecting and analysing ADR data with a view to improving the safety of medicines. The cloud-based platform is accessible by patients, doctors and pharmaceutical companies as a transparent and centralised approach of reporting ADR. Long term the platform is expected to accelerate data-driven drug discovery and minimise ADR.
Objective
The mission of MEDIKURA is to digitize drug safety: our process innovation helps pharma companies to capture, enrich, and analyze drug-related data provided by patients and doctors. We address the societal problem that more than 200,000 European citizens die from Adverse Drug Reactions (ADRs, colloquially referred to as drug side-effects) every year, whereas less than 1% of ADR cases are officially reported by patients and doctors. To improve drug safety, the new EU regulation ICH E2B(R3) came into effect in late 2017 - as a result, pharma companies are subject to increasing cost and time pressure in ADR monitoring.
Our solution is to build the digital infrastructure for ADR data – to improve drug safety, enable more targeted therapies, and accelerate data-driven drug discovery. We streamline the process of capturing, enriching, and analyzing ADR data through a cloud-based platform that connects pharma companies with patients and doctors. Our goal is to replace the decentralized, analogue drug safety process with a transparent, centralized, and digital system. The resulting value proposition to pharma companies is three-fold. In terms of time savings, we reduce the timespan to close a ADR case and report it to public authorities by more than 50%. In terms of money, we can save processing cost of more than 50% per ADR case and reduce liability risk significantly. In terms of data quality, we provide comprehensive information through a digital backchannel to both patients and doctors that allows to enrich drug-related data and prepare it for subsequent analyses.
Fields of science
- medical and health sciencesbasic medicinepharmacology and pharmacydrug discovery
- medical and health sciencesbasic medicinepharmacology and pharmacydrug safety
- medical and health scienceshealth sciencespersonalized medicine
- natural sciencescomputer and information sciencesdata sciencedata exchange
- medical and health sciencesbasic medicinepharmacology and pharmacyadverse drug reactions
Programme(s)
Funding Scheme
SME-1 - SME instrument phase 1Coordinator
80335 MUNCHEN
Germany
The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.