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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - MEDIKURA (MEDIKURA: Digital Infrastructure for Drug Safety in Europe)

Teaser

Summary

MEDIKURA is creating the leading operating system for patient 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 drug side-effects every year, whereas less than 1% of suspected 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 side-effect monitoring. Our solution is to build the digital infrastructure for side-effect data â€“ to improve patient safety, enable more targeted therapies and accelerate data-driven drug discovery. We streamline the process of capturing, enriching, and analyzing side-effect data through a cloud-based platform that connects pharma companies with patients and doctors. Our goal is to replace the decentralized, analogue patient safety process with a transparent, centralized, and digital system. In addition to the numerous advantages for patients and healthcare professionals, we offer a tree-fold value proposition to pharmaceutical companies. In terms of time savings, we reduce the timespan to close a side-effect case and report it to public authorities by up to 90%. In terms of money, we can save processing cost of more than 50% per side-effect case and reduce liability risk. In terms of data quality, we provide comprehensive information through a digital backchannel to patients, doctors and pharmacists that allows to enrich drug-related data and prepare it for subsequent analyses.

Work performed

During the course of action, we conducted a feasibility study to demonstrate the technological, practical and economic feasibility of our system. We did extensive research in the field of healthcare IT to learn about the requirements for our overall system - particularly in terms of scalability, security, and extensibility. Most importantly, we developed specific user interfaces for healthcare professionals and pharmaceutical companies. Furthermore, we set up our sales infrastructure, took several measures to meet necessary quality requirements in terms of pharmacovigilance processes and IT security. We built up a significant sales funnel and attracted the first prospective business clients. Currently, we are beta-testing our interfaces with a limited number of users and set up a landing page where healthcare professionals can register to be notified when we launch for the general public in Germany. Our primary objective to demonstrate the feasibility of our business model was to show traction on the patient side, measured through the number of side-effect reports filed via our platform nebenwirkungen.de, which was launched in September 2018 (formerly: nebenwirkungen.eu). Between August 2018 and January 2019, we attracted more than 80,000 patients per month.

Final results

We developed an integrative process and product innovation that covers the whole pharmacovigilance process chain: collection, communication, and analysis of side-effects. Our MEDIKURA OS constitutes a unique gateway that enables direct communication and drug-related data exchange between patients and pharma companies in particular. This way, we build up a patient-centered approach to address the unmet need for close and constant monitoring of drug reactions in the open market. Our project has three major implications for society:
(1) Facilitating direct communication: we enable drug-related data exchange between patients, healthcare professionals, and pharma companies.
(2) Harvesting real-world evidence: we lay the foundation for data-driven applications in personalized medicine.
(3) Augmenting public efforts: our platform contributes to tackling the severe underreporting of side-effects, providing regulators with more accurate data to monitor and assess risk-/benefit profiles of drugs in the open market.