The aim of SmartMarker is to provide a commercial infrastructure that allows to transform heterogeneous patient health information, typically stored in multiple clinical and health IT systems, into standardized, comparable, consistent, and queryable data. The goal of this infrastructure is to conduct retrospective clinical biomarker validation studies and to foster effective treatments to marker-defined patient subgroups. Our ambition is to dramatically ease the process of clinical biomarker validation starting in the cardiology domain. We propose a research infrastructure that allows meaningful data access to large-scale integrated data repositories. Exploitation of the electronic medical records will allow pragmatic and low cost, but still robust and appropriate analytical retrospective study methods to measure the prognostic and predictive outcome of clinical biomarkers on large patient collections.
In a feasibility study with 500k patient lives we could show that it is possible to perform large scale biomarker validation studies on the basis of available patient data. They can serve as an alternative to prospectively designed clinical trials which are the conventional approach to validate predictive biomarkers, but are still an expensive and time-consuming procedure, and work on a relatively small number of patients.
An in-depth IPR analysis revealed that the SmartMarker platform may not be protected by means of a patent as it lacks the technical feature and technical contribution requirements which would determine its patentability. Instead, SmartMarker IPR shall be protected by means of copyright which is bestowed to the authors due to the simple fact that they have created the software platform. The technology report revealed that there exist some solutions to integrate informatics platforms to patient's clinical care information but most are developed for local use between North American academic institutions, research centres and hospitals. There is a strong market opportunity in Europe, whether manage to overcome certain barriers of political, economic and ethical themes.
The SmartMarker team also produced a detailed business plan describing products and services as well as the SmartMarker management team consisting of experienced entrepreneurs in the eHealth sector. The market analysis revealed biomarkers and phenotypes as one of the “hot threads” of diagnostics and drug development in pharmaceutical and biomedical research, with applications in early disease identification, identification of potential drug targets, prediction of the response of patients to medications, help in accelerating clinical trials, and personalized medicine. The biomarker market generated $13.6 billion in
2011 and is expected to grow to $25 billion by 2016. Competition is still fairly low with providers mainly addressing the US market. A detailed three phase strategy and implementation for fast market penetration has been developed. We expect to make significant revenue beginning in the first year after the funding phase, reaching the break-even in 3-5 years. Regarding financial requirements, we don't expect large financial support for technical developments after SmartMarker Phase II. However, a significant budget will be needed for marketing and rapid market penetration.
