To achieve the promise of personalized medicine (PM), pharmacogenetic knowledge should be applied by physicians and healthcare professionals in routine clinical practice. That this is not yet the case is partly due to the complexity of pharmacogenetics itself and the lack of clinical validation in its application to date.
Through the “PRECISE” project funded by the German Federal Ministry of Education and Research (BMBF) in 2021, the regulatory requirements for a medical device according to MDR Class IIb were elaborated in order to prepare a clinical validation of PGXperts. For the realization of the project HMG cooperates with renowned partners from science.
The cornerstone of financing for the PGXperts system was laid by funding from the Free State of Bavaria, which HMG Systems Engineering GmbH received in January 2014. The goal was to begin research and development of an expert system to optimise individual medication through genotyping.
The project lasted 18 months and was carried out in cooperation with the Practice Network Nuremberg South – Dr. Michael Bangemann – and the Chair of Health Economics at Wilhelm Lohe University – Prof. Jürgen Zerth.
To achieve the energy transition it is necessary to develop automation in rail transport and new components and functions for battery electric vehicles. This requires the use of advanced methods and the mastery of a high level of complexity. From 2021 to 2024, the “MBPLE4Mobility” project funded by the German Federal Ministry of Economics and Climate Protection (BMWK) will bring together approaches from model-based systems engineering (MBSE) and product line engineering (PLE) and apply them to development processes in the specialist domains of rail transport and automotive electromobility. For the realisation of the project HMG cooperates with renowned artners from industry and science: Siemens Mobility GmbH, AVL Deutschland GmbH, AVL Schrick GmbH, AVL Software and Functions GmbH, MID GmbH, Codewerk GmbH, University of Applied Sciences Munich, Friedrich-Alexander-University Erlangen-Nuremberg.
Opening up new sales markets for PGXperts within Europe requires a series of coordinated measures: In addition to medical device approval and market exploration, a company must know the national conditions and successfully establish networks.
In the period between September 2022 and July 2023, the “PGXperts Bridgehead” project funded by EIT Health e.V. will prepare the regulatory path to approval in the U.S. market, develop the commercialization strategy and plan the validation of PGXperts in North America. HMG is cooperating with renowned partners from industry and academia to realise the project KIC EIT Health is one of the eight Knowledge and Innovation Communities (KICs) currently funded by the European Institute of Innovation and Technology (EIT).
KIC EIT Health is supported by the European Institute of Innovation and Technology (EIT), a body of the European Union.