Proof-of-Concept initiative

Faster from the laboratory to the patient: Initiative of Fraunhofer, Helmholtz and Hochschulmedizin promotes pilot project in the health sector

March 19, 2018

In the development of new medications and medical engineering, there is a gap between the discovery of new potential active ingredients and products and their further development into medicinal products and medical devices by the industry. The Helmholtz Association and the Fraunhofer-Gesellschaft, together with the Deutsche Hochschulmedizin, have now jointly brought the Proof-of-Concept initiative into being. It promotes the translation of innovative, promising research projects.

© Fraunhofer ITEM
At the CRC Hannover, experts of Fraunhofer ITEM and Hannover Medical School with unique, extensive experience and capabilities work on different indications in early-phase clinical and proof-of-concept studies.

During the last decade, medical research has made decisive progress: The new understanding of the molecular and cellular basis of diseases allows new, innovative approaches in diagnostics, therapy and prevention. The interlinking of medical knowledge with engineering know-how makes novel medicinal products possible. However, one of the biggest obstacles on the necessary path to new drugs and medicinal products, is still the translation – the further development of new, potentially healing substances and procedures into candidates for usable therapeutic and medicinal products by the industry. "This translation, meaning the fast and targeted transfer of pre-clinical research results into useful medical applications and therapies that benefit people, is a tremendous challenge for health research. Here we see a need to catch up for Germany – the Proof-of-Concept initiative is therefore absolutely pioneering in nature", explains Prof. Reimund Neugebauer, President of the Fraunhofer-Gesellschaft.

In the next three years, the Fraunhofer-Gesellschaft, the Helmholtz Association and the Deutsche Hochschulmedizin will be providing up to twelve million euros for the Proof-of-Concept initiative. At the beginning of February, a high-ranking, specialist jury from science, industry and regulatory authorities determined the most promising research projects for funding. "We chose four innovative and outstanding research projects from a total of 82 interesting applications. Over the next few years we will optimally support the further development of these potentially pioneering active ingredients and therapeutic substances, so that they can quickly find their way into the medical sector and the market", says Prof. Otmar D. Wiestler, President of the Helmholtz Association.

The high number of submissions is proof of the substantial need for the funding of medical development projects, particularly in the field of Proof-of-Concept (PoC) in Germany. "The number of high-quality applications in reply to our invitation to tender was impressive. The submitted projects also show how well the facilities of the Hochschulmedizin already cooperate with their non-university partners", comments Prof. Heyo Kroemer, President of the Medizinischer Fakultätentag.

Translation program for increased research needs

The resulting initiative must now be developed further. Prof. Otmar D. Wiestler points out: "We recognize here not only the purely scientific side, but also the need to take political action: The funding of appropriate medical and diagnostic developments must be improved." Prof. Reimund Neugebauer adds: "In order to cover the increased need for research in this vital medical sector, an in-house translation program should be set up, financed by the Federal government, the Länder and industrial partners through a common fund." The three project partners specifically propose to establish a fund with a budget of about 60 million euros, financed in two equal parts from public and industrial funds over a period of ten years for the development of potential active ingredients. The medical research should also be supervized by an experienced project management team and should benefit from the early incorporation of the regulatory and industrial aspect into the development. "University hospitals are places of translation at the interface between research and patient care. With the PoC initiative we are hoping to make good ideas for patient care come to fruition faster and more comprehensively than before, together with our non-University partners", says Professor Michael Albrecht, 1st chairman of the Association of University Clinics of Germany (VUD).