In order to better translate medical ideas and scientific findings into the practice of patient care, physicians and scientists must consider the issues of patent application, approval, clinical trials and transfer to reimbursement systems at an early stage. This was made clear by the experts at the BVMed special event "Translation: Science and economy - a contradiction?" on May 27, 2014 at the Medical Park in Hannover. One challenge is to gear research more closely to the needs of patient care. Researchers must not only publish their results, but also patent them. And they must include economic expertise at an early stage. An important aspect of successful "translation" is the transfer of knowledge about regulatory requirements and clinical trials. At the beginning of a translation process, there must be precise goal setting and planning of the process, the experts say. Other success factors include a strategy for reimbursement, professional study planning to generate evidence, and a strategy regarding market access, marketing and distribution channels. It is also important to win key customers in the medical profession early on who support the product, and to identify comparative therapies in order to prove the benefits of the innovations. Ingelore Herring from the Lower Saxony Ministry of Economics emphasized the importance of medical technology for the state of Lower Saxony. The state is very well positioned in materials, laser and implant research in particular. The challenge, he said, is to align research more closely with demand and then translate the research results into successful start-ups. Success factors include cooperation platforms in the clinical field and the establishment of technology centers in the vicinity of scientific institutions. The goal of the Medical Park in Hanover, where the conference was held, is to bring science and companies "door to door" to cross-fertilize each other, Hering said. She also suggested breaking down the national medical technology strategy process to the state level. Dr. Manfred W. Elff presented the Lower Saxony Center for Biomedical Engineering, Implant Research and Development (NIFE) in Hannover. Elff is chairman of the center's board and also a BVMed board member and managing director of Biotronik in Berlin, a manufacturer of pacemakers. The center was founded in November 2008 as a joint scientific institution of Hannover Medical School (MHH), Leibniz University, the University of Veterinary Medicine and the Laser Zentrum Hannover, in order to bundle the competencies of implant research at one location. Numerous facilities are being built in the vicinity of the MHH to locate research and industry side by side. Thom Rasche, partner at Earlybird Venture Capital, introduced financing aspects. Venture capital is equity capital provided by public and private financiers to invest in good ideas. Venture capital is thus a "seed financier" for young start-ups. The funds are usually limited to ten years. It is important to assess whether the idea is marketable and whether the idea providers have the management skills to turn it into a commercial reality. The "first money" to start a company is sufficiently available in Germany, for example through the High-Tech-Gründerfonds. There are problems with the second financing phase of 15 to 20 million euros to bring the innovation into practice. Rasche appealed to German clinical research to think not only about publications but also about patent applications. "Research should be more closely intertwined with economic expertise as well. Business people need to be involved early on to make good research results marketable," Rasche said. The culture between physicians and industry must be further developed and improved in Germany, demanded Prof. Dr. Axel Haverich, Medical Director of the Clinic for Thoracic, Cardiac and Vascular Surgery at Hannover Medical School. Doctors should have just as little fear of contact as researchers. This is a lengthy development process. Researchers, for example, not only have to publish, but also have to patent. Haverich cited the topic of "tissue engineering" as an example of innovations from clinical practice that are implemented with the help of industry. This involves tissue cultivation using autologous cells on a matrix. In Hanover, for example, heart valves that grow with the patient are being developed. They are based on the body's own cells and thus belong to individualized medicine. "However, the regulatory requirements in Germany are not geared to these innovations," Haverich said. Haverich pleaded for new cooperation formats to bring researchers, clinicians, industry and regulators to the same table - with the common goal of "getting innovations on the road." The translational alliance "TRAIN" in Lower Saxony was presented by the researcher Prof. Dr. Ulrich Kalinke in front of. He is Executive Director of the TWINCORE Center for Experimental and Clinical Infection Research in Hannover. The goal of the regional competence network is to identify and develop good ideas from basic research. "TWINCORE bridges the gap between basic research and clinical application," says Kalinke. Before know-how can be pooled, however, a good infrastructure is needed, for example through the construction of innovation centers. Networks include the Clinical Research Center (CRC) or the Biomolecular Drug Center (BMWZ). "Enormous opportunities are developing here," says the researcher optimistically. An important aspect of successful translation is the transfer of knowledge about regulatory requirements and clinical trials. The concept of the Clinical Research Center Hannover (CRC) as part of the TRAIN network introduced Prof. Dr. Norbert Krug . He is Medical Director at the Fraunhofer Institute for Toxicology and Experimental Medicine. The CRC is intended to be a "professional test center" for early-phase clinical studies to transfer research results into clinical practice. It is important, he said, that subjects feel comfortable at the center and are treated well so that they can successfully participate in the study over a four-week period. The center also has hotel-style overnight accommodations for relatives for this purpose. Numerous specialized medical tests can also be performed at the CRC. The "synergistic use of infrastructure" at the CSC includes outpatient clinics, research stations, a biobank, laboratories and imaging to enable regulatory studies to be conducted in the future. It will also be an event center and meeting place for scientists, Krug said. How can research results be better implemented? Support for technology transfer is provided by Dr. Christian A. Stein, Managing Director of Ascenion in Munich. One important aspect: patenting the idea. Stein recommended talking to experts early on and not pre-publishing the idea at congresses. "After publication, patent protection is no longer possible," the expert said. A technology transfer office helps the researcher or physician draft an invention disclosure and file the patent application, he said. Substances and new compositions of matter, uses, biochemical processes or methods, production processes, diagnostic processes or software with a technical character can be patented. Scientific theories, discoveries, algorithms, software without a technical character, but also clinical treatments - in contrast to the USA - cannot be patented. The patent can be the starting point for business start-ups, licenses or cooperations. A sale leads to the complete transfer of the rights. Successful company founders presented case studies "from idea to medical product" from the Medical Park in Hanover: Prof. Dr. Moritz N. Wente, Chief Medical Officer of Aesculap in Tuttlingen, used the example of the drug-eluting balloon catheter (DEB) to illustrate that the path from the idea to the patient can be complex and lengthy. In this specific case, it took nine years. The starting point was university research. Once the technology had been developed, the next steps were proof of efficacy in animal experiments, clinical testing, the CE approval process for a combination product, and finally CE approval for the product. An increasing problem, he said, is the shortage of young scientists, not only in the medical field but also in the engineering field. Wente therefore presented various models for promoting young talent. For example, he said, Aesculap cooperates with the Tuttlingen university campus to bring young people to the region for training. The "Industry on Campus Professor" program helps to bridge the gap between university and company. In this program, students rotate between working half-time in the company and half-time on a research project. A second industry view presented Dr. Jürgen O. Böhm, Chief Executive Officer and Medical Director of Xenios in Heilbronn. The company specializes in extracorporeal circulation. The subsidiary medos develops solutions for cardiac surgery and cardiotechnology with a modular heart-lung machine system. The subsidiary Novalung develops products for interventional lung support. Precise goal setting and planning of the process is indispensable at the beginning of a translation process. A critical phase, especially for medium-sized companies, is the approval phase, which involves numerous imponderables. In addition, the requirements for proof of benefit and thus for study planning are increasing. Peter Hartung from the engineering service provider Seleon clarified that the approval process for medical devices is very complex. This includes, among other things, an early benefit, feasibility and cost-effectiveness assessment, the definition of requirements, proof of function and safety, and proof of clinical effectiveness. For complex devices, the requirements from applicable standards are extensive. The requirements for clinical evaluation and testing of medical devices have increased steadily in recent years. Hartung recommended that a clinical evaluation be carried out at the very beginning of product development. The European Medical Device Regulation currently under discussion would mean more bureaucracy and higher costs for manufacturers without creating more patient safety. Not every invention is an innovation that helps people, he argued. Dr. Jan Helfrich, a management consultant at the health insurance company DAK-Gesundheit in Hamburg. Therefore, the requirements for the benefit assessment of medical devices must be increased. A comparison with standard therapy is desirable. The clinical study must be supplemented by health services research under everyday conditions. "We need a real benefit assessment from the patient's perspective in the reality of care and pricing based on the added benefit," Dr. Helfrich said. He also called for rapid testing of innovations under study conditions in centers. In this way, an unchecked expansion of services with dubious quality could be counteracted. The BVMed conference was moderated by the medical journalist Renate Harrington from Hamburg (Source: BVmed) You can find more pictures of the event under the following link http://www.bvmed.de/de/bvmed/mediathek/bilder-veranstaltungen/translation-wissenschaft-und-oekonomie
