
The BioPharma Competition has the aim of giving new impetus to Germany's pharmaceuticals industry at a structural level. Consortiums consisting of small and large companies and partners from science and clinical practice were eligible to submit a joint strategy for effective drug development. An international panel of experts evaluated a total of 37 applications. Ten consortiums made it into the second round. Now, the best three consortiums have been selected. The BMBF will make a total of €100 million available to them in the next five years. In the first round, the teams will receive €20 million each. An evaluation will be carried out after three years. It will form the basis of the decision about the remaining €40 million.
The "Max Planck Drug Discovery & Development Center" (DDC) has the aim of bringing commercially attractive, early-stage therapeutic research projects carried out by Max Planck Institutes to the market more efficiently than in the past. To this end, sustainable infrastructures and financing structures are being created to enable high-risk, early-stage drug projects by German research institutions to continue by allowing private investors and the pharmaceuticals industry to become involved within the framework of a fund.
The "Neuroallianz" consortium has designed an innovative strategic partnership model between publicly funded research institutions, the pharmaceutical industry, biotechnology companies and regulatory authorities which reflects all links of the value added chain. The twelve participating partners aim to transfer both therapeutic and diagnostic approaches for the treatment of neurodegenerative diseases from the research stage to the market. Unlike in many public-private partnerships in the field of biomedicine, the academic partners will have equal status and will be involved in all stages of development. Initial and continuing training will be a further priority, with the aim of giving young researchers an early awareness of industry-relevant issues in drug development and providing industry training to academics.
The consortium Neu2, which focuses on combatting multiple sclerosis, has set itself the target of transferring therapeutic and diagnostic approaches for the treatment of multiple sclerosis patients from the basic research stage to the market. The main partners are northern German research institutions, biotechnology companies and one pharmaceutical firm. The partnership is financed through a sort of fund in which most of the funding comes from private sources. The consortium sees itself as a model for the development of a risk-funded life science project portfolio that will, in its early stages, concentrate on one indication within the area of neurological diseases, but will grow to include further partners in the long term.
The fact is that hardly any biotechnology-based medicines originate from Germany today. Although Germany has numerous pharmaceutical companies, most market innovations are generated in the USA, the UK and Switzerland. A survey by the European Commission revealed that only six of the 140 active substances licensed in 2005 had been developed by German pharmaceutical companies.
Yet Germany has the largest number of biotech companies in the EU and most of them are working on new treatments. Success requires perseverance: developing new treatments from the laboratory to the pharmacy shelf takes about ten years and costs at least €500 million. Many different players are involved in this process: researchers in the lab, clinicians and business enterprises. Manufacturers and licensing agencies also play an important role. But hardly any efforts are made in Germany to ensure networking among these partners in order to support the transfer of innovative treatments from the lab to the market.
In order to improve this situation, the BMBF is currently restructuring its funding policy in the area of innovative pharmaceuticals development. As part of these restructuring efforts, it has launched the Pharmaceuticals Initiative for Germany. Under this initiative, existing and new BMBF measures in the areas of health research and biotechnology will be reorganized in such a way as to close the gaps in the value-added chain and strengthen R&D work on new medicines in Germany. Consideration will be given to production and marketing strategies from an early stage. With its Pharmaceuticals Initiative for Germany, the BMBF will, at the same time, enter into a new, constructive dialogue with all stakeholders involved in the value-added chain in the pharmaceuticals sector.
Overall funding of significantly more than 800 million euros will be provided up to 2011 under the Pharmaceuticals Initiative. These funds will finance both basic and application-oriented BMBF funding measures in the fields of health research and biotechnology.
The Pharmaceuticals Initiative for Germany comprises a general development strategy and targeted support measures for promoting specific aspects on the way from research to market maturity.
The BMBF's BioPharma strategy competition for the future of medicine aims to strengthen the development of innovative pharmaceuticals in Germany, from research to production. The BMBF supports networking, because Germany must pool its strengths to be able to face up to international competition.
The BioPharma competition encouraged business consortiums to submit their best long-term concepts for the efficient design of the biopharmaceutical value-added chain. The aim is to accelerate the application of economically relevant results of biopharmaceuticals research which are approaching clinical trials. The project expressly welcomes the integration of existing BMBF funding schemes.
The focus is on a joint implementation strategy which is based on a development plan. The aim was to identify not only the most relevant innovative ideas and the best minds from the technological and therapeutic viewpoint, but also the most creative and at the same time the most productive partnerships. In addition to their regular contributions, the industrial partners are expected to steadily increase their funding as the project comes closer to market introduction. A total of €100 million will be made available to the three winning consortiums over the next five years.
The BMBF is supporting a number of measures aimed at explaining disease mechanisms and developing new therapeutic approaches. Bioscientific methods of hreflang=en class="linkint">genome and proteome research, such as those applied in the National Genome Research Network (NGFN), are crucial in this context. The funding measures concerning medical systems biology are important for analytical work. The BMBF is coordinating the schemes of national funding agencies in the field of systems biology at the European level. All measures already include relevant industrial partners.
Since 2005, the BMBF's GO-Bio scheme has been supporting high-risk projects with start-up potential which promise commercial success in the medium term. The aim of these funding activities is to help focus research on market aspects at an early stage and promote the systematic development of entrepreneurial expertise.
The development of new diagnostic methods, therapeutic agents and vaccines involves the increasing use of new molecular biological or biotechnological processes based on findings in the field of genome and proteome research. In order to accelerate the development of new targeted therapeutic approaches, the BMBF has launched the funding priority "Innovative therapies on a molecular or cellular basis", in which partners from science, hospitals and industry work together. This is intended to speed up the translation of research findings into therapeutic applications.
The "Innovation in drug development" funding measure aims at improving the methods and processes used in the development of drugs. It is intended to better guarantee the predictability of the toxicity and effectiveness of development substances, reduce the high failure rate and accelerate the development of drugs while at the same time saving development costs.
Biotechnology offers highly specific methods for diagnosing diseases. Under the BMBF's "Molecular diagnostics " funding priority, diagnostic means are being studied and methods developed so that the impact of possible new treatments can be analysed from the outset with the help of relevant biomarker research.
The BMBF is supporting small and medium-sized biotech companies under the BioChancePlus programme in order to create new scope for the development of advanced technology and to realize the economic potential of biotechnology in Germany. Funding is being provided for high-risk research and development projects carried out by networks of biotech and pharmaceutical companies. This supports the integration of biotechnological research as a service in pharmaceuticals development.
BMBF funding for the regional and transregional networking of researchers and health care practitioners aims to improve the translation of scientific results into practical applications. Experts are networking across regions within the framework of the "Disease-specific competence networks". The Integrated Research and Treatment Centres are outstanding regional centres for research into specific topics.
Clinical trials are an indispensable prerequisite for licensing active substances and therapies. The BMBF is pursuing the goal of improving the conditions for clinical research in Germany. This is done under the funding schemes "Clinical Study Centres" and "Coordination Centre for Clinical Trials" as well as via specific modules.
There are numerous locations in Germany where innovative medicines are produced using biotechnological methods. New process technologies need to be developed for this purpose. As part of its Pharmaceuticals Initiative for Germany, the BMBF intends to launch a new scheme before the end of 2007 with the aim of strengthening production in Germany in a public-private partnership.
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