IMI`s collaborative PPP model, involving the pharmaceutical industry and (academic) research institutes, challenges the industry`s business model and “protective behaviour” within science.29 Ip has for many years been a key factor for industry and for (academic) research institutes.30 In the industry more than 10 years ago. , almost all patentable inventions were protected by a patent at very early. Science, aware of this approach, adopted a similar “pro-patent” attitude,31.31 It has been learned, however, that many of these patented inventions have proven ineffective for development on the road to exploitation – for example, few lead compounds or therapies survive demanding phase 3 studies and enter the market.32 The industry business model of the time (which was also the model of the academic university) , too risky and unsustainable.33 Other standardization efforts exist, for example, in summit and U-BIOPRED, which have made a particular effort to unravel the complex regulatory patchwork of national legislation. The consortiums addressed the challenges of handling human samples and related data in a multinational environment, in accordance with relevant legislation and project agreements. The existence of a complex and varied network of national rules and specifications throughout Europe has been a major obstacle to research. Another example is the standardization effort of the NEWMEDS and U-BIOPRED consortia, which have developed new criteria for clinical trials that reduce time and costs and thus improve the time it takes to introduce drugs in patients. In NEWMEDS, for example, the resulting possibility is to reduce the duration of clinical trials in patients with schizophrenia by six to four weeks and from 79 to 46 patients in number of patients. The cost reduction is estimated at 2.8 million euros. According to ImI representatives, the early involvement of the European Medicines Agency (EMA) at this level is essential.
The continuation of IMI is assured, the IMI 2 having been launched in 2014. IMI 2 will encourage new investment in Europe and promote cooperation with other health groups such as imaging and diagnostics.58 The budget has been increased to 3.3 billion euros and the life cycle of IMI 2 will be 10 years. As the world`s largest PPP company, active in the pre-competitive phase and even poC (s) in the health field, IMI serves as a model for many other collaborative models around the world.59 Cooperation between large pharmaceutical companies, SMEs, academic institutions and government agencies accelerates drug development.60 Optimizing IMI as a successful PPP could serve as a model for healthcare and patients in general.61 Do you have you need more information on grant preparation and signing? Watch this Horizon 2020 webiner for successful proposal coordinators. The honest broker model used in eTOX. Reproduced with permission from Synapse Research Management Partners. The role of biotech SMEs participating in IMI consortia plays an important role. Pharmaceutical companies lack bioinformaticians familiar with “wet” experiments 51 and the resources needed to develop important research tools are lacking. The development of these tools, diagnostic devices, database models and applications is at the heart of many biotech SMEs. These tools and applications (software) can be created, tested and validated in such multi-party constructions, which is of extreme value to SMEs. Thus, within the organizational framework provided for in selected IMI projects, pharmaceutical companies share the results of validation with SMEs, which is not always the case for bilateral agreements.