Pharmaceutical Executive Europe - August 2008 - (Page 16) 16 Technology: IT August 2008 Pharmaceutical Executive Europe things stand, it is likely that each project will focus just on its own IT needs and fail to leverage tools, expertise or knowledge across them. In other words, the potential promise of knowledge management will not be fully realised, at least not at the beginning. Key issues At the strategic level, it is fair to ask whether the overall approach taken by IMI will truly address the reasons for the R&D innovation gap within the EU. This would mean a retrospective examination leading to the reasons for R&D investment growing five times in the US versus 2.9 times in Europe. Among the questions to be asked would be the following: ● Is the greater entrepreneurial spirit in the US combined with a greater fear of failure in European cultures inhibiting innovation? ● Is the cost of doing business in the EU driving R&D work to other regions, including the US (given the weakness of the US dollar)? ● To what extent are government controls over pricing and drug utilisation pushing biopharma companies to focus their investments (including R&D) on the US? ● Given the global nature of the industry, is the gap in innovation between the continents really a critical issue? If indeed the IMI initiative wants to compete effectively with the USA or any other emerging R&D powerhouse (i.e. Japan), it then makes sense to evaluate the strengths and weaknesses of the competition and devise projects that would truly set the EU apart. None of the 18 projects shown in the Table have this competitive thrust. Indeed, it could be argued that once the innovations are delivered, they will simply be absorbed by the industry as a whole, including the companies that are based in the US. And yes, I am aware that since many of the companies that will deliver the innovations will be based in EU member states, they will contribute to the economic and scientific well being of those states and the EU as a whole. However, it is difficult to imagine that any of these companies will become very large. If history holds true, we will end up with a lot of small to medium-sized firms performing highly specialised activities. In the context of the competitive edge, it may be appropriate to give an example where the competition has come up short. In the US, the National Institutes of Health (NIH) has an annual budget of roughly US$30 billion (i.e. €19.3B), of which 85% goes to biomedical research. Given that IMI’s budget is a rounding error compared to that of the NIH, it has to substitute quality for quantity to succeed. By knowing what the NIH does badly, IMI can succeed by doing it better. Here are a few examples: ●The NIH funds research projects but does not cover capital expenditures, such as computers or the software that runs on them. So, an academic medical centre could design and run the most innovative trial but not have a decent infrastructure for analysing the data. IMI could focus on a programme that makes infrastructure acquisitions possible. ●The grant submission and approval process at the NIH is cumbersome and time consuming. IMI could ensure that its own review and approval processes are fast and responsive. ● The US has badly mismanaged the ability of companies or universities to attract foreign knowledge workers and students. Table 1 IMI focus areas. Project No. Title Investment (€) Funding duration (Years) 5 5 5 3 5 5 5 5 5 5 5 5 6 7 5 5 5 5 Avg. annual investment (€ M) 2.60 2.50 1.00 3.33 4.20 3.00 2.00 4.00 1.50 2.00 1.50 2.50 1.67 0.71 0.60 0.80 0.60 0.70 IT involvement 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 Improved predictivity of immunogenicity Non-genotoxic carcinogenesis Expert systems for in silico toxicity prediction Improved predictivity of non-clinical safety evaluation Qualification of Translational safety biomarkers Strengthening the monitoring of benefit/risk Islet cell research Surrogate markers for vascular endpoints Pain research New tools for novel therapies in psychiatric disorders Neurodegenerative disorders Understanding severe asthma COPD Patient Reported Outcomes European Medicines Research Training Network Safety sciences for medicines training programme Pharmaceutical medicine training programme Integrated medicines development training programme Pharmacovigilance training programme 13 12.5 5 10 21 15 10 20 7.5 10 7.5 12.5 10 5 3 4 3 3.5 Data management & exploration Knowledge sharing by consortium Expert systems Data analysis across platforms, IT Infrastructure hosting Biomarker clinical trials, common biomarker database Post-marketing surveillance, data management & exploration etc In-silico tools Clinical data analysis, prospective clinical trials, In-silico tools Comparison of pre-clinical /clinical databases, Imaging tools Neuroimaging, electrophysiological readouts None identified yet Collaboration tools for European Asthma Network ePro data collection, EDC tools Collaboration tools, CBT Collaboration tools, CBT Collaboration tools, CBT Collaboration tools, CBT Collaboration tools, CBT
Table of Contents Feed for the Digital Edition of Pharmaceutical Executive Europe - August 2008 Pharmaceutical Executive Europe - August 2008 Contents From the Editor News and Analysis Calendar The Calm Before the Storm Steering Pharma in Russia Built on Sand Renaissance Man IT Meets IMI Send for the Software Specialists Know Your eMarket Last Words Pharmaceutical Executive Europe - August 2008 Pharmaceutical Executive Europe - August 2008 - Pharmaceutical Executive Europe - August 2008 (Page Cover1) Pharmaceutical Executive Europe - August 2008 - Pharmaceutical Executive Europe - August 2008 (Page Cover2) Pharmaceutical Executive Europe - August 2008 - Contents (Page 3) Pharmaceutical Executive Europe - August 2008 - Contents (Page 4) Pharmaceutical Executive Europe - August 2008 - From the Editor (Page 5) Pharmaceutical Executive Europe - August 2008 - News and Analysis (Page 6) Pharmaceutical Executive Europe - August 2008 - News and Analysis (Page 7) Pharmaceutical Executive Europe - August 2008 - Calendar (Page 8) Pharmaceutical Executive Europe - August 2008 - Calendar (Page 9) Pharmaceutical Executive Europe - August 2008 - The Calm Before the Storm (Page 10) Pharmaceutical Executive Europe - August 2008 - Steering Pharma in Russia (Page 11) Pharmaceutical Executive Europe - August 2008 - Built on Sand (Page 12) Pharmaceutical Executive Europe - August 2008 - Renaissance Man (Page 13) Pharmaceutical Executive Europe - August 2008 - Renaissance Man (Page 14) Pharmaceutical Executive Europe - August 2008 - IT Meets IMI (Page 15) Pharmaceutical Executive Europe - August 2008 - IT Meets IMI (Page 16) Pharmaceutical Executive Europe - August 2008 - IT Meets IMI (Page 17) Pharmaceutical Executive Europe - August 2008 - Send for the Software Specialists (Page 18) Pharmaceutical Executive Europe - August 2008 - Send for the Software Specialists (Page 19) Pharmaceutical Executive Europe - August 2008 - Know Your eMarket (Page 20) Pharmaceutical Executive Europe - August 2008 - Know Your eMarket (Page 21) Pharmaceutical Executive Europe - August 2008 - Last Words (Page 22)
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