1. © Fraunhofer ISI Seite 1 Smoke screens and sacred fires: Translational research and grand challenges in European biomedicine. Etienne Vignola-Gagné Fraunhofer ISI, Karlsruhe, Germany Life-Science-Governance research platform, Department of Political Science, University of Vienna, Vienna Eu-SPRI Conference 2012 “Towards Transformative Governance? Responses to mission-oriented innovation policy paradigms” 12/13 June 2012, Karlsruhe, Germany.

2. © Fraunhofer ISI Seite 2 What is TR? Is it a grand challenge?

3. © Fraunhofer ISI Seite 3 What is TR? Is it a grand challenge?

4. © Fraunhofer ISI Seite 4 What is TR? Is it a grand challenge? To spur biomedical innovation, the TR agenda proposes  New experimental practices: biomarkers for drug development and stratification in clinical trials, new early clinical trials models, improved animal models,...  New institutional practices: academic RTD, large public and public-private consortia, new or renewed professional roles, EMA and FDA regulations that promote innovation, …

5. © Fraunhofer ISI Seite 5 What is TR? Is it a grand challenge?

6. © Fraunhofer ISI Seite 6 What is TR? Is it a grand challenge? “The new health-related challenges that Europe and the world face today are exceptional issues that affect society at large and could be the most complex questions to be addressed in the 21st century. New paradigm shifts such as personalised medicine or innovative solutions to research issues such as the translational research gap will be needed to rapidly bring research results to patients …“ European Medical Research Councils. 2011. A Stronger Biomedical Research for a Better European Future. Strasbourg: ESF.

7. © Fraunhofer ISI Seite 7 Arguments Focusing on argumentative practices (Fischer 2003, Gottweis 1998, Hajer 1995) in STD policy making may allow to identify a number of ‘transformative effects’; Discourse coalitions and policy narrative as privileged analytical units; Coalitional politics make certain structures and functions of innovation systems privileged targets of mobilization, and thus privileged sites of „transformative effects“;

8. © Fraunhofer ISI Seite 8 Following the discourses of TR in the field „Crisis in pharmaceutical R&D“ policy narrative; Discussed in journal editorials and state agencies documents; Large-scale “academic pipelines”  Sophisticated division of labor;  Large equipment traditionally found in industry;  Focuses on drug development (rather than say biologics, gene therapy, stem cell therapies, genetic diagnostic for monogenic conditions or genomic risk assessments) ;

9. © Fraunhofer ISI Seite 9 A case study: TRAIN

10. © Fraunhofer ISI Seite 10 A case study: TRAIN Through EATRIS, an ESFRI initiative – the model has an EU reach; Explicit reference to academic pipeline narrative:  „Novel translational infrastructures in academia“ (TRAIN coordinator);  „ Personalised medicine leads to smaller markets for the pharma industry“ (TRAIN researcher); Policy narrative as the main local instrument of coordination; Tensions with research teams? Puts forward different priorities than other, competing narratives.

11. © Fraunhofer ISI Seite 11 Further evidence

12. © Fraunhofer ISI Seite 12 Conclusions Argumentative policy practices - essential aspects of new models of innovation in TR? Follow the discursive practices and argumentative policy activities of specific coalitions to track the transformative effects of grand challenges on experimental and institutional practices. Grand challenges might not be only smoke screens – the sacred fire of some translational investigators, the empty rhetoric of perhaps a small group.

13. © Fraunhofer ISI Seite 13 Thank You! Questions? The research this presentation draws on was financed through the Translational research in genomic medicine: Institutional and social aspects “TRi-GEN” project (http://trigen.isi-projekt.de) as part of the ELSA-GEN initiative (www.elsagen.at) by:http://trigen.isi-projekt.dewww.elsagen.at