CALL FOR PROJECTS 2013 VALORISATION AWARD 7th call for projects from the Fondation Fournier-Majoie (pour l’Innovation) Foreword In line with its mission, the Foundation supports translational research projects and will assist and guide researchers towards the valorisation of the project results. As several of our current grant holders have come to a stage were significant costs/ numbers of samples are required in order to roll-out the validation process, the foundation has decided to open its’ 7th call to follow-on ‘valorisation projects’ for existing laureates only. Subject of the call This call covers any follow-on project that includes a.o. confirmation of differentially expressed molecules in a same sample set using a different technology (biomarker qualification step ) verification and quantitation of differentially expressed molecules in a different, larger sample set than the original discovery set (biomarker verification step) statistical proof and quantitation of biomarker candidates in a number of sample sets, e.g. target disease, healthy, other similar diseases (biomarker validation step) profound assay validation: matching users’ needs , and validating the assays to the standards of regulatory bodies for candidate-biomarkers (including companion biomarkers) or functional imaging markers intended to improve cancer management through either a genuine early diagnostic or prognostic tool and/or indicators/predictors of treatment efficiency or of relapse and metastasis occurrence. The quest for highly performing biomarkers is as enthralling as the medieval quest for the Holy Grail and, potentially, more rewarding for patients throughout the globe. The current challenge isn’t to identify potential biomarkers, but to validate the most relevant ones, ascertaining that they are, in fact, accurate and predictive for certain conditions. In addition, a biomarker often fails to be incorporated into clinical practice, because of poor choice of the assay used for its detection*. (*)Caterina Marchiò1, Mitch Dowsett 2,3 and Jorge S Reis-Filho3 1Department of Biomedical Sciences and Human Oncology, University of Turin, Via Santena 7, 10126 Turin, Italy 2 Academic Department of Biochemistry, The Royal Marsden Hospital, Fulham Road, London, SW3 6JJ, UK 3 Molecular Pathology Laboratory, The Breakthrough Breast Cancer Research Centre, Institute of Cancer Research, 237 Fulham Road, London, SW3 6JB, UK Eligibility criteria Financial support will be allocated to those entrepreneurial research teams that have: • demonstrated detection and identification of differentially expressed molecules between 2+ populations (biomarker identification step) • secured IP The application must include a.o. following elements • status of the patent application • anteriority search (method + result) • full validation plan • valorisation strategy, incl. competitive situation (for both technology and products) • unmet medical need / clinician feedback • modalities of reporting, budgetary control and division of tasks (gant chart with milestones and budget sheet) • implication of the TTO (in the management of IP, competitor analysis, valorisation and with regard to recruiting complementary financial means) Eligible applicants The call is open to current FFMI grant holders only. The application must pertinently address the following scientific and technical criteria on which the evaluation will be based (weighting factor between brackets) 1. Unmet medical need that will be addressed (3) 2. Access to biobanks (retrospective studies) or clinicians (prospective studies) and IP aspects related to such collaboration (3) 3. Access to biostatistical expertise (3) 4. Access to industrial assay development & testing skills: both internal quality control measures and external quality assurance (2) 5. Valorisation strategy (3) 6. Market potential/competitor advantage (3) 7. Intellectual property strategy (2) 8. Planning and budget accuracy (2) 9. Risk appraisal (success/failure ratio) according to existing data (2) 10. Match funding secured or strategy to do so (2) Grants Projects are not completely supported by FFMI. Match funding will have to be secured, if not done already. The grants allocated to successful applicant(s) will not exceed €1,000,000 (including previous grants) and will be paid in two or more instalments . VAT and overheads are excluded from Foundation’s financial support. The current grant is subject to an amendment to the existing grant agreement between the Foundation and the recipient . Follow-up of selected projects The approved grants will be subject to control on their use. The supervision will be carried out through Foundation’s representatives sitting on project management steering committees. Application process Applications must be submitted in English only using a standard application form. Project files must be submitted by e-mail to info@ffmi.eu , January 19, 2013 at the latest. An acknowledgement of receipt and qualification will be sent by e-mail to applicants within a week. Fast-track selection process Qualifying project teams will be invited for an oral audition on February 8, 2013. The Selection Committee (existing out of members of the FFMI scientific advisory board, FFMI board and management) will assess • the application file submitted • the minutes of the last two steering committees • the oral audition Project teams will be informed about the decision by Feb 15 at the latest. Decisions will be conditional to a positive Freedom To Operate analysis by a professional patent lawyer. The costs for such FTO will be borne by FFM. Recommendations drawn up during the review process will be used to improve the project. A maximum of 4 grants will be awarded. The selection decision will be published in March 2013. Contact Fondation Fournier-Majoie (pour l’Innovation) Avenue De Fré, 269b44 B - 1180 Brussels Belgium info@ffmi.eu www.ffmi.eu Tel : +32 2 370 47 25