1. Experiences of Co-Ordinating European Research Programmes: RATHER as a Case Study Prof. William M. Gallagher Director, Irish Cancer Society Collaborative Cancer Research Centre BREAST-PREDICT Associate Professor of Cancer Biology, UCD Conway Institute, University College Dublin Co-Founder/Chief Scientific Officer, OncoMark Ltd.

2. Variability in Patient Responses – A Problem and an Opportunity By 2020, most medicines predicted to be paid on the basis of results PWC Pharma 2020: Challenging Business Models – Which Path Will You Take?

3. Wagle N et al. Journal of Clinical Oncology (2011) Before treatmentAfter 15 weeksAfter 23 weeks A 38-year-old man with BRAF-mutant melanoma and subcutaneous metastatic deposits, treated with Vemurafenib (BRAF inhibitor) Predicting Response and Resistance Approx 50- 55k euro/6 months treatment

4. EU Partnerships in Cancer Diagnostics Now completed

5. FP7 Health Collaborative Project (6 million euro) 5 years from Jan 2011 Expected outputs: Delivery of proof-of-concept therapeutic interventions through personalised diagnostics Rational Therapy for Breast Cancer: Individualized Treatment for Difficult-to-Treat Breast Cancer Subtypes

6. Mutation analysis DNA sequencing Kinase activation RPPA assays Copy number analysis SNP arrays Transcriptomics Expression arrays (RNA seq) Bioinformatics/Cross ‘omic’ analysis Target / biomarker validation Discovery Data Analysis Biomarkers Impact Clinical trial in stratified patient population Validated companion diagnostic Tissue sample collection Tissue Discovery Data Analysis Biomarkers Drug Targets Impact Tissue Drug Targets 150 TNBCs 150 ILBCs Representative cell lines 8 partners (2 SMEs, 6 academic groups) WP1 WP2 WP3WP5WP6 WP10 WP7 WP4 WP8WP9 WP11 – Project and Database Management

7. + PI3K inhibitor Tamoxifen PlaceboTamoxifen + OR Ductal & lobularLobular only Phase II Clinical Trial n=180n=110

8. The Genesis of RATHER Call topic [Collaborative Project] HEALTH.2010.2.4.1-8: Predicting individual response and resistance to cancer therapy Prof. Rene Bernards (NKI/Agendia)

9. Submitted Stage 1 proposal (8 pages) on 28 th October 2009 Submitted Stage 2 proposal (91 pages) on 11 th February 2010 Invitation to negotiate received on 23 rd April 2010 Approx. 1 month for negotiation period Round-table meeting in Schipol Airport (January 2010) The Application Process Invited to submit Stage 2 application on 12 th December 2009

10. Face to Face Meetings Essential Distill Ideas Proposal Preparation Support Programme National Contact Points: Ciaran Duffy (EI), Caitriona Creely (HRB)

12. Devise A Well- Functioning & Complementary Team

13. Clearly Identify Your Target (Audience)

14. Avoid Double-Speak

15. Agree Upfront Whom Gets What

16. Effective Project Management Dr. Karen Misstear Dr. Mairin Rafferty

17. Layered Project Management Structure

18. Getting the Most out of the Interaction Tailor Approach to Individuals

19. People on the Ground are Key RATHER Working Group for Data Integration (July 2013)

20. Effective Communication with Project Officer

21. Some General Words of Advice on Application Have consistent message throughout document; therefore, after inputs, must have singular style Apply evidence-based approach for all sections, not just S&T While simplification of text is preferred, avoid generalisations – be specific/tangible Get central concept diagrams in place first and use these to hone descriptions Each partner should clearly contribute to programme and benefit from participation Partner Profile Form

22. Some General Words of Advice on Implementation Need to ensure that all parties GAIN something from the interaction All good sight on risks and contingency plans (should be built into application from outset) Need to keep focus on common goals, but also allow freedom for investigators to pursue different avenues Keep a tight reign on finances – understand the rules and ensure broad-based implementation Hire a good project manager!

23. www.ratherproject.com Contact Details william.gallagher@ucd.ie