Post on 25-Dec-2015
Experiences of Co-Ordinating European Research Programmes: RATHER as a Case Study
Prof. William M. GallagherDirector, 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.
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?
Wagle N et al. Journal of Clinical Oncology (2011)
Before treatment After 15 weeks After 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
EU Partnerships in Cancer Diagnostics
Now completed
• FP7 Health Collaborative Project (6 million euro)
• 5 years from Jan 2011
• Expected outputs: Delivery of proof-of-concept therapeutic interventions through
personalised diagnostics
6 Academic partners2 Industry partners
Rational Therapy for Breast Cancer: Individualized Treatment for Difficult-to-Treat Breast Cancer Subtypes
Mutation analysisDNA sequencing
Kinase activationRPPA assays
Copy number analysisSNP arrays
TranscriptomicsExpression arrays
(RNA seq)
Bioinformatics/Cross ‘omic’ analysis
Target / biomarker validation
Dis
cove
ry D
ata
Anal
ysis
Biom
arke
rsIm
pact
Clinical trial in stratified patient populationValidated companion diagnostic
Tissue sample collectionTiss
ue
Dis
cove
ry D
ata
Anal
ysis
Biom
arke
rs
Dru
g T
arge
tsIm
pact
Tiss
ue
Dru
g T
arge
ts
150 TNBCs150 ILBCs
Representative cell lines
8 partners (2 SMEs, 6 academic groups)
WP1
WP2 WP3 WP5 WP6
WP10
WP7 WP4
WP8 WP9
WP1
1 –
Proj
ect a
nd D
atab
ase
Man
agem
ent
+PI3K
inhibitorTamoxifen
Placebo Tamoxifen
+
OR
Ductal & lobular Lobular only
Phase II Clinical Trial
n=180 n=110
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)
Submitted Stage 1 proposal (8 pages) on 28th October 2009
Submitted Stage 2 proposal (91 pages) on 11th February 2010
Invitation to negotiate received on 23rd 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 12th December 2009
Face to Face Meetings Essential
Distill Ideas
Proposal Preparation Support Programme
National Contact Points: Ciaran Duffy (EI), Caitriona Creely (HRB)
Devise A Well-Functioning
& Complementary
Team
Clearly Identify Your Target (Audience)
Avoid Double-Speak
Agree Upfront Whom Gets What
Effective Project Management
Dr. Karen MisstearDr. Mairin Rafferty
Layered Project Management Structure
Getting the Most out of the Interaction
Tailor Approach to Individuals
People on the Ground are Key
RATHER Working Group for Data Integration (July 2013)
Effective Communication with Project Officer
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 Part
ner P
rofil
e Fo
rm
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!