Transcript Experiences of Co-Ordinating European Research Programmes

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.
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?
Predicting Response and Resistance
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)
Wagle N et al. Journal of Clinical Oncology (2011)
Approx 5055k euro/6
months
treatment
EU Partnerships in Cancer Diagnostics
Now completed
Rational Therapy for
Breast Cancer:
Individualized Treatment
for Difficult-to-Treat Breast
Cancer Subtypes
• FP7 Health Collaborative Project (6 million euro)
• 5 years from Jan 2011
• Expected outputs: Delivery of proof-of-concept therapeutic interventions through
personalised diagnostics
Kinase activation
RPPA assays
Copy number analysis
SNP arrays
8 partners (2 SMEs,
6 academic groups)
Tissue
WP6
Transcriptomics
Expression arrays
(RNA seq)
WP10
Target / biomarker validation
WP8
Validated companion diagnostic
WP9
Clinical trial in stratified patient population
Drug Targets
WP4
Biomarkers
WP7
Impact
Drug Targets
Impact
Biomarkers
Bioinformatics/Cross ‘omic’ analysis
WP11 – Project and Database Management
Discovery
Data
Analysis
Mutation analysis
DNA sequencing
WP5
Discovery
WP3
WP2
Data
Analysis
Tissue
Tissue sample collection
150 TNBCs WP1
150 ILBCs
Representative cell lines
Phase II Clinical Trial
PI3K
inhibitor
Lobular only
n=180
n=110
+
Tamoxifen
OR
+
Placebo
Ductal & lobular
Tamoxifen
The Genesis of RATHER
Prof. Rene Bernards
(NKI/Agendia)
Call topic [Collaborative Project]
HEALTH.2010.2.4.1-8:
Predicting individual response and resistance to cancer therapy
The Application Process
Submitted Stage 1 proposal (8 pages)
on 28th October 2009
Invited to submit Stage 2 application on
12th December 2009
Round-table meeting in Schipol Airport
(January 2010)
Submitted Stage 2 proposal (91 pages) on
11th February 2010
Invitation to negotiate received on 23rd April 2010
Approx. 1 month for negotiation period
Face to Face
Meetings
Essential
Distill Ideas
Proposal Preparation
Support Programme
National Contact Points: Ciaran Duffy (EI), Caitriona Creely (HRB)
Devise A WellFunctioning
&
Complementary
Team
Clearly Identify
Your Target
(Audience)
Avoid Double-Speak
Agree Upfront Whom Gets
What
Effective Project
Management
Dr. Karen Misstear
Dr. 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
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!
www.ratherproject.com
Contact Details
[email protected]