2. Prof. Jean-Marc Nabholtz, MD, MSc Chairman

3. Cancer Therapy Development
Addition to
Prior standard
NEW SINGLE AGENT
MBC
ADJUVANT
Nabholtz, May, 2001

4. Evolution
BCIRG is the Breast Cancer division of CIRG (Cancer International Research Group)
Present evaluation of potential other divisions
Disease sites eg. LCIRG, GICIRG…
Mechanistic groups: Kinase Inhibitors IRG …others?...
Integration of activities in Global Translational Processes.
with UCLA/JCCC and other Universities
Development of Translational Tools (Cancer International Tumor Bank)….

5. Global Translational Processes

6. Multistep Process: 7 major steps
1. Identification of Gene abnormalities
2. Determination of relevance in human cancers
3. Pathway Identification
4. Identification of therapeutic interventions
5. Identifications of patients sub-populations with given abnormality / Tests
6. Identification of predictive factors / Tests
7. Pivotal clinical development

7. Translationnal Multistep Process (7 of 7)
Pivotal Global Clinical Development
Acces to multiple targeted subpopulations in a timely fashion for proof of concept in humans
CIRG
First Academic Global Translational Intergroup

8. Meeting the Challenges
Phenomenal acceleration of new compounds
Emergence of targeted therapies in subpopulations
Concept of biology based individualized therapy
Need to define new models of development and define new translational strategies
Patient Access
Overall stable number of patients
Targeted therapies: Need to study subpopulations
Need for new processes for developing new drugs

9. Summary: Science is our guide
BCIRG and CIRG were created to meet that need
The concept has been proven to work
Integrated Translational approach
Academic Global Translational collaboration