Number: 2005-050-1-700
Title: Prototype analysis of molecular biomarkers in cancer
Task Group
Chairman: Michael
Liebman
Members: C.
Robin Ganellin, Thomas
Perun, and Richard
Mural
Objective:
Molecular Biomarkers have become a major focus of disease management
and drug development, particularly in oncology. This prototypic study
will identify the existing biomarkers in breast cancer and classify
them in terms of disease progression and also as to their clinical
vs. research use.
Description:
Biomarkers are typically used to establish presence or absence
of disease, genetic risk and endpoints for clinical trials. The Human
Genome Project has identified a large number of potential targets
for drug development, but without the necessary validation for implementation
in drug discovery programs. Our perspective of disease has evolved
from simply the difference between non-disease and disease states
as we recognize the progression from non-disease, potential genetic
risk, diagnosis, disease staging, disease stratification, therapeutic
selection, recurrence and outcome as elements of disease progression.
There is a need to understand the relationship between biomarkers
and their association with these components of disease to optimize
their utility in both research and clinical settings. In addition,
many biomarkers have been noted in research environments without entering
the formal FDA approval process to enable clinical application. We
believe that this level of definition and clarification would be useful
for the drug and diagnostic industries and healthcare, in general,
and would like to use biomarkers in breast cancer as a prototype to
show the potential value of such an undertaking.
We believe that the results of this prototype can help to guide future
development in both the research and clinical arenas by setting standards
for understanding the role of these important chemical and biomolecular
agents.