Abstract
Overview
Introduction
The current focus on biomarker discovery is a result of an improved
understanding of the biologic basis for carcinogenesis. The increasing number
of potential drug targets and a plethora of diverse, new developmental agents
have stimulated the search for biomarkers that can reduce the time, cost and
attrition rates prevalent in oncology drug development.
Scope
- The role of biomarkers in optimizing patient selection and treatment
outcomes and in expediting oncology drug development.
- Biomarker classification in oncology.
- Regulator opinion on the integration of novel, valid and relevant
biomarker endpoints into the design of oncology clinical trials.
- Key commercial benefits and risks of incorporating predictive biomarkers
into oncology drug development.
Report Highlights
It is hoped that the increased adoption of biomarker use in oncology will
enable early proof-of-concept studies for novel therapeutic targets;
accelerate the adoption of population-enrichment strategies for clinical trial
recruitment; and increase the use of biomarker endpoints as surrogates for
clinical benefit in oncology clinical trials.
Advances in imaging analysis technology have shed new light on cancer
progression by enabling the precise measurement of small changes in structure
and function over time. Image-based biomarkers have been singled out by the
FDA as promising tools for every stage of drug development, from preclinical
research to the approval process.
While targeting specific genotypes in clinical trials increases the
opportunity to demonstrate clinical benefit, developers are concerned about
how an increasingly fragmented cancer market may limit a drug's commercial
potential. There is already skepticism among physicians about how readily
Pharma will adopt a more 'personalized' approach.
Reasons to Purchase
- Understand how tumor biomarkers will impact on oncology drug development
as the paradigm to targeted treatment evolves.
- Assess opportunities and risks for novel oncology biomarker development
and commercialization.
- Drive drug development strategies that incorporate prognostic or
predictive biomarkers.
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