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Cancer Biomarkers: Enhancing Diagnostic, Therapeutic and Developmental Strategies
Datamonitor, May 2006, Pages: 73
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 of this title: - 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.
Highlights of this title: - 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 drugs commercial potential. There is already skepticism among physicians about how readily Pharma will adopt a more personalized approach.
Reasons to order your copy: - 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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