Rationale for Biomarkers and Surrogate End Points in Mechanism-Driven Oncology Drug Development

Abstract

Instead, an integrated, collaborative effort is needed among pharmaceutical, biotechnology, government, academic, and patient advocacy groups to translate laboratory insights into rationally designed agents. A key goal of this proposed enterprise is the integration of complementary efforts (e.g., molecular diagnostics and therapeutics technologies). To this end, the enterprise will provide access to key common resources (e.g., development and implementation of a national tissue bank) and information (e.g., data pertinent to target discovery or validation). These efforts will be complemented by the development of consensus standards regarding processes and validation. In addition, the enterprise will establish rational, science-based strategies and frameworks for clinical testing and approval of molecular therapies and imaging modalities. This enterprise can be guided by and build on the success of other collaborative scientific efforts, such as the landmark mapping of the human genome.