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Challenges in Drug and Biomarker Co-Development

  • Sheila E. Taube
  • Tracy Lively
Chapter
Part of the Recent Results in Cancer Research book series (RECENTCANCER, volume 195)

Abstract

Co-development of drugs and biomarkers should be considered when the biomarker is intricately related to the use of the drug. There are risks and benefits to co-development and these need to be considered carefully early in the process. The current chapter attempts to delineate when it is appropriate to plan for co-development and to discuss a range of issues. Challenges include the determination of the type of assay (laboratory-developed test vs. reference laboratory vs. kit), the designs of trials for evaluation of clinical utility, and the regulatory pathway. Successful co-development requires planning very early in the process and assembling the appropriate multi-disciplinary team.

Keywords

Epidermal Growth Factor Receptor Epidermal Growth Factor Receptor Mutation Predictive Marker Assay Development Marker Assay 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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Copyright information

© Springer-Verlag Berlin Heidelberg 2012

Authors and Affiliations

  1. 1.ST-ConsultingBethesdaUSA
  2. 2.National Cancer Institute, NIHBethesdaUSA

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