title: Challenges in drug and biomarker co-development.
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.
authors.affiliation: ST-Consulting, Bethesda, MD, USA. setaube@aol.com
authors.forename: Sheila E
authors.initials: SE
authors.lastname: Taube
authors.forename: Tracy
authors.initials: T
authors.lastname: Lively
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use*; D014408:Biomarkers, Tumor / Q000032:analysis*; D015195:Drug Design; D006801:Humans; D009369:Neoplasms / Q000737:chemistry / Q000188:drug therapy*
chemical_list: D000970:Antineoplastic Agents; D014408:Biomarkers, Tumor