Special Issue of Seminars in Oncology Focuses on Pharmacodynamics in Cancer Drug Development

Experts from the Division of Cancer Treatment and Diagnosis (DCTD), NCI and the Clinical Pharmacodynamics (PD) Program, Leidos Biomedical Research, Inc, Frederick National Laboratory for Cancer Research (FNLCR) were invited to co-edit a special issue of Seminars in Oncology focusing exclusively on PD in cancer drug development. International experts in the field were selected to author articles of the August 2016 issue covering specialized topics in clinical PD and oncology drug development:

• An introduction to clinical PD in cancer drug development
• Immuno-PD biomarkers
• Pharmacological Audit Trail (PhAT): critical path for targeted drug development
• Clinical proof-of-mechanism
• Multiplex immunofluorescence microscopy
• Circulating tumor cell analysis
• Biomarker studies using reverse-phase protein arrays
• Root causes of PD assay failure
• PD assays in multi-laboratory networks
• Incorporating PD analyses into clinical trial design

Rather than serve as a review of current PD assays, this special issue of Seminars in Oncology is intended to inform the research community about the field of clinical PD by providing detailed insights into PD biomarkers and their measurements, fitness-for-purpose evaluations, and roles in early clinical trials. The collaborative effort of the many experts involved in developing this special issue is a testament to the importance of PD to advancing the field of oncology drug development.