Graham Wood is President of Cetero Research Clinical Operations Services in Toronto, Canada and Miami, FL. He has more than 12 years of experience in contract research with a background in clinical pharmacology operations, business development and project management.
Dr. Wood manages the operation of two clinical pharmacology facilities that consist of 213 beds, seven Environmental Exposure Chambers (EEC), clinical trial management, clinical monitoring and scientific affairs.
Dr. Wood has a PhD in Neurology and Neurosurgery from McGill University, Montreal, Quebec, Canada, and Hon. BSc degree in Biochemistry at McMaster University, Hamilton, Ontario, Canada. He has co-authored several publications presentations.
We recommend the following best practices in the development and validation of biomarker assays:
- Establishing parallelism of incurred samples for quantitative assays. Parallelism is the process of diluting samples at various ranges to establish if all the values remain parallel throughout the dilutions. For an assay to be quantitative, parallelism should be demonstrated.
- Establishing sample controls for assay implementation (production phase). If feasible, sample controls, which comprise incurred samples at low, medium, and high levels of the biomarker of interest, should be established and their assigned values determined during assay validation using multiple replicates in multiple runs.
- Careful evaluation and establishment of sample collection, processing, and storage before assay validation occurs should be noted. This process will prevent the quantity of detected forms from being changed due to accidental degradation or activation of biomarkers during the sample handling process.
- Measuring the reference interval of the specific biomarker in the targeted subject population and determining the effect of therapeutic intervention. This practice allows for an accurate estimation of required assay sensitivity to be made. While lower limit of detection can be used to judge assay sensitivity for some biomarker assays, it is a good practice to use lower limit of quantification to measure assay sensitivity for biomarker assays, especially the assays intended for advanced validation.