About Mark Roberts, Ph.D. & Alan Wookey

Mark J. Roberts, received his PhD in Pharmaceutical Sciences from the University of Nottingham (UK) and has worked in the clinical diagnostics arena for over 20 years, holding senior positions in both the in vitro diagnostic and reference laboratory industries. He joined Covance in 2012 to spearhead our Companion Diagnostics initiative, designed to assist pharmaceutical and diagnostic companies in drug/ companion diagnostic co-development. Alan Wookey is Associate Vice President and Executive Director of Companion Diagnostics at Covance. He works across the industry to develop biomarker programs with pharma and biotech, from analytical and clinical validation through to regulatory approval and commercialization. Prior to joining Covance, Alan held leadership positions in oncology clinical development at AstraZeneca. He earned his degrees in Microbiology from the University of Liverpool, and has been focused in pharmacogenetics and personalized medicine for more than 10 years.

Choosing the Best Pathway for CDx Development and Commercialization

Drug developers are increasingly incorporating a CDx development (companion diagnostic) strategy into their programs to deliver safer, more effective and appropriate therapies to the right patients. While the end result can be significantly beneficial forCovance Labs CDx Drug Development and Commercialization patients, and development partners, the path from analytical and clinical validation to demonstrating clinical utility and obtaining regulatory approval is often challenging. It requires a comprehensive understanding of clinical trial design, regulatory submission strategies both for the therapy and the diagnostic assay, and also a line of sight for successful commercialization. Continue reading