The past decade has seen a transition from the traditional model of drug development to a more targeted, personalized approach to drug development and clinical trial design. The use of a companion diagnostic strategy is increasingly an essential component of the drug development process where it facilitates optimal patient stratification and outcome management. Parallel development of the drug and its companion diagnostic assay affords simplified logistics, economies of scale and the potential to accelerate the drug development process through optimal patient selection. The application of the companion diagnostic within the corresponding drug trial also provides valuable insight into the use of the companion diagnostic in a clinical setting and produces valuable data to support the regulatory filing of both the drug and the companion diagnostic.
The speaker will discuss the emerging field of companion diagnostics with focus on its importance in clinical trial design and how drug / companion diagnostic co-development is rapidly changing the drug development process.
Mark Roberts, PhD, Director, Diagnostics Development, Covance
Dr 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 at the end of 2012 to spearhead the company’s companion diagnostics program which is designed to assist Pharmaceutical and diagnostic companies in drug / companion diagnostic co-development.
Covance, with headquarters in Princeton, New Jersey, is one of the world’s largest and most comprehensive drug development services companies, with annual revenues greater than $2 billion and more than 12,000 employees in more than 60 countries. Covance has the people, processes, client service, and global resource capabilities to respond to biotechnology and Pharmaceutical clients’ toughest drug development challenges.