Early Drug Development: Strategies and Routes to First-in-Human Trials

MITCHELL N. CAYEN, PhD, is Principal of Cayen Pharmaceutical Consulting, LLC, a firm that advises pharmaceutical companies in nonclinical and clinical drug develop-ment, with specific focus on candidate drug selection, discovery, drug metabolism and pharmacokinetics, drug development strategies, and regulatory submissions. Previously, he was senior director of drug metabolism and pharmacokinetics at Schering-Plough Research Institute.