George Drusano M.D.,
is Co-Director, Ordway Research Institute and Emerging Infections and Pharmacodynamics Laboratory and also Director, Clinical Pharmacology Studies Unit, Albany Medical College, Dr. Drusano’s main interests are in the area of anti-infective drug effect. He and his team have performed investigations with drugs that affect bacteria, viruses, and fungi. The approach taken by the team is defined by both bench investigations as well as by clinical studies inspired by the bench investigations. In specific, the hollow fiber system allows the performance of Phase I/II clinical trials on the benchtop, allowing identification of the proper drug dose and schedule to achieve the desired endpoint. The unique aspect to this team’s investigational approach is the combination of the bench data with clinical investigation, all of which is tied together through the use of mathematical modeling techniques. Use of molecular biology to define mechanisms of emergence of resistance in bacteria and mathematical modeling employing 5 parallel inhomogenous differential equations to identify a drug exposure to suppress resistance has been the latest innovation from this group. Other approaches have been the original application of Monte Carlo simulation techniques for target identification and use of stochastic optimal design theory, population pharmacokinetic modeling and MAP-Bayesian estimation to elucidate exposure-response relationships in clinical trials, creating a new paradigm for the design and execution of Phase II dose-finding trials.