Maximizing Return on Investment and Minimizing Risk in Partnering with Preclinical Cros

The pharmacoeconomic realities of drug discovery are that biopharmaceutical firms need to discover and develop innovative leads in less time, while shifting costs from a fixed to a flexible basis. The result of this new paradigm is that the need to outsource various aspects of drug development—from preclinical toxicology to postmarketing Phase IV trials—is so strong at the present time that it has created growth in the contract industry as a whole at about 15–20% annually. With new players entering the field, and established contract research organizations (CROs) facing increased demands, it is important to select a CRO with scientific skills of the highest standards and business performance with a compelling sense of urgency. There is substantial risk in choosing a preclinical partner, that is, optimizing a lead compound, achieving financial benchmarks, and success of incipient clinical trials. This review addresses expectations and opportunities in toxicology research, the interactions between companies, and integration of studies to accelerate drug and device development.