The Two Towers: Quest for Drugs from Discovery to Approval

The introduction of new therapeutic drugs typically involves a long and expensive process that may begin with a relatively simple initial discovery but that includes an extended period of development, which addresses formulation, efficacy, safety, and commercial potential. Many constituencies must be involved and satisfied at each step in this process, while the diverse goals and perspectives that each player brings to the enterprise are dealt with. The two main foundations of this activity are academic research and industry; the latter includes both traditional pharmaceutical companies and newer, usually smaller, biotechnology companies. The recognition of the importance and the differing viewpoints of these "two towers" of the intellectual and commercial undertaking may help to foster more effective working relationships among the parties and, ultimately, may increase the efficiency of bringing new therapies to the consumer. An understanding of the process of discovery and development across the disciplines involved may provide a meaningful answer to patients and families who constantly ask, "Why does it take so long?"