Drug Development: Threading Our Way Through the Labyrinth
The drug development process is a wide-ranging and expensive effort that is required before any pharmaceutical product may be marketed or sold. The process varies slightly by geography, but maintains some common features for all regulatory regimes, which uniformly emphasize testing for safety and efficacy. The process is also very time consuming and development can span a decade or more with extremely high failure rates. Understanding the process and pitfalls that healthcare product companies face is key to assessing the risks and rewards of drug development. John Vandermosten will discuss the stages of biopharmaceutical research and development, from drug discovery and pre-clinical work, to clinical trials, and ultimately regulatory review and approval. Drug approval involves a many-step process that mandates testing and consultation and approval from the FDA. This process may be accelerated through participation in the orphan drug or other programs available under certain conditions. This presentation provides an outline of the drug development process with information that can guide you in assessing value for pharmaceutical products as they move from early clinical studies to eventual approval.