The drug development process, some key milestones, and many of its activities are summarized in this figure to help present in one picture the overall process and its elements (Fig. 2.1). This figure, its many facets and complexity, reiterates well the foremost challenge for company leadership, that is, to pull together these six phases of product development with all their possible projects and outcomes (50 plus noted in the figure), accomplished by many different people, over a long timeline, into a coherent flexible achievable plan, and with product success as the end product. The product development schema for a biotechnology or pharmaceutical company is a lengthy (about 10 years or more from disease biology to product approval) and a complex scientific and business endeavor, as the diagram suggests. The six typical phases are displayed in this figure: (1) discovery, (2) preclinical research, (3) government regulatory review (e.g., U.S. Food and Drug Administration [FDA] review of the IND
Was this article helpful?
What you need to know about… Project Management Made Easy! Project management consists of more than just a large building project and can encompass small projects as well. No matter what the size of your project, you need to have some sort of project management. How you manage your project has everything to do with its outcome.