The Logical Organization of Bio/pharmaceutical R&D
Bio/pharmaceutical R&D is organized in a logical manner, Figure 1, i.e. by what happens first and what happens subsequently in a logical order of events. Early research leads to the discovery of a biological (drug) target, the first discovery of chemical or biomolecular agents (leads) which interact with the target in the desired manner (agonist, antagonist, etc.), and the optimization of properties in subsequent analogs of the initial leads resulting in candidate selection. In Drug Discovery projects are formed around biological targets. From candidate selection onward the focus is on a single agent, the drug candidate.
At the beginning, Drug Discovery is engaged in target progression or target validation – developing a body of evidence that relates the biological target to a desired potential therapy. For some disease areas, such as antibacterial and antiviral therapy, target validation is achieved early in Target Discovery. Target validation for psychiatric disorders, however, is only truly achieved when it’s proven in the relevant clinical population. Late Discovery and early Development is engaged in molecule progression – identifying and developing agents which are proven efficacious and safe in humans. It is only in the clinic where the true medical indication for the bio/pharmaceutical agent is elaborated.
All of the work in bio/pharmaceutical R&D tends to be divided into stages (the 7 horizontal arrows starting with Target Discovery and ending in Registration and Launch) and gates, decision points where progress is assessed (the 4 vertical arrows in Figure 1). A full discussion of the Stage/Gate organization of Bio/pharmaceutical R&D occurs in another section.