No surprises

Developing a new drug for market definitely counts as a major program - in fact a succession of major projects. And some drugs are more complicated than others - Biologics are compounds derived from living sources and include antibodies, vaccines and other proteins. The approval process is rightly more complicated than for small molecule drugs. Somewhere in that chain of projects comes a landmark event - Submission of the Biologics License Application (BLA) to the US FDA. The BLA is a massive document that includes all the evidence derived from many trials, studies, tests, analyses, literature searches and so on. It includes information about the drug itself, its manufacture, storage, ingredients, purity, delivery mechanism and more. It includes information about the trials, how they were conducted, how the patients benefited, any adverse reactions, how was impartiality maintained and so on. It's big and it's complex. Add to this the fact that it is a very expensive proposition and the success of a single new drug can affect the fortunes of even the largest drug company. Of course there are commercial pressures to get it done quickly - to bring relief to sufferers, to get to market, to beat the competition and to be able to start work on other opportunities.
So we have a multi-million dollar project - very important to the organisation, under tight time pressure, with scores or hundreds of component deliverables all focused on a single event. The duration and effort for many of these deliverables is very uncertain. The results of analysis of data coming in from clinical trials or from other studies affects the writing of the different components. Consistency of information in different areas is important. A new realisation in one area can require changes to a deliverable in another area. All this makes for a very exciting project management environment and the plea for No Surprises.