Business Considerations - Fundamentals of Industrial Chemistry: Pharmaceuticals, Polymers, and Business - page 67

backtrack. Similarly, the sooner we recognize a fatal flaw with a project
and kill it, the sooner we can shift resources - people, money, equipment,
etc. - to another project with a better chance for success. However, these
decisions are not easily made. You run the risk of killing a good project.
Thomas Edison said, “Many of life's failures are men who did not
realize how close they were to success when they gave up.” Making project
decisions becomes a balancing act but an important one to success. Lipitor ®
is one of the more important drugs in recent history. Millions of people
take it to control cholesterol. It went off patent Nov. 30, 2011 and is now
available in generic form. In 2010, it generated more than $10 billion in
sales. Lipitor ® was invented at Parke-Davis, since acquired by Pfizer. In
1990, the Parke-Davis review board met to decide whether to continue the
project and begin Phase 1 studies. Researchers had worked on the project
for eight years, but at best it would be the fifth statin to reach the market
and animal studies did not distinguish it from other statins. Although the
sentiment was to kill the project, Dr. Roger Newton was able to convince
the review board to continue with the project [8]. The Lipitor ® story is an
example of when it was desirable to continue with the project. The decision
had a major humanitarian and financial impact.
Because of the importance of these decisions many companies have
elected to have a formalized process to review projects and decide which
projects should be supported and which should be discontinued. Without a
rigorous method, the wrong projects often get selected. Instead of decisions
being based upon facts and objective criteria, they are often based upon
company politics and emotion with the end result that too many fail [9]. One
of these formalized processes was introduced by Robert Cooper and is called
the Stage-Gate™ process. It is described in his popular book first introduced
in 1998 and now in its fourth edition [10].
There are typically about six stages or phases from conception to commer-
cialization. For each stage, there are defined learnings or tasks to be done.
A group meets and reviews the work done in the stage and decides whether
there is sufficient probability of success to warrant moving to the next stage.
This is called passing through a gate and the members of the group are
called gate-keepers because they decide which projects pass through the
gate. The project can be killed, sent back for more investigation or passed
along to the next stage. The composition of the gate-keepers might change
as a project moves through the stages. At an early stage, perhaps a literature
search of the chemistry and a preliminary market study is done and the gate
keepers might be an experienced scientist and someone from new business
development. At a later stage, as more investment is needed, representatives
from research and development (R&D), sales, marketing, manufacturing, and
upper management are all likely to contribute and to take part in the decision