December 14, 2000, 9:44 AM — We're quick to pop a pill these days. But we rarely think about the pain
involved in getting that pill to market. The painstaking research and development that
goes into adding a new drug to the shelves of your local pharmacy often requires a
collaborative effort far beyond our imaginations.
Drug companies must conduct broad, expensive trials before their products ever get
to the Food and Drug Administration (FDA) for approval. Out of the tens of thousands of
compounds that are discovered each year, only 7 percent of them make it into your
medicine cabinet. After an extensive development phase, pharmaceutical companies must
back up their claims for a drug's efficacy for the safety of the public by submitting
mountains of paper to the FDA -- the federal agency set up to evaluate pharmaceutical
products before going to market. The FDA's approval process is also a long and detailed
one. In many cases, the documentation that companies must provide to the FDA can grow
to a ponderous number of pages -- typically 1 million.
In addition to the elaborate development and approval process, drug companies are
also facing added pressures from a Congressionally-mandated restructuring of the FDA's
review process. The mandate requires that the FDA shorten its review process to just 12
months from its typical 18 to 24 months in order to get drugs to market faster without
So in an effort to move documentation more swiftly through the FDA's approval
process, Pfizer has switched to an electronic-based drug submission process. The giant
pharmaceutical company's Esub -- Electronic Submission Navigator -- offers a vast
departure from its old paper-centric way of submitting documentation to the FDA.
Pfizer's award-winning system has delivered impressive results. It cost $3.2
million to develop and has so far netted the company at least $142 million in revenues
due to shorter cycle times. But it has also given the company much more than bottom-
line benefits: Esub has changed the way the research clinicians and the IT staff work
"Esub has had enormous impact in that it has transformed the way we do things
internally," says Dr. George Milne, president of research and development for Pfizer's
Central Research Division in Groton, Conn. "Our ability to execute new drug filings has
been brought to an unprecedented scale," he says. "It's much more than just an
interesting computer system. The tools that Esub gives us will stimulate insight. We
expect it to lead to a cascading effect of innovation," he adds.
"Pfizer's results directly affected its industry and served as a role model and a
benchmark," says Gregor Bailar, vice president and CIO at the National Association of
Securities Dealers and an Enterprise Value Award judge.