Gone are the days when drug making was the province of the lone pharmacist or herbalist. Today, drug making is a sprawling
operation—functionally and geographically—requiring the joint efforts of hundreds of people separated by oceans and job titles
to produce a single drug. How do they manage to operate together? The answer in a single acronym is IT, or information technology.
Disparate workers' operational procedures become standardized when they all plug into a single platform brought to them by
Oracle, or SAP, or IBM. In that way, business procedures, workflows, documentation, and reporting structures become uniform
across the entire organization. Indeed, for better or worse, IT is probably the single most important factor in enabling corporate
sprawl. Add to operational management, the drug business is also regulated, more than any other industry, and that entails
documentation—a lot of documentation. So the software companies have also produced compliance packages, risk-management packages,
and incident-reporting packages. The challenge for software producers and users is twofold. First, does the software program
do what it's supposed to? But second, and more critical for the overall success of an enterprise, is how seamless is the software?
Whether it's a single package to manage every function and aspect of the business—which to date just does not exist, or whether
it's a number of software applications—how well do they work together to maximize organizational efficiency and productivity
while minimizing regulatory and financial risk?
Illustration by Melissa McEvoy. Photography: photos.com
To learn a little bit more about the software landscape for the pharmaceutical industry, I sat down with Roger Bottum, vice-president
of marketing at Axentis, Ran Flam, president and chief executive officer of Sparta Systems, and Jim Sabogal, vice-president
for industry solutions for the Life Sciences Product Technology Unit at SAP. Our conversations focused on the present and
future of software for enterprise and risk management, regulatory compliance, and incidence tracking. Arvindh Balakrishnan,
senior director of the Life Sciences Industries Business Unit at Oracle, was unable to attend the live event, but responded
to my questions later—virtually, of course. (For the flow of this article, I have inserted his comments where they seem appropriate.)
What follows is an excerpted transcript of our discussion.
The organization is the palette on which the entire operation is drawn. So it makes sense to look at the software that manages
the entire enterprise. As we started talking about enterprise software, I found myself remembering a theory I'd studied in
a linguistics class—the Sapir-Whorf theory, which says:
"We dissect nature along lines laid down by our native languages. The categories and types that we isolate from the world
of phenomena we do not find there because they stare every observer in the face; on the contrary, the world is presented in
a kaleidoscopic flux of impressions which has to be organized by our minds—and this means largely by the linguistic systems
in our minds. We cut nature up, organize it into concepts, and ascribe significances as we do, largely because we are parties
to an agreement to organize it this way—an agreement that holds throughout our speech community and is codified in the patterns
of our language."
Applied to organizational management, I wondered whether the underlying structure dictated the software and its configuration,
or whether it really was the other way around: The structure of the software determines the organization's structure.
Jim Sabogal started off the discussion of the relation between software and organizational structure by noting that "Life
sciences has been one of the [industries] where they have a varied IT landscape." And that, he says, is because the industry
itself is so "fragmented."
There are different pieces.... When you look at a life science form, there's a whole world called research and development,
there's a whole world called manufacturing, and there's a whole sales and marketing world. They've not been tied together.
And our goal at SAP, at least, is to try and provide common business processes across all three areas, knowing that this is
a regulated industry. Because at the same time what we're trying to do is look for ways to shorten that new product development
time.... So the challenge really becomes: What's the formula for doing that? How do I grow the business?