Programming a Seamless Supply Chain - Pharmaceutical Technology

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Programming a Seamless Supply Chain
Information technology is the glue that should unify a company while ironically, it enables further fragmentation. Experts talk about the successes and challenges for IT in helping a company function efficiently.


Pharmaceutical Technology



Illustration by Melissa McEvoy. Photography: photos.com
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?

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.

Organizational management

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."

Sabogal: 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?


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Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
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Reducing drug shortages
70%
Breakthrough designations
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Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
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