Pfizer’s NOAH Speeds Health Solutions to Animals



Dr. John W. Hallberg picked up the phone. The caller was from the U.S. Food and Drug Administration, and a slow response to the call could delay the approval of an important new product.

Hallberg is a regulatory manager for Pfizer Animal Health, a key division of Pfizer Inc., the world’s largest pharmaceutical company. Although the company’s human drug division is much larger, there are millions of cattle, pigs, dogs, cats, and horses that owe a debt of thanks to Pfizer for its veterinary vaccines and prescription medicines.

Pfizer’s regulatory managers shepherd new products through the federal approval process. They manage large submissions with as many as 35,000 pages of materials. When the government has questions, tracking down the paper version can take valuable time. In 2003, Pfizer acquired Pharmacia Corporation, which had its own veterinary medicine division to be merged into Pfizer’s—exacerbating the challenge of managing documentation.

When Hallberg took that phone call, the government reviewer at the other end of the line requested changes to a proposed label that Pfizer had included with one of its submissions

The hours or days it might take to dig through the paperwork to identify the label and implement the changes could cause the submission to miss an important deadline and require it to go through another full submission cycle. That would delay getting the product into the hands of customers who needed it. It could also mean lost sales, because a drug submitted to the government for approval is already under patent—with the clock ticking toward the day when that patent expires and competitors can copy the drug.

“We need to serve our customers better by decreasing the time it takes to obtain an approval,” says Hallberg. “The system we used to manage the regulatory process wasn’t enough. This phone call was a perfect example of how a small glitch could both affect animal health and set us back in delayed approvals.”

Dilemma Times 50

This dilemma also was a perfect example of the problem facing James M. Tassell, software architecture manager in the information technology unit at Pfizer Animal Health. In fact, multiply Hallberg’s dilemma by 50 and you get an idea of the challenge facing Tassell.

That’s because the software system in Hallberg’s unit was one of 50 such systems throughout Pfizer Animal Health that was suddenly faced with merging and then managing workloads from both Pfizer and Pharmacia. Those systems were diverse, covering virtually every aspect of Pfizer Animal Health operations, including research and development, human resources, marketing, finance, and international operations.

But what they had in common was the need to be upgraded, expanded, or completely revised quickly and effectively to speed the delivery of new health solutions to customers and their animals. However, Pfizer’s technology infrastructure had not been created with that goal in mind. Pfizer’s systems ran on separate databases in separate data centers, connected to Pfizer’s intranet through separate Web servers, used separate personnel to service them, and had separate processes to manage them.

“We had to re-create the wheel with every software system we wrote,” says Tassell. “There was no way that the work to create one system could be used to create another—and no way for us to give all of our software developers a running start on their development. But with the challenges suddenly facing us in providing better lives for pets, that’s exactly what we needed.”

NOAH to the Rescue

In the Bible, it was Noah who saved the world’s animals. And at Pfizer Animal Health, it’s another Noah that’s helping to save the day for today’s animals.

In this case, Noah is an acronym—NOAH—that stands for Next-generation Operations and Application Hosting. Essentially, NOAH is to Pfizer Animal Health’s software developers what a well-stocked kitchen is to a group of chefs. The ideal kitchen stocks all the ingredients that the chefs might need whether they're making stews or soufflés. It has the tools—including ovens, food processors, pots, pans, and utensils—needed to work with those ingredients. And it puts those ingredients and tools in a well-designed workspace that makes it fast and easy for the chefs to grab exactly what they need, exactly when they need it.

Tassell and David Opdycke, System Architect, set out to create the software equivalent of that ideal kitchen for the developers who had to build new systems to support Pfizer’s growing operations. NOAH includes the “ingredients” that developers need to create software systems, such as databases, Web servers, security mechanisms that prevent unauthorized use, and reporting tools that deliver information. Because Tassell and Opdycke put those ingredients into NOAH, software developers can just take them “off the shelf,” rather than having to create them from scratch each time they’re building a new system.

Tassell and Opdycke also ensured that, like a good kitchen, NOAH includes the “tools” to bring these “ingredients” together. Some of those tools are best practices and policies—such as conventions for the way parts of a system are named—that help developers create their systems in ways that will meet Pfizer requirements and government regulations the first time out. NOAH’s “well-designed workspace” is an internal Web site from which software developers can get the ingredients and tools they need to create their systems. This one-stop shopping site, which Tassell and Opdycke call an “application resource kit,” goes by the not-coincidental acronym of ARK.

The Building Blocks Behind NOAH

In creating NOAH, Tassell and Opdycke faced their own version of the challenge that developers throughout Pfizer Animal Health faced. They had to create NOAH just as quickly and effectively as the developers needed to build new systems, so that the rest of Pfizer’s system development could proceed. Building NOAH from scratch would be time-consuming and complex—as would training the NOAH team on new software, such as Java, with which to build the solution.

To give them a leg up on creating NOAH, Tassell and Opdycke decided to use software from Microsoft that included prebuilt parts That Microsoft® software, called the Microsoft .NET Framework, provided building blocks such as a tool to track the progress of a system’s operation. Other Microsoft products provided building blocks to create Web sites and to deliver informational reports from the systems.

Tassell, Opdycke, and their team integrated these building blocks into NOAH rather than creating them themselves. And then Pfizer developers who were using NOAH could just drop these building blocks into their systems, saving the time and trouble of creating them independently.

Tracking Products on NOAH

Thanks to Tassell, Opdycke, and NOAH, developers throughout Pfizer Animal Health are creating the systems they need to speed the delivery of health solutions to pets, as well as to manage Pfizer’s integration with Pharmacia. Fifty such systems now exist. They have been created in about half the time previously required for system development. And because NOAH centralizes the process of managing those systems once they’re created, Pfizer now saves $500,000 over three years on that management—more than half the amount it used to spend.

Dr. Mike Witty is well-acquainted with one of the ways that NOAH helps to enhance the lives of animals. Witty is the group director of global portfolio management for Pfizer Animal Health, responsible for tracking the 100 or more veterinary products that Pfizer has under development or in discovery. Before the merger with Pharmacia, that process had been managed by spreadsheets on the PCs used by Witty’s staff.

“With the smaller portfolio we had before the merger, we were able to make this work,” says Witty. “But with the merger, our portfolio doubled and we saw problems. Pfizer and Pharmacia tracked their products differently, so we needed a way to make ‘apples-to-apples’ comparisons. Because of the immense size of the spreadsheets, they ran achingly slow. And once a spreadsheet was passed along to someone else, it became out of date—and that could cost us credibility.”

To solve these problems, Scott Frederick, a Pfizer business technology project manager, used NOAH to create a Web-based tracking system, called PFTrack, for Witty’s group.

“It took us just two months to get our system up and running on NOAH; that’s a really short time for a system like this,” says Frederick. “We intended it to be a temporary solution while we looked for a packaged product. But it’s proved so valuable, we’ve just continued to expand it over time.”

PFTrack provides more detailed, and more up-to-date, information on products under development than Witty’s group could manage in their spreadsheets. And it allows the group to put that information into the hands of executives outside of the group, who can use it for strategic decision making.

“In the past, decisions about product development were based primarily on return on investment,” says Witty. “With the information in PFTrack, we can also look at how a product aligns with our strategic objectives to improve animal health—what species it is for, what level of risk it entails, when it will be developed—and factor those considerations into our decisions. It means we can be much smarter about aligning our product development effort with our long-term interests in providing better lives for animals.”

Multiply that benefit by 50 and you get an idea of the gains that Tassell and his colleagues have made possible through NOAH.

Calling Dr. Hallberg

With the previous software solution that Pfizer had been using to track regulatory submissions, Hallberg’s only answer to that government reviewer on the phone would have been that he’d get back to her—forcing a delay in both the regulatory review and in the delivery of the new drug to Pfizer’s customers.

But that call came in to Hallberg after Chris Itterly, a Pfizer business technology solutions architect, used NOAH to build a new system for the Regulatory Affairs unit called STOR (for Submission Tracking & Online Repository). NOAH reduced the administrative burden of dealing with the hosting environment by 67 percent, according to Itterly. As a result, STOR was created in six months, about three weeks faster and for 10 percent less than he estimates it would have taken to develop STOR without NOAH.

“NOAH was the key to reducing the administrative burden of the hosting environment, allowing us to stay focused on the functionality STOR needed to provide,” says Itterly. “Eliminating interruptions caused by administrative tasks created more benefit than just the time savings. Being able to maintain our momentum while building components unique to STOR helped us to expedite delivery. Creating Web spaces and databases, using reporting services, and applying security and data integration were all easier, thanks to NOAH."

STOR puts all status information for the hundreds of Pfizer products in regulatory review together with electronic versions of the tens of thousands of pages of documentation that can support each submission. The system lets Hallberg and his colleagues search for a specific submission and then pull up all the documentation that supports it, replacing hours or days of searches with a few mouse clicks.

With the government reviewer on the phone, Hallberg used STOR to bring the image of the proposed label onto his screen—where it already contained the changes that the reviewer wanted. It soon became clear that the problem stemmed from software that was printing the label incorrectly. Hallberg e-mailed the electronic file to the government reviewer while they were still on the phone, she accepted the file, and the review process continued without missing a beat—eliminating a potential delay to Pfizer’s customers that could have cost the company millions of dollars in sales.

Hallberg estimates that STOR could help shave 30 percent off the average 10-year process for government approval. That means customers will be able to put new Pfizer drugs to work about three years sooner than they could before NOAH, enhancing and even saving the lives of animals that would otherwise be lost.

“I’m a veterinarian by training,” says Hallberg. “It’s clear to me that STOR is making the difference in our ability to create and deliver the solutions that will better the lives of animals today and for years to come.

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“It took us just two months to get our system up and running on NOAH; that’s a really short time for a system like this,” says Pfizer’s Scott Frederick.

© 2006 Microsoft Corporation. All rights reserved.

This document is for informational purposes only. MICROSOFT MAKES NO WARRANTIES, EXPRESS OR IMPLIED, IN THIS SUMMARY.

“We had to re-create the wheel with every software system we wrote. There was no way that the work to create one system could be used to create another,” says Pfizer’s

James M. Tassell.

In the Bible, it was Noah who saved the world’s animals. And at Pfizer Animal Health, it’s another Noah that’s helping to save the day for today’s animals.

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By Mark Levenson

Pfizer Animal Health wanted to enhance a variety of business functions—from product planning to regulatory approval—all designed to help meet the division’s goal to enable better, healthier lives for pets and livestock. Its solution: Make it faster and easier for the division’s software designers to create software to support those functions—and, consequently, to meet customer needs.

Pfizer’s NOAH Speeds Health Solutions to Animals

A better way to create software helps Pfizer Animal Health to align product development with customer needs and to expedite regulatory approvals, so customers get new products more quickly.

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