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Pfizers Global PAT teams have played a leading role in the FDA-led PAT initiative. An enabling team for this Global PAT Program within Pfizer is the CPAT Project Core Team, which is dedicated to identifying commodity software for Pfizer. Members include: team leaders and PAT/IT experts Velumani (Lou) Pillai and Martin Warman, procurement expert Jeff Miller, Quality expert Choon Teo, and Chinni Balaji, the technical project manager representing Cognizant Technology Solutions, which is helping to design and develop the platform.
Whats interesting about this team is the way it functions. Its members are based in different cities across several continents: Pillai, Miller and Balaji in the U.S. but in different offices, Warman in the U.K. and Teo in Singapore. It is a team for the globalized era, one that is oceans apart and yet, through technology, keenly attuned to each others thoughts and personalities.
They confer through weekly teleconferences and collaborate via Microsoft SharePoint. They attend the same meetings when they can, but have only met as a group a few times including a recent trip to Singapore, Teos stomping grounds, and India, to which much of the software design and development work is being outsourced. These few face-to-face meetings have proven invaluable as a means of team bonding. We took some personal time to get to know each other, and that has made the team even stronger, says Miller.
In my professional experience, this is the most physically dispersed group of people Ive worked with, Miller adds. But each of us has a passion for this specific technology space. Thats why there is an interest in working together, even though the hours and days were perpetually different for all of us.
To succeed in any project, a team must have a unified voice. This is where the Pfizer teams togetherness and chemistry have paid off. If you talk to any member of our team at any given time, the message of what we are trying to do will always be the same, says Pillai.
The Pfizer search for CPAT software started innocently enough, in the first months of 2005. Pfizer was having success with PAT applications, mainly on a plant-by-plant basis. Pfizers PAT leaders determined that the only way to succeed with PAT was to standardize software globally and use it repeatedly. We were ending up with custom software from every supplier, says Pillai. When we stepped back and looked at it, we realized that this needed to be a commodity to reach a tipping point.
Given a specific charter, we were trying to find commodity software for Pfizer, says Pillai. As people started talking about it, we realized that we were doing something to help Pfizer and to help others as well.
Job one for the group was to generate a requirement document and support documents detailing the sort of platform that they hoped to develop. They outlined specific use cases to illustrate their goals. We decided from the outset what we wanted to achieve and then built functionality into the use cases that would let us achieve that, says Warman.
Going through that exercise, for our team and for people who will have to tie the software to their systems the process automation systems, the MES or LIMS systems, for instance was critical, adds Pillai.
An early challenge was building consensus among suppliers, who would have to see the market potential in such a proposal to support it. Many of them had already begun work on developing their own open platforms, and felt they already had what Pfizer needed. In some ways, were asking suppliers to pull back a bit, says Warman. Their need lists maybe dont represent what the industry has as a need list.
The team presented their functional requirements and use cases to the suppliers in December of 2005. They said that this input was better than they could have done for a product market requirement, says Pillai. This clarity helped them to devise strategies to provide a new class of product for a long time to come.
In the delicate negotiations with suppliers, it has been critical that the team maintain a unified voice and clear mission. It assured this by designating Miller as the single point of contact. He handles all communications with suppliers, requests for information, or product demonstrations, and funnels them to the rest of the team.
Consensus-building among industry peers has been a bit easier. During those early informal discussions, everyone shared common pinch points, says Warman. It became clear that every company has some of the same issues, large and small.
That these competitors were willing to share at all is unique. The PAT element of pharma is different from any other aspect of the industry that Ive ever come across, Warman says. There is much more sharing of best practices across companies, much more informal communication between companies. Its not something that people hold IP [intellectual property] on or try to have ownership of.
Were not trying to say everybody should follow the Pfizer path, Warman adds. Were trying to make sure that there is a commonality of approach and that best practices are shared.
In August of last year, leading PAT experts from across the pharmaceutical industry met a Merck & Co.s headquarters in Whitehouse Station, N.J., to discuss IT roadblocks to implementing PAT. A cross-industry sub-team derived from the Whitehouse Station congregation has also started working on a list of functional requirements for the software. A commodity offering for the whole industry may become reality.
What contributions the Pfizer CPAT team has made can be traced back to the teams innate chemistry. Were subject matter experts in very specific areas of business, but we each have very broad backgrounds as well, says Miller. Each of us has experience in plants and sites around the world. Weve operated in divisional and corporate roles. This global experience and knowledge base has been very important for us.
Theres always been a lot of respect for each other from a professional perspective, Miller says. Theres a wealth of knowledge that each of us carries in our own bag of tools, and that works well together.
But even the most talented and complementary teams can fail if they lack a mission to give them focus and a sense of purpose. I was motivated by the fact that it got me close to what I like to do, which is helping manufacturing sites work in a more optimized way, says Miller. There was a passion and excitement in it. I see what were doing in bringing technology to a space that has already developed in other industries but hasnt matured in the pharmaceutical industry.
His team members share that passion, which drives them all. If the team had a mascot, it would be the Energizer bunny, says Pillai, referring to the groups ceaseless energy. Why do we keep going? Our passion for this work is what got us together and has made this happen.