Notes from ISPE 2007 - President Charlie Portwood on Cultural Change at Wyeth

Bernard PoussotInstallment 6
Wyeth Pharmaceuticals has been through several transformations. Over the past few years, the company has quietly emphasized outsourcing operations, but established robust quality management practices for its contract partners and suppliers.(Click here and here (scroll down to the article on ICE Team for more on these efforts). Wyeth has also built up its pipeline in Japan and Asia Pacific, and, after some struggles, including a 483 for its facility in Guayama, Puerto Rico last year (since resolved), the company is striving to build a culture of operational excellence and compliance. With its Prevnar vaccine, one of several "Class of 1999" blockbusters, the company faced production, GMP training and compliance problems, culminating in a Consent Decree with FDA in October, 2000. Charles Portwood, President of Tech Ops and Product Supply, who joined Wyeth during these challenging years, took ISPE's audience through some of this history, and described the company's Operational Excellence initiatives and the impact they are having, as well as Wyeth's new standardized IT platform,  DART, which he modestly called the "Star Wars of pharmaceutical manufacturing."  Wyeth's now embarking on a new initiative to improve supply chain management (more on that in a brief interview with Mr. Portwood). He attributes Wyeth's success so far in reshaping its priorities to the vision and strategy of CEO-elect Bernard Poussot (photo), who sharpened the company's focus and redefined a new structure based on its key product groups: small molecules, large molecules, vaccines and nutritionals  His keynote speech noted the dramatic change in communications and information management that has occurred within the past few decades. Unlike the media and retail industries, the pharmaceutical industry isn't reaping the benefits of data access, Mr. Portwood suggested. He would like to change that.Wyeth sees leveraging integrated standards as the way to go. This seemed a rather nebulous IT phrase (like so many of the IT terms thrown about by consultants) but it, presumably, denotes the use of open, service oriented architecture and redeployable standard procedures. Mr. Portwood has high praise for the Quality by Design initiative. "Quality by Design and ICH guidelines offer incredible opportunities to change the way we do business," he said, "so do new technologies such as disposibles, microcreactors, and the continuous processing of solid dosage materials."He also mentioned the role that robust IT tools and systems could play. His aims are ambitious. "My passion is to change the entire paradigm, to learn to leverage data into wisdom and perfection in everything that we do." Mr. Portwood sketched a pyramid based on systems such as LIMS, MES, EDMS, ERP , and using integrated standard systems to collect and store data, gather and integrate, and then analyze it to drive improvement. Mr. Portwood then went on to tell the Wyeth story. "We had significant challenges with compliance six or seven years ago.We had a network of very old plants and an aging product portfolio, and many issues that were difficult to sort out," he said. Then, in 1999, he said, Wyeth gained approval for several blockbuster drugs,and operation became incredibly difficult to deliver, he recalled, "We had to change our paradigm." Wyeth's new vision focused on very simple principles, he said. "Focus on product quality first, be leaders in cGMP (that "c" means you're either leading or losing) and focus on compliance¦." Change involved making deliberate and strategic choices, he said, and the company rolled out sustainable compliance initiatives, redesigned organization for manufacturing, developed operating units for biomolecules, vaccines, nutritionals, and used the concept of primary process units to divide large facilities into smaller ones. He charted some success stories and overall progress. "In 2007, we are running at 0.1 major observations for inspections, down from over 0.7 in 2004.in 2002, at the height of the C.D., you couldnt fit it on this Powerpoint page," he joked. "We've come a long way.but it is a challenge every day," he said. Wyeth has also seen a 40% net sales efficiency improvement per employee over this period, he said. With Prevnar manufacturing, the challenges were significant, yet improvements have been dramatic, Mr. Portwood said, and end-to-end cycle times have been dramatically reduced across sites. "In 2004, we were running 456 days. This year, we're at 197. That means lives saved."We've doubled our doses in the last three years." It wasn't easy. The vaccine is "the most complex product I've ever worked on," he acknowledged, involving seven serotypes, each of which requires fermentation, activation, and conjugation, then the process must be run through five different sites. "It's like manufacturing 22 different products," he said. Another drive has been to better utilize data."We've learned that it takes 0.6 metric tons of paper to produce 13.56 kg of protein," he said. Eliminating documentation errors was critical. Last year, Mr. Portwood said, Wyeth completed 217 million Prevnar batch record entries, at failure rate of 0.01 "But that wasn't good enough for what we do," he said. The next move involved implementing MES and LIMS to reduce use of paper processes. "We now achieve over 95% first-time quality all the time." Mr. Portwood sketched a pyramid based on systems such as LIMS, MES, EDMS, ERP , and using integrated standard systems to collect and store data, gather and integrate it and then analyze to drive improvement. The company built on four systems: ERP, MES, LIMS and EDMs, he said, adding ancillary systems,...such as CAPA and MRP to its ERP, data historians, SCADA systems, calibration tools, EBR and BMS to its MES,CDMS to its LIMS, and SOPs and registration documentation systems to its EDMS. "For years, the industry has used point solutions, such as LIMS, often as single-site solutions," Mr. Portwood said. "At some sites we used integrated point solutions, but they were usually hard to transfer between sites and costs were high." Today, he went on, Wyeth's goal is to use integrated standard systems tied together with an integrated service bus. One key part of this system will be a data acquisition and reporting tool, providing a single version of the truth, so that any operator or engineer can go to any site and operate a standard process. To implement the vision, Mr. Portwood says, Wyeth uses off-the-shelf solutions, and has rolled the platform out from site to site, using subject matter experts from the last implementation site to drive programs at the next. "You achieve tremendous knowledge from doing that," he said. Wyeth's DART platform has been implemented at four sites so far, and the company plans to have it running at 70% of all Wyeth sites within the next few years. Mr. Portwood sees integrated standards as the way to "fully capture the power of data to change the world." Biotech, which will be 40% of the company's total revenue, also promises to be a key part of Wyeth's future. We will plan to elucidate more of DART (including what those letters stand for---Genentech has a similar IT acronym for Design and Review tool) in future articles, and will feature interviews with Wyeth's teams at Pearl River, including the Prevnar fill-and-finish team, which won our 2007 Team of the Year award, on our web site soon. AMS
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