That’s brought “extreme focus on cost reduction,” relates Alison Smith, vice president of marketing strategy and research at Aspen Technology Inc. (AspenTech, www.aspentech.com), Burlington, Mass., a provider of process optimization products. “Manpower cuts in manufacturing of 50 percent are not unusual. This is necessitating more automation of previously manual processes.”But economics also drives more outsourcing, a trend that began a few years ago. “The current focus on cost reduction has greatly accelerated the move to outsource manufacturing,” Smith remarks. Besides manufacturing, she also mentions “certain kinds” of research, clinical-trials management and sample management—“anything that can accelerate time-to-market and help manage costs.”Acceleration involves industry linking process design and simulation more closely to operations, “to speed up the tech-transfer process,” she says. But, this is now very much a work-in-progress, “more of an organizational than technical struggle.” She also hears of increased emphasis on data acquisition and analysis to support continuous-improvement efforts.Some companies now abandon manufacturing, however. “Those that don’t view manufacturing as a core competence divest themselves of production assets and allow ‘those who can do it better than us’ to do it,” Smith notes. One example she cites is an AspenTech client, a contract manufacturer, whose business “is positively booming.”Overall, though, pharma segments prosper according to what they produce. “Conventional, small-molecule [product] pharmaceuticals are growing slowly—1 percent per year—as compared with biopharmaceuticals growing at 10 percent to 15 percent annually,” Smith states.Prosperity seems now to point to the Asia-Pacific market. “It’s looking very attractive from not only a consumer-market perspective, but also from a knowledge-pool perspective.” Many of her pharma clients comment on “the vast numbers of talented scientists and mathematicians coming out of the Asian educational system.” According to Smith, that’s a huge talent pool on which to draw, so big that “most large companies are establishing, if they haven’t already established, research centers in Asia to tap into this pool.”Joint ventures blossomAnother pool pharmas tap is joint ventures. “They’re all over the place,” Smith remarks. Why? There’s “a bunch of blockbuster drugs” coming off patent now—and there aren’t any replacements, she explains.  And while new-product pipelines are “full of many products,” each will have smaller associated revenues, she says, and “many are targeted at specific patient populations, and have their origins in biopharmaceuticals.” she says. That means there will be “a lot more” joint ventures to fund research and development (R&D) in specific areas.This joint-venture approach also allows companies to engage in software development called “sprints.”  That is: “You get an idea, you explore it extremely rapidly and then determine if it’s a go or a no-go,” Smith explains. This produces faster iterations in research. It also expands the number of opportunities being explored at any one time.Reducing risk and increasing productivity now also mean movement toward paperless manufacturing and better knowledge management. “The industry still needs paperless manufacturing in not just manufacturing, but also in research and development,” Smith notes. As for implementing knowledge-management tools, “progress is slow,” she says. “But companies are implementing the kinds of tools now in R&D that will allow them to use simulations to run experiments instead of relying on pilot-plant approaches, which are slow and costly.”  Thus, quality-by-design, or QbD, is starting to become a reality, and “is helping R&D and late-stage-development organizations increase productivity,” she adds.Obstructing productivity, though, is the U.S. Food and Drug Administration’s (FDA’s) inability to keep up with changes  that the agency itself has required. “The biggest concerns we’ve heard from industry is that FDA field investigators weren’t able to keep up with the FDA’s new practices” Smith notes. C. Kenna Amos, [email protected], is an Automation World Contributing Editor.Aspen Technology Inc., AspenTechwww.aspentech.com

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