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Looking ahead at the biopharmaceutical industry into 2009.
The new year is a natural time to think about the future. In the current economic crisis, however, pondering the year ahead is unnerving, as it brings unsettling questions to mind. How bad, how broad, and how long will this recession be? And after the crash of the financial and auto sectors, who's next?
More specifically, many of us wonder how much the poor economy will affect the biopharmaceutical world. If you talk to people in the industry—as our Managing Editor Chitra Sethi did for this month's employment survey (see p. 30)—you'll find that most are pretty optimistic. They are confident that the pharmaceutical industry's future lies in biotech, so they feel fairly secure. Even professionals in traditional Big Pharma companies feel confident if their organizations have entered the biologics arena. Small companies, of course, are the most threatened by the economic downturn, because of their dependence on credit. But risk at start-ups is nothing new; it's just more acute right now.
Still, biotech is not exempt from the challenges facing the broader pharmaceu-tical industry, and uncertainty and change lie before us. Although everyone seems to think that large molecules hold the most promise for filling product pipelines, the failure rate in clinical trials remains high. And drug safety issues can pop up anywhere; the 2007 labeling changes to erythropoietin, for example, hurt several of the industry's biggest cash cows. Meanwhile, with a new administration coming to Washington, healthcare reform and biosimilars legislation seem imminent, and both are likely to affect pricing and profits eventually.
Today more than ever, these pressures are trickling down to manufacturing operations, and companies are seeking ways to reduce production costs and improve efficiency. At the same time, regulatory expectations for quality are increasing, and initiatives such as Quality by Design (QbD) are encouraging many companies to invest more, not less, in process development.
The most forward-thinking members of the industry, of course, are already tackling these challenges. And in the coming year, BioPharm is planning several special activities to tap into the ideas of some of these leaders.
First, on March 17, I will host a keynote panel discussion at Interphex. There, executives from manufacturing operations at major companies—including Tim Moore of Genentech, Divakar Ramakrishan of Eli Lilly, and Mike Kowolenko of Wyeth—will explore the future of both small-molecule and biologics manufacturing. We'll hear their views on issues such as managing supply chain risk (from capacity forecasting to threats to raw material quality), whether investments in Quality by Design are good for business as well as quality, and outsourcing strategies, including the pros and cons of outsourcing to Asia, and Big Pharma's shift from manufacturing to sourcing.
Then, at the BIO convention in June, we'll conduct live videocast interviews and small panel discussions on a range of topics, from implementing QbD to ensuring supply chain safety. And even if you can't travel to BIO, you can take it all in through our videocasts. Those who do attend, however, will have access to the niche networking sessions we will hold after the interviews.
Clearly, the curse, "May you live in interesting times" is upon us. I am confident, however, that biopharma can continue to innovate its way to success. So as we enter the new year, let's raise a glass and say, "Here's to taking on those challenges in 2009. Here's to biopharma's future."
Laura Bush is the editor in chief of BioPharm International firstname.lastname@example.org