Biomanufacturing: Getting The Better Of Its Impediments

By Bernard Tulsi, Life Science Leader magazine

The big picture woes of the biotech and pharmaceutical sectors are legion: real and perceived perils lurking within the new administration’s ever-shifting healthcare overhaul plans, acute fiscal pain from an ailing global economy, and constricting financial lifelines — as venture capitalists turn their attention elsewhere while investment bankers and investors, in general, nurse a severe bite from the caution bug.

More troubles emerge when the micro-picture is reviewed — traditional drug developers’ ultraexpensive, though not so fruitful, small-molecule pipelines are turning out new products at a tortoise-like pace; patent expirations, especially on mega-selling drugs, seem ubiquitous; and lack of efficacy and safety issues seem perennial.

Product approvals in the biotech segment slowed in the last six to eight years, as well. In 2009, however, the pipeline seems to be filling up again, which is seen as a hopeful sign by BioPlan Associates, a leading biotech trend research firm, which conducts an extensive annual survey with more than 400 industry participants.