No one is sure what exactly lies behind the drug industry’s productivity slump, and few are ready to hazard a guess about when it will end. But Kenneth Kaitin, director of Tufts University’s Center for the Study of Drug Development, points to several likely causes, including management distractions brought about by a rash of industry mergers and acquisitions and a tightening in FDA regulatory requirements that has made it more difficult to get a drug to market. There is also a suspicion, says Kaitin, that the drug industry spent too much too soon on new biotechnologies, like genomics and proteomics. “It led to increased cost without an increase in productivity,” asserts Kaitin. Still, he adds, “there is no going back. The technology is not going away. You need to find ways to efficiently utilize it.”
Indeed, it seems certain that any replenishment of the industry’s R&D pipeline will be tied to drug companies’ learning to better take advantage of these new biological technologies, which have given researchers an unprecedented window into disease mechanisms and how the body works. But as Pfizer and others have learned over the last few years, turning this wealth of information into actual pills is a tough challenge. And future success will likely depend, at least in part, on how well companies are able to use emerging tools like biomarkers and automated drug-discovery systems to make sense of the increasingly complex biological data. The challenge, as Williams puts it, is to find efficient ways to sort “the gold from the lead.”
While increasing the productivity of drug discovery is an industrywide challenge, it is hard to overstate the importance of Pfizer in getting it right. At the disposal of this giant organization is an annual R&D budget of $7 billion and an exploding cache of new knowledge of human genetics and biology. Pfizer’s attempt to turn these resources into an efficient flow of new and innovative medicines over the next few years is an experiment well worth watching. No one can be sure of the prognosis. But the results are sure to affect the health of us all.