Qualify my BIOMARKER
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Innovation in science is no quick trick, and neither is collaboration. Back in March 2004, FDA sounded a now-famous alarm:
Despite the drug industry's 250 percent jump in spending on R&D, drug-development productivity had plunged by 50 percent over
the previous decade. The report, which became known as the Critical Path Initiative (CPI), last year yielded an industry-wide
call to arms regarding 76 action items (aka, the "Opportunities List") in six key areas: biomarker development, the streamlining
of trials, the harnessing of informatics, improving drug manufacturing, public health initiatives against infections and bioterrorism,
and special programs for adolescents, children, and other at-risk populations.
Whether or not Critical Path succeeds depends, to a surprising degree, less on new science than on new ways of doing science.
Some of these innovations are based on a model of collaboration by which companies share certain kinds of knowledge with one
another and with FDA. Not having to create new science should make things easier, right? "
SHARE the wealth
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Maybe. A few early CPI collaborations are encouraging, but in general, sharing—predictably enough—creates special challenges
for the industry. For one thing, many aspects of the FDA–pharma relationship are inherently adversarial, and decades of practice
cannot be overturned overnight. For another, self-interest is encoded in every drug firm's DNA. Companies are duty bound to
protect their valuable intellectual property and loath to share it with competitors. Ultimately, voluntary collaborations
are doomed to fail unless each partner can find a satisfactory answer to "What's in it for me?"
Collaboration requires an investment of resources and processes. New organizations must be defined, funded, and staffed. Further,
when sharing technical data, legal permissions must be obtained, standard definitions and data structures hammered out, and
a trusted intermediary assigned to convert it all to an agreed-upon format. And where full data sharing is not possible, there
must be explicit disclosure of what is missing, so that users may judge reliability and limitations. This thicket of immediate
drawbacks tends to obscure the bright-but-delayed promises of working in new ways.
Drug Development: By the Numbers
Change is painful. Reasons and excuses not to innovate accumulate every step of the way. It helps to keep in focus the serious
problem that Critical Path is intended to fix. The cost of bringing a new drug from discovery to market keeps rising, currently
consuming $1 billion and 15 years. The latest statistics indicate that Phase III attrition now approaches 50 percent, and
as the recent loss of 10,000-plus jobs at Pfizer has shown, the impact of large, late-stage failures such as torcetrapib can
prove devastating.
The modle solution
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Let's do the math. Real R&D spending, adjusted for inflation, is up 42 percent over the past five years. Where is the money
going? The good news is that slightly over half funds a rising number of projects—the pipeline of active R&D projects (counting
preclinical and clinical) has grown 24.5 percent since 2001. The bad news is that the rest covers the higher cost-per-project,
a 14.2 percent rise over the same period. Most of that bump comes from expensive new tools, such as transgenic animals, robotics,
microchips for fixing DNA samples, new intensive cardiac-safety trials, and information technology.
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