A Revolution in R&D
A Revolution in R&D
A Revolution in R&D
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6<br />
Executive Summary<br />
In the pharmaceutical <strong>in</strong>dustry’s struggle to reach<br />
the levels of growth expected of it, one of its key<br />
aims will be to <strong>in</strong>crease R&D productivity. And a key<br />
means of meet<strong>in</strong>g this challenge is to adopt some of<br />
the new technologies and approaches broadly<br />
def<strong>in</strong>ed as genomics. 1 That is bound to be a complicated,<br />
perilous, and often pa<strong>in</strong>ful process, but if<br />
companies get their strategy right and overcome<br />
the obstacles, they could, <strong>in</strong> the best case, as much<br />
as halve the cost of drug development.<br />
The report is divided <strong>in</strong>to three parts.<br />
The Impact of Genomics<br />
The first great advance of the genomics era is <strong>in</strong><br />
technology—above all, the <strong>in</strong>tegration of new highthroughput<br />
techniques with powerful new comput<strong>in</strong>g<br />
capabilities. The new technologies are active<br />
throughout R&D, most immediately at the drug discovery<br />
stage, and promise to enhance productivity<br />
by boost<strong>in</strong>g efficiency.<br />
The stagger<strong>in</strong>g <strong>in</strong>vestment needed to develop a<br />
drug—$880 million and 15 years is the pregenomics<br />
average—could be reduced by as much as<br />
$300 million and two years by apply<strong>in</strong>g genomics<br />
technologies. Productivity ga<strong>in</strong>s would be realized<br />
at every step <strong>in</strong> the value cha<strong>in</strong>. Potential obstacles<br />
abound, however. In particular, two broad challenges<br />
must be met to realize the sav<strong>in</strong>gs:<br />
•Target quality must be ma<strong>in</strong>ta<strong>in</strong>ed. Pursu<strong>in</strong>g new<br />
target classes could <strong>in</strong>volve unfamiliar costs <strong>in</strong>itially,<br />
and these could delay the rewards—though<br />
only temporarily. But to jeopardize target quality<br />
by withhold<strong>in</strong>g that early <strong>in</strong>vestment would be to<br />
risk higher failure rates downstream, and that<br />
would <strong>in</strong>volve far greater costs <strong>in</strong> the end.<br />
• Bottlenecks must be eased. Ow<strong>in</strong>g to the unevenness<br />
of the efficiency ga<strong>in</strong>s at different steps <strong>in</strong><br />
the value cha<strong>in</strong>, the pipel<strong>in</strong>e’s flow will be<br />
impeded at various chokepo<strong>in</strong>ts. If the requisite<br />
action is taken, an even flow should be restored<br />
and the promised rewards should be safeguarded.<br />
The Impact of Genetics<br />
The second great advance of the genomics era is <strong>in</strong><br />
the quantity and quality of data. From the data,<br />
<strong>in</strong>valuable <strong>in</strong>formation about <strong>in</strong>dividuals’ genetic<br />
variation can be extracted and exploited. In pharmaceutical<br />
R&D, genetics will be applied particularly<br />
to two tasks: identify<strong>in</strong>g genes whose carriers<br />
are susceptible to specific diseases (disease genetics);<br />
and subdivid<strong>in</strong>g patients <strong>in</strong> cl<strong>in</strong>ical trials<br />
accord<strong>in</strong>g to variations <strong>in</strong> drug response (pharma-<br />
1. Genomics <strong>in</strong> its narrow sense contrasts with genetics. Roughly, the former concerns itself with the common “standard” genetic makeup, the latter with<br />
the dist<strong>in</strong>ctive genetic makeup of <strong>in</strong>dividuals. But <strong>in</strong> its broader sense, genomics <strong>in</strong>cludes genetics. In this report, the context makes clear which sense is<br />
<strong>in</strong>tended.