A Revolution in R&D
A Revolution in R&D
A Revolution in R&D
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Methodology<br />
The many diverse studies on drug development<br />
have reached diverse conclusions. They have put<br />
the current price tag at anywhere between $350 million<br />
and $800 million per drug (all underestimates,<br />
<strong>in</strong> our view: our own calculation is $880 million).<br />
Not surpris<strong>in</strong>gly, when it comes to the likely impact<br />
of genomics and genetics on the economics of drug<br />
development, op<strong>in</strong>ions diverge aga<strong>in</strong>.<br />
For our study, we conducted an extensive program<br />
of discussions <strong>in</strong> an effort to compile accurate figures<br />
for all the ma<strong>in</strong> activities <strong>in</strong> the R&D process,<br />
both pre- and post-genomics. The result is a robust<br />
bottom-up model of R&D, based on the time, cost,<br />
and likely success rate for each step of the value<br />
cha<strong>in</strong>.<br />
Our model goes beyond exist<strong>in</strong>g models of R&D <strong>in</strong><br />
three important ways:<br />
• It is the product of primary research. Other estimates<br />
have tended to build on the f<strong>in</strong>d<strong>in</strong>gs of earlier<br />
work; our model also draws on more than 100<br />
discussions at nearly 50 companies and academic<br />
<strong>in</strong>stitutions.<br />
• It analyzes the discovery phase more closely than<br />
has previously been possible. Earlier models typically<br />
assigned a conjectural figure to represent<br />
the sunk cost of discovery, but the art of discovery<br />
is becom<strong>in</strong>g <strong>in</strong>dustrialized, and we have duly<br />
been able to model its activities more scientifically.<br />
A more detailed understand<strong>in</strong>g of the economics<br />
of discovery has resulted, and that <strong>in</strong> turn<br />
has allowed us to more accurately quantify the<br />
impact of genomics on R&D. (See the chart on<br />
page 60 for technologies modeled.)<br />
• It is activity-based and flexible. The numbers<br />
cited <strong>in</strong> this report represent an average drug,<br />
unless noted otherwise, but <strong>in</strong> our research we<br />
ranged far wider than that, and assessed each step<br />
of the value cha<strong>in</strong> under a range of circumstances.<br />
So the model allows for scenario build<strong>in</strong>g<br />
and sensitivity analysis, as well as enables us to<br />
tailor <strong>in</strong>puts to match the unique circumstances<br />
of <strong>in</strong>dividual companies.<br />
As already mentioned, all numbers cited <strong>in</strong> the text<br />
are for an average drug. In any <strong>in</strong>dividual case, cost<br />
and time will vary accord<strong>in</strong>g to factors such as therapeutic<br />
area and target class.<br />
All numbers cited <strong>in</strong> the text are for a relevant<br />
drug, that is, one to which the technology under<br />
discussion could be applied. Various technologies<br />
may not apply to all targets or drugs. Where specific<br />
limitations are likely to be a significant factor, that<br />
is po<strong>in</strong>ted out.<br />
When we discuss the “value added” to a drug, we<br />
are referr<strong>in</strong>g to its net present value: the current<br />
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