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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 />

59

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