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A Revolution in R&D

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60<br />

value of expected profits, discounted by a representative<br />

hurdle rate, less the cost of develop<strong>in</strong>g the<br />

drug. For the average drug, we assume peak annual<br />

sales of $500 million and 11 years to patent expiration.<br />

Also, our numbers reflect the fact that R&D<br />

Post-genomics Pre-genomics<br />

GENOMICS TECHNOLOGY ASSUMPTIONS<br />

Biology<br />

Target ID Target Validation<br />

Target identification<br />

• Limited numbers of genes<br />

• Molecular biology and biochemistry<br />

techniques<br />

Target validation<br />

• Cell and tissue studies<br />

• Mouse knockouts<br />

Target identification<br />

• Large numbers of genes<br />

• Industrialized techniques<br />

(e.g., gene chip expression)<br />

• Bio<strong>in</strong>formatics<br />

(e.g., database searches for homologies)<br />

Target validation<br />

• Cell and tissue studies<br />

• Mouse knockouts<br />

SOURCES: BCG analysis; <strong>in</strong>dustry <strong>in</strong>terviews; scientific literature.<br />

dollars saved are pretax dollars; these “saved” dollars<br />

are subject to taxation, which expla<strong>in</strong>s <strong>in</strong> part<br />

why the expressed NPV calculations can be lower<br />

than the R&D sav<strong>in</strong>gs.<br />

Chemistry<br />

Screen<strong>in</strong>g Optimization<br />

Screen<strong>in</strong>g<br />

• Parallel synthesis for library design<br />

• Assay development for high-throughput<br />

screen<strong>in</strong>g (HTS)<br />

• HTS<br />

Chemical optimization<br />

• Bench synthesis<br />

• Parallel synthesis<br />

Screen<strong>in</strong>g<br />

• Structural biology (target structure)<br />

• SAR profil<strong>in</strong>g of library<br />

• Assay development for LTS1 • Virtual screen<strong>in</strong>g and LTS1 Chemical optimization<br />

• In silico-supported bench synthesis<br />

• In silico early ADME/tox<br />

1 LTS = LOw-throughput screen<strong>in</strong>g; generally more <strong>in</strong>formation-rich, but less standardized, assays that cannot be used <strong>in</strong> HTS.<br />

Development<br />

Pre-cl<strong>in</strong>ical Cl<strong>in</strong>ical<br />

Precl<strong>in</strong>ical (ADME/tox)<br />

• Animal test<strong>in</strong>g<br />

Cl<strong>in</strong>ical<br />

• Patient trials<br />

Precl<strong>in</strong>ical (ADME/tox)<br />

• Animal test<strong>in</strong>g<br />

• In silico ADME/tox<br />

• In vitro toxicology<br />

• Surrogate markers<br />

Cl<strong>in</strong>ical<br />

• Patient trials<br />

• Surrogate markers

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