A Revolution in R&D
A Revolution in R&D
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