Abstract
The application of pharmacogenomics in drug development is widespread today,
in differing degrees of intensity. Indeed, industry leaders have stated that:
"Pharmacogenomics is now an integral part of drug development. It is an
emerging part, but it is already taking place within all the drug companies."
The focus of pharmacogenomics is currently selecting targets that are
validated from a genetics perspective before looking into the entire genome,
attacking attrition early in development (Phase I and II), addressing adverse
reactions in Phase III, and supporting a standardized system of post-launch
surveillance with regulatory oversight.
Addressing attrition earlier in the drug development process can have a huge
impact on development cost. Indeed, moving just 10% of Phase III failures to
Phase I reduces the average total cost of developing a drug by $98 million.
There is considerable concern in the industry, and on Wall Street, that the
net impact of the introduction of pharmacogenomics will be negative. Yet, the
economic and the logistical arguments for not implementing pharmacogenomics
are not sound. The average sales of a conventional drug are approximately $63
million lower than for a pharmacogenomics-developed drug.
Assuming a 30-year revenue lifecycle, the Net Present Value (NPV) of the
pharmacogenomics drug is approximately $85 million higher than the
conventional drug.
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