![]() A phenomenal accomplishment: compare the current forecast of whole genome sequencing for $1,000 or less with the $3 billion price tag on the Human Genome Project completed in 2003. This industry provides genetic data to the public relatively inexpensively. ![]() This third wave comes as we are experiencing a precipitous drop in the price of both genetic sequencing and computing power and memory that has led to the nascent personalized genomics industry. The third, present effort aims to provide precise diagnoses and highly directed treatments based on genetic data. The second, ongoing effort, still too young to evaluate, proposes using genome-wide association studies (GWAS) to investigate genetic sources of complex and often chronic diseases, or in some cases to suggest alternative or more specific uses of a drug. The first attempt entailed finding drug targets within what was largely an unannotated sequence of genetic code. This current incarnation of personalized medicine, however, may perhaps be best thought of as a third attempt to monetize the successful sequencing of the human genome. The concept of personalized medicine isn’t novel orphan drugs, those medicines with very narrow labeling that encompass only a sliver of the population, are in essence a form of personalized medicine, but without all the fancy recent “-omics” innovation driving current efforts in that direction. Patients are required to take a genetic test to determine whether their cancer is HER2 positive before they can be prescribed the drug. ![]() Personalized medicine promises to increase efficacy in subpopulations of patients, providing opportunities to revive defunct or failed drugs with new, narrower indications and minimizing adverse drug reactions among those for whom the drug is no longer indicated.Ī recent example of a personalized medicine drug passing FDA standards is Perjeta, approved for use in combination with Herceptin (itself a personalized treatment specifically approved for use on patients with overactive HER2 receptors) and docetaxel chemotherapy to create a comprehensive blockade of human-epidermal growth factor receptor (HER) signaling pathways for the treatment of HER2-positive metastatic breast cancer. The current bleak economic forecast for biopharm notwithstanding, there are powerful incentives drawing drug companies into this new method of drug development. That industry is eager to exit a particularly difficult innovation slump that also coincides with a “patent cliff,” i.e., the expiration of many patents for blockbuster drugs that heretofore limited generic competition in exceedingly lucrative markets. With more than 70 drugs that may be classified as “personalized” already on the market, this new paradigm in drug development may become a real force in the biopharmaceutical industry. Personalized medicine can be succinctly described as the right dose of the right drug for the right indication for the right patient at the right time, the antithesis of the former blockbuster one-drug-fits-all approach.
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