Experts discuss challenges, promises of personalized medicine

Personalized medicine holds tremendous promise for drugmakers, clinicians and patients alike--the market is estimated at about $232 billion and is projected to grow 11 percent annually, according to a PriceWaterhouseCoopers' report.  But it also presents players with opportunities and challenges--both on the commercial and regulatory fronts.

These challenges and opportunities were discussed recently at a meeting of the Tech Council of MD in Rockville, Maryland. Chris Wasden, a managing director with PriceWaterhouseCoopers, discussed one such opportunity--the use of an iPhone application to collect patient data during a clinical trial. This would let patients to upload their health information to a cloud, allowing researchers to monitor their progress and be on the watch for adverse events. The unanswered question is how the FDA might regulate this and similar applications

Personalized medicine has also given rise to innovative approaches by biotech companies. For example, Eric Rowinsky, CMO of Champions Biotechnology, discussed his company's preclinical platform through which human tumors are implanted in immune deficient mice, followed by propagation of the resulting xenografts in a way  that preserves the biological characteristics of the original human tumor. Champion believes that these tumorgrafts closely reflect human cancer biology and their response to drugs is more predictive of clinical outcomes in cancer patients.

Pfizer and other big pharma companies, are increasingly recognizing the value of partnering with diagnostic companies. Last month, Pfizer entered an agreement with DxS, a unit of Qiagen, to develop a companion diagnostic test kit for PF-04948568 (CDX-110), an immunotherapy vaccine in development for the treatment of glioblastoma multiforme. Stephen Little, Qiagen's VP of personalized healthcare, said such partnerships are smart, as the drug and diagnostic can be tested together. This spares the diagnostic company from spending a fortune on a separate trial.

CDER's Janet Woodcock agreed with Little, as partnering would allow the drug and diagnostic to be approved at the same time. She urged drugmakers to look into such partnerships; with drug development costs go up, companies can now more than ever ill-afford to produce drugs with little to no clinical benefit. - Liz Jones

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