Mind to Market

Thursday, October 25, 2007

Moving Forward with Personalized Medicine

A recent article in Genetic Engineering News highlights the progress Personalized Medicine is making in the healthcare environment and some obstacles that still must be overcome. Although the FDA and health insurance companies are beginning to open up to the possibilities of personalized medicine, this is far from being a common medical practice.

The one shining success in PM is the ability to distinguish between different types of breast cancer based on the expression of the HER2 gene. The results of this test indicate which therapy will provide the best treatment for the patient. One reason for this success has been an absolute convergence between diagnostic testing, devices, drugs and information.

The realization that the current model for drug development will not yield profits when applied to the smaller populations served by PM therapies is beginning to sink in. Yet no viable alternative business model for pharmas exists. There is the thought that PM is still in its infancy, that the blockbuster model still has a few more years left in it. Pharma is trying out some innovative new business models but no clear success has been achieved.

There are also regulatory hurdles to overcome. Very few FDA guidelines for clinical trials of PM therapies exist. PM is also going to require some very highly integrated information systems, combining the whole of the biomedical knowledge base with the patient's own electronic record.

Consensus is that PM will be the norm by 2020 if all stakeholders; regulators, policy makers, and private industry can work together on it. The benefits are compelling but the obstacles daunting.

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