PRINCETON, N.C. – Steven Burrill, the CEO of life science venture capital company Burrill & Co., spoke at a recent conference about some of the challenges facing the growth of personalized medicine in the United States and opportunities that could help in its development. Among the things that would change with the growth of personalized medicine is a shift in physicians roles from being determinants to critical advisers.

Burrill was speaking at a conference this week at a biotechnology industry event in Princeton, New Jersey hosted by BioNJ. Personalized medicine, also referred to as genomic medicine, is an approach to medicine in which individuals’ genome profiles are mapped out and assessed so that physicians can tailor the most effective treatment to the patient.

Harnessing the data. Ten years after the human genome project, we have an enormous amount of data but don’t know exactly what to do with it. The cost of getting a personal genomic map is under $200, but for drug developers and pharmaceutical companies, it’s a question of where to start. As a New England Journal of Medicine article points out, they have to determine which genetic markers have the most clinical significance, limit the off-target effects of gene-based therapies and conduct clinical studies to identify genetic variants that are correlated with a drug response.

Genomic medicine is not the norm for medical schools’ curriculum. By and large, medical schools’ curriculum have almost nothing about genomics. Although it is still in the early stages, there is some concern about how long it will take to become mainstream medicine if it’s not being taught now. Genetic interpretation is expected to be a big future specialty for physicians.
Patients as consumers will have the power. Doctors and payers will take a backseat to consumers. Demonstrating an app on his smartphone that he said could give a clinically accurate EKG reading, Burrill said people will be able to use their smartphones and medical information to make smarter decisions about their healthcare. On the downside, they will most likely be paying more for it. Physicians will shift from being the determinants to the critical advisers. Patients will be empowered with real information, just like they are when they buy a car, Burrill said.

The United States is the early technology innovator, but other countries will be the early adoptors. Although the technology behind personalized medicine is led by the United States, the regulatory structure in this country will prevent it from benefiting from these developments before other countries. The U.S. Food and Drug Administration, singled out as the “black hole” of innovation, will have to provide more guidance on how companies can use genomic medicine .

Facebook is the third-largest “country” on the planet. There’s China and India, and then there’s Facebook. If you combine the previous two points, that’s where a big opportunity may lie. About 70 percent of Facebook users are not in the United States. As people get access to their own medical records, and 6 billion people worldwide have mobile phones, there is a great deal of scope for advancement of personalized medicine even if the patient population that gets it first falls outside of the U.S.

Resistance by entrenched stakeholders. The people who benefit from the structure of the healthcare system are likely to resist change. Hospitals, for their part, are concerned over reimbursement.

Too much hype. Burrill conceded that personalized medicine has been overpromised and underdelivered. Given that it’s still very much an emerging field, but holds some exciting prospects, the hype is understandable. Only last week a study published in the New England Journal of Medicine showed that some tumors are essentially moving targets, and even studying a biopsy can miss key genetic mutations that affect how the disease develops in the body. And that could undermine the whole effort of tailoring drugs to patients’ genetic makeups to target the mutations affecting their tumors, at least in some types of cancer.

Cancer isn’t the only area where personalized medicine has scope. But the benefits of the evolving sector could reduce the cost of drug development, make treatments more effective and improve healthcare.

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