Sean Tunis, Former Medicare Guru, on What Biotechies Gotta Do the Next Five Years

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that you’d use a placebo comparison. Now we’re looking at active comparators in Phase II. You will actually have to show that you’re better than something, not better than nothing.

There’s a lot more attention being paid of patient-reported outcomes, and quality-of-life metrics. The FDA may not be interested in it, but the payers definitely are. There’s some interest in looking at trials that incorporate biomarkers, and being able to identify populations that have particularly favorable responses, or high risk of toxicity that you want to eliminate. There’s a lot of attention being paid to potentially responsive subpopulations.

X: It’s interesting you raise biomarkers. A lot of scientists are skeptical of it, the work hasn’t borne as much fruit as people would like, in terms of being able to really stratify patient populations. Do you think the new economic reality is really going to drive a more intensified focus on personalized medicine?

ST: I do. Up until very recently, the economics of the pharmaceutical industry have made them not very interested in subpopulations. Financially, you do better with the largest possible patient population. That was correct as an economic assessment. It’s not correct now for a product that’s three to five years from the marketplace. The ability to improve outcomes at lower cost will depend on biomarkers and subpopulations. I think the science will advance more quickly once the incentives are really there to advance it more quickly.

X: Are there any other kinds of products that you think will flourish in this new environment, besides drugs and devices? Maybe health IT or wireless applications, things that provide real-time data streams between patients and doctors?

ST: There’s a lot of technology that will be supportive of care outside the hospital, home-based care, remote-monitoring stuff. More real-time, continuous communications between patients and physician offices that could, particularly with chronically ill patients, flag important developments that suggest a clinical issue arising. Chronic disease management supportive technology has a lot of promise.

X: Is there a certain field of technology you think is really poised to grow, given the way we’re going to pay for health innovation?

ST: I definitely think the molecular diagnostics for sure, and diagnostics in general. Nuclear imaging is poised for growth. There will be more spending on diagnostics when the value proposition shows it can really reduce costly interventions later. The IT stuff in the cardiovascular disease space, in terms of remote monitoring, there’s room to grow there. Anything in the diabetes area, particularly anything that helps with early identification of patients who are at risk for getting diabetes. The whole Alzheimer’s diagnostics and therapeutics area has a lot of potential.

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2 responses to “Sean Tunis, Former Medicare Guru, on What Biotechies Gotta Do the Next Five Years”

  1. Darren says:

    Tunis is a fraud who was fired from the Bush administration for falsifying documents and then disobeying subpeonas. He gets his funding from health insurers with the goal of restricting new technology. His whole motive is to control medicine as a beltway bandit.