Imagine you were told that one day you’d be able to take a personalized, digital and trackable drug with real-time data insights about adherence, absorption rate and efficacy. That was part of the conversation in 2000 at the height of the dot-com bubble and when genomics and personalized medicine seemed to capture investors’ imaginations – and led to a gold rush mentality with all the financial speak of picks-and-shovels investment thesis. Healthcare market historians recall the details well, but most of us have moved on and are more interested in the latest version of the iPhone and all its functionality. We might even be secretly concocting the next killer app on Apple’s HealthKit. While much of the early promise of personalized medicine appears to be the equivalent of unicorns in the market, it’s quite possible that our linear mindset obfuscates our ability to notice the exponential nature of meaningful advancements in healthcare (for example, minimally-invasive surgery and robotics).
It’s as if time has compressed in the last five years as innovations hit the market. That drug that seemed but science fiction fifteen years ago is actually closer to reality than many realize. Proteus Digital Health, founded in 2001, is focused on digital medicine therapy of “… drugs that communicate when they’ve been taken, wearable sensors that capture physiologic response, applications that support patient self-care and physician decision making, and data analytics to serve the needs of doctors and health systems.”It sounds familiar. Think of it as a smart drug. For its wearable and ingestible sensor devices, Proteus Digital Health won approvals by the Food and Drug Administration in the United States and a CE mark in Europe. In early September 2015, Proteus and Otsuka Pharmaceuticals jointly announced their submission of Abilify for schizophrenia combined with an ingestible sensor as a new drug application. Now, that’s new!
While Otsuka Pharmaceuticals first received approval for Abilify in 2007, the combination drug will still undergo an approval process of its own. With science fiction now nearer, the obvious question has to do with payer disposition to reimburse for such a novel product. Additional questions get layered. What does it say about the right course of action at the appropriate cost? What if payers prefer this route over traditional mechanisms? Will drug companies more willingly adopt the practice of and pursue the combination of their drugs with sensors? Personalized medicine takes on a new meaning. We may move beyond the discourse around adherence and remote patient monitoring. How do we think about the effect on clinical trials and our ability to peek at a blinded sub-group level for efficacy and perhaps accelerate or even eschew a drug’s market entry? That’s when the fun begins. If Moore’s Law holds in terms of how quickly technology advances, we need to think differently. Get ready for the shifting landscape in healthcare. It’s actually been shifting under us all along.
 Proteus Digital Health LinkedIn page
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