Proteus CMO talks regulation hurdles, future plans for digital pill

By Dave Muoio
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It’s still the early days, but the FDA’s approval of Proteus Digital Health and Otsuka Pharmaceuticals’ Abilify MyCite has changed the discussion of digital technology in healthcare. The first approval of drug delivery via a sensor-equipped pill sparked debates over the tradeoff of privacy for medication adherence, and whether these types of technologies would find a role in future healthcare.

Speaking at HIMSS18, Proteus cofounder and Chief Medical Officer Dr. George Savage recalled the early development and regulation challenges his company faced in developing the novel drug delivery technology, with the very first hurdle being the logistics of developing a safe, ingestible pill like any other.

“For it to have very wide application, it had to be safe,” Savage said during a session. “To start with, the parts list was limited to essential dietary minerals, things that have to be in your diet already. So, the in-total exposure to the device is a bit of silicon, a bit of magnesium, and copper, all three of which you need already, and physical size had to be smaller than what is in your diet already. The idea was to try to make it intrinsically safe as a requirement, and then of course we had to prove that.”

Savage said that his company began courting the FDA as early as 2008. Seeking approval for their pills as a new type of medical device, however, proved a challenge as well.

“The first issue with FDA was that they didn’t really know how to regulate it, and technically the device doesn’t fit the legal definition of a medical device,” he said. ‘I’ll never forget the first meeting with a medical officer, where he looked at me and said ‘the problem with your product is it doesn’t do anything.’ If you think about it, it gets wet and sends a number. That doesn’t diagnose or treat a condition or alter the structure or function of the human body, so by itself that doesn’t meet the definition of a medical device.”

Savage said that his company overcame the confusion by shifting the focus of their regulatory discussions from the tech itself to the medical benefits it could provide, such as improved medication adherence and better informed physicians. Proteus’ pill was eventually cleared by the FDA in 2012 and — following a rejection in 2016 stemming from concerns over the accompanying app and other “human factors” — was approved alongside Otsuka’s treatment via a New Drug Application for a drug-device combination product.

While the approvals certainly give Proteus some clout, Savage said the FDA clearances were mere “table stakes” compared to the larger challenge of proving their technology to the industry.

“What we’ve done is create an information flow that resembles the hospital, so now we can link cause and effect,” he said. “Many digital health companies are doing cool things on the sensor side but, to take an engineering term, that’s open loop [so] I don’t know what the actuator is, what the patient is doing therapeutically. Here, we’ve managed to close that loop, which is extremely gratifying for us, but now we need to demonstrate to a world where nobody does this … that they should care, and it makes a difference.”

Already, many providers have shown that they’re open to Proteus’ pills, Savage said, but are concerned that the benefits of this new approach could be stemmed by increasing complications to their workflows. Savage said that the concern is understandable, but can be addressed with proper implementation and deployment within care centers.

“Most [doctors] are very intrigued by the technology, and then a little more challenged in how to fit this in your busy day,” he said. “Having access to the data can become addictive for the doctors. The key is to craft a use case where you aren’t just adding more burden — the burden of liability, the burden that somehow I have to check this everyday.”

Abilify MyCite is currently indicated for schizophrenia and bipolar disorder, and Savage said that Otsuka is planning to begin rolling out the medication at-large this spring. Beyond mental health, Savage said that the company hopes to move into partnerships that would allow them to deliver infectious disease and oncology medications using the sensor-equipped pills. Further down the line, the company’s ultimate goal is to establish itself well enough across the industry that the platform’s other, non-adherence benefits become explored at the wider scale.

“We’re hopeful that digital medicines [become] a standard of care in several therapeutic areas, and [make] inroads in others,” he said. “[We hope] that there are many pharma partners incorporating this into established medicines and finding new uses for those medicines, finding ways to enter into value-based contracts, … beginning to find other interesting data points, real-world comparative effectiveness … so you start to move from the widget [and] immediate adherence-related effects to now being able to mine the data to move on to the next level of digital innovation.”

Until then, Savage had some advice for other digital startups hoping to introduce novel ideas into healthcare: don’t give up when your vision doesn’t work in “storybook fashion;” view other digital companies in your space as allies working toward a common goal; and always put the patient’s welfare first and foremost.

“That’s why we all went into medicine. Rather than following reimbursement incentives or regulatory pathways because, well, that’s the way the world is — those things are supposed to serve better patient care, not the other way around,” he said. “So focus on the patient, keep doing good science, and then you can change all of that other stuff, even though admittedly it takes longer than you’d think and is hard work.”

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