Smart-pill technology could monitor patient compliance while improving clinical trial data quality
Many pharmaceutical company leaders think they can change the face of health care, but Andrew Thompson is absolutely positive of it.
Thompson is president and CEO of Proteus Biomedical, a Redwood City, Calif.-based company that has developed a microchip that attaches to a pill, which, when ingested, communicates with a patch on the body, thus creating the potential to exponentially increase patient compliance in clinical trials and beyond. Many drugmakers—especially those already working closely with Proteus—are excited about the company’s smart-pill technology.
If all goes as Thompson plans, these smart pills could greatly reduce reliance on patient diaries during clinical trials, as sensor technology would tell those conducting a trial whether patients took their meds, and when. If a dose is missed, they would be informed and could then remind the patient. Data quality could skyrocket as a result.
But that’s not what Thompson finds compelling. He downplays the chip’s potential to merely improve compliance statistics, and instead points to the far more expansive plans he has for the chip and patch combination.
“This not just a compliance tool,” he said. “Our platform can be used as a way to expand the definition of what a pharmaceutical product actually is. What we’re doing is medicine combined with information, education and motivation, making use of the mobile Internet.”
Thompson explained that the patch, with which the chip communicates, not only is able to tell if and when a person ingested his medicine, but also picks up real-time information such as heart rate, respiration, body angle, temperature and sleep status. When the patient is within 30 feet of a mobile device such as a cell phone, this information is transmitted to wherever the patient would like it to go: to his computer, his children’s phones, his doctor’s office, or an investigative site—it’s up to him.
“It’s extremely useful to be able to verify with a very high level of specificity, using a digital signal, exactly which pill was ingested,” said Thompson. “Then, since we’re able to correlate that with other information about the person’s physiology, we can start to look at how they’re responding to the drug.”
In January 2010, Swiss drugmaker Novartis paid $24 million in upfront cash and equity as part of an exclusive worldwide agreement to license Proteus’ sensing technology for drugs for organ transplantation—an area in which strict compliance is critical. If a patient misses even one dose of medication, the organ can be rejected.
Also as part of the deal, Novartis received option rights in cardiovascular and oncology product applications, as well as rights to use Proteus technologies in its clinical development of pharmaceutical products. Thompson said Proteus is also working with other pharma companies, but those deals have not been disclosed.
“We’re working with proven medicines, building frameworks around a drug,” he said. “It’s about a full level of engagement and empowerment” for the person taking the drug.
When will any of this be ready? Novartis did not respond to a request for an interview. Thompson said the timing is unclear, but it’s getting closer. “We have a clear sense that there will be medicines developed using the tools that will be coming in front of the FDA relatively soon,” he said.
Thompson said Proteus has three years of human data showing that its technology works. That includes a pilot project the company undertook with Novartis using 20 patients on Diovan for high blood pressure. Results showed that compliance improved from 30% to 80% after six months.
But Thompson is excited to take the technology much further than that. He wants the feedback that comes from the patch, which he calls the “Band-Aid,” to enable patients to see the state of their health from minute to minute, and to then be able to take steps to improve it. “We personalize the whole experience around the medicine,” he said. “I think we’re the only pharma company that does design ethnography.”
Right now, for example, Proteus is closely following truckers, as this demographic has a very high incidence of diabetes. The company is trying to understand why this group is at higher risk than most, and then will devise ways to help them help themselves. Thompson said it’s ironic how well-maintained the trucks are, as compared to the drivers. “Those 18-wheelers are monitored out the wazoo; they’re never going to break down,” he said.
The hope is to soon monitor people with the same level of depth and intensity, or rather, to enable them to monitor themselves. But what will this cost? Not that much, said Thompson. The chips cost a few pennies per pill and the patch costs about $1 per day.
It will involve thinking about medications differently, said Thompson, and it will involve educating the public. He’s talking to a large consumer electronics chain about the possibility of lending its in-home tech support concept to educating people about how to use the smart pill/patch at home. He’s also in talks with a national pharmacy chain, as he acknowledges that much of the educating will need to take place with a pharmacist.
“A way to think of this is: a drug to Proteus is like a song is to Apple, it’s just content. But Apple makes the content very, very accessible,” Thompson said. “That’s what we’re doing.”