The concept of swallowing microchip-embedded pills that are activated by stomach acid to transmit data Novartis.. But it could go from concept to market quite quickly, predicts Swiss firm
In January, Novartis committed to spending $24 million on the smart pill technology developed by Redwood, Calif.-based Proteus Biomedical. This week, the company projects that it will seek regulatory approval--at least in Europe--within 18 months.
"We hope within the next 18 months to have something that we will be able to submit to the regulators," global head of development Trevor Mundel told the Reuters Health Summit in New York this week. "The regulators all like the concept and have been very encouraging. But...they want to understand how we are going to solve the data privacy issues."
The silicon and metal sensor, which sends data via a faint radio signal to a patch on a patient's skin that then transmits the information wirelessly to a designated smartphone, e-mail account, etc., is first being studied in a drug for transplant patients that helps avoid organ rejection.
Since the drug itself is already approved and established, Novartis might be able to forgo clinical trials and simply conduct bioequivalence tests to show the second-gen pills have the same effect as the originals. (The main difference being that the patient now has a microchip to pass.)
The technology, initially envisioned to monitor whether patients take their meds in the right doses at the right times, could conceivably work with many different drugs to track a wide range of data, including heart rate and body temperature.