“It's so hard to recruit and retain patients for trials today that companies can't afford to require site visits for drug administration. Our solution provides the convenience of home injections with the high quality data of a site-administered protocol,” Alex Dahmani, co-founder and CEO of QuiO, told Outsourcing-Pharma.com.
The digital healthcare company's Smartinjector™ device and connected software platform is a reusable handheld device loaded with a single-use syringe containing a dose of an injectable therapy, either filled by the patient prefilled by the manufacturer.
The company is currently finalizing development and plans to submit its first 510(k) and to run a pilot in parallel, so regulatory clearance and real-world data will be ready for a full product launch next year.
Dahmani explained that contract research organizations (CROs) can use the device to monitor injection events remotely if the trial uses a compatible syringe. However, if the injectable is in a syringe outside the 510(k) clearance, companies can still use the device by including it in the IND application.
“Our device is a general use injector, so it can be deployed by pharma, payers, or providers across multiple injectable therapies,” explained Dahmani. “That means customers can easily deploy and test our product, as opposed to competing devices that are combination products and need to be approved with a specific therapy before being deployed.”
While the device can be used with multiple therapies, Dahmani explained that biosimilars are an important market for QuiO.
“Our current discussions with pharma are focused on branded injectables, but we do plan to engage biosimilar manufacturers in the near future,” he added. “We believe our devices and software can differentiate a biosimilar from the generic competition, and even help achieve a price closer to the branded biologic.”
The company has multiple proprietary devices, including a pen that is currently under development.
“Once we demonstrate the value (improved adherence and outcomes) of our solution through the pilot, we expect pharma to be interested in applying this approach (connected hardware, software, data) across their injectable portfolio,” said Dahmani.