Nik Leist, Senior Director of Ingestible Sensor Manufacturing and Site Leader at Proteus Digital Health, discusses the integration of silicon into ‘digital’ pharmaceutical products.
 

The convergence of digital technologies and healthcare is fundamentally changing the way patients interact with their own health. With greater access to mobile applications and wearable devices, they are actively engaging with their medications. Digital medicines, which are driving this change, open the door for more informed decisions and conversations across the healthcare field.
 

Nik Leist, Senior Director of Ingestible Sensor Manufacturing and Site Leader at Proteus Digital Health, is presenting a keynote session at this year’s CPhI North America Conference. His session, entitled Integrating Silicon with Drugs: Pushing the Boundaries of Pharma Manufacturing with Digital Medicines, underscores the high level of innovation taking place in this area of pharmaceutical development and manufacturing right now. Proteus’ Digital Medicines, oral pharmaceuticals formulated with an ingestible sensor, enable patients and their healthcare providers to see that they’ve taken their medication and at what time, in addition to providing objective information on how the medication is working for that patient.
 

Chemicals Knowledge caught up with Mr Leist to ask him more about his area of expertise. If you are attending CPhI North America in Philadelphia this year, you can hear him yourself on Wednesday 25^th April at 1:15pm.
 

When a patient swallows a digital medicine, the sensor inside the pill communicates the time of ingestion to the wearable patch worn by the patient. That patch then securely sends the information to the patient’s mobile device, and the provider’s portal. This technology ushers in a new era of greater engagement and collaboration between the patient, their physician, family and care team; putting the individual and their data at the centre of the treatment plan. Digital Medicines change the conversation from, “Did you take your medicine, yes or no?” to a conversation in which the patient and provider can discuss medication-taking habits, and assess if the prescribed regimen is really the best course of treatment for that particular patient.
 

The tiny ingestible sensor, the size of a grain of sand, is made of minerals common in our diet: silicon, copper, magnesium, in very small amounts. Silicon, found in foods like bananas and green beans, is coated onto an industry standard gold-plated wafer, along with the other minerals. This wafer gets picked into thousands of individual sensors, which are ultimately integrated with a pharmaceutical that a patient would take like any other medication. When the minerals interact with the patient’s stomach acid, it emits a small, brief signal, like a heartbeat, which is picked up by the wearable patch. Once that process is completed, the sensor becomes part of the regular digestive cycle – like food – and is passed through the body.
 

As mentioned, Digital Medicines come in various solid oral form factors.  Some of these form factors utilize existing manufacturing technology from the pharmaceutical industry to integrate a digital tablet within a drug product. Other toolsets would require minor modification, and the addition of a sensor conveyance module to enable Digital Medicines. The benefit of the latter scenario is that the core skillset required for product realisation on the toolset does not change, and the same skilled personnel can be deployed for a digital product realisation.
 

Ingestible sensors are globally scalable today, with an existing scale of 100 million+ units, and plans for billions already in place. Future partnerships with global pharmaceutical companies will require a bi-partisan approach where we work together to customize the software and analytics to meet the needs of the pharma company, and most importantly, those of the patients in target treatment areas, and their healthcare providers. Once the partnership is in place, Proteus supplies the ingestible sensors, and the pharmaceutical company embeds the technology directly into their pharmaceuticals at point of manufacture.
 

The ingestible sensor and wearable patch were originally approved in 2012 by the FDA through the Center for Devices and Radiological Health via a de novo pathway for low-risk medical devices. Embedding the ingestible sensor directly into pharmaceuticals require a New Drug Application, such as the one we achieved with Otsuka Pharmaceutical’s ABILIFY MYCITE.
 

We’ve been seeing a trend in which consumers are demanding to be in control of their own data, particularly when it comes to their healthcare. As this revolution continues, the key to success will be ensuring patients are at the centre of every product design. This means that digital health programs will need to be secure, easy to use for the average patient, and the path for treatment must be clear to maximize the benefits of the program. If we create products with anyone but the patient in mind, adoption will be severely limited, and the product’s benefits won’t reach full potential.
 

Manufacturing is very much a hands-on job, both on the assembly line and the planning room, and it’s very exciting to work directly on something that no other company has ever made. Every day presents a new opportunity to take existing technology and transform it to meet the needs of the product in ways that may have never been considered.

Proteus is dedicated to empowering and improving patient lives. There has been some concern regarding patient privacy, so I’d like to note that our product is designed with security and safety in mind, and we only share data if a patient has provided consent. There is no geo-location functionality in the products that could be used to physically track the patient, and participation in a Digital Medicines program is completely voluntary. Our ultimate goal is to facilitate a more open dialogue by providing objective information on medication-taking behaviours and physiologic metrics and give physicians better clarity to inform decision-making, and ultimately help patients achieve their health goals.