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Most other industries have already been transformed by using the computers in people’s hands—mobile phones—to make regular activities like shopping, entertainment, and managing finances easier, more accessible and real time. Now healthcare is experiencing its own digital transformation.

Nik Leist
Senior Director of Ingestible Sensor Manufacturing and Site Leader at Proteus Digital Health

Every day, there is a new idea and a new way of helping patients manage and overcome their illnesses. Companies are looking to collect and leverage data that can personalize health treatments and enable patients and healthcare teams to manage health issues with new digital offerings and therapeutic options. Healthcare providers have begun to embrace the power of these powerful products, but pharma, for the most part, has been missing out.

With healthcare trending towards patient data, personalized therapy, and greater access to care, there is an opportunity to develop effective digital solutions for pharma products that will revolutionize the industry. Digital medicines fill this void by enabling patients, and with their permission, their healthcare team, to keep track of their ingestions while also capturing their physiologic behaviors. 

This groundbreaking technology aligns with current industry trends providing solutions for patient data access, and enhancing the ability for healthcare teams to objectively rotate, titrate, and eliminate medications to reach patient goals. This not only helps establish product value, but also enables broader access to medical care via remote solutions.

If patients have the access and knowledge to keep track of their health from the comfort of their own homes, they are more likely to be engaged with reaching their health goals. Doctors, having the ability to see how their patients are doing with their health, such as their maintenance of blood sugar levels, or taking their medications, can remotely support their patients when it is needed the most and objectively define a healthcare plan that best enables the patients to reach those goals. The result is more effective treatments, and better outcomes.

Pharmaceutical Impact

Pharmaceutical companies already have a great foundation integrated in the adaptation of products to realize business outputs. Digital medicines leverage this mindset by providing the next wave of technological advancement from which a pharmaceutical drug manufacturer can deploy from early fast-to-fail development programs, phase III-IV clinical trials, all the way into commercialization. 

During new drug development, digital medicines can help enable pharma companies to prove out effectiveness, and employ a closed loop feedback system through the design phase cycles. Digital medicines can be used to reduce development costs through the use of wirelessly observed therapy, versus directly observed therapy, and patient feedback.

In the existing product space, the pharma industry can create proprietary solutions integrating FDA-approved ingestible sensors into FDA-approved and established medicine, creating digital medicines. This approach leads to extended product lifecycles, and improved outcomes. A major output of digital medicine products is in the ability to track ingestions tied to patient responses. This data, observed together as improved outcomes, enables value-based payer contracts that can be automatically verified.

Today, companies like Otsuka and Novartis have identified the potential benefits of innovative digital technology and have already begun to take part in the health revolution.

Adapting by Design

The power of digital medicines is not only in the outcomes it provides but also in the ability of the product to scale within the technology platforms of today’s pharmaceutical products. The ingestible sensor design leverages high-volume processes developed in semi-conductor manufacturing to realize digital medicine scale-up from millions into billions. 

The sensor is then established into various solid oral form factors utilizing existing pharmaceutical technologies integrated with sensor conveyance to realize final digital products. This approach leverages the unique skillsets of technicians, scientists, and engineers in the pharmaceutical industry for drug formulation and product realization, while adding a revolutionary technological advancement to new and existing medications.

Consumers all over the world have come to embrace technology as a means for getting things done faster, easier, and more efficiently. Healthcare is no different. Patients and providers are embracing digital tools to enhance care, expand access to treatment, and improve communication with patients. The pharmaceutical industry now has the opportunity to leverage the data provided by these digital tools to verify the effectiveness of medications in real-world scenarios, all while reducing development cost and expanding product life-cycles.  

The digital revolution is here, it’s just a matter of adopting, adapting, and advancing.

Nik Leist will be presenting a keynote address, "Integrating Silicon with Drugs: Pushing the Boundaries of Pharma Manufacturing with Digital Medicines," at CPhI North America, on Wednesday, April 25 from 1:15 - 2:00 p.m.

(Source: Proteus Digital Health)

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