Features
July / August 2019

Improving Pharmaceutical Connections with Patients
Jen A. Miller
Improving Pharmaceutical Connections with Patients cover

Being on the cutting edge of drug development is the goal of most pharmaceutical companies, but a new drug won’t work if the patient doesn’t take it. It’s a vexing problem that developers of healthcare technologies hope to address.

An overview of such technologies was provided during the “Digital Health: Opportunities and Challenges of Transformed Healthcare Delivery” session at the 2018 ISPE Annual Meeting & Expo. Pharmaceutical Engineering followed up with the session presenters to continue the discussion about the technological changes underway to improve patient care.

“There’s a growing trend in the pharmaceutical industry to offer other services or value beyond a pill,” said Kevin Sooben, Digital Health Program Lead at AstraZeneca. Such services can help deliver results to patients. Digital opportunities include diagnostic, decision support, self-management, optimized treatment, and dynamic dosing tools.

New technologies can make a difference in helping patients. Even where there may be pharmaceutical treatments for disease, improving patient health can still be a challenge, said Sooben. As an example, he cited diabetes mellitus: despite major innovations in treatment, the disease remains a public health crisis, with 1.5 million people in the United States being diagnosed every year1 .

Added services—and value—are now available in the form of smart technology that is used in tandem with pharmacological products, either to get a better picture of the patient’s health status, activities, and lifestyle or to simply remind the patient to take their medicine. Artificial intelligence (AI) is positioned to take these strides to the next level.

Even where there may be pharmaceutical treatments for disease, improving patient health can still be a challenge.

The Promise of Smart Devices

The widespread use of smart devices like phones and watches may revolutionize both personal health management and communication between patients and providers. Sooben noted that in 2017, IQVIA, a healthcare data science company, reported that about 200 health apps were being released each day to join the more than 300,000 health apps available around the world; at that time, nearly 350 wearable smart devices were on the market2 .

A smartphone or smartwatch “can do a lot with respect to trying to nudge people to manage their medications and provide behavioral change messages and education information,” said Sooben. “It’s a way for data to flow from the patient to relevant other parties involved in that patient’s care and can also send contextual information back to that patient.” In his presentation, he noted the intersection of value trends in healthcare delivery that is helping to drive this potential: Patients are increasingly becoming “active and confident participants in their own treatment and more data is being made available to them than ever before.” Also, the relationship between patients and healthcare providers is changing, with remote monitoring offering opportunities for improved treatment adherence, health outcomes, and patient identification, and payers are open to exploring more patient-centric delivery models that increase quality of care and reduce care costs.

Smart technology can go a step further if the smart device is linked to a connected item, like a connected pill bottle or device injector. Such technology can be used “all the way through being able to collect medical information that captures medical data that you can use to help patients deliver or decide what to take and when to take therapy,” Sooben said.

Remote Patient Monitoring

Remote patient monitoring, where patients don’t necessarily need to go to a physician’s office or hospital, offers exciting opportunities for better care. For example, it could help in treating patients in rural areas, where access to primary care and other services, such as obstetrics, can be especially challenging3 ,4 . (Telemedicine is another area of technological innovation that can expand the reach of patient care5 .)

An example of a remote patient monitoring system that points to the potential of smart devices in pharmaceuticals is Turbu+, a Symbicort inhaler from AstraZeneca. The inhaler is Bluetooth-connected to an app on a smart device, which reminds the patient to use the inhaler, sends motivational messages, tracks adherence, and provides the patient’s physician with data about actual medication use that can be used to inform clinical decision-making.

Sooben reported that Turbu+ has 2,900 patients enrolled in eight countries and, so far, AstraZeneca has found significant improvement in both adherence and the participants’ control of allergic rhinitis and asthma test (CARAT) scores.

“It’s an example of how an existing pharmaceutical delivery device can be combined with an add-on device to provide feedback to the patient and their providers, leading to improvements in the patient’s condition,” Sooben said.

The second example cited by Sooben is Moovcare, a web-mediated follow-up app for patients with lung cancer developed by Sivan Innovation6 ,7 , 8 . Moovcare allows patient-reported symptom data to be sent immediately to the oncology care team so physicians can better manage and support patients in a timely manner. “The patient is reporting data back to their providers, and then the providers can intervene and take any necessary actions,” he said. In a randomized clinical trial involving participants with advanced-stage lung cancer without evidence of disease progression after or during initial treatment, the median overall survival of those in the Moovcare intervention group was 19 months vs. 12 months in the control group6 . “If you were developing a drug and you have that increased overall survivorship, you’d be very excited about it, and yet there’s no drug involved here at all,” Sooben said.

The relationship between patients and healthcare providers is changing, with remote monitoring offering opportunities for improved treatment adherence, health outcomes, and patient identification.

Even so, he points to Moovcare as a technology of interest to the pharmaceutical industry because it exemplifies the potential of remote monitoring “to touch every aspect of drug development.” This sort of technology “could change the way you develop drugs from the preclinical stage all the way through clinical stages because digital health can also be used as a data collection tool.”

Remote monitoring tools may also allow for the development of drugs that couldn’t be developed at all without that kind of constant monitoring and data collection. “There’s an opportunity here to understand the potentials for digital therapies and digital health in the pharmaceutical industry,” he said.

Artificial Intelligence and More

The potential of AI to transform healthcare was also addressed during the Digital Health session at the 2018 ISPE Annual Meeting & Expo and in follow-up conversations with a presenter.

“Developing modularized learning systems is a constructive AI path for any regulated use case,” said Sundar Selvatharasu, Chief Compliance Officer at Sierra Labs. On the other hand, “trying to develop an AI platform is a recipe for uncontrolled outcomes if there are no predefined boundaries, even for adaptive AI applications.”

AI is science that challenges human cognizance like never before. So far, said Selvatharasu, AI has been through the trajectory of hype that promised it would be a platform that will sense, analyze, and address all interlinked challenges in healthcare. But now, he said, those exaggerated expectations are giving way to reality. AI in action is seen as more adaptable when it is specific and deliberate.

In the biopharmaceutical space, “use cases are showing positive results and wider adoption when an AI algorithm is explainable, instinctive, and replicable,” Selvatharasu said. This is occurring “primarily in computer-intensive solutions and in augmenting human decisions. Embedded machine learning can generate algorithms to automate regulatory compliance and shift the regulatory burden to a competitive advantage.”

As for cutting through the AI hype, Selvatharasu said “human trust can override rational logic. It is important to ensure that AI-driven decisions are unemotional and purely logical,” he said. “The need for good ol’ quality and regulatory oversight will still hold, but the approach to oversight needs reinventing. Specifics around data cataloging standards, AI validation models, and quality references can ease the regulatory agency’s burden and provide more clarity for the industry,” he said.