Christoph Koenen

Looking back at 2020, there was an explosion in the advancement of digital technologies, especially around clinical trials where adoption of remote monitoring, virtual visits, electronic case report forms (eCRF) and e-consent tools became standard for the safety of patients and success of trials in the face of a global pandemic. During those 12 months, pharmaceutical companies also began pursuing more targeted digital health innovations, moving beyond the pill to extend the value being delivered to patients. In each therapeutic area, different mechanisms are effective for providing patient education, side effect management, advanced therapeutic value, medication compliance and improved outcomes.

As we progress into 2021 and beyond, there are no signs of this new digital era slowing. On the contrary, the emergence of digital health technologies is more prominent than ever as COVID-19 has forced us to rethink, adapt, and innovate the delivery of health care in ways we could not have previously imagined, hastening the manifestation of these new technologies.

And while the digital health playing field is accelerating, it is also shifting from broad health and wellness apps to clinical-grade digital health solutions which directly impact patient outcomes in condition-specific areas–both diagnostically and therapeutically. These clinical-grade digital health solutions will be required to quantify the impact of their technologies with data that validates improved health outcomes in order to achieve Food and Drug Administration (FDA) approval, as well as provider and payer acceptance.

Truth be told, we have just scratched the surface as we build on the technologies in place while continuing to invest and engage with emerging digital solutions. It is important to point out that the implementation of new technologies will often require partnerships, for it’s through collaboration and harnessing the power of diverse thinking that we can make the greatest global impact and revolutionize what was once considered impossible.

One condition-specific area in which digital therapeutics are being (widely) studied is that of mental health. An epidemic within the pandemic, mental illness skyrocketed in 2020 with a year-over-year increase in anxiety and depression of 93% and 62% respectively according to 

 lists major depression as one of the most common mental disorders in the United States and the 

 (WHO) sites depression as the leading cause of disability worldwide and a major contributor to the overall global burden of disease.

Today there are more than 17 million adults in the US living with Major Depressive Disorder (MDD) with 20%-30% of them not achieving a significant response to currently available treatments. This demonstrates the need to truly go beyond the pill and create digital therapeutics that will empower patients and enhance connectivity between them and their healthcare team to achieve better outcomes. Digital health solutions can also significantly change the playing field by providing safe, effective, convenient, and accessible care. Given that geography will no longer be a barrier to care, the industry will need to make significant efforts to ensure more diverse and underserved populations have access to these new digital therapeutics. 

It is for that reason that we have curated strategic partnerships to identify new and better ways to engage more patients and clinicians in research, increase the speed and ease of conducting studies, and collect more comprehensive, higher quality data, including outside the four walls of a clinic.

As an example, in January Otsuka announced a collaboration with Spencer Health Solutions to jointly create a transformational patient experience using the spencer smart hub, the world’s first at-home medication device that connects patients and their care teams through an easy-to-use, fully integrated platform. Evaluation of the device’s ability to improve medication adherence and patient engagement in clinical trials and commercial applications is underway. In addition, the technology offers improved study compliance and clear drug efficacy through real-time data, while promoting patient safety. When pharma dedicates itself to the democratization of clinical trials, patient engagement, and leveraging these advanced technologies, it helps to not only improve diversity and inclusion, but also drive overall clinical outcomes success.

More recently, in cooperation with Click Therapeutics we launched the Mirai study, the first-of-its-kind, fully remote clinical trial using digital therapeutics as adjunctive therapy in adults with MDD. The primary objective of the study is to investigate the effectiveness of digital therapeutics to retrain the brain in order to reduce depressive symptoms in adults diagnosed with MDD who are on antidepressants (ADT) monotherapy. With 20%-30% of people living with MDD not achieving a significant response to currently available treatments, novel options such as the ones we are researching, are urgently needed.

The many benefits of remote clinical trials are clear and we are more than optimistic about the promise that digital innovations will provide to patients when it comes to managing, understanding, and collaborating with their physician on their treatment journey. As an industry, we must band together to continue supporting digital innovations and technologies that can impact patient outcomes, especially in populations with unmet needs.

This new digital health era aligns perfectly with our perseverance and fierce determination, regardless of setbacks, to develop novel new therapies on behalf of patients and their families.

, EVP & Chief Medical Officer, Otsuka America Pharmaceutical

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Moving beyond the pill to extend the value being delivered to patients.

Christoph Koenen

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