Opinion Considering the Future Pharmaceutical Industry from the Perspective of Advances in Digital Health As a member of "data-driven healthcare

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Takayuki Sasaki, Senior Researcher, Pharmaceutical Industry Policy Institute, Japan

Introduction

Digital technology is making remarkable progress, and in the field of healthcare, we are seeing the emergence of treatment applications, the spread of VR-based rehabilitation, the expansion of the possibilities of AI-equipped medical devices, the development of mHealth using smartphones, the development of treatment using robots and avatars, the application of games to healthcare, and research into the Brain Machine Interface. The application of robots and avatars, the development of treatment using robots and avatars, and the increased research on Brain Machine Interface are just a few of the diverse solutions that are emerging.

This trend is not limited to individual corporate activities, but is also accelerating digital health initiatives across nations and even countries. For example, in recent years, the World Health Organization (WHO) released its draft global strategy for digital health from 2020 to 2024 (March 2019) ¹⁾ and the Global Digital Health Partnership (GDHP (GDHP) (February 2018) ²⁾, the publication of a policy document on digital health by the European Commission (April 2018) ³⁾, and the release of the Global Digital Health Index (draft) (May 2018) ⁴⁾, international initiatives on digital health are simultaneously 4). In Japan, efforts are also underway, ^{including the} establishment of the Headquarters for Promoting Data Health Reform Using Robots, AI, ICT, etc. (MHLW: 2017) ⁵⁾ and the establishment of a study group on promoting private investment in the utilization of health and medical information (Healthcare IT Study Group) (METI: 2018) ⁶⁾.

Looking at Japan's pharmaceutical industry, the Japan Pharmaceutical Manufacturers Association (JPMA) mentions in its "Pharmaceutical Association Policy Recommendations 2019" the "creation of a wide range of healthcare solutions, including prevention, early diagnosis, and preemptive medicine, utilizing digital technology, etc. " ⁷⁾ and individual companies are also taking steps to create healthcare solutions in the "beyond the Pill" area, while considering the use of digital health. 7 ⁾ Individual companies are also increasingly considering healthcare business in the "beyond the Pill" area, with an eye toward utilizing digital ^health8).

Until now, it has taken 10 to 15 years to bring a new drug to market. Although technological innovations and reforms in the approval process are expected to shorten this period in the future, the "paradigm shift in healthcare" brought about by changes in the social structure and advances in digital technology will have an impact on the "future of the pharmaceutical industry" when new drugs under development are brought to market. This paper will focus on the future of the pharmaceutical industry, particularly in the area of digital health technologies. In this paper, we will examine the characteristics of digital health technologies in the future of healthcare, and consider what perspectives will be needed as a member of the healthcare industry in the data-driven society brought about by these technologies, from the perspective of digitization.

Evolution of digital technology and its impact on healthcare

The scope of digital technologies is extremely broad, but this paper will focus on (1) the evolution of IoT, (2) the improvement of always-on connectivity, (3) the spread of artificial intelligence, (4) the use of gamification, and (5) the spread of virtual communities as those with significant applications to the healthcare industry. (5) The spread of virtual communities.

1) Evolution of IoT ⇒ Enhanced digital biomarkers

The evolution of IoT and sensing technologies has accelerated the search for physiological data, or so-called digital biomarkers, to be acquired by wearable devices, etc. for use in predicting the onset of disease and understanding and managing conditions.

It has already been reported that many types of data can be measured by smartphones and watch-type wearable devices, including pulse rate, step count, electrocardiogram, and body movement data during sleep, but in recent years, methods of utilization have further expanded. For example, in Finland, an application has been developed that uses the gyro sensor of a smartphone to determine breathing ^disorders9). Also, in Canada, technology has been developed to measure blood pressure using a smartphone selfie or touch ^operation10).

There are also active attempts to capture signs of biological changes using external sensors: IBM, in collaboration with Pfizer, operates Project BlueSky, which detects signs of Parkinson's disease in real time using sensors installed in smart houses to detect residents' movements (e.g., wrist and forearm movements when turning a doorknob), and has developed an application to detect the movement of the forearms of residents in real time to provide The company has promoted an attempt to provide a monitoring service by using sensors installed in smart ^houses11).

In addition to this, in recent years, efforts have been made to promote even more advanced "understanding of the human condition" by collecting and integrating information such as voice, facial expressions, and the content of conversations in a multimodal manner. As mentioned in Policy Research Institute News No.57, there are attempts to create an objective severity scale for mental disorders based on voice, images, and conversational ^content12), and in the field of affective computing, attempts are being made to integrate and quantify human expressive elements as emotions and apply them to healthcare, 12) In the field of affective computing, attempts are being made to integrate human expressive elements, quantify them as emotions, and apply them to health care. For example, it has been applied to the development of communication technology for use by autistic ^people13) and to the treatment of auditory ^{hallucinations15)} through avatar ^therapy14).

These digital biomarkers are attracting attention as a means of objectively quantifying indicators that have been difficult to quantify in the past, and their correlation with existing indicators is also being actively examined. It can be said that the range of biomarkers that can be obtained with digital technology is expanding to include those in which patients and consumers themselves input and transmit information (e.g., ePRO).

(ii) Improved always-on connectivity ⇒ Integration of research and daily life

In parallel with the technological evolution of the IoT, the evolution of communication technology, the development of communication environments, and the spread of social networking services have led to the realization of mechanisms for the constant collection of biometric-related information from mobile and wearable devices and sensors, as well as the real-time collection of what people are feeling and thinking. Until now, personal medical health data has been dominated by so-called "snapshot" data, such as birth records, vaccination histories, health checkup results, or medical data at the time of illness (laboratory values, images, diagnostic findings, intervention details, etc.). In contrast, data from digital devices enables the continuous collection of data on consumers in a more always-connected manner than has been possible in the past, although the frequency of data acquisition varies.

This technological evolution is also changing research styles, including those in the life sciences. Here, we would like to focus on always-on connectivity in "living labs" as an example.

The OECD is also strengthening cooperation between the public sector and business, and is promoting the use of open innovation that involves citizens and local communities, Based on its usefulness as a place for innovation where local governments and companies can test technologies, etc., examples include the study of smart city services in Antwerp, ^Belgium16), the development of products for the elderly and improvement of care processes in Finland, and the creation of learning environments and digital learning materials in ^schools17), 18), as international case studies.

Living labs, by their very nature, involve participants more strongly in the research, and constant connectivity through the use of SNS and other means is expected to lower the hurdles to participant involvement in living labs. In addition, sensor-based monitoring will add precision to the behavioral data of research participants, for example, and will contribute to improving the accuracy of time-series evaluations, and sometimes the feedback of objective, quantified data may motivate ^{participants19)}.

The "Living Healthtech Lab," a representative project of the "Capital of Sustainable Development: Action Plan for Sustainable Development Goals" formulated by the Danish capital Copenhagen in 2018, is working on a personal registry (electronic health data) and telemedicine, The "Living Healthtech Lab," a representative project of the "Capital of Development: Action Plan for Sustainable Development ^Goals," attempts to create innovation by involving IT-savvy citizens in a test hub that combines personal registry (electronic health data) with telemedicine, e-health, home healthcare, digital healthcare, etc. ²⁰⁾. Living labs, especially in the healthcare field, have many advantages over clinical research based on traditional healthcare systems, starting with obtaining consent, identifying disease signs and physiological trends, collecting outcome data, receiving Patient Reported Outcomes, and providing feedback on results. Digital, always-on connectivity will further enhance these benefits.

(iii) Widespread use of artificial intelligence ⇒ Development of personalized medical devices/solutions

An environment in which patient and consumer data can be collected in near real-time will form the basis for using that multidimensional and voluminous data to provide individually optimized health care. In the field of advertising, AI-based targeted advertising is widely used, and AI-based exercise programs and diet suggestions have become popular in healthcare applications.

In the United States, as part of the Digital Health Innovation Action Plan established in 2017 to appropriately promote and evaluate innovations using digital technologies, a pilot program, the Digital Health Software Precertification Pilot Program (commonly known as Pre-Cert). Software as a Medical Device (SaMD), which is software that functions as a medical device by itself, such as a smartphone app, is constantly being updated and its performance is constantly changing. In addition to the conventional medical device assessment and assessment of the program itself, the effectiveness and safety of the product will also be assessed as necessary after its implementation in ^society21).

The programmed medical devices envisioned in the Pre-Cert were to be reviewed once the program updates were locked and fixed at a certain point in time, but in April 2019, the paper will go further and discuss how to manage programmed medical devices without locking algorithms. In April 2019, a discussion paper was issued from the perspective of how to manage programmed medical devices that do not lock the ^algorithm22). This report presents the concept of "Good Machine Learning Practice" and attempts to capture the regulatory framework from the perspective of data validity, rationality of updates, and transparency of algorithms.

Currently, use cases are envisioned in which an AI that learns data from a database "classifies" patients and other subjects and provides optimal medical care, but future needs are envisioned in which the AI is optimized based on individual data to improve treatment and quality of life. A symbolic example, which has not yet been put to practical use, is Microsoft's "Project Emma" ⁽²³⁾. The Emma Watch provided in this project is a wearable device that reduces tremors by applying vibrations to offset the tremor symptoms of Parkinson's disease. The program that drives the motor that generates the vibration is optimized by the vibration data of the person wearing the device (in this case Emma Lawton).

(4) Utilization of gamification ⇒ Application to behavior change, rehabilitation, etc.

Have you ever heard of the six elements of ^{gamification24)}? According to Yoshihiro Kishimoto, a former Tokyo University of Technology professor and organizer of the "Institute for Play and Learning," they are active participation, praise staging, visualization of growth, attainable goal setting, immediate feedback, and ^{self-expression25)}. This is equivalent to the provision of social reinforcers (praise, approval, achievement) and psychological reinforcers (achievement, pleasure, satisfaction) in cognitive-behavioral therapy, suggesting that the nature of gamification has a high affinity with cognitive-behavioral therapy.

In addition, as discussed in Policy Research Institute News No.57, the use of gamification elements is emerging in Digital Therapeutics (DTx), but as an applied field, it is leading the way in rehabilitation. For example, Mindmaze, a company based in Switzerland and the U.S., has announced its commitment to using game-like VR to support the rehabilitation of neurological patients who have suffered brain ^injuries26). The company has developed the "MindMotion Pro" game-based rehabilitation system for the neurologically impaired and its home version "MindMotion Go," which has already received FDA approval (510(k) clearance) and CE Mark certification. In Japan, MediVR has also developed the "MediVR Pro" and its home version "MindMotion Go. In Japan, MediVR's "Kagura," a self-powered exercise training device with a measurement function, uses VR to provide entertainment, and also emphasizes the importance of having fun while getting ^well27). Such VR-based rehabilitation focuses on gamification elements, adding the immersive essence of games and VR to improve treatment outcomes.

(5) Penetration of virtual communities ⇒ Patient-centered information collaboration

Virtual communities are also becoming increasingly important in healthcare: the 2000s saw the global spread of the Internet, and the 2010s saw the global spread of social networking services, and we will continue to see the emergence and presence of virtual communities segmented by interest, culture, expertise, and other factors.

Virtual communities have already begun to play an important role in patient and consumer decision-making. For example, Patient Like Me, a social network founded and developed in the United States in 2004, allows patients to connect and share experiences with others who have the same disease or condition as they do. With over 600,000 people already registered and more than 100 research studies published, it is gaining a growing presence as a ^platform28).

Recently, the company has begun exploring a personalized virtual avatar called "DigitalMe" that leverages the foundation of this virtual community. This initiative will discover new signals related to health, disease, and aging by receiving a variety of data from patients and consumers in the real world, including experience, environment, medicine, genomics, omics, antibody testing, and microbiome, as well as machine learning The aim is to generate hypotheses about personalized treatment, diagnosis, and prognosis from a system that uses data from the experiences of other patients and ^consumers29).

In Japan, the number of virtual communities of patients utilizing SNS is increasing. The Japan Association for Family Support of Disability and Illness launched the disease-specific SNS "CARE LAND" in 2017. The number of diseases registered on this SNS has surpassed 500, making it one of the leading SNS for patients in ^Japan30). In addition, many other patient communities utilizing the web and applications have emerged, such as the SNS operated by the NPO GISTERS and "Survivor Net" launched by the Japan Cancer Society for those who have been diagnosed with cancer, their families, and supporters. At present, these are virtual communities for the purpose of sharing information among patients, but new mechanisms that provide valuable information to patients beyond the framework of medical information management, such as "Atopiyo," an application that aims to build Japan's largest atopic disease image database and provide patient feedback by utilizing machine learning, are likely to increase. New mechanisms that go beyond the framework of medical information management and bring valuable information to patients may also ^increase31).

Consumer data is the link between the elements of digital health

The elements described so far, from (1) to (5), regarding digital technology are interrelated, influential, and complementary elements. In other words, the enhancement of digital biomarkers, coupled with the improvement of always-on connectivity, will promote further changes in the research environment, and AI elements will become indispensable for virtual communities as well.

What changes, then, will these factors bring about in medicine and how will they affect "how to intervene" in human life and health? The perspectives of personalized medicine and preemptive intervention have been discussed in various places in the past, but in the future, factors such as "sociality," "communication," and "interactivity" will be even more key. Living spaces will become closer to research sites, and the discovery of digital biomarkers will advance. As consumers are increasingly monitored through near-constant connectivity, or by transmitting their own data, they themselves will be able to identify signs of disease onset and health concerns. With the help of gamification, virtual communities, robots, avatars, etc., they will be able to change their behavior and undergo treatment and rehabilitation. After treatment, monitoring will continue in the living space, and data on treatment outcomes, etc. will be collected and fed back to consumers and medical personnel. Interventions that are conscious of the human "mind," based on psychological factors such as a sense of social solidarity, satisfaction of the need for approval, and a sense of accomplishment, will become an important element in future health care (Figure 2).

What connects "customized intervention," "intervention based on real-time data," and "intervention with an awareness of the human mind" is, above all, the data of individual sei-katsu-sha. In other words, data-driven healthcare centered on consumer data will be the key to the realization of healthcare in the 21st century.

As a member of data-driven healthcare

In a future society where pharmaceuticals currently under development or to be developed will be marketed, how will the healthcare domain targeted by new drugs and how will it change? The elements of "customized intervention," "intervention based on real-time data," and "intervention with an awareness of the human mind," as summarized in the previous section, will become important, or the paradigm shift in medicine will occur from "group" to "individual," from "treatment" to "prevention," from "product" to "service," and even from "modality" to "service. In the midst of this paradigm shift, and the possibility of a paradigm shift from "group" to "individual," from "treatment" to "prevention," from "goods" to "things," and even from modalities to "services," such as regenerative medicine, gene therapy, games, applications, VR, and healthcare utilizing communication technology, can pharmaceuticals used only for treatment play a leading role in healthcare? In the pursuit of stratification, will pharmaceuticals be able to respond to "individuals"? What will pharmaceuticals gain from a world that is constantly connected to consumers and how can they be improved? How long will core competencies such as molecular discovery, disease understanding, and clinical trial execution remain dominant? It is not strange that such questions arise.

Should we remain data users?

In Policy Research Institute News No.57, the author introduced the trend of Digital Therapeutics (DTx) from the perspective of global clinical trial implementation. ³²⁾ DTx is a new technology that connects healthcare professionals and patients in a near-constant connection and uses immersiveness to change behavior in some of the elements of 21st century (first half) healthcare mentioned above. The author sees DTx as fulfilling some of the elements of 21st century (first half) type healthcare, however, it is a part of "treatment" in terms of the overall healthcare care cycle, and in terms of a data-driven society, it is in the "closed data" world between healthcare professionals, patients, and device providers. This is the same kind of "data openness" as in the so-called "Around the Pill" area, where digital tools are used for medication management, for example.

On the other hand, in order to realize data-driven healthcare, it is necessary to share data among different industries as "open data. In industries that provide means of transportation, such as the automobile industry, the concept of "Mobility as a Service (MaaS)" has been proposed. This is a system in which users can choose from a wide range of options, including trains, cabs, car sharing, and ride sharing, based on all kinds of data stored in the cloud (or, in the case of freight transport, mixed loads and shared delivery), and make their own ^decisions33). This "paradigm shift in mobility" will affect the businesses of related industries such as the insurance and tourism industries, while at the same time, vast amounts of data will be used to prevent traffic congestion and accidents, to predict and maintain road facilities, and for urban planning and urban development. In other words, MaaS is not just about meeting user needs, but also about meeting social and national needs.

If we consider this in the context of the healthcare industry (the Institute of Electrical and Electronic Engineers (IEEE) issued the concept of "HaaS: Healthcare as a Searvice" in 2014), it can be said that the healthcare industry is not just a framework for medical needs (IEEE, 2014). ³⁴⁾, it will be necessary to collect, analyze, and feed back data while considering the existence of social and national needs beyond the framework of mere medical needs. In order to prevent such efforts from becoming nothing more than a patchwork, it will be necessary to form a "data economy" in which the vast amount of data from consumers and infrastructure is circulated as a business for a fee, similar to the MaaS system.

In this data economy, pharmaceutical companies will have to decide whether to remain as data users receiving bio data, market data, receipt data, and side-effect information, or whether to enhance their points of contact with consumers, collaborate with ICT companies, and become data providers. Or will they become one of the driving forces that drive the health data economy, opening up new avenues of activity as data providers by enhancing contact with consumers and collaborating with ICT companies and others? The development of digital health can be seen as an impetus for transformation, not only from the viewpoint of "what solutions to provide" to the role and state of the pharmaceutical industry, but also from the viewpoint of "the role in the data economy.

As a member of data-driven healthcare

Overseas, collaboration among pharmaceutical companies, data platform providers, medical institutions, insurance companies, and other different industries is already underway, as are a number of initiatives across national borders to improve interoperability, promote standardization, and address cybersecurity. In addition, a number of initiatives are underway across national borders to improve interoperability, promote standardization, and address cybersecurity issues. Furthermore, as described in Policy Research Institute News No.5835 ⁾, "cyber security," "privacy," and "interoperability," which form the foundation of data distribution in particular, are issues that must be considered not only by the ICT industry but also by all data stakeholders. If we aim to become a member of data-driven healthcare, we will be required to actively participate in the establishment of guidelines and voluntary standards, as well as the expression of opinions on legal systems, etc.

However, digital technology is evolving fast. It is well known that tech platformers have a "10x better idea than 10% better than the status quo " ³⁶⁾. Those in the pharmaceutical industry know firsthand that business span, customer access, regulations, R&D positioning, human resources, and many other factors are advancing at a different speed and with a different mindset than the "traditional pharmaceutical industry," so to speak. It is no wonder that there is a debate over whether the same people, the same framework, and the same organizations are appropriate as facilitators of this new healthcare industry as there is for classical prescription drugs. The establishment of the Digital Therapeutics Alliance in the U.S. to promote DTx is just one way to overcome these differences. The "Guidelines for Healthcare Services" issued this year by the Ministry of Economy, Trade and Industry (METI) is a guideline for industry associations to establish voluntary guidelines for the distribution of healthcare services. For example, it may be effective to create a platform involving different industries while utilizing such a framework to provide healthcare solutions of appropriate quality, protect consumers from the perspective of risk/benefit balance, conduct sustainable healthcare business, and eventually expand the global deployment of healthcare solutions.

What role will you play as a member of data-driven healthcare? The pharmaceutical industry needs to backcast from the future society and think about what it should work on now.

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