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Evolving Role of Digital Biomarkers in Healthcare

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February 2021
Evolving Role of
Digital Biomarkers
in Healthcare
White Paper

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The impact of technology intervention in the
healthcare industry is inevitable and its application has
led to improved pat...

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Digital biomarkers have evolved from smart devices
that track an individual’s basic health vitals to playing a
major role ...

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Evolving Role of Digital Biomarkers in Healthcare

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As the adoption of remote monitoring, wearable devices and mobile applications grows, digital biomarkers will play a significant role in better disease identification and health management.

As the adoption of remote monitoring, wearable devices and mobile applications grows, digital biomarkers will play a significant role in better disease identification and health management.

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Evolving Role of Digital Biomarkers in Healthcare

  1. 1. February 2021 Evolving Role of Digital Biomarkers in Healthcare White Paper
  2. 2. The impact of technology intervention in the healthcare industry is inevitable and its application has led to improved patient outcomes from drug development to drug optimization (post-approval). Digital biomarkers enable continuous data collection, empowering healthcare professionals to make data- driven decisions. Insights via Digital Biomarker ▪ Sensors ▪ Data Processing and Analysis ▪ Disease Insights In 1998, the National Institutes of Health Biomarkers defined biomarker as “a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention.” Biomarkers play a critical role in understanding how changes in biological processes affect clinical outcomes. It helps in understanding the relationship between measurable biological processes (e.g., pulse rate, blood pressure, etc.) and its clinical outcome due to therapeutic interventions, which help in better drug development, enhancement of drug effectiveness, etc. Traditional methods lack the ability to continuously monitor biological processes and collect relevant data points for effective treatment of diseases. The advent of digital biomarkers has made it possible to map and leverage hundreds of data points for delivering better treatment. For instance, monitoring and analysis of sleep patterns help doctors diagnose early stages of dementia and provide appropriate recommendation for sleep changes. The contextual map of biomarkers draws all possible parameters that affect biological and pathogenic processes, or pharmacologic responses to a therapeutic intervention or the intrinsic progression of disease. INTRODUCTION 1
  3. 3. Digital biomarkers have evolved from smart devices that track an individual’s basic health vitals to playing a major role in diagnosis, screening, and treatment of patients. For e.g., while treating a dementia patient, sleep monitoring devises with digital biomarkers can help in obtaining insights on patient responses to treatment and disease progression. Earlysense Live, an under-mattress sleep and health tracker, monitors heart rate, respiratory rate, and motion to provide real-time data. It monitors sleep quality, awake time, deep sleep, REM phase, and stress levels. Frequent measures capture intraindividual variability in sleep patterns that act as indicators of change and thus detect subtle health transitions (e.g., Healthy to Mild Cognitive Impairment). A transformative approach can also lead to discovery of novel and innovative digital indicators such as gait- speed variability, metadata usage, etc. Similarly, data can be captured for other factors (see figure 1) through digital biomarkers based on disease of interest and monitoring of patient health. Currently, there are multiple digital biomarkers under development and are categorized based on its functionality. 2 DIGITAL BIOMARKERS: REAL WORLD APPLICATIONS (1/2) Fig. 1 – Factors Influencing Digital Biomarkers Development
  4. 4. 3 DIGITAL BIOMARKERS: REAL WORLD APPLICATIONS (2/2) Table 1 – Types of Digital Biomarkers Biomarker Function Application Susceptibility / Risk Identify potential for disease which does not exhibit any clinically apparent medical condition Detect cognitive changes in healthy subjects at risk of developing Alzheimer's disease using a video game platform Diagnostic Confirm the presence of disease Multiple blood pressure reading Monitoring Assess the status of medical condition Monitor signs of change in disease (e.g., Parkinson's) using smartphone-based measurements Prognostic Identify the disease recurrence or progression of disease Stratify mental health conditions and predict remission using passively collected data from smartphone
  5. 5. 4 DIGITAL BIOMARKERS: ENHANCING DRUG EFFECTIVENESS 1. Identify Recurrence of Disease & Improve Drug Effectiveness Drug effectiveness refers to the extent at which a drug achieves its intended effect in a typical clinical setting. In certain cases, some life-threatening diseases such as cancer have chances of recurrence post surgery. It is arduous to identify and pinpoint the exact location and growth of tumor cells and the onset of cancer. However, prognostic biomarkers can provide data by capturing body weight which is indicative of recurrence of cancer post surgery. This information helps in modifying the prescribed medication by adding other medication(s), changing dosage to increase its effectiveness. 2. Improve Drug Effectiveness In general, drug dosage timing is prescribed in vague language (morning, afternoon and evening). However, via monitoring biomarkers patients can be studied and drug timings can be prescribed precisely. Diabetic patients are usually advised to take insulin shots 30 minutes before eating in order to keep their sugar levels normal. However, studies suggest 20 minutes is the optimum time to administer insulin and is more effective than the customary half-hour. Every individual need is unique and monitoring biomarkers help in prescribing medication precisely for enhancing the effectiveness of drugs. Biomarker Disease Benefit Prognostic Tumor Cells ▪ Increase drug effectiveness ▪ Treatment at initial stages of recurrence Biomarker Disease Benefit Monitoring Type 2 Diabetes Increase drug effectiveness Table 2 – Prognostic Biomarker Table 3 – Monitoring Biomarker
  6. 6. Clinical decision making is another area of opportunity where digital biomarkers can play a crucial role, especially in confirming the presence of a disease. Autism, or autism spectrum disorder (ASD), refers to a broad range of conditions characterized by challenges with social skills, repetitive behaviors, speech and nonverbal communication. Since, wearables are non- invasive, discreet, comfortable and convenient, they are easy for patients to adopt. By constantly monitoring a patient’s behavior, doctors can confirm the presence of disease. Digital biomarkers provide data that can be used to confirm the presence of autism in patients which was not possible earlier. It helps in early identification of rare diseases and increases the possibility to initiate treatment at an early stage, compared to traditional methodologies. Other diseases where diagnostic biomarkers can help identify the presence of a disease are: ▪ Sweat chloride could be used as a diagnostic biomarker to confirm cystic fibrosis ▪ Blood sugar or haemoglobin A1c (HbA1c) could be used as a diagnostic biomarker to identify patients with Type 2 diabetes mellitus (DM) 5 DIGITAL BIOMARKERS FOR CLINICAL DECISION MAKING Biomarker Methodology Output Diagnostic Analysis of facial expressions, gaze behavior, and voice characteristics Confirming presence of the disease Table 4 - Identifying Autistic Patients using Diagnostic Biomarker
  7. 7. 6 DIGITAL BIOMARKERS: APPLICATION IN DRUG DEVELOPMENT Incorporation of real-world data in clinical trials are emerging with the rise of digital biomarkers. There is a shift in measurement, from snapshot to continuous measurement of biological processes, pathogenic processes, and pharmacologic responses. Consequently, the data collection process has become faster, more accurate and presents opportunities to include missed datasets. In traditional clinical trials, data is collected under clinical settings and need to follow certain protocols, which often result in months and years for drug development. Repeated readings must take place at different intervals to understand the impact of the newly developed drug on a particular disease. Digital biomarkers enable the collection of data in a home setting, while adding extra data points beyond the scope of clinical data. This accelerates the data collection process and reduces turnaround time necessary for drug development. In a recent study, patients with neurodegeneration and cancer condition were stratified into different groups based on drug responses. It helped in developing and delivering appropriate medication to the correct patient. Biomarker Disease Benefit Monitoring Type 2 Diabetes 6-Month study allows collection of readings outside a clinical setting Outcome Incorporate missed opportunities through digital biomarker to reduce time required for drug development Table 5 – Digital Biomarker to Reduce Data Collection Time
  8. 8. 7 DIGITAL BIOMARKERS: TECHNOLOGY STACK Although digital biomarkers have gained popularity in clinical decision making and doctors many times use them to monitor patient health, but regulatory authorities still need to validate its reliability and accuracy. Furthermore, integrating the collected data in a meaningful manner for end users is currently demanding. Figure 2 illustrates the flow of data from device to FHIR server (data curation / integration) to its utilization via advanced analytics to generate insights. Digital biomarkers have scientifically defined pillars that are validated along with its operational implementation. The ‘scientific consideration’ includes clinical and analytical validation to complement hypothesis, while ‘operational consideration’ includes user acceptability, data logistic, and data collection parameter. The resulting data from devices and applications are stored and mediated through the health system’s FHIR server (data curation / integration). With the help of advanced analytics and sophisticated tools, analysis and insights can be generated for: ▪ Monitoring Patient Health ▪ Dosage Customization ▪ Studying Drug Effectiveness During Clinical Trials ▪ Confirming Presence of Disease ▪ Predicting Health Outcomes Operational Implementation ▪ Number ▪ Algorithm Meeting Minimum Threshold ▪ Continuous Scientific Consideration & Validation ▪ Accelerometer ▪ Sensitivity ▪ Detect Unique Motion Patterns FHIR Server Fetching data to generate insights on patient health Fig. 2 - Digital Biomarkers – Technology Stack
  9. 9. 8 ▪ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3078627/ ▪ https://www.nature.com/articles/s41746-019-0090-4 ▪ https://ascpt.onlinelibrary.wiley.com/doi/abs/10.1002/cpt.1100 ▪ https://www.pharmaceutical-technology.com/comment/digital-biomarkers-healthcare-trends/ ▪ https://www.karger.com/Article/FullText/479951 ▪ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6032822/ ▪ https://rockhealth.com/reports/the-emerging-influence-of-digital-biomarkers-on-healthcare/ ▪ https://www.nature.com/articles/s41746-020-0218-6 ▪ https://www.karger.com/Article/FullText/502000 REFERENCES
  10. 10. 9 ABOUT THE AUTHORS Shreejit Nair Sr. Vice President, Life Sciences shreejit.nair@citiustech.com Shreejit has 22+ years of experience across technology consulting, program management, business development, account management in healthcare, digital convergence and IT outsourcing space with Fortune 100 companies in US and Europe.​ He leads the Life Sciences market at CitiusTech. He holds a bachelor’s degree in engineering and master’s degree in business administration. Sanjivni Sinha Healthcare BA Consultant, CitiusTech sanjivni.sinha@citiustech.com Sanjivni has a strong experience in the area of healthcare in genomics. She has expertise in Good Manufacturing Practice (GMP) for products, sequencing, and research. She has worked on various healthcare projects related to sequencing and GMP for leading pharmaceutical and biotechnology companies. She holds a bachelor’s degree in Biotechnology and Microbiology from NDSU, US and a master’s of science in management degree from Minot State University, US.
  11. 11. CitiusTech is a specialist provider of healthcare technology services and solutions to healthcare technology companies, providers, payers and life sciences organizations. With over 4,000 professionals worldwide, CitiusTech enables healthcare organizations to drive clinical value chain excellence - across integration & interoperability, data management (EDW, Big Data), performance management (BI / analytics), predictive analytics & data science and digital engagement (mobile, IoT). CitiusTech helps customers accelerate innovation in healthcare through specialized solutions, healthcare technology platforms, proficiencies and accelerators. With cutting-edge technology expertise, world-class service quality and a global resource base, CitiusTech consistently delivers best- in-class solutions and an unmatched cost advantage to healthcare organizations worldwide. For queries contact thoughtleaders@citiustech.com Copyright © CitiusTech 2021. All Rights Reserved.

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