Availability of new data sources and emergence of new technology frameworks Jan Frolík, MD., MBA. Teva Pharmaceuticals

Transcription

1 Availability of new data sources and emergence of new technology frameworks Jan Frolík, MD., MBA. Teva Pharmaceuticals

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3 Mobile Health a term used for the practice of medicine and public health supported by mobile devices mhealth applications include the use of mobile devices in collecting clinical health data, delivery of healthcare information to practitioners, researchers, and patients, real-time monitoring of patient and direct provision of care (via mobile telemedicine) Driven by the smartphone revolution 3

4 Mobile phones: the most rapidly adopted technology in the history of man 2 billion smartphone users world wide 83% of total internet usage is via smartphone First Word Dossier. Patient Centric Mobile Apps, August 2015) 4

5 Internet of Things / e-connectivity all the connected devices and sensors in the world that will collect machine-generated data that can add value to the human experience. Connectivity by billion internet users connected devices for every user Connected Devices for Every Household 5 Source: Erickson, Frost & Sullivan

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7 Big Data Big data is a term for data sets that are so large or complex that traditional data processing applications are inadequate The term often refers simply to the use of predictive analytics or certain other advanced methods to extract value from data NOT to a particular size of data set 7

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9 Fitness vs clinical grade wearables Consumer market: $2.2 bn 72 million units shipped in 2015 Forecast sales of up to $30bn in 2020 Medical device: $2.9bn in % for insulin pumps, 17% for glucose monitoring Forecast sales of $20bn in 2020 * Espicom. Wearable Technologies for Health and Fitness Trends and Opportunities to December

10 Wearables adoption status 2016 % of customers that own a fitness band or a smartwatch of some kind: 12% 6.6% March 2016, Kantar Wearable Technology report Note: Kantar's market data is pulled from a combination of consumer purchase tracking and ongoing surveys. 10

11 Wristbands, smartwatches and other peripherals Mobile self-monitoring software applications Health Clouds, Electronic Health Records 11

12 by end of 2015 clinical trials have built wearable devices into their protocols US National Institutes of Health

13 Wearables in clinical trials technical solution 1. Wearables Vital Connect, Actigraph, Google, ERT, 2. smartphones capture data from wearable devices and collect patient-reported outcomes by apps BYOD bring your own device, Apple ResearchKit, 3. All data pulled into the Clinical Cloud Medidata, 2net, 4. Electronic Health Records Compatibility interplay 13

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15 econnectivity ecosystem 15

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18 Examples of experimental wearables Google partnership with Novartis - development of a smart contact lens to monitor blood sugar levels Pierre Fabre implantable chip to measure ph, temperature, glucose levels In clinical trials. Proof of concept clinical trial in Phase 2 schizofrenia drug. E-button. Fastens to a shirt like a badge, monitoring an individual s caloric intake. The device automatically takes pictures of the wearer s food and matches images against a library. Tooth Sensor (National Taiwan University) - can recognize among a wide range of oral activities, such as eating, speaking, coughing, smoking, drinking and breathing Weight tracking Insoles. The NIH is funding efforts by SmartMove Inc. to develop shoe insoles that will track a person s weight, posture allocation, physical activity and energy expenditure Affdex reads emotional states passively using a webcam. Used commercially to analyze consumer responses, used clinically in autism research, child anxiety studies and sleep research Cogito Corp. And the U.S. Department of Defense to develop a smartphone-based technology that monitors an individual s speech as carrier of emotion and analyzes to identify and monitor psychological distress. 18

19 IBM Watson Health Cloud 19

20 Oncology unmet medical needs over 700,000 oncology articles published per year average researcher reads 200 articles per year n 2016, there will be approximately 1.7 million new cases of cancer and nearly 600,000 people will die from the disease in the U.S. About 40% of Americans will be diagnosed with cancer during their lifetime and it is one of the leading causes of death worldwide. current guidelines aren t granular enough to determine which treatments are best matched to the individual person 20

21 IBM Watson in oncology Collaboration with Memorial Sloan Kettering Cancer Center the world s oldest and largest private cancer center and other centers throughout the world Input: Data from all scientific oncology literature Regular feed of patient data to the system Output: system offers recommendations for lung, breast, and colorectal cancers, and it is expanding to gastric-related cancers history of treatment for similar patients more-informed decisions for individual patients can help to reduce time to start treatment 21

22 Examples of Clinical Research Platforms Apple ResearchKit iphone-based medical research platform third-party devices collecting data and sending it to ResearchKit an open source framework to allow researchers to connect and create apps for medical research partnership with Epic allows for integration of ResearchKit data into the EHRs Medidata cloud based data tool partnership with GlaxoSmithKline to demonstrate feasibility of mobile health devices with cloud-based technologies in a clinical trial Own mobile app for patient-reported outcomes Integration of Validic digital health platform compatibile with Garmin, Fitbit, Jawbone, and Withings devices also contributing to Apple s ResearchKit framework 22

23 The Mount Sinai Hospital ResearchKit Asthma Study Monitoring of triggers of asthma attack, medication usage and clinical outcomes 8,600 participants The app also helps researchers study asthma, educate asthmatics and promote healthy behaviour addition of data into patients Electronic Health Reports may be of great value to the pulmonologists 23

24 Salford Lung Study The Salford Lung Study is a Phase IIIb multi-centre, open label randomised controlled trial (RCT). The objective of the study was to compare the effectiveness and safety profile of Relvar Ellipta with existing COPD usual care. 12 months in a normal clinical practice setting single electronic medical record (EMR) linking primary care, secondary care and pharmacy data The study team was able to monitor all hospital admissions, outpatient and emergency department visits, all healthcare contacts, out-of-hours activity and prescriptions of antibiotics or oral steroids 24

25 EU E-health action plan Vision improve chronic disease and multimorbidity management strengthen effective prevention and health promotion practices foster cross-border healthcare improve legal and market conditions for developing ehealth products and services supporting research, development and innovation in ehealth promoting policy dialogue and international cooperation on ehealth at global level develop common standards to enhance interoperable healthcare systems published by the European Commission ehealth European Interoperability Framework health apps - regulation new medical device regulation new privacy regulation code of conduct for developers

26 Considerations

27 125,000 healthcare apps with 3 billion downloads in 2015 Some facts about health apps (2014) : 5 apps responsible for 15% of all downloads 50% of apps downloaded less than 500 times 65% of apps identified include only basic information Only 17% target specific conditions or treatment journey stages >90% of healthcare apps reviewed scored less than 40 out of a possible 100 for functionality * IMS Consultancy 2015, Mendiola MF et al. Valuable features in mobile apps for patients and consumers.,

28 Challenges for using wearables in clinical setting 89% HCPs think that patients may benefit from using wearable devices 15% HCPs talk about wearables and mhealth apps with their patients + Integration of wearable-generated data into and patient s electronic health records (EHRs) needed 28

29 Frontier between wellness and health is blurring The integration of wearable tech into healthy lifestyle, disease prevention and therapy will transform the way that patients, physicians and the pharmaceutical industry collaborate Clinical value of e-connectivity 29