Harness digital platforms to accelerate R&D and drive proper adoption

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Pioneers in education, medicine and pharma discussed new data-rich approaches to help assess what works and what doesn’t, and for whom, accelerating R&D initiatives and proper adoption.
--Chair: Alvaro Fernandez, CEO & Editor-in-Chief of SharpBrains
--Richard Varn, Director of the Center for Advanced Technology and Neuroscience at Educational Testing Service (ETS)
--Dr. Brian Iacoviello, Director of Scientific Affairs at Click Therapeutics
--Dr. Gahan Pandina, Senior Director, Venture Leader at Janssen Research & Development
--Dr. Sarah Banks, Head of Neuropsychology at the Cleveland Clinic Lou Ruvo Center for Brain Health

Learn more at sharpbrains.com

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  • Inclusion was also meant to be real-world. Very few bases for excluding a person who wanted to participate.
    With this criteria we ended up with heavy smokers (avg 16 cigarettes per day) even though we would have taken far lighter smokers.
  • We are particularly proud of our ability to iterate our recruiting and reach >400 ITT in the study in 2 months
    Recruitment was a complex technological process that was easy and streamlined for the prospective participant. Our success was made more challenging by a required pre-screening call, which was scheduled with pre-screening largely completed before any manual effort involved.
  • Graphic: show all the potential datapoint collected (in light grey/background); highlight/bold ~ 12-15 to depict a sample user.
    “Our system collects vast amounts of data; thousands of datapoint on each user. This enables us to learn so much about each user and then personalize their quit journey. For example, this shows a sample user named George. We know all kinds of valuable information about George. George is XXXXX, smokes XXX, triggers = XXX, … That’s just a small taste of the extensive data we collect on George and utilize to personalize his experience and optimize his outcome.” Tags to include in background: - craving times
    - craving locations
    - craving intensities
    - craving triggers
    - strategies employed to fight cravings
    - craving outcome (smoke/no-smoke)
    - smoke times
    - smoke locations
    - moods with times, locations, and strategies employed
    - daily cigarette counts, reported daily
    - daily cigarette counts, reported weekly
    - weekly quit aid usage
    - times of text messages to us and to social groups
    - time, duration, type, and tempo of breathing exercises
    - quit motives
    - triggers
    - time of journal entries
    - time of supporter comments
    - number of supporters
    - fagerstrom responses
    - habits
    - money-related milestones
    - app opens
    - taps within the app
  • Harness digital platforms to accelerate R&D and drive proper adoption

    1. 1. Harness digital platforms to accelerate R&D and drive proper adoption
    2. 2. Harness digital platforms to accelerate R&D and drive proper adoption Chaired by: Alvaro Fernandez, CEO and Editor-in-Chief, SharpBrains Richard Varn, Director of the Center for Advanced Technology and Neuroscience Educational Testing Service (ETS) Dr. Brian Iacoviello, Director of Scientific Affairs, Click Therapeutics Dr. Gahan Pandina, Senior Director, Venture Leader Janssen Research & Development Dr. Sarah Banks, Head of Neuropsychology Cleveland Clinic Lou Ruvo Center for Brain Health
    3. 3. Richard Varn Harness Digital Platforms to Accelerate R&D and Drive Proper Adoption Director of the Center for Advanced Technology and Neuroscience Educational Testing Service (ETS)
    4. 4. The Growing Basket of Evidence 4
    5. 5. ETS Data Mission • Help equalize and maximize opportunity by supporting evidence-centered decisions • Identify achievement and equity gaps • Provide evidence for decisions and help address achievement and equity gaps through our research, development, products, services, and advocacy 5
    6. 6. Data Mission Impact •Greater fairness and fit in access to educational and career opportunities •Learning and work outcomes are improved •Leading to: •Individuals having a greater chance to be successful in learning, work, and life because we helped them to find the right path, travel the path better, and reach the goals that path evokes 6
    7. 7. Why—Broader and Deeper Uses of Data • Various movements focusing on student success, personalized learning, and improving educational outcomes are part of a tide of change aiming to lift all learners to meet a growing list of challenges • Data and analytics are being used within these movements to improve both quality and equity in education and student opportunity and success • In general, neurometrics and neurocognitive data is absent or under-represented in the this work 7
    8. 8. What--Institutions and Vendors are Making Better Use of Data and Analytics In: • Learning, health, and work • Assessment of Knowledge, Skills, Abilities, Performance, and Experience (KSAPEs) to guide and qualify people in education and workforce opportunities • Outcomes, Accountability, and Accreditation • Student and Career Services • Research • Course Completion, Retention and Degree Attainment • Enhancing opportunities for underserved learners • Others 8
    9. 9. How Is Data Being Used for Improving Student Success? • Identify at-risk learners in order to initiate personalized, timely, and effective interventions and services to improve completion rates • E.g. small improvements in HE retention could yield many more college graduates each year • Continually measure effectiveness and outcomes to improve educational methods, processes, and curriculum as well as educational practitioners and practices 9
    10. 10. How Is Data Being Used for Improving Student Success? • Personalize and document learning at finer grain sizes and provide adaptive feedback to learners • Create a beneficial feedback loop between employers, learners, employees, and educational institutions that improves the fit between learning, career pathways, and employment to increase the employability and career success of graduates 1 0
    11. 11. Analytics Progression 11
    12. 12. The Future of Data in Education 12
    13. 13. ETS and the Inevitable Future of Data in Education 13
    14. 14. ETS and the Inevitable Future of Data in Education 14 What Roles to Play? • Merely a data and research services supplier to analytics companies? • Create services that interpret and validate the meaning of data? • Develop and sell consultative services for data and its interpretation? • Grow services in the B-to-C Channel to compensate for losses in B-to-B?
    15. 15. 15
    16. 16. Computational Psychometrics Strategic View 17
    17. 17. The Value Circle Premise • Assessments and the other data comprises the evidence of the Knowledge, Skills, Abilities, Performance, and Experience (KSAPE) of a person • Value grows with the amount and quality of the evidence, adequate privacy protections, and customer choice • This evidence needs an organizing service • Reports that make valid correlations and inferences from this evidence are key to adding value and meeting user needs • Useful reports will drive demand for more and better evidence 17
    18. 18. Issues • How do we: • Help students progress and succeed within and across the education and workforce lifecycle as far as their skills and talents allow? • How can we better use neurometrics in research and product development in this data rich context? • How can we better use AI, ML, analytics, and data visualization to improve education and student learning and opportunity? 18
    19. 19. How to Use the Growing Basket of Evidence? 19
    20. 20. Questions and Discussion 2 0
    21. 21. WHAT WE DO • Create technology-based interventions to improve health outcomes • These Digital Therapeutics™ are based on our clinically validated platform • They work independently or in conjunction with pharmacotherapies • Data collected are used to continuously improve & personalize interventions • Better outcomes through user engagement and neurobehavioral change 22
    22. 22. A MASSIVE OPPORTUNITY 23 Leader in Digital Therapeutics™ programs for a multi-billion dollar and extremely fast growing market Debut product, Clickotine®, is developed and clinically validated in smoking cessation Commercializing into a > $4B market by industry leading behavioral health insurer: Magellan Health Exceptional healthcare and technology team Extensive pipeline for additional indications in development
    23. 23. 24 CNI Platform Deployment Improved Health and Economic Outcomes Indications with Strong Behavioral Components Addiction Tobacco Alcohol Opiates / Opioids Eating Binge Eating Disorder Obesity Diabetes Mood & Affect Major Depressive Disorder Generalized Anxiety Disorder Sleep Insomnia Sleep Apnea Chronic Pain Chronic Back Pain Cancer Pain Post-surgical Rheumatoid Arthritis Gastrointestinal Irritable Bowel Syndrome Gastroesophageal Reflux Disease Crohn's Disease Click Neurobehaviorial Intervention (CNI) Platform
    24. 24. CLICKOMETRICS® THE COMMON DATA PLATFORM 25 PERSONALIZED Measures and optimizes the effects of the Digital TherapeuticsTM program for each user. STATISTICALLY RIGOROUS ANALYSIS Collect data across the user-base to generate indices of population effectiveness. SAMPLING & ANALYTICAL STRATEGIES Increase statistical power and detect intra-individual change. CLICK Neurobehavioral Intervention Platform CT-100 Smoking Cessation CLICKOMETRICS® ObesityChronic Pain InsomniaMajor Depressive Disorder
    25. 25. CLICKOMETRICS® DIGITAL THERAPEUTICS™ SOLUTIONS MEET BIG DATA 26 User engages with program Data Sales We engage users intensively, intelligently, and individually. The Clickometrics® platform enables our Digital Therapeutics™ programs to learn from users and continuously personalize the experience - tailoring the therapeutic to best fit each individual. Program adapts to user to aid recovery Program collects usage & feedback Clickometrics® Analyzes Data Clickometrics® Data Store Pharma, Payer, Health Data Partners Our Intellectual Property Portfolio Research Output Tech Licensing Platform Licensing
    26. 26. NEUROBEHAVIORAL INTERVENTION PIPELINE 27 PRODUCT INDICATION RESEARCH DEVELOPMENT PILOT STUDY EFFICACY TRIAL CT-100: CLICK Neurobehavioral Intervention (CNI) Platform Smoking Cessation Obesity Chronic Pain Insomnia Clickotine® CT- 101 CT- 110 CT- 130 CT- 141 CT- 151 Major Depressive Disorder Clickadian™
    27. 27. 28 Medication Adherence Digital Diversions Controlled Breathing Financial Incentives Personalized Messaging Social Engagement Professional Caregiving Partner Dashboard Providing a web-based portal for partners enables observation of population trends, as well as detailed user-by-user data streams Individualized Data Outcomes & ROI Live Coaching Clickotine® is a patent-pending clinically-validated fully digital smoking cessation programA Digital Therapeutics™ Program for Smoking Cessation Individualized reminder system to optimize use of effective treatment Real-life support from friends, family and community. Quitting with a small quit team is proven to be a powerful tool for engagement Out-of-app incentives such as refunds & reimbursements provided by partners Adaptive text messages tailored to user profile, and provides contextualized, personalized support and guidance Controlled, mindful breathing experiences coupled with multi-sensory stimuli Timed and targeted strategies to cope with cravings, withdrawal symptoms & lapses Real-time access to qualified professional caregivers, quit coaches & counselors Population Engagement Data Partnered with Download the Clickotine fact sheet
    28. 28. RAPID RECRUITMENT AND STUDY CONDUCT 29 1. Social Media Postings Sponsored posting targeted to people who search for “quit smoking” on Facebook. 1. Social Media Postings
    29. 29. 30 2. Website for Intake and Inclusion/ Exclusion Pre-Screening Inclusion Criteria: • Age 18 to 65 • Smokes at least 5 cigarettes daily • Is interested in quitting in the next 30 days • Owns an iPhone with iOS 8 or higher capabilities • Willing and able to receive SMS text messages • Able to comprehend the English language and the informed consent form • Lives in the United States RAPID RECRUITMENT AND STUDY CONDUCT
    30. 30. 31 3. Scheduler for Pre-Screen Call, Call Conducted, Automated Email Invite with Link to Study Portal RAPID RECRUITMENT AND STUDY CONDUCT
    31. 31. 32 4. Study portal: Informed Consent, Baseline Survey, Automated Email link to Apple iTunes with Access Code RAPID RECRUITMENT AND STUDY CONDUCT
    32. 32. 33 • 4/2/2016 Approval by Western IRB • 5/4/2016 Recruitment initiation • 5/16/2016 First participants enrolled • 7/6/2016 Recruitment complete (total: 63 days) • 9/14/2016 Last participant completed • 9/19/2016 Database lock RAPID RECRUITMENT AND STUDY CONDUCT
    33. 33. CLINICALLY VALIDATED PLATFORM 34 Mean Age Years of Smoking Cigarettes Per Day Nicotine Dependence Score / Level 36 18.1 16.7 6.1 / High AVERAGE PARTICIPANT PROFILE A Digital Therapeutics™ Program for Smoking Cessation In September 2016 we completed our 416-participant 8-week clinical study in smoking cessation Participants opened the Clickotine application 100.5 times and performed an additional 130.4 substantive interactions with the program on average ASSOCIATION 45.2% of participants (n=188) had stopped smoking at the end of the study2 ; 26.2% of participants (n=109) achieved 30-day sustained abstinence after 8 weeks Participants who remained engaged at the end of the 8-week study were 2.4 times more likely to achieve 30-day sustained abstinence than those who did not (p<0.0001) EFFICACY ENGAGEMENT 2. No cigarettes, not even a puff, for at least 7 days 1 1. Fagerstrom Test for Nicotine Dependence and scoring
    34. 34. SMOKING BEHAVIOR BREAKDOWN 35 68%of participants quit or reduced average cigarettes smoked per day by more than 50% 26 Lost to follow-up < 50% Cigarette Per Day Reduction > 50% Cigarette Per Day Reduction 7-Day Quitters 14-Day Quitters 30-Day Quitters Meaningful outcomes % 11% 8%23% 20% 12% At the end of the 8-week study
    35. 35. INCREASED ACCESS AND UTILIZATION OF PHARMACOLOGIC QUIT AIDS 36 Baseline Outcome Change Chantix 3 9 +200% Zyban/Wellbutrin 3 7 +133% Any Meds 6 16 +167% Gum 7 28 +300% Inhaler 1 3 +200% Lozenge 3 9 +200% Patch 18 23 +28% Any NRT 25 53 +112% ANY QUIT AID 29 66 +128% Upon enrollment: 29 of 416 participants were using a pharmacologic smoking cessation aid. By study outcome: that number rose to 66 of 416. That is a 128% increase in pharmacologic cessation aid use during the study.
    36. 36. ENHANCED ADHERENCE TO PHARMACOLOGIC QUIT AIDS 37 The distribution of the MMAS-4 scores at baseline: The distribution of the MMAS-4 scores at outcome: Distributions of scores on the Morisky Medication Adherence Scale, 4-item version (MMAS-4). A score of 0 indicates “High Adherence,” 1-2 = “Medium Adherence,” and 3-4 = “Low Adherence.” Mean MMAS-4 score at baseline was 2.35 (SD= 1.43) compared to 1.26 (SD= 1.30) at outcome (t(87)= 3.36, p= 0.001), indicating an increase in adherence to quit aids during the trial. The distribution of MMAS-4 scores is significantly different between baseline and outcome (χ2(4)= 10.94, p= 0.027); there is a significant shift toward increased adherence during the Clickotine® trial. 0 2 4 6 8 0 High… 1 Medium…2 Medium… 3 Low… 4 Low… Count 0 10 20 30 0 High… 1 Medium…2 Medium… 3 Low… 4 Low… Count
    37. 37. ENGAGEMENT / USER EXPERIENCE 38 Overwhelmingly positive feedback SAFE With the program throughout the 8-week study period 1. RCT of Jiff/SmartQuit vs. NCI QuitGuide 1 “Smoked for 6 years and had many failed quit attempts. This actually worked.” 1 No treatment-related adverse event signal identified Participants opened the Clickotine application 100.5 times on average FREQUENT SmartQuit 37.2 QuitGuide 15.2100.5 Clickotine Participants performed an additional 130.4 substantive interactions with the program on average MEANINGFUL “I didn’t think I could stop smoking and this app made it possible. I would recommend this app to anyone that is trying to quit smoking. Amazing app!” “When you’re ready this if by far this best app with the greatest support that I have ever used!!! I would recommend this to anyone who is ready to quit!!! Thanks to the support team at Clickotine, I am smoke free!!!” Exceptional User Experience
    38. 38. EFFICACY 39 1. 45% achieved 7-day and 26% achieved 30-day sustained abstinence 2. 30-day abstinence rate as per Chantix® and Zyban® product labels Advantages Over Other Cessation Strategies 3. 30-day sustained abstinence rate as per Early and recent efficacy studies 4. Average 30-day sustained abstinence rate from 2002 Cochrane Tobacco Addiction Group review 5. 30-day abstinence rate as per RCT of Jiff/SmartQuit vs. NCI QuitGuide 6. CDC report (2011) Quitting Smoking Among Adults
    39. 39. ROBUST & ACTIONABLE DATA COLLECTED 40
    40. 40. CLICKOMETRICS® DIGITAL THERAPEUTICS™ SOLUTIONS MEET BIG DATA 41 User engages with program Data Sales We engage users intensively, intelligently, and individually. The Clickometrics® platform enables our Digital Therapeutics™ programs to learn from users and continuously personalize the experience - tailoring the therapeutic to best fit each individual. Program adapts to user to aid recovery Program collects usage & feedback Clickometrics® Analyzes Data Clickometrics® Data Store Pharma, Payer, Health Data Partners Our Intellectual Property Portfolio Research Output Tech Licensing Platform Licensing
    41. 41. 42 Empirically Supported Interventions Mindful Breathing Medication Adherence Smart Grouping Private Team Chat Interest-based small teams Physician Dashboard HCP DashboardProviding a web-based portal for partners enables observation of population trends, as well as detailed user-by-user data streams A Digital Therapeutics™ Program for Major Depressive Disorder Modules for Behavioral Activation, Cognitive Restructuring and Addressing Acute Mood States. Allow users to monitor and report their moods, and provide targeted strategies to address symptoms Clickteam is what we call a small, algorithmically- designed community to enable users to connect and communicate Scientific algorithm to group people together based on age, location, gender, interests, health profiles, genetic profiles, life goals and personality matching Real-life support from small teams has been clinically proven to be a powerful tool to provide contextualized care, personalized support and guidance Fun, interactive, controlled, mindful breathing experiences coupled with multi-sensory stimuli Fostering stronger connections and facilitating communication between provider and patient CT-151 Individualized Data Live Assistance Individualized monitoring and daily reminder system for antidepressant and anti- anxiety medication prescriptions Patient Tracking & Outcomes Symptom and Side Effect Monitoring Individualized monitoring of relevant side effects and symptoms over time Patient Engagement Data CT-151 is a science-backed solution for major depressive disorder Partnered with
    42. 42. 43 Stimulus Control Sleep Hygiene Management Relaxation Techniques Sleep Restriction Personalized Sleep Support Cognitive Restructuring Professional Caregiving HCP Dashboard Interactive messaging provides continuous support and guidance to help with the treatment of insomnia Paced breathing, and relaxation techniques decrease the high arousal in insomnia and promote sleep onset and continuity Providing a web-based portal for healthcare providers enables observation of population trends, as well as detailed user-by-user data streams Correcting the maladaptive beliefs in insomnia has been shown to effectively improve sleep and maintain improvements in sleep over time Guided individualized sleep restriction program improves sleep quality and quantity in insomnia Remove the conditioned association of maladaptive sleep behaviors with sleep Training to develop sleep habits improves sleep onset and continuity Real-time access to qualified professional caregivers and sleep counselors Collaborating with researchers at Clickadian™ is a science-backed fully digital program for insomnia Download the Clickadian fact sheet
    43. 43. The Janssen Autism Knowledge Engine (JAKE®) - a novel system to revolutionize ASD clinical trials SharpBrains Summit Janssen Research & Development, LLC Gahan Pandina| December 7, 2016
    44. 44. 46
    45. 45. 47
    46. 46. 48
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    50. 50. 52
    51. 51. 53
    52. 52. 54
    53. 53. 55
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    55. 55. 57
    56. 56. 58
    57. 57. TARGETTING NEUROPLASTICITY: EXPERTISE AND VULNERABLE BRAIN REGIONS SARAH BANKS, PHD, LOU RUVO CENTER FOR BRAIN HEALTH, CLEVELAND CLINIC
    58. 58. TAXI DRIVER STUDY (MAGUIRE, 1997)
    59. 59. REGIONAL SPECIALIZATION FOR SMELL AND MEMORY: IMPORTANCE FOR NEURODEGENERATIVE DISEASE Brettschneider et al 2015
    60. 60. MASTER SOMMELIERS • 4 exam process • Covers taste, smell, regional law, chemistry, history….. • Required to make quick decisions in a logical way, all associated with smell • At time of recruitment there were 217 MS worldwide • By limiting to this population, we know we were getting true experts
    61. 61. ONLY IN VEGAS?
    62. 62. STIMULUS PRESENTATION
    63. 63. ARE SOMMELIERS’ BRAINS STRUCTURALLY DIFFERENT Banks, SJ et al 2016
    64. 64. ARE SOMMELIERS’ BRAINS FUNCTIONALLY DIFFERENT?
    65. 65. CONNECTIVITY DIFFERENCES Sreenivisan et al under revi
    66. 66. WHY DOES THIS MATTER? • Sommeliers hone their craft in adulthood • Older sommeliers with the most experience have larger entorhinal cortex • Connectivity and activity differences hint at a mechanism for structural differences • Suggests that adult-based practice and learning can shape the part of the brain most vulnerable to many neurodegenerative disease • But: • We don’t know if bigger means more protected • We don’t know how our results would generalize to “regular” people • The press jumps on studies like this, over interpretation is rampant
    67. 67. NEXT STEPS • Longitudinal research • Studies using sensory-cognition intervention in healthy people and those at risk of decline • It’s the end of the day! time for wine!
    68. 68. ACKNOWLEDGMENTS Sommelier study team Deanna Baldock Erik Beall, PhD David Weintruab, PhD Karthik Sreenivisan Xiaowei Zhuang Dietmar Cordes, PhD Michael Noback Gabriel Leger, PhD Meghan Pierce Johannes Frasnelli, MD Funding: Jeff Cummings, MD; Larry Ruvo Jay James, MS
    69. 69. Q&A
    70. 70. Thank you to all Participants!
    71. 71. Sponsors Thank you to all Speakers & Sponsors!
    72. 72. To learn more, visit sharpbrains.com

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