1.
Harness digital platforms to accelerate R&D and
drive proper adoption

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.
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.
The Growing Basket of Evidence
4

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.
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.
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.
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.
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.
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.
Analytics Progression
11

12.
The Future of Data in Education
12

13.
ETS and the Inevitable Future of Data in Education
13

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

16.
Computational Psychometrics Strategic View
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.
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.
How to Use the Growing Basket of Evidence?
19

20.
Questions and Discussion
2
0

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.
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.
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.
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.
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.
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.
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.
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.
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.
31
3. Scheduler for Pre-Screen Call, Call Conducted, Automated Email Invite
with Link to Study Portal
RAPID RECRUITMENT AND STUDY CONDUCT

31.
32
4. Study portal: Informed Consent, Baseline Survey,
Automated Email link to Apple iTunes with Access Code
RAPID RECRUITMENT AND STUDY CONDUCT

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.
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.
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.
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.
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.
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.
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.
ROBUST & ACTIONABLE DATA COLLECTED
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.
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.
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.
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

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57.
TARGETTING
NEUROPLASTICITY:
EXPERTISE AND VULNERABLE
BRAIN REGIONS
SARAH BANKS, PHD,
LOU RUVO CENTER FOR BRAIN HEALTH,
CLEVELAND CLINIC

58.
TAXI DRIVER STUDY (MAGUIRE,
1997)

59.
REGIONAL SPECIALIZATION FOR SMELL
AND MEMORY: IMPORTANCE FOR
NEURODEGENERATIVE DISEASE
Brettschneider et al 2015

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.
ONLY IN VEGAS?

62.
STIMULUS PRESENTATION

63.
ARE SOMMELIERS’ BRAINS
STRUCTURALLY DIFFERENT
Banks, SJ et al 2016

64.
ARE SOMMELIERS’ BRAINS
FUNCTIONALLY DIFFERENT?

65.
CONNECTIVITY DIFFERENCES
Sreenivisan et al under revi

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.
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.
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.
Q&A

70.
Thank you to all Participants!

71.
Sponsors
Thank you to all Speakers & Sponsors!

72.
To learn more, visit sharpbrains.com