©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential.
Digital Mental Health:
the Hurt, the Hype, the Hope
(with an introductory editorial on the changing ecosystem)
Tom Insel,MD
Co-founder and President, Mindstrong Health
December 6, 2017
©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential.
Political Economic
Scientific Cultural
Populism/Nationali
sm
Conflict/Chaos
Income Disparities
Bull Market
Health Care
Reform
Tax Reform
Mergers and
Acquisition
Opioid Epidemic
Social Media
Disintermediaries
Precision Medicine
BRAIN Initiatives
Big Data/AI
Open Science
December,
2017
©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential.
The Changing Ecosystem of Biomedical Research
2000 - 2010
Public Sector
NIH, NSF, DARPA
Pharma
Biotech/Med Devices
Other (Philanthropy)
Public Sector
NIH, NSF, DARPA
Pharma
Biotech
Other
Tech
2015 - 2020
©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential.
The Changing Ecosystem of Biomedical Research
Start-ups:
$15B invested in Health Tech since 2012
> 1,000 new companies
(Rock Health, 2017)
Insel, Nature, 2017
Tech Giants with health/biomedical
initiatives:
Alibaba, Alphabet, Apple, Facebook,
Fitbit, GE, IBM, Intel, Microsoft
Philanthropy spawned by tech or AI:
Allen Brain Institute
Chan Zuckerberg Initiative
Flatiron Institute/SFARI
Gates Foundation (+ personal funds)
©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential.
The Changing Ecosystem of Health Tech
AI comes of age
Google and Baidu become “AI companies”
Diagnostics incorporate “neural nets” (Gulshan et al, JAMA, 2016)
Treatments via chatbot (Lark, Woebot, Triggr, Koko, et al)
China will be the innovation hub
Alibaba purchases 50 hospitals
Tencent lead investor in both US and China health tech
iCarbonX – remains in stealth
FDA begins to adapt; CMS fails to adopt
Pre-cert pilot (9/17)
Approval of Proteus and Pear
CMS rejects MDPP (11/17) but remote monitoring on deck
©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential.
Digital Mental Health – The Hurt, The Hype, The Hope
Tech and Mental Health
©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential.
The Hurt
©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential.
U.S. Burden of Diseases: 291 diseases and injuries
Leading Categories of DALYs 2010
US Burden of Disease Collaborators, JAMA, 2013.
DALY = disability adjusted life year
©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential.
The most disabling disorders before age 50
©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential.
U.S. suicide rate unchanged in 2 decades
Homicides have dropped from 9.8/100,000 in 1992
to 4.8/100,000 in 2010 (<15,000/yr)
RatePer100,000
SOURCES: Bureau of Justice Statistics (homicide); Centers for Disease Control (suicide)
2014 Suicides: 42,773
2014 Homicides: 14,249
©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential.
Total overdose deaths
> 64K in 2016
Source: NIDA
©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential.
©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential.
Why have we failed to bend the curve?
©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential.
Why have we failed to bend the
curve?
Lack of measurement – We can’t manage what we can’t measure
Peter Drucker
• 60% not receiving careLack of Rx
Delay
Quality
• DUP 74 weeks
• Fragmented, episodic, reactive
More counterfactuals:
Treatments work
Clinicians help
Individuals recover
©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential.
The Hype
©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential.
Digital
Phenotyping
Mobile
Interventions
Care
Management
The Digital Mental Health Landscape
©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential.
Digital
Phenotyping
Mobile
Interventions
Care
Management
CBT, DBT, IPT
Coaching
Peer Support
Crisis Intervention
Sensors
HCI
Voice
Socialit
y
Coordination
Data capture
Quality metrics
Feedback
Learning Engine
The Digital Mental Health Landscape
©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential.
WHAT WE DO TODAY
• Subjective
• Episodic
• Clinic-based
• Reactive
MEASURING MOOD, COGNITION, AND BEHAVIOR
©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential.
MEASURING MOOD, COGNITION, AND BEHAVIOR
Mood 24/7 Measure
14 day Average Negative Peak End Peak-End Mood
Retrospective PHQ
2wk Depression Score
0.48 0.57 0.56 0.61
Peak – End Rule
Kahneman and Tversky
Srijan Sen
unpublished
©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential.
WHAT WE DO TODAY
• Subjective
• Episodic
• Clinic-based
• Reactive
MEASURING MOOD, COGNITION, AND BEHAVIOR
WHAT WE NEED
• Objective
• Continuous
• Ubiquitous
• Proactive
©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential.
23
Smartphones
A medical tool for global health – improving diagnosis and connecting care
Over 3 billion globally and 6 billion
by 2020
Over 70 daily checks
Over 2600 daily “touches”
More ubiquitous than clean water,
indoor plumbing, and stable
electricity
Smartphone subscriptions per region 2014-2020
©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential.
©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential.©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential.
24
SENSORS
Activity
Location
Sociality
VOICE/SPEECH
Prosody
Sentiment
Coherence
HCI - KEYBOARD
Reaction Time
Attention
Memory
Executive Function
DIGITAL PHENOTYPING
A New Kind of Biomarker
Digital PhenotypeRaw Features Digital Biomarkers
MACHINE LEARNING
Pattern Identification
Feature Extraction
©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential.
26
HCI STRATEGY
Digital Phenotyping with Machine Learning
‣Begin with 45 keyboard and scroll patterns (e.g.,
latency between space and character, scrolling
patterns)
‣Create a time-series of performance measures
from each of the 45 patterns
‣Apply 23 signal processing transforms to each
time-series to derive 1,035 potential digital
biomarkers
‣Test highest performing biomarkers with 2-fold
cross validation and with replication studies to
avoid overfitting errors
‣Validate in clinical trials along three dimensions:
(1) psychometric properties; (2) neural
correlates; (3) clinical constructs
©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential.
DIGITAL BIOMARKER PSYCHOMETRIC PROPERTIES
Sensitive and specific for cognitive performance
©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential.
28
THE BEST DIGITAL BIOMARKERS CREATE SIGNATURES THAT
REPRODUCE GOLD STANDARD TESTS
COGNITIVE METRIC MEAN (SD) RANGE R(predicted)
WORKING MEMORY
Digits Forward 10.9 (2.9) 7 — 15 0.82*
Digits Backward 8.3 (2.9) 4 — 14 0.84*
EXECUTIVE FUNCTION
Trails A 22.6 (7.6) 12 — 39 0.81*
Trails B 57.4 (14.5) 42 — 88 0.80*
LANGUAGE
Animal Fluency 21.9 (3.5) 15 — 29 0.78*
FAS Phonemic Fluency 41 (7.2) 27 — 52 0.60*
DEXTERITY
Grooved Pegboard Test (dominant hand) 61.2 (7.3) 46 — 75 0.85*
EPISODIC MEMORY
California Verbal Learning Test (delayed
free recall)
13.6 (2.1) 9 — 16 0.85*
WMS-III Logical Memory (delayed free
recall)
28 (5.3) 19 — 40 0.50**
Brief Visuospatial Memory Test (delayed
free recall)
10.0 (2.0) 5 — 12 0.71*
*p < 10-5
**p<0.01
‣Highest correlating biomarkers
are selected for each cognitive
metric
‣Cross-validated kernel PCA
ensemble is used to make
predictions
‣Predictions are as good as the
test-retest variability of the tests
themselves
Will digital biomarkers become a new clinical ground truth for cognition?
©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential.
WHAT WE DO TODAY
• Subjective
• Episodic
• Clinic-based
• Reactive
MEASURING MOOD, COGNITION, AND BEHAVIOR
WHAT WE NEED
✓ Objective
✓ Continuous
✓ Ubiquitous
✓ Proactive
Passive
©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential.
The Hope – Better Outcomes
Reducing
Suicide
Reducing
Relapse
Preempting
Psychosis
©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential.
Digital
Phenotyping
Mobile
Interventions
Care
Management
CBT, DBT, IPT
Coaching
Peer Support
Crisis Intervention
Sensors
HCI
Voice
Socialit
y
Coordination
Data capture
Quality metrics
Feedback
Learning Engine
The Digital Mental Health Landscape
©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential.
>53M messages since 2013, >2M/month
1/3 of messages -- depression and suicide
19% from 10% lowest income zipcodes
9% Native American; 14% Hispanic
> 3K active rescues
Text 741741
Immediate access
Support for free 24/7
©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential.
7 Cups – an online global peer support system
1.5M monthly users -- 220K listeners
189 countries providing support in 140 languages.
7 Cups approach:
Anonymous – no stigma
Community-focused
On demand 24/7
Convenience – smartphone/laptop
Task shifting/stepped care
Data driven
©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential.
The Efferent Limb – From Decision Support to Optimal Care
Consumer
Self Care
Crisis Intervention
Psychotherapy
Coaching
Peer Support
Education
Provider
Collaborative
Care
Digital Alerts
Dashboards
Digital triage
Digital Assistants
Enterprise
Integrated
Care
Coordination
EHRs
Primary-Specialty
Quality Metrics
Digital Interventions
Technologies: AI, Apps, Conversational Bots, Virtual Reality
Value: On demand, Scalable, Data-driven, Efficient
©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential.
Technologies to Reduce Suicide
Predictive signals
HCI data
Speech/text signals
Online classifiers
Crisis intervention
Upskilling tools for volunteers
On demand support
Social networks
Postvention
Care management
Peer support
AI nurse
Goal: 20% reduction in 5 years.
©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential.
Technologies to Reduce Relapse
Predictive signals
Digital phenotype
Adherence tools
”Smoke alarms”
Connected Care
Dashboards
AI nurse
Integrated care
Building community
Online peer support
Online education
Goal: 50% reduction in 5 years.
©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential.
Technologies to Prevent Psychosis
Predictive signals
Digital phenotyping
Semantic signals
Sleep monitoring
Cognitive Training
Cognitive games
Supportive employ/educ
Coordinated spec care
Psychoeducation
Online education
Family-to-family
Goal: 20% reduction in 5 years.
©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential.
Value Trust
Transparency
Agency
Responsibility
Empowering Patients and Families
With Information
The Digital Mental Health Challenge
Efficacy
Engagement
Efficiency
©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential.
“We always overestimate the change that will occur
in the next two years and underestimate the change
that will occur in the next ten.”
--Bill Gates Jr.
Finally
©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential.
Tom Insel MD
Co-founder, President
tom@mindstronghealth.com
Keynote Template
Thank You
©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential.
©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential.
Top Brainnovations to measure Brain Health & Performance
Savonix — pitch by Greg
Wong, VP Product
Management
HealthTech Connex — pitch
by Dr. Ryan D’Arcy, President
& Chief Scientific Officer
NeuraMetrix — pitch by Jan
Samzelius, Co-Founder &
CEO
Judges
Dr. Adam Haim, Chief of the
Small Business Innovation
Research (SBIR) and Small
Business Technology Transfer
(STTR) Programs at
the National Institute of
Mental Health (NIMH)
Dr. Edward Kliphuis,
Investment Director at Merck
Ventures
Dr. David Barash, Chief
Medical Officer and ED of
Global Health at GE
Foundation
Dr. Karen Postal, President of
the American Academy of
Clinical Neuropsychology
(AACN)
Digital Cognitive Assessment Platform
PROBLEM
1,002
Neuropsychologists
are licensed to administer cognitive testing
43K+
patients per qualified clinician
That’s
43.4 million
people in the U.S. have been diagnosed with cognitive
disorders
SAVONIX as a SOLUTION
Designed for Research and Clinical
Applications
Range of cognition
Virtual clinician
Test behavior flags
Normed percentile reports
Mobile platform
Psychomotor control sensitive
Real time compliance monitoring
HIPAA, Part 11 compliant
Daily Digit Span
The Virtual Clinician ensures consistent, valid administration
through written and spoken instructions
ABOUT SAVONIX
Practice Mode ensures standard clinical administration
with adaptive feedback
ABOUT SAVONIX
Detailed test data delivered to the Savonix Dashboard for clinical review
ABOUT SAVONIX
CUSTOM
ANALYTICS
SCALABLE &
FLEXIBLE
PERSONALIZED
MEDICINE
OPTIMIZED
CLINICAL TRIAL
DESIGN
ENABLES DATA-
DRIVEN R&D
SaaS Licenses
Generate immediate revenue
and enable data collection for
Savonix Cognitive Database
HEALTHCARE
SYSTEMS
INSURANCE
COMPANIES
ACTUARIAL
COMPANIES
PHARMA &
BIOTECH
SAVONIX
COGNITIVE
DATABASE
PATIENT DATA
COLLECTION
DaaS Licenses
Deliver Value to 4 customer segments
• $10.00-$40.00/test range
• Enterprise business buys blocks of test
licenses
• Recurring revenue
HOW SAVONIX WORKS
CUSTOM
ANALYTICS
SCALABLE &
FLEXIBLE
PERSONALIZED
MEDICINE
OPTIMIZED
CLINICAL TRIAL
DESIGN
ENABLES DATA-
DRIVEN R&D
SaaS Licenses
Generate immediate revenue
and enable data collection for
Savonix Cognitive Database
HEALTHCARE
SYSTEMS
INSURANCE
COMPANIES
ACTUARIAL
COMPANIES
PHARMA &
BIOTECH
SAVONIX
COGNITIVE
DATABASE
PATIENT DATA
COLLECTION
DaaS Licenses
Deliver Value to 4 customer segments
• $10.00-$40.00/test range
• Enterprise business buys blocks of test
licenses
• Recurring revenue
HOW SAVONIX WORKS
ADRESSABLE MARKET $15.2B
TAM $23.4B
MARKET OPPORTUNITY
MYLEA CHARVAT, PHD
CEO & Founder
MANAGEMENT TEAM
DAN KOGAN
VP Engineering
DAVID COOPER
COO
GREG WONG
VP Product
BRAIN HEALTH = OVERALL HEALTH
Monitor cognition relative
to baseline assessment
Detect cognitive
impairment early
Define optimal treatment
& management plan
Assess cognition at
multiple time points
HEALTHIER PEOPLE LIVE LONGER LIVES
Thank You
ENDING NEUROLOGICAL ILLNESS
Combining technology and clinical innovation
healthtechconnex.com l @brainvitalsigns
WHAT ARE YOUR
BRAIN VITAL SIGNS?
120/80
60 bpm
?
45 mL*kg
/min
Brain Vital Signs Framework (2012)*
+
Portable EEG technology
increasingly affordable
#1 Most Cited Article in Frontiers of Neuroscience
More than 200 Published Works; 44 Trademarks, Patents and Technical Reports
20+ years of clinical R&D
70+ years of research evidence
NeuroCatch Platform™
✓ ✓ ✓Rapid Automated User-friendly
Tones Words
n = 60
5 mins
5 secs
Auditory sensation (N100): 1-5
Basic attention (P300): 1-5
Cognitive processing (N400): 1-5
Includes N100 + P300 + N400✓ Objective and Physiological
0.00
20.00
40.00
60.00
80.00
100.00
Auditory
Sensati…
Auditory
Sensati…
Basic
Attenti…
Basic
Attenti…
Cognitive
Processi…
Cognitive
Processi…
Baseline
0.00
20.00
40.00
60.00
80.00
100.00
Auditory
Sensati…
Auditory
Sensati…
Basic
Attenti…
Basic
Attenti…
Cognitive
Processi…
Cognitive
Processi…
Concussio
n
0.00
20.00
40.00
60.00
80.00
100.00
Auditory
Sensati…
Auditory
Sensati…
Basic
Attenti…
Basic
Attenti…
Cognitive
Processi…
Cognitive
Processi…
Return to
Play
Concussion Profile using
Brain Vital Signs™ and NeuroRadar™
IMPACT
HEALTH INSTITUTIONS
Accuracy & Efficiency
Risk Mitigation
SOCIETY
Reduced Tax Burden
Global Health
INDIVIDUALS
Evaluation
Prevention
1 in 3 people will experience a
neurological condition in their lifetime
Upfront Charge: NeuroCatch Platform™
Recurring Revenue: Reports
Generated
Pay-Per-Scan
Subscription Model
Lease
Purchase
Future: Big Data Analytics
SALES
PROJECTION
Baseline Evaluation
Prognostics
$750M BVS
10%
$75M by 2020
Total addressable market:
Comparison (US alone)
GLOBAL MARKET
Neuro Healthcare Market: Over $30 billion within 5 years
(Grand View Research: Neuroscience Market Analysis 2015)
WE CAN HAVE A VITAL SIGN
FOR BRAIN FUNCTION
healthtechconnex.com l @brainvitalsigns
TRANSLATING ADVANCED NEUROSCIENCE R&D INTO PRACTICAL SOLUTIONS
ConfidentialDecember 6, 2017
SharpBrains Virtual Summit
Jan Samzelius, CEO
68
• Rid the world of passwords
Novelty
69
• Rid the world of passwords
• Discovered that typing cadence is the strongest
habit
Novelty
70
• Rid the world of passwords
• Discovered that typing cadence is the strongest
habit
• “I bet you that can also be used to detect
Alzheimer’s”
Novelty
71
• Rid the world of passwords
• Discovered that typing cadence is the strongest
habit
• “I bet you that can also be used to detect
Alzheimer’s”
• “You realize we have been looking for this for 30
years.” - Bob Mahley, Founder, Gladstone
Novelty
72
Digital Bio-marker
•Install and forget
•Passive
•No tests
•No sensors
•Cadence NOT content
•Runs in background
•Fully automated
•Cloud-based
•Big data analytics
•Proprietary algorithms
•HIPAA compliant
•Sub-clinical (ms)
•Binary
•Continuous
•Predictive
•Personalized
All software and internet – infinite scalability and
great economics
+ =
73
Drug Development Clinical
Management
Consumer
Use Cases
• New therapies
• Early detection/
applications
• Monitor
• Manage
• Differentiate
• Monitor
• Self-manage
74
PD Patient - Unstable
PD Patient – Unstable/Getting Worse Control - Diagnosed/Treated?
PD Patient - Stable
Research
75
Early Diagnosis Tool?
Fox Trial Finders – Control
76
Academic
institutions
Research
Programs
Diseases/
Disorders
Countries
10 14 10 5
Ongoing Research
77
IP Approach
• Patents
• Trade Secrets
• Reverse engineering not possible
• Size of database
• 100M data points > 1B by end of Q1
• Disease fingerprints
78
Impact
• Millions of patients enjoying a better life
• Early detection enabling pharma to develop drugs
leading to people enjoying life without suffering
from the disease or outright cures
79
• Large unmet need
• Huge market
• Lots of well protected IP
• Very simple solution
• Internet and software = great financials
Summary
ConfidentialDecember 6, 2017
SharpBrains Virtual Summit
Jan Samzelius, CEO
Thank you, Speakers & Participants!
Thank you, Summit Sponsors!
Thank you, Summit Partners!
To learn more, visit sharpbrains.com

Digital Mental Health: the Hurt, the Hype, the Hope + Brainnovations Session 1

  • 3.
    ©2014 Mindstrong. AllRights Reserved. Proprietary and Confidential. Digital Mental Health: the Hurt, the Hype, the Hope (with an introductory editorial on the changing ecosystem) Tom Insel,MD Co-founder and President, Mindstrong Health December 6, 2017
  • 4.
    ©2014 Mindstrong. AllRights Reserved. Proprietary and Confidential. Political Economic Scientific Cultural Populism/Nationali sm Conflict/Chaos Income Disparities Bull Market Health Care Reform Tax Reform Mergers and Acquisition Opioid Epidemic Social Media Disintermediaries Precision Medicine BRAIN Initiatives Big Data/AI Open Science December, 2017
  • 5.
    ©2014 Mindstrong. AllRights Reserved. Proprietary and Confidential. The Changing Ecosystem of Biomedical Research 2000 - 2010 Public Sector NIH, NSF, DARPA Pharma Biotech/Med Devices Other (Philanthropy) Public Sector NIH, NSF, DARPA Pharma Biotech Other Tech 2015 - 2020
  • 6.
    ©2014 Mindstrong. AllRights Reserved. Proprietary and Confidential. The Changing Ecosystem of Biomedical Research Start-ups: $15B invested in Health Tech since 2012 > 1,000 new companies (Rock Health, 2017) Insel, Nature, 2017 Tech Giants with health/biomedical initiatives: Alibaba, Alphabet, Apple, Facebook, Fitbit, GE, IBM, Intel, Microsoft Philanthropy spawned by tech or AI: Allen Brain Institute Chan Zuckerberg Initiative Flatiron Institute/SFARI Gates Foundation (+ personal funds)
  • 7.
    ©2014 Mindstrong. AllRights Reserved. Proprietary and Confidential. The Changing Ecosystem of Health Tech AI comes of age Google and Baidu become “AI companies” Diagnostics incorporate “neural nets” (Gulshan et al, JAMA, 2016) Treatments via chatbot (Lark, Woebot, Triggr, Koko, et al) China will be the innovation hub Alibaba purchases 50 hospitals Tencent lead investor in both US and China health tech iCarbonX – remains in stealth FDA begins to adapt; CMS fails to adopt Pre-cert pilot (9/17) Approval of Proteus and Pear CMS rejects MDPP (11/17) but remote monitoring on deck
  • 8.
    ©2014 Mindstrong. AllRights Reserved. Proprietary and Confidential. Digital Mental Health – The Hurt, The Hype, The Hope Tech and Mental Health
  • 9.
    ©2014 Mindstrong. AllRights Reserved. Proprietary and Confidential. The Hurt
  • 10.
    ©2014 Mindstrong. AllRights Reserved. Proprietary and Confidential. U.S. Burden of Diseases: 291 diseases and injuries Leading Categories of DALYs 2010 US Burden of Disease Collaborators, JAMA, 2013. DALY = disability adjusted life year
  • 11.
    ©2014 Mindstrong. AllRights Reserved. Proprietary and Confidential. The most disabling disorders before age 50
  • 12.
    ©2014 Mindstrong. AllRights Reserved. Proprietary and Confidential. U.S. suicide rate unchanged in 2 decades Homicides have dropped from 9.8/100,000 in 1992 to 4.8/100,000 in 2010 (<15,000/yr) RatePer100,000 SOURCES: Bureau of Justice Statistics (homicide); Centers for Disease Control (suicide) 2014 Suicides: 42,773 2014 Homicides: 14,249
  • 13.
    ©2014 Mindstrong. AllRights Reserved. Proprietary and Confidential. Total overdose deaths > 64K in 2016 Source: NIDA
  • 14.
    ©2014 Mindstrong. AllRights Reserved. Proprietary and Confidential.
  • 15.
    ©2014 Mindstrong. AllRights Reserved. Proprietary and Confidential. Why have we failed to bend the curve?
  • 16.
    ©2014 Mindstrong. AllRights Reserved. Proprietary and Confidential. Why have we failed to bend the curve? Lack of measurement – We can’t manage what we can’t measure Peter Drucker • 60% not receiving careLack of Rx Delay Quality • DUP 74 weeks • Fragmented, episodic, reactive More counterfactuals: Treatments work Clinicians help Individuals recover
  • 17.
    ©2014 Mindstrong. AllRights Reserved. Proprietary and Confidential. The Hype
  • 18.
    ©2014 Mindstrong. AllRights Reserved. Proprietary and Confidential. Digital Phenotyping Mobile Interventions Care Management The Digital Mental Health Landscape
  • 19.
    ©2014 Mindstrong. AllRights Reserved. Proprietary and Confidential. Digital Phenotyping Mobile Interventions Care Management CBT, DBT, IPT Coaching Peer Support Crisis Intervention Sensors HCI Voice Socialit y Coordination Data capture Quality metrics Feedback Learning Engine The Digital Mental Health Landscape
  • 20.
    ©2014 Mindstrong. AllRights Reserved. Proprietary and Confidential. WHAT WE DO TODAY • Subjective • Episodic • Clinic-based • Reactive MEASURING MOOD, COGNITION, AND BEHAVIOR
  • 21.
    ©2014 Mindstrong. AllRights Reserved. Proprietary and Confidential. MEASURING MOOD, COGNITION, AND BEHAVIOR Mood 24/7 Measure 14 day Average Negative Peak End Peak-End Mood Retrospective PHQ 2wk Depression Score 0.48 0.57 0.56 0.61 Peak – End Rule Kahneman and Tversky Srijan Sen unpublished
  • 22.
    ©2014 Mindstrong. AllRights Reserved. Proprietary and Confidential. WHAT WE DO TODAY • Subjective • Episodic • Clinic-based • Reactive MEASURING MOOD, COGNITION, AND BEHAVIOR WHAT WE NEED • Objective • Continuous • Ubiquitous • Proactive
  • 23.
    ©2014 Mindstrong. AllRights Reserved. Proprietary and Confidential. 23 Smartphones A medical tool for global health – improving diagnosis and connecting care Over 3 billion globally and 6 billion by 2020 Over 70 daily checks Over 2600 daily “touches” More ubiquitous than clean water, indoor plumbing, and stable electricity Smartphone subscriptions per region 2014-2020
  • 24.
    ©2014 Mindstrong. AllRights Reserved. Proprietary and Confidential.
  • 25.
    ©2014 Mindstrong. AllRights Reserved. Proprietary and Confidential.©2014 Mindstrong. All Rights Reserved. Proprietary and Confidential. 24 SENSORS Activity Location Sociality VOICE/SPEECH Prosody Sentiment Coherence HCI - KEYBOARD Reaction Time Attention Memory Executive Function DIGITAL PHENOTYPING A New Kind of Biomarker Digital PhenotypeRaw Features Digital Biomarkers MACHINE LEARNING Pattern Identification Feature Extraction
  • 26.
    ©2014 Mindstrong. AllRights Reserved. Proprietary and Confidential. 26 HCI STRATEGY Digital Phenotyping with Machine Learning ‣Begin with 45 keyboard and scroll patterns (e.g., latency between space and character, scrolling patterns) ‣Create a time-series of performance measures from each of the 45 patterns ‣Apply 23 signal processing transforms to each time-series to derive 1,035 potential digital biomarkers ‣Test highest performing biomarkers with 2-fold cross validation and with replication studies to avoid overfitting errors ‣Validate in clinical trials along three dimensions: (1) psychometric properties; (2) neural correlates; (3) clinical constructs
  • 27.
    ©2014 Mindstrong. AllRights Reserved. Proprietary and Confidential. DIGITAL BIOMARKER PSYCHOMETRIC PROPERTIES Sensitive and specific for cognitive performance
  • 28.
    ©2014 Mindstrong. AllRights Reserved. Proprietary and Confidential. 28 THE BEST DIGITAL BIOMARKERS CREATE SIGNATURES THAT REPRODUCE GOLD STANDARD TESTS COGNITIVE METRIC MEAN (SD) RANGE R(predicted) WORKING MEMORY Digits Forward 10.9 (2.9) 7 — 15 0.82* Digits Backward 8.3 (2.9) 4 — 14 0.84* EXECUTIVE FUNCTION Trails A 22.6 (7.6) 12 — 39 0.81* Trails B 57.4 (14.5) 42 — 88 0.80* LANGUAGE Animal Fluency 21.9 (3.5) 15 — 29 0.78* FAS Phonemic Fluency 41 (7.2) 27 — 52 0.60* DEXTERITY Grooved Pegboard Test (dominant hand) 61.2 (7.3) 46 — 75 0.85* EPISODIC MEMORY California Verbal Learning Test (delayed free recall) 13.6 (2.1) 9 — 16 0.85* WMS-III Logical Memory (delayed free recall) 28 (5.3) 19 — 40 0.50** Brief Visuospatial Memory Test (delayed free recall) 10.0 (2.0) 5 — 12 0.71* *p < 10-5 **p<0.01 ‣Highest correlating biomarkers are selected for each cognitive metric ‣Cross-validated kernel PCA ensemble is used to make predictions ‣Predictions are as good as the test-retest variability of the tests themselves Will digital biomarkers become a new clinical ground truth for cognition?
  • 29.
    ©2014 Mindstrong. AllRights Reserved. Proprietary and Confidential. WHAT WE DO TODAY • Subjective • Episodic • Clinic-based • Reactive MEASURING MOOD, COGNITION, AND BEHAVIOR WHAT WE NEED ✓ Objective ✓ Continuous ✓ Ubiquitous ✓ Proactive Passive
  • 30.
    ©2014 Mindstrong. AllRights Reserved. Proprietary and Confidential. The Hope – Better Outcomes Reducing Suicide Reducing Relapse Preempting Psychosis
  • 31.
    ©2014 Mindstrong. AllRights Reserved. Proprietary and Confidential. Digital Phenotyping Mobile Interventions Care Management CBT, DBT, IPT Coaching Peer Support Crisis Intervention Sensors HCI Voice Socialit y Coordination Data capture Quality metrics Feedback Learning Engine The Digital Mental Health Landscape
  • 32.
    ©2014 Mindstrong. AllRights Reserved. Proprietary and Confidential. >53M messages since 2013, >2M/month 1/3 of messages -- depression and suicide 19% from 10% lowest income zipcodes 9% Native American; 14% Hispanic > 3K active rescues Text 741741 Immediate access Support for free 24/7
  • 33.
    ©2014 Mindstrong. AllRights Reserved. Proprietary and Confidential. 7 Cups – an online global peer support system 1.5M monthly users -- 220K listeners 189 countries providing support in 140 languages. 7 Cups approach: Anonymous – no stigma Community-focused On demand 24/7 Convenience – smartphone/laptop Task shifting/stepped care Data driven
  • 34.
    ©2014 Mindstrong. AllRights Reserved. Proprietary and Confidential. The Efferent Limb – From Decision Support to Optimal Care Consumer Self Care Crisis Intervention Psychotherapy Coaching Peer Support Education Provider Collaborative Care Digital Alerts Dashboards Digital triage Digital Assistants Enterprise Integrated Care Coordination EHRs Primary-Specialty Quality Metrics Digital Interventions Technologies: AI, Apps, Conversational Bots, Virtual Reality Value: On demand, Scalable, Data-driven, Efficient
  • 35.
    ©2014 Mindstrong. AllRights Reserved. Proprietary and Confidential. Technologies to Reduce Suicide Predictive signals HCI data Speech/text signals Online classifiers Crisis intervention Upskilling tools for volunteers On demand support Social networks Postvention Care management Peer support AI nurse Goal: 20% reduction in 5 years.
  • 36.
    ©2014 Mindstrong. AllRights Reserved. Proprietary and Confidential. Technologies to Reduce Relapse Predictive signals Digital phenotype Adherence tools ”Smoke alarms” Connected Care Dashboards AI nurse Integrated care Building community Online peer support Online education Goal: 50% reduction in 5 years.
  • 37.
    ©2014 Mindstrong. AllRights Reserved. Proprietary and Confidential. Technologies to Prevent Psychosis Predictive signals Digital phenotyping Semantic signals Sleep monitoring Cognitive Training Cognitive games Supportive employ/educ Coordinated spec care Psychoeducation Online education Family-to-family Goal: 20% reduction in 5 years.
  • 38.
    ©2014 Mindstrong. AllRights Reserved. Proprietary and Confidential. Value Trust Transparency Agency Responsibility Empowering Patients and Families With Information The Digital Mental Health Challenge Efficacy Engagement Efficiency
  • 39.
    ©2014 Mindstrong. AllRights Reserved. Proprietary and Confidential. “We always overestimate the change that will occur in the next two years and underestimate the change that will occur in the next ten.” --Bill Gates Jr. Finally
  • 40.
    ©2014 Mindstrong. AllRights Reserved. Proprietary and Confidential. Tom Insel MD Co-founder, President [email protected] Keynote Template Thank You
  • 41.
    ©2014 Mindstrong. AllRights Reserved. Proprietary and Confidential.
  • 42.
    ©2014 Mindstrong. AllRights Reserved. Proprietary and Confidential.
  • 43.
    Top Brainnovations tomeasure Brain Health & Performance Savonix — pitch by Greg Wong, VP Product Management HealthTech Connex — pitch by Dr. Ryan D’Arcy, President & Chief Scientific Officer NeuraMetrix — pitch by Jan Samzelius, Co-Founder & CEO
  • 44.
    Judges Dr. Adam Haim,Chief of the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Programs at the National Institute of Mental Health (NIMH) Dr. Edward Kliphuis, Investment Director at Merck Ventures Dr. David Barash, Chief Medical Officer and ED of Global Health at GE Foundation Dr. Karen Postal, President of the American Academy of Clinical Neuropsychology (AACN)
  • 45.
  • 46.
    PROBLEM 1,002 Neuropsychologists are licensed toadminister cognitive testing 43K+ patients per qualified clinician That’s 43.4 million people in the U.S. have been diagnosed with cognitive disorders
  • 47.
    SAVONIX as aSOLUTION Designed for Research and Clinical Applications Range of cognition Virtual clinician Test behavior flags Normed percentile reports Mobile platform Psychomotor control sensitive Real time compliance monitoring HIPAA, Part 11 compliant
  • 48.
    Daily Digit Span TheVirtual Clinician ensures consistent, valid administration through written and spoken instructions ABOUT SAVONIX
  • 49.
    Practice Mode ensuresstandard clinical administration with adaptive feedback ABOUT SAVONIX
  • 50.
    Detailed test datadelivered to the Savonix Dashboard for clinical review ABOUT SAVONIX
  • 51.
    CUSTOM ANALYTICS SCALABLE & FLEXIBLE PERSONALIZED MEDICINE OPTIMIZED CLINICAL TRIAL DESIGN ENABLESDATA- DRIVEN R&D SaaS Licenses Generate immediate revenue and enable data collection for Savonix Cognitive Database HEALTHCARE SYSTEMS INSURANCE COMPANIES ACTUARIAL COMPANIES PHARMA & BIOTECH SAVONIX COGNITIVE DATABASE PATIENT DATA COLLECTION DaaS Licenses Deliver Value to 4 customer segments • $10.00-$40.00/test range • Enterprise business buys blocks of test licenses • Recurring revenue HOW SAVONIX WORKS
  • 52.
    CUSTOM ANALYTICS SCALABLE & FLEXIBLE PERSONALIZED MEDICINE OPTIMIZED CLINICAL TRIAL DESIGN ENABLESDATA- DRIVEN R&D SaaS Licenses Generate immediate revenue and enable data collection for Savonix Cognitive Database HEALTHCARE SYSTEMS INSURANCE COMPANIES ACTUARIAL COMPANIES PHARMA & BIOTECH SAVONIX COGNITIVE DATABASE PATIENT DATA COLLECTION DaaS Licenses Deliver Value to 4 customer segments • $10.00-$40.00/test range • Enterprise business buys blocks of test licenses • Recurring revenue HOW SAVONIX WORKS
  • 53.
    ADRESSABLE MARKET $15.2B TAM$23.4B MARKET OPPORTUNITY
  • 54.
    MYLEA CHARVAT, PHD CEO& Founder MANAGEMENT TEAM DAN KOGAN VP Engineering DAVID COOPER COO GREG WONG VP Product
  • 55.
    BRAIN HEALTH =OVERALL HEALTH Monitor cognition relative to baseline assessment Detect cognitive impairment early Define optimal treatment & management plan Assess cognition at multiple time points HEALTHIER PEOPLE LIVE LONGER LIVES
  • 56.
  • 57.
    ENDING NEUROLOGICAL ILLNESS Combiningtechnology and clinical innovation healthtechconnex.com l @brainvitalsigns
  • 58.
    WHAT ARE YOUR BRAINVITAL SIGNS? 120/80 60 bpm ? 45 mL*kg /min
  • 59.
    Brain Vital SignsFramework (2012)* + Portable EEG technology increasingly affordable #1 Most Cited Article in Frontiers of Neuroscience More than 200 Published Works; 44 Trademarks, Patents and Technical Reports 20+ years of clinical R&D 70+ years of research evidence
  • 60.
    NeuroCatch Platform™ ✓ ✓✓Rapid Automated User-friendly
  • 61.
    Tones Words n =60 5 mins 5 secs Auditory sensation (N100): 1-5 Basic attention (P300): 1-5 Cognitive processing (N400): 1-5 Includes N100 + P300 + N400✓ Objective and Physiological
  • 62.
  • 63.
    IMPACT HEALTH INSTITUTIONS Accuracy &Efficiency Risk Mitigation SOCIETY Reduced Tax Burden Global Health INDIVIDUALS Evaluation Prevention 1 in 3 people will experience a neurological condition in their lifetime
  • 64.
    Upfront Charge: NeuroCatchPlatform™ Recurring Revenue: Reports Generated Pay-Per-Scan Subscription Model Lease Purchase Future: Big Data Analytics SALES PROJECTION Baseline Evaluation Prognostics $750M BVS 10% $75M by 2020 Total addressable market: Comparison (US alone)
  • 65.
    GLOBAL MARKET Neuro HealthcareMarket: Over $30 billion within 5 years (Grand View Research: Neuroscience Market Analysis 2015)
  • 66.
    WE CAN HAVEA VITAL SIGN FOR BRAIN FUNCTION healthtechconnex.com l @brainvitalsigns TRANSLATING ADVANCED NEUROSCIENCE R&D INTO PRACTICAL SOLUTIONS
  • 67.
    ConfidentialDecember 6, 2017 SharpBrainsVirtual Summit Jan Samzelius, CEO
  • 68.
    68 • Rid theworld of passwords Novelty
  • 69.
    69 • Rid theworld of passwords • Discovered that typing cadence is the strongest habit Novelty
  • 70.
    70 • Rid theworld of passwords • Discovered that typing cadence is the strongest habit • “I bet you that can also be used to detect Alzheimer’s” Novelty
  • 71.
    71 • Rid theworld of passwords • Discovered that typing cadence is the strongest habit • “I bet you that can also be used to detect Alzheimer’s” • “You realize we have been looking for this for 30 years.” - Bob Mahley, Founder, Gladstone Novelty
  • 72.
    72 Digital Bio-marker •Install andforget •Passive •No tests •No sensors •Cadence NOT content •Runs in background •Fully automated •Cloud-based •Big data analytics •Proprietary algorithms •HIPAA compliant •Sub-clinical (ms) •Binary •Continuous •Predictive •Personalized All software and internet – infinite scalability and great economics + =
  • 73.
    73 Drug Development Clinical Management Consumer UseCases • New therapies • Early detection/ applications • Monitor • Manage • Differentiate • Monitor • Self-manage
  • 74.
    74 PD Patient -Unstable PD Patient – Unstable/Getting Worse Control - Diagnosed/Treated? PD Patient - Stable Research
  • 75.
    75 Early Diagnosis Tool? FoxTrial Finders – Control
  • 76.
  • 77.
    77 IP Approach • Patents •Trade Secrets • Reverse engineering not possible • Size of database • 100M data points > 1B by end of Q1 • Disease fingerprints
  • 78.
    78 Impact • Millions ofpatients enjoying a better life • Early detection enabling pharma to develop drugs leading to people enjoying life without suffering from the disease or outright cures
  • 79.
    79 • Large unmetneed • Huge market • Lots of well protected IP • Very simple solution • Internet and software = great financials Summary
  • 80.
    ConfidentialDecember 6, 2017 SharpBrainsVirtual Summit Jan Samzelius, CEO
  • 82.
    Thank you, Speakers& Participants!
  • 83.
  • 84.
  • 85.
    To learn more,visit sharpbrains.com