This document discusses opportunities and challenges of using mobile health technologies, wearables, and sensors in pharmaceutical research. It describes a vision for the clinical research of the future where patients can be directly dosed, monitored, and engaged through digital tools from their home. Examples are provided of how electronic patient-reported outcomes, biosensors, medical records, drug delivery, and a study companion app could be integrated into a direct-to-patient research model over the course of a day. The document also outlines considerations for determining whether a particular digital health approach or device is well-suited for integration into a patient registry.

1. © Copyright 2015 Quintiles
Opportunities and Challenges of Mobile Health,
Wearables and Sensors for Pharma
John Reites
Head of Digital Health Acceleration
Quintiles
@Quintiles
@JohnReites
Boston, MA
05 April 2016

2. 2

3. 3
Day 1 8:00 am
10:05
am
10:30
am
1:00
pm
3:00
pm
5:00
pm
7:00
pm
Day 2 Day 3
Delivery
and
Compliance
ePRO
Prompt patient via app to
complete validated
questionnaire and/or
cognition spatial memory
task
BioSensor
Worn by
Patient
Patient
Reported
Data
Medical Records Update
Data from the physician visit/lab
inputted into eMR, routes to
patient and study database
Drug Delivery
IP or prescription
delivered direct-to-
patient connected to
unique ID to maintain
consent requirements
Continuos Monitoring
As IP metabolises, begin
continous monitoring.
At Home
Lab Kit
Home Lab
Lab kit sent directly to
patient and
completed/returned to
central lab
Study Companion
App Support and
Compliance
Engagement
Reminder, education content and
med risk rating prompt patient to
take investigational /prescribed
product linked to adherence
support solution
Design
Scientific rigor and patient
experience-based design
consents patient directly
through informed process
Protocol
and
Consent
Medical
Record
Data
Study Companion
App Support and
Compliance
Feedback
Patient provided with
follow-up on their
activities, progress chart,
positive reinforcement and
direct reimbursement
Day 1 - Patient Dosing, Monitoring and Patient Engagement
Clinical Research of the Future?

4. 4
Partner
Strategic
Initiative
Customer
Idea
OfferingIdea
Idea
Idea
Internal innovation
• Innovation themes
• BU offering need
• Internal ideation
External innovation
• Joint partnership
• Customer co-development
• Startup integration pilot
Idea
Alignment with partner including funding per project + dedicated
domain expert resource(s) + senior leadership sponsor
Startup
Idea
Workspace
• Co-located space
• Mix of on-site/off-site
• Casual, agile
environment + dress
code
Team
• Dedicated +
empowered domain
experts from BU
• Solution Design
Studio (developer +
designer)
• Acceleration PM
Mentors
• Rotated attendance
from
advisors/mentors
• Access to internal
SMEs
• Regulatory and Legal
input at stage-gates
Process
• Quintiles approach and
methodology + Lean
Startup for 90 day
session
• Learning/testing-driven
process
• Stage-gate reviews with
limited stakeholders for
validation
Tools
• iRise (simulation)
• Appian (process)
• Box (file storage)
• HP PPM (PM tool)
• Amazon WS /
Microsoft Azure
(web storage)
KPIs
• Weekly progress
report to stakeholders
• Go/Fail stage-gates
• A/B testing
documented
• MVP V1.0 is the
deliverable with exit
transition to BU

5. 5
strategies to influence
and execute digital
health approaches4

6. 6
Sell your business
case and influence
stakeholders1

7. 7
Digital Health Acceleration
Lean Canvas Business Case <Project Name>
<date>
<version>
Cost Structure
Anticipated management costs, distribution costs, hosting,
resources, vendors, etc.
Revenue Streams
Revenue model, lifetime value, projected gross margin, etc.
Customer/Quintiles
Challenge
Problem this project is
working to solve
Potential Solution
Key features planned
Metrics/KPIs
Key activities you
measure
Unique Value
Proposition
Single, clear,
compelling message
that states why this
innovation is different
and worth paying
attention for our
customer and/or
market
Unfair Advantage
Can’t be easily copied
or bought as a
differentiator
Channels
Path to customers
and/or market via
integration, sales,
process, etc.
Customer
Segments
Target customers and
product users including
company divisions,
roles, etc.
PRODUCT MARKET
Accelerator Start Date: <insert date> Accelerator Complete Date: <insert date>

8. 8
PURPOSE
1
What is the key objective for using this digital health approach in
the study (i.e. what will we accomplish by integrating it into the
registry)?
USABILITY
2
What is the plan for integration of the approach in the operations of
the registry with the physician and patient?
3
Would a patient use the digital health approach and see direct
benefit/engagement?
4
Who will be providing patients with technical support should
something go wrong with the device itself?
DATA CAPTURE
5
Can the provenance of data captured be verified? Are you willing to
accept the risk that data may be from another person who is not
the patient?
6
Could the data collected be stored in one country or would it have
to be stored in multiple countries?
7
Are there any restrictions on where the data could be analyzed
(e.g., country restrictions)?
When determining which digital health approach or device will be utilized in a registry, it is important for the following criteria to be met as a baseline for
evaluation. This checklist is intended to serve as a guide in the decision making process and is not comprehensive of all study issues that should be evaluated
prior to the use of a digital health approach or device within a registry. If the study team involved is unable to answer the criteria question below or if the
response does not hold “significant” impact to the registry, careful consideration should be given to whether or not the approach/device is best suited for use.
Digital Health Approach Criteria Worksheet

9. 9
Digital Health Intelligence Report

10. 10
Your stakeholder
opportunity
2m 8m

11. 11
Plan for the omni-
channel experience2

12. 12
“Give me six hours to chop
down a tree and I will spend
the first four sharpening
the axe.”
Abraham Lincoln

13. 13
Direct-to-Patient via mHealth
IDEA DEVELOP DEPLOY
Conduct a direct-to-patient
program via web and
ResearchKit for rapid data
collection in niche patient
population
Developed entire direct-to-patient
study with inclusion of several
Quintiles business units and
launched project within IRB
approval in ~5 weeks – FPI in
minutes
Enrolled and completed 300th
patient 7 weeks ahead of
accelerated schedule – increased
enrolment to 700 completers 5
weeks ahead of original 300
completer schedule – full project
completed in <120 days
Scientific
Design,
Protocol and
Content
US CIRB /
ROW CEC
Approval
Content ePROResearchKit
and Web
Study
Launch
Informed
Consent
Module
Survey
Module
Survey
Payment Wearable Chart
Email
SMS
Data
Analysis /
Publication
Active
Tasks
Modules
Dash-
board
Health
Data
Medical
Record
Survey
Module
Infosario Integrated Data Collection & Cloud Storage

14. 14
Consumer Device Provisioning

15. 15
Connect insights to
design the solution3

16. 16

17. 17
Apple ResearchKit Enhancement
IDEA DEVELOP DEPLOY
Enhance Apple ResearchKit
to include patient
engagement approaches for
better use in Phase I – IV
programs
Gained deep insights and
developed ResearchKit source
code framework to include new
functionality and the Patient
Engagement Module
GitHub approval and
integration of Patient
Engagement Module code –
offering now available for
customer projects – project
completed in <120 days
Quintiles and ResearchKit website - http://www.quintiles.com/landing-pages/research-kit
Wearable Connect Video

18. 18
Plan for the Global Landscape
Regulatory, privacy, cultural and digital enablement knowledge

19. 19
Engagement Index for Wearables
Extremely or very likely to
continue with daily (digital
direct-to-patient) diary only
86%
Extremely or very likely to
continue with a different
biosensor device
83%

20. 20
Source: http://sethgodin.com
“What matters now is trust,
permission, remarkability,
leadership, stories that spread
and humanity: connection,
compassion, and humility”
– Seth Godin
The Icarus Deception

21. 21
Launch with the end
in mind to scale4

22. 22
Direct-to-Patient w/ ePRO, mHealth diary + biosensor
IDEA DEVELOP DEPLOY
• Customization of the
device for clinical study
use and integration
• Can device data replace
standard ePRO
collection?
• Custom-branded study w/ patient
community and experience
• Digital recruitment was
conducted with a process to
deliver/integrate digital health
devices with patients
• 150 patients enrolled in
three (3) weeks
• Study completed in
months as opposed to
years if a site-based
project

23. 23
Innovation Roadmap Example
Q3 Q4
2015 2016
Q1 Q2 Q3 Q4
Version1DevelopmentMap
Strategy Plan Budget
Approved
IT Platform
Fully Released
Version 2
~$TBD
ROI metric #1
New channel (i.e. mobile, new indication, etc.)
Version 1 innovation
Future version innovation
Product
Rationalization
Version 3
~$TBD
ROI metrics to confirm progress
Expand innovation
ROI Metric #2
KPI #1 KPI #2 KPI #3 KPI #4

24. 24
Direct-to-Patient w/ ePRO, Chart + Lab

25. 25
What’s Next?