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Copyright © 2016 QuintilesIMS. All rights reserved.

Innovation and new trends in clinical trials QuintilesIMS – Next Generation Clinical Development

Site and Patient Networks QuintilesIMS

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Digital Health

Digital health is the convergence of the digital and genomic

revolutions with health, healthcare, living, and society. As we are seeing

and experiencing, digital health is empowering us to better track,

manage, and improve our own and our family’s health, live better, more

productive lives, and improve society. It’s also helping to reduce

inefficiencies in healthcare delivery, improve access, reduce costs,

increase quality, and make medicine more personalized and precise.

https://en.wikipedia.org/wiki/Digital_health

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Digital health

• The essential elements of the digital health revolution include wireless devices, hardware

sensors and software sensing technologies, microprocessors and integrated circuits, the

Internet, social networking, mobile and body area networks, health information

technology, genomics, and personal genetic information.

Source: http://storyofdigitalhealth.com/solutions/

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530M patient records*; 30+ countries including deep clinical EMR

and claims

14.3M+ healthcare professionals

4.9M potential investigators

Hospital data: 40 countries

Prescription data: 90 countries

300,000 social media sources

15+ petabytes of unique data

100,000+ data suppliers

800,000+ data feeds

QuintilesIMS

Significant scale and complexity of healthcare data

Electronic

medical

and health

records

Social

media

Consumer

Claims

Hospital

Healthcare

professionals

Pharmacy

Lab/Biomarkers Disease registries

Deterministic linkages across multiple healthcare

settings on global and local basis

* anonymous

BROAD

DEEP

Ran

ge o

f d

ata

typ

es

Population coverage

Deep, flexible therapy-area-specific data

Nationally relevant databases

Augmented datasets

Biobanks, labs,

registries

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Deep insights

informed by

evidence and

experience

Industrialized analytics for rapid insight delivery

Seamlessly integrated to support complex decisions and drive actions

• Teams of dedicated advanced analytics

experts including machine learning,

epidemiologic, quality of life and HEOR

• 4 global design hubs

• Clinical trial optimization (CTOS)

• Real-time therapy area and patient

analytics (E360™)

• Unified investigator/site identity

management (OneKey)

• Patient data: 30+ countries including

deep clinical EMR and claims

• Hospital data: 40 countries

• Prescription data: 90 countries

• 4.9M potential investigators

• ~1,050 PhDs

• >1,100 MDs

• Local expertise in 100+ countries

• Seamless integration of analytics

and operations

Patients Sites Design Initial focus areas Planning

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Leveraging Telemedicine to Modernize Clinical Drug

Development

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Why do we need to modernize drug development?

Unsustainable development costs

Costs of developing a drug

increased 145% since 2003

Note: all figures are inflation adjusted to 2013 dollars

Source: Tufts Center for the Study of Drug Development

$2.6b

$1.04b

$413m

$179m

Clinical studies

Pre-Clinical studies

1970s 1980s 1990s –

early 2000s

2000s–

early 2010s

$1.5b

$1.09b

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1962: Elroy Jetson participates in a telemedicine visit from his home

And even reshaping healthcare...

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Telemedicine for Clinical Development The delivery of health services via information technology (voice, video,

email)

Substitute for a visit

• Substitute for office or emergency visit

• Bridge gap between supply vs. demand

Ancillary services

• Teleradiology, telepathology, teledermatology

Remote monitoring

• Disease management

Spoke (Patients)

Spoke (Patients)

Hub Site (Specialization)

Spoke (Patients)

Spoke (Patients)

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Key market drivers for telemedicine

Ubiquitous technology – 2 billion smart phones globally, 194

million in the U.S.; 165k healthcare apps out there (as of Sep-2015),

but only 36 get 50% of the downloads

Economics – cost containment with telemedicine visits compared to

standard care1, 2

Physician shortages – rural areas; gaps in specialist coverage

(i.e. emergency medicine)

Consumer – shaped by interactions with other industries (banking)

1. RAND, Health Affairs, 2015,

2. AMA (2015)

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• Reduced Patient and Partner Burden

• Speed Recruitment – Extend the geographical

reach of sites

• Convenience – Impact retention

• Enhance safety surveillance

• Cost savings

• Increase site capabilities – Examples

Application to Clinical Development

Payoffs

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Social media & Digital Patient:

The evolving impact on clinical trials

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Partner to bring innovation to the clinical trial space

• Our Antidote Partnership is driving increased

awareness of clinical trials as a care option and

increased participation in research

• Working together with mobile providers like

mProve Health allows study teams to provide

enhanced experiences for trial participants and

investigators

via app based technology

• Partnering with AMC Health to leverage their

powerful telehealth clinical trials platform to

reach new populations of Alzheimer’s patients

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January 2016 – Year-on-year growth • How the digital world in Europe has evolved over the past 12 months

Total

population

Active internet

users

Active social

media accounts

Unique mobile

users

Active mobile

social accounts

+115 million +332 million +219 million +141 million +283 million

+1.6% +10% +10% +4% +17%

http://wearesocial.com/special-reports/digital-in-2016

SINCE JAN 2015 SINCE JAN 2015 SINCE JAN 2015 SINCE JAN 2015

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oWe consume, share and search for information differently

oWe now must engage and identify our patients differently

oEmbrace a patient-first and digital approach to clinical trials

Digital Patient

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Digital patient: Path to care

Source: Makovksy Health and Kelton, Feb-2015

Start … Begins

ONSET OF SYMPTOMS

Upward trend by patients when

searching for information about

their health shows that the first

step is to search online

41 % symptoms

26 % options

18 % specialists

PHYSICIAN OFFICE VISIT Increasingly, patients bring

a preliminary diagnosis …

… Patients will even ask

for medications by name

RETURNING TO

ONLINE SEARCH

After office visit, online

search continues to validate

initial diagnoses … 55 % prescriptions

40 % alternatives

36 % equivalents

41% 26% 18%

55% 40% 36%

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… Continues

Digital patient: Path to care

Source: Makovksy Health and Kelton, Feb-2015

ENGAGING IN

THEIR OWN CARE

• Research diagnosis and

prescription from the doctor

• Search for alternative

treatments or care

• Engage with patient groups Men

tal h

ealth

83%

Gast

roin

test

inal

79%

78%

Obes

ity

75%

Pulm

onar

y

73%

Card

io

MONITORING,

KEEPING SCORE,

DIGITAL HEALTH

• Patients more empowered

by apps and wearables

• Personal health monitoring

• Collaborative care with

physician and other patients

Digital

Patient

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Adopting a patient-first approach

Patient

Persona

Omni-channel

Outreach

Patient

Champion

Pathways

To Care

Understanding the

patient beyond the

eligibility criteria

Right message,

right time and

right method

Listen, adjust,

respond and

predict their needs

Explore all

pathways to care,

beyond sites

Digital

Patient

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Case study: Patient-first approach

© 2016 QuintilesIMS. All rights reserved. 19

Increase

Recruitment

Rate

More Potential

Patients

per week

Greater

Engagement,

Faster

Recruitment

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Our Industry faces a number of challenges

3.3% Decline in investigator

participation each year Jan 2015

48% Investigator sites do not

meet enrollment targets Jan 2013

Source: Statistics from TUFTS CSDD

60% Protocols undergo

amendments Sept 2011

33% Increased investment in

personalized medicine

over next five years May 2015

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Electronic Health Records

• The vast majority of physicians and healthcare institutions

now capture patient data in electronic health records

(EHR), creating an immense storage of individual patients,

and population health. And that resource is growing every

day. Experts estimated, that as of 2016, the average

hospital was producing more than 665 terabytes of data,

which is equivalent to 697,303,040 megabytes. This data

give doctors instant access to more complete patient

information which improves their ability to make the right

treatment decisions quickly, eliminates errors, and adds

efficiencies and costs savings that benefit the facility and

the patients.

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EHR

• http://www.quintiles.com/blog/evidence-at-your-fingertips#sthash.LW7veEXJ.dpuf

• Using EHR data in clinical research has also gained the attention of the US

Food and Drug Administration (FDA). Last June the Center for Drug

Evaluation and Research (CDER) announced interest in considering the use

of electronic health records with electronic data capture (EDC) in order to

improve clinical trials for new and investigational drugs. Test projects would

"ideally test the use of a standards-based technology solution to enable the

collection of related healthcare and clinical research information within a

single system and workflow," according to the notice. Stakeholders could

include EHR and EDC vendors, academic medical centers and others.

• This should be capturing the attention of biopharma companies who are

interested in finding new ways to improve recruiting, inform post market

research, and to unearth real world evidence that can be used to

improve the time, cost and efficiency of their projects.

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Answer research questions around medical exposure

among sub-populations of

patients

Prove the conversion

from efficacy to

effectiveness in real-world

settings.

Get a broad picture of

total healthcare utilization

Track market uptake

For biopharma companies embarking on new studies, or continuing work

on existing efforts, here are four ways that EHR databases may be able to

support their efforts.

EHR databases have longitudinal

data that can capture when

exposure to particular medicine

occurs, how it aligns with other

healthcare events, and what are

the patient outcomes. All of this

provides insight into the impact of

associated exposure before and

after a medical event, as a way to

track the long term safety of a

drug.

Biopharma teams can use EHR data

to run research studies comparing

outcomes of interest across various

treatment groups without requiring

any interaction between patient and

sponsor. By observing standard of

care practices we are able to see if

results in the real-world match

clinical trial outcomes, where the

patient population may be less

representative of the total population

with the underlying disease.

When EHR data is linked to

other data sources, like

pharmacy refills, payer data,

and hospitalization data, it can

provide insight to support a

variety of important healthcare

considerations.

EHR databases are frequently

updated, giving researchers

near real-time evidence

regarding how quickly a new

drug is prescribed, who is

prescribing it, whether it is

being prescribed strictly for

on-label use, and whether the

prescription trends continue.

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The benefits of these inquiries are clear: EHR data is a

valuable tool that can be used to deliver real-world evidence

in support of clinical and market research. The companies

that take advantage of these tools will gain speed and

confidence in the validity of their results.

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Case Study

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The combined use of Q and IMS data demonstrates our potential to predict patient

recruitment

Case Study: Predictive Performance

Alzheimer’s Disease

Investigator

Performance

Q mean

(benchmark)

ML Model

IMS Data

ML Model

IMS & Q data

Incremental

Improvement

Top 10% 28.1% 28.2% 44.1% 56.4%

Top 30% 49.1% 47.7% 61.6% 47.0%

Top 50% 56.9% 63.4% 75.0% 31.8%

Top 70% 78.0% 80.1% 80.9% 3.7%

Why is this important and useful:

• The IMS data alone yields a nearly indentical predictive value than the Q benchmark data

• Applying the machine learning model to the Q data alone improves the results

• However, the use of the IMS and Q data together significantly improves the accuracy over the

benchmark, with which we can predict the likelihood that the investigator will perform above his peers

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• There are > 3,000 US physicians that see this study-targeted patients (treatment naïve

w-AMD, age 50+) in the recent one year; 261 are experienced investigators (black

markers on the map).

Case Study: Investigator Heat Maps - US Wet AMD patients

• Analysis of medical claims data determined the impact of

eligibility criteria and overall patient demographic

information

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Case Study: Investigator Heat Maps – Ex US

Ulcerative colitis patients

Paris Heat Map London Heat Map

• US data have become table stakes, and access to global data improves our competitive

position

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Working with numerous advocacy groups to empower

patients to drive study success

• Develop comprehensive knowledge of the

patient experience

• Facilitate introductions between

investigative sites and local groups

• Leverage patient insights to engage

patients

• Implement patient-centric operations

Working with Patient Advocacy Groups to

share patient pathways and perspectives and

to ensure a robust support model for patients

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Using innovative but easy communication

methods such as webinars and portals

to provide ongoing support

Helping sites meet their goals through

communications, training, and support

• Regular communications with sites bring

personnel up-to-date and facilitate

information sharing among and in-between

sites, such as our Site Connect Newsletter

• Sharing competitive enrollment data

and best practices between sites

• Training with use of:

> STeP Program

> Conversation guides

> Tools for overcoming common objections

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We’re engaging with patients around the world and

connecting them with sites to supplement recruitment

Social listening finds where patients are looking for

information and talking to others about their disease (e.g., social media, website forums)

Direct-to-patient outreach alerts patients to clinical trial

opportunities and directs them to study websites to learn more

Patients complete online questionnaires to

pre-screen and connect with sites in their areas

Quintiles regularly engages with >3.5 million patients

within our online community and uses “listening tools”

to connect with others

World’s largest

pharmacovigilance community

Clinical research community

and trial matching service Condition-specific

Facebook communities

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21 d

ays

Leverage site networks to drive

more efficient oncology study enrollment

Quintiles

Precision

Enrollment

Find

patient Enroll site Treat

Enroll site Find patient Treat

Sta

rt o

f in

ve

sti

ga

tor

invo

lve

me

nt

Short timeframe to treatment

Designed to open sites within

21 days

0 Non-enrolling sites

0 Screen failures

Traditional patient enrollment

Long timeframe to treatment

Some non-enrolling sites

Frequent screen failures

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EU Early Phase Oncology Network delivers better

to transform clinical development

faster

differently

with higher

quality

De

liv

er

15 sites in 5 countries

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Sites reduce administrative burden

and drive study success with

Quintiles Infosario® Site Gateway

Q3

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Vis

ion

Improve quality Learning management

On-demand access to study-related training and up-to-date study materials

Reduce timelines Document center

Expedites document collaboration & tracking (with eTMF integration)

Enhance compliance Safety letter distribution

Distributes SUSAR letters electronically, automating compliance tracking

Increase site visibility Profile development

Site profiles ensure pre-population of key forms (e.g., site ID surveys)

Strengthen oversight Enhanced laboratory management

Provides near-real-time visibility into results reports

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Thank you for your attention