EMEA USERS CONFERENCE • BERLIN, GERMANY © Copyright …cdn.osisoft.com/osi/presentations/2016-users-conference... · 2016. 9. 28. · $18.9B in 2020, growing at 29.9% CAGR** *

© Copyright 2016 OSIsoft, LLC EMEA USERS CONFERENCE • BERLIN, GERMANY

CONFIDENTIAL © 2016 PAREXEL INTERNATIONAL CORP.

TRANSFORMATION IN THE

CLINICAL RESEARCH

INDUSTRY

Peter Shone,

2016 OSIsoft EMEA User Conference,

Berlin, Germany

“In God we trust, all others bring their data.”

W.E. Deming

© 2016 PAREXEL INTERNATIONAL CORP. / CONFIDENTIAL 3

• Introduction to clinical research and PAREXEL

• Our vision

• How OSIsoft supports the vision

• Conclusions

AGENDA

© 2016 PAREXEL INTERNATIONAL CORP. / CONFIDENTIAL 4

TIME In the United States, it takes an

average of 12 years for an

experimental drug to travel

from the laboratory to your

medicine cabinet.

That is, if it makes it

* Medicinenet

http://www.medicinenet.com/

Health Care expenditure: 10% (2.8% - 17.1%) of GDP

Pharma expenditure: ~15% of Health Care

…and growing every year

https://data.oecd.org/healthres/pharmaceutical-spending.htm

http://data.worldbank.org/indicator/SH.XPD.TOTL.ZS

RISK 1 in 5 drugs that are tested in

people is approved. However,

the chance for a new drug to

actually make it to market

is only 1 in 5,000. Even

then payers may choose not to

adopt the treatment

* Medicinenet

http://www.medicinenet.com/

COST The average cost to develop

and gain marketing approval

for a new prescription

medicine, a process often

lasting longer than a decade, is

now

$2.56 billion dollars.*

* Tuft CSDD Outlook 2015

CLINICAL RESEARCH - BRINGING NEW TREATMENTS TO PATIENTS

© 2016 PAREXEL INTERNATIONAL CORP. / CONFIDENTIAL

PAREXEL IS A GLOBAL BIOPHARMA SERVICES ORGANIZATION

• Medical Education

& Communications

• Meetings, Events

& Exhibits

• Educational Services

• Scientific Publications

• Drug Development

Planning

• Regulatory Affairs

• Strategic Compliance

& Risk Management

• Clinical & Manufacturing

• Quality Process

Consulting

• Reimbursement & Patient

Assistance Programs

• Commercialization

• Medical Imaging

• IVRS/IWRS

• Electronic Data Capture –

DataLabs®

• Clinical Trial Management

System –IMPACT®

• ePRO

• MyTrials™

• eLogistics Suite

• Regulatory Publishing and

Submissions

• Supply Forecasting

• & Simulation

• Phase I-IV

• Project Management

• Site Management

• Data Management

• Biostatistics

• Bioanalysis

• Medical Services

• Protocol Optimization

• Clinical Trial Supply and

Logistics

• Import/Export Management

• Partnership/Transition

Office

Communications Strategy & Consulting Technology Clinical Research

30+ years of clinical research experience

PAREXEL INFORMATICS IS THE TECHNOLOGY DIVISION OF PAREXEL

© 2016 PAREXEL INTERNATIONAL CORP. / CONFIDENTIAL

PAREXEL AT A GLANCE

*Excluding circa $100M of technology related acquisitions

PAREXEL INFORMATICS AT A GLANCE

© 2016 PAREXEL INTERNATIONAL CORP. / CONFIDENTIAL 7

CHALLENGES FACING CLINICAL RESEARCH: THE NEED FOR DIGITAL TRANSFORMATION

The lack of information sharing throughout drug development lifecycle

impedes efficient and timely collaboration

Healthcare payers are looking for ever more evidence to underpin cost

effective results-driven treatment plans

Research processes have not evolved to keep pace with global

technological advances

The mapping of the human genome has increased rather than reduced the

complexity of bringing a drug to market

The end of the blockbuster drug era is putting pressure on R&D budgets and

personalized medicine makes research more expensive

© 2016 PAREXEL INTERNATIONAL CORP. / CONFIDENTIAL 8

We are at an inflexion point in clinical trials

digital technology. The focus will shift from

data collection to risk mitigation, from silos

of activity to consumer centricity, from

reaction to proactivity.

INDUSRTY LANDSCAPE:

© 2016 PAREXEL INTERNATIONAL CORP. / CONFIDENTIAL

• File transfer or even snail

mailed

• 2-6 weeks delay after collection

• Mb and Gb class data

• Transfer Through the Wire

• Near Real-Time

• Tb and Pb class data

• Limited Cleaning Needed: Data Recorded Standardized at the Source

• Near Real-Time, Ongoing

Visualization

• After Data Have Been

Integrated and Cleaned

• Months After Data Collection

• Patient Instrumentation - Wearables and sensors - Mobile data - Medical Records - Genomic Database

• Data entered manually in

fragmented systems

• Often paper based primary data

• Poor data quality

9

COLLECT DATA AT THE SOURCE, WITH NEAR REAL-TIME VISUALIZATION &

ANALYSIS SUPPORTING DECISIONS

THE FUTURE (Real time, predictive, data driven decisions)

THE PAST (Slow, reactive, siloed)

Data Collection

Data Transfer

Visualization & Reporting

© 2016 PAREXEL INTERNATIONAL CORP. / CONFIDENTIAL

THERE IS A GROWING WAVE OF NEW TYPES OF SENSOR BASED DATA

SOURCES TO INCREASE MEDICAL VALUE

• There are many sensors available today, though

not many are validated as clinical end points - yet -

with high value for clinical trials

• New sensors are coming to market every year and

we can expect medical value and data volume to

increase exponentially in the coming years

• We need a platform to manage these Petabytes of

data

Expected revenue in wearables:

$18.9B in 2020,

growing at 29.9% CAGR**

* Adapted with permission of Frost & Sullivan

** Source: Frost & Sullivan, “Wearable Technologies in

Clinical and Consumer Health”, 2016

EEG

Cortical Stimulator

Eye Tracking

Ear/Audio

ECG/EKG, Heart Rate

Heart Rate Variability Respiratory Rate

SpO2

Blood pH

Body Temperature

Total Activity

Calorie Meter

EMG

Body Pressure

Muscle Tension

Body Motion

Body Weight

Insulin Level

Blood Glucose

Blood Pressure

Body Posture

Fall Deduction

Sleep

Stress

Critical/High Value

Nice to Have

General/Wellness Va

lue t

o H

ea

lth

Wearables Harnessing Human Body Data/Biometrics*

© 2016 PAREXEL INTERNATIONAL CORP. / CONFIDENTIAL 11

PAREXEL INFORMATICS & OSISOFT PARTNERSHIP

•PAREXEL & OSIsoft have formed a Strategic Alliance Partnership

•OSIsoft PI System technology to be embedded within PARXEL’s

technology framework to develop a next generation sensor

platform for to transform the delivery of clinical trials in the

Biopharmaceutical industry

• Initial focus on 2 PAREXEL use cases

–Patient Direct (wearable devices)

–Active Tracking (temperature controlled drug shipments)

© 2016 PAREXEL INTERNATIONAL CORP. / CONFIDENTIAL

Trial Supply

Logistics

Customer Care

Service

12

PAREXEL NEXT GENERATION SENSOR PLATFORM USE CASE 1. PATIENT WEARABLES

GxP Services

PAREXEL Systems and Services

Business Intelligence & Analytics Researcher

Data Acquisition & Transport Systems

Workflow

Focused persona-

based apps

Secure, scalable, and integrated clinical data infrastructure

Cloud-based Data

Aggregation

Multi-Channel Data

Collectors

Body Area Network Devices

Investigator

Patient

Data Manager

CTMS

EDC

MI

RIM

RTSM

Safety

Site

Feedback

LIMS

GxP Systems

Care Provider

Secure Data

Infrastructure

Consumers

© 2016 PAREXEL INTERNATIONAL CORP. / CONFIDENTIAL

EXAMPLE - PATIENT ACTIVITY MONITORING DASHBOARD

13

Mean amount of time device worn for

each patient, grouped by study and site.

Green region represents compliance

Mean value of activity parameters for all

patients, grouped by study, over the time

range

Activity value for each day in time range,

for each patient.

Compliance metric for each day in time

range, for each patient.

© 2016 PAREXEL INTERNATIONAL CORP. / CONFIDENTIAL

Trial Supply

Logistics

Customer Care

Service

14

PAREXEL NEXT GENERATION SENSOR PLATFORM USE CASE 2. CONDITION SENSITIVE TREATMENT - ACTIVE TRACKING

GxP Services

PAREXEL Systems and Services

Business Intelligence & Analytics Researcher

Data Acquisition & Transport Systems

Workflow

Focused persona-

based apps

Secure, scalable, and integrated clinical data infrastructure

Cloud-based Data

Aggregation

Multi-Channel Data

Collectors

Body Area Network Devices

Investigator

Patient

Data Manager

CTMS

EDC

MI

RIM

RTSM

Safety

Site

Feedback

LIMS

GxP Systems

Care Provider

Secure Data

Infrastructure

Consumers

Real-time management of condition controlled products (‘cold chain’) across supply chain

© 2016 PAREXEL INTERNATIONAL CORP. / CONFIDENTIAL 15

OSISOFT PI SYSTEM TECHNOLOGY WITHIN THE PAREXEL PLATFORM

Key Benefits of OSIsoft Technology

• Quick to integrate time series data flow

• Minimal coding required

• SDK available to code key functions

• Functions required to access data already available

QUALCOMM® 2net

Data Cloud

PAREXEL Analytics Systems

Sensor Data Archive

Asset Framework

Integrator for BA

SDK

Coresight

© 2016 PAREXEL INTERNATIONAL CORP. / CONFIDENTIAL

COMMUNICATION & ANALYTICS TECHNOLOGY IS THE CORE

Data from human sensors are collected a high frequency and produce high volume of data – unknown to pharma industry today

OSIsoft is helping us managing volume of data in near real time

• Data infrastructure that allows us to capture, store and access continuous data

• Integration with communication & analytics

Key benefits of OSIsoft technology

• Quick to integrate time series data flow

• Minimal coding required

• SDK available to code key functions

• Functions required to access data already available

OSIsoft PI System infrastructure will allow us to manage and analyse petabytes of continuous data, enabling new approaches to research problems

© 2016 PAREXEL INTERNATIONAL CORP. / CONFIDENTIAL

TRANSFORMING CLINICAL RESEARCH - ACCELERATE DRUG DEVELOPMENT

The availability and timeliness of data will dramatically affect the future conduct and approach to clinical research and regulation

These new influences will have profound effects on:

• Collapsing the cost of research

• improving the quality of the data

• increasing timeliness of decisions

• maximizing the scientific outcome of the trial process

Decisions will become real time and collaborative, moving us from phased and costly drug development process to lean and adaptive approaches

The focus will shift from data collection to risk mitigation, from silos of activity to consumer centricity, from reaction to proactivity

The PAREXEL Digital Transformation will simplify the research journey so safe new treatments can reach patients quicker, tackling disease and changing lives

© 2016 PAREXEL INTERNATIONAL CORP. / CONFIDENTIAL © 2016 PAREXEL INTERNATIONAL CORP. / CONFIDENTIAL 18

THANK YOU

© Copyright 2016 OSIsoft, LLC EMEA USERS CONFERENCE • BERLIN, GERMANY