The Evolution of Drug Development and Market Access via Connected Data-Driven Solutions

© 2017 PAREXEL INTERNATIONAL CORP. ALL RIGHTS RESERVED
THE EVOLUTION OF DRUG
DEVELOPMENT & MARKET
ACCESS VIA CONNECTED
DATA-DRIVEN SOLUTIONS

© 2017 PAREXEL INTERNATIONAL CORP. / ALL RIGHTS RESERVED2
WELCOME
• Introduction:
- The Connected Journey™
Case Studies:
- Accelerating the Journey
While Decreasing Costs
- Protocol Optimization
- Transforming Real-World
Evidence with Data
- Impacting Customer
Satisfaction
AGENDA

THE CONNECTED JOURNEY™ OF DATA-DRIVEN
SERVICES POWERED BY PAREXEL® ANALYTICS
THE CONNECTED JOURNEY™
Predictive Data-Driven Insights
DRUGDEVELOPMENTJOURNEY
DISCOVERY EARLY STAGE LATE STAGE POST APPROVAL
PROCESS
Design Startup Execute Submit Commercialize
PEOPLE
Regulatory Clinical Commercial
TECHNOLOGY
Design
Analytics
Clinical
Analytics
Regulatory
Analytics
PAREXEL® Analytics

We are at an inflexion point in BioPharma digital
technology. The focus is shifting from data
collection to deriving data-driven insights that
drive value for clients. Today, it’s all about
predictability and proactivity.

THE CONNECTED JOURNEY IN ACTION
THE VALUE OF
CONNECTING
TECHNOLOGY,
PROCESSES AND
EXPERTISE TO
DRIVE DATA-DRIVEN
INSIGHTS

KANAZAWA, JAPAN
ACCELERATING THE
JOURNEY
WHILE DECREASING
COSTS

CASE STUDY 1
INNOVATIVE DYNAMIC
DESIGN FOR MULTI-
INDICATION DRUG
Challenge
• Post-marketing study to evaluate promising
oncology drug for 4 distinct indications with
fast-track for 1 indication.
• Desire to run dynamic safety study, without
waiting on data for all indications to start
study.
• Operational and cost efficiencies key.
Connected Journey Solution™
• Unique dynamic modular design with one
protocol and dedicated x-functional team
across modules.
• Expert-led design with integrated KOL
insights, address needs of regulatory &
commercial stakeholders.
• Customized data platform with data lake
to pool metadata and therapy safety
data across modules
• Bespoke portal to support MSL/field
staff training, physician and marketing
company engagement.
• Study optimization to improve feasibility,
site selection and support patient
pathways.

Connected Journey Results™
Efficiencies: Innovative design generates process efficiency in study set-up with one protocol, one
team, one kick-off meeting, central oversight of process, communication, single EDC build and much
more.
Cost savings: $14M cost saving vs running a non-modular, basket study. Smarter planning and
forward-thinking will allow further efficiencies for future modules and in preparation for market
access & lifecycle management.
Accelerated results: Integrated team of experts from regulatory, clinical, commercial and
communications disciplines, drive innovative design and robust infrastructure.
Technology-enabled: Bespoke study communication platform provides single-point-of-access to all
documents, supports site engagement and MSL/field-staff training; stores site documents, news and
performance metrics.
Cross-module analytics: Single data view across multiple databases supports quality across
modules. Data surveillance tool with safety data integrated from multiple source drives greater insights,
time and cost efficiencies.
CASE STUDY 1
INNOVATIVE DYNAMIC DESIGN FOR MULTI-INDICATION
DRUG

CASE STUDY 2
IMPLEMENTING ADVANCED
AND INTUITIVE LATE
PHASE TECHNOLOGY
Challenge
• Significant diabetes observational study
required extensive site identification and
qualification to achieve challenging
patient recruitment goals.
• 4,500 sites across dozens of countries,
huge volumes of patient data, mandate
to reduce oversight costs
• An innovative web-based platform was
designed that not only functioned as a
user-friendly portal, but also as an
integrated Clinical Trial Management
System and Electronic Data Capture
technologies to streamline the flow of
data, accelerate site start-up, increase
data management efficiency and
expedite clinical processes.
• Site management costs were
reduced by over 50%, all while more
than 50,000 patients were recruited
in dozens of countries. What’s even
more remarkable, the study was
completed ahead of schedule.

KOBE, JAPAN
PROTOCOL OPTIMIZATION

PROTOCOL OPTIMIZATION - HOW DOES THIS WORK?
OUR GOAL
Help clients develop
multiple study designs
in order to find
the optimal one.
1
2
4
Standard
Building
Blocks in
Every Study
Considerations
for Each
Building
Block
Leverage
30 Years
of
PAREXEL®
Experience
& Data
Interrogate
Relevant
Building
Blocks
Scenarios
that assist
Clients
with trade-
off
decisions
3
5
A
B
C
D
E

Identified Savings
• Increase patients, reach PFS endpoint faster
• Increase % of patients in N.A. to reduce cost
of comparator drug (reimbursed in NA, but
not ROW)
• Reduce data collected
• Eliminate investigator procedures that don’t
support endpoints
CASE STUDY 3
TYPICAL OUTPUT: COST+TIME SAVINGS
Phase III
Oncology Study
Phase II Alzheimer’s
Dose-Finding Study
Phase IIIB
Oncology Study
• Design
- 2 arms, Open label, PFS end-point
• Baseline Operational Plan
- 210 sites, 24 countries
• Design
- Stage 1 – 2x arms; Stage 2 – 4x arms
• Plan
- All sites in North America
• Design
- Single arm long-term safety study
• Two patient population types
- PS0 to 1 and PS2
Identified Savings
• In Stage 2, replace low-performing North
America sites with sites lower cost sites in
Easter Europe
• Reduce Stage 1 treatment period from 24 to
12 weeks
• Eliminate non-value add interim analysis
Identified Savings
• Eliminate PS0 to 1 patients (already have
safety data for population)
• Add control arm to demonstrate what SAEs
are disease related vs. study drug related
(increases cost + time, but generates useful
data)
Cost Difference
vs. Baseline
Time
Difference
vs. Baseline
+20% +10% -10% -20% -30%
-30%
-20%
-10%
+10%
+20%
Cost Difference
vs. Baseline
Time
Difference
vs. Baseline
+20% +10% -10% -20% -30%
-30%
-20%
-10%
+10%
+20%
Cost Difference
vs. Baseline
Time
Difference
vs. Baseline
+20% +10% -10% -20% -30%
-30%
-20%
-10%
+10%
+20%
NET FINDING:
PAREXEL® repeatedly helps clients reduce both costs and time with no reduction in study quality.
1
2
3
4 5
6
1
1
1 2 3

TOKYO, JAPAN
TRANSFORMING REAL-WORLD
EVIDENCE WITH DATA

CASE STUDY 4
UTILIZING SECONDARY
DATA SOURCES WITH
PRIMARY CLINICAL DATA
TO DRIVE COST SAVINGS
Connected Journey Results ™
• Calculations resulted in the capture of
selected data points through EMRs and
claims data could save as much as 20%
when compared to traditional, prospective-
only research methods.
Challenge
• Identify evidence gaps and drive costs
saving in prospective study for the
treatment of overactive bladder.
• PAREXEL analyzed the potential cost
savings of conducting a payer-mandated
Phase IV randomized, active control trial
in 1,049 overactive bladder patients, at
100 sites, using hybrid data collection
techniques.
• Leveraged EMR and claims data
alongside traditional primary research to
reduce the burden of data collection from
investigative sites, and drive cost savings.

CASE STUDY 5
UNIFYING PAPER AND
ELECTRONIC DATA CAPTURE
IN CLINICAL TRIALS
Challenge
• Client needed to demonstrate the safety and
efficacy of a new stroke treatment
• Desired sites preferred various data capture
methods which hindered site recruitment
• DataLabs® EDC solution accommodates
various types of data capture. Paper and
electronic data was entered into a common
interface and stored in a single database
• The client was able to recruit the desired
investigator sites
• Client realized approximately 50% savings in
time typically involved with set up and
maintenance of separate systems

CASE STUDY 6
EXPLORATION OF 6
SENSING DEVICES
AS STUDY ENDPOINTS
• Transmission worked as expected with
minimal or no data loss. Devices were able
to be used in-clinic setting with minimal help
• The client was able to cost-effectively
compare remote medical devices to in-clinic
assessments in the necessary timeframe.
Challenge
• Client wanted to evaluate medical devices
as study endpoints and compare remote
monitoring medical device data with
standard in-clinical assessments.
• The client was able to leverage a planned
Phase I study to keep project costs down
and benefit from PAREXEL’s Phase I Unit’s
experience with multiple assessments.
• PAREXEL was able to deliver in-clinic
assessments and add two remote sensors
to the core protocol. Plus, four additional
devices were evaluated in the extension
protocol
Blood
Pressure
Spirometry Weight
Blood
Glucose
Pulse
Oximetry
Activity
Tracking

KYOTO, JAPAN
IMPACTING CUSTOMER
SATISFACTION

CASE STUDY 7
ACHIEVING A PERFECT
CUSTOMER SATISFACTION
SCORE FOR A FAST-TRACK
CLL BREAKTHROUGH TRIAL
Challenge
• Rigorous study design that enabled
compression of a typical year’s worth of
effort into less than two months
• Collaborative partnership between the
sponsor and PAREXEL
• Daily reconciliation of data submitted by
the sites
• Top-quality central reads by a small
group of highly competent and
dedicated reviewers
• Impeccable customer satisfaction score
• Full FDA acceptance of the regulatory
submission and strong market acceptance

PAREXEL’S CONNECTED
JOURNEY™:
TAKING ON EVERY STEP OF THE DRUG
DEVELOPMENT JOURNEY – DESIGN,
START-UP, EXECUTION, SUBMISSION AND
COMMERCIALIZATION.
First-of-its-kind custom-built ecosystem
that brings together PAREXEL’s 40-plus
data-driven services to expedite the drug
development journey.
• Drives smarter decisions across design,
start-up, execution, submission and
commercialization stages.
• Delivers data-driven insights by
connecting technologies, processes and
expertise.
• Completes clinical trials 22 percent faster
than the industry average.
• Powered by PAREXEL® Analytics
KMR Group - Clinical Group, 2015

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