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The Evolution of Drug Development and Market Access via Connected Data-Driven Solutions
1.
© 2017 PAREXEL
INTERNATIONAL CORP. ALL RIGHTS RESERVED THE EVOLUTION OF DRUG DEVELOPMENT & MARKET ACCESS VIA CONNECTED DATA-DRIVEN SOLUTIONS
2.
© 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
3.
© 2017 PAREXEL
INTERNATIONAL CORP. / ALL RIGHTS RESERVED3 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
4.
© 2017 PAREXEL
INTERNATIONAL CORP. / ALL RIGHTS RESERVED4 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.
5.
© 2017 PAREXEL
INTERNATIONAL CORP. / ALL RIGHTS RESERVED5 THE CONNECTED JOURNEY IN ACTION THE VALUE OF CONNECTING TECHNOLOGY, PROCESSES AND EXPERTISE TO DRIVE DATA-DRIVEN INSIGHTS
6.
© 2017 PAREXEL
INTERNATIONAL CORP. / ALL RIGHTS RESERVED6 KANAZAWA, JAPAN ACCELERATING THE JOURNEY WHILE DECREASING COSTS
7.
© 2017 PAREXEL
INTERNATIONAL CORP. / ALL RIGHTS RESERVED7 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.
8.
© 2017 PAREXEL
INTERNATIONAL CORP. / ALL RIGHTS RESERVED8 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
9.
© 2017 PAREXEL
INTERNATIONAL CORP. / ALL RIGHTS RESERVED9 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 Connected Journey Solution™ • 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. Connected Journey Results™ • 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.
10.
© 2017 PAREXEL
INTERNATIONAL CORP. / ALL RIGHTS RESERVED10 KOBE, JAPAN PROTOCOL OPTIMIZATION
11.
© 2017 PAREXEL
INTERNATIONAL CORP. / ALL RIGHTS RESERVED11 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
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© 2017 PAREXEL
INTERNATIONAL CORP. / ALL RIGHTS RESERVED12 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
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INTERNATIONAL CORP. / ALL RIGHTS RESERVED13 TOKYO, JAPAN TRANSFORMING REAL-WORLD EVIDENCE WITH DATA
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INTERNATIONAL CORP. / ALL RIGHTS RESERVED14 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. Connected Journey Solution™ • 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.
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INTERNATIONAL CORP. / ALL RIGHTS RESERVED15 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 Connected Journey Solution™ • 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 Connected Journey Results™ • 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
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INTERNATIONAL CORP. / ALL RIGHTS RESERVED16 CASE STUDY 6 EXPLORATION OF 6 SENSING DEVICES AS STUDY ENDPOINTS Connected Journey Results™ • 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. Connected Journey Solution™ • 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
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INTERNATIONAL CORP. / ALL RIGHTS RESERVED17 KYOTO, JAPAN IMPACTING CUSTOMER SATISFACTION
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INTERNATIONAL CORP. / ALL RIGHTS RESERVED18 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 Connected Journey Solution™ • 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 Connected Journey Results™ • Impeccable customer satisfaction score • Full FDA acceptance of the regulatory submission and strong market acceptance
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INTERNATIONAL CORP. / ALL RIGHTS RESERVED19 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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INTERNATIONAL CORP. / ALL RIGHTS RESERVED20 THANK YOU © 2017 PAREXEL INTERNATIONAL CORP. / 20 ALL RIGHTS RESERVED
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