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Janssen’s Journey Towards a Culture of Innovation

Sumesh KalappurakalHead, Analytics Innovation

Sangeeta BhattacharyaTA Head Immunology

Marion WolfsHead, Risk Management Central Monitoring

PhUSE EU connect - 2019

Lisa LyonsDM Head, Central Services

Disclaimer

The presentation is intended for educational purpose only and does not replaceindependent processional Judgement. Statements of fact and opinions expressed arethose of the participant individually and, unless expressly stated to the contrary, arenot the opinion or position of Janssen Pharmaceutical Research and Development.

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Acknowledgement

We would like to thank the following individuals for their encouragement, guidance and support on this journey.

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Darren Weston

Olivier Leconte

Samar Noor

Neil Garrett

Also extending our sincere thanks to Frank Meloni (Director, RMW), Stephen Bamford (Head, IDAR Data Transparency), Tammy Guld (Sr. Director, Janssen Clinical Innovation) and Paul Hilton (IDAR Therapeutic Area Lead)for their great insights and contributions to the paper and presentation.

Finally thanks to our PhUSE EU connect 2019 Leadership & Innovation Stream Chairs(Leanne, Jasmine and Gary)

(Global Head Regulatory Medical Writing)

(VP IDAR GCDO)

(Global Head Statistical Programming & Analysis)

(Global Head DATA Management & Clinical Standards Development)

Agenda

Introduction to Innovation

Overview of IDAR

Innovative approaches

Challenges and Roadblocks

Building Innovative culture

Conclusion

Q&A

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Introduction to Innovation

Introduction to Innovation

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Overview of IDAR

Integrated Data Analytics and Reporting

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IDAR Therapeutic Area Leads

Statistical Programming & Analysis

Regulatory Medical WritingRisk Management

& Central Monitoring

Data Transparency

Business OperationsData Management

& Clinical Development Standards

“Converting data into knowledge in order to support the best possible data-driven decisions”

Janssen Clinical Innovation

Innovative approaches

Innovative approaches to Data Collection

Clinical Trials: Moving to era of continuous electronic data collection utilizing devices and techniques

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This has a disruptive impact on the way we manage our clinical trials and requires the need to manage risks.

As leaders we need to provide strategic vision to our teams, create a culture that embraces change…… help connect the “dots” and prepare for this digital transformation.

Within IDAR we are leading our teams to drive value through standardization, innovation and technology

Integrated Smart Trial Engagement Program (iSTEP)

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Site Kit Tracking

Patient AppPersonalized patient support & data collection

Smart BlisterChip enabled medication packages tracks pill dispensing

Track supply activities via medication scanners

iSTEPIntegrated Smart Trial Engagement Platform

Patient app

Smart blister

Databases & data entries

Site kit tracking

Innovation of Automated Data Flow

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MDR therapeutic and disease

area standards

Data Acquisition

Data Ingestion

Data Transformationpre-post quality checks

DRM* SDTM

Data SubmissionSubmission-ready SDTM

Our strategic roadmap includes metadata driven automated data flow

Robotic process automation quality checks for submission packagesReports and Visualizations

for real-time decision making and central data

review*Data Review Model (DRM))

Next Generation Risk Management and Central MonitoringA shift from reactive, rigid, manual and subjective to predictive, agile, automated and data driven

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A B C D E F

Risk Risk Risk Risk Risk Risk

Data wrangling and analytics support for Innovative Approaches – Novel Biomarker

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RNA Seq

Clinical Study DataCluster Analysis

Collaborating with external companies

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Innovative Approaches de-identificationDICOM – Digital Imaging and Communications in Medicine

MetadataReview

New ID mapping &Strategy

Anonymization

Metadata Extraction

De-identified CT scans

Innovative Approach Direct-to-Patient Trial Model Overview

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Current Model: Investigator-Centric

Patient-Centric

§ Conventional model:

§ Direct-to-patient model:

Graphic courtesy of Science 37

CRO

SponsorDirect-to-Patient

Model

Sponsor

Challenges & Roadblocks

Challenges and Roadblocks

“Unknown and unseen dots can make many people and enterprises uncomfortable”

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it is too risky

that’s not the way we do things

time / resource/ budget

Innovative Culture

Innovative Culture To keep our vision and innovations alive

Technology

ProcessPeople

Enable employees to adopt an "entrepreneurial mindset" to showcase their ideas and they become the foundation for organizational growth and sustainability, allowing employees to

propel innovation and show initiative is the key to success.

Conclusion

Conclusion

We as leaders, need to be energized in a manner that inspires hope and evolution in order to propel innovative opportunities for growth, prosperity and

sustainability.

“Innovation is the difference between a leader and a follower.”Steve Jobs

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Q&A