Janssens’ Discovery Data Integrity program (DDI): A journey over the last 7 years

Research Integrity: Position yourself for success!David J. Gallacher, PhD DDI Co-Lead, Global Head of Safety PharmacologyGhent University, December 6th, 2017 | Janssen Research & Development a division of Janssen Pharmaceutica NV

Agenda

1. Janssen R&D2. Pharmaceutical industry & data integrity3. Janssen’s DDI (Discovery Data Integrity) Initiative

• Approach• Key success factors• Broadening our scope

Disclaimer: ‘The views expressed in this presentation are solely those of the individual

author, and do not necessarily reflect the views of my employer’

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Janssen R&D

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Our organization is global, yet our focus is the local community

36,000Employees Countries

150+Manufacturing

Sites

30R&D Centers

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North America Europe, Middle East & Africa

Asia PacificLatin America

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HIV Hepatitis CRespiratory

Vaccines

INFECTIOUS DISEASES & VACCINESSchizophrenia

Mood disordersAlzheimer’s disease

Chronic pain

NEUROSCIENCE

IMMUNOLOGY

Inflammatory bowel diseaseRheumatoid arthritis

Psoriasis Pulmonary disease

ProstateLung

B-cell malignancies Immuno-Oncology

ONCOLOGY

End-to-end strategy focused

on five therapeutic

areas CARDIOVASCULAR

& METABOLISM

Cardiovascular disease Diabetes

Janssen’s Therapeutic Area Research Focus

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J&J’s Shifting Strategy: Innovation Centers (2012)

San Francisco

London

Boston

Shanghai

San Diego

Minneapolis

Israel

Innovation Center

Satellite

Tokyo

Sydney

Target mix of Portfolio of 50% from Internal and 50% External Science 

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The pharmaceutical industry & data integrity

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Non‐Regulated

Regulated

Discovery

Preclinical Development

Phase I & II clinical trial

Phase III clinical trial

Registration & Marketing

Clinicalcandidate

IB

$2.6 billion over 10‐15 years

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Translation issues affecting Pharmaceutical Industry

“Only healthy datalead to healthy patients”

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Janssen’s DDI initiative

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InnovationResearchExploration

IntegrityAccuracy

Reconstructability

Finding the Balance…Innovation & Quality

http://74211.com/Great‐Man‐Wallpaper‐Albert‐Einstein‐Imagination‐is‐More‐Important‐than‐Knowledge‐1280X1024‐free‐wallpaper‐download/

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Janssen’s Discovery Data Integrity (DDI)

• Started in 2010: Baseline analysis of practices/systems across legacy J&J Pharmaceutical family of companies

• Motivation: Only “healthy data lead to healthy patients”

• Key words:AccuracyTraceabilityReconstructionAn unbiased approachOpen scientific collaboration

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Janssen’s DDI Initiative: Cross‐Company Baseline Practices/Systems Analysis

Outcome:• Highly motivated scientists eager to share best practices• Cross‐functional collaboration to improve systems• Momentum for change

Gaps identified across various locations/business groups

• Variety of data management systems and processes, some more adequate thanothers

• Storage space issues (want to keep everything, without archiving )• Limited support from biostatisticians• Opportunity to improve cross referencing/linking data for easy retrieval

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DDI community model

IMMUNOLOGY SM/LM/Biomarkers

Infectious Diseases&Virology+Biomarkers

NeuroscienceSM/LM/Biomarkers

Cardiovascular‐Metabolism

ONCOLOGY SM/LM/Biomarkers

Discovery Sciences

Biologics CoE 

Non regulated R&DQA“The findings”

DDI CORE TEAM“The solution”

Discovery Leadership

DDI Core Team(Discovery, QA & IT)

• Analyses• Metrics• Advice, support, training

DDI Discovery Champions“The ideas”

member(s) from each group

• Identify opportunities• Generate concepts• Cross-fertilization

DDI Workstreams

Storage space

Reporting process

Training program

.......

Partners: IT, Biostatisticians, Project managers, Legal, Communications, ...

• Setup & direct workstreams

• Provide & Implement solutions

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15 DDI workstreams

Whatdata tostore

Safe data storage

Whereto store data

Where did I put it?

Internal andexternal

non reg QA program 

Quality maintenance program

MandatoryDDI sectionin electronicprotocol templates

How to deal with fraudallegations/suspicions

IncreasedBiostatsupport

Bias prevention

Clinicalcandidatereporting

Reporting process

Reporting of individual

experiments

Externalcontracts External dataPublication

process

1 centralDDI portal

Basic training program 

andplatform

Mandatoryglobal DDI training

Culture & Communication

Rewardingsystem

Participativeposter 

campaign

Implementation phase

Fully implemented

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Janssens’ DDI quality system

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Culture & CommunicationE.g. Participative poster campaign

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GAP ANALYSISE.g. Shortage of storage space

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HELP …I need more room or to find the way to

the archive !

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E.g.FORM MULTIDISCIPLINARY TEAMS TO LEVERAGE BEST PRACTICESE.g. Expert biostatistician’s support

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E.g.

Great news ! ... can you send us these

data for our Nature publication ?

Ooops, was it in the contract that we were supposed to save them ?

FORM MULTIDISCIPLINARY TEAMS TO LEVERAGE BEST PRACTICESE.g. Contractual language

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IMPLEMENT BEST PRACTICES E.g. reporting guidelines

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‐ Data spot checks‐ Feedback on good practices & gaps‐ Pulse check of guidelines‐ Measure success of DDI program

Quality program and metrics

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Janssen’s DDI initiative: Key success factors

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Key success factors1. Role Models: Senior leaders sponsorship & support

1. “Talking the talk, walking the walk”

2. Mandatory education for all staff

3. Community participative poster campaigns

4. Partnerships: QA, IT, Biostatisticians, Communications, ...

5. Simple, sustainable solutions and “fit for purpose” guidancea) By scientists, for scientists

6. Transparency: central data sharing for teams, projects etc

7. Spot check program (= measure of success)

8. Speak up culture (hotline)

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Janssen’s DDI initiative: Broadening our scope

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Quality data = Quality decisions

Global research environment 

Common guidelines

Data sharingplatforms 

Publication of replicatestudies & negativeresults

CROs, Collaborators, Innovation centers

Contract language

Data capturing & transfer platforms

Internal research

Training Global Guidelines Spotchecks

Broadening our scopeLong term

starting

ongoing

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Clinical Trial Data Sharing Agreement with Yale School of Medicine’s Open Data Access (YODA) ProjectA new approach to evaluation and transparency

Yale School of Medicine will serve as an independent body to review requests from investigators and physicians seeking access to Janssen clinical trials

TransCelerate BioPharmaJoint effort between Janssen & nine other companies

Non-profit organization focused on advancing innovation in R&D, identifying and solving common R&D challenges and improving patient safety (ie. repository where key clinical trial information about clinical sites, such as infrastructure & GCP training records is housed, thus reduce time-consuming and sometimes redundant administrative work involved in identifying appropriate clinical trial sites)

Last Updated: 11/24/2014

Ongoing: Transparency Initiatives in clinical space to open sharing of data (Jan 2014, Nov 2012)

https://www.jnj.com/office‐chief‐medical‐officer/yale‐open‐data‐access‐project

https://www.jnj.com/news/all/janssen‐research‐development‐announces‐establishment‐of‐global‐cross‐pharmaceutical‐clinical‐trial‐investigator‐databank

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Started: Improving Data Quality as Key Deliverable though IMI Initiative ‘EQIPD’

European Quality in Preclinical Data

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https://www.alphagalileo.org/ViewItem.aspx?ItemId=180325&CultureCode=en

10 EFPIA partners, 10 universities, 7 Service Companies, 1 scientific society, 1 technology  company, 7 associate collaborators, 5 advisors

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Ongoing-Long Term: Training & guidelines

‐ Training to scientists & QA personnel (external)‐ International societies‐ Janssen collaborators

‐ Participate & present in international conferences: ‐ Scientific: WCRI, ECNP, FWO, …‐ QA: RQA, SQA

‐ Contribute to guidelines (RQA)

12/7/2017

http://www.therqa.com/

Co‐ordinate the development of common European standards

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Our ultimate goal is to make a difference for patients by identifying the most promising opportunities and collaborating with the best minds in the world to develop innovative new solutions to advance healthcare

We are all in this together…. !

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The world is our laboratory

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Bedankt!Thank you !

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