Janssens Discovery Data Integrity program (DDI): A journey over the last 7 years Research Integrity: Position yourself for success!

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1 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 Pharmacology Ghent University, December 6 th, 2017 Janssen Research & Development a division of Janssen Pharmaceutica NV

2 Agenda Disclaimer: The views expressed in this presentation are solely those of the individual author, and do not necessarily reflect the views of my employer 1. Janssen R&D 2. Pharmaceutical industry & data integrity 3. Janssen s DDI (Discovery Data Integrity) Initiative Approach Key success factors Broadening our scope 2

3 Janssen R&D 3

4 Our organization is global, yet our focus is the local community North America Europe, Middle East & Africa 36, Employees Countries Manufacturing Sites R&D Centers Latin America Asia Pacific 4

5 Janssen s Therapeutic Area Research Focus NEUROSCIENCE Schizophrenia Mood disorders Alzheimer s disease Chronic pain IMMUNOLOGY Inflammatory bowel disease Rheumatoid arthritis Psoriasis Pulmonary disease End-to-end strategy focused on five therapeutic areas INFECTIOUS DISEASES & VACCINES HIV Hepatitis C Respiratory Vaccines CARDIOVASCULAR & METABOLISM Cardiovascular disease Diabetes ONCOLOGY Prostate Lung B-cell malignancies Immuno-Oncology 5

6 J&J s Shifting Strategy: Innovation Centers (2012) London San Francisco Minneapolis Tokyo Shanghai San Diego Israel Boston Innovation Center Satellite Target mix of Portfolio of 50% from Internal and 50% External Science Sydney 6

7 The pharmaceutical industry & data integrity 7

8 Non Regulated Discovery Clinical candidate Regulated Preclinical Development IB Phase I & II clinical trial Phase III clinical trial Registration & Marketing $2.6 billion over years image 8 8

9 Translation issues affecting Pharmaceutical Industry Only healthy data lead to healthy patients 9

10 Janssen s DDI initiative 10

11 Finding the Balance Innovation & Quality Innovation Research Exploration Integrity Accuracy Reconstructability Man Wallpaper Albert Einstein Imagination is More Important than Knowledge 1280X1024 free wallpaper download/ 11

12 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: Accuracy Traceability Reconstruction An unbiased approach Open scientific collaboration 12/7/

13 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 than others Storage space issues (want to keep everything, without archiving ) Limited support from biostatisticians Opportunity to improve cross referencing/linking data for easy retrieval 13

14 DDI community model Discovery Leadership Biologics CoE Discovery Sciences ONCOLOGY SM/LM/ Biomarkers IMMUNOLOGY SM/LM/ Biomarkers Neuroscience SM/LM/ Biomarkers Cardiovascular Metabolism Infectious Diseases &Virology +Biomarkers DDI Discovery Champions The ideas Identify opportunities Generate concepts Cross-fertilization member(s) from each group Non regulated R&DQA The findings Analyses Metrics Advice, support, training DDI CORE TEAM The solution DDI Core Team (Discovery, QA & IT) Setup & direct workstreams DDI Workstreams Storage space Reporting process Training program... Provide & Implement solutions Partners: IT, Biostatisticians, Project managers, Legal, Communications,... 14

15 15 DDI workstreams Basic training program and platform 1 central DDI portal Participative poster campaign Where did I put it? Where to store data What data to store Safe data storage Culture & Communication Mandatory global DDI training Rewarding system How to deal with fraud allegations/ suspicions Mandatory DDI section in electronic protocol templates Internal and external non reg QA program Quality maintenance program Reporting of individual experiments Clinical candidate reporting Reporting process Bias prevention Increased Biostat support Publication process External contracts External data Implementation phase Fully implemented einstein background.jpg image 15

16 Janssens DDI quality system photo 16

17 Culture & Communication E.g. Participative poster campaign 17

18 GAP ANALYSIS E.g. Shortage of storage space HELP I need more room or to find the way to the archive! image 18

19 FORM E.g. MULTIDISCIPLINARY TEAMS TO LEVERAGE BEST PRACTICES E.g. Expert biostatistician s support 19

20 E.g. FORM MULTIDISCIPLINARY TEAMS TO LEVERAGE BEST PRACTICES E.g. Contractual language 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? image 20

21 IMPLEMENT BEST PRACTICES E.g. reporting guidelines 21

22 Quality program and metrics Data spot checks Feedback on good practices & gaps Pulse check of guidelines Measure success of DDI program image 22

23 Janssen s DDI initiative: Key success factors 23

24 Key success factors 1. 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, Simple, sustainable solutions and fit for purpose guidance a) 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) 12/7/

25 Janssen s DDI initiative: Broadening our scope 25

26 Broadening our scope Quality data = Quality decisions Long term Global research environment Common guidelines Data sharing platforms starting Contract language CROs, Collaborators, Innovation centers ongoing Internal research Publication of replicate studies & negative results Data capturing & transfer platforms Training Global Guidelines Spotchecks ed=0ahukewj sfqmuejxahxca1akhud1cyeqjrwibw&url=http%3a%2f%2fclipartlibrary.com%2fcartoon trafficlight.html&psig=aovvaw3rxrg8s52cocr7i2ugx3jn&ust=

27 Ongoing: Transparency Initiatives in clinical space to open sharing of data (Jan 2014, Nov 2012) Clinical Trial Data Sharing Agreement with Yale School of Medicine s Open Data Access (YODA) Project A 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 chief medical officer/yale open data access project TransCelerate BioPharma Joint 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) research development announces establishment of global cross pharmaceutical clinical trial investigator databank Last Updated: 11/24/

28 Started: Improving Data Quality as Key Deliverable though IMI Initiative EQIPD European Quality in Preclinical Data 10 EFPIA partners, 10 universities, 7 Service Companies, 1 scientific society, 1 technology company, 7 associate collaborators, 5 advisors

29 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) Co ordinate the development of common European standards 12/7/

30 The world is our laboratory 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.! Point 1 Point 2 Point image 30

31 Bedankt! Thank you! 31

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