IQPC ELNs, Brussels 28th- 30th Sept 2009

1. e-Lab Notebooks at Pfizer -
A comparison between Chemistry & Biology
implementations
IQPC ELNs
(Brussels 28th- 30th Sept 2009)
Joanna Mulgrew
Data Support & Management Team
Pfizer Global Research & Development
Sandwich, UK

2. Contents
• Benefits of e-Lab Notebooks
• Core Requirements & Products chosen
• Implementation of Chemistry & Biology e-Notebooks
• Feedback from users
• Comparison of implementations
• Summary
IQPC ELNs
28th-30th Sept 2009
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3. Benefits of e-Lab Notebooks
• Single source for all write-ups – access to information across the
organisation - knowledge acquisition & collaboration benefits
– Searchable
– Establishing links between experiments & tracking changes in study
design
• Readability & Quality of information
• Improved standardisation
– e.g. team level write up templates capture information consistently
– Common procedures copied from one experiment to another or even
stored in a central library
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28th-30th Sept 2009

4. Benefits of e-Lab Notebooks contd.
• Improved compliance (and easier to check compliance) and
intellectual property protection
• Access to Computational tools within the e-workbook
• Reduce overhead of paper notebooks – cost & time/admin
• Overall improvements in efficiency particularly with increasing data
volumes & complexity
• Improved Data Security
4IQPC ELNs
28th-30th Sept 2009

5. Core Requirements & Products Chosen
Chemistry Requirements
– Enable global replacement of paper notebooks and ADF
(Auxiliary Data Folders) for synthetic/analytical and design
chemists
– Follow normal workflow involved in writing up / drawing the
synthetic reaction steps in singleton medicinal chemistry
– Integration with existing corporate compound registration and
sample inventory systems, analytical data warehouse
Choice : Development of in-house product: CeN
– Why? Nothing at the time (2004) that had ‘specific’ ELN
features – integrated tools for registration & calculations
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6. Biology Requirements
– Improved efficiency in non-plate based pharmacology
– Improved reporting and sharing of data & results
Choice : COTS : IDBS’s E-WorkBook suite for Biology
incorporating Biobook spreadsheets
– Why? Data-analysis & reporting capabilities in Biobook (a multi-
dimensional spreadsheet) – flexibility to address these core
requirements
“If you always do what you’ve always done,
you’ll always get what you’ve always got”
Most (if not all) Global Biology applications were written in house at Pfizer –
with the risk that development times are impacted by complex requirement
discussions
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Core Requirements & Products Chosen contd.
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28th-30th Sept 2009

7. Implementation of Chemistry e-Lab Notebook
• Development of ‘thin client’ in-house in 2004
• Pilot in 2005
• Rollout in 2005 by department
– Chemists asked to write up next experiment in CeN
• SAFESign system implemented later in year – workaround in
meantime (print and wet signature)
• Challenges in implementation
– Performance, Stability, Bugs, acceptability of rendering in PDFs,
Rollout of SAFESign with smart card certificate management
• These challenges led to implementation of a thick client version in
2006
7IQPC ELNs
28th-30th Sept 2009

8. Implementation of IDBS Biology e-Lab Notebook - 2007
• 2007 pilot (v6), followed by integration work with SAFESign,
corporate database etc..
• Pilot then rollout of E-WorkBook by group on two weekly cycles in
UK. Classroom training for E-WorkBook and SAFESign . 400 + users
trained in UK by Jan 2008
• In UK - Sharepoint and internal wiki areas for support, tips,
technical sheets etc – No more paper books issued
• US deployment - build Biobook spreadsheets for users with
specific data analysis requirements – Provide these users only with
E-WorkBook + Biobook - Paper books continued to be issued
8IQPC ELNs
28th-30th Sept 2009

9. • Corporate database integration – create custom dictionary to map
data codes
• 2008 v8 rollout - addressed performance
• 2008 Biobook spreadsheet deployment in UK – 70 different
workflows. Team of statisticians, Informatics, Data managers, IDBS
developers and Scientists. Parallel development of ~8 spreadsheets
per round (10 rounds). Evolved process during the year
• 2009 V8.1.1 point release- addressed text editor issues and
improved searching
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IQPC ELNs
28th-30th Sept 2009
Implementation of IDBS Biology e-Lab Notebook
2008-2009

10. Evolving Spreadsheet Deployment Process - 2008
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11. Spreadsheet Deployment Process 2009
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Biobook spreadsheet deployment at SW
Knowledge transfer - took ~ 6 months for in-house team (~2 FTE) to
gain sufficient product knowledge to troubleshoot/fix existing
spreadsheets and develop new ones autonomously
Learning when to use the spreadsheet and how to “manage” the users
when we are developing a spreadsheet takes a little longer than 6
months ….
IQPC ELNs
28th-30th Sept 2009

12. Things don’t always go to plan…..
Jo: Here’s the final version of your spreadsheet as per all our requirements
discussions
User: Looks great, but now can I have an ANOVA?
Jo: OK. But you didn’t mention that in the initial requirements. What do you want the
ANOVA to compare? You have no vehicle animals, only test compound ones
User: Oh, I probably will have vehicle animals. I just didn’t include them in the data
set I sent you. Can’t I just compare each Analyte?
Jo : OK, but how do you want to compare the Analytes?
User: Ermm. Maybe each Analyte at each time point?
Jo: But that would require multiple ANOVAs which will adversely affect the
performance of the spreadsheet. Is this really what you need?
User: Oh, I’m not really sure now
Jo: How about comparing the max % increase over basal?, Or the % basal at
endpoint?, Or Area under curve (AUC)?
User: Right, I think I need to speak to Research Statistics before we go any further
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28th-30th Sept 2009

13. Feedback from Biology Users
What they liked
• E-WorkBook:
– Copying of experiments and templates, enabling compliance
and improved data quality
– Improved security & no need to archive notebooks
– Quicker than paper; better organised; easier to navigate and
search, collation of associated files
• Spreadsheets:
– Saved time, presented opportunity to revisit methodology &
standardise, and enhanced data quality
• V8.1.1 release:
– Extra flexibility in terms of ewb hyperlinks, searching and better
interface/feedback in Digital Signature window
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28th-30th Sept 2009

14. “It would not have been possible for us to analyse the
complex data generated appropriately and report the
findings to the FDA deadline”
“It has saved us months worth of analysis and helped to
eliminate cut and paste errors”
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Feedback from Biology Users
What they liked
IQPC ELNs
28th-30th Sept 2009

15. Feedback from Biology Users
Challenges & Opportunities
• E-WorkBook:Performance; Tracking & formatting of published
experiments (PDFs); Fixing of usability issues
– Text editor issues – adversely affected PDF rendering or
prevented publishing – hints/tips support page
– 2008 Performance and Digital signature feedback issues - lower
take up than desired
– Performance and signature tracking improved, so from
September 1st 2009 E-WorkBook use as Biology ELN has been
mandated across Pfizer
• Spreadsheets: Exploit built in data warehouse to enable
further integration of challenging workflows
– Proof of concept work nearing completion
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28th-30th Sept 2009

16. • Spreadsheets : when and how to use
– Learning when to use a Biobook spreadsheet – unclear requirements
extend build times and affect performance
– Most useful to standardise analysis for established assays, less so for
assay development requiring frequent multiple changes to the code.
Significant user input and initial support is often required to ensure it
will meet their needs ….and will be used….
– Integration with external statistics packages
“because of issues with spreadsheet set up and complexity around number
of tables etc, ..I have not been using it”
“I managed several times to “break” the spreadsheet without knowing
what went wrong exactly”
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28th-30th Sept 2009
Feedback from Biology Users
Challenges & Opportunities contd.

17. Feedback from Chemistry Users
What they liked
– Improved search functionality
– Reagent calculation
– Legible ‘handwriting’
– Fast registration
– Not over spec’d – easy to get the best out of it
– Efficiency savings
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“This application is loaded first thing, everyday, by everyone -
It stays on all day, people ‘live’ in it. They ‘save’ on every
page”
IQPC ELNs
28th-30th Sept 2009

18. – Challenges
• Issues/Bugs during implementation: Stability issues,
performance, e-signature setup, server outages, Special
characters in PDFs .... now resolved
• Workflow changes: Keeping “in step” with changes to workflows
e.g new compound ordering application, impact of outsourcing
– Opportunities
• Further integration with in house systems e.g. ordering systems,
and development of parallel chemistry extension
• Standard PDF export for CRO
• RSS alerting
• Reaction Knowledge Base
• Concept records – confirming IP by recording the “idea” for an
experiment whether pursued or not
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Feedback from Chemistry Users
Challenges & Opportunities
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28th-30th Sept 2009

19. Similarities
• Issues
• Benefits observed
• Local training and support is vital - particularly in early stages
• Data sharing, visibility, what’s written up, what tasks do I
need to do, report compiling are all easier in the ELN
• Ensuring compliance with corporate policies for write-up and
sign-off is common to all ELNs – cf prior presentation by Letitia
Fearon, Pfizer on processes around ensuring compliance
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28th-30th Sept 2009

20. Differences
• Biology ELN had very broad & dynamic set of requirements,
which adapted over time as new ways to use the product
became apparent
• Chemistry ELN - opposite is true – every chemist gets the
same product, no customisation allowed or possible
• Heavy training and support burden for E-WorkBook/Biobook
– UK Implementation team ~ 15 colleagues across
Informatics, Statistics and Business actively involved for ~ 18
months from pilot to completion. Core team of 7 continue to
manage this
20IQPC ELNs
28th-30th Sept 2009

21. Differences contd.
• Knowledge transfer takes longer with an external product
compared to in-house – Most learning takes place post
implementation, whereas the in-house product is built to fit
an existing (albeit simpler) workflow
• Cycle time for implementation of bug fixes – depends who’s
“driving”
• Cost of maintaining Chemistry in house system – new
workflows and integrations
• Chemistry replacement of paper notebook was quicker than
Biology’s
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28th-30th Sept 2009

22. Dilbert says it best….
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What really makes the difference?
www.gapingvoid.com
IQPC ELNs
28th-30th Sept 2009

23. Summary
• Nobody wants to go back to paper!
• At the outset, invest time in understanding which toolsets
would result in the greatest ROI
• Developing new tools is an opportunity to re-evaluate analysis
methods, create best practice and increase efficiencies – this
requires time and much learning – but brings long term benefit
“A person ignorant of the possibility of failure can be a half-
brick in the path of the bicycle of history” Terry Pratchett, Equal Rites
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28th-30th Sept 2009

24. Summary contd.
• User expectations of performance must be defined up front
• Partnership between multiple parties is key both between
vendor/client and internal groups in a large organisation
• There are a number of considerations in terms of change
management in particular cultural changes, that will impact
the acceptability of ELNs
• Although the initial hurdle is inherently a cultural one , once
users have started using it, the ELN (however developed) is
well accepted
24IQPC ELNs
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25. Acknowledgements
• Ian Johns
• Abdul Ingar
• Philip Laflin
• Jerry Lanfear
• Letitia Fearon
• Paul Driscoll
• Nuzrul Haque
• Tim McLellan
• Phil Stanley
• Dafydd Owen
• Jonathon Pryke
• Graham Baker
• Daffyd Owen
25IQPC ELNs
28th-30th Sept 2009