Iqpc eln joanna mulgrew

e-Lab Notebooks at Pfizer -A comparison between Chemistry & Biology

implementations

IQPC ELNs

(Brussels 28th- 30th Sept 2009)

Joanna MulgrewData Support & Management Team

Pfizer Global Research & DevelopmentSandwich, UK

Contents

• Benefits of e-Lab Notebooks

• Core Requirements & Products chosen

• Implementation of Chemistry & Biology e-Notebooks

• Feedback from users

• Comparison of implementations

• Summary

IQPC ELNs28th-30th Sept 2009

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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

3IQPC ELNs28th-30th Sept 2009

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


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


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.


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


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


• 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


Implementation of IDBS Biology e-Lab Notebook 2008-2009

Evolving Spreadsheet Deployment Process - 2008


Spreadsheet Deployment Process 2009

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Biobook spreadsheet deployment at SWKnowledge 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 ….


Things don’t always go to plan…..

Jo: Here’s the final version of your spreadsheet as per all our requirements discussionsUser: 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 onesUser: 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 nowJo: 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


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


“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


Feedback from Biology UsersChallenges & 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


• 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”


Feedback from Biology Users Challenges & Opportunities contd.

Feedback from Chemistry UsersWhat 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”


– 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


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


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


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


Dilbert says it best….

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What really makes the difference?

www.gapingvoid.com


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


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


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


Technology

Iqpc eln joanna mulgrew