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Global Integration of Pre-clinical Chemistry and Biology Data – Challenges and Benefits. Jayne Cartmell Global Integration of Pre-clinical Chemistry and Biology Data – Challenges and Benefits. Jayne Cartmell Bowden, Ph. D. Global Program Manager Abbott Laboratories.

Overview l l l l Discovery IT at Abbott - 1999 Project deployment and Overview l l l l Discovery IT at Abbott - 1999 Project deployment and timelines Status details Impact TDB savings TDB metrics Lessons learned

Abbott Discovery IT - 1999 l l l l Biologists, chemists or ‘Paper-shufflers’? Frequent Abbott Discovery IT - 1999 l l l l Biologists, chemists or ‘Paper-shufflers’? Frequent duplicate, manual entry of data -slow, tedious, error-prone. Limited viewing and sharing of data. Out-of date Structure-Activity Relationships. Data scattered through-out Discovery Lack of standard tools made data sharing a challenge… Excel, 4 D, Ark, Access, Word, Accord, etc.

Consultant Report l l l Tripos conducted IT analysis of Discovery data manipulation. Abbott Consultant Report l l l Tripos conducted IT analysis of Discovery data manipulation. Abbott needed a system for projects to store and retrieve all project-related data… …make project decisions wisely and quickly via ready access to accurate information. Reduce ‘time-to-market’ and increase time under patent protection. Reduce project costs via increased productivity. Abbott would save between $1. 25 MM and $10 MM per year if such a database system was in place.

“Integration”…. l ‘…a process in which separately produced components are combined…’ “Integration”…. l ‘…a process in which separately produced components are combined…’

Integration of Discovery data “In which assays has this compound/structure been run? ” l Integration of Discovery data “In which assays has this compound/structure been run? ” l Effective access to project compound information structures, chemical properties and biological data is critical for productive drug discovery. l Chemical Structure Biology Data Chemical Properties In vitro In vivo PK ADME

Requirements l l l Central, shared data repository. Easy desktop access. Creation of SARs Requirements l l l Central, shared data repository. Easy desktop access. Creation of SARs including chemical structures and data. Standard report generation by the scientists. Data should be secure but not restricted. l l l Distinction made between published and unpublished data. Storage of raw data avoids having to re-load data and provides data context. Agreed on terminology. Minimal customization. Flexible – configurable by scientists.

Therapeutic Area Database (TDB) Data Assay Explorer ISIS/Base Reader Format Calculation Model Export ISIS Therapeutic Area Database (TDB) Data Assay Explorer ISIS/Base Reader Format Calculation Model Export ISIS for Excel Curve Fit

Rollout Process and Timelines TDB rollout cycle (9 weeks) 2 Projects deployed in parallel Rollout Process and Timelines TDB rollout cycle (9 weeks) 2 Projects deployed in parallel (23 AP Projects in total) DEV Requirements PRD Development Test Final 1 2 3 4 5 6 Train 7 8 9 10 11 Train Go Live 1. 5 days training for each scientist (detailed user manuals)

Global TDB Status l l l Abbott Park Deployment to all 23 projects complete Global TDB Status l l l Abbott Park Deployment to all 23 projects complete (07/03) Germany - Deployed October, 2002 Massachusetts - Deployed March, 2003 Support ramp-down and subsequent roll-outs on-going Positive feedback from Discovery scientists… “…TDB is a huge time-saver…” “…far superior to our old database…” “…searching. . is a huge improvement…”

TDB Impact l l l Automated data entry (= less error). Updated data immediately TDB Impact l l l Automated data entry (= less error). Updated data immediately accessible (= accurate). On-the-fly generation of SAR tables (= current). More time to focus on science. Broadens scope of data review. Facilitates research collaborations. Allows Discovery executives to monitor progress. Access to all Discovery data – globally. Terminology and standards applied across all sites. Data permanently accessible and understandable. Ability to perform tasks not possible before TDB.

TDB Impact – Hard Savings l l l Estimate that IT support costs have TDB Impact – Hard Savings l l l Estimate that IT support costs have been halved. Scientists at AP were queried one month after TDB launch. Based on 40 hour week, 48 weeks/year; on average, for one project, hours saved… Per Project Hours/wk $/year 27. 5 181 000 Chemists (6) 6 40 000 Biology Group Leader 6 40 000 Chemistry Group Leader 1. 5 10 000 Project Leader 1. 5 10 000 Biologists (5) Total 281 K/yr

TDB Usage 2003 TDB Usage 2003

Lessons Learned l l l Ensure accurate and realistic scope verification. Thorough user testing Lessons Learned l l l Ensure accurate and realistic scope verification. Thorough user testing is critical. Use realistic cost estimates. Do not underestimate the requirement for detailed scientist training. Take frequent ‘reality-checks’. Effectively manage the scientists expectations and the importance of their role in the deployment process.

Factors that helped us l l l l Executive support TDB team dedication and Factors that helped us l l l l Executive support TDB team dedication and work ethic Scientific administrator TDB team experience and knowledge In-house trainers Documentation Support process Scientists on board

Thank-you…. Abbott Park - Sponsors Don Halbert Jim Summers Juergen Seega Randy Chen Bob Thank-you…. Abbott Park - Sponsors Don Halbert Jim Summers Juergen Seega Randy Chen Bob Hogan Ludwigshafen Agnes Metanomski Alfred Stefan Gunther Stumpf Heinz-Peter Vogel Jonathan Bosley (MDL) Martine Heinrich Peter Gruener Peter Hellmann Susanne Buechler Tom Marron Uwe Christman MDL - Sponsors Bill Balke Debra Toburen Lars Barfod Mike Drake Roger Abraham Sara Bertsch Seth Pinsky Worcester Alan Williams Bill George Chris Sprangel Joanne Kamens Keith Glavin Keith Huss Abbott Park Albert Crescenzo (MDL) Brett Erkman Brian Devendorf Cynthia Collins Dan Mendro Devin Ridge Diana Pell (MDL) Eric Schaefer Faisal Waheed Jack Zhi John Burns (MDL) John Crary (MDL) John Mc. Carthy (MDL) Julia Donavant Karunakar Chikoti Kelly Below (MDL) Kim Davis Larry Buchanan Leonard Sagalov Matt Gianni (MDL) Mike Edwards (MDL) Ron Delmendo (MDL) Subhash Nigam Zafar Ahmed

Thank-you…. Chris Butler Manli Zheng David Bacino Martin Markley Fernando Egea Mike Karrmann Gary Thank-you…. Chris Butler Manli Zheng David Bacino Martin Markley Fernando Egea Mike Karrmann Gary Young Omar Kazi Grace Chiou Ramesh Thangarajan Jin Liu (MDL) Tom Brady (MDL) Karen Alexander Kalyan Chintagunta