HARNESSING PHARMA WORKFLOW WITH ELNs

-ELECTRONIC LABORATORY NOTEBOOKS

WANDA HARTMANN OEHRLI

Contents

Importance of Notebooks

Current ELN Customers

Barriers

Architecture

Predictions & Recommendations

20% growth rate per year one of the fastest growing technologies

ELN • A daily record-keeping of the pharma process that includes

at least the content of a paper notebook• Helps to manage data from discovery to commercialization

Manage Workflow

Store Data

Share Data

Search Data

Pharma Workflow Example

Scientist

Manager

Verifier

Quality Contro

l

Importance of Notebooks

Intellectual asset

• Legal document, patents, IP

Document control

• Verified and controlled by QA• Data used for submissions to FDA• Paper notebooks no longer meet needs!• 1997 FDA passed new rules on electronic documents

Necessity of ELNsACCELERATION OF DRUG DISCOVERY!

•Eliminate Loss/Theft of Notebooks

•Improve Protection of IP

•Increase Collaboration

•Enhance Search Capabilities

•Improve Monitoring & Auditing

Current ELN Usershttp://www.genengnews.com/articles/chitem.aspx?aid=2481

GSK 103,000

employees$ 45.8 B

Lilly 40,500 employ

ees $20.3 B

Abbott 69,000

employees$29.5B

Current or Future Client?

Merck 59,800 employ

ees $23.9 B

Barriers to Implementation

RiskResistance, adapt to change

Privacy, control, imposed

ChallengeTraining, improper use, security

Increase in complexity

Cost

Resistance levels are low

ELN ArchitectureDatabase Application/Web server

PDA laptop Computer

Software mainly handles work

processflow

Copies of files will reside locally, short and long term on webservers and DB

Most Popular Vendor

Company

Cambridge Soft

DB

Oracle, SQL

Cost

$10K to install

group of 10

Predictions

Recommendations• :

Elimination of Paper Notebook

s

• Standardized workflow

• Management tool

• Collaboration

• Security of IP & Data Archiving

• loss, theft & damage

• traceable record of ownership

• work and data record for legal purposes

CambridgeSoft is the #1 choice for pharma

workflow ELN

To keep pace with com

petitors –

do it

References1. http://www.informationliberation.com/files/anthraxVaccine.jpg2. http://www.healthsystem.virginia.edu/internet/uvamellon/images/DrugDiscovery.jpg3. http://www.clinical-trials-info.com/wp-content/uploads/2009/02/drug-discovery-11.jpg4. http://www.labtronics.com/Images/eln-small.jpg5. http://en.wikipedia.org/wiki/Electronic_lab_notebook6. http://acdlabs.typepad.com/my_weblog/2007/07/electronic-lab-.html7. http://www.krackeler.com/graphics/0007/jpg/63001000a1.jpg8. http://www.labtrack.com/files/q1_blank_screen.jpg9. http://www.genengnews.com/articles/chitem.aspx?aid=107510. www.indiana.edu/~cheminfo/C571/ELNlecture20030825.ppt 11. http://www.scientific-computing.com/products/product_details.php?product_id=30212. http://knol.google.com/k/shawn-mcclelland/electronic-lab-notebooks/3mhmqlqy4k0no/1#13. http://www.scientificcomputing.com/Electronic-Laboratory-Notebooks-Enter-Mainstream-Informatics.aspx14. Elliott, Michael H; Electronic Laboratory Notebooks: A Foundation for Scientific Knowledge Management Edition III; Atrium Research &

Consulting LLC; Wilton, CT USA 15. http://www.measurementdevices.com/index.php?name=News&file=article&sid=159716. http://www.chem.agilent.com/en-US/Products/software/kalabieeln/Pages/default.aspx17. http://www.streetinsider.com/Earnings/

Symyx+Announces+Electronic+Laboratory+Notebook+and+LIMS+Partnership+With+Thermo+Fisher+Scientific/4491417.html18. Some images are from Microsoft Clip Art19. http://www.medicalnewstoday.com/articles/29934.php (resistance to ELN)20. http://www.pr.com/press-release/44174 (LabTrak)21. http://www.ddw-online.com/industrynews/124013/new_enterprise_electronic_lab_notebook.html (Symex notebook)22. Networking will slow things down; cost http://pipeline.corante.com/archives/2008/02/07/write_it_down_write_it_down.php23. http://www.genengnews.com/articles/chitem.aspx?aid=248124. http://www.phschool.com/science/science_news/articles/images/electron_runs_through_01.jpg25. http://www.sxst.it/siti/sxst/sxst.nsf/seminari/cambridgesoft/ELN-Intro.pdf26. Pharma company logs came from company websites.

Google Keyword searches review of ELN electronic laboratory notebook Market potential for electronic laboratory notebook at pharmaceutical companies cost of electronic laboratory notebooks cost of cambridgesoft eln

I would like to acknowledge help from IT experts, friends and family who reviewed this presentation.