harnessing pharma workflow with elns
DESCRIPTION
HARNESSING PHARMA WORKFLOW WITH ELNsTRANSCRIPT
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.