Simon Coles from Amphora Research Systems gave a presentation on lessons learned from implementing electronic lab notebooks (ELNs) across different industries. He emphasized that the term "ELN" can mean different things. Key differences that impact ELN projects include whether the organization is life sciences vs other industries, and within life sciences whether it focuses on biology vs chemistry. He advised that for success, one should understand an organization's specific needs and customize the solution rather than assuming a general purpose ELN can work for all.
4. About Amphora
• Started in ELNs in 1996
• Globally deployed, fully electronic ELN
for Kodak
• Grew from there...
• Now work with large & small companies
• Biotechs, Pharma, Chemicals
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8. What we do
• Patent Evidence Creation & Preservation
• Make lawyers happy
• Which means you can make scientists
happy
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9. What we do
• Sometimes our stuff is used...
• Standalone
• In conjunction with other “ELN”
products
• With in house systems
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10. Why me?
• We do the Patent Evidence problem
• You still need to make the scientists happy
• So we get a ring-side seat on some of
these problems
• We cross all the different ELN industries
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11. This Presentation
• Adapted from an all-day workshop given
every year at the Association for Lab
Automation in Palm Springs
• Come and join us!
• Hot, Sunny, and informative...
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12. So…
• You’ve been asked to get an ELN
• You turn up to different conferences
and hear different case studies
• How do you know what’s applicable to you
or not?
• How can you increase your chances of
success?
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13. The “ELN” Word
• Very ambiguous
• Probably best if you didn’t use it
• Say what you mean
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14. What do you mean?
• The term “ELN” means different things to
different people
• Somewhere the scientists will work
• A Patent Evidence system (& long term
record)
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15. What is an ELN?
Corporate aspects
(Records, IP protection, Sharing)
Medicinal Chemistry
Process Chemistry
Molecular Biology
Pharmacology
Etc.
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16. Patent Evidence
• Typically this is a broad, thin layer
• Consistently applied across the whole
company
• Keep it out of the scientific systems
• Single, well defined place
• Under the control of Custodian
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17. Patent Evidence
• Typically this is a broad, thin layer
• Consistently applied across the whole
company
• Keep it out of the scientific systems
• Single, well defined place
• Under the control of Custodian
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18. Industry/Company Type
• Life Sciences
• Biotech or Pharma
• Biology Vs Chemistry
• Diverse Chemicals
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19. Biotech Vs Pharma
• Pharma tend to be much more “Mature”
organisations
• Everything is done in an Enterprise Way
• Biotech can be much lighter on their feet
• Simpler problems
• Smaller, younger organisations
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20. Differences that make a
Difference
• There are 2 key aspects which impact the
character of your ELN implementation
• Regulated Vs Unregulated
• Industry
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21. Regulated or not?
• If you are regulated, chances you are talking
about process automation, enforcement,
and compliance
• This isn’t easy, but it is
• Relatively unambiguous
• Fairly well mapped already
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22. ELNs in a Regulated
Area
• The functions of a “Notebook” will often
be done electronically by something else
• It won’t be called an “Electronic Lab
Notebok”
• Mixing regulated none regulated generally
makes life unbearably exciting
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23. Chemistry Vs Biology
• In Life Sciences, the biggest distinction is
between Chemists and Biologists
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24. Chemistry
• Chemistry is pretty structured
• Buy (or build) them a Chemistry-centric
ELN and let them get on with it
• The selection process is detailed but at
least the work relatively consistently
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25. Sources of Chemistry
ELNs
• If you’re a big pharma, you’re probably
already set
• With varying success - this isn’t easy
• Solutions
• Buy off the shelf
• Build from what you have
• Vendor capture
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26. Sources of Chemistry
• In Biotechs, you probably can’t afford to
build or do vendor capture
• Unless Cheminformatics is a core strength
• So you’re going to have do as much as you
can with off-the-shelf (customised as
needed)
• Nice selection of vendors, have fun!
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27. Biology
• Massive diversity
• Lots of Microsoft Office and other “non
ELN” applications
• Best approach is to get out of their way
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28. Examples
• Biology in Janssen (IQPC Brussels 2007)
• Really good example of in-depth analysis
of process
• 98% approval rate on a project that size
is pretty stunning
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29. Small/Medium
Chemicals
• Lots of point solutions
• Rarely have the money do to anything
other than implement an off-the-shelf
package in a small area
• Relatively simple problem
• Significant successes in certain cases
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30. Large Chemicals
• Somewhat boring places you may or may
not have heard of
• But employ 1,000 of scientists and make
most of the fun stuff in your house and car
• e.g. companies like Kodak, BASF, PPG,
Milliken, USG, etc.
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31. Large Chemicals
• Massive diversity
• R&D is typically very close to the customer
• Tight timescales
• Low tolerance for “non-value add”
activities
• Not as much “Chemistry” as you’d think
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32. Large Chemicals
• The ELN project will “Open the can of
worms” in terms of
• The tools people are using
• The records they are creating
• The patent evidence that is generated
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33. General Purpose ELNs
• “You all use the same Paper notebook don’t
you?”
• “So surely you can all use the same
Electronic notebook?”
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34. General Purpose ELNs
• You can do it for small numbers of users
and certain styles of work
• Where workflow is important
• For large numbers of users
• The diversity in process will kill you
• You end up building an expensive version
of Word & Excel
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35. General Purpose ELNs
Functionality
Number of users
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36. General Purpose ELNs
Functionality
Possible
Number of users
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37. General Purpose ELNs
Functionality
Possible
Possible
Number of users
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38. General Purpose ELNs
Functionality
Possible
Doomed to fail
The organisation will frustrate you
Possible
Number of users
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39. Front end tools
• Most organisations will end up providing
different front ends to different users
• Examples
• BMS, Solvay, J&J, BASF, all the other large
companies
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40. Patents
• As a rule, what you need to do from a
Patent perspective is pretty generic
• You might have some specific needs, but
95% of what you need can be done off the
shelf
• This is one area where you want to stick
with convention
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41. Security
• In Life Sciences things are relatively sane
• In Large Chemicals, you get all the fun of
“Chinese Walls” created by Commercial
agreements
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42. Security
• This is another whole can of worms
• That didn’t really exist until the ELN came
along
• No one could find anything in the paper
notebook anyway
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43. Security
• Ultimately you have to do what the
organisation requires
• But you need to avoid massively complex
regimes
• If you do NDA-related Chinese walls, you
need to have that tagged into the record at
creation
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44. Security
• The security problem isn’t a technical one
• Most “Security” regimes are quite easy to
implement
• But often organisations aren’t wired up the
right way
• e.g. who keeps the list of projects and
who can read what?
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45. Records Management
• The Cinderella of ELN projects
• Desperately important
• Clearly something that’s dependent on your
own processes
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46. Conclusions
• Our original question
• Some thoughts
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47. Our Questions
• What’s the differences that make a
difference?
• What simple things can you do to
increase your chance of success?
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48. Differences
• Life Sciences Vs Everyone else
• In Life Sciences
• Biology Vs Chemistry
• Biotech-ish Vs Pharma-ish
• Regulated or not?
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49. Beware the ELN word
• Say what you mean
• Expect different front ends to support
different work
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50. Changing the world
• Unless you have been specifically charged
with changing the workflow
• Don’t pick the fight
• You’re there to support the science
• Today and in the future
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51. Conclusions
• They’ve probably already got what they
need anyway
• Or a very good idea of what they need
• That’s why they asked for an ELN in the
first place
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52. Conclusion
• If you are charged with changing the
workflow
• That’s your project, not “ELN” or
whatever
• Try to keep the scope as small as possible
• Size and diversity will kill you
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53. Patent Evidence
• Stick with best practice unless you really
know what you are doing
• One single system
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54. Security
• Do what you have to do
• But try to keep it simple
• It isn’t a technical problem, really
• But joining the dots internally can be
interesting
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55. Conclusion
• Chemistry - buy, or build, the best you can
• Biology - get out of their way
• Large chemicals - you’ll never fully
understand everything in detail
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56. Thank You
• Slides will be on our web site tonight
• Any questions?
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