2008 03 11 ELNs in different industries

Lessons from Different Industries

Simon ColesCTO & Co-Founder, Amphora Research Systems

http://www.amphora-research.com/ 2

http://www.amphora-research.com/

Copies of these slides

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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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Who we work with

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Who we work with

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Industry

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What we do

• Patent Evidence Creation & Preservation

• Make lawyers happy

• Which means you can make scientists happy

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What we do

• Sometimes our stuff is used...

• Standalone

• In conjunction with other “ELN” products

• With in house systems

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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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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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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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The “ELN” Word

• Very ambiguous

• Probably best if you didn’t use it

• Say what you mean

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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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What is an ELN?

Corporate aspects(Records, IP protection, Sharing)

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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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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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Industry/Company Type

• Life Sciences

• Biotech or Pharma

• Biology Vs Chemistry

• Diverse Chemicals

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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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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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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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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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Chemistry Vs Biology

• In Life Sciences, the biggest distinction is between Chemists and Biologists

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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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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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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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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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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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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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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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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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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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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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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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Doomed to failThe organisation will frustrate you

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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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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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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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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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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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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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Records Management

• The Cinderella of ELN projects

• Desperately important

• Clearly something that’s dependent on your own processes

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Conclusions

• Our original question

• Some thoughts

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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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Differences

• Life Sciences Vs Everyone else

• In Life Sciences

• Biology Vs Chemistry

• Biotech-ish Vs Pharma-ish

• Regulated or not?

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Beware the ELN word

• Say what you mean

• Expect different front ends to support different work

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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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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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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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Patent Evidence

• Stick with best practice unless you really know what you are doing

• One single system

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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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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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Thank You

• Slides will be on our web site tonight

• Any questions?

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Technology

2008 03 11 ELNs in different industries