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Lessons from Different
      Industries
              Simon Coles
CTO & Co-Founder, Amphora Research Systems
http://www.amphora-research.com/   2
Copies of these slides




http://www.amphora-research.com/   2
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
http://www.amphora-research.com/   3
Who we work with




       4
Who we work with




       4
Industry




http://www.amphora-research.com/      5
What we do

             • Patent Evidence Creation & Preservation
              • Make lawyers happy
              • Which means you can make scientists
                       happy



http://www.amphora-research.com/       6
What we do

             • Sometimes our stuff is used...
              • Standalone
              • In conjunction with other “ELN”
                       products
                 • With in house systems

http://www.amphora-research.com/       7
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

http://www.amphora-research.com/        8
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...

http://www.amphora-research.com/      9
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?

http://www.amphora-research.com/          10
The “ELN” Word

             • Very ambiguous
             • Probably best if you didn’t use it
             • Say what you mean

http://www.amphora-research.com/   11
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)



http://www.amphora-research.com/      12
What is an ELN?
                                                 Corporate aspects
                                                         (Records, IP protection, Sharing)
                                   Medicinal Chemistry


                                                             Process Chemistry


                                                                                 Molecular Biology


                                                                                                     Pharmacology


                                                                                                                    Etc.
http://www.amphora-research.com/                                                    13
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
http://www.amphora-research.com/   14
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
http://www.amphora-research.com/   14
Industry/Company Type

             • Life Sciences
              • Biotech or Pharma
              • Biology Vs Chemistry
             • Diverse Chemicals

http://www.amphora-research.com/   15
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
http://www.amphora-research.com/    16
Differences that make a
                  Difference

             • There are 2 key aspects which impact the
                   character of your ELN implementation
                 • Regulated Vs Unregulated
                 • Industry

http://www.amphora-research.com/    17
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
http://www.amphora-research.com/     18
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


http://www.amphora-research.com/      19
Chemistry Vs Biology


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




http://www.amphora-research.com/     20
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



http://www.amphora-research.com/       21
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
http://www.amphora-research.com/     22
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!
http://www.amphora-research.com/      23
Biology

             • Massive diversity
             • Lots of Microsoft Office and other “non
                   ELN” applications
             • Best approach is to get out of their way

http://www.amphora-research.com/       24
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



http://www.amphora-research.com/            25
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
http://www.amphora-research.com/      26
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.


http://www.amphora-research.com/         27
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
http://www.amphora-research.com/    28
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

http://www.amphora-research.com/    29
General Purpose ELNs

             • “You all use the same Paper notebook don’t
                   you?”
             • “So surely you can all use the same
                   Electronic notebook?”



http://www.amphora-research.com/      30
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

http://www.amphora-research.com/         31
General Purpose ELNs
       Functionality




                                   Number of users
http://www.amphora-research.com/          32
General Purpose ELNs
       Functionality




                                        Possible


                                   Number of users
http://www.amphora-research.com/          32
General Purpose ELNs
       Functionality

                       Possible




                                        Possible


                                   Number of users
http://www.amphora-research.com/          32
General Purpose ELNs
       Functionality

                       Possible




                                           Doomed to fail
                                   The organisation will frustrate you



                                                Possible


                                      Number of users
http://www.amphora-research.com/                  32
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



http://www.amphora-research.com/       33
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

http://www.amphora-research.com/      34
Security

             • In Life Sciences things are relatively sane
             • In Large Chemicals, you get all the fun of
                   “Chinese Walls” created by Commercial
                   agreements



http://www.amphora-research.com/      35
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



http://www.amphora-research.com/      36
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

http://www.amphora-research.com/      37
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?

http://www.amphora-research.com/      38
Records Management

             • The Cinderella of ELN projects
             • Desperately important
             • Clearly something that’s dependent on your
                   own processes



http://www.amphora-research.com/   39
Conclusions


             • Our original question
             • Some thoughts


http://www.amphora-research.com/        40
Our Questions

                 • What’s the differences that make a
                       difference?
                 • What simple things can you do to
                       increase your chance of success?



http://www.amphora-research.com/       41
Differences

             • Life Sciences Vs Everyone else
             • In Life Sciences
              • Biology Vs Chemistry
              • Biotech-ish Vs Pharma-ish
              • Regulated or not?
http://www.amphora-research.com/        42
Beware the ELN word


             • Say what you mean
             • Expect different front ends to support
                   different work




http://www.amphora-research.com/    43
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

http://www.amphora-research.com/    44
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



http://www.amphora-research.com/        45
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
http://www.amphora-research.com/       46
Patent Evidence


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


http://www.amphora-research.com/    47
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


http://www.amphora-research.com/      48
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



http://www.amphora-research.com/       49
Thank You


             • Slides will be on our web site tonight
             • Any questions?


http://www.amphora-research.com/       50

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Lessons from Different Industries on Choosing the Right ELN Solution

  • 1. Lessons from Different Industries Simon Coles CTO & Co-Founder, Amphora Research Systems
  • 3. Copies of these slides http://www.amphora-research.com/ 2
  • 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 http://www.amphora-research.com/ 3
  • 5. Who we work with 4
  • 6. Who we work with 4
  • 8. What we do • Patent Evidence Creation & Preservation • Make lawyers happy • Which means you can make scientists happy http://www.amphora-research.com/ 6
  • 9. What we do • Sometimes our stuff is used... • Standalone • In conjunction with other “ELN” products • With in house systems http://www.amphora-research.com/ 7
  • 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 http://www.amphora-research.com/ 8
  • 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... http://www.amphora-research.com/ 9
  • 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? http://www.amphora-research.com/ 10
  • 13. The “ELN” Word • Very ambiguous • Probably best if you didn’t use it • Say what you mean http://www.amphora-research.com/ 11
  • 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) http://www.amphora-research.com/ 12
  • 15. What is an ELN? Corporate aspects (Records, IP protection, Sharing) Medicinal Chemistry Process Chemistry Molecular Biology Pharmacology Etc. http://www.amphora-research.com/ 13
  • 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 http://www.amphora-research.com/ 14
  • 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 http://www.amphora-research.com/ 14
  • 18. Industry/Company Type • Life Sciences • Biotech or Pharma • Biology Vs Chemistry • Diverse Chemicals http://www.amphora-research.com/ 15
  • 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 http://www.amphora-research.com/ 16
  • 20. Differences that make a Difference • There are 2 key aspects which impact the character of your ELN implementation • Regulated Vs Unregulated • Industry http://www.amphora-research.com/ 17
  • 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 http://www.amphora-research.com/ 18
  • 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 http://www.amphora-research.com/ 19
  • 23. Chemistry Vs Biology • In Life Sciences, the biggest distinction is between Chemists and Biologists http://www.amphora-research.com/ 20
  • 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 http://www.amphora-research.com/ 21
  • 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 http://www.amphora-research.com/ 22
  • 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! http://www.amphora-research.com/ 23
  • 27. Biology • Massive diversity • Lots of Microsoft Office and other “non ELN” applications • Best approach is to get out of their way http://www.amphora-research.com/ 24
  • 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 http://www.amphora-research.com/ 25
  • 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 http://www.amphora-research.com/ 26
  • 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. http://www.amphora-research.com/ 27
  • 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 http://www.amphora-research.com/ 28
  • 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 http://www.amphora-research.com/ 29
  • 33. General Purpose ELNs • “You all use the same Paper notebook don’t you?” • “So surely you can all use the same Electronic notebook?” http://www.amphora-research.com/ 30
  • 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 http://www.amphora-research.com/ 31
  • 35. General Purpose ELNs Functionality Number of users http://www.amphora-research.com/ 32
  • 36. General Purpose ELNs Functionality Possible Number of users http://www.amphora-research.com/ 32
  • 37. General Purpose ELNs Functionality Possible Possible Number of users http://www.amphora-research.com/ 32
  • 38. General Purpose ELNs Functionality Possible Doomed to fail The organisation will frustrate you Possible Number of users http://www.amphora-research.com/ 32
  • 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 http://www.amphora-research.com/ 33
  • 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 http://www.amphora-research.com/ 34
  • 41. Security • In Life Sciences things are relatively sane • In Large Chemicals, you get all the fun of “Chinese Walls” created by Commercial agreements http://www.amphora-research.com/ 35
  • 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 http://www.amphora-research.com/ 36
  • 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 http://www.amphora-research.com/ 37
  • 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? http://www.amphora-research.com/ 38
  • 45. Records Management • The Cinderella of ELN projects • Desperately important • Clearly something that’s dependent on your own processes http://www.amphora-research.com/ 39
  • 46. Conclusions • Our original question • Some thoughts http://www.amphora-research.com/ 40
  • 47. Our Questions • What’s the differences that make a difference? • What simple things can you do to increase your chance of success? http://www.amphora-research.com/ 41
  • 48. Differences • Life Sciences Vs Everyone else • In Life Sciences • Biology Vs Chemistry • Biotech-ish Vs Pharma-ish • Regulated or not? http://www.amphora-research.com/ 42
  • 49. Beware the ELN word • Say what you mean • Expect different front ends to support different work http://www.amphora-research.com/ 43
  • 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 http://www.amphora-research.com/ 44
  • 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 http://www.amphora-research.com/ 45
  • 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 http://www.amphora-research.com/ 46
  • 53. Patent Evidence • Stick with best practice unless you really know what you are doing • One single system http://www.amphora-research.com/ 47
  • 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 http://www.amphora-research.com/ 48
  • 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 http://www.amphora-research.com/ 49
  • 56. Thank You • Slides will be on our web site tonight • Any questions? http://www.amphora-research.com/ 50