Discusses the issues of Records Management and Patent Evidence in Laboratories, with particular emphasis on Electronic Lab Notebooks. Delivered at IQPC Data Management & Knowledge Discovery. 21st April 1009, Frankfurt, Germany.

1. Lessons from the Edge
(think now, or pay later)
Simon Coles
CTO
http://www.amphora-research.com/ 1

2. A copy of this
presentation can be
downloaded from our
web site
http://www.amphora-research.com/ 2

3. A copy of this
presentation can be
downloaded from our
web site
http://www.amphora-research.com/ 2

4. Lessons from the Edge
• What we do
• How we work
• What we’ve learned
• Takeaway lessons
http://www.amphora-research.com/ 3

5. What we do
• We allow scientists to concentrate on
science
• Using the tools they need to get the job
done
• Without worrying about IP concerns
http://www.amphora-research.com/ 4

6. Scientists use a variety
of tools
http://www.amphora-research.com/ 5

7. Scientists use a variety
of tools
http://www.amphora-research.com/ 5

8. Scientists use a variety
of tools
http://www.amphora-research.com/ 5

9. Scientists use a variety
of tools
http://www.amphora-research.com/ 5

10. Scientists use a variety
of tools
http://www.amphora-research.com/ 5

11. Scientists use a variety
of tools
http://www.amphora-research.com/ 5

12. Scientists use a variety
of tools
e
c
n
ie
c
S
http://www.amphora-research.com/ 5

13. Scientists use a variety
of tools
e
r
u
t
e p
c a
n
ie C
c IP
S
http://www.amphora-research.com/ 5

14. Example Scenarios
http://www.amphora-research.com/ 6

15. Example Scenarios
• Typical Biotech – Chemistry-centric ELN
for Chemists, Microsoft Office (esp. Excel)
etc. for Biology
http://www.amphora-research.com/ 6

16. Example Scenarios
• Typical Biotech – Chemistry-centric ELN
for Chemists, Microsoft Office (esp. Excel)
etc. for Biology
• Pharma – 3 commercial ELNs, 2 in-house,
Microsoft Office
http://www.amphora-research.com/ 6

17. Example Scenarios
• Typical Biotech – Chemistry-centric ELN
for Chemists, Microsoft Office (esp. Excel)
etc. for Biology
• Pharma – 3 commercial ELNs, 2 in-house,
Microsoft Office
• Chemicals – Whole variety of tools
http://www.amphora-research.com/ 6

18. Example Scenarios
• Typical Biotech – Chemistry-centric ELN
for Chemists, Microsoft Office (esp. Excel)
etc. for Biology
• Pharma – 3 commercial ELNs, 2 in-house,
Microsoft Office
• Chemicals – Whole variety of tools
• Universities & quasi-academic – a bit of a
zoo!
http://www.amphora-research.com/ 6

19. Some people we work with
http://www.amphora-research.com/

20. Some people we work with
http://www.amphora-research.com/

21. How we do it
http://www.amphora-research.com/ 8

22. How we do it
• A product - PatentSafe®
•Simplest, safest, easiest replacement for the
Paper Notebook (we hope! :-)
http://www.amphora-research.com/ 8

23. How we do it
• A product - PatentSafe®
•Simplest, safest, easiest replacement for the
Paper Notebook (we hope! :-)
• An implementation approach
•Pilot – does this work for the scientists?
•Fire Drill – does the system create good
evidence?
http://www.amphora-research.com/ 8

24. How we do it
• A product - PatentSafe®
•Simplest, safest, easiest replacement for the
Paper Notebook (we hope! :-)
• An implementation approach
•Pilot – does this work for the scientists?
•Fire Drill – does the system create good
evidence?
http://www.amphora-research.com/ 8

25. How we do it
• A product - PatentSafe®
•Simplest, safest, easiest replacement for the
Paper Notebook (we hope! :-)
• An implementation approach
•Pilot – does this work for the scientists?
•Fire Drill – does the system create good
evidence?
(System = People + Process + Software)
http://www.amphora-research.com/ 8

26. The Fire Drill
• This presentation is basically comprised of
lessons from the Fire Drill exercise we run
• After a few weeks, all the participants get in a
room and “War game” taking a record from
PatentSafe into Court
• Often the first time all participants have a 360°
view of the process
• Excellent communication & discovery exercise
http://www.amphora-research.com/ 9

27. Fire Drill outcomes
http://www.amphora-research.com/ 10

28. Fire Drill outcomes
• Scientists often had no idea what would
happen
• Radically change how they write things up
http://www.amphora-research.com/ 10

29. Fire Drill outcomes
• Scientists often had no idea what would
happen
• Radically change how they write things up
• IT had no idea what happens when a bunch of
lawyers start asking questions
http://www.amphora-research.com/ 10

30. Fire Drill outcomes
• Scientists often had no idea what would
happen
• Radically change how they write things up
• IT had no idea what happens when a bunch of
lawyers start asking questions
• Lawyers get a bigger picture of the scientists
world
http://www.amphora-research.com/ 10

31. Fire Drill outcomes
• Scientists often had no idea what would
happen
• Radically change how they write things up
• IT had no idea what happens when a bunch of
lawyers start asking questions
• Lawyers get a bigger picture of the scientists
world
• Everyone (and their bosses!) now
understands the fuller picture
http://www.amphora-research.com/ 10

32. Lessons Learned
• That “ELN” word
• User-focused
• IT Architecture
• Records Management
http://www.amphora-research.com/ 11

33. “ELN”
http://www.amphora-research.com/ 12

34. “ELN”
• “Electronic Laboratory Notebook” is more of
a marketing term than anything else
• Designed to separate you from your money
• It isn’t that useful when describing systems
http://www.amphora-research.com/ 12

35. “ELN”
• “Electronic Laboratory Notebook” is more of
a marketing term than anything else
• Designed to separate you from your money
• It isn’t that useful when describing systems
• Say what you mean
• Somewhere for scientists to work
• Somewhere to create & preserve evidence
http://www.amphora-research.com/ 12

36. Being clear helps
• Helps you understand requirements
• Helps you understand target audience
internally
• Helps you understand who pays for it
• Helps you understand how you’re going to
run it
http://www.amphora-research.com/ 13

37. Users
• Scientists are a varied and challenging user
base
• Treated right they will really help you
• But you need to approach with care
• Ultimately, a good ELN will revolutionalise
your Scientist’s world
http://www.amphora-research.com/ 14

38. Diversity needs dealing
with
• Many projects get stuck on the sheer complexity
of the scientific process
• Especially in larger firms
• With many different spheres of activity
• Two frameworks which might help
• Look at the diversity of activity and where to
put your attention
• Tease out what data is important and what isn’t
http://www.amphora-research.com/ 15

39. Dealing with Diversity
http://www.amphora-research.com/ 16

40. Medicinal Chemistry
http://www.amphora-research.com/
Process Chemistry
Molecular Biology
Pharmacology
16
Etc.
Dealing with Diversity

41. Dealing with Diversity
Corporate aspects
(Records, IP protection, Sharing)
Medicinal Chemistry
Process Chemistry
Molecular Biology
Pharmacology
Etc.
http://www.amphora-research.com/ 16

42. Dealing with Diversity
Corporate aspects
(Records, IP protection, Sharing)
Medicinal Chemistry
Process Chemistry
Molecular Biology
Let them use
Pharmacology
whatever systems
they want here
Etc.
(because they will
anyway)
http://www.amphora-research.com/ 16

43. Dealing with Diversity
Corporate aspects Focus IP concerns
here
(Records, IP protection, Sharing)
Medicinal Chemistry
Process Chemistry
Molecular Biology
Let them use
Pharmacology
whatever systems
they want here
Etc.
(because they will
anyway)
http://www.amphora-research.com/ 16

44. Dealing with Diversity
Corporate aspects Focus IP concerns
here
(Records, IP protection, Sharing)
Medicinal Chemistry
Process Chemistry
Molecular Biology
Pharmacology s
Let them use
o whatever systems
ha
they want here
C
Etc.
(because they will
ive
anyway)
at
re
C
http://www.amphora-research.com/ 16

45. Dealing with Diversity
y s,
nc es
te oc
Corporate aspects
sis , Pr
Focus IP concerns
on e
C lin
here
(Records, IP protection, Sharing)
ip
isc
D
Medicinal Chemistry
Process Chemistry
Molecular Biology
Pharmacology s
Let them use
o whatever systems
ha
they want here
C
Etc.
(because they will
ive
anyway)
at
re
C
http://www.amphora-research.com/ 16

46. Don’t be tempted
• Don’t be tempted to mix where the scientists work, and
the record keeping system
• We tried that with the paper notebook and that didn’t
work out well for anyone
• Creates lots of issues for introduction & ownership
• Also, don’t mix systems for IP protection and Regulatory
Compliance
• Different problems
• Very hard (impossible?) to do in one place
http://www.amphora-research.com/ 17

47. What’s Important
• Most scientific activity
creates electronic “Stuff”
• Some of this is more
useful than others
•
Programmes
Useful to look at things
as a pyramid Projects
Experiments
Interpreted Data/Reports
Raw Data
http://www.amphora-research.com/ 18

48. What’s Important
• Most scientific activity
creates electronic “Stuff”
• Some of this is more
useful than others
•
Programmes
Useful to look at things
as a pyramid Projects
Experiments
Not so interesting, Long Term Interpreted Data/Reports
Harder to preserve anyway Raw Data
http://www.amphora-research.com/ 18

49. What goes in the
notebook
Programmes
Projects
Corporate aspects Experiments
(Records, IP protection, Sharing)
Process Chemistry
Interpreted Data/Reports
Molecular Biology
Pharmacology
Chemistry
Medicinal
Raw Data
Etc.
http://www.amphora-research.com/ 19

50. What goes in the
notebook?
• Nothing need change from the paper notebook process
• Just because you can dump loads of raw data in,
doesn’t mean you need to
• Scientists will often need specific guidance on what to
put in for different circumstances
• Often what’s currently happening isn’t what you
need
• One advantage of an electronic system is you can
sample what they’re doing and offer gentle assistance
http://www.amphora-research.com/ 20

51. Don’t torture them
• Be careful about requiring a particular workstyle or
front end tool
• You won’t change their behaviors
• Just that anything that falls outside what you view
as correct working won’t be protected
• Be careful about requiring lots of extra work
• Their good intentions won’t survive a busy period
• Then you’ve got inconsistent practices
http://www.amphora-research.com/ 21

52. Notebook Practices
• How people keep notebooks
• What they put in them
• The other stuff they keep
• The impact of moving to Electronic
Systems
http://www.amphora-research.com/ 22

53. People aren’t keeping
notebooks properly
http://www.amphora-research.com/ 23

54. People aren’t keeping
notebooks properly
• Typically in most larger organistions
• 20% of the people who are laboriously creating
notebooks (fully witnessed) don’t need to
because their work isn’t IP sensitive
• A fair number of the most prolific inventors
aren’t keeping notebooks at all and there’s very
little evidence of their work
http://www.amphora-research.com/ 23

55. People aren’t keeping
notebooks properly
• Typically in most larger organistions
• 20% of the people who are laboriously creating
notebooks (fully witnessed) don’t need to
because their work isn’t IP sensitive
• A fair number of the most prolific inventors
aren’t keeping notebooks at all and there’s very
little evidence of their work
• Most companies have a very low compliance with
their paper process for signing & witnessing
http://www.amphora-research.com/ 23

56. They’re writing the wrong
stuff down
• Often very difficult for scientists to know
what they should be writing up
• Some think all that matters is data, when
we really care about what was going on
in their brains
• Need simple guidance which can be applied
in a variety of situations
http://www.amphora-research.com/ 24

57. They keep too much
stuff
http://www.amphora-research.com/ 25

58. They keep too much
stuff
• Most scientists view any data as valuable
http://www.amphora-research.com/ 25

59. They keep too much
stuff
• Most scientists view any data as valuable
• So they keep everything
• Generally anywhere
• With little indexing
http://www.amphora-research.com/ 25

60. They keep too much
stuff
• Most scientists view any data as valuable
• So they keep everything
• Generally anywhere
• With little indexing
• A nightmare when it comes to legal discovery
http://www.amphora-research.com/ 25

61. They keep too much
stuff
• Most scientists view any data as valuable
• So they keep everything
• Generally anywhere
• With little indexing
• A nightmare when it comes to legal discovery
• Your Records Manager is your best friend
• A well thought and consistent Records Management
process is your best asset
http://www.amphora-research.com/ 25

62. They keep too much
stuff
• Most scientists view any data as valuable
• So they keep everything
• Generally anywhere
• With little indexing
• A nightmare when it comes to legal discovery
• Your Records Manager is your best friend
• A well thought and consistent Records Management
process is your best asset
• This isn’t really a Notebook problem – but it is your
problem
http://www.amphora-research.com/ 25

63. SOPs
• Fairly simple
• Write down what you are planning to do
• Do it
• Avoid the temptation to be overly ornate
or prescriptive
• An ELN SOP is generally shorter than the
paper one it replaces
http://www.amphora-research.com/ 26

64. Site Vs Global
http://www.amphora-research.com/ 27

65. Site Vs Global
• Most multi-site organisations have site-
specific Paper Notebook SOPs
• Merger/acquisition
• Historic working practices (& legal
considerations)
• Work style
http://www.amphora-research.com/ 27

66. Site Vs Global
• Most multi-site organisations have site-
specific Paper Notebook SOPs
• Merger/acquisition
• Historic working practices (& legal
considerations)
• Work style
• Most ELNs are rolled out globally
http://www.amphora-research.com/ 27

67. Site Vs Global
• Most multi-site organisations have site-
specific Paper Notebook SOPs
• Merger/acquisition
• Historic working practices (& legal
considerations)
• Work style
• Most ELNs are rolled out globally
• You will hit these issues in the Fire Drill!
http://www.amphora-research.com/ 27

68. Some good news
http://www.amphora-research.com/ 28

69. Some good news
• A properly designed ELN/Patent Evidence system will
give you better more reliable records than the
existing paper system
• And save an awful lot of scientist time!
http://www.amphora-research.com/ 28

70. Some good news
• A properly designed ELN/Patent Evidence system will
give you better more reliable records than the
existing paper system
• And save an awful lot of scientist time!
• With an electronic system you get a much better idea
of what’s really going on
http://www.amphora-research.com/ 28

71. Some good news
• A properly designed ELN/Patent Evidence system will
give you better more reliable records than the
existing paper system
• And save an awful lot of scientist time!
• With an electronic system you get a much better idea
of what’s really going on
• You will get very high levels of compliance with your
requirements
• For example documents tend to be witnessed in
less than an hour compared to weeks
http://www.amphora-research.com/ 28

72. IT Architecture
• Overall Architecture
• System Design
• Dealing with your organisation
http://www.amphora-research.com/ 29

73. Split the Systems
• Keeps the lawyers out of the scientist’s
tools
• Can build/buy the science-facing ELNs as
needed, and manage as appropriate
• The Patent Evidence system can be
unperturbed
http://www.amphora-research.com/ 30

74. Evidence Systems
• For this problem, dependancies bring
complication risk and little reward
• They can only help with a few small areas,
which should be easy to do internally
• Generally on balance of risks, it isn’t worth
it
http://www.amphora-research.com/ 31

75. Reduce Dependancies
• You really want everything under your
control
• Makes it easier to run the system
• Makes it easier to defend the system
• Makes sure everyone pays attention
http://www.amphora-research.com/ 32

76. Reduce Dependancies
• This applies to internal infrastructure as
much as it does to external parties
• Your infrastructure team might not be
prepared for a legal invasion
http://www.amphora-research.com/ 33

77. Your Organisation is
Stupid
http://www.amphora-research.com/ 34

78. Your Organisation is
Stupid
• I don’t worry about the integrity of things
in the short term
http://www.amphora-research.com/ 34

79. Your Organisation is
Stupid
• I don’t worry about the integrity of things
in the short term
• I do worry about 10, 20, 30 years in the
future
• Murphy’s law hasn’t been repealed
• Simplicity and accountability is key
http://www.amphora-research.com/ 34

80. Your Organisation is
Stupid
• I don’t worry about the integrity of things
in the short term
• I do worry about 10, 20, 30 years in the
future
• Murphy’s law hasn’t been repealed
• Simplicity and accountability is key
• Most IT organisations aren’t setup for this
http://www.amphora-research.com/ 34

81. Records Management
• Your Unsung Heroes
• Can finally manage Electronic Records in
R&D
http://www.amphora-research.com/ 35

82. Unsung Heroes
• Nobody really pays attention to Records
Management until things go wrong
• In fact, they’ve got a lot of really useful
things to say, even without legal issues
• The ELN Project often puts Records
Management on the agenda in a wider
sense
http://www.amphora-research.com/ 36

83. Pay attention to what
you’re creating
• Not just about experimental write ups
• More data isn’t necessarily better
• We spend a lot of time making sure we don’t
store “unhelpful” things
http://www.amphora-research.com/ 37

84. Pay Attention to how
you keep it
• Records retention rules are key
• You shouldn’t be planning to keep everything
forever
• You can’t
• You don’t want to
• Evidence system will have long retention period
• Working systems might have a lower retention
perion
http://www.amphora-research.com/ 38

85. IT & Records Management
• Make sure you nominate a Custodian of every IP-
critical system you have, at the outset
• Most IT tools have well-meaning features which are
really nasty from a records perspective
• e.g. regulatory systems which create masses of
unhelpful detailed data with no way of purging it
• Few IT tools are built with long term records
involved
• It really isn’t in the vendor’s interest to worry
http://www.amphora-research.com/ 39

86. System Ownership
• What do you optimise for:
• Happy, productive scientists?
• Good, strict, reliable records?
• Splitting out the science systems into
separate systems, with a separate record
keeping layer makes things a lot easier
http://www.amphora-research.com/ 40

87. Interesting Thoughts
• A lot of people in Discovery aren’t keeping
the right stuff in their notebooks
• Sometimes too detailed, sometimes not
enough
• Sometimes the people keeping the best
notebooks don’t need to keep them
• Sometimes the people who should aren’t!
http://www.amphora-research.com/ 41

88. Interesting Thoughts
• The lawyers don’t want to torture you
• Really, honestly
• You can create good patent evidence
reasonably painlessly
• Decent front-end system
• Good backend
http://www.amphora-research.com/ 42

89. End Result of
Electronic Evidence Systems
• Scientists are happy and productive
• You don’t spend all that much money (good
ROI!)
• Lawyers get a reliable process and good
evidence
• It costs less
• It lasts longer
http://www.amphora-research.com/ 43

90. Takeaways
• If you’re looking for a new career, Records
Management is hot
• If you’re introducing a new system, make
Records Management part of the system
design & introduction
http://www.amphora-research.com/ 44

91. Takeaways
• Electronic Systems can make everyone
happy
• Splitting out records keeping & patent
evidence makes things a lot easier
http://www.amphora-research.com/ 45