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
2
http://www.amphora-research.com/
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
3
Who we work with
4
Who we work with
4
http://www.amphora-research.com/
Industry
5
http://www.amphora-research.com/
What we do
• Patent Evidence Creation & Preservation
• Make lawyers happy
• Which means you can make scientists happy
6
http://www.amphora-research.com/
What we do
• Sometimes our stuff is used...
• Standalone
• In conjunction with other “ELN” products
• With in house systems
7
http://www.amphora-research.com/
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
8
http://www.amphora-research.com/
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...
9
http://www.amphora-research.com/
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?
10
http://www.amphora-research.com/
The “ELN” Word
• Very ambiguous
• Probably best if you didn’t use it
• Say what you mean
11
http://www.amphora-research.com/
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)
12
http://www.amphora-research.com/
What is an ELN?
Corporate aspects(Records, IP protection, Sharing)
Med
icin
al C
hem
istr
y
Proc
ess
Che
mis
try
Mol
ecul
ar B
iolo
gy
Phar
mac
olog
y
Etc.
13
http://www.amphora-research.com/
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
14
http://www.amphora-research.com/
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
14
http://www.amphora-research.com/
Industry/Company Type
• Life Sciences
• Biotech or Pharma
• Biology Vs Chemistry
• Diverse Chemicals
15
http://www.amphora-research.com/
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
16
http://www.amphora-research.com/
Differences that make a Difference
• There are 2 key aspects which impact the character of your ELN implementation
• Regulated Vs Unregulated
• Industry
17
http://www.amphora-research.com/
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
18
http://www.amphora-research.com/
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
19
http://www.amphora-research.com/
Chemistry Vs Biology
• In Life Sciences, the biggest distinction is between Chemists and Biologists
20
http://www.amphora-research.com/
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
21
http://www.amphora-research.com/
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
22
http://www.amphora-research.com/
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!
23
http://www.amphora-research.com/
Biology
• Massive diversity
• Lots of Microsoft Office and other “non ELN” applications
• Best approach is to get out of their way
24
http://www.amphora-research.com/
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
25
http://www.amphora-research.com/
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
26
http://www.amphora-research.com/
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.
27
http://www.amphora-research.com/
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
28
http://www.amphora-research.com/
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
29
http://www.amphora-research.com/
General Purpose ELNs
• “You all use the same Paper notebook don’t you?”
• “So surely you can all use the same Electronic notebook?”
30
http://www.amphora-research.com/
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
31
http://www.amphora-research.com/
General Purpose ELNsFu
nctio
nalit
y
Number of users32
http://www.amphora-research.com/
General Purpose ELNsFu
nctio
nalit
y
Number of users
Possible
32
http://www.amphora-research.com/
General Purpose ELNsFu
nctio
nalit
y
Number of users
Possible
Poss
ible
32
http://www.amphora-research.com/
General Purpose ELNsFu
nctio
nalit
y
Number of users
Possible
Poss
ible
Doomed to failThe organisation will frustrate you
32
http://www.amphora-research.com/
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
33
http://www.amphora-research.com/
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
34
http://www.amphora-research.com/
Security
• In Life Sciences things are relatively sane
• In Large Chemicals, you get all the fun of “Chinese Walls” created by Commercial agreements
35
http://www.amphora-research.com/
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
36
http://www.amphora-research.com/
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
37
http://www.amphora-research.com/
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?
38
http://www.amphora-research.com/
Records Management
• The Cinderella of ELN projects
• Desperately important
• Clearly something that’s dependent on your own processes
39
http://www.amphora-research.com/
Conclusions
• Our original question
• Some thoughts
40
http://www.amphora-research.com/
Our Questions
• What’s the differences that make a difference?
• What simple things can you do to increase your chance of success?
41
http://www.amphora-research.com/
Differences
• Life Sciences Vs Everyone else
• In Life Sciences
• Biology Vs Chemistry
• Biotech-ish Vs Pharma-ish
• Regulated or not?
42
http://www.amphora-research.com/
Beware the ELN word
• Say what you mean
• Expect different front ends to support different work
43
http://www.amphora-research.com/
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
44
http://www.amphora-research.com/
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
45
http://www.amphora-research.com/
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
46
http://www.amphora-research.com/
Patent Evidence
• Stick with best practice unless you really know what you are doing
• One single system
47
http://www.amphora-research.com/
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
48
http://www.amphora-research.com/
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
49
http://www.amphora-research.com/
Thank You
• Slides will be on our web site tonight
• Any questions?
50