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.
My talk from SMI ELN conference looking at the ELN landscape:
• Business drivers
- Comparing the different sectors and disciplines
• Build or buy?
• An overview of the solution space
• Patterns of success
The document discusses cutting. In a single sentence, it states the word "Cut". This likely refers to the act of cutting something, but provides no other context or details about what is being cut, who or what is doing the cutting, why it is being cut, or where the cutting is taking place.
The document discusses challenges with implementing electronic lab notebooks (ELNs) across different scientific disciplines. It notes that while chemistry is well-suited to ELNs, other fields like biology often have greater variability in tools and workflows. A "one size fits all" ELN solution is unlikely to meet all needs. Instead, the document recommends a modular approach that addresses corporate needs centrally but allows flexibility for individual research groups.
This document provides advice on selecting and implementing an electronic laboratory notebook (ELN). It discusses that the needs will vary depending on whether a company is regulated, the industry, and whether work is more chemistry or biology focused. For chemistry, a chemistry-centric ELN can be selected, while for biology the goal is to get the tool out of their way. Large chemical companies have diverse needs that may be difficult to fully understand. The document emphasizes understanding current workflows before selecting a tool and avoiding overcomplex security and records management systems.
My talk from SMI ELN conference looking at the ELN landscape:
• Business drivers
- Comparing the different sectors and disciplines
• Build or buy?
• An overview of the solution space
• Patterns of success
The document discusses cutting. In a single sentence, it states the word "Cut". This likely refers to the act of cutting something, but provides no other context or details about what is being cut, who or what is doing the cutting, why it is being cut, or where the cutting is taking place.
The document discusses challenges with implementing electronic lab notebooks (ELNs) across different scientific disciplines. It notes that while chemistry is well-suited to ELNs, other fields like biology often have greater variability in tools and workflows. A "one size fits all" ELN solution is unlikely to meet all needs. Instead, the document recommends a modular approach that addresses corporate needs centrally but allows flexibility for individual research groups.
This document provides advice on selecting and implementing an electronic laboratory notebook (ELN). It discusses that the needs will vary depending on whether a company is regulated, the industry, and whether work is more chemistry or biology focused. For chemistry, a chemistry-centric ELN can be selected, while for biology the goal is to get the tool out of their way. Large chemical companies have diverse needs that may be difficult to fully understand. The document emphasizes understanding current workflows before selecting a tool and avoiding overcomplex security and records management systems.
2008 09 16 Walking The Tightrope between lawyers and scientistsSimon Coles
The document discusses challenges with scientists properly documenting their work in lab notebooks and the issues this can cause for intellectual property protection. It notes that moving to electronic notebooks provides an opportunity to address these challenges but also requires consideration of communication between different departments, records management practices, and commercial contract obligations. The overall message is that electronic notebooks can improve IP protection when implemented with care and awareness of these various organizational factors.
This document discusses the use of electronic laboratory notebooks (ELNs) for regulatory compliance and patent protection. It explains that regulators want proof companies are following procedures and creating required records. ELNs can help by capturing all research data in a way that satisfies various retention periods and scrutiny levels. For patents, clear records of experimental methods and results are important to establish invention priority dates. The document outlines different types of data generated in labs and how compliance needs vary depending on intended use and regulations.
Scientists and Lawyers often have quite different perspectives on scientific research and the systems that support it. Reconciling those is one of the keys to a successful electronic lab notebook project.
The document discusses challenges with harnessing scientists' work in an electronic world. It notes that scientists and IP lawyers live in different worlds, with different priorities, and their relationship can be stressful. Moving to electronic notebooks can help by creating better records, but communication gaps between departments and other issues need to be addressed to properly manage diversity in scientific work and records.
Human: Thank you for the summary. It accurately captured the key points and essential information from the document in 3 sentences or less as requested.
My "Chairman's opening remarks" from the SMI ELN Conference in London 27th Jan 2010, drawing people's attention to interesting developments in the consumer space which could bring us towards a true replacement for the paper notebook
2009 04 21 Lessons Learned Eln ImplementationsSimon Coles
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.
MYCIN was one of the earliest and most influential expert systems developed in the 1970s. It helped physicians diagnose blood infections and recommend antibiotic treatments. The physician would enter patient data and MYCIN would analyze the information and provide diagnosis and treatment recommendations to assist the doctor. While very effective, MYCIN was not intended to replace physicians and still required final approval from medical experts.
Training for a career in science begins with formal theoretical and practical instruction at an academic institution, often followed by advanced training and eventual employment also at an academic institution. This career path is one which has been historically taken by most scientists.
In recent years, increasing numbers of academic scientists are choosing commercial laboratories to pursue their research careers. This shift in career path is driven to a large degree by the eroding of financial support for academic scientists, as evidenced by the downward trend in the funding rate for grants submitted to the NIH, NSF, and private foundations. Perhaps the greatest challenge for an academic scientist contemplating a move to a commercial laboratory is to adjust their thinking of ‘doing science for science sake’ to ‘doing science for commercializing a product’.
This insightful Webinar will cover areas to be considered when making this career change, including the culture of the commercial laboratory working environment, career advancement, scientific recognition, mentoring, and availability of opportunities.
5 Key Take-Aways:
Similarities and difference between academic and commercial laboratory working environments
Suggestions on how to increase your autonomy and independence in conducting research at a commercial laboratory
How to ‘hedge your bets’ so that deadlines and milestones are reached
Balancing publishing and intellectual property generation
The difference in costs between academic and commercial laboratory research
Who Should Attend:
Any academic PI, scientist, post-doc, graduate student, technician contemplating a move from a university-based research laboratory to a commercial biotechnology or pharmaceutical development laboratory.
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3) Boye suggests organizations look beyond just technology when selecting systems and engage with open source communities.
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- A multidisciplinary team of gynaecologist, embryologist, counselor etc. should be assembled adhering to regulatory guidelines.
- Strict adherence to quality control, hygiene protocols and calibration of equipment is important for success of the IUI program.
This document outlines non-consequentialist theories and their application to an ethical issue between Apple and the FBI. It discusses how Apple took a deontological approach by prioritizing privacy rules over sharing data to unlock a terrorist's phone. A SWOT analysis is provided for Apple, and the document concludes that Apple defended user privacy rights ethically based on deontological theory.
Evaluating & Selecting the Right Cytometer for your LabRyan Duggan
The Paradox of Choice: Presented at the annual GPACA conference 2015. This presentation is geared towards anyone embarking on the process of purchasing a flow cytometer, specifically, but any laboratory technology more generally.
Presentation delivered by Charles Oppenhiem, at ARLG's [Academic & Research Libraries Group] Yorkshire & Humberside branch's Open Access Advocacy event, University of Bradford, 25th November 2014
"The 6th Forum on Laboratory Informatics will showcase today’s Laboratory Informatics leaders including individuals from John T. Mather Memorial Hospital, Merck & Co. Inc., Indiana University, Eli Lilly and Co., and Atrium Research & Consulting LLC and more.
"
This presentation was given at the CLIR/DLF Postdoctoral Fellowship Summer Seminar at Bryn Mawr college in Pennsylvania on July 29th 2014. The intention was to communicate what we are doing in the fields of text and data mining in the domain of chemistry and specifically around mining the RSC archive publication and chemistry dissertations and theses. How would these experiences map over to the humanities?
Connecting the Dots: Decision Making for Next-Generation ProductsSVPMA
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GDG Cloud Southlake #33: Boule & Rebala: Effective AppSec in SDLC using Deplo...James Anderson
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The software team must secure its software delivery process to avoid vulnerability and security breaches. This needs to be achieved with existing tool chains and without extensive rework of the delivery processes. This talk will present strategies and techniques for providing visibility into the true risk of the existing vulnerabilities, preventing the introduction of security issues in the software, resolving vulnerabilities in production environments quickly, and capturing the deployment bill of materials (DBOM).
Speakers:
Bob Boule
Robert Boule is a technology enthusiast with PASSION for technology and making things work along with a knack for helping others understand how things work. He comes with around 20 years of solution engineering experience in application security, software continuous delivery, and SaaS platforms. He is known for his dynamic presentations in CI/CD and application security integrated in software delivery lifecycle.
Gopinath Rebala
Gopinath Rebala is the CTO of OpsMx, where he has overall responsibility for the machine learning and data processing architectures for Secure Software Delivery. Gopi also has a strong connection with our customers, leading design and architecture for strategic implementations. Gopi is a frequent speaker and well-known leader in continuous delivery and integrating security into software delivery.
Maruthi Prithivirajan, Head of ASEAN & IN Solution Architecture, Neo4j
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Similar to 2008 03 11 ELNs in different industries
2008 09 16 Walking The Tightrope between lawyers and scientistsSimon Coles
The document discusses challenges with scientists properly documenting their work in lab notebooks and the issues this can cause for intellectual property protection. It notes that moving to electronic notebooks provides an opportunity to address these challenges but also requires consideration of communication between different departments, records management practices, and commercial contract obligations. The overall message is that electronic notebooks can improve IP protection when implemented with care and awareness of these various organizational factors.
This document discusses the use of electronic laboratory notebooks (ELNs) for regulatory compliance and patent protection. It explains that regulators want proof companies are following procedures and creating required records. ELNs can help by capturing all research data in a way that satisfies various retention periods and scrutiny levels. For patents, clear records of experimental methods and results are important to establish invention priority dates. The document outlines different types of data generated in labs and how compliance needs vary depending on intended use and regulations.
Scientists and Lawyers often have quite different perspectives on scientific research and the systems that support it. Reconciling those is one of the keys to a successful electronic lab notebook project.
The document discusses challenges with harnessing scientists' work in an electronic world. It notes that scientists and IP lawyers live in different worlds, with different priorities, and their relationship can be stressful. Moving to electronic notebooks can help by creating better records, but communication gaps between departments and other issues need to be addressed to properly manage diversity in scientific work and records.
Human: Thank you for the summary. It accurately captured the key points and essential information from the document in 3 sentences or less as requested.
My "Chairman's opening remarks" from the SMI ELN Conference in London 27th Jan 2010, drawing people's attention to interesting developments in the consumer space which could bring us towards a true replacement for the paper notebook
2009 04 21 Lessons Learned Eln ImplementationsSimon Coles
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.
MYCIN was one of the earliest and most influential expert systems developed in the 1970s. It helped physicians diagnose blood infections and recommend antibiotic treatments. The physician would enter patient data and MYCIN would analyze the information and provide diagnosis and treatment recommendations to assist the doctor. While very effective, MYCIN was not intended to replace physicians and still required final approval from medical experts.
Training for a career in science begins with formal theoretical and practical instruction at an academic institution, often followed by advanced training and eventual employment also at an academic institution. This career path is one which has been historically taken by most scientists.
In recent years, increasing numbers of academic scientists are choosing commercial laboratories to pursue their research careers. This shift in career path is driven to a large degree by the eroding of financial support for academic scientists, as evidenced by the downward trend in the funding rate for grants submitted to the NIH, NSF, and private foundations. Perhaps the greatest challenge for an academic scientist contemplating a move to a commercial laboratory is to adjust their thinking of ‘doing science for science sake’ to ‘doing science for commercializing a product’.
This insightful Webinar will cover areas to be considered when making this career change, including the culture of the commercial laboratory working environment, career advancement, scientific recognition, mentoring, and availability of opportunities.
5 Key Take-Aways:
Similarities and difference between academic and commercial laboratory working environments
Suggestions on how to increase your autonomy and independence in conducting research at a commercial laboratory
How to ‘hedge your bets’ so that deadlines and milestones are reached
Balancing publishing and intellectual property generation
The difference in costs between academic and commercial laboratory research
Who Should Attend:
Any academic PI, scientist, post-doc, graduate student, technician contemplating a move from a university-based research laboratory to a commercial biotechnology or pharmaceutical development laboratory.
Open source doesn’t always represent best valueJanus Boye
1) Janus Boye discusses the confusion around whether open source always represents the best value compared to commercial options.
2) Open source has benefits like lower costs, customization, and community support, but also risks like lack of support and responsibility for bug fixes.
3) Boye suggests organizations look beyond just technology when selecting systems and engage with open source communities.
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This document provides guidance on setting up an IUI facility, including necessary infrastructure, equipment, personnel and quality control measures. The key aspects covered are:
- A dedicated IUI laboratory space with sterile work areas is required along with necessary equipment for semen processing.
- A multidisciplinary team of gynaecologist, embryologist, counselor etc. should be assembled adhering to regulatory guidelines.
- Strict adherence to quality control, hygiene protocols and calibration of equipment is important for success of the IUI program.
This document outlines non-consequentialist theories and their application to an ethical issue between Apple and the FBI. It discusses how Apple took a deontological approach by prioritizing privacy rules over sharing data to unlock a terrorist's phone. A SWOT analysis is provided for Apple, and the document concludes that Apple defended user privacy rights ethically based on deontological theory.
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The Paradox of Choice: Presented at the annual GPACA conference 2015. This presentation is geared towards anyone embarking on the process of purchasing a flow cytometer, specifically, but any laboratory technology more generally.
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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
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