eLN SUPPLEMENT


and acquisitions, collaborations, consortia and outsourcing have become the norm rather than exception. Managing data in such a complex environment requires standardisation and a high level of data quality in order to allow collaboration and data exchange across organisational boundaries. In some areas such as Clinical Research good data standards exist


Date Activity 1998


designed configured and integrated will the eLN piece fit and help complete that puzzle. It resides in the space between many other critical systems making it unique. Like many other systems, eLN has data that is interesting in the context of a solitary system, but its uniqueness is in its relationship to other applications. It is connected to, and compiles


Table 1The Progression of eLN in Pfizer’s Pharmaceutical Sciences Division


Early versions of electronic notebook implemented in Pfizer Pharmaceutical Science for Process Chemistry users. 2005 An immature electronic notebook market began to consolidate and early Pfizer users managed product evolution.


2006 Pfizer R&D begins considering enterprise-wide eLN solution. Decision is made to proceed in Pharmaceutical Sciences division and vendor selection begins in 2006. A Vendor is chosen later that year.


2007 2009 Early requirements gathering & story boarding for a next generation eLN begins.


2008 Development and prototyping of this new platform continues with the selected vendor focusing mainly on core functions, Analytical Chemistry use cases, and user interface evolution.


First implementation of a new eLN platform for 120+ Analytical Early Adopters.


2010 New upgraded version of software; increasing user base beyond Early Analytical Adopters to include all Analytical & Formulation Scientists (650+ users).


2011 Product continues to evolve and new version of software is implemented expanding the user base further (750+). Further expansion of user base occurs to include Process Chemistry users increasing the user based to ~1000, and advanced system optimisations begin to align system across the organisation.


and data exchange between CRO’s and sponsors is well defined, in other areas such as Preclinical Research and Pharmaceutical Development those standard data exchange formats are not as highly evolved or missing all together. Agreeing on open standard data formats e.g. JCAMP5 AnIML6 etc., and implementing them across the


,


commercial software applications has become a key requirement. Standardisation at the system or at least


system-interface level would be the next logical step to reduce the integration effort for the industry. In times of constrained resources not every company can afford or should have to rebuild all those interfaces individually. Precompetitive consortia like the Pistoia Alliance7


will be needed to facilitate this process.


An overall integration backbone that allows the different software vendors to connect their applications in a ‘plug and play’ fashion will hopefully be the business model for the future, but still seems a long time away.


Summary and conclusions Pfizer has just finished a successful journey of implementing an eLN as part of an overall Laboratory Informatics Strategy (LIS). Collaboration between end-users, internal informatics professionals and the software vendor have proven core to that success. The eLN is an important piece in the very complex LIS puzzle. Only when properly


8


European Pharmaceutical Review Volume 16 | Issue 4 | 2011


Acknowledgements The authors wish to thank all the colleagues in Pharmaceutical Sciences and Business Technology that have contributed to the successful implementation of eLN. Special thanks goes to Keith Murphy, Vijay Bulusu, Paul Schmitz and Sue Blevens and their teams in Business Technology. In Pharmaceutical Sciences, this project could not have worked without Steve Brown, Richard Green and Robert Wade and everybody on their teams.


“Working with a software vendor that is committed to collaboration with their customer base is a prerequisite for a successful implementation of an eLN”


data from, numerous other systems; once internalised and aggregated the data is converted to information by applying context. The knowledge then comes from further aggregating that information with data/information from other systems where context has also been applied. The next level of eLN evolution involving


integration of data and business processes will not happen within individual companies but across corporate boundaries, between


References


1. Du P, Kofman JA (2007) Electronic Laboratory Notebooks in Pharmaceutical R&D: On the Road to Maturity. JALA 2007; 12: 157-65


2. Accelrys Case study (2011) Millennium’s eLN empowers Chemists and Biologists


3. Molecular Connection Case Study (2009) Implementing and Enterprise eLN: Lessons learned at Lilly


4. Elliott MH (2009) Thinking Beyond ELN in Scientific Computing


5. An XML-Based File Format for Archival Storage of Analytical Instrument Data (2010) XML Analytical Archive Format.doc 3/8/2010


6. Julian, RK (2010) The IUPAC/ASTM Unified Standard for Analytical Data: AnIML in Scientific Computing


7. Pistoia Alliance at http://www.pistoiaalliance.org/


Rory Quinnholds a Masters degree in Forensic and Analytical Chemistry from the University of Strathclyde. After graduating, he joined Pfizer in 2004 where he worked as an analytical development scientist supporting a number of candidates from discovery through to product launch. With


a keen interest in informatics solutions for the scientist, he became involved as a domain SME in the selection of an electronic laboratory notebook (eLN) solution for Pharmaceutical Sciences. Over the last five years, his role on this project has developed and expanded into his current role as the Global Analytical Business lead for the notebook solution deployed.


Gerhard Noelken is a Research Fellow heading the global Business IT function across Science and Technology in Pharmaceutical Sciences. He received his MD at the University of Mainz, Germany. After 14 years with Aventis, he joined Pfizer in Sandwich in 2001 as the Discovery


Research Informatics Site Head. Since 2007, he has worked in his current position for Pharmaceutical Sciences.


Stan Piper is a Principal Scientist specialising in informatics projects in Pfizer’s Pharmaceutical Sciences division. Stan has been with Pfizer since 1998. He began as an analytical lab scientist, and for the past 10 years Stan has worked as a member of several Business Systems and


integration teams, evaluating and implementing laboratory solutions including: LIMS, CDS, ELN and Lab Data Archive applications. He is currently serving as Business Lead for several global informatics initiatives. Stan received his BSc in Chemical Biology from Stevens Institute of Technology in 1998, and his MBA from Rensselaer Polytechnic Institute in 2006.


Pharmaceutical companies, CRO’s, academia and regulators. This evolution depends on the standardisation of vocabularies, alignment of metadata and open standard data formats. Delivering standards and compatibility that


allow for that level of business flexibility will be the challenge which the pharmaceutical industry, software vendors and other partners will have to resolve together.


Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25