Incomplete Documentation in Pharmaceutical R&D Lab Notebooks
I came across this excellent article in the Oct. issue of Scientific Computing and wanted to make people aware of it.
This article by Robin Y. Smith comments on the elephant in the room for most pharmaceutical companies as well as fine chemicals companies in R&D. The problem is the incomplete and sloppy notebooks. This is the elephant in the room that no one wants to talk about.
He found, based on auditing 10 years of lab notebooks from a top 10 pharmaceutical company, that 15% of the pages had major problems such as being illegible, incomplete, or had some other error meaning the experiment could not be reproduced.
In some of the worst cases, 60% of the pages were deemed not reproducible and this did not count vague phrases such as “worked up in the usual fashion”. If there was ever an area in R&D that could is ripe for improvement, this is it.
Cases of scientists being judged on the number of notebooks filled leading to “dry labbing”. This is where lab notebooks are padded with many planned experiments which are never carried out. Just looking at the number of notebooks filled these scientists appear to be very productive.
I’ve always been frustrated when trying to find info in others lab notebooks. Lack of table of experiments in the front resulting in having to flip through the notebook until you find the right result. Not knowing which of dozens of lab notebooks contains the information you need. Experimental results such as chromatograms or NMR printouts not being in the notebook or even worse, being in another 3 ring notebook that isn’t identified by anything other than a volume number. I have spent too much time trying to find information rather than analyzing and coming up with new experiments.
The problem is at its worst in discovery or med chem groups but I will note that even in most process development groups it is better but still not great.
The article doesn’t comment on stats for use of phrases such as “typical work-up procedure”, “standard procedure”, etc. without referencing some other document or lab notebook page. As a process development chemist, I always found this sort of documentation mind boggling. I had one case were I was repeating a drug discovery process on a small scale to become familiar with the process and at one point encounter a horrible emulsion. I went to the discovery chemist and asked if this is what he saw and if so, what did he do about it. He said yes, he saw that too and he just left it to sit overnight until it separated. This was NOT noted in his lab notebook! Needless to say, this required a lot of work in process development to get a process that would work on even a 22L scale.
The other complaint I have is even when a work-up procedure it listed, most of the time in my experience, the procedure did not list volumes of solvent or aqueous washes used. In another case, it said the organic layer was washed repeatedly with water. I found out that it was washed 15 times with huge amounts of water each time!!! None of that was documented. When I asked the chemist, they said all these washes with that large of volume of water was indeed required to get rid of some inorganic salts. Ends up, using equal volumes and doing 3 washes worked fine.
All of these are huge problems and I do indeed think that electronic notebooks are needed. I’d like to see them used much more widely than they are currently and think this could go a long way towards increasing R&D productivity.
I should point out that the author, Robin Y. Smith is Vice President of Product Strategy at Symyx Technologies and they make software for electronic notebooks.
Technorati Tags: documentation, lab notebooks, R&D productivity
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