Improvement of Innovation Productivity in Life Science R&D requires "big action". M&A, site closure, strategic partnerships and so on. That is at least the take from dozens of publications on the topic.
Not necessarily wrong but just one part of the picture. Small topics can have a significant impact on Innovation Productivity as well. Since the large topics are already well covered, this Blog is dedicated to the small ones. Don't hesitate to share this Blog if you like the entries.
At discovery’s bottom line, important equipment may fail to operate according to required standards, potentially compromising the overall success. Due to the technology level of modern drug discovery, dangerous malfunctions will happen rather sooner than later.
Die Pflanze hatte viel Sonnenschein, ausreichend Dünger und genug Kohlendioxid. Sie hatte allerdings etwas wenig Wasser. Wir nannten es Urlaub. Die Pflanze nannte es Engpass.
All processes and and activities are well known and clearly understood by all those who need to know – in theory. As soon as two or more participants of a given activity are asked to describe it in a detailed and precise form, the resulting discrepancies are frequently astonishing.
Like the canaries used in coal mines to detect dangerous gases, FDA warning letters can be used to detect the latest focus of the agency. But why should discovery units care about FDA focus?
Details of Experimental Design can have a negative impact on Innovation Productivity. The stability of radiolabelled reference standards, widely used for binding assays in initial selection of drug candidates, belongs in this category.
Einen Antrag auf Erteilung eines Antragformulars, zur Bestätigung der Nichtigkeit des Durchschriftexemplars, dessen Gültigkeitsvermerk von der Bezugsbehörde stammt, zum Behuf der Vorlage beim zuständ'gen Erteilungsamt. (Reinhard Mey, 1977)
Methodologies: Potent Roadblocks for Smart Concepts in Drug Discovery
Tools and methodologies as such may be useful but neither is their universal application (“if you have a hammer, every problem looks like a nail”) nor their over-extensive use (10 level FMEA).
“In God we trust, all others need documents!” is a notorious quote, attributed to a probably foul-tempered US FDA inspector. We do not expect the FDA to show up in the discovery units of our clients, demanding documents with nasty remarks, but we strongly advocate documentation of the results of any quality project.