The end of this quarter marks our 25th anniversary as the company was founded April 1 1987. A lot of water has gone under the bridge since then but not all has been forgotten and some highlights of that period deserve attention at this memorable moment in time. During the first couple of years I kept on my own but eventually I had to decide whether to stay alone or to give it a try and to build up a team of consultants to face the increasing and increasingly complex workload. Thanks to this decision in 1990 our team is now serving over 80 clients from various countries and continents with all kinds of drug regulatory issues.
Increasingly complex means the replacement of our national drug regulatory framework by the rapidly expanding European collection of directives and guidelines. Starting with the prehistorical “Multi-State Procedure” we have since long entered the EU labyrinth which involves things like pharmacovigilance, environmental risk assessment and pediatric investigation programs. Things nobody cared about in the beginning and which make you wonder whether the life of patients, children or EU-citizens in those early days really were in great danger……
Increasingly complex also relates to the profound influence of information technology on the drug regulatory domain. The replacement of a pallet full with binders by a single CD-ROM surely represents invaluable progress at the one hand. But performing a GAMP-validation of an automated production line is quite another thing. And only in 1996 we introduced e-mail in our office sharing access to the internet with only one desktop computer (who mentioned laptop’s?) shared by 3 consultants receiving only a handful of messages per week. Compare that to our current score of 300 per week.
It is hard to imagine what developments will take place in the next 25 years. Will this regulatory expansion and increase of complexity continue at the same pace or will the pendulum of time reverse and introduce and era of deregulation? Or will there be another paradigm shift and will the age of biotechnology fade away with some totally new medicinal concept taking its place, as proteins did with small molecules? We can’t tell, but we will keep the old Dylan song in mind: “please get out of the new one if you can’t lend a hand, for the times they are a changing:”