REGULATORY INTERACTIONS  – 1

It can feel like the mountain stage of the Tour de France… A lot of effort goes into preparing for meetings with Regulators.  There is also a lot we can learn at such meetings. Today we start a series of blogs detailing personal experiences and learnings, highlighting do’s and don’ts. Continue reading REGULATORY INTERACTIONS  – 1

PK/PD of BIOLOGICALS

Sometimes we come across an article we wish we had read earlier.  This was the case with the publication by Zhao and colleagues[1].  The article, now more than 12 years old, was written in the ‘early’ days of biological drug development, after the first wave of mAbs had already been Continue reading PK/PD of BIOLOGICALS

About A Prepared Mind – In R&D

“Chance favors the prepared mind” is the short form of a statement by Louis Pasteur which actually reads: “In the fields of observation chance favours only the prepared mind” or ” Dans les champs de l’observation le hasard ne favorise que les esprits prepares”. [1] There is no better example Continue reading About A Prepared Mind – In R&D