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 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 Continue reading PK/PD of BIOLOGICALS

NANOBODIES FOR AUTOIMMUNE DISEASES

Thrombotic thrombocytopenic purpura (TTP) is a devastating disease with a downhill course of neurologic, renal and cardiac complications leading to death at a young age if untreated.  Thrombocytopenia and thrombosis are its hallmark, with fever, anemia and neurologic deficits. It Continue reading NANOBODIES FOR AUTOIMMUNE DISEASES

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 Continue reading About A Prepared Mind – In R&D

The 10 x ’20 Initiative – A Retrospective

It started all so well with fanfare and great expectations. Fifteen years ago, the 10 x ’20 initiative got underway. Its goals were spelled out clearly: To ‘Pursue a Global Commitment to Develop 10 New Antibacterial Drugs by 2020 ’[3].  It Continue reading The 10 x ’20 Initiative – A Retrospective