ANDREW PARKER
Catalent Pharma Solutions, United Kingdom

Abstract

In December 2019, Catalent invited academics and industry experts to Nottingham, U.K., to discuss the salient advances, emerging themes and major talking points at a conference centred around recent advances in early drug development, providing an open forum on current drug delivery issues. Across ten presentations, delivered by experts from eight institutions, the meeting considered how drug delivery techniques in early development could improve bioavailability of poorly-soluble drugs, and produce formulations more likely to perform positively in preclinical and clinical studies. 

This included discussion on how physiologically-based pharmacokinetic (PBPK) modelling could be used to assess molecule developability. Other themes included advances in in vitro tools, modelling, and enabling technologies. This review is authored as a commentary on the conference and not an exhaustive review of the field.

The conference was driven by the pharmaceutical industry’s ongoing need to assess new chemical targets as drug candidates against therapeutic targets, their developability considerations, and most importantly, identifying the key challenges and risks in progressing drugs through preclinical and clinical studies.

Such challenges have been well documented (1-4) where incomplete physical, chemical and/or biological information is available on a compound; yet the timelines for demonstrating proof-of-concept in vivo are often shortened because of financial pressures and competition. This dichotomy is further intensified by issues such as limited materials (and variable quality and particle size), unknown dosing requirements for therapeutic effect, unexplored relationship of dose versus exposure in dose escalation studies, limited drug metabolism and pharmacokinetics (DMPK) studies undertaken, and instances where drug solubility may be poor. This last point has been the subject of increasing research as the number of larger and less soluble molecules displaying permeability- and/or solubility-limited absorption has increased year on year (5).