Abstract

The familiar multistage model of drug discoveryand development has been in place for decades. Attritionrates under that model have been and still are frighteninglyhigh. The associated debilitating issues, such as weak patientengagement, limited involvement of key stakeholders at criticalstages and slow routes to market, are clear for all to see. Thisarticle argues that the time is nigh to consider a new approach,based upon what has been learned from other industry sectorsdeveloping products for customer markets. The regulators aredemanding it through modernisation initiatives, but industry has,to date, been tardy in its response. The suggestion here is thatis because it is holding grimly on to the ‘tried and tested’ oldmethod. The new approach suggested is based on a broadtwo stage model, comprising design/prototyping as stage oneand manufacture for patient supply (including commercial)as stage two. Almost every other industry sector develops itsproducts this way, devising predictive methods (eg wind tunnelsto examine thermodynamic characteristics of aircraft) beforeexposing customers to their final marketed product. The articleproposes how this could work in pharmaceuticals, together withan exploration of some supporting organisational and mindsetchanges needed to support. The challenges of devising andimplementing such an approach are enormous, but so arethe potential benefits. For those benefits to accrue, it is arguedthat a fundamental shift in perception needs to take placeat the most senior levels in this industry. This means acceptingthat extra time taken at the early stage of drug developmentcreates a vastly improved value: cost relationship. In otherwords, the extra costs incurred in terms of time and resourcesearly on are greatly outweighed by reduced attrition rates andtime to market.