Methods and Findings in Experimental and Clinical Pharmacology
Vol. 25, Suppl. A, 2003
ISSN 0379-0355
Copyright 2003 Prous Science, S.A.
CCC: 0379-0355/2003
http://www.prous.com

Researching New Pharmacological Targets: From Speculation to Clinical Confirmation

I. Izquierdo

Clinical Research, R&D Area, Grupo Uriach, Barcelona, Spain

Several recent publications have painted a rather conservative picture of the pharmaceutical industry, with cautious predictions for the future. This view is based on the observation that in spite of the continuing increase in R&D investment, product development times have not decreased and the output of new medicines remains a cause of concern.

Many of the diseases that fueled the enormous explosion in profit and turnover in the pharma industry in the 1980s and 1990s--asthma and gastric ulcers, for example --are now well controlled, reducing the potential added-value of any new treatment in these areas. Furthermore, the diseases for which treatment is still inadequate--such as neuropsychiatric diseases or cancer--are chronic, with complex pathophysiology and difficult outcome measurements.

Indeed, new approaches over the past few years that have optimized how new lead compounds are identified, such as computer-aided drug design, combinatorial chemistry, high-throughput screening and genomics, only serve to highlight that the problem lies not in identifying new leads but in the rigorous selection of those to be investigated. Identifying molecules that are unlikely to reach registration and stopping their development as soon as possible brings big rewards. For this reason, more and more effort is being put into the early selection of compounds by, for example, including biomarkers in the initial stages and introducing early proof of concept studies.

In this session, the speakers will discuss topics such as the confirmation of a new molecular entity from the clinical and regulative point of view.

Methods and Findings in Experimental and Clinical Pharmacology Vol. 25, Suppl. A, 2003
ISSN 0379-0355 Copyright 2003 Prous Science, S.A. CCC: 0379-0355/2003 http://www.prous.com