Do’s and Don’ts in Early Drug Development

Abstract

Over the last decade, the health science landscape has been occupied by numerous biotech’s and start-up companies. Most of the time, the scientific level of these companies is outstanding, the way new molecular entities have been developed has evolved with no doubt but despite this evolution changes it must be acknowledged that it still has certain limitations as to the way it functions. Drug development should be regarded as a drawer chest where each drawer represents a drug development step, such as preclinical, preformulation, formulation, regulatory affairs and clinical should be opened and closed at the same time. This short communication will put the emphasis on the preclinical and the chemistry manufacturing and controls (CMC) phases since it has been noted that these sections are plus or less neglected in early drug development. This is confirmed by the fact that almost 50% of the new chemical entities are failing during the preclinical phase and the fact that new molecular entities are becoming more and more difficult to formulate (showing bad druggability profile), that has shown without a doubt that early drug development should be tailored around these two early drug development steps