Addressing Gaps in Early Drug Development: A Focus on Preclinical and CMC Phases

This present study serves as an indispensable guide for researchers, offering valuable insights to navigate the complexities of drug discovery. Over the last decade, the health science landscape has been occupied by numerous biotech and start-up companies. Most drug development policies in developing countries are enacted without achieving the desired results. Minimizing the uncertainties associated with drug development by strengthening the aforementioned factors is a major catalyst that can encourage pharmaceutical industries to invest more money in drug development. The scientific caliber of these companies is typically excellent; there is no doubt that the development of new molecular entities has changed over time, but it is still necessary to recognize that these developments have constraints on how they may be used. Drug development should be regarded as a drawer chest where each drawer represents a drug development step, such as preclinical, pre-formulation, formulation, regulatory affairs and clinical should be opened and closed at the same time. However, it should be kept in mind that early drug development should rely on seasoned people showing proven track records in development; prior to relying on science, most research scientists think that scientific degrees give all the answers and the ability to succeed.

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 more 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 a bad druggability profile). This shows without a doubt that early drug development should be tailored around these two early drug development steps.