The Compounding Benefits Of The Right Preclinical Development Approach

By Novotech Drug Development Consulting

Navigating the preclinical and clinical divide in drug development can be daunting, with the journey from discovery to commercial success beset with pitfalls linked to data integrity, trial recruitment and retention, analytics and assay development, regulatory hurdles, and other key factors. Traversing the so-called “valley of death” and forging a successful pathway to clinical development hinges on determining the optimal strategy for a product and indication.

Drug development is an expensive, highly regulated, and complex process. Despite considerable investment and time, the vast majority of new drugs fail to ever reach the clinic – in fact, between just 5 and 10 percent of the most promising preclinical studies are translated into clinical applications. Furthermore, the relative complexity of this pursuit is likely to increase, as more and more advanced therapeutic modalities enter the development pipeline. Innovations in the cell and gene therapy space, as well as pioneering exploration into new drug formats and delivery methods, have transformed the landscape. While an increasing number of these therapies are achieving commercialization both in the U.S. and globally, the relative novelty of many of these drugs means an uneven understanding of their design and manufacturing needs, as well as a dearth of capacity with the necessary expertise to realize clinical success.