Improving the Drug Development Process: A New Paradigm for Preclinical Development

Abstract

In this thesis, the current process of pharmaceutical development in the United States is shown to require significant investment in terms of cost and time, which by extension causes high drug prices and reduced innovation in the pharmaceutical industry. The implications for drug accessibility and unmet medical need as a result of prohibitively high drug prices and low pharmaceutical innovation warrant attention and scholarship on this topic. I analyze the process of drug development for possible inefficiencies contributing to its excessive cost and timeline, and create a multi-faceted recommendation to reduce inefficiency by applying recent advances in molecular biology; this could then lower drug prices and increase pharmaceutical innovation. Preclinical development, which occurs after drug candidate discovery and before clinical trials, is determined to be the most effective stage upon which to focus improvement efforts because of significant resource saving potential and inherent flexibility in this stage. If, through improved preclinical testing, earlier attrition of unsafe or ineffective pharmaceuticals occurs and promising drugs are better optimized for human use in clinical trials, cost and time investments would be reduced. I propose three categories for improvement in preclinical testing: data-sharing and FDA communication shortcomings, biological and physiological knowledge base gaps, and technology deficits. Recommendations and paradigm shifts are designed for each category with the aim to make preclinical development, and by extension the entire drug development process, more efficient.