History and Evolution of Innovations in Clinical Pharmacology.

Abstract

Foundational scientific discoveries and inventions, with some dating back nearly 80 years laid the groundwork for many of today's innovations in clinical pharmacology. Beginning in the 1970 to 1980's, these discoveries began to rapidly mature, leading to widespread adoption in new and generic drug development and in regulatory decision-making. Over time, there has been a gradual transition toward a greater focus on quantitative modeling and simulation technologies, reinforced by enormous improvements in data collection in preclinical studies with translational bridges to relevant information derived from early phase human clinical trials. These innovations have opened the door to may improvements such as more precise assessments of dosage form performance, optimized dose selection to maximize the benefit-to-risk of numerous therapies, more in-depth understanding of drug-drug interactions, and informed dosage adjustments in specific populations. This review traces the history and evolution of innovations in clinical pharmacology through the lens of the interconnected pharmaceutical industry-regulatory agency relationship. It discusses three categories of innovations: established, in progress, and emerging, and discusses how specific innovations have played out, or are expected to shape, the future of the drug development and regulatory science enterprise tasked with bringing effective, safe, and needed new and novel therapies to the marketplace.