0123456789 ();: control for multiple mechanisms being employed during a product's
development, we modelled clinical development time and, separately, review time between …

The process of clinical development and regulatory review of new therapeutics in the United
States was significantly changed by a number of legislative acts passed in the 1980s and …

The first decade of the 21st century was a challenging period for the pharma sector and
could prove to be a turning point in the evolution of the industry. We examine drug …

Although the number of global clinical trials (GCTs) conducted in multiple countries
including Japan has increased recently, it is not clear how much these GCTs help in …

This study utilizes both public and private data sources to estimate clinical phase transition
and clinical approval probabilities for drugs in the development pipelines of the 50 largest …

Objectives: This study examines the financial benefits that can accrue to drug developers
from improvements in the drug development process. The effect on drug development costs …

Background Over the past decades, US Congress enabled the US Food and Drug
Administration (FDA) to facilitate and expedite drug development for serious conditions …

The topic of R&D productivity in the pharmaceutical industry has been discussed for more
than 20 years. It has been largely a story of decline. In fact, around 90% of potential drugs …

The FDA's new “breakthrough therapy” designation for investigational drugs adds to the
agency's portfolio of expedited programs for serious conditions. The designation requires …

This paper estimates a duration model of late stage drug development in the pharmaceutical
industry using publicly available data. The paper presents descriptive results on the …