With hundreds of companies and clinical trials investigating CAR T-cell therapies, there exist opportunities to expand the applications of—and broaden access to—these novel therapeutics to address unmet medical needs. Fundamental to these efforts to make CAR T-cell therapies more broadly available is the need to improve the safety, efficacy, and cost of these treatments. In...
The drug development process is a long journey, beginning with drug discovery, moving through nonclinical and clinical studies, and ultimately culminating in regulatory approval. With many steps in between, each as important as the next, multiple factors regarding development strategy and approach must be considered at the earliest stages. This blog post offers advice for...
Developing a new biopharmaceutical product is a lengthy, high-stakes journey. It takes, on average, at least 10 years and more than $2 billion to successfully bring a new drug to market, and only 10 to 15 percent of products ultimately receive regulatory approval. A comprehensive plan and the right regulatory and therapeutic expertise can significantly...
Introduction For those who have been through it, a rescue study transition from one contract research organization (CRO) to another can be a difficult ordeal, often accompanied by logistical hurdles and communication challenges. When a sponsor of a Phase 1 dose expansion trial for a novel oncology therapy contacted Premier Research, they were more than...