Drug development is a resource-intensive endeavor. Seeking input from the U.S. Food and Drug Administration throughout the journey can help optimize those resources and maximize the likelihood of regulatory approval. When preparing to submit a new drug application (NDA), a...
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Not surprisingly, the majority of nonclinical contract research organizations are not in glamorous locations. So arriving at the front door of one at 7:30 on a snowy or rainy morning isn’t likely on anyone’s bucket list. However, the experienced nonclinical...
As a sponsor designs clinical studies, the respective comparison control groups become a critical factor to consider. Often, to gain clinical trial design insights, a sponsor reviews the physician package inserts from approved New Drug Applications (NDAs) and Biologics License...
A clinical hold from the U.S. Food and Drug Administration can significantly prolong the time and increase the cost of drug development, which is particularly concerning for emerging/small biotech and specialty pharma companies.
Throughout the lifecycle of a drug development program, sponsors are confronted with a range of key questions. They must decide on the correct… Regulatory pathway, FDA center, Key Opinion Leaders (KOLs), Target Product Profile (TPP) inclusions, Data to rely on,...
With smartphones now ubiquitous, interest has increased in digital health solutions such as telemedicine platforms and apps used to track symptoms or medication usage. In recent months, the COVID-19 pandemic has only accelerated the adoption of these technologies. While many...
With smartphones now ubiquitous, interest has increased in digital health solutions such as telemedicine platforms and apps used to track symptoms or medication usage. In recent months, the COVID-19 pandemic has only accelerated the adoption of these technologies. While many...
Whether you plan to out-license or commercialize your product, getting the label right matters. When putting together a comprehensive drug development plan, it’s important to remember one of Premier Research's key approaches to drug development: “Begin with the end in...
Have you ever wondered about the difference between preclinical and nonclinical studies? While those in scientific fields like pharmaceutical development are accustomed to words with specific, agreed-upon definitions to facilitate communication and minimize misunderstandings, these terms seem to have slipped through the cracks. Their...
In this in-depth case study for an immuno-oncology program, discover how Premier Research’s multidisciplinary development strategy assessment reduced a sponsor’s risk, controlled expenses, and optimized speed to market. This case study will answer questions like: What disciplines should be canvassed...