Consulting
Expertise: Consulting 38 results
Consulting
Abie Ekangaki, Ph.D.
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…
One of the most common formulation issues that sponsors of new drug or biologic products face is the qualification of novel excipients. Although novel excipients can be a part of any new drug application (NDA) or biologics license application (BLA) development program, they seem to be more common with the 505(b)(2) pathway, since many companies…
Before the 2012 Food and Drug Administration (FDA) Nonprescription Safe Use Regulatory Expansion (NSURE) initiative, sponsors were transitioning prescription drugs (Rx) to over-the-counter (OTC). Streamlined access to effective treatments clearly benefits patients and payers. At the same time, easier access for consumers typically results in increased sales and profitability for pharma and biotech companies. As…
Morrisville, N.C., February 22, 2022 — Premier Research launched Premier Consulting today by consolidating two legacy brands within its portfolio — Regulatory Professionals, Inc. (RPI) and Camargo Pharmaceutical Services. Premier Consulting is a unified strategic product development and global regulatory consulting brand positioned for market leadership in support of emerging biotech and specialty pharma companies. The new…
For developers seeking to obtain approval for previously approved drug products in the United States, the U.S. Food and Drug Administration offers two abbreviated approval pathways — an abbreviated new drug application (ANDA) and a 505(b)(2) application. Both of these applications rely on the agency’s finding of safety and effectiveness for a listed drug, but…
Morrisville, N.C., May 18, 2021 — Premier Research announced today that it has acquired Camargo Pharmaceutical Services based in Cincinnati. Premier Research is a leading provider of strategic and regulatory advisory services as well as clinical development services to the biotechnology, specialty pharma, and medical device industry. Camargo is a leading global strategy, regulatory, and…
Traditionally, Phase 1 trials commonly utilize 3+3 designs to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D). Studies have shown, however, that two out of three trials employing a 3+3 design failed in identifying the MTD, and better approaches are needed.1 During Premier Research’s recent webinar Alternative Designs to the…
Developing a new biopharmaceutical product is a lengthy, high-stakes journey. It takes, on average, at least 10 years and over $2 billion to successfully bring a new drug to market, and only 10% to 15% of products ultimately receive regulatory approval.[1] A comprehensive plan and the right regulatory and therapeutic expertise can significantly accelerate the…