“Feeling appreciated is important to me, and I value the honest feedback which has helped me to grow, understand, and perform my work better.” I applied to become Project Coordinator at the urging of one of my colleagues, even though...
Premier Research
Background An international company developing an orphan drug product needed a partner experienced in FDA interactions to help it navigate the U.S. regulatory process from beginning formulation to NDA approval. The sponsor’s product used a novel delivery platform designed to...
Premier Partners has worked on more than 200 nonclinical programs since its inception in 2005, many of which include rare routes of administrations (ROAs) and use of uncommon animal species. We have collaborated with sponsors on many niche programs that have shone...
New treatment options for medical aesthetic indications are in record-high demand, fueled by growing awareness of the effects of physiological and environmental aging and the influence of lifestyle on skin health. By 2025, the global aesthetic medicine market is projected...
This is the final installment in a four-part blog series highlighting FDA designations for products with rare disease indications: orphan drug designation (ODD), rare pediatric disease designation (RPDD), and humanitarian use device (HUD) designation. In this post, we examine the humanitarian...
In a survey conducted by Informa Pharma Intelligence on behalf of Oracle Health Sciences, 76 percent of respondents indicated that the pandemic hastened their adoption of decentralized clinical trial (DCT) approaches. While the shift to DCTs is well underway, concerns...
Conducting a clinical study in a pediatric patient population requires careful planning, as providing treatment to a child without causing harm is a weighty responsibility. The first tasks in striking this balance are dose selection and dosing interval determination, and this blog...
Cancer is not a single disease, but rather hundreds of different diseases. Thus, there will never be a single cure to cancer. As our knowledge of oncology science advances and expands, a growing number of malignancy types and subtypes are...
In 2020, CDER approved 68 NDAs that used the 505(b)(2) pathway, representing important advances in patient care across a wide range of therapeutic areas. 505(b)(2) Drug Improvement Approvals by Year In spite of an unusual year due to the COVID-19...
Rare Disease Clinical Trials Most Often Terminated Due to Regulatory and Recruitment Issues The difficulty associated with successfully completing rare disease clinical trials is well-known. Most people believe that recruitment is the primary reason because, by definition, the number of...