Expertise: Consulting 225 results

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...

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...

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...

This is the third 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. Part 2 examined orphan drugs, and in Part...