Quintiles Pharmacokinetic, Clinical and Regulatory Expertise Come Together to Deliver Results

Five Weeks Ahead of Schedule

The Need

A major pharmaceutical company needed to conduct trials of its top-selling drug to gain exclusivity in the pediatric market. The customer needed to align itself with an organization that had a combination of extensive respiratory expertise and wide-ranging contacts among allergists and immunologists throughout the country.

The Challenge

The customer and Quintiles had to move very quickly to meet stringent FDA requirements concerning safety and efficacy data for a pediatric population in which no studies had yet been conducted. If the trial met the exacting terms of the Pediatric Exclusivity rules, the FDA would provide an additional six months of patent protection for the product.

The Solution

Initially, Quintiles conducted both pharmacokinetic and safety studies in children aged two to five. These studies were run in parallel on over 300 children and the work was completed within six months of program launch. When the FDA requested additional data on the six-month to two-year age group, Quintiles ran pharmacokinetic studies to identify appropriate doses for two subsets and subsequently launched safety studies. The demanding studies required Quintiles to access 50 sites, including Phase I pharmacokinetic centers, private investigators, clinics and university research centers. And, in total, the study involved nearly 800 children.

The Outcome

All studies were completed, reported, and filed a full five weeks ahead of the customer’s target date – and an additional month before the FDA’s target date.