Case #3 - Creating a Pediatric Clinical Development Department

Situation — In the late nineties, pediatricians were pushing for legislation requiring drug companies to test products in children, to ensure that medications are safe and effective for them. In response, the FDA created the 1998 Pediatric Rule, which allowed the agency to require companies to conduct clinical trials in children. The client company did not have physicians with pediatric specialties on board to successfully meet the FDA guidelines.

What We Did — In the course of other assignments, Blair & Company came across a world-renowned physician who was advising the FDA on its guidelines for conducting pediatric clinical trials. Blair knew that the company had a major franchise in products for children, and that FDA was increasing its attention to the unique needs of children. Blair proposed that the client consider the candidate for a leadership role related to pediatric drug development across all the divisions of the company. This individual was recruited as Global Head of Pediatric Development. Blair & Company was subsequently retained to recruit qualified pediatric specialists in Gastroenterology, Pain and Psychiatry.

Results — The original candidate joined the company in 1998. Blair & Company recruited three other specialists to provide leadership within the department. Four years later, they had established one of the most successful pediatric drug development units in the world. The department successfully developed new knowledge for labeling medicines for safe and effective pediatric use and helped advance new approaches to clinical investigation in children. The department head led efforts in Congress on behalf of the Best Pharmaceuticals for Children Act, which passed and signed into law in 2002. He has promoted pediatric investigation of new medicines, international harmonization of drug development regulations for children, and the highest ethical standards in pediatric investigative programs.