Dr. Susan McCune is the Vice President for Pediatrics & Clinical Pharmacology in the Medical Science and Strategy Group and part of the Rare Diseases and Pediatrics Center of Excellence. She has more than 35 years of clinical care (board certified in pediatrics and neonatology), research, and regulatory experience. With 18 years at the FDA, her depth of experience consists of regulatory consulting for all phases of pediatric trials including the review of study protocols and analysis of data submitted to the FDA.