Dr. Kearns has more than 35 years of scientific experience in pediatric clinical pharmacology and toxicology. He has extensive expertise in the design, conduct and analyses of early phase clinical trials of pediatric medicines with a focus on the impact of development and pharmacogenomics on drug disposition (PK) and action (PD). Dr. Kearns’ therapeutic area experience includes infectious disease, gastrointestinal disease, allergic disease/asthma and the development of biomarkers to assess pharmacodynamics in infants and children. His regulatory experience includes service on several FDA advisory committees, consultancies with EMEA and 12 years of ongoing service as a member of the World Health Organization Committee on the Selection and Use of Essential Medicines. Dr. Kearns’ research has produced 193 peer-reviewed research publications since 1982 which includes 79 studies supported by pharmaceutical companies, 58 of which contributed to the labeling of medicines used in pediatrics.