Mario González Sales, Ph.D. has over 10 years of experience as a pharmacometrics consultant and was previously a pharmacometrics reviewer for the FDA. He is an expert in conducting complex population PK analyses across diverse therapeutic areas including infectious diseases, HIV, new oral anticoagulants, neurological disorders, psoriasis, and oncology. His broad experience in data analysis extends to population PK/PD and exposure-response modeling, clinical trial simulations, and pediatric extrapolation. As a former FDA pharmacometrics reviewer, Dr. Sales can support client’s needs to meet the regulatory expectations with regards to modeling and simulation. Dr. Sales uses PK/PD modeling and state-of-the-art pharmacometrics techniques to support decisions made under tight timelines as well as turning data into more informed strategic decisions. In addition, Dr. Sales’ achievements include the development of the population PK analyses and model simulations used to support the worldwide accelerated approval of a drug for adult and pediatric patients with solid NTRK tumors.