Mario González Sales, Ph.D.

Mario has over 15 years of experience turning data into decisions. He is a former FDA pharmacometrics reviewer awarded for tackling difficult regulatory issues and delivering high quality reviews.

Mario has analyzed data from hundreds of clinical trials involving virtually all therapeutic areas and has extensive experience working with both small molecule and biologic drugs. In this regard, his analyses have contributed significantly to the approval of several drugs including pediatric indications.

Regarding the technical aspects, Mario is proficient in NONMEM and R. Under tight timelines, he can program NONMEM ready datasets, perform population PK, PK/PD and exposure-response analyses, develop shiny apps, create R packages, writing reproducible reports, and more.

Mario will bring value to you throughout the drug development process. For example, in the early stages, he can advise you with your clinical development strategy. During development, he will help you make better and faster decisions through the use of modeling and simulation. At the end, he will prepare a report ready to be submitted to regulatory agencies. If necessary, Mario will also support you in answering regulatory questions. His FDA experience ensures that your analysis will be consistent with regulatory expectations.

Mario formed his own PKPD consulting company (Modeling Great Solutions) in 2018 and joined Nuventra Pharma Sciences/Allucent as an independent VP pharmacometrics consultant. Currently, he is a member of the Syntegrity Quantitative Clinical Pharmacology Collaborative.