Dr. Smith has over 17 years of global drug development experience. Working across all phases of development, he has particular expertise in infectious diseases, oncology, and inflammation, including significant experience with novel early development program design, and applying modeling and simulation to solve critical development problems. As a co-founder of d3 Medicine (now Certara), Dr. Smith has led many development and due diligence projects for clients ranging from pre-clinical development/IND strategy, design and execution of entry-into-human and proof of concept studies, design and implementation of modeling and simulation strategies, and crafting clinical pharmacology and clinical development plans. He has extensive clinical development experience globally, and has interacted with all major health authorities.
Dr. Smith was the US Site Head for Clinical Pharmacology for Roche, and a member of key corporate governance committees defining disease area and portfolio strategy. He served as an Associate Professor at the University at Buffalo School of Pharmacy and Roswell Park Cancer Institute. He obtained his PharmD degree from UCSF, and completed a clinical residency at Duke University Medical Center. Dr. Smith currently holds a Research Professor appointment at the University at Buffalo School of Pharmacy, and has authored more than 100 peer reviewed publications in journals including The Lancet and New England Journal of Medicine.