Mr. Smith has consulted with pharmaceutical, biotechnology, private equity, and strategic consulting companies in the US, Canada, Europe, Asia, and Australia and have a lot of experience with FDA, EMA, oncology, central nervous system, inflammation, virology, respiratory, rare diseases, drug metabolism, pharmacokinetics, bioanalysis, clinical pharmacology, prediction of human pharmacokinetics, drug interactions, dose selection for clinical trials, pediatric trials, health authority questions, investor meetings, due diligence, partnering, and IND, NDA, CTA, MAA preparation.