Drug development consulting on safety and efficacy issues from discovery through POM/POC and beyond. Proactive risk assessment and product differentiation -Strategic safety assessment planing -Design, placement, oversight and analysis of GLP and non-GLP Pharmacology, ADME and Toxicology studies; review and editing of study reports -Drafting/editing and finalizing INDs sections, IBs, protocols, -Clinical study dose selection -Clinical safety assessments -Clinical outcome measures, surrogate markers, biomarkers and genomics for POM/ POC and pivotal trials