Stan Roberts consults in toxicology, drug metabolism (ADME), pharmacokinetics (PK) and drug development. His experience includes biotherapeutics (peptides, proteins, monoclonal antibodies & nucelotides), stem cell therapies, small molecules and medical devices. He has over 30 years in scientific and management positions in large (Sandoz, Abbott & Pfizer) and small (CovX) companies. He has planned, conducted, interpreted and reported all types of toxicology studies plus created preclinical development plans and regulatory strategies. Accomplishments include authoring over 400 internal final reports, major contributions to regulatory strategies/submissions (Pre-IND, IND & NDA) and conducting research that determined the human relevance of animal toxicities (e.g., liver, kidney, CNS, lung, male and female endocrine system, immune system, blood cells and bone marrow). These achievements were often critical to continuing research into or for the regulatory approval of new drugs. While directing a global ADME/PK organization his group played a major role in reorienting the selection process for new drug candidates. Using novel methods,approaches and strategies (radiochemistry, PK, biological & analytical chemistry); new compounds were selected with the best ADME/PK characteristics which directly reduced failures in human Phase 1/2 testing. Stan’s experience in therapeutic areas includes; oncology, neuroscience, anti-inflammatory, immune modulators, lipid modulators, anti-infectives (viral, bacteria and fungi) & metabolic disease. Stan is experienced with in-/out-licensing, multidisciplinary teams and has presented to the FDA. He has and continues to participate in numerous committees and special projects for BIO and PhRMA and provides post-graduate lectures and webinars on a variety of topics including toxicology, ADME/PK and drug development.Specialties: Toxicology, Drug Metabolism (ADME & PK) and Drug Development