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Stanley Roberts

Dr. Stan Roberts is currently an independent consultant in toxicology, drug metabolism (ADME), pharmacokinetics (PK) and drug development. He has over 30 years in scientific and management positions in large (Sandoz, Abbott & Pfizer) and small (CovX) pharmaceutical companies. During this time he has planned, conducted, interpreted and reported on all types of toxicology studies including acute/sub-chronic/chronic/carcinogenicitygenotoxicity, mechanism, dermal/ocular safety and developmental/reproductive toxicology in many laboratory animal species. Stan has also created preclinical (i.e., non-clinical) development plans and strategies for many types of pharmaceuticals including both small molecular weight (NCE), biotherapeutics (NBE, peptides, proteins, monoclonal antibodies and nucleotides), stem cells and biomedical devices. Stan’s experience in disease targets includes oncology, neuroscience, inflammation, immune modulators, lipid modulators, atherosclerosis (both drugs and medical devices [stents]), infectious (bacteria, fungi and viruses) and metabolic disease.

Stan’s accomplishments include authoring over 400 internal final reports, major contributions to numerous regulatory documents/strategies/submissions (white papers, IND & NDA) and conducting research that determined the human relevance of animal toxicities. Several of these mechanistic based research projects directly led to the successful human marketing of new drugs that had significant animal specific toxicities. In addition, to Stan holding leadership roles in Toxicology, he has also led an ADME/PK organization during which a significant achievement was the significant reorientation of the ADME/PK groups under his direction to improve their support of new drug discovery research (including both bench assays/studies and research strategies). This change directly led to a marked improvement in the quality of new drug candidates selected for further development in human and markedly reduced the failure rate. Stan’s administrative experience has included establishing and monitoring large budgets (over $11 million/year), personnel management (up to ca. 70 FTE’s across multiple global sites) plus establishing and insuring success for scientific resources, visions and strategies. Stan’s long and diverse experience has provided a unique skill set for participating in both with in-/out-licensing activities along with managing and representing multidisciplinary management and research teams.

Stan has successfully presented to the FDA on a number of occasions as part of a multidisciplinary industrial team or while representing a trade association. In this regard, Stan has served on a number of committees for Pharmaceutical Research Manufacturers of America (i.e., PhRMA) including In Vitro Toxicology, Drug Metabolism Technical Working Group, Drug Safety and Biomarkers). Stan has also been active in serving for the Biotechnology Trade Association (BIO) where he was the founding President of the

Pharmacokinetics and Disposition Expert Working Group and after serving on the BIO Drug Safety (BioSafe) committee now serves as an ex officio member.

Stan’s academic activities have included presenting well over 50 lectures to undergraduate, graduate and post-graduate students through Rutgers University, Purdue University and the University of California at San Diego. He has served on the Corporate Advisory Board for the University of Washington – School of Pharmacy since 2003. Additionally, has served the National Institutes of Health (NIH/NIMH) by acting as a primary reviewer for 10 grants and contract proposals in 2011 and, to date, in 2012. Of note, he has also provided expert testimony to the governing committees of the New Jersey state Senate and House of Representatives to support the role of basic animal research in the development of new medications. Stan has 25 invited presentations, 3 book chapters, 18 peer-reviewed publications and 27 scientific meeting abstracts. Stan is an active member of the Society of Toxicology and International Society for the Study of Xenobiotics. He has been certified as a Diplomate of the American Board of Toxicology since 1995.

Stan has a BS (Animal Science), MS and PhD (Pharmacology & Toxicology) from Purdue and post-doctoral fellowship in Molecular Toxicology (Medical University of South Carolina).

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