DABT - Diplomate American Board of Toxicology
B.S. Chemistry, Allegheny College, 1972 Ph.D., Pharmacology, Univeristy of Illinois, Chicago, 1977 Post Doctoral Training in Toxicology, Vanderbilt University, Nashville, TN 1980.
Agricultural Chemicals/Pesticides, Art Materials, Biologics/Biotherapeutics/Biotechnology, Cardiovascular Toxicology, Dermal Toxicology, Dietary Supplements, Drug/Pharmaceutical Development, Drugs of Abuse and Alcohol, Endocrine Toxicology and Endocrine Disruptors, Expert Witnessing, Food and Food Additives, GLP Study Auditing, Hazard Communication, Hepatic Toxicology, Immunotoxicology, Industrial and Occupational Toxicology, Inhalation and Respiratory Toxicology, Medical Devices, Metals Toxicology, MSDS And Labels (Hazard Communication), Ocular Toxicology, Over-The Counter Products, Pharmacokinetics/Toxicokinetics, Product Safety Assessment, Regulatory Toxicology, Renal Toxicology, Risk Assessment, Safety Pharmacology
Toxicology, Pharmacology (with a focus in cardiovascular), ADME/PK, non-clinical Safety Assessment (small and large molecules), disease models, lead optimization strategies; Program design, implementation and management; Report Preparation, data review and assessment, In license assessments; Laboratory operation assessment; Expert witness and litigation support, with focus on ethanol and solvent related issues; Chemical safety, risk assessment, industrial plant inspections and MSDS preparation.
Thirty three years of experience in the pharmaceutical and CRO sectors. Held increasingly high levels of management and leadership, I finished my corporate career as Chief Scientific Officer at WIL Research (now CRL/Ashland)Laboratories, with multi-disciplinary and multi-site oversight and, responsibility for over 400 people. Responsible for several innovations at WIL Research, including a well-regarded study director training system Hands on Study Director on over 500 different toxicity/ safety assessment studies involving all species and routes of administration, both small and large molecules; experience with safety assessment of therapeutic stem cells. Extensive experience with intravenous infusion. Most work has been in the biopharmaceutical sector, and I have worked at all levels -from directing a few studies to complete program oversight - on many different (both large and small) molecules. These activities included preparation of documents preparations for regulatory submission (INDA, eCAC, NDA etc) and I have represented clients before both the FDA and the EPA. In addition, I have worked on a the various types of non-pharmaceutical projects, examples include, Toxicity and carcinogenicity assessment of a new cooking oil, toxicity assessment of PFOS replacements, cardiac sensitization of potential halon replacements, and ASTM labeling for a local crayon distributing company. Author and/or coauthor on over 100 peer reviewed papers, book chapters, and presentations. Member of various professional organizations, including the Society of Toxicology, American College of Toxicology (Past President), International Society for the Study of Xenobiotics, and the American Society for Pharmacology and Experimental Therapeutics (both the Drug Metabolism and Toxicology Divisions).
1623 Olde Post Road