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Name
Charles B. Spainhour
Educational Degrees
PhD, VMD
Certifications
DABT - Diplomate American Board of Toxicology, DABFM - Diplomate American Board of Forensic Medicine, DABFE - Diplomate American College of Forensic Examiners
Education
Michigan State University (BS) University of Pennsylvania (VMD) Texas A & M University (Ph.D.)
Expertise
Biologics/Biotherapeutics/Biotechnology, Dietary Supplements, Drug/Pharmaceutical Development, Expert Witnessing, GLP Study Auditing, Litigation Support, Medical/Clinical Toxicology, Metals Toxicology, Ocular Toxicology, Over-The Counter Products, Product Safety Assessment, Regulatory Toxicology, Safety Pharmacology, Veterinary Products, Veterinary Toxicology
Specialties
Safety Pharmacology, Pharmacology & Toxicology. Preclinical pharmaceutical development strategy and planning for conventional pharmaceuticals, biotechnology products, biologics, nutraceuticals, dietary supplements and medical devices. Program & study monitoring. Regulatory document preparation and review. Expert reports. Design and management of drug discovery screening and lead optimization programs. Technical & GLP training. Facility and program auditing. USDA & AAALAC Inspection preparation inspections. Animal rights situation management. Mycotoxins and mycotoxicoses. Litigation support.
Experience
Thirty-six years in biomedical research composed of fifteen years as a senior level scientist at a major pharma company, eight years teaching courses at a major university in toxicology and veterinary medicine, and thirteen years designing IND, NDA, PLA, 510(k) and PMA programs along with directing the science and overseeing the conduct of studies at a well-respected mid-size CRO. Seventeen total years in toxicology consulting. Background encompasses wide variety of therapeutic classes of compounds and indications. Regulatory experience.
Address
27 Briarwood Way
City
Clarks Summit
State
PA
Zip Code
18411
Country
USA
Telephone
570-586-7779
Fax
570-587-4094