Over 35 yearsof trial experience in biomedical science, toxicology and regulatory compliance for drugs, biologics, diagnostics, biotechnology, medical devices, pesticides and chemical specialties. Additional expertise in drug and medical product development, licensing, patents and acquisitions. Trial experianced expert witness in drug side effects and interactions, malpractice, product liability, FDA, EPA, and OSHA toxic tort suits for corporations. Represents companies before these agencies for product approval requirements. Lecturer in toxicology and product safety, Fairfield University and Hartford Graduate Center. GCPs, GMPs and GLPs audits.
PROFESSION: Pharmacologist/Toxicologist - Biomedical, Regulatory, Pharmaceutical and Environmental Consultant to drug, device and biochemical firms with scientific, FDA/EPA regulatory and quality assurance problems.
WORK HISTORY: Principal, Food, Drug, Chemical Services, 1975 to present: Formerly Director, Scientific and Regulatory Affairs, Richardson-Merrell, 1968-1975; Vice President, Pharmacology & Toxicology, Rosner-Hixson Laboratories, 1960-1968; Research Pharmacologist, American Cyanamid, 1958-1960; Research Associate, Rohm & Haas, 1956-1958.
EXPERIENCE: Over 35 years experience with expertise in drug and medical product development, licensing, patents and acquisitions, biomedical science, toxicology and regulatory compliance for drugs, biologics, diagnostics, biotechnology, medical devices, pesticides and chemical specialties. Trial experianced expert witness in drug side effects and interactions, malpractice, product liability, FDA, EPA, and OSHA toxic tort suits for corporations. Represents companies before these agencies for product approval requirements. Lecturer in toxicology and product safety, Fairfield University and Hartford Graduate Center. GCPs, GMPs and GLPs audits.
ALTERNATIVE DISPUTE RESOLUTION EXPERIENCE: Served as member of arbitration panel concerning a multi-million dollar dispute between biotech companies over licensing and distribution agreements. Has appeared before FDA/EPA gobvernment advisory panels and as an expert witness in medical/legal cases. Adequacy of efficacy and safety data for a new drug from overseas for compliance with U.S. FDA requirements and standards.
ALTERNATIVE DISPUTE RESOLUTION TRAINING: AAA basic and advanced arbitrator training. Washington, D.C., October 1991
PROFESSIONAL LICENSES: Licensed Pharmacist, State of Vermont, 1952; State of New York, 1953
PROFESSIONAL ASSOCIATIONS: Drug Information Associationn (Past President); Association of Research Directors; American Society for Pharmacology and Experimental Therapeutics; Society of Toxicology; Assocition of University Technology Managers; Association of Pharmaceutical Scientists; Listed in "Who's Who in America" and "Who's Who in Medicine and Health Care."
EDUCATION: Purdue University, Ph.D., 1956; Purdue University, M.S. 1954; Albany College of Pharmacy, Union University, B.S. 1952
PUBLICATIONS: Numerous publications and presentations in pharmacology, toxicology, scientific communications, drug information and regulatory affairs.
LEGAL EXPERIENCE; RESEARCH DEPOSITION AND TESTIMONY: Fen-Phen, compliance with FDA ADR regulatory issues. Safety of Dog Repellent to individuals inadvertently exposed, Central Illinois Power & Light, Peoria, Illinois Adequacy of Directions for Use & Proper Dispensing of Topical 8 Methoxypsoralen - Law firms in Memphis, Tennessee; Phoenix, Arizona and Jacksonville, Florida Safety of Topical Hydroquinones, Long Island, U.S., FDA and South African Health for International Consortium Formaldehyde, Safety in Mobile Homes, Wisconsin State Health Hearings, SOCMA Safety of 8 Methoxypsoralen for Psoriasis - U.S. FDA Advisory Panel, Elder/ICN Safety of bovine bone implants for cervical diskectomy, U.S. & Canadian FDA, Unilab and Washington FDA law firm Toxicity of Antibiotic Combinations on Prolonged Use - Pennsylvania, Joseph Murray, Esq. Drug Combinations and Alcohol on Sobriety - New Jersey Nickel Compounds on Skin - Connecticut for AMAX Compliance of Surgial Products with U.S. FDA Regulations - Washington and Connecticut Qualifications, Adequacy of an Expert Witness - New Jersey FIAU Safety and Compliance with FDA Regulations Trimethoprim (sulfonamides) and Stevens-Johnsons Syndrome Toxicity, Hazards of Petroleum distillates and Butyl cellosolve in irritant induced asthma Toxicity, Hazards of water treatment chemicals such as cyclohexylamine and morpholine Addiction liability of muscle relaxants and pain killers Drug Induced Gullain-Barre Syndrome Dispute resolution between biotech companies over liensing and distribution agreements Adequacy of warnings for PREMPRO and REGLAN/Metoclopramide. Adequacy of toxicological data for Phase I of human clinical trial. Pulmonary hazards of environmental exposure to fatty acid and organic acid fumes. Adequacy of warnings for an investigational drug for Phase II-III clinical trial. Proper pharmaceutical preparation on a compounded potentially hazardous pharmaceutical formulation.
Fee Schedule for Expert #1322
Expert Designation Fee----------------$750.00 ( Amount charged to use expert's name as applied to the case. ) Retainer Fee--------------------------$1600.00 ( wishes to receive this before he begins his Work and will be held toward the final invoice. ) Non-Testimonial Fee-------------------$315.00 per hour ( for consulting,for analysis,for written report, for research ) Testimonial Fee-----------------------$375.00 per hour ( for deposition, for court, for waiting for court ) Travel Policy-------------------------$315.00 per hour ( for work done on the case while while traveling ) Travel Fee----------------------------Lodgings,Meals,tips,car rental,car insurance,gasoline, airfare,train fare,to be paid at cost by client.If travel is within driving distance of expert's place business the rate is $.55 per mile to be paid by the client. Miscellaneous-------------------------Any expenses related to the preparation and presentation and research to be paid by the client at cost.
|
|