Toxicologist Consultant: OTC Drugs, Pharmaceuticals, Cosmetics and Personal Care Products

Expertise

• Consulting in toxicology and product safety evaluation and assessment to the following industries: OTC drugs, pharmaceuticals, cosmetics, personal care products, chemical household products, medical devices and biotechnology.
• Establish and manage product safety compliance, regulatory standards and approvals.
• Design and manage safety evaluation and toxicology research programs that meet industry standards and are successful in achieving regulatory approval.
• Consultation and scientific support for product liability and toxic injury.
• California Proposition 65 compliance.
• Prepared safety dossiers on cosmetic and personal care products accepted in the United States and Europe.
• Expert reports for pharmaceuticals and medical devices.
• Provide toxicological expertise to legal, medical and consumer affairs departments on issues of product liability.

Experience

Independent Consultant, 1992 - Present

SmithKline Beecham, Consumer Healthcare, Parsippany, NJ, 1978 - 1991

Manager, Toxicology, 1991 - 1995

Section Head, Toxicology, 1978 - 1991

• Managed toxicology department with a $ 2 million budget.
• Assessed product safety and supervised the conduct (in-house and contract) of acute through chronic pre-clinical toxicology testing and research on OTC drugs, pharmaceuticals, personal care products, medical devices, cosmetics, dietary supplements and consumer and household products for U.S., Canadian and international markets.
• Designed and managed programs to assure product ingredients and finished products are safe for consumer use and are in compliance with regulatory safety requirements.
• Designed and managed IND/NDA toxicological research programs.
• Advised management on safety related issues, taking appropriate courses of action to resolve problems.
• Provided support to product development, clinical and regulatory affairs, legal and marketing groups to coordinate safety related activities to best meet project and company goals and objectives.
• Evaluated pharmacology and toxicology of new product ideas and new compounds developed both within and outside SmithKline Beecham.
• Optimized use of outside pathologists and other consultants.
• Established and managed an in-house animal toxicology facility. This facility was offsite on a university campus and required extensive interaction with university administration, faculty and staff.
• Hired and staffed toxicology department and trained senior scientists.
• Established program to assure products were in compliance with California Proposition 65.
• Successful at maintaining company's reputation for safe products by providing support to Consumer Affairs regarding adverse reactions and safety issues and to legal for liability and litigation issues.
• Made submissions, presentations and interacted with regulatory agencies (FDA, EPA, CPSC) on safety related issues.
• Actively represented SmithKline Beecham on trade association (CTFA, NDMA) and industry committees and task forces resolving safety and toxicological issues facing the industry and to gain regulatory approval for new drugs.
• Developed process that coordinated, expedited and documented new formulation review process between toxicology, clinical research and regulatory affairs departments.
• Developed various new animal and alternative test models.

Beecham Products, Parsippany, NJ, Section Head, Biomedical Sciences, 1976 - 1978

• Advised management on regulatory, safety and efficacy related issues and taking appropriate courses of action.
• Conducted safety assessment on ingredients and finished products: Dentifrices, cosmetics, toiletries and personal care products.
• Designed and managed pre-clinical and clinical safety testing programs conducted at contract laboratories.
• Managed clinical efficacy testing programs.
• Reviewed product labeling for claims substantiation.
• Monitored and addressed regulatory issues affecting products and ingredients.

Accomplishments

• Successfully prepared submissions to regulatory agencies (FDA, CPSC) to gain regulatory approval.
• Provided safety support for submissions to American Dental Association to gain approval seal on oral care products.
• Interacted with Poison Control centers on adverse reaction reporting to maintain company's reputation for safety products.

Block Drug Company, Jersey City, NJ, Pharmacologist/Toxicologist Section Chief, 1975 - 1976

• Managed pre-clinical and clinical toxicology research and product safety assessment and efficacy programs on OTC drugs, personal care products, medical devices and toiletry products.
• Managed regulatory affairs and interacted with regulatory agencies to gain product safety approval.

Food and Drug Research Laboratories, Maspeth, NY, Toxicology and Pharmacology Scientist

• Conducted acute through chronic laboratory animal pharmacology and toxicology studies on pharmaceuticals and chemicals for industrial clients.

Teaching Experience

Fairleigh Dickinson University, Hackensack, NJ, 1983 - 1987

• Taught general toxicology course in cosmetic graduate program.

Rutgers University, Piscataway, N, 1982 - 1988

• Visiting assistant professor in the graduate toxicology program.

Honors & Publications

Credentials

Completed Studies

• Dermal
• Gastrointestinal
• Inhalation
• Neurological
• Liver Toxicology
• Regulatory Toxicology
• Carcinogenicity
• Risk Assessment
• Vitro Toxicology

Certifications

• American Board of Toxicology (DABT)
• Fellow Royal Society of Chemistry (FRSC)
• American Board of Forensic Examiners (BCFE

Academic and Professional Affiliations

• Society of Toxicology
• Society of Toxicology Mid-Atlantic Chapter
• American College of Toxicology
• American Board of Toxicology (Board Certification)
• Several additional professional CTFA and NDMA activities

Honors

• Dean's List, Long Island University
• Rho Chi Honor Society, St. John's University

Publications

• Over 12 publications and presentations.

Education

• Ph.D. Chemical Engineering, University of Arkansas, Fayetteville, AR
• M.S. Chemical Engineering, University of Arkansas, Fayetteville, AR
• B.S. Chemical Engineering, University of Arkansas, Fayetteville, AR