Gary W. Wolfe, Ph.D., D.A.B.T., Principal Toxicologist

Dr. Gary W. Wolfe is a board-certified toxicologist with over 30 years of experience in the conduct of nonclinical animal studies, supervision of GLP animal laboratories, and preparation of regulatory submissions and documents. He received his M.S. and Ph.D. from Purdue University in 1976 and 1978, respectively. He is a member of the Society of Toxicology, American College of Toxicology, and Teratology Society.

Dr. Wolfe has worked at Hazleton Laboratories (now Covance) and TherImmune Laboratories (also known as R.O.W. Labs and GeneLogic Labs) where he served as GLP study director on many types of nonclinical studies intended for FDA or EPA submissions as well as holding positions of increasing responsibility in both technical and management roles. He also served as the Principal Investigator for the NTP General Toxicology and Reproductive Assessment by Continuous Breeding Programs for over 15 years.

During the last five years, Dr. Wolfe has been involved in designing drug development programs and placing of the nonclinical studies at various domestic and international contract research laboratories. He has also been involved in writing various documents and submissions to the FDA.

Read Gary W. Wolfe, Ph.D., D.A.B.T.’s resume for a full history.

Services Provided by Gary Wolfe Toxicology:

Nonclinical Study Design and Management

    Study Identification and Design
    Study Placement and Contract Negotiation
    Study Monitoring
    Study Data Interpretation
    Study Reporting and Auditing
    Peer Review
    Quality Assurance/Quality Control

Document Preparation and Review

    Regulatory Documents
    Study Reports
    Proposal Preparation (Commercial and Government)
    Peer Review
    Standard Operating Procedure (SOPs
    Material Safety Data Sheet (MSDS)
    Literature Searches and Position Papers

Additional Professional Expertise

    Auditing of Nonclinical Studies
    Animal Facilities
    Due Diligence
    Gap Analysis
    Litigation Support and Expert Witness Services
    Animal Use Documentation
    IACUC Advisor

Identification and Coordination of Professional Experts

    Clinical Pathology
    Analytical Chemistry
    Bioanalytical Chemistry