Consultants in Toxicology and Nonclinical Development

Experience

  • Board-certified (Diplomate, American Board of Toxicology; DABT), doctoral-level toxicologist.
  • 35+ years of experience in toxicology/nonclinical drug development, including director level positions in the pharmaceutical industry, contract research organizations, and academia.
  • Developed, placed and monitored nonclinical development programs for drugs & biologics at 15+ CRO facilities.
    • General toxicology
    • Genotoxicity
    • Pharmacokinetics
    • Developmental and reproductive toxicology
    • Safety pharmacology
    • Bioanalytical methods
  • Directed GLP Toxicology Laboratories – 18 years of experience within the pharmaceutical industry and contract research organizations:
    • Examples of Conducted Studies
      • General toxicology
      • Developmental and reproductive toxicology
      • Pharmacokinetics
    • Species Studied
      • Rats
      • Dogs
      • Nonhuman primates, e.g., Rhesus, Cynomolgus, Baboons, and Stumptails
      • Mice
      • Rabbits
      • Ferrets
  • Classes of therapeutic agents include:
    • Small molecules
      • Oncology agents
      • Anti-inflammatory drugs, e.g., to treat rheumatoid arthritis (MAP kinase inhibitors)
      • Drugs to treat gout
      • Drugs for congestive heart failure (natriuretic peptides)
      • Antiplatelet agents
      • Drugs to treat anemia (erythropoietins)
      • Diagnostic agents
      • Drugs of abuse treatments
      • Cancer chemopreventive agents
    • Biologics/Biosimilars
      • Monoclonal antibodies
      • Proteins
    • Medical Devices
    • Cell Therapies
  • Prepared nonclinical sections of INDs, NDAs, etc., in Common Technical Document (CTD) format for regulatory submissions, and Investigator’s Brochures.
  • Served as an IACUC committee member in an AAALAC-accredited, USDA-compliant animal facility.
  • Ancillary Experience
    • Government Contracts – Principal Investigator on numerous government contracts (NCI, NIH, US Army, World Health Organization)
    • Academic Teaching Experience – Fifteen years (Associate Professor of Pharmacology). Lectures/courses given to graduate and medical students
    • Forensic Toxicology Experience – Twenty years including expert witness testimony
    • 56 publications, 76 abstracts, 2 book chapters, and numerous technical reports

Website Builder