Experience

Board-certified (Diplomate, American Board of Toxicology; DABT), doctoral-level toxicologist.
43+ 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