Since 1985, my corporate career has included experience as regulatory scientist, encompassing safety assessment of pesticides (environmental assessment, plant pesticide metabolism, residue methods, tolerances) and animal health drugs (in vitro or in vivo metabolism, ADME & PK, residue methods, setting MRL standards). I retired in January, 2018, from Elanco Animal Health after 22 years in Drug Metabolism and Human Food Safety.
Responsibilities have included design and implementation of veterinary drug development programs or studies to support new animal drug applications (NADA), oversight of GLP analytical, in vitro or in vivo studies in multiple laboratory and food animal species, cross-functional scientific leadership and expertise leveraging communities of practice to provide Knowledge Management and personnel development within an R&D environment.
I provide services in the following areas:
Human Food Safety assessment in support of USFDA, EMA and other international animal health drug registrations for veterinary drugs used in food animals.
Support for method validation in regulated laboratories (GLP, Cannabis).
Expert consulting and support for conducting studies involving :
- Preparation of Safety/Human Food Safety/ Residue Sections of Regulatory Dossiers
- Drug metabolism and pharmacokinetics (DMPK)
- Absorption, distribution, metabolism and excretion (ADME)
- Tissue residue analytical method development and validation
- Bioanalytical method development and validation
- Residue safety & DMPK program development
- Oversight of residue safety studies
- Clinical monitoring (veterinary drug)
- Experience in all major food animal species
- Companion animal DMPK
- Biomarker expertise for proof of concept and clinical trial support