BA, MS, PhD
PhD Cornell University 2000 MS Cornell University 1996 MBA DePaul University 2003 BA Hiram College
Biologics/Biotherapeutics/Biotechnology, Cardiovascular Toxicology, Drug/Pharmaceutical Development, Formulations, Genetic Toxicology and Cytogenetics, GLP Study Auditing, Hazard Communication, Hepatic Toxicology, Pharmacokinetics/Toxicokinetics, Product Safety Assessment, Regulatory Toxicology, Risk Assessment, Safety Pharmacology, Toxicologic Pathology, Veterinary Toxicology
Develop and implement preclinical strategies to support small and large molecule pharmaceuticals including antibodies, antibody-drug conjugates, peptides, and RNA-based drugs.Regulatory writing (IND, IB, BLA, CTA).Study support: design, implement, monitor, and interpret, toxicology studies. Study types include genetic toxicity, safety pharmacology, general toxicology, and reproductive toxicology.
My background includes 15 years of pharmaceutical industry experience with small molecules, monoclonal antibodies, proteins and RNA preceded by a PhD (Cornell University) and MBA (DePaul University). In those 15 years, I supported over 30 clinical trials and regulatory filings including 21 INDs, numerous Phase 2 starts, bioequivalence trials and 1 supplemental NDA. I am currently authoring the preclinical section of a Biologics Licensing Agreement. My experience includes designing ICH compliant programs and implementing over 197 GLP toxicology studies; conducting numerous PK/PD/ADME and pharmacology assessments; outsourcing and monitoring external studies; supporting clinical development and regulatory affairs; leading teams; strategic publications; and communicating recommendations to management. Therapeutic areas include inflammation, oncology, bone growth, and pain.
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