I have been involved in the field of toxicology for 17 years within the pharmaceutical industry. I have many years of experience as part of cross-functional clinical/preclinical teams, successfully managed and lead all  toxicology activities and effectively collaborated with project team members regarding clinical plans and regulatory documents. I have experience with toxicology study designs, dose selection, including interpreting toxicology data, generating toxicology study reports and experience with regulatory authority submissions and interactions. I have a solid background and experience in both drug discovery and development and understand the requirements and processes needed to advance drugs from target selection/validation, to lead ID/optimization, through toxicology and into clinical development.  I have prepared and overseen the preparation of numerous preclinical sections of regulatory filings, including Pre-IND briefing documents/meeting packages.

 

I have a strong molecular biology background with experience developing assays to support a variety of discovery/preclinical/clinical projects, development and application of molecular profiling capabilities in the areas of predictive and mechanistic toxicology, including biomarker studies.  I have provided scientific and technical leadership related to nonclinical development using in silico, in vitro and in vivo toxicology methods to investigative molecular and cellular mechanisms of toxicity.  I also have experience in cancer molecular diagnostics and generation/evaluation of kits and methods. 

 

I previously served as co-chair of the Vascular Injury working group as part of the Critical Path Institute/Predictive Safety Testing Consortium, and a past member of the Testicular Toxicity working group.  The goal of these working groups were to identify clinically translatable biomarkers of preclinical drug induced vascular and testicular injury.

 

I have been an invited speaker at scientific conferences, symposia, and workshops in the U.S., and Canada.  I am an author/co-author on 34 scientific abstract and 24 peer-reviewed manuscripts (Science, Journal of Biological Chemistry, Journal of Pharmacological & Toxicological Methods, Toxicology and Applied Pharmacology, Toxicologic Pathology, Toxicology in Vitro, etc.).  I am a co-author on 2 issued patents, a current active member of the Society of Toxicology, American College of Toxicology, Society of Toxicological Pathology and a Member of The Roundtable of Toxicology Consultants.

 

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