Comprehensive nonclinical toxicology and safety assessment for drug development. Safety pharmacology (cardiovascular/respiratory/CNS), toxicology, carcinogenicity, nonclinical modeling for unique administration routes/procedures. Experienced in systemic, parenteral, dermal, ocular and target organ compound administration. ICH compliant program management, CRO selection, study design and monitoring. Nonclinical regulatory document preparation (IND, NDA, CTA, IB), report writing and review, risk assessments, nonclinical due diligence.
Experience
More than 25 years experience in safety pharmacology, physiology/model development, toxicology and nonclinical drug safety evaluation. Experienced scientist and program director in industrial, contract research and global pharmaceutical development companies. Experienced in ICH compliant laboratory setup and staff training. Has authored numerous manuscripts, book chapter, INDs, NDA, IBs, technical assessments. Serves as scientific advisor on corporate advisory board.
