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