• Provider of comprehensive, transparent integrated scientific evaluations and assessments of nonclinical toxicology and safety data for the pharmaceutical industry• Specialist in the development of nonclinical safety strategies and issue resolution for large and small molecular weight therapeutic candidates across a broad range of therapeutic areas• Experienced in pharmaceutical development from both the regulatory (FDA Pharm/Tox reviewer) and industry perspective (large and small pharma)• Extensive expertise advancing therapeutic candidates along the development path including preparation for initial clinical trials, marketing authorizations, and addressing post-marketing safety issues from the nonclinical perspective• Identifies, selects and negotiates contracts with high-quality service providers; designs and oversees studies to ensure that nonclinical safety data meets expectations of global regulatory authorities• Delivers polished, submission-ready written documents and oral presentations that focus on the concise delivery of the key information that is deemed essential for decision-making by company leadership and regulatory authorities• Recognizes the importance of attention to detail and the timely delivery of work packages in the advancement of therapeutic candidates; tailors business workload to ensure that individual client needs are met

• Independent leadership of nonclinical safety evaluation of small molecular weight tyrosine kinase inhibitors for oncologic indications• Developed nonclinical safety strategy to address clinical and regulatory questions arising from adverse post-marketing experiences of an approved therapeutic• Leadership of small in vivo group that characterizes the efficacy, PK and safety of therapeutic candidates

• Led the nonclinical safety group in the development and implementation of appropriate overall nonclinical safety strategies (i.e., toxicology, PK, bioanalytical aspects) for pipeline antibody therapeutic candidates for oncologic indications, including program and study design, selection of contract research organizations, review and approval of study protocols and reports, monitoring the conduct of outsourced toxicology and kinetic studies, and management of departmental budget • Supported ImClone Research organization, numerous diverse Program/Project Teams and the ImClone Development organization by providing timely nonclinical safety evaluations of clinical candidates, input on overall development strategies, and addressing critical issues as needed to advance candidates• Led several successful initial IND submissions to support First Human Dosing; prepared nonclinical safety sections, and supervised the preparation of nonclinical pharmacology sections for all regulatory submissions (e.g., IND, BLA, CTA, IMPD)• Represented nonclinical safety in interactions with global health authorities• Collaborated with colleagues from new parent organization (Eli Lilly and Co.) on the integration of ImClone Nonclinical Safety into the Lilly organization, and alignment of business practices as needed for harmonization across sites

• Led and supervised an integrated group of project team toxicologists and pharmacokineticists • Assigned projects, mentor and review performance of senior scientific staff• Assisted staff in generating strategic direction for projects, and issue resolution • Reviewed regulatory documentation (IBs, IND and NDA Summaries, Responses to regulatory authorities) for all Nutley-based projects• Led project subteam of Technical, Safety and Discovery Scientists during successful Phase 0 EIH-enabling studies• Functional nonclinical safety expert on local Metabolic Disease Biology Team• Member of Safety and Delivery teams for siRNA therapeutic group• Developed Nonclinical Section of Roche IND “Best Practices” guidance document for Global Drug Regulatory Affairs• Oversaw the successful initial IND or CTA filings of numerous small and large molecules for oncologic, metabolic and inflammatory indications

• Planned, designed and oversaw the execution of new drug candidate safety evaluations; ensure that safety information supports drug development and registration, and met international regulatory requirements• Prepared safety documentation for submission to regulatory authorities and presentations to senior management • Represented Nonclinical Safety Department on cross-functional project teams; provided input to project decision-making and development of strategic direction; evaluate in-licensing opportunities• Preclinical Leader for successful, simultaneous, global accelerated approval of Fuzeon marketing applications for HIV• Led investigative efforts to resolve project-related issues of hepatotoxicity, neurotoxicity and immunosuppression

• Reviewed, summarized and evaluated nonclinical studies supporting numerous INDs and three successful NDAs• Provided input to clinical team on dosage selections and safety assessments for clinical trials• Recommended product labeling sections related to nonclinical data• Provided regulatory input to sponsors on drug development programs

• Preclinical discovery and development of potential therapies for Parkinson's and Alzheimer's disease• Directed in vivo microdialysis studies of drug-induced neurotransmitter release• Developed analytical methods for pharmacokinetic studies of drug candidates• Collaborated in efficacy evaluations using animal models of cognitive and motor deficits• Supervised activity of technical personnel• Preparation of Research grants and IND research reports• Evaluation of in-licensing candidates

• Mechanistic studies of substituted amphetamine neurotoxicity

• Electrophysiology of potassium channels