TOXICOLOGY, SAFETY PHARMACOLOGY, & DRUG DEVELOPMENT 
PERSONAL PROFILE
- Board-certified toxicologist with more than 20 years of experience in pharma drug development, including small and large molecule programs at all stages of development in a wide variety of therapeutic areas.
EXPERTISE
Nonclinical Safety – Toxicology, Pharmacology, PK / ADME, Small / Large Molecule Programs, Nonclinical Program Design / Implementation, CRO Selection, Protocol Design / Development, Study Monitoring, Data Interpretation / Reporting, Compliance, Regulatory Document Preparation, Regulatory Interactions, Due Diligence, In- / Out-licensing, Gap Analysis, Budgets / Timelines, and Program Challenge Management.
PROFESSIONAL EXPERIENCE
Consultant, Aclairo Pharmaceutical Development Group, Inc.
Provide advice and strategic planning for scientific and regulatory issues in drug development. Contribute toxicology program and regulatory support, including study plans and preparation of IND, CTD, NDA, EOP2, and pre-IND / NDA submissions to FDA. Expertise in toxicology study design, protocol development, study implementation, monitoring, data analysis, and review of nonclinical reports. Conduct impurity assessments and gap analysis.
Director, Nonclinical Safety Assessment, Acorda Therapeutics
Established Toxicology as a functional area. Responsible for nonclinical safety (toxicology, safety pharmacology, PK / ADME) for both biologic and small molecule programs. Implemented policies and procedures. Designed and planned (budget, timing, resources) nonclinical development programs. Performed toxicology study coordination: CRO selection, protocol design, study monitoring, data interpretation, reporting, and compliance. Resolved study and development program challenges.
Wrote sections of regulatory documents: IND / NDA filings, meeting packages, investigator brochures,
FDA annual reports, and package inserts. Communicated with regulatory and partner organizations. Evaluated in-licensing candidates for toxicology risk assessment, gap analysis, and proposed future development plans.
Director, Toxicology, Cara Therapeutics, Inc.
Key decision-maker and manager of nonclinical safety. Participated in candidate selection for drug discovery to establish criteria for desirable molecules, with integration of safety endpoints into the screening process. Designed and planned (budget, timing, resources) preclinical development programs. Coordinated toxicology studies: CRO selection, protocol design, study monitoring, data interpretation, and reporting. Prepared investigator brochures and wrote appropriate sections of IND / CTA filings. Communicated with regulatory and partner organizations. Coordinated activities with other departments.
Held similar toxicologist roles in other organizations, including Forest Research Institute (a division of Forest Laboratories, Inc.) and Emisphere Technologies, Inc. In addition, served as a toxicology study director for a nonclinical Contract Research Organization (CRO).