This Ph.D has over thirty years experience in the Pharmaceutical industry from basic research to clinical drug evaluation, including IND-enabling activities and filings, design of Phase I/II clinical trials, and NDA filings.  Leader or member of project teams in many therapeutic areas.  Thirteen years experience working with start-up companies in a 'hands-on' capacity providing nonclinical support for regulatory filings.  Ten years experience teaching a Drug Development Process course for a major University as well as in-house for companies.  Involved with all aspects of pharmaceutical development with emphasis on nonclinical (Pharm/Tox and CMC) support to Clinical (IB, Protocols, IC).  Fully current with all FDA/ICH requirements (Regulatory Affairs).  Represent sponsors at the FDA.

• Early Clinical Studies
• Early CMC
• Early Formulation
• FDA / ICH Regulatory Requirements
• Licensing Candidate Evaluation
• Pharmaceutical Development Process
• Pharmacokinetics
• Pharmacology
• Regulatory Submissions ( US, EU )
• Toxicology

• Ph.D., Organic Chemistry
• P.Sc. ( Honors ), Mathematics, Physics, and Chemistry

Expert Witness Experience;

• Technical Consultant