I have 30 years of experience, and specialize in the field of drug and biologics regulation and product develoment with specific knowledge in the areas of toxicology, regulatory affairs and clinical development. I have published on such topics as preclinical testing, chemistry, manufacturing and controls and quality assurance and the new drug application process. I have testified on drug development and precedence, laws related to regulation of toxic substances and drug ingredient safety. I moved from research and laboratory based work to become chief executive officer of two firms.