Tony Championsmith

Tony Championsmith has over 28 years of experience in the pharmaceutical industry, of which, 21 years has been focused in Regulatory Affairs. His regulatory experience encompasses filing a successful electronic marketing application for an oncology drug, utilizing dendridic cells, to providing regulatory strategies, which allow companies to navigate early stage investigational drugs through the FDA approval process. In addition, he has experience with the new promotional and advertising regulations, and providing due-diligence reports. He has worked for a broad range of biotechnology companies, including start-ups, mid sized biotechnology companies and major pharmaceutical organizations. Tony work includes filings for conjugate vaccines, small molecules, monoclonal antibodies, proteins, recombinant products, and gene therapy drugs. He has prepared for, and conducted, face to face meetings with the FDA. Tony's regulatory experience has taken him to countries in Canada, China, Italy and the United Kingdom. Tony holds a BS in Biochemistry from the University of California Riverside. A breath of regulatory knowledge and experience, coupled with his science background, has been the basis for his success.