Food and Drug Administration (FDA) Statistical Analysis Expert

Case Description:

A food and drug administration (FDA) statistical analysis expert was needed for a patent dispute that arose in connection with a request for FDA approval for the commercial manufacture, use, and sale of a generic drug. A major pharmaceutical company alleged that a generic manufacturer infringed on certain patents and sought to enjoin the manufacture of the generic drug until expiration of the patents at issue.

IMS ExpertServices was asked to locate a food and drug (FDA) statistical analysis expert with experience in statistical usage as it relates to FDA clinical trials. This expert was requested to have consulting and statistical work experience in preparation and presentation of clinical data filings to the FDA on behalf of pharmaceutical companies as clients.

Experts Presented:

  • Statistical Analysis Expert

    This expert has substantial regulatory statistician experience, including extensive experience with the Food and Drug Administration (FDA). Currently, this expert is president and principal of a private statistical consulting firm, where his work includes clinical and preclinical study design, data analysis, and methodological research in statistics. He has statistical application experience relating to clinical trial design and analysis. Prior to founding his own consulting firm, this expert had a twenty-five year career with the FDA and the Center of Drug Evaluation and Research (CDER). He holds an A.B. in mathematics and statistics, an M.S. in statistics, and a Ph.D. biomathematics. IMS Reference #5059916.

  • Statistical Analysis Expert

    With twenty-five years of experience with major pharmaceutical companies and distinguished university hospitals from around the world, this expert’s expertise lies in the areas of biostatistics, clinical data management, and statistical programming. He is president of a private firm which specializes in the biotechnology and pharmaceutical industries, providing statistical consulting services in areas such as biostatistics, regulatory matters, and statistical programming. This expert has served as statistical advisor to an international committee which recognizes world renown achievements and contributions in areas of Medicine and Physiology. This expert holds a Ph.D. in statistics and a B.Sc. in mathematics and statistics. IMS Reference. #5059886

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