Biotechnology Expert in Clinical Trials

Case Description:

A biotechnology expert with knowledge of FDA clinical trials and procedures was requested for an arbitration case involving biotherapeutics. The plaintiff had invested heavily in biotechnology research and had been disappointed in the results of clinical trials designed to gauge the biotherapeutics safety and efficacy.

IMS ExpertServices was asked to locate a biotechnology expert, specifically someone with substantial experience with clinical trials in connection with Investigational New Drug applications and New Drug Applications for FDA approval. The biotechnology expert was required to have an understanding of antibodies, drug classification, and the concept of class effects.

Experts Presented:

  • Drug Development Expert

    This drug development expert is a scientist and business executive with thirty years of diversified experience in the chemical, pharmaceutical, and biotechnology industries. He is academically qualified with science and business degrees and has published widely. During his career, he was responsible for numerous NDA, IND, and 510(k) submissions and approvals. He currently works as an expert consultant to the pharmaceutical industry in areas of quality assurance, regulatory affairs, and new product development. He holds both a doctorate degree and an M.B.A. IMS Reference #4578036

  • Biotechnology Expert

    This biotechnology expert has served in a clinical directorship role for a major pharmaceutical company and as director of pharmacokinetics and pharmacodynamics for a life sciences firm. Additionally, she has worked for the U.S. Food and Drug Administration in the Office of Clinical Pharmacology and Biopharmaceutics in the Center for Drug Evaluation and Research. While at the FDA, she was involved in clinical trials and reviewed or supervised reviews of anti-infectives, analgesics, anti-inflammatories, drugs of abuse, anesthetics, nuclear medicine and radiopharmaceutical drug products. This expert earned her Ph.D. in biopharmaceutics/pharmacokinetics and has been an invited speaker nationally and internationally. IMS Reference #5020450

  • Biotechnology Expert

    This biotechnology expert is a well recognized authority in the metabolic and endocrine space with extensive FDA experience. He served twelve years with the FDA where he was extensively involved with clinical trials and was responsible for the regulation of the earliest biotechnology products and landmark approvals for many biotherapeutics. He is a medical doctor board certified in both internal medicine and endocrinology. IMS Reference #5018364

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