Pharmaceutical Development Expert with FDA Approval Experience

Case Description:

A pharmaceutical development expert was sought for a misappropriation of trade secrets claim against the Food and Drug Administration. The FDA regulates the pharmaceutical industry to ensure the potency and stability of the drugs on the market. The plaintiff invented a secret formulation and filed a New Drug Application, NDA. The drug received FDA approval but the drug derivation was published on the FDA's web page allowing competitors to access it.

IMS ExpertServices was asked to locate a pharmaceutical development expert to consult on chemical formulations in the drug industry and the research and development value. The plaintiff was suing for loss of potential market value and compensatory damages. The expert was also required to be knowledgeable in the FDA approval process.

Experts Presented:

  • Drug Development

    This expert in drug development has substantial experience with the FDA approval process. He began his career leading the organization and management of over 15 Investigational New Drug applications, or IND, and 9 NDAs, as well as spearheading FDA review and approval, while directing regulatory department functions for antifungal, anesthesia, cardiovascular, and gastrointestinal drugs. In his current role, he consults on pharmaceutical development, assisting in FDA regulatory development strategies and drug regulatory submissions. He received his B.S. in biological chemistry, and his M.S. and Ph.D. in bacteriology. IMS Reference #4578036

  • Pharmaceutical Development

    This pharmaceutical development expert provides evaluation and analysis of product development plans for pharmaceuticals and biologics, providing strategic direction based on regulatory, scientific, and marketing issues. In addition, he evaluates and provides advice to clients on adequacy of draft regulatory submissions, manages revisions of pharmacology, clinical, toxicology and manufacturing sections as needed. He previously worked with the FDA and was involved with the review of the human pharmacokinetics and bioavailability section of New Drug Applications. This expert holds a B.S. in pharmacy and a Ph.D. in pharmacology. IMS Reference #4997183

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Industry: All, Pharmaceuticals