Pharmaceutical Chemistry Expert in Drug Manufacturing Processes

Case Description:

A pharmaceutical chemistry expert was needed for an intellectual property case involving the drug manufacturing processes of an injectable form of a veterinary medicine. At issue in the case was a pharmaceutical preparation approved by the FDA which constituted combining the original unaltered form of the drug with a chemical salt as opposed to purchasing a proprietary form and manufacturing an aqueous suspension. The plaintiff alleged that the pharmaceutical preparation utilizing the in situ chemical salt was proprietary and the defendant was infringing on its trade secrets. The defendant's position was that the pharmaceutical preparation would be obvious to anyone with knowledge of pharmaceutical chemistry and is therefore not proprietary.

IMS ExpertServices sought a pharmaceutical chemistry expert with a background in pharmaceutical research and development. Specifically the expert was expected to be a chemist with experience in the pharmaceutical industry and was knowledgeable of drug manufacturing processes.

Experts Presented:

  • Pharmacology

    This pharmacology expert is widely recognized as an international authority in medicinal chemistry. His areas of expertise include pharmacology, toxicology, drug patent infringement, drug adverse reaction causation, and pharmaceutical research. He has had extensive experience with drug toxicity and drug dosage evaluations, such as FDA requirements, precautions, etc. He has a strong background in drug chemistry and design, and pharmaceutical patent issues. He has a Ph.D. in pharmaceutical chemistry and more than 20 years of practical experience in medicinal and bioscience licensing and patenting issues from both private industry and an academic environment. IMS Reference #1213204

  • Pharmaceutical Chemistry

    This pharmaceutical chemistry expert is a former professor of pharmaceutical sciences and FDA consultant on drug manufacturing processes. His extensive experience includes more than 20 years as a Director of Pharmaceutical Development, where his responsibilities included new product formulation and resolving production problems involving formula or processing. He is a frequent lecturer on FDA procedures for IND, NDA, ANDA, and over-the counter drug development. He holds a B.S., an M.S., and a Ph.D. in Pharmaceutical Science. IMS Reference #1213206

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Industry: All, Pharmaceuticals