Pharmacokinetics Expert in Drug Formulation

Case Description:

A pharmacokinetics expert in drug formulation was requested for pre-litigation consultation in a patent infringement case. The client was a company that develops, manufactures, and markets pharmaceutical products. The client had filed a New Drug Application with the FDA for a patent claiming drug formulation for time-release of opioid drugs for pain management. The client was anticipating a patent infringement action by a pharmaceutical research and development company specializing in pain management and cancer therapies.

IMS ExpertServices was asked to provide pharmacokinetics experts with experience in drug formulation, specifically as it relates to the time-release formulation of opioid drugs. The ideal expert needed to have an advanced degree in either pharmaceutical sciences or pharmacokinetics and work in academics with no industry ties. The client preferred an expert with patent experience and previous testimony experience.

Experts Presented:

  • Drug Design Expert

    This pharmacokinetics expert is a professor of pharmaceutical science at an eastern university. Internationally known for his research work in drug discovery, delivery, and development, which includes drug design and synthesis, pharmacophore development, and drug biotransformation studies, his research also focuses on preclinical drug development, dosage form development, drug delivery assessment using both conventional and non-conventional routes, and preformulation/formulation studies. He is a member of the American Association of Pharmaceutical Scientists and has served on the Drug Development and Drug Delivery NIH Study Section and the NIH NCDDG Study Section. This expert has previous expert witness experience in intellectual property matters and has provided testimony in deposition. IMS Reference #5027646

  • Pharmacokinetics Expert

    This pharmacokinetics expert is a chair and tenured professor of pharmaceutical sciences at a respected university in New England. He has previously held positions at Pharmakon Research International, Inc., the American Pharmaceutical Association, and the National Institutes of Health. He holds a bachelor's degree in pharmacy from Columbia University and his M.S. in pharmacy and his Ph.D. in pharmacy-pharmacokinetics. This expert has substantial experience as an expert witness, providing testimony at deposition on ten occasions and at trial on three occasions. IMS Reference #5018560

  • Pharmaceutical Development Expert

    An assistant clinical professor of pharmaceutics at a large southern university, this pharmacokinetics expert spent sixteen years with Pharmacia & Upjohn. He has authored numerous publications and presentations on intellectual property, pharmaceutics, pharmacy education, and the history of pharmacy. His personal research interests include dose form design, microencapsulation and other sustained release delivery systems. This expert has served as a litigation consultant on several occasions and has substantial experience with patents and providing his expert opinion to clients and their legal counsel. IMS Reference #5018555

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