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The below expert witness bios represent a small fraction of those Mislabeling experts known by Cahn Litigation Services. These bios are provided to give attorneys a sense of the Mislabeling landscape.
This expert is a Pharmacology Ph.D. This expert's specific specialties are drug advertising, labeling and regulatory affairs, as well as clinical regulatory compliance and trial design. As the Senior Consultant in a firm, this expert provides regulatory and scientific input and strategy to clients planning submission of their biomaterials to the FDA. This expert regularly advises on the preparation and submission of INDs, IDEs, NDAs, PMAs, and PLAs. Previously, this expert was responsible for all clinical and pre-clinical reviews of INDs, NDAs Amendments, Supplements, Orphan Drugs and ANDAs. This expert has over 35 publications and is active in many professional organizations and associations. This expert has written four expert reports, given three depositions, and testified twice at trial.
This expert is a long-time Food and Drug Administration authority. This expert's current consulting firm is focused on FDA compliance, specifically the CMC (Chemistry, Manufacturing and Controls) section of the FDA submission which governs labeling, and exactly what quantities, purities, strengths and other specifications the applicant is allowed to bring to market. This expert possesses Regulatory, Technical and Management expertise in FDA compliance. This expert also holds two US patents and is well published in the field. This expert has served as an Adjunct Professor.
This expert is a consultant to national and international corporations in the areas of product development, manufacturing, packaging, warnings and instructions. This expert has consulted on more than five thousand matters involving human factors, safety, personal injury and product liability. A licensed P. E. with a specialty in Safety Engineering and Design, this expert has many years of experience consulting to insurance companies, municipalities, government agencies and the legal profession. In addition to participating in numerous product liability cases, this expert has authored and presented on the topic extensively. In addition, this expert holds a PhD in Chemistry, has many of experience in polymers and is the named inventor on numerous U.S. patents involving plastics that have been commercialized, including protective headgear and numerous household products. This expert's areas of specialty include new product development, human factors, OSHA, safety, voluntary standards, statutes, labeling, custom and practice, technology and cost in relationship to the hazards, and dangers and risks involved in the use and application of consumer products. An active member of the ASTM for years, this expert has been involved in the creation of the standards and testing involved with polymeric products. Directly involved with the safety and design analysis of consumer products, warnings and instructions, this expert has created and pioneered an innovative approach for evaluating the adequacy and communication effectiveness of the warning and instructional materials associated with any product. This expert has created and critiqued warnings and instructions for a large variety of products and standards used throughout the world. This expert is well published in the areas of plastics, safety engineering and design, and household and industrial product safety. In addition to participating in numerous product liability cases (testified 9 times, deposed 20+), this expert has authored and presented on the topic extensively.
This expert is known internationally as one of the top experts on kinetics of reactions related to loss in food quality, nutrient degradation and pathogen growth and death kinetics.
This expert is also well known for teaching, working with and mentoring Ph.D. students, post-docs and visiting scientists. This expert has helped over many mentees gain faculty positions around the world, most of whom are doing research on reaction kinetics.
This expert is the author or co-author of over 280 scientific refereed research articles, 18 textbooks, 78 book chapters, eight patents and more than 100 other semi-technical articles. This expert has 14 refereed research papers, books or chapters and reviews that have been cited more than 200 times in other research papers or books, two at over 600 times and six others between 300-400 times, another five between 200-300 times and 30 more between 100-200. This expert’s research group has published an average of 10 research papers a year, including work in the Journal of Food Science, Journal of Agricultural and Food Chemistry, Journal of Analytical Chemistry, Chemical Sciences, Analyst, Journal of the Royal Chemical Society, Journal of Raman Spectroscopy, Food Chemistry, Journal of Food Protection and Critical Reviews in Food Science and Nutrition.
This expert’s research has been supported by grants from the Department of Homeland Security, the US Center of Excellence, as well as grants from the USDA National Institute of Food and Agriculture. Additionally, this expert has received grants from the American Egg Board, Almond Board, Dairy Research Inc., and the Beef Council.
This expert’s Areas of Research include
Shelf life testing
Shelf life dating
Time-Temperature Integrator Tags
Contaminants in food
Glass Transition Phenomena
In addition to academic work and research, this expert serves as Chief Scientist at a company that makes smart sensors used to monitor temperature or both temperature and freshness. The company’s patent and copyright intellectual property portfolio centers around radio frequency sensor identification devices, labels, tags and liners, radio frequency data capture software, cloud services and analytics. The IP also includes systems, software and methods for using the above tools for managing perishables in the cold chain and for tracking wear-and-tear of non-perishable items throughout their life or warranty period.
This expert has prior patent litigation experience and has been deposed and testified before a jury. Additionally, this expert has served as an expert for litigation in a case involving Time-Temperature Integrator (TTI) shelf life tags.
This expert has had primary responsibilities in drug development, regulatory affairs and agency policy compliance. With many years of experience, this expert's consulting firm advises pharmaceutical companies on product labeling, drug safety and efficacy, analysis of clinical studies, and other compliance issues. This expert is well published with over 50 articles, and has been called to testify before Congress. This expert currently serves on two industry research journal editorial boards. This expert has expert witness experience in about a dozen matters. As is common in this field, none of these matters went to trial.