Chemistry: Clinical Chemistry/Biochemistry - Chemical Pathology Expert Witnesses: 4

Dr. Glenn Prestwich  is a National Academy of Inventors fellow with over 45 years of experience as a professor, entrepreneur, and biotech startup C-suite executive. Dr. Prestwich specializes in Biomedical Intellectual Property. He has been a prolific inventor since 1977, and an expert witness in IP law cases since 2007. He is an inventor on over 95 patents and patent applications, including 48 issued patents.

Litigation Support - Dr. Prestwich brings to all legal and technical cases a deep appreciation for how chemistry informs the invention and development of products that offer solutions to problems in the life sciences and medicine, ranging from disease detection and treatment to tissue healing and regeneration. He’s been involved in intellectual property litigation that concern medical devices, diagnostics, new pharmaceuticals, drug delivery, agrochemicals, and consumer products.

As an expert witness, Dr. Prestwich enjoys the challenges of dissecting the validity (or invalidity) of patents in litigation. He appreciates the subtleties of claim construction and works collaboratively with attorneys to identify successful arguments based on sound science and legal principles. He has drafted over 40 expert reports, declarations, and affidavits in support of his attorney clients.  He has been deposed 18 times and testified in Court four times.

Glenn D. Prestwich on Accessible and Experienced Expert Witnesses

Areas of Expertise:

Organic Synthesis Natural Products Chemistry Medicinal Chemistry Mechanistic Enzymology Agricultural Chemistry Chemical Biology Biochemistry

Intellectual Property Litigation Medical Devices Diagnostics New Pharmaceuticals Drug Delivery Agrochemicals / Pesticides Consumer Products

Publications - Dr. Prestwich is an organized, clear, and effective writer. He has co-authored  over 610 additional peer-reviewed articles in the scientific literature, and written over 50 single-author scientific publications, reviews and book chapters. His publications encompass areas such diverse topics as anti-cancer drugs, gels for wound repair, cell therapy, and regenerative medicine, insect and pest control agents, cholesterol-lowering agents, lipids and cell signaling tools, and anti-inflammatory agents.

Gary D. Fletcher, PhD,  is the Founder and Principal Consultant at RnDDx Solutions LLC, a consulting firm founded in 2015, focused on Industrial Mechanical Engineering and Biomedical Engineering and Research and Product Development.  In his 30 years of experience, he has been co-inventor on 23 patents for devices and methods in blood collection and processing.

Litigation Support - Dr. Fletcher has subject matter expertise in Medical Device Mechanical Engineering and subject matter expertise in Medical Devices for blood and specimen collection and sample processing for in vitro diagnostics, point of care diagnostics, and therapeutics, including glucose monitoring. He serves as an expert witness in patent infringement cases involving medical device and diagnostic biomedical engineering, blood collection, separation, fluidic preparation, glucose monitoring, and cell therapy preparation devices.

Dr. Fletcher offers patent litigation services to law firms and lawyers supporting medical device and diagnostic industry clients, who need physical science and mechanical and biomedical engineering expertise for District Court, PTAB, and ITC patent cases. As an industry consultant, his ideal clients are R&D, product development, and innovation leaders in startup, emerging, and established medical device and diagnostic companies, who face product development and competitive challenges.

Areas of Expertise:

Mechanical Engineering Biomedical Engineering Medical Devices Product Development Clinical Diagnostics Blood Collection Blood  / Cell Separation Needles / Lancets Biospecimens Point of Care Testing Microfluidics

X-Ray Spectroscopy Cell Therapy Intellectual Property / Patent Infringement Microscopy Physics Biomedical Sensing Optics Imaging Mathematics Glucose Monitors Lasers

Dr. Fletcher is an entrepreneurial executive with expanding R&D roles in business, technology, and new product development leadership and execution, building and guiding teams in both Fortune 500 and startup companies. With a PhD in physics from Yale, he has a proven record of leadership in creating innovative new businesses and products in healthcare, medical devices, diagnostics, life, materials, and optical sciences.

Ted W. Simon, PhD, DABT, is an award winning Environmental Toxicologist and Scientist. His expertise is in toxicology, risk assessment, mathematical modeling, statistics, neuroscience, and environmental / ecological health issues.

Dr. Simon has over 10 years of experience as a toxicologist employed by the Environmental Protection Agency (EPA). He served as EPA’s senior toxicologist in the waste management division working on risk and soil cleanup.

Teaching Experience - Since 2001, Dr. Simon has served as an Instructor / Adjunct Professor in the Department of Environmental Health Science, College of Public Health, at the University of Georgia.

Public Speaker - Well published, including the author of a textbook on toxicology and environmental risk assessment, Dr. Simon has extensive national and international public speaking experience. Since 1996, he has been delivering seminars and lectures to universities and national institutes on many subjects within his area of expertise. In 2016, he delivered a lectures on “Bayesian Methods for Application of Uncertainty Factors,” to the Society of Toxicology Annual Meeting, New Orleans, LA, and “Quantitative Prediction of Phenotypic Change from High Throughput Assay Results,” to the EPA's Workshop on In Vitro to In Vivo Extrapolation, Research Triangle Park, NC.

Litigation Support - Dr. Simon has over 15 years of experience offering expert witness services to counsel representing both plaintiff and defendant. He has been retained over 20 times since 2000 for cases involving environmental risk, drug and alcohol cases, DUI, accidental poisoning, and intellectual property. Dr. Simon has particular expertise in dioxin-like chemicals and polychlorinated biphenyls (PCBs). His services include consulting, reports, deposition, and trial testimony when necessary.

Areas of Expertise:

Dioxins PCBs Drugs Alcohol Poisoning DUI / DWI Water Contamination Soil Contamination Environmental Risk Assessment

Environmental Toxicology Carcinogenicity Food Contamination Pesticides Fracking Lead Marijuana Polychlorinated Biphenyls Intellectual Property

Joel Gagnier, PhD, is an experienced clinical Epidemiologist with over 25 years of experience in the assessment of general and specific causation in cases of Exposures to Chemicals and Medical Interventions, and the Risks of Disease or Adverse Events. He is a tenured professor with over 20 million dollars in funding and over 210 peer-reviewed publications.

Dr. Gagnier has methodologic expertise in human subject epidemiologic research (and more generally epidemiology), clinical research, systematic reviews and meta-analyses, as well as basic science research, statistics and biostatistics  

Litigation Support - Dr. Gagnier is an expert at finding the relevant literature, assessing the quality of the evidence, extracting the data, performing meta-analyses, finding the magnitude of the association, doing a causation assessment (Bradford hill analysis) and coming to final conclusions. He has been an expert on 15 separate cases, been deposed 10 times, and testified 4 times.

Areas of Expertise:

Epidemiology Health Risk Assessment Environmental Medicine Toxicity Heavy Metals Glyphosate-based Herbicides Pesticides and Herbicides

Volatile Organic Compounds (ethylene oxide, benzene, PFOS/PFAS) Vaccines Medical Devices (hip and knee implants) Natural Health Products Nutritional Supplements Nutrition Patient Safety