FDA Expert Witnesses

San Francisco, California

Intellectual Property, Medical Devices - Imaging, Patent, Ultrasound, Electronics, Transducer, ASIC, MEMS, FDA, Signal Processing, Neuromodulation, Regulatory, Integrated Circuit, Semiconductors, Biometric Security, Wearable Biometrics, Tomography, Neural Networks, Artificial Intelligence, Wearable Medical Device, Product Liability

Award winning, Oxford Educated scientist whose areas of expertise include medical imaging, electronics, semiconductors, medical devices, sensors, MEMS, signal processing and image processing. - 5 trial testimonies and 14 depositions. - Litigation experience includes district court, ITC and PTAB matters. - Extensive Intellectual Property experience including patent development, analysis, licensing, and litigation. - Serial inventor holding 27 U.S. Patents with 20 applications pending. - Diverse industry experience including multi-nationals such as GE, Medtronic, Fujifilm, Samsung and Siemens as well as several start-ups. - Well published. - Winner of grants from National Institute of Health and DARPA. - Extensive international consulting experience. - IEEE (Institute of Electrical and Electronic Engineers) Senior Member since 2004. - Three years’ experience teaching electrical and computer engineering at the University of Illinois. Holds BA and MA in Physics from...

East Alton, Illinois

Medical Devices, Biomedical Engineering - FDA, Medical Devices, FDA Compliance, FDA law, FDA Inspections, FDA medical device regulation, FDA medical device labeling, FDA regulation of clinical trials, FDA approval of medical devices. Medical Device Recalls, Medical Device Complaints

A recognized expert on the FDA regulation of Medical Devices. Experience as an expert witness involving medical device firms and FDA requirements regarding approvals, recalls, complaint investigations, and labeling. Over 20 years of FDA experience encompassing virtually all of the FDA field positions. Also eighteen years of industry experience as a mid-level manager and senior executive in clinical, regulatory, and quality in the medical device industry. Personally designed quality systems, prepared regulatory submissions (510(k), IDE and PMA) and managed 7 multi-center clinical trials for class 3 medical devices. From 1989-1993, was the Industry Representative on the FDA Circulatory Systems panel which reviewed over 30 PMA clinical studies for cardiovascular device. Serve as an expert witness for cases involving FDA regulation compliance for medical devices. Regularly perform webinars regarding FDA and issues regarding clinical studies and medical devices. Finally, a ...

Gambrills, Maryland

Medical Devices, Products Liability - ceramics, processing, zirconia, hard materials, coatings, device failures, medical ceramics, dental ceramics, medical device standards, properties of materials, FDA, IP, Patents

Gary Fischman is the principal and owner of Future Strategies Solutions LLC. He is a domain specialist in hard materials, specifically ceramics and hard coatings. Dr. Fischman has breadth working in and with academia, industry and government. Dr. Fischman has worked with discovery, written expert reports, been deposed and testified as an expert witness. Formerly, a tenured faculty member at the New York State College of Ceramics at Alfred University, Dr. Fischman worked in processing hard, strong materials that ranged from non-oxide semiconductors to oxide ceramics for biomedical applications. During the early years of biomedical applications of materials, Dr. Fischman was front and center developing classes, doing research specifically in hard material (non-oxides) as well as medical oxides (aluminas and zirconias). During that time, he teamed with a colleague and created a small business that made ceramics for biomedical applicationsn (Xylon Ceramic Materials). Dr. Fischm...

STEVENSVILLE, Maryland

Pharmaceutical Regulation, Medical Devices - FDA, FDA Compliance, FDA Regulations, FDA MAUDE, FDA Drug Safety, FDA Warnings, FDA Drug Warnings, FDA Medical Device, FDA law, FDA regulatory, Drug Safety/FDA, FDA Medical Devices, Biologics Safety FDA, Implant Safety/FDA, Medical device product liability

Worked as an FDA regulatory expert witness in over 50 cases, deposed 16 times and testified 5 times. Based on experience training over 40,000 staff at FDA-regulated companies on technical and regulatory topics, skilled in explaining FDA related topics to juries. Broad and deep skills in drug, biologic and medical device development. Hands-on experience in the entire lifecycle of product development from initial regulatory strategy, clinical trial planning and execution, to submission preparation and review at FDA. Authority in the collection, statistical analysis, interpretation, and presentation of information to FDA. Expert in understanding FDA reviewer’s actions and reactions. Specialist in analyzing FDA compliance information to answer three questions: 1) What did the company know and when did they know it? 2) What should the company have known and when should they have known it? 3) What should the company have done and when should they have done it? Provide FDA related ...

Charlevoix, Michigan

Cannabis, Laboratories & Testing - Laboratory, Cannabis, Marijuana, Compliance, Regulatory, Cannabinoid, THC, Potency, Contaminant, Quality Management System, Audit, ISO 17025, FDA, Clinical, DNA, Molecular, Genetic, Testing

Dr. Opie is a previous founder of multiple analytical testing laboratories in both clinical diagnostics and cannabis compliance testing. He has been a plaintiff, defendant, and cannabis laboratory testing expert witness in multiple legal matters. Since 2018 he has been advising laboratory owners and investors about regulatory, quality, scientific, and business operations issues. In addition to being a regular invited speaker at national conferences, He is also the editor and contributing author to the textbook, "Cannabis Laboratory Fundamentals". Dr.Opie has written a variety of articles around laboratory operations including: Cannabis Laboratory Planning, Design, Licensing, Instrumentation, and Staffing, A Hemp Growers Guide to Compliance Testing for THC and CBD Levels, A Guide to Preparing Cannabis Laboratory Business License Applications, and How to Start a Cannabis Testing Lab: A Step-by-Step Guide. Dr. Opie is a quality management system lead assessor for laboratories ...

Chapel Hill, North Carolina

Regenerative Medicine - cell therapy, gene therapy, stem cell therapy, immunotherapy, regulatory, FDA, due diligence, HCT/P, Good Manufacturing Practices (GMPs), Good Tissue Practices (GTPs), viral vectors, T cells, CAR-T cells, NK cells, stem cells, autologous cell therapy, allogeneic cell therapy

Dr. Burger has 30 years of experience developing cell therapy and gene therapy products for immunotherapy and regenerative medicine. Since 2002 he has been a full-time consultant on development, GMP manufacturing, regulatory, and strategic aspects of cell and gene therapy. He has served over 180 companies, from biotech startups to Big Pharma, in North America, Europe, Asia, and Australia, consulting on cell and gene therapies from preclinical development through Phase I/II/III, and commercialization. Dr. Burger has been an expert witness in cases involving cell and gene therapy intellectual property, commercialization, FDA regulatory affairs, and GMP compliance. He is frequently an invited speaker at international conferences and has served on the USP Cell, Gene and Tissue Therapies Expert Committee, the ISCT advisory board and ISCT committees on gene therapy, regulatory affairs, commercialization, and product/process development. A graduate of the University of Pennsylvania Sc...

Blue Bell, Pennsylvania

Pharmaceutical Regulation, Warnings & Labels - Pharmaceutical Industry, Drug Development, Product Labeling, Regulatory Labeling, Prescribing Information, Indications, Dosage, Contraindications, Warnings, Precautions, Adverse Experiences, Regulatory Compliance, Safety, FDA, Off-label Use

Ethical Full Lifecycle Labeling/Prescribing Information That Never Cuts Corners For Pharmaceutical Giants Merck, Shire, and J&J: Labeling strategy and leadership that brings product labeling and products to market supporting vaccines and treatments for infections, internal medicine, oncologic, and rare diseases. These include life-saving, ground breaking, and first-of-its-kind products. Bring decision makers across divisions to the table to negotiate resolution of labeling issues - leading to the creation, revision, and maintenance of clear and compliant product labels that educate health care professionals and patients in the US, EU, Japan, and Rest of World. Gain consensus and champion proactive consensus-building across Research, Statistics, Regulatory, Joint Ventures, Legal, and Marketing on labeling - laser-focused on the bottom line: “What do the doctor and patient need to know?” Provide leadership in support of label development for new applications, supplemental appl...

Austin, Texas

Oncology, Pharmaceutical Research - Oncology Drug Development, Patent Validity, ICH GCP, Written description, Enablement, Obviousness, Anticipation, Pharmacology, FDA, EMA, NMPA/China, PMDA/Japan, Drug formulation, Medical Safety, Phase 1-3 Clinical Trials, Drug Product Safety/Compliance, Medical Oncology

Frederick (Fred) Hausheer, MD, FACP Physician-scientist with over 35 years of international executive leadership and management experience in US and international (EU, JP, China, others) overseeing commercial oncology pharmaceutical research and development (Phase I-III), drug discovery, preclinical translational and clinical medicine, clinical pharmacology, and commercial development strategy and risk management. Inventor/co-inventor on more than 400 issued United States and international pharmaceutical patents, author/co-author of more than 200 scientific/medical publications. Experienced former CEO and current Chief Medical Officer executive with several biopharma companies. He is a former NCI-Designated Clinical Investigator, NCI-Institutional Review Board voting member, and NCI-Experimental Therapeutics Study Section member, and an ad hoc external expert medical advisor for the US FDA. Some of his major awards include the American Cancer Society Fellowship Awards, the Natio...

Lovettsville, Virginia

Pharmaceutical Research, Infectious Diseases - pharmaceutical regulation, FDA, drug development, antimicrobials, antiseptics, disinfectants, clinical trials, post-marketing surveillance, drug labels, biologics, medical devices, microbiology, biochemistry, molecular biology, food poisoning, data fraud, biological defense, dairy micro, IP

25 years of experience in infectious disease including food microbiology, chemical/ biological defense and regulatory science. Initial employment in the Federal Government was with the Agricultural Research Service (ARS) performing genetic engineering of dairy bacteria. From there, he went to the Department of Defense, specifically Naval Surface Warfare Center (NSWC), working in chemical and biological warfare defense. Spent 12 years as a Clinical Microbiology reviewer in the Center of Drug Evaluation and Review (CDER) at FDA. He has extensive experience with FDA submissions including: pre-IND, IND, NDA, labeling supplements, and post-marketing for antibiotics, topical antiseptics, biologics and generic drugs. As an independent consultant, provided guidance on microbiology and regulatory affairs for clients developing antimicrobials, medical devices and biologics allowing clients to navigate through the FDA regulatory process. This guidance included providing advice for deve...