Regulatory 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...

San Luis Obispo, California

Securities & Investments, Banking - RIA, Broker Dealers, Banking, Lending, Estates, Trusts, Fiduciary, Securities, Crypto & Specialty Assets, Reg BI, Accredited, International, Firm Practice, Regulatory, Risk Management, 1031/DST, Complex Insurance Plans, FINRA, OCC, SEC

With over 35 years of experience in the financial services industry and as an entrepreneur, I have founded consulting firms serving both consumers and businesses. I am currently the Chief Compliance Officer, and Owner of Wealth Innovation, a boutique Registered Investment Adviser firm. I am the President and Owner of Esoteric Advisors, a collaborative consulting and expert witness firm dedicated to fostering a robust and extensive collegial network of fellow experts in the financial services sector. We specialize in expert knowledge within and about financial services. Previously, as a Region Manager and then Wealth Manager at a Fortune 500 financial services company, I collaborated with several leaders across various business lines to establish a unique hybrid Montecito Wealth office. My responsibilities included overseeing risk management, human resources, public relations, and corporate leadership. I am committed to maintaining the highest standards of compliance, legal integr...

Oceanside, California

Geriatrics, Nursing Homes - Nursing Home - Skilled Nursing Facility, Hospice - End-of-Life Care, Palliative Care, Home Health, Assisted Living, Regulatory, Decubitus, Pressure Ulcers, Falls, Dementia - Alzheimer's, Medicare, Medicaid, Managed Care - HMO, Life Care Planning, Personal Injury, Family Medicine, Addiction Medicine

Experienced Expert, 250+ depositions, 25+ trials. Speedy and Objective Records Reviews (plaintiff/defense); Standard of Care, Causation and Damages Opinions, including Life Expectancy and Future Care Costs, Regulatory Actions; Comprehensive Report Writing. References Available on Request. In clinical practice of post-acute and long-term care medicine, Geriatrics & Hospice in San Diego area since 1992; Chief Medical Officer, Mariner Health Care (nursing facility management company); Chief Medical Officer, Beecan Health; Delegate, AMA and California Medical Association House of Delegates; Chair, CMA Council on Ethical, Legal & Judicial Affairs; Clinical Faculty UCSD School of Medicine and Family Medicine Dept. Adjunct faculty, Case Western Reserve University; Affiliate Faculty, California State University's Institute for Palliative Care (San Marcos), Past President of CALTCM, Past President of AMDA--The Society for Post-Acute and Long-Term Care Medicine (www.paltc.org, formerly kn...

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...

Harrison, Tennessee

Insurance, Transportation - Insurance Claims Mgmnt, Insurance Bad Faith, Aviation, Insurance Automotive, Insurance Policy Form, Compliance, Accident Investigation, Trial Strategy, Insurance Claims Handlling, Regulatory, Errors and Ommissions, Jury Selection Strategy, Insurance Contracts, Trucking, Risk Management, Voir Dire

John Ballinger, an insurance insider and risk mitigation expert, sees unsecured operational risk as the biggest blind spot for many of today’s most successful small to medium-sized companies. Mr. Ballinger is also a decorated veteran of the United States Army and holds over a dozen awards and certifications in aviation safety and risk management. As an expert witness, Mr. Ballinger has assisted with and/or testified in more than 50 court cases related to insurance liability matters. With over 20 years of experience leading business owners through the complicated matrix of insurance coverage, Mr. Ballinger has saved organizations over $100 million in potential loss through risk analysis and mitigation. Working with clients in a variety of industries has allowed Mr. Ballinger to develop a deep understanding of ACA, EPA, DOL, IRS, OSHA, and DOT regulations. He routinely guides business owners through complex federal mandates and their impact on daily operations. Mr. Ballinger is well...