Regulatory Expert Witnesses

Intellectual Property, Medical Devices - Imaging, Patent, Ultrasound, Electronics, Transducer, ASIC, MEMS, FDA, Signal Processing, Neuro modulation, Regulatory, Integrated Circuit, Semiconductors, Biometric security, Ablation, Tomography, Parallel Computing, Surgical Guidance, 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. - Dr Daft has deposition and trial testimony experience including 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 16 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. - 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 Oxford University as well as a ...

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, Forensic, Fraud, Human Resources, Case Strategy, Supervision.

With over 38 years of experience in the financial services industry, I currently hold the positions of President, Chief Compliance Officer, and Owner of Wealth Innovation, a boutique Registered Investment Adviser firm. Additionally, I am the founding advisor at Wealth Advocacy, a consultancy specializing in business and consumer financial services. I am the President, Founder, and Owner of Esoteric Advisors, a collaborative consulting and expert witness company that aims to foster a robust and extensive collegial network of fellow experts. My professional journey includes serving as a FINRA and court admitted expert witness. I have authored numerous expert reports, participated in depositions, and provided testimony in arbitration and court proceedings. My unwavering commitment to business and personal compliance, legal integrity, and creditworthiness is impeccable. I have held several significant positions with a major financial institution. These roles have encompassed audit-ris...

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; 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 known as American Medical Directors Association); Past Chair; Coalition for Compassionate Care of California; Editor Emeritus of...

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 ...

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...