Biologics Expert Witnesses

Chino Hills, California

Orthopedic Surgery, Sports Medicine - Joint Preservation, Cartilage Restoration, Arthroscopy, Knee Replacement, Shoulder Replacement, Hip Replacement, Robotics, Trauma, Fractures, Stem Cell, Biologics, Minimally Invasive Surgery, Qualified Medical Evaluator, QME

Board-Certified Orthopedic Surgeon with specialized expertise in Sports Medicine, Arthroscopy, and Total Joint Replacements, serving as an active Team Physician for a local university and providing Level 1 Trauma care. Qualified Medical Evaluator with a reputation for exceptional bedside manner and credibility. Education & Affiliations: Renaissance Scholar, Magna Cum Laude, University of Southern California Fellow of the American Academy of Orthopaedic Surgeons (AAOS) Fellow of the American Association of Hip and Knee Surgeons (AAHKS) Medical Director Total Joint Program at Local Hospital Experience with complex cases and a solid foundation in evaluating injury mechanisms, treatment appropriateness, and standard of care in legal settings: Joint Preservation: cartilage transplantation, biologics (PRP, stem cell, amnion), reconstructive ligamentous surgery, meniscal repair/transplantation, rotator cuff repair, labral repair, and shoulder instability. Modern Joint Replacement: m...

Beverly Hills, California

Rheumatology, Internal Medicine - Lupus, Fibromyalgia, Rheumatoid Arthritis, Rheumatology, Arthritis, Osteoporosis, Osteo Arthritis, Fatigue, Flare, Autoimmune, Scleroderma, Sjogrens, anti lipid antibodies, ANA, Malar Rash, trauma, auto immune infertility, auto immune fertility, biologics, benlysta

I have been practicing clinical rheumatology since 1979 with a special interest in systemic lupus erythematosus (SLE). I was fortunate to take over the clinic of Dr. Edmund Dubois on his passing in 1985 and developed the largest single practitioner lupus cohort in the United States. In collaboration with Cedars-Sinai Medical Center, our institution has participated in SLICC, the Lupus Clinical Trial Consortium, and several disease criteria committees. I have been the editor of the last 7 editions of Dubois Lupus Erythematosus; the patient handbook “The Lupus Book”, has sold more than 135,000 copies. Our center has performed over 150 lupus clinical trials, biomarker, genetics, quality of life and observational studies which has resulted in 450 peer-reviewed publications and 54 books/book chapters. I have had first authorship on manuscripts relating to celecoxib, mycophenolate mofetil, leflunomide, baritcitinib, belimumab and epratuzumab and 8 publications (6 as lead author) in the Ne...

Westminster, Colorado

Products Liability, Biomedical Engineering - Medical device, Biologics, Manufacturing, Risk Management, Design History File, FMEA, Stem Cells, Biomaterials, Product Liability, Intellectual Property, Implant, Collagen, Device testing, Design Controls, Product labeling, CDMO, Quality/Regulatory, Allograft, Forensic Science, Accident Recon

Qualified Nuclear Engineering Officer in the US Navy First author for 3 peer-reviewed original scientific research articles 10+ years in medical device/biologics design, development, and manufacture 15 years in design and operational engineering Inventor on two biomedical patents

Westmont, Illinois

Toxicology, Pharmaceutical Research - Pharmacology, Neuroscience, Toxicology, Industrial Chemicals, Contract Research Organizations, Academic Research, Drug Development, Human Health Risk Assessment, Diplomate of the American Board of Toxicology, DABT, US FDA, US EPA, Gene Therapy, Biologics, Toxicologist, Pharmacologist

I am toxicologist and pharmacologist with a board certification in toxicology. I have 20 years of experience working with in the biotech, pharmaceutical and chemical industries to address pharmacology/toxicology, regulatory affairs issues and human health risk assessment. I have more than 30 years of research, consulting and regulatory experience. I have worked with law firms for the last 15 years in various capacities to support litigation. I am an active member of the American College of Toxicology, Society of Toxicology, and American Society of Gene and Cell Therapies. I also am a Diplomate of the American Board of Toxicology (DABT) since 2018.

Brooklyn, Ohio

Wound Care, Nurse Practitioner - pressure injuries, vascular wounds, non-healing wounds, burns, atypical ulcer, nursing homes, arterial ulcers, biologics, osteomyelitis, diabetic ulcers, venous ulcers, negative pressure wound therapy, wound infection, decubitus ulcers, lymphedema, surgical wounds, wound debridement

The founder of Legal Expert Wound Care Consultants, Seana has been a licensed nurse for the past 15 years, and a working Nurse Practitioner since 2015. Overseeing our team of clinicians, Seana is distinctively qualified as a Certified Wound Specialist under the American Board of Wound Management and is also Wound Care Certification under the National Alliance of Wound Care and Ostomy, where she is a Clinical Preceptor. Her experience is extensive across the continuum of care with clinical experience in hospitals, home care, long-term care, and domiciliary care settings. As a Nurse Practitioner, Seana’s clinical practice continues to be based in wound care today. She functions as a Nurse Practitioner treating both acute and chronic wounds in patients across the lifespan, primarily focused in the long-term care setting. Her education, training, and experience have made her intently familiar with the standards of care applicable to cases involving patient wound care management — e...

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...