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Physics, Mechanical Engineering, Medical Device Product Development, Blood Collection for Diagnostics & Therapeutics, Patent Litigation Expert Witness
Expert is Founder and Principal Consultant at a consulting firm founded in 2015, focused on industrial mechanical engineering and research and product development, in medical devices, diagnostics, optical, imaging, and laser devices, point-of-care blood sample testing, and on expert witness…
Orthopedic Surgery and Orthopedic Device Regulation
Expert did his undergraduate and medical school at the University of Michigan, an Alpha Omega scholar. His internship and residency were at the University of California at Davis, where he was an outstanding resident of the year on two occasions.…
Biomechanical Engineering
Expert is a bioengineer, a discipline that applies mathematics, physics, and engineering technologies to the study of biology and medicine with a focus on human health. He is the owner and principal investigator of a business entity recognized by federal…
Neurology and Sleep Medicine
Expert is a Harvard-trained neurologist with special expertise in the areas of behavioral neurology and sleep medicine. He is a cognitive neurologist with sub-specialties in behavioral neurology (such as Alzheimer's), sleep medicine, headaches, and epilepsy. Expert is currently an Attending…
Pharmaceutical Science; Preformulating, Development, Chemistry, Manufacturing & Control (CMC) Issues; Paragraph IV Hatch-Waxman & Canadian Notice of Allegation
As the development of a pharmaceutical reaches Phase 3, prior to submission of an NDA, method validation is required. Validation is a demonstration of optimization. By demonstrating the capacity of a method within the bounds of validation, optimal conditions for…
General Industrial Hygiene; Toxicology; Laboratory Safety; Hazard Communication; Chemical Hygiene
Expert has worked as a consulting industrial hygienist for 24 years. He is both a Certified Industrial Hygienist (CIH) and a Certified Safety Professional (CSP). He has conducted many detailed compliance evaluations/inspections and has developed helpful code interpretations for clients.…
Medical Device & Pharmaceutical Quality Systems; Regulatory. Affairs; Quality Fitness Reviews
Advised and trained Operations and QA employees in a large pharmaceutical plant on effective practices to investigate and document deviation events on the manufacturing floor and quality control laboratory. The aim of such investigations was to determine a root cause…
Physical Therapy, Molecular Biology, Genetics
Expert has been practicing as a physical therapist since 2007. He has worked in both outpatient orthopedic and inpatient physical therapy settings, including major medical institutions such as University of North Carolina Hospitals and Employer Health Hospitals, as well as…
Biochemistry; Infectious Disease Diagnostics Technology and Running of COVID-19 Clinical Diagnostics Lab
Expert, Ph.D., is an Assistant Adjunct Professor in the Department of Microbiology and Immunology at a university in California. Her work is focused on the development of new methods for infectious disease diagnostics, with a particular focus on diagnostic uses…
Medical Oncology: Patents, Medical Malpractice, Drug Development, Strategy, Biomarkers, and Theranostics
Expert possesses nearly two decades of experience in oncology and drug development. He is currently leading the clinical sciences program for a biotech company focused on CAR-T therapy for cancer. Before that, he served as the Director of Phase I…