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Parasitology, Immunology, Microbiology, Bioterror Agents, Grant Writing, Med Writing, Expert Witness
Expert has extensive experience in the preparation and submission of 510(k) documents to the FDA for approval of Class II medical devices. His first work in 510(k) preparation and submission was in 1987 for acceptance of a rapid immunoassay for…
Medical Consulting, Medical Writing, Effective Ad Strategies Targeting Physicians
Expert is a physician and medical writer with 16 years of experience. He has written research protocols and completed the studies while at NYU Medical Center. While in clinical practice, he published 8 articles in medical journals and published 5…
Medical Device, Diagnostic, and Pharmaceutical Clinical Trial Design and Strategy
Expert has over 25 years experience in commercializing medical products. Her experience includes management at Abbott Labs in clinical research and regulatory affairs and as a CEO of a venture capital backed medical diagnotic company. Expert has raised venture money…
Molecular Biophysics, Nucleic Acid Physical Chemistry, Biomimetic Ligand Design
Beginning with his graduate work on nucleic acid physical chemistry, the primary focus of his research has been in the area of molecular biophysics/biophysical chemistry. His Ph.D. was in polymer physical chemistry, and he has taught a variety of courses…
Biomaterials: Biocompatibility, Pathology, Devices
Expert J. Expert is a D.V.M. with a Ph.D. in veterinary pathology. He is also board certified by the American College of Veterinary Pathologists. As part of his Ph.D. research training he was involved in the characterization of several spontaneous…
Emergency Room Nursing
Expert is experienced in assisting physicians in emergency department control of arterial bleeding. He also assists physicians in the emergency department with arterial line placement and maintenance. He is experienced in the care of patients with restrictive airway disease in…
Healthcare Consulting: Strategic Planning, Product Development, and Product Launch
Expert has been providing expert strategic and operational advisory services to healthcare investors and development stage healthcare companies for nearly 10 years. He has been involved in direct healthcare management for over 15 years, and has been practicing medicine since…
Developmental and Reproductive Toxicology Study Design, Data Evaluation, and Report Review
Expert (prefers “Expert”) has acquired knowledge and expertise on birth defects in three ways: 1) teaching university courses on human embryology and on causes and manifestations of birth defects; 2) conducting lab animal research; and 3) extensive technical consulting and…
PK/PD Modeling and Simulation; Nonclinical and Preclinical Statistics; Experimental Design
He managed group of 5 biostatisticians working on Phase I and PK/PD trials. His responsibilities included protocol design, statistical analysis plan writing, specification writing, and delivery of product to customers. He was responsible for meeting all timelines and budgets, assuring…
Practical Application of GLP, GCP, and cGMP to Pharmaceutical, Device, and Biotechnology Firms
As Vice President at a pharmaceutical company, Expert formulated eight pharmaceuticals for use in their patented buccal delivery platform technology. Five formulations were acceptable to FDA and were allowed to proceed into human clinical trials under IND controls. Four of…