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Pharmaceutical Marketing
Working both in an agency environment and for a number of leading pharmaceutical organisations Expert has managed the challenge of gaining patients access to innovative therapies. Although the industry has been slow to recognize the issues and move away from…
Environmental and Spatial Statistics, Especially Site Assessment and Remediation
Expert is a statistician with many years of experience in environmental statistics, especially related to site characterization and remediation. He has developed numerous environmental sampling designs for field projects and experimental designs for studies and has analyzed and reported the…
Pharmaceutical Manufacturing Processes, Quality Management, and FDA Interactions
Expert is a consultant to the US FDA for Quality issues associated with the manufacture of pharmaceuticals. Expert is a subject matter expert for the US FDA in Warning Latters and Consent Decree work and data Integrity issues. Expert provides…
Clinical Trials, Drug Development, Medical Monitoring, AIDS, FDA Regulation, Safety Assessment
Expert is a public health professional who has extensive international and domestic experience. She has worked for pharmaceutical/biotech companies, hospitals, public health institutions, non-profit organizations, in the areas of clinical trials design and management, community-based research, educational programs’ development and…
Veterinary, Farm Animal Medicine, Management, Preventive Medicine, Welfare
Expert is an Expert Witness in Criminal and Civil Litigation and worked in England, Scotland, Wales, Northern Ireland, Eire, and Holland. His expertise is in farm animals in disease, identification, fraud, preventive medicine, animal health, animal welfare, animal nutrition and…
Infectious Disease, Immune Deficiencies, Molds, Toxins, Acupuncture and Integrative Medicine
Expert’s expertise as an internist combines Internal Medicine and Infectious Disease with Medical Nutrition. As such, she is well equipped to recognize and manage challenging medical conditions, especially in those with different types and degrees of weakened immunity. A graduate…
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…
Virology, Anti-infectives, Gene Therapy, Bioterrorism Research
He has extensive experience in the development and use of viral vectors for gene transfer and in particular has worked with both adenovirus and AAV vector delivery systems. His work with adenovirus vectors included some of the earliest research focused…
Mechanical Engineering Design and Prototype Development
Expert received a Ph.D. in mechanical engineering from the University of California, Berkeley (UCB), with an emphasis in composite manufacture and analysis. His Ph.D. dissertation dealt with manufacturing analysis for axisymmetric composite structures. Part of the research included building a…