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Statistical Consulting, Biostatistics, Statistical Support to Litigation
Expert has over 13 years experience as statistician and Director of Biometrics in the pharmaceutical industry. In addition, he has 8 years experience as a Professor of Statistics at the University of Florida. He served as functional manager for statistics,…
Medical Pharmacology and Toxicology
Expert is a medical-legal consultant who specializes in cases that relate to drugs and drug pharmacology/toxicology. He has over 20 years of experience. Expert has experience in civil, criminal & administrative cases--both plaintiff and defense. Expert has been certified as…
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…
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…
Medical Packaging: Project Management, Design, Validation, Equipment
Expert is a certified packaging professional with over 20 years experience providing packaging engineering services to the biotechnology and medical device industries. These services include package and labeling development, packaging equipment selection and validation, and package materials and systems performance…
Virology, Drug Discovery, Diagnostics, Bioterrorism, and Vaccines
Expert (, pronounced "Berr-oo-in") has spent over 20 years in the pharmaceutical and diagnostics industries. During that time he has been involved primarily in viral vaccine and antiviral drug discovery, although he has also run general molecular biology groups primarily…
Biotechnology Product Reviews, Biologics, Drugs & Medical Devices, FDA Litigation, Vaccines, etc.
Over 18 years experience with legal, scientific, business and regulatory issues affecting the research, development and commercialization of biomedical and information security products. Recognized expertise in strategy development, audit and due diligence, outsourcing, and FDA regulatory matters, including consulting for…
Pharmaceutical Product Development, Drug & Medical Device Safety, Regulatory Affairs
Expert is active in U.K. General Practice with wide therapeutic area knowledge and practical patient prescribing. He has a good understanding of the U.K. health system, formulary adoption, N.I.C.E., and reimbursement. Expert has 15 years of experience in the design,…
Microbiology, Biotechnology, Cleanroom Microbiology, Sterilization, etc.
As a consultant, Expert has used his broad-based scientific background to work with a variety of clients. These clients have required expertise in such widely divergent subjects as the production of cellulosic ethanol (requiring a knowledge of basic thermodynamics, enzyme…