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Vaccines, IVD, Animal Health, Coronavirus Virus and Vaccine Models
Expert has excelled in the animal vaccine field for over 21 years. He has directed licensing for over 40 U.S. and 55 international registrations for avian, bovine, canine, equine, feline and ovine species. Expert has consulted with the world's leading…
Biotechnology, Pharmaceuticals,
Expert in Biopharmaceutical molecule development and licensure. Experience with top Biotech companies (BMS, sanofi, MedImmune, AZ, Adello, etc.). Designed successful Analytical strategy for 100s of IND and many BLA submissions in multiple countries. Expert in the following areas: Scientific writing…
Public Health, Epidemiology, Infectious Diseases, Vaccines, Internal Medicine, Environmental Health
The overarching vision of Expert's research program is the reduction of disease burden associated with bacterial and viral infections among infants, children and adults. His research program focuses on the study of infections using innovative, multi-disciplinary tools that enable more…
Manufacturing Technologies for Pharmaceuticals, Biologicals, Biotech and Vaccines
Expert is an independent consultant to bio-pharmaceutical, medical device and vaccine manufacturers, associated equipment suppliers and investors, with over 40 years experience in aseptic process technology, new product and business development, marketing strategy and regulatory compliance for manufacturing of pharmaceuticals…
Pharmaceutical Development
Expert is a former FDA Review Chemist, with > 39 years of career experience in pharmaceutical R&D, Quality Operations and Regulatory Affairs. For 25+ years as a consultant in his own pharmaceutical development advisory firm, Expert has furnished clients with…
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…
Protein aggregation, characterization, purification
Expert leads a team of exceptionally talented downstream scientists to develop scalable downstream processes for viral vectors for use in Gene, Cell and Oncolytic therapies and for Vaccine production and for therapeutics proteins and antibodies. Keywords: Process development, DSP, Downstream…
IVD Assays and Diagnostic Tests Development
Expert's areas of expertise include the following: IVD (in vitro diagnostics) clinical laboratory regulation molecular diagnostics blood assay diagnostic instrumentation assay development CLIA-88 (Clinical Laboratory Improvement Amendments of 1988) clinical laboratory regulation quantitative risk analysis (risk assessment) laboratory management GLP…
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…
Biotechnology, Pharmaceuticals, Business Development, Technical Assessment, Business Strategy
Expert brings over 20 years of research and business development expertise in biotechnology. Expert received his Ph.D. in cell and molecular biology from Tulane University. After completing his postdoctoral training at the NIH, Expert worked at Applied Biosystems, where he…