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Forensic DNA Analyst
Expert founded his company in 1993, a forensic scientist who specializes in the analysis of DNA and the use of insects in legal investigations. Expert has evaluated and provided expert guidance for more than four hundred criminal and paternity cases,…
Intellectual Property, Licensing, Various Technologies & Tech Standards
Expert is the Chief Intellectual Property Officer of a large healthcare conglomerate based in Los Angeles, CA.; Comprised of numerous companies which proudly hold foundational intellectual property in a number of disciplines including by not limited to blood based biopsies,…
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…
Vaccine Development
More than 30 years vaccine development at GSK Biologicals managing process development, GMP clinical lots manufacturing, validations activities, regulatory submissions, Quality matters,..... Overall, development of more than 50 projects (bacterial, viral, recombinant yeast, CHO, viruses, E.coli and adjuvant systems)with signifiant…
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…
Biopharmaceutical Process and Product Development; Patents and Trade Secrets in the Biotechnology Industry; and Biosimilar Patent Infringement
Expert is a classically trained biochemist with 30 years of experience in the biopharmaceutical industry as both a hands-on scientist and scientific leader in process, analytical, and formulation development, product commercialization, and product quality assessment. During his long tenures at…
Pharmaceutics
Expert is a process and chemical engineer with a Bachelor from Univercity Laval in Quebec City. He has more than 15 years experience in engineering, automation, validation of manufacturing equipments, clean utilities, pharmaceutical systems and computer systems (cGMP, GAMP5, CFR-21…
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…
Organic Chemistry, Biocatalysis, Fermentation, Industrial Biotechnology, Chemical Process Development, Patent Liaison, Expert Witness for Patent Litigation
Expert has over 30 years of experience leading process development groups in a variety of fields. He employs biocatalysis and other biological methods to perform organic synthesis. In his current role, Expert offers executive-level technical strategy, project management, and due…
Pharmaceutical Formulation (Tablets, Capsules, Semi-solids, Liquids), QbD, and CMC Regulatory/Risk Assessment Issues
Expert is a Pharmaceutical Formulation Scientist with 25+ years' industry/FDA experience developing and commercializing tablets (fast dissolving, effervescent, chewable, coated), capsules, ODT's, coated beads (i.e., controlled release and taste-masked), topicals (liquids and semi-solids), & CBD/hemp products. He also has experience…