Find an Expert
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…
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…
Aerospace Coatings Process Engineering & Technical Training
The expert has served in the aerospace coatings industry for over 23 years serving some of the most prestigious OEM and MRO aircraft companies in the world. Some of the core competencies that this expert offers include: + Customer Aircraft…
Plant Biotechnology, Crop and Climate Modelling
Expert is an expert in the broad area of plant biotechnology and its applications in agriculture for improved food security. She has proven expertise in producing research-based knowledge using plant molecular biology concepts that are relevant for informing agricultural practices…
BioStatistics, Pharmaceutical Devices, Biotechnology, and FDA and EMA Submissions
Expert holds a Ph.D in Statistics and has 25 years' applicable industry experience. He currently serves as a biostatistical expert witness in high-stakes pharmaceutical and medical device litigations. He has expertise in pre- and non-clinical, Phases I-IV in biostatistics, data…
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 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…
Pharmaceutical Manufacturing, Combination Products, Medical Devices, and Good Clinical Practices
Expert is a retired Public Health Service (PHS) Officer with 16 years of FDA experience in Pharmaceuticals, Medical Devices, Biologics, and Bioresearch Monitoring. She has held the positions of Investigator, Pre-Approval Manager, Supervisory Investigator, and Foreign Inspection Cadre Member. She…
Avocado Fruit Production, Orchard Management and Botany, Nursery Management and Clonal Propagation Procedures
Expert experience in horticulture research includes 10 years of research on avocado (Persea americana) including rootstock selection and evaluation, pruning techniques, post harvest fruit evaluation, and simulated shipping. He serves as Commercial Horticulturist for one of the world's largest avocado…