Drug Safety & Pharmacovigilance

Brigitte Simons is a business development executive in support of leading-edge laboratory services and data management tools for the development of safe cannabis. Bridging expertise within analytical science, pharma drug development and environmental testing – Brigitte have a professional track record for laboratory testing instrumentation, software and sample contract design for the Canadian federal agencies, such as Canadian Food Inspection, Health Canada, Agriculture Canada and Environment Canada. She spent over 6 years working in the Drug Toxicology and Analysis Division at Health Canada in a mass spectrometry facility testing. She completed two post-doctoral fellowships at the Clinical Sciences Hospital of the National Heart, Blood & Lung Institute within the famous NIH campus in Maryland, USA. Continuing on in lab specialties, Brigitte then joined SCIEX, a global instrumentation vendor for hardware and software for mass spectrometry. With over 15 years experience with operating mass spectrometers, Brigitte managed Canadian federal and provincial government sales for full laboratory services, covering clinical, forensics to product health and environmental safety. Prior to working abroad, Brigitte received her Ph.D. in Chemical Biology at the University of Ottawa in a joint chemistry program with drug pharmacology at Health Canada. 

Manuela Neuman is the CEO of In Vitro Drug Safety and Biotechnology, Toronto, ON., Canada. She is also teaching Pharmacology and Toxicology at the Faculty of Medicine, University of Toronto, Toronto, Canada. She is the Chair of Clinical Toxicology and Drug of Abuse Committee of the International Association of Therapeutic Drug Monitoring and Clinical Toxicology. She published 300 peer review articles. Her specialized laboratory provides personalized medicine and precision medicine results for Canada, USA and Europe. 

Metabolomics plays an important role in discovering potential disease biomarkers from blood plasma or serum samples. Due to the distinctive complexity of whole blood as the sample matrix, either plasma or serum are used as the primary sample in metabolomics biomarker discovery research. During the transformation of whole blood into plasma or serum followed by extraction of targeted or non-targeted metabolites using conventional sample preparation techniques including solid phase extraction (SPE) and liquid-liquid extraction (LLE), a significant portion of the analytical information disappears, resulting in negligible success in discovering potential disease biomarkers. Fabric phase sorptive extraction (FPSE), a new generation sample preparation technology, has offered a paradigm shift approach in metabolomics sample preparation. FPSE innovatively combines the benefits of solid phase extraction (SPE) (works under exhaustive extraction principle) and solid phase microextraction (works under equilibrium extraction principle) into a single sample preparation technology platform. FPSE utilizes a flexible and permeable fabric substrate, coated with high-performance sol-gel sorbents as the extraction media. This uniquely designed extraction medium is capable of extracting target analyte(s) directly from whole blood. Due to the special geometry of FPSE medium (flexible, flat and permeable) and sponge-like porous architecture of sol-gel sorbents, rapid analyte mass transfer occurs between the bulk sample and the extraction medium, resulting in a near-exhaustive extraction within a fraction of time required for other comparable sample preparation techniques. FPSE is particularly suitable for analyzing target analytes e.g., metabolites, biomarkers directly from whole blood without requiring any protein precipitation or other pre-extraction sample cleaning/manipulation. After extracting the target analyte(s) directly from the whole blood sample, FPSE media is exposed to a small volume of organic/organo-aqueous solvent for eluting the extracted analyte(s). The low viscosity of the organic solvent, the capillary force of the fabric support and sponge-like porous sol-gel network allows fast diffusion of organic solvent into the FPSE medium for quick and complete recovery of the extracted analyte(s). As a result, FPSE completely eliminates time-consuming and error-prone solvent evaporation and sample reconstitution step often considered as an integral part of solid phase extraction/liquid-liquid e work-flow. During the solvent-mediated elution/back-extraction, any protein or matrix interferents adhered to the FPSE medium precipitates out and a final centrifugation of the resulting solution prior to injecting into the analytical instrument ensures clean particle-free highly concentrated target analyte(s). Fabric phase sorptive extraction has already developed a large number of sol-gel sorbents specifically suitable for polar metabolites/biomarkers such as sol-gel polyethylene glycol, sol-gel chitosan, sol-gel Carbowax 20M, sol-gel polycaprolactone-dimethylsiloxane-caprolactone to name a few. These high-efficiency sorbents have been found equally effective for analytes with a wide range of polarity. As a consequence, searching for a new disease biomarker from whole blood in presence of numerous endogenous and exogenous interferents is no longer a wishful thinking but an achievable reality. In the current talk, some new and fascinating data on metabolomics sample preparation using FPSE and a comparison between FPSE and conventional sample preparation techniques will be presented.