Scientific Program

Conference Series LLC Ltd invites all the participants across the globe to attend International Conference and Exhibition on Drug Safety & Pharmacovigilance Park Inn By Radisson Toronto Airport West, 175 Derry Road East, Mississauga, ON, L5T 2Z7, Canada.

Day 2 :

Keynote Forum

Brigitte Simons

Molecular Science Corp., Canada

Keynote: Differentiating cannabis products within the brands of the legalized adult use markets

Time : 09:00-09:40

Drug Safety 2018 International Conference Keynote Speaker Brigitte Simons photo
Biography:

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. 

Abstract:

Within the framework of Bill C-45, Canada is positioned to become the global leader in the legal cannabis economy and global exporter. The enactment of this Canadian Cannabis Act provides legal access to marijuana and to control and regulate its production, distribution and sale. The primary objective of Health Canada’s regulatory policy bears stringencies with respect to public health and safety and strict requirements for quality assurance, record keeping and mandatory testing by 3rd party laboratories for product contamination. This opens an opportunity for advancing analytical development for cannabis metabolite profiling of active natural products and bleeds through to the accurate quantitative reporting of pesticides, mycotoxins and heavy metalloids that serve regulatory audit to clear products for sale. A complete LC-MS/MS workflow is described to quantitate 14 cannabinoids and screen for over 40 terpenoids to fingerprint various top cannabis dried flower brands from the large enterprise-producers in a method that is delivered in under 15 mins of analytical run time using a dual ESI and APCI ionization strategy. A wide linear dynamic range of 0.03 to 90% measurement (104 orders LDR) of cannabinoid per LC-MS injection can be reported to provide a more accurate view for product labeling and dosing recommendations. Terpene expression and metabolite measurement in plant cultivars are becoming less challenging with newly identified terpene synthases and availability of new mono-terpenes and sesquiterpene standards. It is of high interest for results of these metabolite profiling experiments to be correlated with plant cultivation parameters to achieve quality control and strengthen the consumer's experience with a brand of cannabis and differentiate products for retail. Furthermore, pesticide residue analysis in cannabis flower and oil formulations has been developed to meet the reporting requirements of Health Canada’s banned pest control ingredients list. With UHPLC linked tandem mass analysis covering all of the 96 banned pesticides except for 11 compounds best suited by GC separation, it is possible to achieve a validated cannabis product certificate of analysis for issuance to cannabis licensed producers in rapid turn-around. Analytical method details include LC separation using the Raptor Restek Column, Raptor Biphenyl and newly available mixtures of pesticide standards to meet the Canadian Pest Management Agency’s list of required pesticide maximum residual levels (down to 10 ppb in most cases). The addition of mycotoxins and other organo-contaminants can also be inserted into our methods with the use of optimized Scheduled MRM mass spec scanning techniques. The assembly of all the potency and ingredients data collection possible can provide information to consumers and track benefits to the cannabis producers stride to bring powerful brands to the global cannabis market.
 

 

Keynote Forum

Manuela G Neuman

University of Toronto, Canada

Keynote: Alcohol and drugs

Time : 09:45-10:25

Drug Safety 2018 International Conference Keynote Speaker Manuela G Neuman photo
Biography:

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. 

Abstract:

The interplay of alcohol with drugs includes multiple facets. These include the effects of alcohol on the effects of other hepatotoxicants and on the pharmacological effects of various drugs. Also relevant is the possible role of alcohol on the effects of carcinogenic agents. Less striking, but significant, are the effects of other drugs on the effects of ethanol. More difficult to identify but presumably significant, are the effects of alcohol-drug interplay on the development of an alcoholic liver disease. A common denominator of them is the role of ethanol-induced P-4502E1 (CYP2El) in affecting the toxicity of some hepatotoxicants and the effects of some drugs. Less prominent but also relevant is the effect of interplay with alcohol dehydrogenase and aldehyde dehydrogenase in the toxicity of some drugs. Alcohol has been shown to be responsible for cirrhosis in the 18th century and was labeled a hepatotoxin in the 19th century. During the second half of the 20th century alcohol has been recognize to enhance the toxic effect of other hepatotoxic agents such as acetaminophen, aflatoxin B1, allyl alcohol, bromobenzene, cocaine, enflurane, galactosamine, halothane, isoniazid, nitrosamines, thioacetamide, vinyl chloride and vitamin A. The toxicity of several hepatotoxicants is unaffected and of at least one, amanitine, is decreased by ethanol. The effect of ethanol on the toxicity of carbon tetrachloride and acetaminophen have been studied most extensively. The enhancement of toxicity by ethanol does not depend on an ethanol-induced hepatic injury but rather on the activity of the cytochrome P450 2E1 that converts the respective toxicants to their active metabolites. Nevertheless, inhibition by ethanol of regenerative response to injury may contribute to an enhancement of toxicity by ethanol. The toxicity produced by ethanol may have a bearing on the liver disease of alcoholism as well as on the toxicity and carcinogenicity of individual toxicants.
 

 

Drug Safety 2018 International Conference Keynote Speaker Abuzar Kabir photo
Biography:

Abuzar Kabir, a Research Assistant Professor at the International Forensic Research Institute (IFRI), Department of Chemistry and Biochemistry, Florida International University (FIU), Miami, Florida, USA, is a Separation Scientist and Materials Chemist. He has received his Ph.D. in analytical chemistry from University of South Florida (USF), Tampa, Florida, USA with specialization in sol-gel synthesis. He has invented 16-patented technologies in the area of chromatographic separation and analytical/bioanalytical sample preparation. He has also authored/co-authored 9 book chapters, 6 review articles, 46 research articles and 89 conference papers. 

Abstract:

 
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.
 

Keynote Forum

Peng Chen

Chemic Labs Inc., USA

Keynote: Applications of UPLC-MS QTOF in structural elucidation of small molecules

Time : 11:30-12:10

Drug Safety 2018 International Conference Keynote Speaker Peng Chen photo
Biography:

Peng Chen received a Ph.D. in Analytical Chemistry from Indiana University in 1998 and a M.S. in Organic Chemistry from the University of Louisville in 1994. His graduate research includes the introduction of osazones as MALDI matrices for carbohydrate analysis and the structural elucidation of fluorescent aging markers. He has been working in various chemical industry sectors in the fields of chromatography and mass spectrometry. His work in recent years at Chemic Labs Inc. involves structural elucidation of small molecules in pharmaceuticals and medical devices by high-resolution QTOF mass spectrometry. 

Abstract:

The structural elucidation of small molecules by high-resolution mass spectrometry plays important roles in development and quality control of pharmaceuticals and medical devices. Trace amounts of small molecules can be present in forms of impurities, by-products or degradation products, etc. It is often difficult to separate and fractionate enough quantities of these analytes for conventional structural analysis by NMR and FTIR. Recent advances in instrumentation and software of UPLC-MS QTOF with MS/MS fragmentation capability can give structural insight into molecules of interest and in many cases offer structure candidates at high confidence. This presentation will use several practical examples in the analysis of synthetic compounds and identification of impurities associated with pharmaceuticals and medical devices to illustrate the convenience and power of UPLC-QTOF high-resolution mass spectrometry.