Biography:

Prof. Dr. Maha Abdelmonem Hegazy has completed her PhD in Analytical Chemistry by Faculty of Pharmacy, Cairo University. She has worked as professor of Analytical Chemistry at Cairo University. She has published 108 papers in reputed journals in the field of chemometrics and pharmaceutical analysis. She had achieved 1029 citations and an h index of 16 (goo.gl/u7Qf1V) and was ranked within the top ten researchers of Cairo University in the year 2015. She has been serving as a director of the computer center at Faculty of Pharmacy, Cairo University. She has been working in the field of Accreditation of testing laboratories and PT providers since 2010 at the Egyptian Accreditation Council.           

Abstract:

A need for new approaches for assuring biopharmaceutical products quality has been emerged with the increased complexity of medicines and addopting advanced manufacturing ways. Moreover an increased regulatory emphasis on process understanding and quality have been emerged. FDA, EMA and ICH have drawn attention to a number of structural features that have to be assessed to confirm consistent batch production and ensuring control of the manufacturing process for regulatory acceptance of biotherapeutics. Critical quality attributes (CQAs) have to be assessed through structural characterization. Significant differences between batches need to be investigated, therefore new tools of design of experiments (DOE) and data analysis are needed to generate maximum information for quality assessment of biotherapeutics. Mapping analytical methods for multiple quality attributes is also required to ensure method’s ability to detect relevant differences between samples. Recently, monoclonal antibodies (mAbs) have generated much interest in treatment of various life-threatening diseases. Ramucirumab (RAMI) was recently approved for stomach cancer treatment. RAMI was subjected to different physicochemical stress conditions namely;  mechanical agitation, pH, temperature, and repeated freeze-thaw cycles. SE-HPLC method was developed and validated for monitoring RAMI monomer peak (mono-RAMI) under the former stress conditions. An optimized SE-HPLC system was established. Percent degradation was shown to reliably reveal slight changes in product stability, rather than expressing the results using % Purity. Results augmented an alarm regarding the safety and effectiveness of multi-dose RAMI vials of refrigerating storage. The necessity for developing validation of in-house testing practice by local regulatory authorities is crucial to avoid the entrée of substandard bio-therapeutics to local markets was discussed.

Biography:

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Abstract:

UPPER is a comprehensive model for the estimation of 16 bio-relevant physicochemical properties of organic compounds, including Heats of boiling and melting, entropies of boiling and melting, melting point, boiling point, molar volume, vapor pressure, solubilities in water and in octanol, and octanol-water, air-water, and air-octanol partition coefficients.

The key to the success of UPPER is its use of the calculation of melting point from the enthalpy and entropy of fusion.  Both are dependent on chemical structure, but in different ways.  UPPER utilizes group contribution values to calculate enthalpic properties and geometric parameters to calculate entropic properties.  It is based on a system of sound thermodynamic relationships that relate these properties to one another.

Because UPPER doesn’t use a melting point training set for the calculation of melting points, it can serve as a guide for the design of compounds with optimal physical properties

Biography:

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Abstract:

Alzheimer’s disease (AD) is an irreversible progressive neurodegenerative disorder currently afflicting >5 millionAmericans and >46 million people worldwide. By the mid-century these numbers are expected to escalate by>16 million Americans and >130 million people worldwide suffering from AD, if effective Alzheimer’s diseasemodifyingtreatment(s) are not discovered. Currently, there are only five drugs approved by the FDA to treat AD.These approved drugs including cholinesterase inhibitors, N-methyl-D-aspartate (NMDA) receptor antagonist ortheir combination usually provide temporary and incomplete symptomatic relief accompanied with severe sideeffects. The marginal benefits were unable to slow the progression of AD. Thus, developing drugs for moreeffective AD treatment is in urgent need. Despite the development of many hypotheses based on themultifactorial nature of AD, amyloid cascade hypothesis continues to dominate AD therapeutics, reinforcing Aßclearance by immunotherapy as an important choice for treating AD. Although the first active AD vaccine(AN1792) developed by ELAN showed some beneficial effects such as less cognitive decline, it was suspendedowing to serious side effect, or meningoencephalitis. Systemic passive immunotherapy did not do much betterthan active immunotherapy. Different antibodies targeting different epitopes of Aß i.e. BapineuzumabCrenezumab, Solanezumab and Ponezumab have failed in clinical trials, along with the failed phase IIIEXPEDITION3 trial of Solanezumab showing moderate benefit in Clinical Dementia Rating and Mini-MentalState Examination. Despite these limitations, immunotherapy may still be the better approach to modify theextent of neurodegeneration in AD, if successful in circumventing systemic adversities. Major problemsassociated with active immunization include hypo-immune state of aged patients who are unable to producesufficient amount of anti-Aß antibody and blood brain barrier (BBB) penetrance. While systemic passiveimmunization is posed with >10 greater loading of periphery with anti-Aß antibody to facilitate sufficient amountof anti-Aß antibody to reach the brain, that produces hemorrhage. In that regard, we have shown that that directdelivery of anti-Aß antibodies via intracerebroventricular (ICV) route, circumvented systemic adversities andexerted pronounced beneficial effects in the transgenic mouse models of AD, even when used in small quantities.To further overcome the “invasiveness” of direct delivery ICV route, the use of a non-invasive nasal route of braintargeting is gaining considerable attention which utilizes olfactory, rostral migratory stream, and trigeminal routesto reach the brain. The nasal mucosa offers a large surface area, rapid absorption, and avoidance of first-passmetabolism increasing drug bioavailability with less systemic side effects. This presentation discussestranslational potential of nasal passive immunization in Alzheimer’s disease.

Biography:

Danxin Wang earned her M.D degree at Fudan University Medical School, Shanghai China and Ph.D. at Institute of Pharmacology and Toxicology Beijing, China. Currently, she is an Associate Professor in Department of Pharmacotherapy and Translational Research at University of Florida. She has published over 70 research papers and has several United Sate Patent Applications. Her research interest is to discover pharmacogenetic/pharmacogenomics biomarkers for personalized drug therapy, focusing on understanding the genetic, epigenetic and non-genetic factors determining inter-person variability in drug metabolism.

Abstract:

Drug exposure and therapeutic outcomes are greatly affected by substantial variability in drug metabolism.  Cytochrome P450s (CYPs) constitute the main enzyme metabolizing nearly 70% of currently used drugs.  Genetic factors play a major role in determining an individual’s enzyme activities, but are still partially resolved, despite intense studies performed over decades.  Common protein-coding variants of drug metabolizing CYPs are readily detectable and have been extensively studied; yet, a large portion of inter-person variability in CYPs’ activities remain unaccounted for.  Variable gene expression and regulation represent a second main cause of variability in CYPs but have not been systematically analyzed for most drug metabolizing CYPs thus far.  In this talk, I will focus on regulatory polymorphisms in several drug metabolizing CYPs (CYP3A4, CYP2D6 and CYP7A1), and discuss their clinical relevance.  Moreover, I will discuss the interactions between more than one variants in the same gene locus.  The results emphasize the importance of identifying all variants (coding and regulatory), understanding their interactions, and incorporating them into pharmacogenetics testing panels to improve genotype-phenotype predictions.

Biography:

Prof. Zafer Guney graduated from Ankara University School of Medicine in 1992. He was specialized in Medical Pharmacology in 1997 from Gazi University School of Medicine. Currently he is a professor in department of Pharmacology and Translational Medicne at Gazi University. He is a member of Biyoteg TUBITAK & The Ethics Committee of Zekai Tahir Burak Hospital Ankara.

Dr. Zafer is the owner of the RD Drug Consultancy Ltd., in Ankara. He is also the president of the Biotechnological Drugs Society (BIYILDER).

Abstract:

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Biography:

Prof. Rasha Moustafa Youssef is a Professor of Pharmaceutical Analytical Chemistry and Quality Control at the Faculty of Pharmacy, Alexandria University, Egypt. She is an Editorial Board Member of International Journal of Environmental Research and Development (IJERD); WORLD JOURNAL of PHARMACY AND PHARMACEUTICAL SCIENCE (WJPPS) and “Journal of Pharmacovigilance”.

Currently she is also serving as an Associate Editor of “World Research Journal of analytical Chemistry” and Editorial Review Board of “Journal of American Academic Research (JAAR)”.

She was also the scientific Committee Member for several conferences like International Conference on Pharmaceutical and Healthcare Science (PHS) 2019 and Program Technical Committee Member of 3rd Science Conference of Drug Discovery and Development (3rd SCDDD).

Prof. Rasha also served as a reviewer for highly ranked international journals specialized in analytical chemistry and its applications (e.g.Talanta, Spectrochimica Acta, Pharmaceutica Analytica Acta, Spectroscopy-Biomedical Application, African Journal of pharmacy and pharmacology and Chem Ind. Chem. Eng. Q.).

Abstract:

Capillary electrophoresis (CE) provides an alternative and complementary method to the more frequently used chromatography. CE has high selectivity as it uses a non-reactive capillary surface at a pH chosen by the analyst to provide good separation. It has variable advantages such as good efficiency with short migration time, small quantity of required reagents and the possibility to analyze even unprocessed biological samples. Thus, it was valuable efforts to perform CE method for separation and quantitative determination of binary mixture of  Mometasone Furoate and Salicylic acid in their ointment formulation to overcome two problems; the extremely high concentration ratio of the two drugs in topical formulation and the interference from the topical formulation excipients particularly on the minor component (Mometasone Furoate). A sensitive capillary electrophoresis technique coupled with a diode array detector has been developed for the simultaneous determination of Mometasone Furoate and Salicylic acid in bulk powder and ointment. Separation of both Mometasone Furoate and Salicylic acid was achieved utilizing fused silica capillary of the following dimensions: 50 cm effective length, and 50 μm internal diameters (id).  The background electrolyte solution consisted of borate buffer (150 mM, pH 7.2). The proposed method was validated according to ICH guidelines by testing its specificity, linearity, precision, accuracy, recovery, and detection limit/quantitation limit values. The method was linear over the range 0.2 – 40.0 μg/ml for Mometasone Furoate (r = 0.9998) and 0.1 – 200.0 μg/ml for Salicylic acid (r = 0.9998). Within-day and between-day RSD for Mometasone Furoate and Salicylic acid were <2% and <1.5%, respectively. The detection limit was 0.13 μg/ml for Mometasone Furoate and 0.10 μg/ml for Salicylic acid. The validated method was successfully employed for the determination of both drugs in ointment with no interfering peaks from common pharmaceutical excipients.

Biography:

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Abstract:

Obesity is the fifth leading cause of global mortality. At least 2.8 million adults are dying each year as being overweight or obese in the world. These statistics justify the need of new anti-obesity drugs. It is well- known that obesity is a major risk factor for chronic diseases like hypertension/cardiovascular diseases, type-2 diabetes, various cancers, digestive and respiratory diseases. Products from natural sources can be developed faster and less expensively than conventional pharmaceuticals. Fa Ban Xia (Pinelliae Ternatae)/rhizome) is mainly used in Chinese tradition Medicine and in Korea. for treating cough, headache & ulcers. Chickweed (Stellaria media)/ Whole plant) has diuretic, expectorant, anti-asthmatic properties. Fenugreek (Trigonella foenum graceum)/ Leaves) leaves & seeds are used in remedies for diabetes and hyper cholesterolemia in Indian, Arabic and Chinese medicine. Bottle Gaurd (Lagenaria siceraria)/ Skin) is recognized to have anti-hyperglycemic and anti-hyperlipidemic properties especially used in South-East Asia. There are no reports found in literature on their anti-adipogenic/-obesity effects. We, therefore, decided to study these properties using 3T3-L1 pre-adipocytes. Extracts were prepared in 15% ethanol (at room-temperature), lyophilized and were reconstituted in distilled water. For experiment purpose, two dilutions (high = 32.4 mg/ml and low = 16.2 mg/ml concentrations) were prepared for all plant extracts. 3T3-L1 preadipocytes (ATCC) were cultured in growth medium (DMEM+10% calf serum + 1% PS) in cell culture flask, later cells were grown in culture media, and harvested for experiment. Differentiating media was used for diffentiating cells into matured adipocytes. and maintained in maintenance media. Controls (cells having culture medium only and no plant extract) were run along with experimental wells (cells having different conc. of plant extracts). Oil-O-Red (for lipid content) and cell proliferation assays were carried out using 24 and 96 well plates respectively. For Oil-O-red assay and Cell proliferation assay absorbance was recorded at 490nm using ELISA plate reader. Cell Proliferation assay was done using Promega one step cell titer kit (Cell titer 96® Aqueous one solution cell proliferation assay) kit. Undifferentiated cells had lowest level of lipid content. Lipid content increased as they differentiated into adipocytes. The highest lipid content was noticed in control wells. Orlistat treated wells had similar lipid content to that found for control. The most potent plant extract was that of Fa Ban Xia because it did not allow cells to differentiate and had lowest lipid content in comparison to extracts of chick weed. The effect on differentiation: potency wise (low to high) -can be expressed as: Media control< Orlistat control< Chickweed(low) Fenugreek leaves> Bottle Gourd> Fa ban Xia. Our study showed that the plant extracts studied had anti differentiating, lipid lowering, and antiproliferative properties.

Biography:

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Abstract:

The present study considered the pharmacokinetic evaluation of empagliflozin after administration to Egyptian volunteers, and the results were compared with other ethnic populations. The FDA recognizes that standard methods of defining racial subgroups are necessary to compare results across pharmacokinetic studies and to assess potential subgroup differences. The design of the study was as an open labeled, randomized, one treatment, one period, single dose pharmacokinetic study. The main pharmacokinetic parameters estimated were Cmax, Tmax, t1/2, elimination rate constant, AUC0-t and AUC0-inf. The insignificant difference in pharmacokinetic parameters between Egyptians and white German subjects suggests that no dose adjustment should be considered with administration of 25mg empagliflozin to Egyptian population. A new LC-MS/MS method was developed and validated, allowing sensitive estimation of empagliflozin (25–600ng mL⁻¹) in human plasma using dapagliflozin as an internal standard (IS). The method was applied successfully on the underlying pharmacokinetic study with enhanced sample preparation that involved liquid-liquid extraction. Multiple Reaction Monitoring (MRM) of the transition pairs of m/z 449.01 to 371.21 for empagliflozin and m/z 407.00 to 328.81 for dapagliflozin (IS) was employed utilizing negative mode Electro Spray Ionization (ESI). The validated LC-MS/MS method is suitable for further toxicodynamic and bioequivalence studies.

Biography:

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Abstract:

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