Pharma Middle East November 02-04, 2015 Dubai, UAE

Biography:

Dong-Kwon Rhee has completed his PhD at University of Illinois at Chicago in 1988 and Postdoctoral studies from Yale University School of Medicine. He was the Director of World Class University at Sungkyunkwan University, which is ranked 47th in Pharmacy and Pharmacology World rankings 2014. He has published 154 papers in reputed journals and is serving as a President of Korean Society of Ginseng.

Abstract:

Panax ginseng C A Meyer is one of the most popular herbal medicines in Korea, and has long been used in Asian countries for stimulating immunity and inhibiting various cancers. Although the role of ginseng in regulating the development of cancer is well defined, the mechanism by which it protects brain cells from oxidative stress is not well understood. Since brain myelin sheaths contain relatively large amounts of iron and lipids and have high rates of oxidative metabolism with limited antioxidant capacity, brain is highly susceptible to oxidative damage. In this study, Korean Red Ginseng (KRG) extract was shown to inhibit oxidative stress-induced apoptosis in neuro-blastoma cells. This apoptosis inhibition was mediated by ER-β up-regulation via the PI3K/AKT signaling pathway. The up-regulation of PI3K/AKT signaling inhibited apoptotic signals by decreasing p-p53 and caspase-3 expression, but increasing BCL2 expression. Therefore, KRG protected brain cells from oxidative stress-induced cell death. Collectively, these data suggest that activation of ER-β by KRG inhibits apoptosis in oxidatively stressed

Biography:

Mehmet Bilgehan Pektas has completed his PhD at the age of 28 years from Gazi University and postdoctoral studies from Afyon Kocatepe University School of Medicine. He has published more than 7 papers in reputed journals and has been serving as an editorial board member of repute

Abstract:

Visfatin is a recently discovered hormone known to be synthesized in adipocyte, hepatocyte and granulocytes and its production or suppression is modulated with diabetes mellitus. It has many cellular functions such as cell proliferation, biosynthesis of nicotinamide mono- and dinucleotide and posesses insulin-like hypoglycemic effect. This study aims to investigate the effects of diabetes on the hepatic visfatin, Asymmetric Dimethylarginine (ADMA), Erythropoietin (EPO) levels and histo-pathological features in streptozotocin-induced diabetes. In addition, the effects of resveratrol known as strong protective molecule were explored. Recruited Wistar male rats randomly divided into four groups; (1) control/vehicle; (2) control/20 mg/kg resveratrol; (3) diabetic/vehicle; (4) diabetic/20 mg/kg resveratrol. Hepatic visfatin, ADMA, EPO and insulin levels were measured with ELISA kits. Histo-pathological examinations were carried out to reveal hepatic tissue damage and inflammation. Body weight, hepatic insulin and ADMA levels reduced significantly but hepatic glucose, visfatin and EPO levels increased in the diabetic group. Furthermore, diabetes amplified damage, nuclear atypia and density of Kuppfer cells observed in the liver. Resveratrol treatment normalized these complications in the diabetic group. Oxidative damage triggered by diabetes enhanced ADMA levels but decreased visfatin and resveratrol improved this situation. This may be due to the protective activity of resveratrol on relationship between inflammation-visfatin pathways.

Biography:

Novotny L was born on October 5, 1955 in Svitavy, Czechoslovakia. He had obtained his Bachelor’s Degree in Pharmaceutical Science from Kharkov Pharmaceutical Institute, Ukraine in 1980; Doctor of Pharmaceutical degree from Charles University in 1981; Doctor of Philosophy degree from Czechoslovak Academy of Sciences in Prague in 1984; Doctor of Science degree from Slovak Academy of Sciences, Bratislava in 1997. He is working as a Professor of Pharmaceutical Chemistry in Kuwait University, since 1998. He is the acting dean of Faculty Pharmacy, since 2003. He is the member of Kuwait Pharmaceutical Association, European Association Cancer Research, American Association Cancer Research, Slovak Pharmacol. Society, Slovak Pharmaceutical Society. He contributed more than 140 articles to reputed Science journals.

Abstract:

In search for new therapies, traditional medicines of plant origin are investigated using modern scientific techniques. One of such products is produced under the name Natural Diabetea. It is a mixture of powders of several medicinal plants. It is prescribed as a drink for diabetes and other diseases in some Asian countries. The active constituents of this mixture of medicinal plants were investigated by Gas Chromatography-Mass Spectrometry (GC-MS) for identification and quantification of active natural compounds present for possible elucidation of the therapeutic action. GC-MS analysis of the methanol extract of the tea product indicated the major biologically active constituents, i.e. caffeine, β-sitosterol, β-amyrin, lupeol, linoleic acid and vitamin E. The identification of the substances was performed based on retention times and molecular ion masses by matching the MS spectra of GC chromatographic peaks with spectra of reference compounds in the NIST library. Furthermore, GC/MS analyses of available individual herbal constituents of this tea mixture, e.g., Nuga (Ficus bengalensis) and Attikka (Ficus racemosa) extracts were also conducted for comparison. The analysis indicated the presence of lupeol and β-amyrin in Nuga extract and β-sitosterol in Attikka extract. Quantification of the major active constituents, β-sitosterol, β-amyrin and lupeol, was based on measurement of the peak areas of these components in herbal extracts of tea product in comparison to β-sitosterol, β-amyrin and lupeol reference solutions of known concentrations. Using the above formula, approximate concentrations of lupeol, β-amyrin and β-sitosterol at 10 mg, 3.0 mg and 7.0 mg per 1 gm of the tea mixture were calculated. Conclusion: The beneficial properties of Natural Diabetea are likely, at least partially, due to the presence of phytosterols, namely β-amyrin, lupeol and β-sitosterol. Several of these substances were detected, confirmed and quantified using GC/MS analysis.

Biography:

Dr. Ahmed Mohamed Kabel had the Ph.D. degree in Pharmacology in 2013 from Faculty of Medicine, Tanta University, Egypt. He is involved in teaching undergraduate and postgraduate students as well as supervised one master student and one Ph.D. student in Egypt. He has published more than 21 research articles in reputable international peer reviewed journals. His areas of research interests are pharmacy practice, oncology and pediatric pharmacology.

Abstract:

Solid Ehrlich carcinoma is a transplantable tumor model used in tumor studies. Adriamycin is a cytotoxic anthracycline antibiotic used in treatment of many types of cancer. Metformin is anti-diabetic drug and is under investigation for treatment of cancer. The aim of this work was to study the effect of each of adriamycin and metformin alone and in combination on solid Ehrlich tumor in mice. One hundred albino mice were divided into five equal groups: Control untreated group, SEC, SEC+adriamycin, SEC+metformin, SEC+adriamycin+metformin. Tumor volume, survival rate, tissue catalase, tissue reduced glutathione, tissue malondialdehyde, tissue sphingosine kinase 1 activity, tissue caspase 3 activity and tissue tumor necrosis factor alpha were determined. A part of the tumor was examined for histo-pathological and immune-histochemical study. Adriamycin or metformin alone or in combination induced significant increase in the survival rate, tissue catalase, reduced glutathione and tissue caspase 3 activity with significant decrease in tumor volume, tissue malondialdehyde, tissue sphingosine kinase 1 activity and tumor necrosis factor alpha and alleviated the histopathological changes with significant increase in p53 expression and apoptotic index compared to SEC group. The combination of adriamycin and metformin has a better effect than each of adriamycin or metformin alone against transplantable tumor model in mice.

Biography:

V Ravi Chandran is a distinguished alumnus of the University of Florida, USA where he graduated with a PhD in Pharmaceutical Sciences in 1986. Since then, as an independent scientist and business leader, he has been engaged in pharmaceutical manufacturing, research and development of new drug molecules, hitech drug manufacturing and distribution in USA, and has more than 25 patents for excess of 9000 new molecules in various countries including USA, Japan, Australia and others. With his breakthrough research in anti-platelet drugs, he demonstrated that to develop a new drug, it is not necessary to start with thousands of molecules. Instead, by combining ideas from a multidisciplinary approach, few drugs can be zeroed in on at a very early stage and carry them to final regulatory approval.

Abstract:

While guerilla marketing and guerilla warfare are well known, guerilla innovation is a new concept. Guerilla tactics used by a pharmaceutical drug discovery innovator are not only effective, but also force one to think outside the box. The techniques used to bring the drugs to market without compromising safety and efficacy is of paramount importance to a guerilla innovator. How does guerilla innovator different from a drug discovery scientist? A guerilla innovator does not spend huge amount of other people’s money to design and develop a new drug. Instead, the guerilla innovator uses bridging two apparently disjointed concepts, brings them together to postulate a mechanism of action, and then reverse engineers to the right molecule with extreme precision. This means a guerilla innovator does not synthesize thousands of chemicals and go through an expensive screening process. Instead, based upon reverse engineered process, zeros in on either two to four molecules right for the treatment of any underlying disease. Yes, one or all of the three or four molecules are the ultimate drugs, and they all should work, if the guerilla innovators thinking process is correct. Key requirement for the guerilla innovation is that the safety of a drug is critical, the precise molecules must be almost devoid of toxicity, and thus therapeutic efficacy is multifold compared to existing drugs.

Biography:

Mohamed Zakaria Gad is Professor and Head of Biochemistry Department at German University in Cairo. He graduated 1st of 500 from Pharmacy, Cairo University and completed PhD from Medical College of Pennsylvania, USA. He worked as Professor/Head of Biochemistry at Cairo, October 6 and Helwan Universities, Vice-Dean for Research and Graduate Studies at Ain Shams University, Chief Coordinator of TEMPUS Curriculum Development Project in Pharmacy (5 European and 3 Egyptian Universities). He received Fellowship from American Heart Association and National Promotional Prize in Biomedical Sciences (2002) and also received STDF grant from National Academy of Science (2011-2014). He is a Board Member of Egyptian National Committee of Biochemistry and Molecular Biology and a Reviewer to several scientific journals. He has 56 publications and 65 conference abstracts, published selected articles in “Biology of Nitric Oxide” book, Portland Press, 2000, was the Principal Author and Editor of book: A Model Pharmacy Curriculum: An Egyptian-European Experience, Higher Education Academy, UK.

Abstract:

Cardio-vascular disease (CVD) remains the leading cause of death worldwide. Coronary artery disease (CAD) represents the major CVD among several populations. Despite huge efforts and great advances in studying the genetic component of CAD, there is still a great need for exploring the genetic and environmental factors contributing in the development of this disease. Among these factors emerge modulation of Nitric Oxide (NO) homeostasis and oxidative stress as central players according to recent reports. A range of biochemical disturbances including reduced availability of NO and oxidative stress has been shown to be associated with Endothelial Dysfunction (ED). Many studies described the contribution of ED in the predisposition of CAD; in particular Myocardial Infarction (MI). Recent evidence indicates that ED may be genetically determined. This presentation points out to the key players that influence vascular NO levels and their role in the protection and/or predisposition to CAD.

Biography:

Mohamed Salah Omar has completed his PhD from Ludwik Hirszfeld Institute of Immunology and Experimental Therapy, Polish Academy of Sciences, Wrocław, Poland. He is currently an Assistant Professor of Biochemistry in the College of Clinical Pharmacy, Taif University, KSA. He has three patents, one is US, one is European and the third is Polish. He has published more than 11 papers in reputed journals.

Abstract:

One of the means to improve therapeutic activity of drugs is their conjugation with biological or synthetic macromolecular carriers. The idea of the carrier is to provide selectivity to the system. Past reports described synthesis, chemical and anti-tumour assays of Methotrexate (MTX) conjugates, but high selectivity was spoiled by toxicity. We developed a new method of coupling MTX with carriers (US 8,623,998 B2): MTX was transformed into its anhydride by treatment with dicyclohexyl carbodiimide. Then, MTX anhydride was coupled to native and glycated fibrinogen in aqueous solution at room temperature. At these conditions, only one of the two carboxylic groups could be acylated, thus chemical cross-linking was avoided. The obtained conjugates were characterized by reasonable uniformity, high purity, lower hydrophobicity and lack of cross-linked fractions as compared to those obtained without control of the reactivity of dicarboxylic functionality of MTX. These effects together reduced the non-specific interactions with hydrophobic components of tissues and thus emphasized the selectivity of the carrier. Native and glycated fibrinogen-MTX conjugates were a prospective way for new anti-cancer drug development due to their high anti-tumor activity. Moreover, their anti-arthritic activity was significantly more effective in suppression of the onset of arthritis in a mouse model than was free MTX. In conclusion, a correct selection of the drug and carrier as well as the type of chemical modification is important. The conditions of modification reaction should allow retention of biological activities of both the drug and the carrier. Native and glycated fibrinogen appear to be a suitable carrier in leukemia and RA.

Biography:

Medani A B has completed her PhD from University of Khartoum and Postdoctoral studies from University of Medical Sciences & Technology. She is an Assistant Professor of Pharmacology & Toxicology, Faculty of Pharmacy, UMST. She has published more than 5 papers in reputed journals and has been serving as an Editorial Board Member of repute.

Abstract:

New Zealand rabbits were purchased, weighed and divided into 3 groups, each of three. Group 1 animals were the undosed controls. Test groups were given alum at dose rates of 1% and 20% for groups 2 and 3, respectively for acute toxicity under ideal experimental conditions. Clinical signs, post-mortem and histo-pathological changes were observed. Serum investigations included enzymatic concentrations, metabolic changes, fluctuations in electrolyte levels and hematological changes. Mortalities occurred to variable degrees irrespective of the dose level. The tested rabbits showed uncontrolled diarrhoea, uncontrolled salivation, dullness, shivering, inappetance and finally recumbency depending in severity on the dose. On atomic absorption, only the lungs kept residual alum, while the livers washed it out. Oral dosing with alum caused congestion of livers with white spots, stiff-greenish lungs and inflammed empty intestines. The un-dosed group 1 rabbits showed a normal picture. On histopathology, alum-dosed group of rabbits showed nephro-necrosis in the cortex and medulla, emphysema in the lungs and congestion and necrosis of the hepatocytes. Alum was considered toxic to New Zealand rabbits at all dose rates tried.

Biography:

Abstract:

Objectives: To assess the overall safety of high-dose intravenous immunoglobulin (IG) products used to treat patients with neuro immunological disorders in a supervised home-based setting. Methods: The incidence of adverse reactions was assessed in a retrospective chart review of 420 patients who consecutively received 4076, home-based, individual, intravenous immunoglobulin (IVIG) infusions between January 2009 and December 2009. Results: A total of 90 patients (21.4%) developed adverse reactions related to IVIG administration (2.6% per individual infusion). A total of 95.5% of adverse reactions were mild, and no serious side effects were observed. The incidence of adverse reactions was significantly lower in the subgroup of patients with neuro immunological disorders who received premedication (18.2% compared with 29.3%, P = 0.02). There was no significant statistical difference in the incidence of side effects among the different brands of IVIG used in this study. Conclusions: The combination of premedication and well defined clinical, IVIG infusion policies may reduce the incidence of high-dose IVIG adverse reactions administered in a home-based setting in patients with neuroimmunological disorders.

Biography:

Camilia Michel has completed her Ph.D. at the age of 34 years benefiting from a channel system between Cairo University and Institute of Pharmaceutical Biology, Bonn, Germany. She is working as Deputy Manager at the Quality Assurance Unit of the Faculty of Pharmacy, Cairo University and as External Evaluator at the National Authority for Quality Assurance and Accreditation for Education (NAQAAE) in Egypt, the only responsible authority for accrediting Higher Educational Institution in Egypt. She has published more than 20 papers in reputed journals and serving as an editorial board member of repute.

Abstract:

Citrus maxima (Burm.) Merr., commonly known as Shaddock or Pomelo, is an original citrus plant belonging to family Rutaceae. Essential oils of peels of four different cultivars (Giza, Jordan, Syria, and Alexandria) obtained by hydro-distillation and by Solid Phase Micro Extraction (SPME) were analyzed by Gas Chromatography coupled with Mass Spectrometer (GC/MS). Limonene was found to be the major constituent reaching a percentage of 97.4% (Giza), 93.2% (Jordan), 90.8% (Syria) and 87.2% (Alexandria). The hydro-distilled essential oils of leaves at four different seasons were similarly analyzed by GC/MS and showed that the percentage of hydrocarbons (α–pinene, Β-pinene, α–phellandrene, camphene, sabinene, myrcene, cymene, limonene, careen, terpinine) were higher than that of oxygenated compounds (1-terpinen-4-ol, terpineol, santalol, eucalyptol, linalool, fenchone, citronellol, citral, eugenol methyl ether, bergamol) with no major constituent. Anti-inflammatory, antioxidant and antimicrobial activities of oils obtained from the peel were investigated.

Biography:

Salwa Elmeligie has completed her PhD from Cairo University and Postdoctoral studies from Faculty of Pharmacy, Iowa University, USA. She is Head of Pharmaceutical Organic Chemistry Department, Faculty of Pharmacy, Cairo University. She is also Reviewer for Higher Education Institutions (HEIs), conducted by the National Authority of Quality Assurance and Accreditation of Education (NAQAAE), and credited trainer in Egypt. She has published more than 36 papers in reputed journals and has been serving as an Editorial Board Member of repute in addition to attending more than 20 training courses in Quality Assurance systems.

Abstract:

Stereochemistry is a unique science concerned with the study of how molecules are affected by the way their atoms are arranged in space. It is also known as 3D chemistry. Stereochemistry has become a significant issue for both of the pharmaceutical industry and the regulatory authorities. There are different types of stereoisomers especially enantiomers. Accordingly, this workshop reviews the concepts of stereochemistry and enantiomers, emphasizes the potential biological and pharmacological differences between the 2 enantiomers of a drug, and highlights the clinical experience with single enantiomers of the selective. Most natural products, the essential products of life, are asymmetric and this established the only well marked line of demarcation between chemistry of dead matter and the chemistry of living matter. So, the importance of stereochemistry in drug action is gaining greater attention in medical practice, and a basic knowledge of the subject will be necessary for clinicians to make informed decisions regarding the use of single-enantiomer drugs. For some therapeutics, single-enantiomer formulations can provide greater selectivity for their biological targets, improved therapeutic indices, and/ or better pharmacokinetics than a mixture of enantiomers. Indeed, more stereochemically pure drug agents will become clinically available and pharmacists will be relied upon for their knowledge and expertise in this area.

Biography:

Prof. Dr. Mohamed Taky El-Din Khayyal, emeritus Professor of Pharmacology, Faculty of Pharmacy, Cairo University, Egypt, was born on 26th October 1937. He obtained his B.Pharm Degree in 1958 from Alexandria University and his PhD from London University (UK) in 1964. He is presently President of the Egyptian Society of Pharmacology and is a member of many scientific societies, including the German Pharmacological and Pharmaceutical Societies, the American Gastroenterology Association, the German Society of Neurogastroenterology, and served as Councillor to the International Union of Pharmacology (2002 – 2010).He obtained Fellowships from Alexander von Humboldt Foundation, (1978), and Fulbright Foundation (1987).He has nearly 100 scientific publications in national and international Journals. His main interests lie in the field of inflammatory and gastrointestinal disorders, herbal medicine and the effects of radiation exposure. He is fluent in both spoken and written English, German, and French apart from his native tongue, Arabic.

Abstract:

Intestinal mucositis is a common adverse effect in patients undergoing radiotherapy and constitutes a treatment-limiting condition. Since no agents are yet known that can adequately guard against its development, the search continues to find safe and effective measures that could prevent this serious side-effect of radiation without affecting its anti-tumor activity. The present study was intended to investigate whether the herbal preparation, STW 5, could offer a potentially effective agent in this respect. STW5 is a multi-target herbal preparation consisting of standardized extracts of bitter candytuft (Iberis amara), lemon balm (Melissa officinalis), chamomile (Matricaria recutita), caraway fruit (Carum carvi), peppermint leaf (Mentha piperita), Angelica root (Angelica archangelica), milk thistle (Silybum marianum), celandine herb (Chelidonium majus), and liquorice root (Glycyrrhiza glabra). The preparation is of proven clinical efficacy in functional dyspepsia and irritable bowel syndrome. Intestinal mucositis was induced in rats by exposing them to different exposure levels of whole body gamma-irradiation. According to these results, a level of 6 Gy was used in later experiments. Rats were treated orally with STW 5 (5 or 10 ml/kg) for five days before and two days after irradiation. One day later, rats were sacrificed and segments of small intestine were examined histologically to assess mucosal integrity. Intestinal homogenates and serum samples were used to assess relevant parameters for mucosal functional activity, such as the brush border enzymes sucrase and alkaline phosphatase, citrulline and cholecystokinin, as well as different markers for inflammation, oxidative stress and apoptotic changes. Exposure to radiation produced dose-dependent extents of intestinal injury associated with changes in functional activity and apoptotic parameters with high radiation levels. Apoptosis was associated with an increase in cytosolic calcium, depletion of mitochondrial cytochrome c, B-cell lymphoma-2 and complex I. Oxidative stress parameters (reduced glutathione, thiobarbituric acid reactive substance and total nitrate/nitrite) were deranged. Inflammation markers (tumor necrosis factor and myeloperoxidase) and indices of intestinal damage (serum diamine oxidase) were increased. STW 5 protected to a large extent against histological changes and counteracted the deranged parameters indicative of apoptosis and of functional integrity. The findings provide strong experimental evidence for the potential therapeutic usefulness of STW5 in protecting against the development of radiation-induced intestinal mucositis and in preserving the functional activity of the small intestine in the face of radiation exposure.

Biography:

Kadriye Benkli has completed her PhD from Anadolu University. She is a Professor and works at Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Anadolu University. She has published more than 40 papers in reputed journals and has been serving as an Editorial Board Member of repute.

Abstract:

The use of fosfomycin is in the treatment of multidrug-resistant bacterial infections and in the treatment of pediatric cancer patients. The continued chemotherapeutic application of cisplatin cis-diammine dichloroplatinum [II] necessitates reduction of its dose-limiting toxicity without decreasing its tumoricidal effect. Fosfomycin is considered a potential antidote for the doselimiting ototoxicity and nephrotoxicity of cisplatin chemotherapy. In this research, some metal complexes of the fosfomycin have been synthesized. The characterization of the intermediate and final compounds arising from this work was carried out by means of a variety of spectroscopic methods, which include 1H NMR, IR, MS, and elemental analysis.

Biography:

Dalia Hussein Soliman has completed her PhD from AL-Azhar University and Postdoctoral studies from the same University in addition to Ain-Shams University. She is currently working as an Associate Professor of pharmaceutical chemistry, pharmaceutical chemistry department at the Egyptian Russian University. She has published more than 12 papers in reputed journals

Abstract:

Prostate cancer is one of the most commonly diagnosed cancers in men, and the second leading cause of cancer deaths in the European Union and United States of America. The high mortality rate is mainly attributed to the invasiveness and metastasis of advanced prostate cancer. Cathepsin B is a cysteine protease found mainly in the lysosomes. The increased expression and secretion of cathepsin B have been shown to be involved in migration and invasion of numerous human and experimental tumors. Therefore, the use of cathepsin B inhibitors reduces both tumor cell motility and invasiveness in vitro. In the present study a series of novel chalcones were prepared and studied for both their anti-prostate and cathepsin B inhibition. Furthermore, a QSAR study was carried out where models were successfully built from which the physicochemical parameters were correlated to the activity.

Biography:

Suad Yousif Abdalla Alkarib has completed her PhD from University of Khartoum. She is the Founder of College of Pharmacy in Karary University. Before that, she was a Director General Manager for the Wafrapharma Laboratories Ltd. She is a Member of the Sudanese Medical Council, the Scientific Researches Committee in Gum Arabic Board (Sudan), and the Arab Administrative Development Organization (League of Arab States). She is the Rapporteur of the Industrial Pharmacy Committee in the Pan Arab Colleges of Pharmacy (October-2012). She is the Member of the proposed Fellowship in Technology of Industrial Pharmacy (Council of pharmaceutical specialties, Sudan). She has got a Certificate of Honor as a Leader in the field of pharmacy, and the first female Major-General (Jan-2011) of Sudan. She has got major awards and decorations in Competency - Duty - The National Rescue - Golden Defense. She has published more than ten papers in different journals and conferences.

Abstract:

Introduction: Gum arabic is a complex, loose aggregate of sugars and hemicelluloses composed of arabic acid nucleus connected with calcium, magnesium, potassium and sugars arabinose, galactose, and rhamnose. In this study, the use of gum arabic acacia in the manufacturing of tablet coating material, using water and plasticizer to add elasticity and flexibility is detailed. Methodology: The study was performed using a solution of gum arabic acacia in a concentration (10%), using a pilot small coating machine with an inlet temperature 400C, and spraying rate 10ml every 5 minutes on the top of placebo tablet bed while continuous drying. The ratio of gum: water and plasticizer plays good roles in final coat characteristic. Physical tests were done for the tablets before and after the process. Results: The final placebo products after coating, should be inspected and tested for appearance and performance inspection should include checks for color, size, appearance, and any physical deficits in the coating, which could affect the performance or/and stability of the product. Conclusion: However, the effect of such variables water: plasticizer ratio gives different profiles with different physical characteristics. This study concludes optimized and stable coating formula from gum arabic. The use of colors and anti-transparency additives is highly required for both film and enteric coat, for technological identification, and according to customers reeds.

Biography:

Kal Ramnarayan, Ph.D. is Founder, President and Chief Scientific Officer of Sapient Discovery and co-founder of Focus Synthesis, LLC. He was formerly the co-founder, Vice President and Chief Scientific Officer of Cengent Therapeutics, Inc. Dr. Ramnarayan (Dr. Ram) was also the co-founder and Chief Scientific Officer of Structural Bioinformatics, Inc. He was part of the management team that raised over US$50M from venture capitalists. In addition he has lead several projects with big-pharma and biotech companies resulting in over $US50M in revenues to the company making his division very profitable. He was the former Head of Computational Chemistry at ImmunoPharmaceutics Inc., where he contributed to the design of a highly active endothelin receptor antagonists (which has resulted in one approved drug in EU, Thelin and one in Phase III clinical trials, Sitaxsenten), TNF antagonists, and FGF antagonists. Previously, Dr. Ram was a Senior NIH Research Associate at the Scripps Research Institute, La Jolla. He has authored numerous scientific papers on computational protein and peptide structure determination and protein structure-based drug design. He is also a co-inventor on U.S. Patent No. 5,571,821 and 6,541,498 covering small molecule endothelin receptor antagonists which entered the clinic in Oct. 1996 and U.S. Patent No. 6, 436, 933 covering the discovery of inhibitors of anthrax lethal factor activity. He has several patent applications pending. He is on the Advisory Board of IBM’s BlueGene program, Keck Graduate Institute and Strand Genomics. He is on the editorial board of Current Proteomics. Dr. Ram holds a Ph.D. degree in Molecular Biophysics from the Indian Institute of Science, Bangalore, India.

Abstract:

Drug discovery has evolved from serendipity to rational design to high throughput screening to focused screening. Success and failures in each of these approaches could be extracted from literature as well as from the number of drugs in the “pipeline” of Pharma companies. It is hard to pinpoint any single reason as the root cause of failure of compounds at the safety studies stage or at clinical studies stage. Each of these methods have their merits and in this era of tight research budgets as well as the lack of venture/angel funding for “Discovery” projects one has to adapt the best practices to enhance success and prove druggability very early on. At Sapient Discovery we use computer derived methods to design molecules that have lower attrition rate by adapting “Target class” approach in combination with focused screening and enhanced drug-like filtering of “hits” prior to actual biological assays. Our technology “Genes to Leads” has been applied to over 30 targets and has resulted in compounds making to clinic and preclinical stage. We will outline our methodology and show our successes.

Biography:

Abstract:

The Androgen Receptor (AR) is one of the most validated therapeutic targets in Prostate Cancer (PCa). Conventional anti-androgens lose effectiveness as cancer therapeutics because anti-androgen resistance usually develops after long term treatment. The challenge is that the current therapeutics should bind to the same site of the AR (hormone binding pocket) and act via the same mode, to which the receptor has already developed effective resistance mechanisms. Hence, there is a pressing need for novel therapeutics that inhibit the AR through novel, alternative modes of action. Recent studies have identified a novel binding pocket on the surface of AR called Binding Function 3 (BF3) that is important for the AR transcriptional activity. In order to identify compounds that specifically bind to BF3 site and inhibit the AR, we conducted a systematic in silico screen (that included large-scale docking, in-site rescoring, and consensus voting procedures) followed by experimental validation of the identified hit molecules. As a result, we have discovered a novel chemical series of indoles as lead BF3 inhibitors. One of the most potent inhibitors identified, VPC-13566, demonstrated an IC50 of 0.20 uM in AR eGFP transcriptional assay. Confirming it as a true BF3 binder, VPC-13566 neither displaced the co-activator from an alternative co-activator binding site, activation function 2 site, nor androgen from the hormone binding pocket. Additionally, the Biolayer Interferometry assay detected direct reversible interactions between the AR ligand binding domain and the inhibitor. VPC-13163 demonstrated strong anti-proliferative activity against LNCaP and Enzalutamide-resistant prostate cancer cell lines (MR49F) whereas it did not affect the growth of AR independent PC3 cell line. It also inhibits Prostate Specific Antigen (PSA) in both LNCaP and MR49F and reduces expression of AR target genes, PSA and TMPRSS2. These findings suggest that VPC-13566 exhibits AR BF3 specific mechanism of action. Furthermore, VPC-13566 reduces AR-dependent growth of xenograft tumors in vivo. Based on these outcomes, it can be anticipated that such drug prototypes will lay a foundation for the development of alternative or supplementary small-molecule therapies capable of combating PCa even in its drug resistant forms. Because the emergence of castration resistance is the lethal end stage of the disease, we anticipate that the proposed research will eventually have a substantial impact on patient survival.

Biography:

Hesham Haffez has completed his Master’s degree in 2011 from Pharmacy College, Helwan University, Cairo, Egypt. Now, he is pursuing his PhD degree in Medicinal Chemistry from Durham University, United Kingdom.

Abstract:

All-Trans Retinoic Acid (ATRA) is widely used to direct differentiation of cultured stem cells and pluripotent Embryonal Carcinoma (ECs) stem cell lines into neuronal cells. EC23 and EC19 are synthetic analogues of Retinoic Acid (RA) differing from each other with respect to the position of the carboxylic acid group. EC23 has been shown to be a more potent inducer of neuronal differentiation than either EC19 or ATRA. In order to investigate the molecular basis of the functional difference, binding assays to RA Receptors (RAR α, β and γ, respectively) and molecular modeling studies were performed. EC50 values for EC23 are generally lower than for EC19 or ATRA on RAR-α and-β, indicating a higher binding affinity and co-activator recruitment. In silico molecular docking studies confirmed these differences in binding interactions, and showed that the carboxylic acid group of EC23 in the para-substitution creates the best fit to the ligand binding site with minimal steric hindrance, favoring the downstream binding of transcriptional co-activators. For EC19, the meta-substitution of the carboxylic acid group points away from a favorable interaction with Arg278 (RAR-γ) or create steric clashes with RAR-α/-β, resulting in interference with downstream co-activator binding activity. In comparison, ATRA shows similar protein-ligand interactions to EC23, supporting the notion that ATRA and EC23 possess similar molecular activation mechanisms. This study was able to combine chemical structures, receptor binding assay and molecular docking tools to shed light on the reported biological activity of these synthetic retinoids.

Biography:

Rashid Mahmood has 13 years diversified work endurance of Laboratory Management, Quality Assurance, Registration Affairs, NDA, ANDA, BLA, GMP Requirements, Drugs Laws, Statistical Methodology, Method Validation, Process & Cleaning Validation, Equipment Validation, etc. He has done Certificate Courses on cGMP, cGLP, Process Validation, ISO/IEC 17025:2005, 14001:2004, OHSAS 18001:2007, SA 8000 and 9001:2008. With strong scientific, analytical, statistical, planning, managerial and training skills, he has written several articles and attended many international conferences as a Speaker and presented various speeches in USA & China on Cleaning Validation, cGMP Guidelines, Quality Risk Management, etc. Currently, he is working as a Senior Manager Quality Assurance & Quality Management Representative for Surge Labs. (Manufacturer of Microencapsulated APIs, Liquid & Dry Powder Parentrals) which is the best export oriented company in Pakistan and we are the only manufacturer of microencapsulated APIs in Pakistan using European Technology and it has taken over lot of Business of Ranbaxy & Ind. Swift India worldwide. We are participating as Exhibiter in all the CPhIs taking place worldwide round the year. Stancos Private Limited (Cosmetic Plant), it is the only cosmetic plant in Pakistan which is ISO 22716:2007 GMP & ISO 9001:2008 QMS Certified by BVC and we are also exporting our cosmetic products to European countries. We are the Contract Manufacturer of L'oreal Paris Products and Sanofi famous brand (Selsun Blue Shampoo) in Pakistan.

Abstract:

Cleaning Validation can be defined as “The process of providing documented evidence that the cleaning methods employed within a facility consistently controls potential carry-over of product (including intermediates and impurities), cleaning agents and extraneous material into subsequent product to a level which is below predetermined levels”. The cleaning validation program shall primarily address the cross contamination of active ingredients of previous product into next product by means of sharing common equipment contact surfaces. In accordance with this, all equipments that have product contact surfaces shall be brought into the purview of cleaning validation. Special emphasis shall be given to cleaning procedure requirements as part of design requirement. Cleaning is one of the critical processes in pharmaceutical manufacturing. It is critical to avoid carryover of trace amounts of either active or other materials from one batch to another in order to avoid cross-contamination of the subsequent product. For that reason, equipment used in pharmaceutical manufacturing must be cleaned meticulously, and the cleaning procedure used must be validated. In the pharmaceutical industry, Good Manufacturing Practices (GMP) requires that the cleaning of drug manufacturing equipment be validated. Many different validation techniques can demonstrate that the manufacturing equipment is cleaned and essentially free from residual active drug substances and all cleaning agents. Common analytical techniques in the validation process include HPLC, Spectrophotometry (UV/Vis) and TOC. Cleaning validation must be performed using a pre-approved protocol. Selection of appropriate sampling to demonstrate that residues are removed to an acceptable level is vital for the success of cleaning validation. In addition, use of sampling techniques such as recovery study for swab and rinse and thorough visual inspection can reduce the number of samples required for cleaning validation. This article provides background on cleaning validation and the associated regulations, cleaning methods, validation strategy, and new product introduction. It also covers validation samples, acceptance criteria, clean hold time, training, change control, and revalidation. The intention of this article will be to define a comprehensive approach to the validation of cleaning procedures in pharmaceutical manufacturing facilities. It defines the basic concepts and terms associated with cleaning validation in the pharmaceutical industry. It also serves as a guide from which master plans, protocols and reports may be compiled

Biography:

Dr. Khairia Youssef is a Professor of Organic Chemistry since 1999. Dr. Khairia had the Bachelor of Pharmaceutical Sciences, the Master degree and Ph.D. in Organic Chemistry from Faculty of Pharmacy, Cairo University on 1977, 1980 and 1984, respectively. In 1988, Dr. Khairia was on a special research assignment with Etreby Computer in Los Angeles, California, U.S.A. in order to: 1) Assist in the design of a stand alone Drug Interaction query system 2) Practical study in Computer Application in Pharmacy Field. 3) Practical study in Computer and its role in the educational process. In 1992, Dr. Khairia was on a Peace Fellowship for Post Doctoral Research which concerns with "Design and Synthesis of Potential Antileukemic and/or Antiviral 2'-Deoxymethylene Nucleosides" at the University of Southern California, Los Angeles, California. U.S.A., under the supervision of Dr. Eric J. Lien, Ph. D. The design of the work is based on QSAR. Prof. Dr. Youssef is interested in drug design, synthesis and evaluation of certain pharmacologically active compounds. She published 62 papers in national and international journals. Professor Youssef supervised many researchers and teaching assistants. Professor Youssef published more than 60 publications into National and International Journals in the field of Drug Synthesis. The most recent papers were published between years 2007-2014 while Professor Youssef has been worked at FUE. From time of graduation till now Dr. Khairia taught different undergraduate and post-graduate courses. Prof. Youssef had been awarded the Bronze award from King Abdul Aziz city for science and technology for the exclusive research “Synthesis of Curcumin Analogues as Potential Antioxidant, Cancer Chemopreventive Agents” which had been granted by King Abdul Aziz city for science and technology, Project No. AR 19-39. Prof. Youssef had been awarded a certificate from The Marquis Who's who Publications Board as a subject of biographical record in Who's who in Science and Engineering 2008-2009. Inclusion in which is limited to those individuals who have demonstrated outstanding achievement in their own fields of endeavour and who have, thereby, contributed significantly to the betterment of contemporary society. She had been awarded the silver award from King Abdul Aziz city for science and technology for the exclusive research “Novel Modified Estrogens: Synthesis, Binding Affinity to Estrogen Receptor, Biological and Antitumor Activities of various Novel Modified Estrogen” which had been granted by King Abdul Aziz city for science and technology, Project No. AR 24-4. Prof. Youssef had been awarded the FUE Azazi Award for Outstanding Research for the academic year 2012/2013. This reflects well on the important contributions to the scholarly reputation of FUE. Perzigian, Anthony (perzigaj) PERZIGAJ@UCMAIL.UC.EDU Prof. Youssef as an International Conference Organizer had been awarded a Certificate for Participating as Organizer for the 1st FUE International Conference on Pharmaceutical Technologies (1st FUE-ICPT), Feb, 2012.http://icpt.fue.edu.eg/ Also, Prof. Youssef had been awarded a Certificate for Participating as Organizer for 3rd FUE International Conference of Pharmaceutical Sciences (3rd FUE-ICPS), Feb, 9-11, 2015.

Abstract:

Targeted Drug Delivery System (TDDS) is the most important research field for the design and development of pharmaceutical drugs. The basic premise of a TDDS is to concentrate the drug in the tissues of interest while reducing the relative concentration of medication in other remaining tissues. As a result, the drug is localized to a greater degree on the targeted site while leaving surrounding tissues unaffected. The ideal drug delivery system delivers drug at rates finely tuned to the biological requirement of the body. Due to their high specificity and efficacy, TDDS are the future in rational drug design and development. The significant advantage with TDDS includes protecting the payload and improving therapeutic index. TDDS has several advantages for the treatment of disease quantitatively. For instance, drug localization, decreased side effects, reduced dosage, modulated pharmacokinetics, controlled bio-distribution, and most importantly, improved patient's compliance. In this context, TDDS, especially Gold-Based Nanoparticles (AuNPs) will be used as a model system in this work. The main objective and basic principle behind the concept of targeting is that, the specific drug receptor is targeted to fit and improve their binding affinity, to the specific receptor that ultimately will trigger the pharmacological activity.

Biography:

Nashiru Billa has completed his PhD in 2000 at the University of Science, Malaysia. He worked at the International Medical University from 2000-2005 as Lecturer and Cheif Scientist of Bioequivalence lab. He joined the University of Nottingham, Malaysia Campus since 2005. He is currrently a Professor and Associate Dean of Research (Faculty of Science). He has published more than 30 papers in reputed journals and has been serving as an Editorial Board Member of reputable journals.

Abstract:

Boronic acid was functionalised onto chitosan and was successfully formulated into insulin containing nanoparticles via ionotropic gelation and polyelectrolyte complexation. The nanoparticles produced by PEC method were smaller in size and showed higher insulin encapsulation efficiency. The individual steps in the formulation process parameters have significant effect on the encapsulation efficiency of the system. The release of insulin from the nanoparticles depended on a complex interplay between the buffer effects and the sugar effects and hence choice of buffer for such studies must be carefully selected and its effects must also be rightly assessed. Though there was glucose and fructose dependent insulin release, the release is affected by the concentration of the sugar. High concentrations of sugars favour the retention of the nanoparticle integrity through interactions with the boronic acid moiety. This is particularly pronounced with fructose, where bidentate association with boronic acid ensures that the particle remain intact by a seemingly knitted matrix. This results in a diminished permeation of insulin into the media.

Biography:

Nabil Mohie Abdel–Hamid is a Professor of Cancer Biology and Head of Department of Biochemistry, Ex- Dean and Founder of Pharmacy College, Kafrelsheikh University, Egypt. He is the member of Higher Consulting Organization of Egyptian Scientists Council. He is the Deputy of the Director of Egyptian Association of Cancer Research. He is the Head of Drug Manufacturing Committee, Arab Union of Rights of Intellectual Property, and Arab League. He is a Member in The Arab Evaluators for Scientific Degree Promotions. He is a member in Egyptian Evaluators for Scientific Degree Promotions. His Research Interest is Cancer Biology. He is a Principal Instructor of Hepatocellular Carcinoma Research Programs. His Research goals are Early Detection and New Trends in Management of Hepatocellular carcinoma, including chemo and radio sensitization to cancer therapy. He is the Editor in Chief for American Journal of Cancer Prevention, USA and Archives in Cancer Research, Spain. He is an Editorial Board Member for Twenty International Journals. He Published Forty Six International Publications and Six Books (Including 2 international, USA and UK).

Abstract:

Globally, scientists work on finding new accurate modalities to set down, think and execute critical tasks within the living cells, then get out, as if being in a minute voyage to solve a threatening problem. In this voyage, either they could study an ancient uncovered disease or solve a previously unresolved problem. Human health seems to be a fascinating interest to make a great race and competition among scientists to introduce a gift to the humanity each single second. At the nano level, materials begin to demonstrate entirely new chemical and physical properties and can be stronger, lighter and highly soluble. The invention of nano and femto techniques and devices opened a new era in medical and pharmaceutical applications. Currently, cancer management in a very specific targeted manner could be achieved using nano gold and other metal particles, and nano-vehicles for boron delivery to tumor cells, with least side effects, although still in preclinical phases, but seems quite promising. Additionally, relevant applications were reported in surgery (femtolaser), cancer diagnosis, bio-detection of disease markers, molecular imaging, implant technology, tissue engineering, devices for drug, protein, gene and radionuclide delivery. Many medical nanotechnology applications are still in their infancy. One of the scientific achievements using femtosecond lasers was taking pictures of chemical reactions while they take place. Nanopharmacy: A few nano-devices were tested to deliver drugs into specific sites of human tissues to manage some diseases like cancer. In the future, drugs are planned to be packed into microscopic plastic spheres which can be inhaled, and new type of porous polymer particles for releasing drugs in an environment resembling lungs for respiratory diseases, also, robotics are planned for cell and tissue repair, no specific celling is known.

Biography:

Dr. Fathia El Sharkawi has obtained her PhD in biochemistry and molecular biology from Faculty of Pharmacy, Cairo University in 2000. She has completed postdoctoral studies in Germany from Paul Ehrlich institute in 2006 and Institute of virology, Essen University in 2007. She has been working in Faculty of Pharmacy, Helwan University since 2002. She is currently a head of biochemistry and molecular biology department. She is a member of many scientific societies and a reviewer for few international scientific journals. She is a member of editorial board of Austin Journal of molecular and cellular biology; also she is a member of Tempus project (Advanced Training and Life Long Program in Applied Health Science) with Linnaeus University, Sweden. Research interest: in Cancer biomarkers, cancer therapy, hepatocellular carcinoma, gene therapy and genetic variability of different diseases. Dr. Fathia El Sharkawi had previously worked as manager of scientific development in Kahira Pharmaceutical Company (1995-2000) and as scientific affairs and registration consultant, Sigma Pharmaceutical Company, Egypt (2000-2008).

Abstract:

Effective therapy to Hepatocellular Carcinoma (HCC) is currently lacking, creating an urgent need for new therapeutic strategies. Gene therapy approach that relies on the transduction of cells with apoptotic genetic materials such as Phosphatase & Tensin homolog (PTEN) and Tumor Necrosis Factor (TNF)–related Apoptosis-Inducing Ligand (TRAIL) genes have the potential to become promising anti-tumor therapy reagents and may provide a novel approach for cancer treatment. PTEN gene is one of the most frequently mutated genes in a variety of cancers its mutation has been observed in 40% to 50% of HCC tumors has been implicated in regulating cell survival signaling. TRAIL gene belongs to the TNF cytokine super-family, it induces apoptosis in a wide variety of transformed cell lines. The killing activity of it is cancer-specific and has little or no effect on most normal cells. The therapeutic genes may be delivered by viral or non-viral vectors. The toxicity associated with viral vectors would preclude them from being used systemically to treat diseases, The success of gene therapy is largely dependent on the development of a vector or vehicle that can selectively and efficiently deliver a gene to target cells with minimal toxicity such as to incorporate genetic materials into functionalized nanoparticles with little toxicity, this demonstrates a new era in pharmacotherapy for delivering genes selectively to tissues and cells. The aim of the current study is to deliver TRAIL & PTEN genes on suitable nanoparticle as a novel therapy for hepatocellular carcinoma.

Biography:

Amna Beshir Medani Ahmed has completed her PhD from University of Khartoum. She is the founder of Toxline.org, a new approach to connect professionals around chemical safety for the human, animal and environment safety. She has published more than 12 papers in reputed journals and conferences.

Abstract:

This workshop was prepared to elevate the standard of knowledge of toxinology among the medical and paramedical staff who are concerned with the treatment of patients poisoned by natural sources of toxins, classify natural toxins and relate this classes to certain geographical area to ease diagnosis in case of suspicion, facilitate the availability of antidotes in the appropriate geographical districts in relation to toxin background, enhance easy, toxin-specified and economic models of research, connect personnel interested in this field, train them and lead an open access for contact between them and, of course, ease communication between companies investing in therapy and the medical staff (toxicology personnel, emergency room staff, first aid personnel, lay public in highly endemic areas, community and public health personnel, drug biotechnology manufacturers and other interested segments). This course contains an introduction (history, culturally associated stories and social legends), a classification according to origin and geographical distribution, causes of intoxication due to toxins from plant origin, causes of intoxication due to toxins from animal origin and causes of intoxication due to toxins from microbial origin.

Biography:

Dr. Matthias Steiert is the co-founder and Chief Scientific Officer of Los Gatos Pharmaceuticals. He has extensive experience with nano-scale systems both for the development of drug delivery systems and diagnostics. He serves also as a consultant for various companies involved in nanotechnology and is co-founder of Afaf Translations LLC, a scientific language service provider. Previously, he held a position as Senior Director of R&D at Matrix Sensors Inc. and prior to that 10 years of senior-level research positions at several biotechnology companies in the fields of nanotechnology, drug development, diagnostics, and blood safety. Earlier in his career, Dr. Steiert was Senior Scientist at GlaxoSmithKline (Italy), a research fellow at the National Institute of Health and Environment (The Netherlands), and a consultant for the World Health Organization in Egypt and the Lebanon. He received his postdoctoral training from the University of California, Berkeley. Dr. Steiert holds a degree in plant physiology from the University of Freiburg (Germany) and obtained his Ph.D. in biochemistry from the University of Basel (Switzerland).

Abstract:

A novel proprietary product is under development that overcomes existing challenges based on the compound SN-38 and its parent compounds Topotecan and Irinotecan. It overcomes the short tumor half-life (Topotecan and Irinotecan) and enterohepatic/GI toxicitiy (SN-38). A chemical modification of SN-38 resulting in a product that will be metabolized into the active compound combined with a nanoparticle formulation using PLGA and other block-copolymers has demonstrated improved efficacy in vitro and in vivo as compared to parent camptothecins. Increased tumor concentrations and duration of exposure as compared to native SN-38 should, therefore, be achievable via passive targeting resulting in potentially improved safety profile by reducing entero-hepatic recirculation. Target indication chemotherapy of solid tumors of this product is colorectal cancer, NSCLC, and others.

Biography:

Dr. Pardeep Gupta the Burroughs Wellcome Professor at Philadelphia College of Pharmacy, University of the Sciences in Philadelphia. He earned his PhD degree in pharmaceutics from University of Wisconsin. He has published numerous scientific papers in the area of drug delivery. His work at the university has resulted in filing of two patent applications in the area of drug delivery. He served on the editorial board of Remington-The Science and Practice of Pharmacy and has authored chapters in several books

Abstract:

A novel peptide that mimics the binding properties of growth hormone binding protein (GHBP) was designed and synthesized. This peptide, termed growth hormone binding peptide (GHBpep) contains the functional epitopes of GHBP that allow it to bind to GH. This peptide was studied for its binding to GH in solution to characterize its binding affinity and thermodynamics of the binding process. These studies show that GHBpep binds to GH in a 1:1 ratio. GHBpep was covalently linked to bio-functionalized biodegradable PLGA nanoparticles. Reversible binding of GH to immobilized GHBpep was studied using equilibrium binding studies. The results of these studies indicate that GH can be loaded onto functionalized biodegradable nanoparticles in a reversible manner, and can be used as a delivery system for GH.

Biography:

Madhuri Sharon has completed her PhD from University of Leicester and postdoctoral studies from Bolton Institute of Technology. She is the director of Walchand .Research Centre for Nanotechnology & Bionanotechnology. She has published 170 papers in reputed journals, Published 5 books by international publishers and has 11 patents. She has guided 17 PhD students and 180 M.Tech and M.SC students. She has served as consultant to United Nations Asia Pacific zone for nanotechnology and on honorary positions of many national and international bodies. Has received 4 national awards for her contribution to science and has been to Japan as Visiting-Professor.

Abstract:

Our efforts are in developing small water-soluble nanoparticles that can facilitate uptake and uniform distribution of drug. Photoluminescent, <5nm Carbon dots as well as conjugates of carbon dots with Mesoporous silica and gold nanoparticles have been envisaged by us as delivery vehicle because of their high chemical stability, resistance to photodegradation, biocompatibility, low toxicity, easily tuned optical properties and good water solubility. We have explored use of natural (Gum Arabic, Neem Gum, Rice husk and Sugar-cane juice) as well as chemical precursors (Sorbitol & Phenylalanine) for synthesis of crystalline C-dots using microwave assisted heating in alkaline environment. naOh was used as it acted as passivating molecule. Sucrose density gradient centrifugation was used to separate C- dots, which separated them into three fractions showing green fluorescence of different intensities in UV light. Optical and morphological properties of the C-dots were confirmed by UV-Vis spectroscopy, Fluorescence spectroscopy, Raman, XRD and FE-SEM. UV-Vis spectra recorded in the spectral window 200-600nm displayed typical signature absorption of C-dots. FE-SEM showed presence of spherical 5-10nm C-dots. C-dots/drug complex (using linkers) was synthesized & dialyzed against nanopure water to remove unattached drug and characterized by FTIR and TGA. Drug loading efficiency of C-dot was calculated as per different mathematical pharmaceutical models. The drug used for the present study included anti-cancer drug Doxorubicin, where folic acid was used as navigating molecule and Haloperidol a drug for treating neurodegnerative disease; here Cysteamine was used as targeting molecule.

Biography:

Sreenivas Patro Sisinthy received his PhD in Pharmaceutical Technology from Berhampur University, India. Currently, he is the Head of the Department of Pharmaceutical Technology at Taylors University, Malaysia. His research focuses on controlled drug delivery, solubility enhancement of poorly soluble drugs, and analytical method development. He has published more than 20 research articles in reputed journals and has presented his work in many conferences. He is a Member of Indian Pharmaceutical Association and Malaysian Pharmaceutical Society.

Abstract:

Olmesartan Medoxomil (OLM), a BCS Class II drug, approved for use in the treatment of hypertension is a selective and competitive Angiotensin-II Receptor Blocker (ARB). The oral bioavailability of OLM in healthy humans is only 26% due to its poor water solubility. Hence, this limitation necessitates the systematic development of a suitable formulation to increase the solubility and dissolution and thereby bioavailability. Self Nano Emulsifying Drug Delivery System (SNEDDS) is a promising approach and is used in this study to increase the solubility of olmesartan medoxomil. The objective of the present study was to design, optimize and characterize SNEDDS for OLM by experimental design approach. The SNEDDS were systematically optimized using three factor Box Behnken design. Concentration of formulation variables, namely, X1 (Capryol 90), X2 (Kolliphor EL), and X3 (Transcutol P), was optimized for its impact on mean globule size (Y1), percentage drug release in 20 minutes (Y2) and turbidity (Y3) of the formulation. The prepared SNEDDS were characterized for globule size, zeta potential, dissolution studies, turbidity and Transmission Electron Microscopy (TEM). The optimized SNEDDS were found to have a globule size of 13.83 nm and a drug release of 98.31% in 20 minutes. In vitro drug release studies shown a 3-fold increase in dissolution compared to a commercial tablet. TEM studies demonstrated spherical droplet morphology. Based on the results, it was concluded that the SNEDDS is a promising drug delivery approach for the enhancement of solubility and dissolution of OLM.

Biography:

Amira S. Hanafy has registered for her PhD thesis on CNS delivery of neurotherapeutics in Sep 2013 in Faculty of Pharmacy, Alexandria University, Egypt. She is an assistant lecturer at Faculty of Pharmacy and Drug Manufacturing, Pharos University in Alexandria (PUA). She is a referee in AAPS PharmSciTech journal. She had the opportunity to attend the IBRO-UNESCO Interregional School on computational neuroscience, 2012, India; organized by International Brain Research Organization (IBRO), and won a travel grant for this school. She was an organizer in the “Nanoscience and Nanotechnology at Glance” International Conference, Cairo-Alexandria, Egypt, 15-16 January 2009.She has 4 publications.

Abstract:

The employment of biodegradable polymeric nanoparticles to deliver therapeutic drugs and macromolecules to the CNS has been pioneered in 1999. Since then, various polymers have been utilized to tailor nanoparticles with desirable properties from the “efficiency” point of view. In comparison with liposomes, a platform that have been enrolled into clinical trials and proved successful, several challenges face the development of CNS-targeted polymeric nanoparticles. The formulation, stability, processability, and cost/benefit ratio are not the sole factors holding back the development of polymeric nanoparticles. The safety parameter of short- and long-term administration of such nanoparticles is usually overlooked, especially that the exact in vivo fate of polymeric nanoparticles is not fully understood. Less that 2% of the published articles relating to CNS targeted polymeric nanoparticles between 2011 and 2015 dealt with the nanotoxicological assessment especially in the brain, liver, and kidney. In this presentation, the formulation factors that might affect the overall safety of the polymeric nanoparticulate delivery systems such as the particle size, surface properties, coatings, tendency to aggregation, and the addition of stabilizers will be discussed. In addition, the several in vitro and in vivo experimental models used to assess the toxicity of polymeric nanoparticles will be summarized. This presentation aims to redirect the current interest of pharmaceutical researchers to nanotoxicological aspects, and encourage them to comb their efforts with those of pharmacologists and toxicologists so as to push forward the development of polymeric nanoparticles for CNS drug delivery in the near future.

Biography:

Nabil Mohie Abdel–Hamid is a Professor of Cancer Biology and Head of Department of Biochemistry, Ex- Dean and Founder of Pharmacy College, Kafrelsheikh University, Egypt. He is the member of Higher Consulting Organization of Egyptian Scientists Council. He is the Deputy of the Director of Egyptian Association of Cancer Research. He is the Head of Drug Manufacturing Committee, Arab Union of Rights of Intellectual Property, and Arab League. He is a Member in The Arab Evaluators for Scientific Degree Promotions. He is a member in Egyptian Evaluators for Scientific Degree Promotions. His Research Interest is Cancer Biology. He is a Principal Instructor of Hepatocellular Carcinoma Research Programs. His Research goals are Early Detection and New Trends in Management of Hepatocellular carcinoma, including chemo and radio sensitization to cancer therapy. He is the Editor in Chief for American Journal of Cancer Prevention, USA and Archives in Cancer Research, Spain. He is an Editorial Board Member for Twenty International Journals. He Published Forty Six International Publications and Six Books (Including 2 international, and USA AND UK)

Abstract:

Ancient Kemetic (Egyptian) medicine was incredibly advanced. The Ancient Kemetic People were probably the first people in the world to have based their knowledge off of careful observations, as well as trial and error. By careful observation, early doctors or physicians’ priests of Ancient Kemet began healing practices that were world renowned. Their was a medical system that was developed over three thousand years and gave much toward the advancement of medical science worldwide, and any monarch or noble to have an Egyptian physician in their employ was a mark of high status. There was not the exact separation of Physician, Priest and Magician in Ancient Kemet that we think of today. Many times there was crossover from one "specialty" into that of another. This lecture will focus on surgery, surgical tools, veterinary, contraception, magic as a medical tool and herbal medicine about three thousands years ago in the era of Ancient Egypt. This will specially stress on pyramids builder way of preventive medicine as well

Biography:

Maziar Moradi-Lakeh (MD MPH) is a community medicine specialist who has worked in academic and public health systems for more than 10 years. He is a senior fellow of global health at the Institute for Health Metrics and Evaluation (University of Washington, USA). He has published more than a hundred papers in peer-reviewed journals which are mainly related to community and social health, burden of disease and population-based health interventions.

Abstract:

Chronic diseases and their risk factors are common in the Kingdom of Saudi Arabia (KSA) and most of them require long-term management through medications. We examined patterns of medication use for chronic conditions in KSA based on a national household survey. The Saudi Health Interview Survey (SHIS) was a cross-sectional national multistage survey of 10,735 individuals aged 15 years or older conducted in 2013. The survey included a detailed household questionnaire. Current medicines for chronic conditions of each respondent were observed by trained interviewers and classified based on the Anatomical Therapeutic Chemical (ATC) classification to five levels. Among the respondents, 11.8% (SE=0.4) reported taking at least one medication for their chronic conditions with a mean number of 2.05 (SE=0.05). In addition to older age (OR=1.94 per each decade, 95% CI: 1.83-2.05) and male gender (OR=1.22, 95% CI: 1.06- 1.41), those with higher income, were more likely to take any medication. The most common medicines were drugs used for diabetes (A10), drugs acting on the renin-angiotensin system (C09), lipid modifying agents (C10), antithrombotic agents (B01), drugs for obstructive airway disease (R03), calcium channel blockers (C08) and beta blocking agents (C07). The top 20 used items accounted for about 80% of all medication items. Only 32.7% of medications were reported to be used exactly as prescribed. Compared to the prevalence of chronic conditions such as diabetes, hypertension and hypercholesterolemia in KSA, our study indicates a potential underuse of medications as well as non-adherence to the directions for use. Interventions such as improved clinical guidelines for healthcare providers to increase utilization of necessary medication and educational programs to improve patients’ adherence are needed. Moreover, our results provide a list of commonly used medications in the Kingdom to help the Ministry of Health and other health authorities to better plan and manage medications purchases and management.

Biography:

Lilian M Azzopardi completed her PhD in the area of Validation of Community Pharmacy. She is Professor and Head of Department of Pharmacy at the University of Malta. She co-ordinates the teaching of pharmacy practice and clinical pharmacy for Undergraduate and Post-Graduate students. Her research is developing and evaluating clinical pharmacy interventions. She has published several papers and has been invited to give lectures and short courses in several universities. She has received Research Awards by the International Pharmaceutical Federation and the European Society of Clinical Pharmacy. She is the President of the European Association of Faculties of Pharmacy.

Abstract:

Pharmacy professional services evolve over time in response to social needs and in tandem with developments in technology, regulatory and economic forces. Failure to respond and adapt may result in the profession’s loss of efficacy. Hence, innovative processes within pharmacy professional services to ensure individualized patient care are essential. Focal contributions of the pharmacists in the different healthcare delivery settings are ensuring access to medicinal products, collaboration with other healthcare professionals in disease management to ensure rational, safe and effective use of medications, risk management with pharmacotherapy, and patient advocacy. From an education perspective, the challenge is to drive academia to also move in tandem with the developments in the profession. How do we integrate pharmaceutical sciences with clinical pharmacy education? Concepts of establishing the developments in innovative medicinal products and medical devices and how these are used within an interdisciplinary care model to ensure safe, rationale and effective patient care are presented. Different methods of teaching can be adopted to ensure clinical pharmacy education that is relevant for contemporary needs and which empowers graduates to deliver care with a vision for future innovations. How can pharmacy education support the delivery of innovative pharmaceutical services for individualized patient care? Examples of activities in clinical pharmacy education and research are reviewed. Models of supporting practicing pharmacists within post-graduate education programs are presented.

Biography:

Yousef A Alomi is the Head of General Administration of Pharmaceutical Care Administration, and Head of National Drug Information Center, MOH KSA. He obtained Bachelor of Pharmaceutical Sciences degree from King Saud University in the year 1992. After six-years of higher study, he earned his Master of Clinical Pharmacy from the same University in the year 1998. He is an affiliated Clinical Instructor of Purdue University in the USA. He is adjunct Assistant Professor of King Saud University College of Pharmacy. He was a member of Pharmacy Board at Saudi Commission for Health Specialties for 1998-2002 and 2008-2012 and Head of Pharmacy Accreditation Committee during 2010-2012. In the year 2005, he obtained Board Certification of Pharmacotherapy Specialist (BCPS). In the year 2008, he obtained his Diploma in Business Administration from American University in Egypt, and Board Certification of Nutrition Support Pharmacy (BCNSP) in 2009. He worked as Clinical Pharmacist in critical care area and nutrition support. He had established and implemented several programs at MOH Hospitals including Clinical Pharmacy Program, Medication Safety Program, Pain Management Program, Anticoagulation Program and Pharmacy Infection Control, and 30 Adult & 20 Pediatrics Clinical Pharmacy Programs. He is the Founder of Mass Gathering Pharmaceutical Care in KSA. He became a member of advisory board of the Arab Pharmaceutical Journal in 2010. He became as Pharmacy Board Member of Saudi Commission of Health Care Specialties (2010-2013). He had conducted several researches and presented at various conferences in Clinical Pharmacy and Pharmacy Practice which were published in ACCP and ISPOR conferences.

Abstract:

Antimicrobial stewardship is continuous work to optimize antimicrobials usage to improve patient outcomes and prevent antimicrobial related problems. General administration of pharmaceutical care established the program in 2013 by formulate Central Antibiotic Committees, this committee established antimicrobial stewardship program consisting of formulating peripheral antibiotics, infectious diseases team, antibiotics physician order form, antibiotics consumption and usages, antibiogram regulation and USA general of disease control antimicrobial stewardship monitoring outcome indicators. In 2014, Peripheral Antibiotics Committees was established in twenty regions to follow up the program implementation, and antimicrobial stewardship education and orientation was started. In 2015, the real applications of the program were started in more than ten regions and forty hospitals. Antimicrobial stewardship will be expanded to cover 20 regions and 90 biggest hospitals, medical cities, private hospitals and primary care centers in KSA. In this talk, I share experiences of our program, and the changes that faced during the program, and strategies to implement it to all Middle East countries.

Biography:

Heba Moustafa Mohamed has completed her MSc and PhD degrees in Pharmaceutical Analysis from Faculty of Pharmacy, Cairo University, Egypt. She has extensive experience in different analytical techniques and she focuses on implementing green analytical chemistry principles in pharmaceuticals analysis. She has published more than 15 papers in highly reputed international journals and has been serving as reviewer for many highly esteemed journals.

Abstract:

Safety and ecological friendliness are now of paramount importance, because of the increased awareness of the negative impact of hazardous chemicals on human and environment. Several trials have been applied to increase the greenness of chromatographic methods, and introduce the solvent replacement strategy, the most important one, as most of the used solvents are classified as Volatile Organic Compounds (VOCs) which can easily diffuse and have both acute and chronic toxic effects. Huge amount of these hazardous organic solvents are used in chromatographic methods; either as solvents, reagents or/and mobile phases. In this work, Green Analytical Chemistry (GAC) principles were implemented in the chromatographic determination of pharmaceutical ternary mixture in their bulk powder and in their dosage forms. The main challenge was to design methods that neither use nor produce harmful chemicals and produce minimum waste for the routine analysis of the studied drugs without harming the environment alongside without affecting the analytical method parameters and performance. The methods were validated with respect to linearity, precision, accuracy, system suitability, and robustness. The developed methods were compared to the reported conventional chromatographic methods with regard to validation parameters and greenness profiles. The suggested methods were found to be greener and more time and solvent-saving than the reported ones. Hence, they can be used for routine analysis of the studied mixtures in a safer way.

Biography:

Dalia A Hamdy completed her PhD in Pharmacokinetics at the Faculty of Pharmacy and Pharmaceutical Sciences, University of Alberta (Canada) in September 2010. Prior to this, she obtained a Master of Pharmaceutical Sciences (Pharmaceutical Analytical Chemistry) at Alexandria University (Egypt) and a BSc (Pharmacy and Pharmaceutical Sciences) at the same institution. She is a Licensed Clinical Pharmacist in Egypt and in Alberta, Canada. Her research interests are in the fields of pharmacokinetics, pharmacodynamics, drug metabolism, pharmaceutical analysis and pharmaceutical education. She has published 18 papers and 29 posters. She holds several grants and has served as Reviewer and Editorial Board Member.

Abstract:

Acute Lymphoblastic Leukemia (ALL) is one of the most common malignancies. Vincristine (VCR) is widely used in the treatment of ALL worldwide. Its antineoplastic effect may be accompanied by dose and duration of treatment dependent neurological side effects, with most symptoms disappearing by about the sixth week after discontinuation of therapy. Azole antifungals are commonly used as prophylaxis therapy in such treatment regimens. Posaconazole (PSZ), a structural analogue of itraconazole, is a new triazole antifungal agent that has been approved for the prophylaxis of invasive Aspergillus and Candida infections in severely immunocompromised patients. Those immunocompromised patients include those with hematopoietic stem cell transplantation with graft-versus-host disease or hematologic malignancies with prolonged neutropenia from chemotherapy. PSZ has been used for this indication since 2005 in several countries. Co-administration of azoles (as prophylaxis or treatment of fungal infections) and VCR have been shown to increase VCR neurotoxic effects due to the inhibition of cytochrome P450 (CYP) isoform 3A4, for which VCR is a substrate. Concomitant disease conditions were shown to possibly alter the pharmacokinetic (PK), pharmacodynamic and toxicodynamic properties of drugs. Therefore, it is important to test the effect of alteration in PSZ PK and/or its drug interaction with VCR that accompany those concomitant disease conditions. The impact on the clinical decisions needs to be also considered

Biography:

Nabil Mohie Abdel–Hamid is a Professor of Cancer Biology and Head of Department of Biochemistry, ex-Dean and Founder of Pharmacy College, Kafrelsheikh University, Egypt. He is the member of Higher Consulting Organization of Egyptian Scientists Council. He is the Deputy Director of Egyptian Association of Cancer Research. He is the Head of Drug Manufacturing Committee, Arab Union of Rights of Intellectual Property, and Arab League. He is a Member in The Arab Evaluators for Scientific Degree Promotions and Egyptian Evaluators for Scientific Degree Promotions. His research interest is Cancer Biology. He is a Principal Instructor of Hepatocellular Carcinoma Research Programs. His research goals are early detection and new trends in management of hepatocellular carcinoma, including chemo and radio sensitization to cancer therapy. He is the Editor in Chief for American Journal of Cancer Prevention, USA and Archives in Cancer Research, Spain. He is an Editorial Board Member for 20 International Journals. He published 46 international publications and 6 books.

Abstract:

Ancient Kemetic (Egyptian) medicine was incredibly advanced. The Ancient Kemetic People were probably the first people in the world to have based their knowledge off of careful observations, as well as trial and error. By careful observation, early doctors or physicians’ priests of Ancient Kemet began healing practices that were world renowned. There was a medical system that was developed over three thousand years and gave much toward the advancement of medical science worldwide, and any monarch or noble to have an Egyptian physician in their employ was a mark of high status. There was no exact separation of physician, priest and magician in Ancient Kemet that we think of today. Many times there was crossover from one “specialty” into that of another. This lecture will focus on surgery, surgical tools, veterinary, contraception, magic as a medical tool and herbal medicine about three thousand years ago in the era of Ancient Egypt. This will specially stress on pyramids builder way of preventive medicine as well.

Biography:

Derar Omari has completed his PhD from Cairo University and MSc from Jordan University of Science and Technology. As an Assistant Professor in Faculty of Pharmacy, Yarmouk University, he is teaching Industrial Pharmacy, Pharmaceutics and Physical Pharmacy. He published many papers in reputed journals.

Abstract:

Esomeprazole is the S-isomer of omeprazole. It is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of (H+/K+) ATPase in gastric parietal cell. It is marketed by Astrazeneca Co., under the brand name Nexium® 20 mg and 40 mg as gastro-resistant film coated pellets compressed to tablets (MUPS). Generic products are identical drugs with the brand name drug and are interchangeable with them, and they are therapeutically equivalent. US FDA and other similar authorities do not recognize the term ‘‘Supergenerics’’. These products are also referred as ‘added value generics, new therapeutic entities or hybrids’. These products differ from the original product in formulation or method of delivery. Moreover, these products could be an improved formulation of a known product. A pharmaceutical product developed and manufactured with less excipients and unit operation while maintaining the product therapeutic performance compared to the originator could be considered as an improved therapeutic entity as it reduces the overall cost for manufacturing that could lead to reduced healthcare spending. In this study, enteric coated mini-tablets of ESM were prepared. Bioequivalence studies both under fed and fasting conditions were carried out for the minitablets 40 mg versus Nexium 40 mg MUPS. The results for fasting conditions were within acceptable limits, while fed conditions results were not (higher extent of absorption which means less in vivo degradation than Nexium). The argument of this presentation: Do we accept or reject, particularly when it has no negative effect on the therapeutic efficacy?

Biography:

David W Moskowitz is pioneer in the field of medical genomics. He majored in Chemistry at Harvard College, Biochemistry at Merton College, Oxford, and received an MD from the Harvard-MIT Division in Health Sciences and Technology. He is the Founder of DzGenes, LLC and GenoMed, Inc.

Abstract:

Everyone agrees that precision medicine will revolutionize healthcare, changing it from a complex, expensive, largely futile inpatient exercise to a simple, inexpensive, highly effective out-patient affair. Nowhere, is this more obvious than kidney failure. Genomic epidemiology using the ACE insertion/deletion polymorphism led to the observation that 90% of kidney failure can be prevented using the right ACE inhibitor at the right dose at the right time. No genotyping is required. Dialysis prevention should be the highest priority for every country, since dialysis patients suffer extreme morbidity and mortality. Not even the richest country can afford the dialysis epidemic engulfing the planet. Pharmacists are ideally suited to lead this effort, since dialysis prevention involves careful medication management, which pharmacists already perform. Measuring their customers’ blood pressure is all that is required; a blood pressure cuff can be obtained for each pharmacy for under $40. Pharmacies are well distributed throughout the patient population. The cost of such a prevention effort is low enough for patients with diabetes and hypertension to pay out of pocket, in case government funding is not available. GenoMed would be delighted to provide training and quality control to each participating pharmacist.

Biography:

Anthia Zammit completed her Bachelor of Laws (LL.B), and Doctor of Laws (LL.D) degrees, at the University of Malta. She advises multinational mega-cap and start-up companies operating in healthcare; life sciences; biotechnology; and pharmaceutical industries. She has experience in global expansion of private and publicly-listed companies in established and emerging markets; business development; medicinal product launches; drug and vaccine licensing; regulatory affairs; regulatory compliance (EU-GMP and EU-GDP); pharmacovigilance; data privacy; pricing; and marketing. She worked at the Office of the CEO of Malta’s National Competent Authority, the Medicines Authority (the “Malta FDA”). She regularly participates as a Guest Speaker at high-level conferences on invitation of the European Commission.

Abstract:

Malta’s annual pharmaceutical export turnover exceeded €208 million in 2010, reached €256 million by 2012 (EFPIA), and was estimated at over €295 million in 2014 (Times of Malta). Active stakeholders in Malta include licensed wholesale distributors, importers, re-packagers, and manufacturers of finished dosage forms, active pharmaceutical ingredients (APIs), medical gases, and devices. The successful outcomes and expansion of multinational companies are testament to Malta’s role as a global business and distribution hub of pharmaceuticals and medical devices to the European, U.S., North African, and Middle Eastern markets. The cost of researching and developing a new chemical/biological entity was estimated at €1,172 billion in 2012 (EFPIA). The critical need for innovation and R&D of safe, high quality, efficacious medicinal products requires cross-disciplinary international collaboration. Malta, the smallest island-member state of the EU with strategic geographic location and unique history, is gaining momentum and reputation in pharmaceutical, life science, and biotechnology development in the Mediterranean. In November 2014, representatives of the US FDA met with those of the European Medicines Agency (EMA), the European Commission, and Good Manufacturing Practice (GMP) experts from EU member states to make progress on mutual reliance between the FDA and EU on GMP inspections, demonstrating strengthened momentum on this issue. As a EU member state, Malta is a party to Mutual Recognition Agreements (MRAs) for Good Manufacturing Practice (GMP) with Switzerland, Australia, New Zealand, Canada and Japan. The body of EU legislation regulating medicinal products for human use is transposed into Maltese legislation. The Malta Medicines Authority grants EU GMP and EU GDP certification to compliant companies. Manufacturing plants and facilities in Malta successfully pass U.S. Food and Drug Administration (FDA) inspections. Malta’s national competent authority furthermore engages in discussions on the harmonisation of medicines regulation via the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), and as a member of the Pharmaceutical Inspection Cooperation/Scheme (PIC/S).

Biography:

Tolu Taiwo is the Director of Medical Information at Horizon Pharma plc. located in Deerfield, IL. She provides scientific direction and oversight for the Medical Information Department (MID) and any MID related projects. She is also an Adjunct Professor of Pharmacy at both the University of Illinois at Chicago, College of Pharmacy and the Rosalind Franklin University of Medicine and Science, College of Pharmacy. Her professional focus is on the expert delivery of Drug Information within the Pharmaceutical Drug and Device Company setting. She holds a BSc in Botany from University of Ibadan, Nigeria, a PharmD from the University of North Carolina, Chapel Hill, and an MBA from the University of Illinois, Urbana Champaign

Abstract:

The core value proposition of an effective functioning medical or Drug Information Center (DIC) in a pharmaceutical or biotechnology company is the delivery of a combination of a high-quality customer service and unbiased Drug Information (DI) to Health Care Practitioners (HCPs) and End Users (EUs) of the company’s products. In fulfilling these obligations, a ‘Pharma-DI-contact call center’ alliance might be warranted. These same values are also the cornerstone of a successful DI contact call center. This makes it increasingly necessary to get the most out of a Pharma DI (client)-call center (vendor) relationship. This session will provide practical approaches to effective vendor selection and management, as well as best practices on how to ensure strategic alignment and a mutually beneficial relationship between the client and the vendor, most especially between the client and the DI specialists at the call center that provide the core values mentioned above. At the end of the session, participants will understand • Vendor Selection Process: Do you offshore or outsource? • Utilizing training to mitigate quality issues • Ensuring DI specialist’s best fit • Ensuring client-vendor relationship transparency

Biography:

Dr. Janak Padia is presently working as a Professor in the Center of Biomolecular Therapeutics (To evaluate and prioritize its project portfolio and to accelerate development of innovative drugs) at University of Maryland, United States. He was Vice President, Drug R&D Services at Pharmaron and managed integrated projects for chemistry, lead optimization, preclinical candidate identification and development, and IND enabling studies for clients. He has over 25 years of industrial experience in cutting edge drug discovery and development experience and has held management positions of increasing responsibility. Prior to Pharmaron, he was also Director of Chemistry and Drug Development at Avalon Pharmaceuticals where he oversaw a range of drug discovery and development programs and participated in the strategic management of the company. He has extensive experience in drug discovery and development processes, technology evaluation and implementation of project management tools to drive the projects to completion. He also has excellent knowledge drug development, formulation development, IND enabling studies, GLP Tox evaluations, GMP drug manufacturing and regulatory affairs. Dr. Padia has also worked for Parke-Davis/Warner-Lambert (now Pfizer), Discovery Partners, and the NCGC-NCATS-NIH in the therapeutic areas of Cancer, Cardiovascular, CNS and antiviral therapeutics. He has led drug discovery and development efforts during his career that resulted in the identification of several development candidates in the cancer and CNS area. He has authored several scientific publications and is also the inventor of many patents. He holds an adjunct position at Georgetown University Medical Center and serves as an advisor for Drug Discovery Program at GUMC and NIDDK/NIH.

Abstract:

Drug discovery process is an iterative process and prioritizing compounds is a natural process with ultimate goal of selecting a lead compound as a preclinical development. Typically scientists prioritize compounds based on potency, selectivity, DMPK profile and in vivo efficacy; while toxicity studies were performed later part of the process or even after selecting the pre-clinical candidate. Several reports suggest that more than half of pre-clinical candidate and about one quarter of drug candidates entering clinical development fail due to non-clinical toxicology or clinical safety issues. The late stage failure account for a large proportion of the cost of pharmaceutical R & D, recently estimated to be $2 B per marketed drug. Recently, the toxicity profiling studies have been shifted to early part of the discovery process and many tools including surrogate in vitro assays and in silico prediction software. FDA is also developing their guidelines to replace/reduce animal studies with other tools for the humane consideration. We will present recent advances in predicting toxicity profile of drug candidates and case studies to show the benefits of incorporating toxicity profile early in the drug discovery process.

Biography:

Abstract:

Dr. Janak Padia is presently working as a Professor in the Center of Biomolecular Therapeutics (To evaluate and prioritize its project portfolio and to accelerate development of innovative drugs) at University of Maryland, United States. He was Vice President, Drug R&D Services at Pharmaron and managed integrated projects for chemistry, lead optimization, preclinical candidate identification and development, and IND enabling studies for clients. He has over 25 years of industrial experience in cutting edge drug discovery and development experience and has held management positions of increasing responsibility. Prior to Pharmaron, he was also Director of Chemistry and Drug Development at Avalon Pharmaceuticals where he oversaw a range of drug discovery and development programs and participated in the strategic management of the company. He has extensive experience in drug discovery and development processes, technology evaluation and implementation of project management tools to drive the projects to completion. He also has excellent knowledge drug development, formulation development, IND enabling studies, GLP Tox evaluations, GMP drug manufacturing and regulatory affairs. Dr. Padia has also worked for Parke-Davis/Warner-Lambert (now Pfizer), Discovery Partners, and the NCGC-NCATS-NIH in the therapeutic areas of Cancer, Cardiovascular, CNS and antiviral therapeutics. He has led drug discovery and development efforts during his career that resulted in the identification of several development candidates in the cancer and CNS area. He has authored several scientific publications and is also the inventor of many patents. He holds an adjunct position at Georgetown University Medical Center and serves as an advisor for Drug Discovery Program at GUMC and NIDDK/NIH.

Biography:

Abstract:

1- What is Pharmacovigilance 1.1 Smooth orientation to the idea 1.2 WHO Definition of Pharmacovigilance 2- Why do we need Pharmacovigilance 2.1 Learning from History 2.2 Drug safety throughout product life cycle 3- Scope of Pharmacovigilance 4- Important Terminologies in Pharmacovigilance 5- Marketing the idea of Pharmacovigilance 6- Global vision of Pharmacovigilance 6.1 WHO programme for International Drug Monitoring 6.2 Harmonization between the Arab Countries 6.3 Implementation of the Common Arab Guidelines 7- Reporting of Adverse Drug Reactions (ADRs) 7.1 Spontaneous reporting of ADRs 7.2 Individual Case Safety Reports (ICSRs) 7.3 Who should report? 7.4 Role of MAHs in reporting ADRs 7.5 What should be reported? 7.6 Characters of a good case report 7.7 Seriousness of ADRs 7.8 Expectedness of ADRs 7.9 Workflow of reporting & Reports Managing 8- How to build a powerful & an interactive Pharmacovigilance Department in your company. 9- Departments involved in Pharmacovigilance activities 10- What are the benefits of these reports for the patients and the HCPs? 11- Is the Pharmacovigilance objective is to withdraw Medications? 12- Vital & practical examples of the practical implementation of Pharmacovigilance and its impact on the public health. 13- What is next?

Biography:

Rajashekar KS has 12 plus years of experience in pharmaceutical industry working for quality assurance department, where he have handled different roles like process, systems and qualifications. He was also involved in various audits like US FDA, MHRA, ANVISA, MCC etc., and many client audits. He worked with major pharma companies like Strides Arcolab, Apotex Private Limited and Syngene international limited a Biocon company. He completed his graduation (B Pharm) in Oxford college of Pharmacy, Bangalore and Post graduation (MS in Operation and Management) from BITS Pillani.

Abstract:

Good Manufacturing Practices of various nations and how are there similar, what are the different regulations available. Regulatory findings on the manufacturing units, about their practices and procedures been followed and implications of the same. How should be this learning lesson to other manufacturing and how can be this achieved. Advantages of following GMP and Quality by Design techniques.

Biography:

Menyfah Q Alanazi is a Pharmacist and is currently working at the Drug Policy and Economic Center of Ministry of National Guard Health Affairs, Kingdom of Saudi Arabia. She has been awarded Clinical Pharmacy Practice degree in 2007.

Abstract:

Background: Research is a systematic investigation to establish fact. It is often viewed as the corner stone of scientific progress. research is a systematic process based on scientific method that consists of testing hypotheses, careful observation and measurement, systematic evaluation of data, and drawing valid conclusions. There are different research methods which are used in research, the main two types of research designs are the quantitative research design and the qualitative research design. Objective: To describe and discuss the elements of the clinical research process: research methodology and study design, basic statistic for scientific research, how to write a scientific manuscript?, how to write a proposal?, and ethical consideration in research. Steps of a research process: The steps start with a broad idea of the topic which is then focused on formulating a specific hypothesis or a question. The key steps in conducting research can be summarized as follows: identification of research problem, carrying out a literature review, formulating the research question/research objective, proposal writing, Institutional Review Board (IRB) approval and ethical consideration, data collection, entry, cleaning, and management, data analyses, and research dissemination. Publishing the research project is the final step of the research process, which entails summarizing the whole research findings such as a manuscript published in a journal. Conclusion: Clinical research is an important tool to help develop solutions that with benefit people all over the world. Research is the systematic collection, gathering, interpretation , analysis of data to answer a certain questions or solve a problem.

Biography:

Anthony Serracino-Inglott studied at University of Malta and University of Cincinnati. He carried out research in clinical pharmacy with a completion of a residency programme under the supervision of the eminent Professor Don E Francke. He has started taking lectures and started his research work at the University of Malta where he established the Institute of Health Care now the Faculty of Health Sciences. He has been elected as a Chairman of the Medicines Authority.

Abstract:

Regulatory affairs started to get organised over 50 years ago following unfortunate incidents such as the thalidomide tragedy. The quality of medicines was established in different countries through the development of pharmacopoeias, such as the British and the United States pharmacopoeia. Pharmacopoeias were harmonised in regions such as the European Pharmacopoeia and on an international basis, the international pharmacopoeia. The regulation of production and the authority to market medicines were also harmonised in regions, such as the Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) in Europe. The authorisation of third countries to be able to produce and market their medicines in other regions is carried out by the regional bodies independently and with restricted cooperation. Attempts to harmonise the regulatory affairs internationally were made such as the use of ISO standards and ICH guidelines. If the regulatory forces are developed into a scientifically-based status and thus, the nomenclature from regulatory affairs to regulatory sciences could be rightly undertaken, then, the internationalisation and hence the harmonisation of regulatory sciences should follow with relative ease in the same way that the laws of science have been accepted internationally. If the rules of innovation, research and education were followed, using today’s technology and communication, the harmonisation process should become achievable. This is especially essential today where the science of pharmacovigilance is developing at a great pace. If pharmacovigilance is tackled on an international basis, then the benefits to the world community cannot be overestimated.

Biography:

Manal Zaidan holds BSc (Pharm), PharmD degrees. She obtained her BSc Pharmacy from University of Jordan in 2001 and PharmD degree from Purdue University, Indiana, USA in 2013. She is currently the Pharmacy Director at the NCCCR Since 2007 and was the Director of the Heart Hospital Pharmacy from 2007 to Feb 2015. She has worked as Program Coordination Assistant to the Dean of the College of Pharmacy, Qatar University from December 2006 to July 2007. Her role was mainly to assist the new Dean in the planning, development and establishment of the new College of Pharmacy according to the Canadian Accreditation Standards CCAP Canada. She has conducted several research projects, has published several papers in reputable pharmacy journals and has presented several papers in local and International conferences

Abstract:

Chemotherapy is the mainstay of cancer treatment. However, chemotherapy treatment may cause nausea and vomiting, which could cause 25–50% of patients to consider delaying or refusing further cancer treatment. Chemotherapy-Induced Nausea and Vomiting (CINV) can be prevented in 70–80% of patients with evidence-based anti-emetic regimen. The purpose of this study is to assess prescribing patterns with regard to prevention of CINV, in the NCCCR, and develop and implement a standardized evidence-based guideline for the management of CINV. Methods: 25 anti-emetic prescriptions were audited to assess their conformity with either of the published guidelines; Multinational Association of Supportive Care in Cancer (MASCC), American Society of Clinical Oncology (ASCO), or the National Comprehensive Cancer Network (NCCN), to establish baseline data. A multidisciplinary team of clinical pharmacists and oncologists developed and implemented a guideline for the prevention of CINV. The guideline was promoted using a variety of strategies; education, pocket cards, academic detailing and pharmacist intervention. Physician anti-emetic orders were audited by pharmacists, to assess their conformity with NCCCR anti-emetic guidelines. A data collection form was developed to capture relevant information including; patient demographics, type and emetogenic level of chemotherapy, and the conformity of anti-emetic order with NCCCR guidelines. SPSS statistical software was used to analyze the data. Results: The conformity of anti-emetic physician order with NCCCR anti-emetic guidelines increased from 0% baseline in June 2008 to an average of 60.006% (n=331) by December 2010 and consistently increased reaching 94.3827% (n=792) by December 2013, (p value=0.0002). Conclusion: The introduction of anti-emetic guidelines succeeded in standardizing CINV management, toward an evidence-based approach

Biography:

Lamia W Mohamed has completed her PhD in the year 2005 from Cairo University and Postdoctoral studies from Faculty of Pharmacy, Cairo University (FOPCU). She is the Director of Career Center, FOPCU. She has published more than 10 papers in reputed journals and has been serving as Member in the American Chemical Society. She is also a Reviewer at Science Publishing Group. In addition, she has participated in organizing both 5th and 6th International conferences of Faculty of Pharmacy, Cairo University

Abstract:

During mitosis, tightly regulated microtubule dynamics is essential for spindle formation and chromosomal separation. Microtubules are cylinder-shaped protein polymers composed of α-tubulin and β-tubulin heterodimers arranged head to tail. Microtubules are elements of the cell cytoskeleton that play key roles in cell division and cell shape. Indeed, targeting tubulin is a successful strategy for cancer therapy. Many natural and synthetic products of varied structures bind to the colchicine site of tubulin, thus suggesting a high plasticity of tubulin at the colchicine site. Combretastatins are strong inhibitors of tubulin polymerization, which have attracted much attention owing to their potent cytotoxic and vascular disrupting activities. Many SAR studies have established the key structural elements responsible for high antitubulin and cytotoxic activities in combretastatins and related compounds are the trimethoxyphenyl ring. Several rings were synthesized as tubulin polymerase inhibitors in addition to inducing apoptosis. 1,3,4-benzotriazepine ring system was previously synthesized and was found to have anti-tumor effect by inhibition of several enzymes. Combining both colchicine and combrestatins structures new 1,3,4-benzotriazepine analogues were designed, their docking to the tubulin site has been studied, finally their inhibition of tubulin polymerase and anti-tumor effect were screened

Biography:

Prof. Dr. Salwa Elmeligie has completed her PhD at the age of 29 years from Cairo University and postdoctoral studies from Faculty of Pharmacy, Iowa University, USA. She is Head of Pharmaceutical Organic Chemistry Department, Faculty of Pharmacy, Cairo University. She is also reviewer for Higher Education Institutions (HEIs), conducted by the National Authority of Quality Assurance and Accreditation of Education (NAQAAE), and credited trainer in Egypt. She has published more than 36 papers in reputed journals and has been serving as an editorial board member of repute in addition to attending more than 20 training courses in Quality Assurance systems.

Abstract:

Special interest in targeted cytotoxic agents is directed towards protein kinases which play several roles in cell proliferation, and targeting these proteins has been shown to be a successful strategy towards controlling different malignancies. In an attempt to develop novel antitumor agents acting through inhibiting Vascular Endothelial Growth Factor Receptor (VEGFR), a series of new aryl phthalazine derivatives has been designed and synthesized. The targeted compounds were planned and implemented into docking studies to qualitatively predict their affinity and binding modes with VEGFR-2 kinase enzyme. Docking studies were performed on the designed compounds using Accelry’s Discovery Studio 2.5 software CDOCKER protocol. The structures of the synthesized compounds were confirmed by elemental analyses and spectral data (IR, 1H NMR, 13C NMR and Mass spectroscopy). Furthermore, biological screening in the National Cancer Institute (NCI), USA is applied to test the cytotoxic activity for the prepared compounds against full NCI 60 cell panel at a single dose (10 μM). Additionally, the target compounds are evaluated for their enzymatic inhibition of VEGFR-2 kinase

Biography:

Abstract:

External whole breast radiotherapy (WBRT) is standard treatment after breast-conserving treatment for breast cancer. WBRT markedly reduces recurrence rates and also improves survival. However the RT course lasts 5-7 weeks, and in many countries RT centers cannot meet the demand and may be distant from the patient’s abode. There was therefore much interest in developing intra-operative RT which would complete the RT treatment in a single intra-operative session during surgery. There is also interest in performing only partial irradiation of the tumor bed instead of the whole breast since most recurrences occur close to the scar. In 1999 the European Institute of Oncology (EIO) started a new method of irradiation called ELIOT (intra-operative RT with electrons) which employs a mobile linear accelerator to deliver electrons directly to the reconstructed tumor bed after the surgeon has removed the tumor. The electrons are directed by a Perspex collimator, placed by the surgeon, after a radiation shield has been placed between the breast tissue and the chest wall. The method applies sufficient radiation to the tumor bed, but irradiation to the skin and chest wall is greatly reduced. The aims of this talk are to present the results our ELIOT trial and assess which patients are suitable to ELIOT in the future. The randomized controlled trial to evaluate recruited in 1305 breast cancer patients treated by quadrantectomy and randomized to either conventional external radiotherapy (RT) (654) or ELIOT (651). ELIOT patients received a single dose of 21 Gy to the tumor bed, immediately after quadrantectomy. Patients in the conventional RT arm received 50 Gy in 25 fractions followed by a boost of 10 Gy in 5 fractions. After a median follow-up of 5.7 years, distant metastases and deaths were similar in the two arms, but local relapses (20 cases) in the index quadrant were significantly (p=0.0004) more numerous in the ELIOT than in external RT arm (4 cases). Subsequent analyses found that the excess recurrences in the ELIOT were mainly confined to specific subgroups (those adhering to ASTRO guidelines), allowing indications for ELIOT to be refined. ELIOT appears safe (no difference in survival compared to conventional radiotherapy) and its particular advantage is that it permits definitive surgical and RT treatment for early breast cancer in a single session.

Biography:

An industrial pharmacist with over 20 years experience in area of quality. He received his Bachelor of Science in Pharmacy from the University of Mansoura in Egypt in 1990. Started his career in 1993 pharmaceutical industry as a Quality inspector in Gulf pharmaceutical industries (Julphar). Has an extensive experience in manufacturing and control of Large volume parentrals , gained this experience during his 16 years tenure in Pharmaceutical Solutions Industry (PSI) , The leading manufacturer of large volume parentrals (LVP’s) in MENA region. Having extensive knowledge of Blow/ Fill/ Seal (BFS) Technology, Form/fill/seal (FFS) and Large volume parentrals manufacturing, participated in many projects of erecting , qualifying and operating large volume parentrals lines. Strong expertise of moist heat sterilization processes and autoclaves. Highly knowledgeable of packaging materials solutions for LVP’s. During his career in PSI, Mr. Mohab has been Extensively involved in development of container closure sytems and packaging components of many of PSI new products and forms. Has been recognized for his efforts as key participants in SAP implementation project in PSI as well as for his contribution in it’s relevant computer system validation. Accredited by American Society of quality as a certified GMP professional in 2014. Currently working as a quality control manager in Arabio, A leading biopharmaceutical company in MENA region.

Abstract:

Large volume parentrals (LVP’S) represent a strategic medicinal product that is essential to Health care industry. With increasing expenditure on health care services supported by policies in MENA region states, the demand for a quality LVP’s become essential. • Definition, What are LVP’S? Evolution and History. • What are the characteristics of LVP’s over other categories of injection dosage forms. • Types of LVP’S and their indications. • Process description and control points. • Quality Control of LVP’S • Container closure systems and product stability. • Blow-fill- Seal Technology. • Regulatory requirements and expectations.

Biography:

Sherif Kamal is one of the second generation Egyptian Clinical Pharmacists, with more than fifteen years of experience in this field, involved in the planning, designing and implementation of pharmaceutical care in oncology centers as Senior Clinical Pharmacy Consultant. He is the Director of Pharmaceutical Services at the Children’s Cancer Hospital in Egypt. He earned his BS in Pharmacy and is undergoing Post-Graduate studies from Cairo University School of Pharmacy and completed a Visiting Fellowship at St. Jude’s Children Hospital in the United States. He conducted a wide variety of research studies involving the pharmaco-therapeutics management on pediatric oncology diseases and presented his work at international meetings (35 poster presentation accepted and 3 papers). His primary research interest focuses on pharmacy practice, patient safety, pharmacogentics, pharmacoeconomics, pharmacovigulance and pharmacoepidemiology of pediatric cancer.

Abstract:

Peter Drucker, the man who invented management said: “We cannot manage what we cannot measure” and “What is measured improves’. In this context, the WHO 7 star pharmacists listed the role of pharmacists including being a leader and a manger. Being a manger of the patient care process and the medication management process made the pharmacist an integral part of the clinical decision making and made the pharmacist responsible for the patient safety. We will discuss the medication management process, the pillars of quality, the 7 quality values, the role of the pharmacist in translating theory into practice, creating the culture of patient safety and we will be introduced the human factor and proactive approaches to prevent errors. Moving from the 6 R rules, through the Swiss Cheese Model, Poka Yoka, touching base with the FMEA process, the role of pharmacist in risk management and looking into some tools that will help the pharmacists improve the patient safety in their setting. I will urge all of us to proactively empower pharmacist to be an integral part of the clinical decision making and encourage patient safety research and clinical guidelines implementation Initiatives as a tool to improve patient safety.

Biography:

Mr. Ben Ajepe is a licensed & registered Pharmacist. He started his sales career in Pfizer a multinational Company in 1987. He loves to understand goals and objectives. He has had a 28+year’s career which has reflected continual advancement, a depth of valuable, diversified leadership experience in cost-effective sales and marketing strategies. All his career life has been involved in improving supply chain management of pharmaceutical products in Nigeria and some African countries. He is currently the MD/CEO of Today’s Pharmacy and Stores Ltd and B.Perazim Pharmaceuticals Ltd.

Abstract:

Introduction: The pharmaceutical supply chain is often a 'hidden' element within healthcare systems – the elaborate pathway between a medicine leaving the manufacturer and being dispensed to the patient. Middle men sit in the middle, playing a vital role in ensuring constant supply of high quality medicines to the medical front line. Africa like the middle-east countries is a continent ripe with potential, but the challenges for developing a viable market strategy are formidable, with distribution being consistently one of the largest challenges for drug makers. Inefficient or expensive distribution increases the final price to patient, reducing volume sales and hurting family finances in the largely out-of-pocket private market for medicines. That said, the problems in African distribution also provide an opportunity for those willing to take on this challenge. Pharmaceutical supply chains are one of the most complicated of logistics processes. Not only do they rely upon infallible temperature control and meeting stringent border regulations across regions, but logistics providers also have to guarantee the integrity and security of the products throughout the process. A single loose link in the chain could mean that costly and essential pharmaceuticals are left in an unusable or even potentially dangerous state, with the spin off problems associated with lack of adequate vital medicinal stocks or even legal procedures. Conclusion: (1) Strengthening supply chain management: The government should establish a structured supply chain management system with a logistic manager at both state & local government level ensuring the distribution system to flow in top to bottom approach. (2) Strengthening procurement system: In order to ensure hassle free procurement all the level of government should create a procurement society to make the process even faster. It will be a great idea if the government at grass-root level has decentralized small purchases at the local government level.

Biography:

Alireza Behshadfar has completed his Doctorate in General Medicine in 1991, from Medicine Faculty of Tehran University, Iran and his MBA in Integrated Information Processes in 2011 from Julius-Maximilians-Universität, Würzburg, Germany. He is Chairman of the Board in Rahaward Co. Ltd., a leading Medical Device Supplier, and Vice President of Nikan Medical Group, a premier pharmaceutical organization. He has translated Schwartz's Principles of Surgery, Clinical Neurology (Aminoff), and Clinical Gynecologic Endocrinology and Infertility (Speroff) to Persian and has been serving as an Editorial Board Member of Kowsar Corp., a medium open access publisher of more than 72 journals, a COPE Member.

Abstract:

The history of Iran pharmaceutical industry returns back to about 70 years ago with a structure mostly based on generic and brand-generic medicines. More than 85 domestic pharmaceutical factories cover more than 96% of country demand and consumption in terms of quantity which generate 65% of the value market size. In 2014, around USD 2.5 Milliard investment in medicine production resulted in more than USD 4.5 Milliard sales value in Iran market. Although Iran pharma industry shows 100% self-reliance and self-sufficiency, it is mostly true in materials used for primary and secondary packaging steps in production lines but not in APIs as a whole (40% of domestic demand), or APIs for vitamins, hormones, and enzymes (70% of local requirement), and high tech medicines. However, the main policy of Iran Ministry of Health and Food and Drug Organization stands on expansion of production facilities either through governmental pharmaceutical holdings or supporting investors from private sector specially in biotic, recombinant medicines, and vaccines. In this respect, GMP revising and upgrading have been instructed to manufacturing premises to meet PIC/s guidelines providing an integrated GMP scheme throughout the country as a requisite for being a member of this convention founded in 1970. Apart from the medicine, there is a significant market for supplements with market size of around USD 1 Milliard and promising consumption trend for nutrition and probiotics. In our study on these market dynamic trends, valuable opportunities were revealed in consistent with and in favor of local and global investments

Biography:

Dr. Malik has completed her PhD in 2013, at the age of 30 years from University Sains Malaysia in Pharmacy Practice. She has been serving as an Assistant Professor and coordinator for M.Phil Pharmacy Practice at Faculty of Pharmacy, Hamdard University Islamabad, Pakistan. At present she has been working as Post-doctoral research fellow at Medicine Usage in South Africa (MUSA), School of Pharmacy, Faculty of Health Sciences, North-West University, Potchefstroom Campus, Potchefstroom. She has published more than 50 papers in reputed journals and serving as an editorial board member of repute.

Abstract:

Background: Malaria is one of the global public health problems and imposes a major health burden in developing countries. It is a major health problem, threatening the health of the people due to prevailing socio-economic conditions and epidemiological situation in Pakistan. Malaria control program was initiated in Pakistan in 1950s and has passed through several evolutionary phases. A malaria control strategy was adopted in 1975 with provincial commitment to implementation and Pakistan joined the global Roll Back Malaria (RBM) initiative in 1998 to combat the disease, thus a qualitative study was designed to explore the role of malaria control program, major outstanding challenges faced by the program in promoting rational drug use, achievements and future prospective of the program for advancing resource mobilization and collaborative partnerships. <\br> Purpose & Methods: A qualitative study design was used to explore the perceptions’ of malaria control program officials regarding role of malaria control program in Pakistan. The study was approved by experts at Malaria Control Program, Ministry of Health, Pakistan. Eight semi-structured interviews with all the officials working at malaria control program in Islamabad were conducted by using an interview guide. The interviews, which were audio-taped and transcribed verbatim, were evaluated by thematic content analysis and by other authors’ analysis. <\br> Results: The interviews with officials focused on three major components, i.e., working and outreach of the program, strategies and major challenges faced for promoting rational drug use in malaria control and achievements and future prospective of the program. Thematic content analysis of these components yielded additional major themes and sub-themes. In view of most of the officials’ inappropriate diagnosis, anti malarial resistance, lack of trained staff and inappropriate drug management are the major factors promoting irrational drug use in the treatment of malaria in Pakistan. All the respondents agreed on successful implementation of malaria control program in Pakistan in controlling malaria by improving diagnostic and treatment facilities and promotion of rational case management through training of prescribers. Most of the officials think training, rational drug use, low number of cases of resistance and effective treatment of confirmed cases of malaria as the major achievements of the program. Monitoring plan and reviewing the sale of antimalarial drugs are seen as the tools for monitoring of the program by the officials. Public awareness, proper coordination with health care system and extensive coverage of the program are seen as the future prospective by the officials. <\br> Conclusion: The findings suggest that malaria control program in Pakistan has targeted high endemic areas which focus in the nineteen districts of the country and successful in achieving its targets. But still, funding is the major challenge faced by the program for its implementation in future. Thus, government of Pakistan, private sector, stakeholders and development partners have to unite their efforts and work together to expand the national malaria control program for achieving the national millennium development goals.

Biography:

Abstract:

Compounds when presented in the crystalline state to the gastrointestinal tract are typically dissolution rate limited and dissolution rate is directly proportional to the solubility of compound. The compounds are typically BCS class II or class IV compounds. The rate and extent of absorption of class II compounds is highly depended on the performance of the formulated product. Solid dispersion are one of the most promising strategies to improve the oral bioavailability poorly water soluble drugs. Carvedilol is poorly water soluble (BCS class II) antihypertensive drug. The purpose of this study was to increase solubility of Carvedilol of solid dispersion (SDs) technique with poloxamer (PXM) 407 in aqueous media. The Carvedilol- PXM 407 solid dispersion system was prepared by solvent evaporation, kneading method and melting method. It was characterized by differential scanning Calorimetry (DSC),X-ray powder diffraction (XRD) analysis, Fourier transformation infra-red spectroscopy (FT-IR) and Scanning electron microscopy (SEM) and in vitro dissolution studies. The results from DSC, XRD and SEM studies shows that PXM 407 inhibits the crystallization of Carvedilol. The solid dispersion prepared in this study were found to have higher dissolution rates compared to intact Carvedilol.

Biography:

Amina Mahdy has completed her PhD in 2002 from College of Pharmacy, Cairo University, Egypt, in the specialty of Pharmacology & Therapeutics. She got a Clinical Pharmacy Preparatory Diploma from Oxford Academy for Medical Science, United Kingdom. She is currently an Associate Professor and Head of Pharmacology Department in Dubai Pharmacy College, UAE. She has published 14 original articles in peer-reviewed journals and is serving as an Editorial Board Member in a reputed journal.

Abstract:

Prescription analysis highlights the prescribing behavior of clinicians and helps achieving rational drug use. The incidence of drug toxicity is higher in elderly than younger population due to several factors. The present study was undertaken to investigate the trends of drug prescribing for elderly patients in an attempt to assess the extent of potentially-inappropriate prescribing for this population in a tertiary hospital in Dubai, United Arab Emirates. Using a retrospective analysis, 718 prescriptions issued to elderly outpatients at different clinics were investigated. The study was performed from 1st of January till 20th of February 2013. WHO prescriber indicators were used to analyze prescriptions recording the average number of medicines per encounter, number of medicines prescribed as generics, number of prescriptions containing an antibiotic, or an injection, and therapeutic group of all the prescribed medicines. The extent of potentially-inappropriate prescribing was estimated using American Geriatrics Society Updated Beer’s criteria (2012). Data were presented using SPSS program. Findings revealed poly pharmacy in elderly with an average number of drugs per prescription being 3.2 deviating from the WHO standard of 1.6 to 1.8. Cardiovascular drugs were the most widely prescribed medications. Prescriptions were found to contain antibiotics and injection by a percentage of 10.8% and 12.9%, respectively. 14.7% of prescriptions had one or more potentially inappropriate medication with anticholinergics, NSAIDs and aspirin being the most common. A feedback through personal interviews as well as workshops for the health care team may be considered an effective intervention to optimize the prescribing pattern for the elderly.

Biography:

Ola Sayed Mohammed Ali had received her Bachelor’s degree in Pharmaceutical Sciences, Faculty of pharmacy, Cairo University in 1982 and PhD in 1995. She worked as a Professor of Biochemistry in 2007 and as an ex-Dean of Faculty of Pharmacy at Al Azhar University during 2009-2012. She is currently working as a Head of Biochemistry Department from 2009 till now. She supervised 30 members in obtaining their PhD thesis. She had published 30 papers in different National & International Journals. She is a reviewer of 3 National & 2 International scientific journals.

Abstract:

Aim: The current study investigates the hypothesis that obesity increases serum hepcidin level and hence worsens anemia in hemodialysis patients through an observational case controlled study. Anemia is an important complication of CKD. Hemodialysis patients are subjected to repeated blood loss and hence they suffer more severe anemia. Hepcidin the iron regulatory hormone that has an iron blocking effect plays an important role in anemia in CKD. Obesity in normal population is associated with an increased risk of CVD and mortality, but among HD patients with higher BMI is associated with survival advantage. This is known as obesity survival paradox. Methods: The study included 90 CKD 5HD with corrected anemia divided according to BMI into three groups (normal weight, overweight and obese groups). Hemoglobin and iron indices including serum iron, TIBC, ferritin and TSAT% for all groups was measured in addition to URR and creatinine. Hepcidin and HsCRP level were measured by ELISA. Results: The obese HD group showed significant higher mean age than the normal weight group (54.04±10.95, 45.22±13.67 years, respectively, at p<0.05). The median of HsCRP of obese group is significantly higher than both normal weight and overweight groups (23.5 (3.5-128), 8.9 (0.1-42.3) and 11.53 (0.1-108.5) mg/l, respectively, at p<0.001. The mean hepcidin level of the obese HD group is significantly higher than both normal weight and overweight groups (221.56±44.89, 153.56±22.44, 176.3±45.01 ng/ml, respectively, both at p<0.01). No significant difference was found among the three groups as regard to URR, creatinine, Hgb and any of iron indices. The correlational analysis revealed a positive correlation between hepcidin and each of BMI (p<0.01, r=0.49), HsCRP (p<0.05, r=0.24) and ferritin (p<0.01, r=0.46) and a negative correlation with hemoglobin (p<0.01, r=-0.59), URR (p<0.01, r=-0.35) and TSAT (p<0.01, r=-0.38). BMI has a positive correlation with CRP (p<0.01, r=0.49) and age (p<0.01, r=0.317) and a negative correlation with hemoglobin (p<0.05, r=-0.22). Hemoglobin has a positive correlation with each of TSAT (p<0.01, r=0.61), iron (p<0.05, r=0.24) and URR (p<0.01, r=0.65) and a negative correlation with ferritin (p<0.01, r=-0.67). The direct effect of BMI on hemoglobin was lost after multivariate linear regression analysis of hemoglobin as the dependent variable. Only hepcidin, ferritin and URR have an independent relation with hemoglobin. Conclusion: Obese HD patients have higher hepcidin and HsCRP levels than their normal and overweight counterparts. The negative effect of BMI on hemoglobin is indirect; it is through its effect on hepcidin which consequently affects iron indices, especially ferritin.

Biography:

Muhammad Ijaz is a PhD student at the University of Innsbruck Austria. He did his Master of Philosophy (Pharmaceutics) from The Islamia University of Bahawal Pur and secured an Outstanding Research Scholarship for PhD from Higher Education Commission of Pakistan (HEC). He has published a review article on pre-activated thiomers in reputed journals of Expert Opinion on Drug Delivery and is currently working on various projects of advanced drug delivery systems using thiolated polymers.

Abstract:

The objective of the present study was to synthesize and characterize Cysteamine conjugated β-Cyclodextrin (β-CD-Cys) as a novel muco-adhesive polymeric excipient for vaginal drug delivery. Increasing concentrations of cysteamine (0.25%, 0.5% and 0.75%) were covalently attached to oxidized β-CD via reductive amination. Quantification of immobilized thiol groups through Ellmans test revealed 851.84±107 µmol/g, 1040.44±132 µmol/g and 1563.72±171 µmol/g of free thiol groups attached to the polymer backbone, respectively. Viability studies of thiolated derivatives of β-CD at concentrations of 0.5% (m/v) showed no toxic effects on Caco-2 cells within 72 hours. Solubility of thiolated β-CD was furthermore 3.5-fold improved in comparison to unmodified β-CD. Thiolated derivatives of β-CD (β-CD-Cys851, β-CD-Cys1040 and β-CD-Cys1563) showed 3, 12.47 and 32.13-fold improved muco-adhesive properties on porcine intestinal mucosa and 5.84, 15.95 and 17.14-fold improved muco-adhesive properties on porcine vaginal mucosa, respectively. Inclusion complexes of antiviral drug acyclovir with thiolated β-CD resulted in increased drug solubility. According to these results, thiolated β-CD might be a promising novel tool for vaginal delivery of poorly water soluble therapeutic agents, such as acyclovir.

Biography:

Kesinee Netsomboon is a PhD student of Department of Pharmaceutical Technology, Institute of Pharmacy, University of Innsbruck, Austria since 2012. She graduated Bachelor of Pharmacy from Chiang Mai University, Thailand in 2008 and Master of Science in Pharmacy from Chulalongkorn University, Thailand in 2012. She was awarded the scholarship from the Chula-Chiba University Pharmaceutical Student Exchange Program during her Master’s degree study to carry on a part of her research at Chiba University, Japan in 2009.

Abstract:

Apomorphine is a non-selective dopamine agonist which is used for the treatment of Parkinson’s disease. Apomorphine, however, shows low oral bioavailability of less than 2% due to hepatic first-pass metabolism. Thus, the aim of this study was to investigate an improvement of apomorphine absorption through nasal mucosa by co-administration with a pre-activated thiomer. Poly(Acrylic Acid) (PAA) molecular mass of 250 kDa was used as polymer backbone. PAA was first thiolated by coupling with L-cysteine (Cys) followed by pre-activation via immobilization of 2-Mercapto-Nicotinic Acid (2MNA) in order to protect sulfhydryl groups towards oxidation. In vitro permeation across freshly excised porcine nasal mucosa was investigated. The influence of degree of pre-activation on drug absorption was thereby addressed. In total, 2816.7±185.0 μmol of thiol groups were immobilized per gram of polymer. Due to the omission of DMSO and pH variations, different degrees of pre-activation were achieved. In the presence of thiomer, 67.3% and 82.6% pre-activated thiomers, the cumulative amount of apomorphine permeating the mucosa was 1.2, 2.7 and 3.4 fold higher than the control (buffer only). Because of this pronounced effect, highly pre-activated thiolated PAA could be considered as promising excipient for nasal apomorphine delivery.

Biography:

Background: Malaria is one of the global public health problems and imposes a major health burden in developing countries. It is a major health problem, threatening the health of the people due to prevailing socio-economic conditions and epidemiological situation in Pakistan. Malaria control program was initiated in Pakistan in 1950s and has passed through several evolutionary phases. A malaria control strategy was adopted in 1975 with provincial commitment to implementation and Pakistan joined the global Roll Back Malaria (RBM) initiative in 1998 to combat the disease, thus a qualitative study was designed to explore the role of malaria control program, major outstanding challenges faced by the program in promoting rational drug use, achievements and future prospective of the program for advancing resource mobilization and collaborative partnerships. Purpose & Methods: A qualitative study design was used to explore the perceptions’ of malaria control program officials regarding role of malaria control program in Pakistan. The study was approved by experts at Malaria Control Program, Ministry of Health, Pakistan. Eight semi-structured interviews with all the officials working at malaria control program in Islamabad were conducted by using an interview guide. The interviews, which were audio-taped and transcribed verbatim, were evaluated by thematic content analysis and by other authors’ analysis. Results: The interviews with officials focused on three major components, i.e., working and outreach of the program, strategies and major challenges faced for promoting rational drug use in malaria control and achievements and future prospective of the program. Thematic content analysis of these components yielded additional major themes and sub-themes. In view of most of the officials’ inappropriate diagnosis, anti malarial resistance, lack of trained staff and inappropriate drug management are the major factors promoting irrational drug use in the treatment of malaria in Pakistan. All the respondents agreed on successful implementation of malaria control program in Pakistan in controlling malaria by improving diagnostic and treatment facilities and promotion of rational case management through training of prescribers. Most of the officials think training, rational drug use, low number of cases of resistance and effective treatment of confirmed cases of malaria as the major achievements of the program. Monitoring plan and reviewing the sale of antimalarial drugs are seen as the tools for monitoring of the program by the officials. Public awareness, proper coordination with health care system and extensive coverage of the program are seen as the future prospective by the officials. Conclusion: The findings suggest that malaria control program in Pakistan has targeted high endemic areas which focus in the nineteen districts of the country and successful in achieving its targets. But still, funding is the major challenge faced by the program for its implementation in future. Thus, government of Pakistan, private sector, stakeholders and development partners have to unite their efforts and work together to expand the national malaria control program for achieving the national millennium development goals.

Abstract:

Malik M has completed her PhD in 2013 from University Sains Malaysia in Pharmacy Practice. She has been serving as an Assistant Professor and Coordinator for MPhil Pharmacy Practice at Faculty of Pharmacy, Hamdard University Islamabad, Pakistan. At present, she is working as a Post-doctoral research fellow at Medicine Usage in South Africa (MUSA), School of Pharmacy, Faculty of Health Sciences, North-West University, Potchefstroom Campus, Potchefstroom. She has published more than 50 papers in reputed journals and serving as an Editorial Board Member of repute.

Biography:

Liljana Makraduli is currently completing her PhD thesis at the “Ss Cyril and Methodius University” Skopje, Macedonia. She is R&D Director at Replek Farm Ltd., Skopje, Macedonia. She is an expert in Pharmaceutical Technology with specialization at the “Faculty of Pharmacy”, “Ss Cyril and Methodius University” Skopje, Macedonia. She participated in two scientific projects financed by the Ministry of Education of Republic of Macedonia and by the NATO Science for Peace Program. She participated in more than 20 Workshops, Forums, Congresses and Symposia with published scientific work. Her paper “Factorial design analysis and optimization of alginate-Ca-chitosan microspheres” was published in Journal of Microencapsulation.

Abstract:

The purpose of this study is to apply experimental design in order to determine the influence of the formulation factors and their interactions on the dissolution of the active substance mesalamine (mesalazine) from the mesalazine film-coated tablets 500 mg. The delayed release of the active substance from the film-coated tablets at pH 1.2 during 120 minutes; at pH 6.8 during 60 minutes and at pH 7.2 during 90 minutes was analyzed according to USP/NF monograph for mesalamine delayed-release tablets. The formulation for achieving the best dissolution profile was chosen. The desired dissolution profile is as follows: maximum 1% of dissolved mesalamine/film–coated tablet expressed as a percentage of the declared content at pH 1.2 in 120 minutes and at pH 6.8 in 60 minutes; and minimum 80% (Q) dissolved mesalamine/film–coated tablet expressed as a percentage of the declared content at pH 7.2 during 90 minutes. With the study, it was shown that design of experiments could be successfully used in planning the experimental design, performing series of well-selected experiments and gaining the most informative combination out of the given factors. It is a science based and effective approach to analyze and optimize a given formulation; in contrast to the most frequently used “trial and error” approach when the experiments are first performed and the gained data are analyzed afterwards.

Biography:

Reenu Yadav is PhD student at NIMS University, Jaipur (RJ). She had done her MPharm and MBA from RGPV and Barkatullah University, Bhopal (MP). She has published more than 20 papers in reputed journals and is the Author of two reputed books. She is working as an Assistant Professor at IES College of Pharmacy, Bhopal (MP).

Abstract:

Natural products have served as a major source of drugs for centuries, and about half of the pharmaceuticals in use today are derived from natural products. The use of natural substances, particularly plants, to control diseases is a centuries old practice that has led to the discovery of more than half of all modern pharmaceuticals. Oral diseases continue to be a major health problem worldwide. Dental caries and periodontal diseases are among the most important global oral health problems, although conditions such as oral and pharyngeal cancers and oral tissue lesions are also significant health concerns. Despite general advances in the overall health status of the people living in industrialized countries, including oral and dental health, the prevalence of dental caries in school aged children is up to 90% and the majority of adults are also affected. There is a strong association between severe periodontal diseases and diabetes. There is also evidence linking poor oral health and systemic diseases, such as cardiovascular diseases, rheumatoid arthritis and osteoporosis, while periodontal diseases and may also contribute to the risk of pregnancy complications, such as preterm lowbirth weight. Hence, the search for alternative products continues and natural phytochemicals isolated from plants used in traditional medicine are considered as good alternatives to synthetic chemicals. The development of bacterial resistance to presently available antimicrobial agents has necessitated the search for new antibacterial agent. It is considered worldwide to explore Indian tradition medicinal herb for development of the poly herbal dental formulations with dental protection potential. Purpose: The aim of the present work was to develop an oral gel for brushing with antimicrobial activity which will cure/ protect from various periodontal diseases such as periodontitis, gingivitis, and pyorrhea. Methods: Plant materials procured from local suppliers, extracted and standardized. Screening of antimicrobial activity was carried out with the help of disk diffusion method. gel was formulated by dried extracts of Beautea monosperma, and Cordia obliqua gels evaluated on various parameters and standardization of the formulation was performed. Release of drugs was studied in pH 6.8 using a mastication device. Total phenolic and flavonoid contents were estimated by Folin-Ciocalteu and aluminium chloride method, and stability studies were performed (40 oC and RH 75%±5% for 90 days) to assess the effect of temperature and humidity on the concentration of phenolic and flavonoid contents. The results of accelerated stability conditions were compared with that of samples kept at controlled conditions (RT). The control samples were kept at room temperature (25 oC, 35% RH for 180 days). Results: Extracts possess significant antimicrobial activity at very low concentration (15 μg/disc, 20 μg/disc and 15 μg/disc) on oral pathogenic bacteria. Formulation has optimal characteristics as well as has pleasant appearance, fragrance, texture and taste is highly acceptable by the volunteers. The diffusion coefficient values ranged from 0.6655 to 0.9164. Since, the R values of Korsmeyer Papas were close to 1, drug release from formulation follows matrix diffusion kinetics. Hence, diffusion was the mechanism of the drug release. Formulation follows non-Fickian transport mechanism. Most formulations released 50% of their contents within 25-30 minutes. Results obtained from the accelerated stability studies are indicative of a slight reduction in flavonoids and phenolic contents with time on long time storage. When measured degradation under ambient conditions, degradation was significantly lower than in accelerated stability study. Conclusion: Plant extracts possess compounds with antimicrobial properties, can be used as. Developed formulation will cure/ protect from various periodontal diseases. Further development and evaluations oral gel including the isolated compounds on commercial scale and their clinical and toxicological studies are the future challenges.

Biography:

Amira Sayed Mahmoud Hanafy has registered for her PhD thesis on CNS delivery of neurotherapeutics in Sep 2013 in Faculty of Pharmacy, Alexandria University, Egypt. She is an Assistant Lecturer at Faculty of Pharmacy and Drug Manufacturing, Pharos University in Alexandria (PUA). She is a Referee in AAPS PharmSciTech journal. She had the opportunity to attend the IBRO-UNESCO Interregional School on Computational Neuroscience, 2012, India, organized by International Brain Research Organization (IBRO), and won a travel grant for this school. She was an Organizer in the “Nanoscience and Nanotechnology at Glance” International Conference, Cairo- Alexandria, Egypt, 15-16 January 2009. She has 4 publications namely, ‘Novel treatment strategies for brain tumors and metastases’, Pharmaceutical Patent Analyst; ‘Pulsatile core-in-cup valsartan tablet formulations: In vitro evaluation’, Asian Journal of Pharmaceutical Sciences; a poster published in the 4th International Conference and Exhibition on Pharmaceutics & Novel Drug Delivery Systems, March 24-26, 2014 at Hilton San Antonio Airport, USA, titled as ‘Valsartan time-clock pulsatile tablet formulations: Preparation and in vitro evaluation’; a poster published in the IBRO-UNESCO Interregional School on Computational Neuroscience, 2012, India, titled as ‘Formulation and Evaluation of Some Pulsatile Drug Delivery Systems’.

Abstract:

The employment of biodegradable polymeric nanoparticles to deliver therapeutic drugs and macromolecules to the CNS has been pioneered in 1999. Since then, various polymers have been utilized to tailor nanoparticles with desirable properties from the “efficiency” point of view. In comparison with liposomes, a platform that have been enrolled into clinical trials and proved successful, several challenges face the development of CNS-targeted polymeric nanoparticles. The formulation, stability, processability, and cost/ benefit ratio are not the sole factors holding back the development of polymeric nanoparticles. The safety parameter of short and long-term administration of such nanoparticles is usually overlooked, especially that the exact in vivo fate of polymeric nanoparticles is not fully understood. Less that 2% of the published articles relating to CNS targeted polymeric nanoparticles between 2011 and 2015 dealt with the nanotoxicological assessment especially in the brain, liver, and kidney. In this presentation, the formulation factors that might affect the overall safety of the polymeric nanoparticulate delivery systems such as the particle size, surface properties, coatings, tendency to aggregation, and the addition of stabilizers will be discussed. In addition, the several in vitro and in vivo experimental models used to assess the toxicity of polymeric nanoparticles will be summarized. This presentation aims to redirect the current interest of pharmaceutical researchers to nanotoxicological aspects, and encourage them to comb their efforts with those of pharmacologists and toxicologists so as to push forward the development of polymeric nanoparticles for CNS drug delivery in the near future.

Biography:

Marwan Ahmed has recently completed his Master’s in Pharmacology from the University of Pretoria, South Africa. He also holds Diploma in Pharmacology (University of North West, South Africa, 2011), Post-graduate Diploma in Research Methodology and Biostatistics (University of Medical Sciences and Technology, Sudan, 2007) and Bachelor of Pharmacy (University of Sanaa, Yemen, 2003).

Abstract:

Context: The association between long-term metformin use and low vitamin B12 levels has been proven. However, the prevalence estimates of metformin-induced vitamin B12 deficiency showed considerable variation among the studies and have not been studied in African settings. The potential of the deficiency to cause or worsen peripheral neuropathy in T2DM patients has been investigated with conflicting results. Objectives: The main objectives were to determine the prevalence of vitamin B12 deficiency among metformin users and to examine the association between the vitamin status and neuropathy in those patients. The secondary objective was to investigate the risk factors for vitamin B12 deficiency. Research Design & Methods: In this cross-sectional study, consecutive T2DM patients on long-term metformin attending the diabetes clinics in two public hospitals in Pretoria, South Africa, were approached for participation. Serum vitamin B12 levels were measured and neuropathy was assessed using the Neuropathy Total Symptom Score-6 (NTSS-6) questionnaire. Records were used to obtain other data. Vitamin B12 deficiency was defined by levels <150 pmol/L. Those with NTSS-6 scores >6 were considered to have neuropathy. The percentage of vitamin B12-deficient patients was determined. The relationship between vitamin B12 and neuropathy was investigated by using Chi-square test and Spearman’s correlation coefficient (rho) when the two variables were in the binary and continuous forms, respectively. Stepwise multiple logistic regression was used to determine the risk factors for vitamin B12 deficiency. Results: Among 121 patients, the prevalence of vitamin B12 deficiency was 28.1%. There was no difference in presence of neuropathy between those with normal and deficient vitamin B12 levels (36.8% vs. 32.4%, P = 0.209). The level of vitamin B12 and the NTSS-6 scores were not correlated (rho = 0.056, P = 0.54). Stepwise multivariable logistic regression analysis showed that metformin dose (gram) (OR = 1.96, P = 0.053), HbA1c (OR = 0.71, P = 0.003) and black South African race (OR = 0.34, P = 0.033) were the only risk factors significantly associated with vitamin B12 deficiency. Conclusions: Close to third of metformin-treated T2DM patients had vitamin B12 deficiency. The deficiency was, however, not associated with peripheral neuropathy. Black South African race was a protective factor for vitamin B12 deficiency.