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.