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Egyptian Drug Authority: An Overview
The session will discuss an overview on the Egyptian Drug Authority (EDA).
Aiman S. El-Khatib , Ph.D.
Vice President of Egyptian Drug Authority (EDA)
Professor of Pharmacology and Toxicology, Faculty of Pharmacy, Cairo University, Egypt.
FUTURE OF NATURAL PRODUCTS IN FRONT OF PANDEMICS (COVID-19)
During December 2019, a novel coronavirus disease 2019, (COVID-19) pandemic has been appeared and resulted in a tremendous unexpected economic loss and unprecedented health crisis across the globe. The pandemic is continuous with unknown prediction to end, all health organizations as well as highly reputable research centers spared no effort in taking necessary actions to confront the crisis and averted it. Now, crisis covered the world. all the probabilities are possible for eradication or exacerbation of the pandemic. Natural products and herbal medicine systems have been historically used for acute respiratory infection and generally show acceptable toxicity. The favorable stability for oral formulation and ease of scaling up manufacture make it ideal candidate for prophylactic. The natural products showing inhibitory effect on human coronavirus, and herbal medicines used for COVID-19 as prophylactic and relieving certain symptoms even the side effects of different vaccine especially the focusing on the herbal products already approved by regulatory agency with identifiable patent number. More collaboration in different disciplines and scientific fields should be arranged to be ready for international pandemics.
Abdel Nasser B. Singab, Ph.D.
Former Vice President of Ain Shams University
Consultant of the Minister of Health and Population for the Pharmaceutical affairs
Acting Head of Egyptian Pharmacists Syndicate
Chairman of Center for Drug Discovery Research & Development
Professor of Pharmacognosy, Faculty of Pharmacy, Ain Shams University
Pharmacy Education Reform:” CBE and Training Missing Link
The session will discuss the improvement of pharmacy education. The missing link between training and the competency-based education (CBE) of pharmacy in Egypt.
Ragia Ali Taha , Ph.D.
Vice President of The National Authority for Quality Assurance and Accreditation of Education “NAQAAE”
Professor of Pharmacology and Toxicology, Faculty of Pharmacy, Al-Azhar University
Pharmaceutical industry strategy in line with Egypt’s vision for sustainable development (2030)
- Egypt should regain its regional and international position in the research, industry and export of safe and effective medicine in accordance with the latest international standards over the next 10 years.
- Preparing the technical plan on the needs of the Egyptian pharmaceutical market to more traditional pharmaceutical factories according to actual consumption until 2030 in which each party of the pharmaceutical system participates in Egypt.
- Increase the volume of exports of medical products to 5 billion pounds until 2030
Mohy Hafez , PhD, Senator
Egyptian Senate Senator
Board member of the pharmaceutical education planning sector at the Supreme Council of universities
Founder, Chairman and CEO For DELTA PHARMA BIO Company
Member of Chamber Industry of Cosmetics & Medical Supplies
Tips for running problem based learning group
The principle idea behind PBL is that the starting point for learning should be a problem, a query, or a puzzle that the learner wishes to solve. The inception and propagation of PBL in modern medical education is rightly credited to McMaster University Faculty of Health Sciences in Canada. PBL was first introduced in 1969. Many factors encouraged medical educators to adopt the revolutionary PBL system including the fact that traditional medical curricula were of highly lecture-based and discipline-oriented nature. This style of teaching rendered medical students into passive learners who failed to correlate basic science information during clinical years and students lacked motivation and preparation for life-long learning. Health care students used to learn content independent of one another and then have difficulty seeing how it fits together. They were unable to apply their knowledge to real-life cases. This is where the disconnect happens in the traditional curriculum. PBL helps to connect what students are learning to the real world so they can react to it accordingly when they face it. This lecture will give tips , explain the PBL process, the classroom dynamics, PBL participants’ roles and the characteristics of a good PBL case.
Randa Mostafa , Senator, Ph.D.
Senator , Vice President of Education , Research and telecommunication at Egyptian senate
Member of Pan African Parliament South Africa
Fellow of Foundation for Advancement of Medical Education and Research
Professor of Physiology, Faculty of Medicine, Benha University
Development and Evolution of Bioequivalence Studies in Egypt
The needs for Bioequivalence Studies (BE) for pharmaceutical industry, Drug Regulation, Development of BE in Egypt, Scientific Committee of BE, BE studies Regulations, Conduction of Bioequivalence Study, Institutional Review Board (IRB), Study Protocol, INFORMED CONSENT FORM, Case Report Form, Dispensing of Investigational Medicinal Product, Study Completion /Termination and finally Tour in ICBR
Fathy Ibrahim , Ph.D.
CEO and Managing Director of The International Center for Bioavailability, Pharmaceutical, and Clinical Research (ICBR)
Professor of Pharmaceutics and Pharmaceutical Industries, Faculty of Pharmacy, Azhar University
Dihydrofolate Reductase as Antitumor Molecular Target
DHFR inhibition is an important molecular target to combat cancer. A new series of 6-substituted amido, azo or thioureido-quinazolin-4(3H)-one was synthesized and tested for their in-vitro antitumor activity. Compounds 21, 53 and 60 showed broad spectrum antitumor activity with average IC50 values of 6.7, 7.6 and 9.1 mM, respectively compared with methotrexate (1, IC50 19.26 mM). As an attempt to reveal the mechanism of the antitumor potency, cell cycle analysis and DHFR inhibition were performed. Compounds 59 and 61 induced their cytotoxicity in Hela (IC50 10.6 μM) and HCT-116 (IC50 15.5 μM) cell lines, respectively through Pre-G1 apoptosis, inhibiting cell growth at G2-M phase. Compounds 29, 33, 59 and 61 showed DHFR inhibitory potency at IC50 0.2, 0.2, 0.3 and 0.3 mM, respectively. The active DHFR inhibitors showed high affinity binding toward the amino acid residues Thr56, Ser59 and Ser118. The active compounds obeyed Lipinski’s rule of five and could be used as template model for further optimization
Hussein I. El-Subbagh, Ph.D, D.Sc
Professor of Medicinal Chemistry
Faculty of Pharmacy, Mansoura University
An Expert Overview on Antimicrobial Chemotherapy with Special Emphasis on Combating Bacterial Biofilms
Biofilm refers to the complex microbial communities found attached to living or non-living surfaces via extracellular matrix. The biofilm matrix renders the bacteria tolerant to ruthless conditions and challenging to antibacterial therapies. Furthermore, the biofilms are responsible for various chronic diseases due to their resistance to antibiotics and evasion of the immune system. Additionally, the available antibiotics are unsuccessful in eradicating biofilm-associated infections which necessitate escalating antibiotic doses and consequently it might lead to patient’s toxicity. This overview addresses some important studies on biofilms of Pseudomonas aeruginosa, Staphylococcus aureus, Staphylococcus epidermidis, and MRSA. Also, it summarizes the potential interactions between antibiotics and non-antibiotic agents (e.g Calcium channel blockers, and Zinc ions), and PK-PD modelling of antibiotics for treatment of bacterial biofilms. Furthermore, our studies shed light on utilization of quorum quenching, implementation of nanobiotics, and designing of novel peptides as promising strategies for combating bacterial biofilms.
Walid Elkhatib , Ph.D.
Vice Dean of Faculty of Pharmacy, Galala University
Professor of Microbiology and Immunology, Faculty of Pharmacy, Ain Shams University, Egypt.
Governance as Evolving Mandate in Current Pharmacy
Pharmacy as a dynamic sector of healthcare realm contributes significantly to societies and population thru interconnecting many fields of health sciences, technologies and demographics. Furthermore, pharmacy as a profession is multifaceted and knowledge-based with particular reference to medicine related pharmacological, ethical, legislative, economic, and sociologic contexts. Meantime, pharmacy practice constructs legitimate, theoretical and economic aspects underlying all professional practice models and processes. So, pharmacists are duly engaged with their societies in a tough challenging and ever-changing multisectoral environment that greatly overwhelmed with ethics and politics. Besides, a view through governance lens gives an instance that pharmacy is genuinely practiced within three main unique structures hold and sustain a set of three principal macro processes. The first one is the research and development macro process and subs; aimed at production of new pharmaceutical moieties based on medical practice and patient care needs. The second is manufacturing and profiling of the resulted new medicine products in the best form, formulation, package etc.., that comply with standards, regulations, and patient needs. Then the third is the on-ground utilisation macro process or the deployment and intervention with medicines and patients; it involves knowledge and outcomes of the preceding two structures in addition to supply chain logistics and particular interventions with healthcare spheres and workforce. Consequently, governance in pharmacy is now an evolving mandate as governance fundamentally defines fiduciary duties within these structures, helps setting and aligning the strategic direction for duty of care, functions and processes in the healthcare system. Uniformly, governance encourages and sustain excellence amid facilitating integration of macro/ meso / micro processes that help define authority, relationships and crossovers influences between several actors and bodies. In addition, governance strategies depict overseeing legal and functional compliance, through perpetual deployment and enforcement of tools and directives of partnership, audit, transparency and accountability as well as fighting corruption. Accordingly, governance assures the delivery of safe, responsive and integrated pharmacy services, that cope with individualised yet holistic needs in more appropriate and timely ways. And authorises care coordination and integration around the health system improving accessibility, affordability and quality of care.
Emad ElAzazy , PhD, PharmD, MPA, MBA
Professor of Governance Practices
C.E.O. Arab Academy for Excellence in Governance
Managing Director of the Arab Alliance for Governance
Secretary General of Egyptian Healthcare Society (EHS)
Board Member of Arab Union for Combating Counterfeiting & Forgery (AUCCF)
Biochemical Mechanisms of Laboratory Investigation in COVID-19
A subset of COVID-19 individuals develops severe disease, requiring ICU treatment and ventilation. Laboratory investigations show that hyper-inflammation, hyper-activation, and cytokine storm production cause significant changes in the immunological and clotting systems. Furthermore, organ-specific biomarkers show that cardiac muscle, kidney, and liver dysfunction are all present in many patients. The use of laboratory biomarkers for diagnosis, illness progression, and risk assessment is covered in this presentation.
Ahmed Soliman , Ph.D.
Vice Dean for Research and Postgraduate Affairs
Professor of Biochemistry
Badr University in Cairo
Metabolomics gateway for milestone discoveries in the prehistoric and post genomic era
The ability to sequence whole plant and human genomes has taught us that our knowledge with respect to gene function is rather limited. Functional genomics analyses include investigations at the level of gene expression (transcriptomics), protein translation (proteomics) and more recently the metabolite network (metabolomics). Metabolomics is the study of global metabolite profiles in a system (cell, tissue, or organism) under a given set of conditions. The analysis of the metabolome is particularly challenging due to the diverse chemical nature of metabolites in a cell and the massive number of molecules detected which warrants the use of bioinformatics for its analysis. This presentation provides an overview of metabolomics and discusses its complementary role within system biology. It highlights how metabolome analyses are being conducted using different spectroscopic techniques, and how the highly complex data generated are analyzed using bioinformatics tools. Specific examples will then be presented to illustrate how metabolomics can lead to valuable information relative to natural products biosynthesis, herbal medicines quality control analysis and lastly analysis of ancient Pharaonic food.
Mohamed A. Farag, Ph.D.
TWAS fellow in Agriculture
Alexander von Humboldt fellow
Visiting Professor, American University in Cairo (AUC)
Professor, Faculty of Pharmacy, Cairo University, Egypt.
Advances in Clinical Pharmacy Practice
The session will discuss the recent advances in clinical pharmacy practice and the road to its implementation in Egypt
Sherif Kamal
Chief Pharmacist and Pharmacy Program Director
The Children’s Cancer Hospital Egypt 57357 (CCHE)
Morphologic design of sugar-based polymer nanoparticles for delivery of antidiabetic peptides
Zwitterionic polymer nanoparticles of diverse morphologies (spherical, cylindrical, and platelet-like) constructed from biocompatible sugar-based polymers are designed to extend the pharmacological activities of short- and long-acting insulin peptides, thereby providing potential for therapeutic systems capable of reducing the frequency of administration and improving patient compliance. Laser scanning confocal microscopy imaging of three-dimensional spheroids of vascular smooth muscle cells and fibroblasts after treatment with LIVE/DEAD® stain and FITC-insulin-loaded nanoparticles demonstrated high biocompatibility for the nanoconstructs of the various morphologies and significant intracellular uptake of insulin in both cell lines, respectively. Binding of short-acting insulin and long-acting insulin glargine to nanoparticles resulted in extended hypoglycemic activities in rat models of diabetes, thus providing evidence of biocompatible nanoconstructs that are poised for further development toward the management of diabetes.
1Elsabahy, M. et al. J Control Release, 334, 1 (2021).
Mahmoud Fahmy Elsabahy , Ph.D.
Director of the BUC Science Academy
Vice Dean of Faculty of Biotechnology
Professor of Pharmaceutics Badr University in Cairo
ON THE PERSPECTIVE OF CAPILLARY ELECTROPHORESIS AS AN ALTERNATIVE SEPARATION TECHNIQUES
Capillary Electrophoresis (CE) has grown to become a collection of a range of separation techniques, which involve the use of high voltages across buffer-filled capillaries to accomplish separations. These techniques based on size and charge differences between the analytes (Capillary Zone Electrophoresis, CZE), separation of neutral compounds using surfactant micelles (Micellar Electrokinetic Chromatography, MEKC), sieving of solutes through a gel network (Capillary Gel Electrophoresis, CGE), and separation of Zwitterionic solutes within a pH gradient (Capillary Iso-Electric Focusing, CIEF). Capillary Electro-Chromatography (CEC) is an associated electrokinetic separation technique which involves applying voltages across capillaries filled with silica gel stationary phases. Separation selectivity in CEC is a combination of both electrophoretic and chromatographic processes. Many of the CE separation techniques rely on the presence of an electrically induced flow of solution (Electro-Osmotic Flow, EOF) within the capillary to force the analytes to migrate towards the detector.
Samy E.S. Emara , Ph.D.
Vice Dean of Community Services and Environment Development Affairs at Faculty of Pharmacy, Misr International University
Professor of Pharmaceutical Analytical Chemistry
Machine learning methods in Drug Delivery: Novel Pharmaceutics Informatics approach
Machine learning methods are a branch of artificial intelligence that utilizes certain software algorithms in order to make computers “learn” and to make hard and critical decision functions from representative data samples. They are specifically useful when certain software that is needed to perform a specific task or reach a targeted goal is unavailable or unfeasible. With the advent of the internet and the enormous growth of data that are obtained from huge number of sources, the recent advances in various statistical and programming tools and the continuous innovations in machine learning algorithms have resulted in a rapid increase in new applications in the different areas of pharmaceutics and drug delivery disciplines. Over the past 20 years, this new approach of data analysis has been extensively used in drug development and delivery. Machine learning methods offer several advantages over the other conventional statistical methods. First, the majority of these methods can model nonlinear relationships that are hard-to-model using the common quantitative structure-bioavailability or structure–property relationships methods. Second, they can model incomplete data or nontrending data and the users do not have to suggest any models or particular deigns before use. In other words, no restrictions are encountered while implementing machine learning algorithms where all types of data whether binary classification, multiple classes and continuous data can be analyzed and modeled. And finally, these methods can they offer. Integrating the machine learning methods into drug delivery saves costs, resources, time, and effort. In this talk, different types of the machine learning methods that were exploited in drug delivery aspects and applications will be demonstrated and discussed. These methods are currently considered important elements of the new approach of computer-aided drug formulation design (CADFD) and computer- aided pharmaceutical technology. The cross-disciplinary integration of drug delivery and machine learning methods as a branch of artificial intelligence may shift the paradigm of pharmaceutical research from experience-dependent investigations to data-driven studies.
Rania Mohammed Hathout , Ph.D.
Professor and Head of Department of Pharmaceutics and Industrial Pharmacy – Faculty of Pharmacy – Ain Shams University.
Structure-Based Modification of Tadalafil into a Potent and Selective PDE4 Inhibitor
Phosphodiesterase 4 is the primary enzyme responsible for degradation of the second messenger cAMP in many of the cells releasing proinflammatory mediators. Inhibition of this enzyme could help in the management of various inflammatory conditions such as asthma, chronic obstructive pulmonary disorder, arthritis, and psoriasis. In this study, two novel series of tetrahydro-β-carbolines were designed by combining the pharmacophoric features of both tadalafil and piclamilast. Twenty-two compounds were synthesized and assessed for Phosphodiesterase 4 inhibition, four of them showed superior activity to the reference compound IBMX. Docking studies showed that the prepared compounds interact with the crucial Gln443 with variable interactions with the hydrophobic pocket Q2.
Mohamed Helal , Ph.D.
Associate Professor of Medicinal Chemistry, Zewail City of Science and Technology & Suez Canal University
Estimating the utilities for a generic health outcomes measurement
Health and insurance reform plans necessitate rigorous economic and clinical evaluations when considering new health technologies to optimize health resource allocation. Cost-utility analysis (CUA) is a vital tool in economic evaluations that uses utilities from Preference-Based Measurements such as Short form 6 Dimensions version 2 (SF-6Dv2). Eliciting public preferences can be done using several techniques the require optimization. Herein, I plan in my talk to display, examine and compare the feasibility of using an online population sample to elicit preference utility values for the SF-6Dv2 from Best-Worst Scaling case 2 (BWS), Discrete Choice Experiment (DCE), and Time Trade-Off (TTO).
Ahmed M.Y. Osman , Ph.D.
School of Pharmaceutical Science and Technology, Tianjin University, China
Insights into Pharmacovigilance
Pharmacovigilance has been defined by the World Health Organization as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. Information received from patients and healthcare providers via pharmacovigilance agreements, as well as other sources such as the medical literature, plays a critical role in providing the data necessary for pharmacovigilance to take place. Consequently, The Guideline of the Egyptian Pharmacovigilance Center (EPVC) has been developed to bring guidance on the requirements, procedures, roles, and activities in the field of human Pharmacovigilance for medicinal products use.
Samar Darwish , Ph.D.
Lecturer of pharmacology & Toxicology, Vice manager of Quality Control Unit, Faculty of Pharmacy, Badr University in Cairo