Day 2 :
Keynote Forum
Ting-Chao Chou
PD Science LLC, USA
Keynote: Scientific definitions and computerized algorithms for advancement of medical and pharmaceutical regulatory affairs
Time : 10:00-10:30
Biography:
Ting-Chao Chou received MS in Pharmacology from National Taiwan University, and PhD from Yale University, and Postdoctoral Fellowship at Johns Hopkins University, School of Medicine. He joined the Memorial Sloan-Kettering Cancer Center (MSKCC) and became a member in 1988, and was a Professor of Pharmacology at Cornell University, Graduate School of Medical Sciences during 1988-2000. He was the Director of Preclinical Pharmacology Core at MSKCC, where he retired on January 06, 2013. He is the Founder of PD Science, LLC., USA. He published 273 articles that have been cited by 16,421 papers in 620 biomedical journals worldwide including Thomson Reuters Web of Science and Google Scholar Citations with 22,336 citations, h-index 65 and 38 U.S. Patents. He introduced the “Unified Theory of the Median-Effect Equation of the Mass-Action Law” in 1976 for single drug, and with Prof. Paul Talalay (JHU) in 1984, created the “Combination Index Theorem” for multiple drug dynamics. His dynamics equations and software have been utilized to advance Econo-Green Bio-Research.
Abstract:
Disparity in basic scientific concept and theory lead to weakness in setting policy and regulatory affairs. At least three major areas in biomedical-research and pharmaceutical development exist confusion that need clarifications to improve research efficiency, developmental cost-effectiveness and rigorous regulatory affairs: (I) Loose in consensus on “synergy definition and its quantification” in drug combination synergy claims, especially in cancer and AIDS. (II) The terms PK/PD referred as Pharmacokinetics and Pharmacodynamics are used casually, where PD dose-effect dynamics for effi cacy and toxicity algorithm for simulation is not yet defined clearly and with insufficient emphasis on PD comparing with PK. (III) The care and use of laboratory animals are good policy and regulation. However, the mass-action law-based conservation of animals to increase efficiency/cost-eff ectiveness and to minimize experimental size and data points, remain to be implemented and utilized. All the above important improvements can be implemented by employing the unified theory of the median-effect equation and the combination index theorem, based on the physico-chemical principle of mass-action law, using CompuSyn computer soft ware for automatic simulation, that have, so far, been adopted by >10,000 scientists in over 5,000 papers worldwide as indicated by Thomson Reuters Web of Science core database.
Keynote Forum
Michael Drues
Vascular Sciences, USA
Keynote: Commercializing disruptive medical technologies in an evolutionary world
Time : 10:30-11:15
Biography:
Michael Drues, PhD, is the President of Vascular Sciences, an education, training, & consulting company offering a broad range of services to medical device, pharmaceutical & biotechnology companies including (but not limited to): stimulating & innovative educational programming, brain-storming sessions, prototype design, product development, bench top & animal testing, regulatory strategy & clinical trial design, FDA presentation preparation & defense, reimbursement, clinical acceptance, business development & technology assessment. He received his BS, MS, and PhD degrees in Biomedical Engineering from Iowa State University in Ames, Iowa. He has worked for and consulted with leading medical device, pharmaceutical and biotechnology companies ranging in size from start ups to Fortune 100 companies. He also works on a regular basis for the US Food and Drug Administration (FDA), Health Canada, the US and European Patent Offices, the Centers for Medicare and Medicaid Services (CMS) and other regulatory and governmental agencies around the world. He is an internationally recognized expert and featured keynote speaker on cutting-edge medical technologies and regulatory affairs. He conducts seminars and short-courses for medical device, pharmaceutical and biotechnology companies, the US Food and Drug Administration (FDA), Health Canada, the US and European Patent Offices, the US Centers for Medicare and Medicare Services (CMS) and other regulatory and governmental agencies around the world. Finally, as an Adjunct Professor of Medicine, Biomedical Engineering & Biotechnology, he teaches graduate courses in Regulatory Affairs & Clinical Trials, Clinical Trial Design, Medical DeviceRegulatory Affairs & Product Development, Combination.
Abstract:
Most product development in medical technology is evolutionary, i.e. make a drug or medical device then modify it slightly to create a new drug or device. There are many advantages to this approach but there are disadvantages as well. For example, the light bulb did not evolve from the candle nor did the car evolve from the horse. You can tweak a horse as many times as you want but you will never end up with a car! The light bulb and the car are examples of revolutionary a.k.a. destructive technologies. Our current regulatory environment was designed for and indeed encourages evolutionary advancements. However, when it comes to bringing revolutionary or disruptive technologies to market, the regulatory challenges are immense. Using case studies from 3-D printing, pharmacogenomics, tissue engineering and nanotechnology, this presentation will discuss the regulatory challenges of commercializing revolutionary technologies in an evolutionary world and how manufacturers can successfully meet them.
- Track 4: Regulatory Requirements for Pharmaceuticals
Track 5: Requirements for Medical Devices
Track 6: Biologics and Other Novel Therapies
Location: Sciphol
Chair
Michael Drues
Vascular Sciences, USA
Co-Chair
Antonio Trejo Diaz
Teva Pharmaceuticals, Mexico
Session Introduction
Ting-Chao Chou
PD Science LLC, USA
Title: Toward better and effi cient equilibrium dynamics of research, development, and regulation
Time : 11:30-11:55
Biography:
Ting-Chao Chou received MS in Pharmacology from National Taiwan University, and PhD from Yale University, and Postdoctoral Fellowship at Johns Hopkins University, School of Medicine. He joined the Memorial Sloan-Kettering Cancer Center (MSKCC) and became a Member in 1988, and was a Professor of Pharmacology at Cornell University, Graduate School of Medical Sciences during 1988-2000. He was the Director of Preclinical Pharmacology Core at MSKCC, where he retired on January 06, 2013. He is the Founder of PD Science, LLC., USA. He published 273 articles that have been cited by 16,421 papers in 620 bio-medical journals worldwide including Thomson Reuters Web of Science and Google Scholar Citations with 22,336 citations, h-index 65 and 38 U.S. Patents. He introduced the “Unified Theory of the Median- Effect Equation of the Mass-Action Law” in 1976 for single drug, and with Prof. Paul Talalay (JHU) in 1984, created the “Combination Index Theorem” for multiple drug dynamics. His dynamics equations and software have been utilized to advance Econo-Green Bio-Research.
Abstract:
The triangular bi-directional dynamic equilibrium relationships among Research, Development and regulation set the reality framework of our nation and the world for scientific innovation, developmental status and legal security. Basic bio-science research is fundamental but is heavily influenced by NIH, foundations, peer review, and scientific trend. The eventual purpose in research is to improve knowledge and to produce something useful and beneficial to our life. These lead to the emergency of applied sciences such as those in pharmaceutical industry. To ensure the advancement and to constrain the behavioral selfishness and greed and to safeguard security, we have regulatory agencies such as FDA and USPTO to enforce law and order. The scientific community, from time to time, need to review and reform in the reverse directions in the triangular equilibrium dynamics, based on the sound and rigorous scientific basis. This is the main objective of my talk at 5th International Conference and Exhibition on Pharmaceutical Regulatory Affairs-2015. We hope to have an open forum to exchange ideas and to formulate the scientific consensus for our better tomorrow.
Juhi Tiwari
Jayoti Vidya Peeth Womens’ University, India
Title: Urolithiasis-anti urolithic activity of extracts of roots of Ricinus communis
Time : 11:55-12:20
Biography:
Juhi Tiwari is an MPharm in pharmacology from Jayoti Vidya Peeth Womens’ University, Jaipur, India. She has attended National and International conferences and has published research paper on antipyretic effect.
Abstract:
Phytomedicine are the staple of medical treatment in many developing countries. According to article Phytomedicine in clinical trials, “Phytomedicine has become an important alternative treatment option for patient in western world, as they seek to be treated in a holistic and natural way aft er an unconventional response to conventional drugs. Various plant products have been tested and found to be possessed with anti urolithiatic activity. The present study was designed to investigate the anti urolithiatic activity of extracts of the roots of Ricinus communis. Ricinus communis has anti inflammatory activity, antidiabetic and hepato protective and CNS stimulant actions. To assess effect of hydroalcoholic and pet ether extracts of Ricinus communis on Ethylene glycol and Ammonium chloride induced urolithiasis, both extracts was dissolved in hydroalcoholic and DMSO solution for oral administration at a dose of 200 mg/kg bwt and 400 mg/kg bwt. The standard cystone at 750mg/kg bwt significantly reduced the induced urolithiasis. Result: Result obtained for standard drug treated and hydroalcoholic extract and pet ether extract were compared with control (0.75% EG and 1% AC in drinking water) group and signifi cant reduction in size and number of stone was observed. Conclusion: Th us from present investigation, it can be concluded that hydro alcoholic extract of roots of Ricinus communis possess signifi cant anti urolithiatic activity.
Mariam Aslam
PAREXEL International, UK
Title: The practice of Regulatory Intelligence: Case studies
Time : 12:20-12:45
Biography:
Mariam Aslam has 10 years of regulatory affairs experience. Her current role is working as a Senior Consultant at PAREXEL International, UK. Her experience includes working with conventional medicines, herbal medicines, cosmetics and medical devices regulations. She studied a degree in Chemistry at the Manchester Metropolitan University in the UK. She also attended and participated as a Moderator and Speaker in the OMICS Group Inc., at the 4th 5th International Conference and Exhibition on Pharmaceutical Regulatory Affairs (8-10 September 2014) in Raleigh, NC, USA. Her speech was on “Herbal Medicines: Product License to Traditional Herbal Registration in the UK”.
Abstract:
Regulatory Intelligence (RI) is likely to have been practiced in some way or other from when regulations first came into existence. In the recent years, RI has become more of a phenomenon in the pharmaceutical regulatory sector. Although the brilliance of this concept is still evolving, two definitions have been created for RI; one from the Drug Information Association’s Regulatory Intelligence Network Group (DIA RING) and the EU Regulatory Intelligence Group (EU RING). The DIA RING definition is: ‘The act of gathering and analyzing publicly available regulatory information. This includes communicating the implications of that information, and monitoring the current regulatory environment for opportunities to shape future regulations, guidance, policy, and legislation. The EU RING definition is: ‘Regulatory intelligence is the act of processing targeted information and data from multiple sources, analysing the data in its relevant context and generating a meaningful output – e.g. outlining risks and opportunities–to the regulatory strategy. The process is driven by business needs and linked to decisions and actions.’ However you interpret these definitions, RI key aspect is applying the acquired knowledge from drug discovery to post approval. A vast amount of years and cost is invested in getting the drug on the market. Then when it gets to the market, what happens next? This is when the importance of RI ensures the best regulatory strategy so that your drug’s safety, quality and efficacy are maintained during its lifecycle.
Avong
Institute of Human Virology, Nigeria
Title: Prospects and challenges of providing pharmacovigilance services in resource limited countries
Time : 13:45-14:10
Biography:
Avong is a public health pharmacist, implementer of public health initiatives and a certified operational researcher. He holds a Bachelor of Pharmacy (BPharm) from the Ahmadu Bello University, Zaria, Nigeria and a Master of Public Health (MPH) from the University of the Western Cape, South Africa. He is also in the process of pursuing a PhD in Pharmacovigilance and Pharmaco-epidemiology. In 2009, he inspired the setting- up of the spontaneous reporting system (SRS) in two public health programs (ART and MDRTB) and supervised the collection and analysis of over 2000 individual case reports (ICRs) from these programs. He has published papers in ADRs and adherence to anti-retroviral therapy (ART). Furthermore, he has peer-reviewed many manuscripts and participated in several international researches like the START study, while contributing to the development of the current “Integrated National Guidelines for HIV Prevention Treatment and Care in Nigeria”. As the head of the Pharmacy Division and Associate Director with the Institute of Human Virology, Nigeria (IHVN) – a US PEPFAR and Global Fund implementing partner with over 200,000 HIV/AIDS patients in care, he oversees the delivery of pharmaceutical care service in all the grants. He served as the liaison officer between the Martindale Pharmaceutical Limited, UK and the Federal Government of Nigeria for the importation of Narcotics for the public sector in 2003/2004. His current interest is promoting pharmacovigilance in public health programs.
Abstract:
Adverse drug reactions (ADRs) were the 4th to 6th cause of death in the United States of America (USA) in 1994. In other countries, ADRs have increased the cost of providing health care and are complicating the management of co-morbidities like HIV/AIDS and TB. Thus, in many western countries, pharmacovigilance (PV) has been instituted as an effective public health measure to protect the general population from the harmful consequences of ADRs. In Sweden, France and Italy, reporting of ADRs is compulsory. In the USA and more recently in some other countries, patients can also report directly to the spontaneous reporting system (SRS). In developing and resource limited countries, the PV systems are emerging; in recent times, the factors that have promoted the development and strengthening of pharmacovigilance in the developed countries are emerging in the developing countries. For instance, having a national policy on PV and a strong governmental commitment, a robust drug manufacturing sector, a vibrant health system with the potential to track and recall suspected drugs from the market, a strong central regulatory system working in collaboration with the global pharmacovigilance center and an enlightened work force, are predictors of an effective PV system. In this presentation, we shall highlight the emergence of these factors using the case of Nigeria to demonstrate the prospects of PV in resources limited countries. We shall also unveil the challenges that have to be addressed in order to strengthen PV in poor countries.
Demet Sag
ClearRoadMap, USA
Title: Enabling, people and businesses to improve the quality of life, to do so faster and better
Time : 14:10-14:35
Biography:
Demet Sag is director of translational genomics at symmetric computing, ClearRoadmap, USA.
Abstract:
Carver Global Health Group LLC (CGHG) is a privately owned company that builds and distributes ClearRoadmap, a cloud based data analytics platform to automate the manual, time consuming mHealth and medical device regulatory and reimbursement due diligence process. All new medical devices are required to complete this step. ClearRoadmap improves data accuracy and reduces time to completion from days or weeks to minutes. CGHG’s innovative approach provides the potential to transform how mHealth and medical devices are developed and brought to market. Solution: ClearRoadmap applies Best Known IT Practices from Big Data to automate these highly manual processes. Benefits include: improving data accuracy and relevance for related mHealth and medical devices; speeding access to relevant data both initially and through ongoing market activities. ClearRoadmap provides value to a range of healthcare industry players. ClearRoadmap flexible subscritption allows users to try each mondule individually, leverage savings with package rates, and an enterprise seat bring value to those who visit : The single Search interface across all datasets is accessible globally on tablets, laptops and desktops. The detailed product information is displayed in a side-by-side Comparison, for market evaluation. Details can be downloaded into Reports with the search criteria documented, and hyperlinks to original document sources. Users can save customized searches as an Alert to receive notifications when changes or new information becomes available. Users can plan their Idea to Market using step-by-step Pathways which consolidates state legislations, federal regulations, reimbursement policies, technical standards, and business strategy with Best Practices and Helpful Hints.
Rajiv Mahendru
B.P.S. Government Medical College for Women, India
Title: Anti-oxidant intake in antenatal cases high-risk for pregnancy induced hypertension and intrauterine growth restriction
Time : 14:35-15:00
Biography:
Rajiv Mahendru completed Post-Graduate Degree in Obstetrics and Gynaecology from Himachal Pradesh University at the age of 29 years and became one of the youngest Professors. Presently, he is the Head of the Department in the only second women medical college of India. He has 41 publications in reputed journals and is the recipient of a prestigious award for excellence in medical field. He is appointed as the Chief-Editor of the special issue of an international journal of repute and has numerous presentations to his credit at international arena as an invited guest speaker. He is the member of editorial board of international journals, academic board of many universities, member of recruitment for medical teachers, and assessor for establishing Medical colleges. He has chaired numerous sessions in the national and international conferences.
Abstract:
Objective: For assessment of effects of supplementation of antioxidant lycopene in antenatal cases considered high risk candidates for pregnancy induced hypertension (P.I.H) and/or fetal growth restriction. Materials & Methods: A pilot study comprising 107 pregnant women between 13 and 28 gestational weeks with factors considered high risk for developing pre-eclampsia were considered and randomly allocated into two groups: I (n=55) and II (n=52), with orwithout lycopene supplementation, respectively. Lycopene in a dose of 4 mg once daily starting from the date of entry was given to the antenatal subjects of the study group (Group-I) and were instructed to continue the drug regularly until delivery. Women of the other group (Group-II) were not provided with lycopene supplementation. Main observation measures considered were whether there was development of preeclampsia and its severity, period of gestation at delivery, mode of delivery, fetal weight and perinatal outcome as regards to admission to neonatal intensive care unit and neonatal death. Observations: There were no signicant differences in development of preeclampsia in both the groups but severity was more in the group-II where patients did not receive lycopene. Significant adverse finding noticed, having no mention in the literature earlier, was: one case of eclampsia. Women in the lycopene supplementation group had not only signicantly lesser incidence of growth restricted babies but also signicantly healthier babies and had a signicantly better perinatal outcome compared to women in non- supplementedgroup. Conclusion: Supplementation of lycopene although does not decrease the incidence of preeclampsia in high risk women but may help in reducing its severity and there is reduced incidence of intrauterine growth restriction with better prenatal outcome.
Bellaje R
University Ibn Tofail, Morocco
Title: Poisoning lightening creams in Morocco: Epidemiological profile
Time : 15:00-15:25
Biography:
Bellaje R is Faculty of Sciences in Ibn Tofail University at Kenitra, Morocco.
Abstract:
Objectives: In Morocco the large number of cosmetic products is sold freely without control or registration. Some of these products can lead adverse reaction or poisoning in case of misuse or voluntary ingestion. The lack of knowledge of the composition of these products make therapeutic management in case of poisoning very difficult and sometimes causes unnecessary health spending even if these poisoning are oft en benign. The objective of this study is to establish the epidemiological profile of a poisoning by lightening creams collected at the Moroccan Poison Control and Pharmacovigilance center. Methods: This is a retrospective study of poisoning case by lightening creams collected at the Moroccan Poison Control and Pharmacovigilance Center between 1987 and 2011. Results: During the study period, 95 cases were collected. The mean age is 20 years±1.4 [1-70 ans], and the F/M sex ratio is 1.73. In 90 (95%) cases, the route of poisoning was oral. The suicide attempts represent 33% of cases. Women are oft en voluntarily intoxicated. However, men were concerned by involuntary intoxication (p=0.003). Eighty three cases were urban (87%) and 90 cases occurred at home (95%). The digestive disorders were found in 68 cases associated or not with a neurological disorders (33 cases), cardiovascular disorders (14 cases), and respiratory distress (6 cases). The evolution was favorable in all cases. Conclusions: The implementation of the new law recording to the registration of cosmetic products in the ministry of health before marketing will ensure certainly a better orientation of the poisoning case management and improve the patient safety.
Sara Hegazi
Philips Healthcare, UAE
Title: Challenges & latest regulations have to know about medical devices in Middle East region
Time : 15:40-16:05
Biography:
Sara Hegazi is Quality & Regulatory professional in medical devices in Philips Healthcare covering Middle East &Turkey (MENA region), her pervious experiences as regulatory expert in pharmaceutical industry. She is a member of Mecomed, and she has experience in managing registration requirements in 14 countries in Middle East. She has directed Post-Market Surveillance/Vigilance served as compliance officer, throughout her career. She has also had responsibility for Quality Assurance, Audit Management, Healthcare Compliance, and Clinical functions.
Abstract:
Middle East region is one of fastest growing medical devices market in the world, providing signifi cant opportunities for medical devices development and marketing. At the same time, the Middle East region is one of the most vibrant areas in the world and presents a major challenge: Challenges facing the healthcare industry throughout the MENA region as populations grow and life expectancy increases. A key issue in the region remains the growing number of chronic conditions and diseases such as diabetes, obesity and heart disease. The medical infrastructure must also improve and expand; healthcare authorities in the MENA region are playing a vital role to develop & improve advanced regulatory guidelines to adapt to new challenges, as well leading educating and training local workforces, which can only be achieved by partnering with international companies. It is estimated the GCC healthcare market is to grow 11% per annum to $43 billion by 2015 and on to $60 billion by 2025. The UK healthcare system is highly regarded throughout the MENA region and opportunities are available across all aspects of the healthcare sector. The challenges are different for each country. Challenges are still remaining, which include understanding the local requirements, communicating effectively with the authorities, managing the time to receive the approvals, and providing solutions for the unexpected problems. A successful regulatory strategy requires a strong understanding of the regulations, guidelines, and effective communications with internal stakeholders and with the health authorities & take advantage of the opportunities to expand their products in this dynamic part of the world.
Bellaje R
University Ibn Tofail, Morocco
Title: Poisoning by hydrogen peroxide hair bleaching: Moroccan Poison Control Center data
Time : 16:05-16:30
Biography:
Bellaje R is Faculty of Sciences in Ibn Tofail University at Kenitra, Morocco.
Abstract:
To assess the extent and severity of poisoning by hydrogen peroxide dye hair used as the Moroccan population, a retrospective epidemiological study of all cases of poisoning reported, collected by the Moroccan poison control and pharmacovigilance center, between 1987 and 2011 was realized. The center has received 43 reports. The mean age was 18±2 years [0.1-50 years] and the female/male ratio was 2. The majority of cases of poisoning were occurred in the urban area (35 cases) and at home (31 cases).The digestive disorders were found in 17 cases, associated or not with a neurological disorders (2 cases), cardiovascular disorders (1 case) and skin disorders (1 case). Twenty patients were referred to the emergency care unit. Symptomatic treatment was ordered in 26 cases and gastrointestinal decontamination in 11 cases. The evolution was favorable in all cases.
Solomon Getnet Meshesha
Addis Ababa University, Ethiopia
Title: SWOT analysis of the Addis Ababa City administration food, medicine and health care administration and control authority
Time : 16:30-16:55
Biography:
Solomon Getnet Meshesha has completed his Bachelor of pharmacy from Addis Ababa University in 2008. He has been working in Addis Ababa City Administration health bureau as a director of pharmaceutical service since October 2008. He is a member of Ethiopian Pharmaceutical Association. Now he is a postgraduate student in pharmacoepidemiology and social pharmacy at Addis Ababa University.
Abstract:
Issues related to the quality of medicines are becoming an increasing global concern especially in developing countries. Achieving a high level of quality requires effective medicine legislation and regulation, a competent medicines regulatory authority, good clinical and manufacturing practices with adequate medicines, quality assurance programs and medicines, quality control systems and appropriate medicines information. A qualitative study design was used to obtain primary and secondary information through interviewing key informants and reviewing all available relevant documents from the Addis Ababa city administration medicine regulatory and control authority. Addis Abba medicine regulatory authority is an independent organization whose top management committed to implement quality management and data on licensed and resisted health facilities and professionals are up to date but the authority has no policy on confidentiality and code of conduct for staff s, guideline to ensure requirements on quality, safety and efficacy of drugs and also mechanism to trace any counterfeit and substandard drugs. It has no any scientific body (laboratories) to advise the organization on scientific issues. The regulatory authority was an independent authority established to ensure food safety and quality, efficacy and proper use of medicines, competence and ethics of health professionals and standards of health institutions through licensing, registration and regulations against the set standards. The authority has to keep those findings as strength of the organization and much has to be done to meet the authority’s goals and objectives.
Varley Dias Sousa
University of Brasilia, Brazil
Title: Sharing regulatory data as tools for strengthening health systems in the region of the Americas
Biography:
Varley Dias Sousa is a Pharmacist (2003), post-graduated on health surveillance (2007) and international health systems (2006), and has completed his MSc (2010). Currently he is performing PhD studies at the University of Brasilia. He is a senior Auditor on Brazilian Health Surveillance (ANVISA) since 2005, been certified in Good Manufacturing Practices (inspecting international facilities in almost 10 different countries) and Good Clinical and Laboratory Practices (Inspecting more 30 international CROs). He has evaluated more than 150 bioavailability and bioequivalence (BA/BE) studies and more than 150 Medicine Applications. Also, he is member of the commission in charge of confidentiality classification on Medicine Dossier. Dâmaris Silveira is a Pharmacist (1986), with PhD in Natural Product Chemistry (1999). Currently she is Associate Professor at the University of Brasilia, and coordinator of Laboratory of Quality Control as well as of the Pharmaceuticals – Regulation and Public Policies research group.
Abstract:
Backgrounds: Regulatory transparency is an imperative characteristic of a reliable National Regulatory Authority. In the region of the Americas, the building process of an open government is still fragile and fragmented on Health Regulatory Agencies (HRA) even on Regional Reference Authorities (RRA). Purpose: This paper assesses the transparency status of RRA, focusing on some medicine life-cycle documents (Medicine Dossier, Clinical Trial Report, and Inspection report), as tools for strengthening health systems. Methods: Through a qualitative and descriptive evaluation of regulatory transparency on RRA, it was portrayed in two different branches: information public disclosure and inter-agency data and work sharing. Results: The risk benefits of information public disclosure were assessed considering the involvement and roles of multi-stakeholders (healthcare professionals, regulators, industry, community, and academics) bearing in mind the protection of commercially and personally confidential data. Inter-agency data and work sharing were inserted in the context of harmonization and co-operation projects that focus on regulatory convergence. Conclusions: Technical and practical engagements are proposed to improve and strengthen health systems in the region of the Americas through establishment of an openness directive over pharmaceutical regulatory environment. To successfully address these challenges is crucial that regional leadershipssteer and support collaborative regional alliances toward the development and establishment of a trustful regulatory environment as well as a sustainable public health system in the Latin America and the Caribbean, using as reference international successful initiatives besides taking into account domestic characteristics and experiences of each single country.
Shujie
Cancer Biology Research Center, China
Title: HPV16 E5 peptide vaccine in treatment of cervical cancer in vitro and in vivo.
Biography:
Shujie is Professor in Cancer Biology Research Center at Huazhong University of Science and Technology, China
Abstract:
Despite the encouraging development of a preventive vaccine for human papillomavirus (HPV), it cannot improve ongoing infections. Therefore, a new vaccine is urgently needed that can prevent and treat cervical cancer, and cure pre-cancerous lesions. In this study, we constructed two peptide-based vaccines. The first was a short-term, long-peptide (ST-LP) vaccine that simultaneously targeted three key carcinogenic epitopes (E5-E6-E7) on HPV16. We tested this vaccine in murine TC-1 cells infected with a recombinant adeno-associated virus (rAAV) fused with HPV16E5 DNA (rTC-1 cells), which served as a cell model; we also tested it in immune-competent mice loaded with rTC-1 cells, which served as an ectopic tumor model. The ST-LP injections resulted in strong, cell-mediated immunity, capable of attacking and eliminating abnormal antigen-bearing cells. Furthermore, to prolong immunogenic capability, we designed a unique rAAV that encoded the three predicted epitopes for a second, long-term, long-peptide (LT-LP) vaccine. Moreover, we used a new immune strategy of continuous re-injections, where three ST-LP injections were performed at one-week intervals (days 1, 8, 15), then one LT-LP injection was performed on day 120. Our in vitro and in vivo studies revealed that this strategy could boost the immune response to produce longer and stronger protection against target cells, and mice were thoroughly protected from tumor growth. Our results showed that priming the immune system with the ST-LP vaccine, followed by boosting the immune system with the LT-LP vaccine could generate a rapid, robust, durable cytotoxic T-lymphocyte response to HPV16-positive tumors.
Mahmoud A S Morsi
Menoufia University, Egypt
Title: Neuroprotective effect of silymarin on diabetic peripheral neuropathy in streptozotocin-induced diabetic rat model
Biography:
Mahmoud A S Morsi is Professor at Menoufia Medical School, Menoufia University, Egypt
Abstract:
Background: Diabetic neuropathy is the most common complication of diabetes mellitus. Oxidative stress is considered the key mechanism in the diabetic peripheral neuropathy (DPN) therefore; Silymarin may have a neuroprotective effect against the development of DPN via its anti-oxidant activity. Objectives: In this study, we investigate the possible effects of silymarin on DPN using STZ diabetic rat animal model. Methods: Forty-five male albino rats will be used along the study. Diabetes will be induced by a single Intra-peritoneal injection of Streptozotocin (STZ). All rats with BGL (blood glucose level) ≥250 mg/dl will be randomly assigned into 2 groups; Silymaringroup receiving 100 mg/kg/day of Silymarin by oral gavage for 2 months and Diabetic group receiving equal amount of saline for same duration. Behavioral tests will be done; including open field assessment of vertical and horizontal motor activities and tail immersion test for thermal hyperalgesia. At the end of the experiment, morphological, histopathological, biochemical and immunohistochemical changes of sciatic nerve will be examined. Results: This is an ongoing research and the experiment is still underway. We anticipate finding a possible neuroprotective effect of Silymarin in delaying the development of diabetic peripheral neuropathy in diabetic rats. Conclusions: The current work will add more evidence to the use of Silymarin as one of non-conventional medications of DPN. Silymarin can be used simultaneously as an adjuvant therapy to delay the onset of DPN in diabetic patients.
Mouna Jrad
University of Sfax, Tunisia
Title: Antibacterial properties of new bacterium isolated from date palm leaves affected by brittle leaf disease
Biography:
Mouna Jrad from Laboratory of Plant Biotechnology Applied to Crop Improvement, Faculty of Science of Sfax. University of Sfax, Tunisia
Abstract:
An actinomycete strain was isolated from date palm leaves affected by brittle leaf disease (Deglet Nour, Tunisia). The strain was classified as a new bacterium, an endophytic strain. Identification was based primarily on the morphological characteristics. This strain was grown on a medium rich tryptic soy broth (TSB) with K2HPO4 (1 mM) and MgSO4, 7H2O (2 mM) at 28°C and neutral pH. It is a Gram-positive filamentous bacterium with broad spectrum antimicrobial activity. The optimum pH for the product was 7 to 7.4. The highest product yield was with glucose and tryptone at 1% (w/v) as carbon and nitrogen sources, respectively. Incubation between 25°C and 30°C for 24 hours was optimal for the bioactive metabolite(s) production. The product remained stable up to 50 hours. The bioactive metabolite(s) produced by endophytic bacteria was partially purified and studied for antibacterial characteristics using the wells technique. Analysis by bioautography and gas chromatography/mass spectroscopy (GC/MS) of the supernatant from precipitation with 100% ammonium sulphate indicated that the strain produced a high percentage of fatty acid. Additionally, a cyclic compound could be involved in the antibacterial activity. After silica plate scraping, bioactivity disappeared at 70°C. Bioactive molecule(s) may be involved in the brittle leaf disease, because its product isolated by a strain from date palm leaves is affected by the brittle leaf disease enough. In addition, this endophytic has shown best lipolytic activity and produced a lipidic biomolecule(s), this result explains the implication of metabolite(s) in the brittle leaf disease. Finally, determination of MIC and MBC of bioactive molecule(s) against strains (Bt, Bs).
Avong
Institute of Human Virology
Title: Prospects and challenges of providing pharmacovigilance services in resource limited countries
Biography:
Avong am a public health pharmacist, implementer of public health initiatives and a certified operational researcher with a Master in Public Health (MPH). Avong currently pursuing a PhD in Pharmacovigilance and Pharmacoepidemiology (2P). In 2009, Avong set up a SRS in two large public health projects for the detection, monitoring, treatment and reporting of ADRs related to anti-retroviral drugs and second line anti-tuberculosis drugs. Avong have supervised the collection and analysis of over 2000 individual case reports from the projects leading to the publishing of papers in ADRs and adherence to anti-retroviral therapy (ART). Avong participated in the development of the current “Integrated National Guidelines for HIV Prevention Treatment and Careâ€. As the head of the Pharmacy division and Associate Director with the Institute of Human Virology, Nigeria (IHVN) – a US PEPFAR and Global Fund implementing partner with over 200,000 HIV/AIDS patients in care, I oversee the delivery of pharmaceutical care service in all the grants awarded to the IHVN. I have also served the Nigerian government as secretary of the tender committee for the importation of narcotics for the public sector. My current interest is promoting pharmacovigilance in public health programs.
Abstract:
Adverse drug reactions (ADRs) were the 4th to 6th cause of death in the United States of America (USA) in 1994. In other countries, ADRs have increased the cost of providing health care and are complicating the management of co-morbidities like HIV/AIDS and TB. Thus, in many western countries, pharmacovigilance (PV) has been instituted as an effective public health measure to protect the general population from the harmful consequences of ADRs. In Sweden, France and Italy, reporting of ADRs is compulsory. In the USA and more recently in some other countries, patients can also report directly to the spontaneous reporting system (SRS). In developing and resource limited countries, the PV systems have been weak making drug regulation a herculean task. However, in recent times, the factors that have promoted the development and strengthening of pharmacovigilance in the developed countries are now emerging in the developing countries. For instance, having a national policy on PV and a strong governmental commitment, a robust drug manufacturing sector, a vibrant health system with the potential to track and recall suspected drugs from the market, a strong central regulatory system working in collaboration with the global pharmacovigilance center and an enlightened work force, are predictors of an effective PV system. In this presentation, we shall highlight the emergence of these factors using the case of Nigeria to demonstrate the prospects of PV in resources limited countries. We shall also unveil the challenges that have to be addressed in order to strengthen PV in poor countries.
Biography:
Neerja S is a MPharma graduate from JNTU University, and PG Diploma in IPR and Regulatory Affairs from Nalsar Law university. She is heading the QA for Piramal Clinical research. She has a vast experience of 11+ years working in various departments (Quality Assurance, Medical writing, Regulatory Affairs, Site coordinator for Phase III trial) of leading CROs and pharma
Abstract:
It is very usual and common for any pharmaceutical industry to get regulatory inspections may be in manufacturing or in a CRO. Regulatory inspections guide us to make our systems more robust The presented talk will discuss about the Inspections are of majorly two types; _ Triggered by projects submitted majorly from USFDA, EU/ UKMHRA, WHO, _ To assess the system and facility which is been applied for the facility approval to conduct the trials and analysis. Eg ANVISA, MOH Turkey, DCGI. _ Key problems extracted from various Warning letter issued in Bio-analytical investigators from where the problems can be anticipated in our labs too. Also how to have a corrective and preventive action on this so that we do not have in our scenario. For Example: o Falsified laboratory records wrt - employee time/date records inconsistent and/or falsified Analytical Procedure (AP) raw data sheets o Manipulation of Samples - FDA has determined that your firm manipulated test samples in order to meet predetermined acceptance criteria _ How we can modulate our routine practice to be prepared for the inspections without any hick ups and last minute rush. o Maintenance of all calibration and qualification records. o Maintenance access control records o Maintenance of attendance of staff o Deviations to be addressed properly. _ Focus on routine activities to bring the system and facility in line to regulatory requirements so that we can bring down the non compliances drastically. o Gap analysis o RACI/ 6 Sigma like tools . o Regular IQA and focus on the closure of the same. o System department to more focus on SOP, Protocol compliance.
Preet Mohinder Singh Bedi
Guru Nanak Dev University, India
Title: Regulations on export and manufacture of drugs in India
Biography:
Preet Mohinder Singh Bedi has completed his PhD at the age of 33 years from Guru Nanak Dev University and Postdoctoral studies from University of Bath. He is the Professor of Department of Pharmaceutical Science, a premier academic organization. He has published more than 50 papers in reputed journals and has been serving as an Editorial Board Member of repute.
Abstract:
Exports form a vital component of the growth strategy of most Indian pharmaceutical companies. The industry has made rapid strides in this area in the last few years and export sales of companies such as Ranbaxy have been growing at a faster rate than their domestic sales. The compounded annual growth rate of pharmaceutical exports over the last five years has been more than 20 percent although in 2000-2001, exports grew by 11 percent. While overall pharmaceutical exports have grown, India’s exports to a few of its leading markets have declined. For instance, India’s pharmaceutical exports to USA have declined to Rs. 671.8 crores in 1999-2000 from Rs. 724 crores in 1998-99; Germany to Rs. 325 crores from Rs. 375 crores. Notwithstanding the decline in exports to some key markets, India’s export prospects remain bright. The potential for growth is enormous, annual growth in exports over the next five years will take the overall export figure to $4 billion.
Avong
Institute of Human Virology, Nigeria
Title: The effectiveness of the spontaneous reporting system
Biography:
Avong am a public health pharmacist, implementer of public health initiatives and a certified operational researcher. Avong hold a Master in Public Health (MPH) and currently pursuing a PhD in Pharmacovigilance and Pharmacoepidemiology (2P). Avong set up a SRS in two large public health projects and have supervised the analysis of over 2000 individual case reports from the projects leading to the publishing of papers in adverse drug reactions and adherence to anti-retroviral therapy (ART). Avong am the head of the Pharmacy division in the Institute of Human Virology, Nigeria – a US PEPFAR and Global Fund implementing partner with over 200,000 HIV/AIDS patients in care. My current interest is estimating the risk of medicines in public health programs.
Abstract:
Background: Spontaneous reporting systems (SRS) as the United Kingdom Yellow Card Scheme for reporting suspected adverse drug reactions (ADRs), operate in most developed and developing countries. We tested the SRS in a national cohort of multidrug-resistant tuberculosis (MDR-TB) patients in Nigeria. Methods: Using the Nigeria Yellow Form, we collected and analyzed suspected adverse drug reactions from MDR-TB patients undergoing the eight months intensive phase treatment. These patients were treated with a standard regimen, consisting of injectable Kanamycin, Amikacin or Capreomycin and oral Cycloserine, Levofloxacin, Pyrazinamide, Prothionamide and Pyridoxine for at least eight months. Characteristics of AEs were documented and risk factors assessed. Results: We included 460 patients in the analysis: 62% were males; median age and weight were 33 years [Interquartile Range (IQR):28-42] and 51 kg (IQR: 45-59) respectively. Majority of the participants (44%) experienced AEs: four died of AEs associated conditions. The most commonly reported AEs were gastro-intestinal (n=100), neurological (n=75), ototoxic (n=72) and psychiatric (n=60). Ototoxic and psychiatric AEs were debilitating and required medical intervention and hearing aids. Most AEs occurred after 1-2 months of therapy; some treatment centers were twice as likely to report AEs compared with others, highlighting significant inconsistencies in reporting at different treatment centers. Patients with a higher body weight had an increased risk of experiencing AEs. No differences were observed in risk of AEs between HIV-infected and uninfected patients. Age was not significantly associated with AEs. Conclusion: The SRS proved effective at providing information on adverse drug reactions, which could aid post-marketing drug safety surveillance. Given its low cost, the SRS could be used in resource limited settings to detect, monitor and report ADRs, especially in public health initiatives like the anti-retroviral therapy programs.
Sami Alsager
Saudi Food and Drug Authority, Saudi Arabia
Title: Cosmetics regulations in Saudi Arabia
Biography:
Sami Alsager is a pharmacist graduate from the college of pharmacy King Saud University Riyadh Saudi Arabia in 2002 and got a master degree in health administration from King Saud University Riyadh Saudi Arabia in 2007 he joined the SFDA in 2006. He worked in several positions including the pharmaceutical license department and now is the director of the Department of the cosmetics department.
Abstract:
Pharmaceuticals, cosmetics, medical device and food were scattered between different government organizations before the establishments of the Saudi Food and Drug Authority (SFDA) in 2004. It took the SFDA about ten years to take all the responsibility in these years the SFDA built the infra-structure and invest heavily in the training and education by sending its young generation employee to the best universities in the west. Also during this time a lot of laws, regulations and guidelines based on best international practices were written and went through the approval processes. One of these laws is the cosmetics law which is in the final stages of the approval processes. The cosmetics law will be the first in the region, and Saudi Arabia will be the first to have a comprehensive law covering all aspects of cosmetics regulations, to cover the huge market of cosmetic products which is around 2 billion dollar; some of these products are manufactured locally and some are imported from all over the world, with a market open the necessity for a good regulatory system. a system that will control the cosmetic product at the points of entry (borders) as well as in the local manufacturers until it reaches the consumer by establishing a good notification system, Cosmovigilance, developing cosmetic products safety guidelines and establishing good labs that will analyze the product to be sure it fits the standards and no hazardous material been used. In this presentation all aspects of cosmetic regulations in Saudi Arabia will be discussed.
Ibrahim Alshowaier
Saudi Food and Drug Authority, Saudi Arabia
Title: Cosmetics regulations in Saudi Arabia
Biography:
Ibrahim Alshowaier worked in several positions including the pharmaceutical license department and now is the director of the Department of the pharmaceuticals department.
Abstract:
Pharmaceuticals, cosmetics, medical device and food were scattered between different government organizations before the establishments of the Saudi Food and Drug Authority (SFDA) in 2004. It took the SFDA about ten years to take all the responsibility in these years the SFDA built the infra-structure and invest heavily in the training and education by sending its young generation employee to the best universities in the west. Also during this time a lot of laws, regulations and guidelines based on best international practices were written and went through the approval processes. One of these laws is the cosmetics law which is in the final stages of the approval processes. The cosmetics law will be the first in the region, and Saudi Arabia will be the first to have a comprehensive law covering all aspects of cosmetics regulations, to cover the huge market of cosmetic products which is around 2 billion dollar; some of these products are manufactured locally and some are imported from all over the world, with a market open the necessity for a good regulatory system. a system that will control the cosmetic product at the points of entry (borders) as well as in the local manufacturers until it reaches the consumer by establishing a good notification system, Cosmovigilance, developing cosmetic products safety guidelines and establishing good labs that will analyze the product to be sure it fits the standards and no hazardous material been used. In this presentation all aspects of cosmetic regulations in Saudi Arabia will be discussed.
Doaa M Hasan
Kasr el-Aini Hospital, Egypt
Title: Integrated teaching of clinical pharmacy among medical and pharmacy students: Dream changing to reality
Biography:
Doaa M Hasan works in Department of Neurosurgery Kasr el-Aini Hospital, Egypt
Abstract:
Studies had proved that cooperation between physician and pharmacist provides the patient with best health care outcome. Unfortunately, here in Kasr el-Aini Hospital there is a gap between doctors and pharmacists despite correlation between their studies and work. Clinical pharmacist has proved to be very helpful to physician in many hospitals. Despite this fact, most of medical students in Kasr el-Aini don’t know the meaning of clinical pharmacy. Students in medical college think of pharmacist as salesman. This gap leads to medical errors. It is important to study about the role of pharmacist in the process of treatment, who deals with the drug better and know more about side effect contraindication and drug interaction. This gap between our doctors and pharmacist needs to be filled to provide patients with best health care. The aim of this study is to assess the feasibility of applying the clinical pharmacy education among Kasr El-Aini medical students as well as exploring the possible collaboration perspectives between students of both medical and pharmacy colleges. Also, the study aimed to explore the team work concept among both the medical and pharmacy student after graduation. A cross-sectional descriptive study was conducted among both medical and pharmacy students. The study included 123 medical students aged from 19-24 years who agreed to participate in the study and 100 students from pharmacy colleges aged from 18-25 years. A questionnaire was distributed to the study participants to explore their training experience and measure their knowledge regarding the medical system and the treatment process flow cycle. The study revealed that 60% of medical student don’t know what the clinical pharmacist is, 7% never heard about it. Also, 14% of the medical students think the pharmacist is useless. While 69% of them, did not study about the role of pharmacist in treatment process. As for the pharmacy students, 33% of them see the doctor as arrogant person and 29% see doctor ignorant about drugs. Also, 26% of pharmacy students perceive the doctor as competitor and 29% wouldn’t accept that the doctor correct them if they admit an error about drug or drug reaction. The study revealed a wide gap between the medical and pharmacy students. They don’t know that they are on the same side, which make them as doctors and pharmacist competitors more than one team. Need to teach them how to work as one team, how to cooperate together for providing the best medical care to the patient.
Florian M Kovar
Medical University of Vienna, Austria
Title: Management of bite wounds in children and adults – An analysis of over 5.000 cases at a level I trauma centre
Biography:
Florian M Kovar is a Professor in Department of Trauma Surgery, General Hospital Vienna, Medical University Vienna, Austria
Abstract:
Introduction: Bite wounds account for 5% of the total traumatic wounds evaluated in the ED (emergency department) and approximately 1% of all ED visits. Dog, cats, or humans provoke most mammalian bite wounds. Early estimation of infection risk, adequate antibiotic therapy and if indicated surgical treatment, are cornerstones of successful cure of bite wounds. However, antibiotic prophylaxis and wound management are still discussed controversial in the current literature. In our study we retrospectively investigated those aspects. Methods: 5.248 consecutive trauma patients were collected prospectively and analyzed retrospectively over a period of 15 years in this study at a Level I Trauma Center, Department of Trauma Surgery, Medical University of Vienna, Austria. Data for this study were obtained from our electronic patient records and follow up visits. For antibiotic therapy, amoxicillin/clavulinate (Augmentin, Glaxo Smith Kline) and in case of allergy clindamycin (Dalacin, Pfizer) were administered according to age and dosage recommended by the producer. Results: During the 15 year study period, 5.248 trauma patients met the inclusion criteria. The mean age was 33.8 years (range 0 to 97), 2.620 (49.9%) were males and 2.628 (50.1%) were females. In our study population a total of 2.530 dog-bites (48.2%), 930 cat-bites (17.8%), 357 other-animal bites (6.8%), 426 human-bites (8.1%), and 1.005 human self bites (19.2%) have been observed. A total of 995 wounds (19.0%) have been infected. Surgery was done in 132 wounds (2.5%). Conclusion: Total infection rate for sutured wounds (7.6%), and surgery were (35.6%), versus (19.4%) for open treatment. Observed infection rate of puncture wounds and wounds greater than 3 cm was 1.5 times higher than for all other wounds in the present study. Total infection rates within 24hours to antibiotic administration was 29.3%, compared to 65.0% <48 hours, and 81.1% <72 hours. Time interval also influenced the overall outcome showing a 2.6 increase in acceptable and 1.3 increase in poor outcome after 72 hours. We could demonstrate, that prophylactic antibiotics in all cases as recommended by some authors, and primary combinations of different antibiotics does not have any benefit, but might lead to higher resistance rates in patients.
Hayam I Gad
King Saud University, Saudi Arabia
Title: The potential role of anti tumor necrosis factor (tnf-ï¡) antibodies on some renal functions and vasoregulatory factors in preeclamptic pregnant Wistar rats
Biography:
Hayam I Gad is an Assistant Professor in Physiology Department, College of Medicine, King Saud University, Riyadh, Kingdom of Saudi Arabia
Abstract:
Introduction: Investigate the potential role of anti TNF-ï¡ antibodies on some renal functions and release of vasoregulatory peptides using nitric oxide synthase deprived pregnant rats. Methods: The study was carried out at King Khalid university Hospital, King Saud University, Riyadh. Forty female Wistar rats were divided into four groups (10 rats each); Group I: Included virgin non-pregnant rats. Groups II: Included pregnant rats that received saline, gropuIII included pregnant rats that received NG-nitro- L- arginine methyl ester (L-NAME) while group IV included pregnant rats that received both L-NAME and anti TNF-ï¡ antibodies respectively. Treatment of pregnant rats started from day 7 up to day 20 of gestation.Mean arterial blood pressure, urine volume, creatinine clearance and 24 hours urinary albumin excretion were measured on day20 of gestation. Blood samples were taken on day 20 of gestation for measurement of plasma endothelin-1 (ET-1), angiotensin II (Ag II) and serum levels of total nitric oxide (NO) products, interleukin-6 (IL-6) and soluble vascular cell adhesion molecule (sVCAM-1). Viable pups were also weighed. Results: Treatment of pregnant rats with anti TNF-α antibodies restored the urine volume, creatinine clearance, the plasma ET-1, the serum IL-6, and the serum sVCAM-1 to normal levels on day 20 of gestation. However, it showed no effect regarding serum NO. Also pup weight was insignificantly changed in anti TNF-α antibodies treated rats when compared to non treated pregnant rats. In fact administration of anti TNF-α antibodies to rats from day 7 up to day 20 of gestation decreased significantly the 24 hour urinary albumin excretion and the plasma Ag II when compared to L-NAME treated rats but still showed significant increase as compared to controls (P<0.001). Conclusion: Preeclampsia is associated with disturbed renal function, overproduction of cytokines and vasoregulatory factors, and fetal growth restriction. Treatment of pregnant rats with anti TNF-α antibodies restored urine volume, creatinine clearance, plasma ET-1, serum IL-6 and sVCAM-1 to normal levels. Hence, anti TNF-α antibodies may have beneficial effects in preeclampsia. Additional studies are warranted to confirm these results.
Tesfaye Zerihun
Addis Ababa University School of Pharmacy, Ethiopia
Title: Phytochemical screening of the exudete of Aloe otallensis and its effect on the Leishmania aethiopica and Leishmania donovani
Biography:
Tesfaye Zerihun is graduated in Chemistry Diploma from Kotebe teaching college on JUN 2006, and employed at Addis Ababa university aklilu Lema institution of Pathobiology Research center on September 2007 as Laboratory Technician. He has worked at the entomology unit from Sep. 2007- Dec. 2011. In these Unit he experienced with different Experiment’s Like Maintaining of Insectary colonies of Malaria and Leishmaniasis vectors , preparing of Laboratory solution, Bio efficacy test on Bed-nets, Insecticide susceptibility test, blood meal and Sporozoite test with enzyme Linked Immunosorbent Assay (ELISA). He is trained on the area surveillance of insecticide resistance mosquitoes at KEMRI, Kenya. With all these experience he is assisting Master and PhD students both on the field and Laboratory. On July, 2012 he has graduated in pharmacy from Addis Ababa university School of Pharmacy and to get more experience on clinical Part he is transferred to one of the faculty of Addis Ababa University College of Health Science Black lion Specialized Teaching Hospital as a pharmacist. Currently he is working as a pharmacist on Different dispenser’s area, and Drug Supply Management coordinator, the head of special Pharmacy of the hospital, the secretory of DTC (Drug therapeutic Committee) of the hospital and assisting under graduate pharmacy students who are coming to the hospital for clinical attachment both at the warred and dispensary area. He is also participating in some of Clinical research which under go in the Hospital beside the routine work. Some of the papers which are ready for publication are- • Antibiotic conception on the Black Lion specialized Hospital • On the area of Oncology Patient in Relation to the severity of pain particularly on Breast cancer.
Abstract:
Background & Objectives: Several plant products have been tested and found to possess antileishmanial activity. The present study was undertaken to evaluate antileishmanial activity of methanolic extract of Aloe otallensis, which is endemic plant to Ethiopia, on the promastigot stage of Leishmania aethiopica and Leishmania donovani comparing to standard drugs and also tried to screen its phytochemical constitute. Methods: Phytochemical screening was done on Methanolic extract of the exudates to the leaf of Aloe otallensis. Theserial dilution of the Extract was also evaluated for in vitro antileishmanial activity against Leishmania aethiopica and Leishmania Donavan on the strain of L. aethiopica (LDC/134) and L. Donovani (AM 563), which is found from the black lion hospital parasitology unit and the result was compared to standard drug of Sodium stibogluconate, milfostin and paramomycin. Result. The extract has an antileishmaniacidal activity with an IC50 of 141 μg/ml on L. ethiopica (LDC/134) and 123μg/ml on L. donovani (AM 563). The experimental data shows that relatively it has better activity than paramomycin and milfostin but less activity than sodium stibogluconate, which is given in Ethiopia as a first line drug. The data analyses was done by pad graph prison version 5 software after it was read by ELISA redder at the wave length of 650 nm. The phytochemical screening of the exudates of Aloe otallensis showed the presence of phenol, alkaloid and saponin. Conclusion: The methanolic extract of exudate of Aloe otallensis has a good anti leishmanisis activity relatively to paramomycin and milfostin and this activity may be attributed to phenol, Alkaloid and Saponin present in the plant. But it needs further analysis for the conformation of which constituent present in much concentration and to know which one have highest role.