Day 2 :
Keynote Forum
Anka G. Ehrhardt
Bristol-Myers Squibb Company, USA
Keynote: Science and Business Drivers in Clinical Biomarkers: Focus on Innovation and Quality
Time : 9:30-10:10
Biography:
Dr. Anka G. Ehrhardt is a biophysicist with a doctorate degree in human physiology. She is currently working in the United States building and directing a team applying the latest technologies in support of the development of new live saving drugs
Abstract:
As science-driven businesses, innovative Biopharma companies must manage the inherent risks of being dependent on new discoveries with unknown probability of success. Besides business development activities, combined with various target- and compound- discovery strategies, biomarkers play an increasing role as tools to improve the probability of success. At the same time, the discovery and implementation of biomarkers becomes an additional investment, often with significant risk. On the example of flow cytometry based biomarkers, the presentation will illustrate strategies to develop and implement robust biomarker strategies for maximized return on investment.
Keynote Forum
Arik Dahan
Ben-Gurion University of the Negev, Israel
Keynote: The solubility-permeability interplay in Formulation Development for Low-Solubility Drugs
Time : 10:10-10:50
Biography:
Arik Dahan is an Associate Professor of Pharmaceutics and Bio pharmaceutics at the Department of Clinical Pharmacology and the School of Pharmacy, Ben-Gurion University of the Negev in Beer-Sheva, Israel. He is also an Adjunct Professor of Pharmaceutical Sciences at the College of Pharmacy, University of Michigan. Dr. Dahan received his Ph.D. (2007) from the Hebrew University of Jerusalem. He was a Post-Doctoral Research Fellow at the University of Michigan (2007-2010) with Professor Gordon Amidon. Dr. Dahan's research interest is the integration of up-to-date molecular/cellular mechanistic investigations of drug disposition in the context of the human body. In implementing this molecular biopharmaceutical approach to ADME research, Dr. Dahan is seeking to enable mechanistic-based successful solutions to drug delivery/therapy, in challenging scenarios e.g. low-solubility, low-permeability, extensive metabolism, poor site targeting, various pathophysiological conditions, and paediatrics. He has published over 60 top-notch Journal papers
Abstract:
While each of the two key parameters of oral drug absorption, the solubility and the permeability, has been comprehensively studied separately, the relationship and interplay between the two has been largely ignored. For instance, when formulating a low-solubility drug, what are the effects on the apparent permeability? The direct correlation between the intestinal permeability and the membrane/aqueous partitioning, which in turn is dependent on the drug's apparent solubility in the GI milieu, suggests that the solubility and the permeability are closely associated, exhibiting certain interplay between them, and the current view of treating the one irrespectively of the other may not be sufficient. In this lecture, our results on this solubility-permeability interplay will be presented. Decreased apparent permeability accompanied the solubility increase when different solubilisation methods are employed; however, increasing the apparent solubility by super saturation e.g. via amorphous solid dispersions, circumvented the solubility-permeability trade-off, and the permeability remained steady. Most recently, even increased permeability was discovered, when the super saturation saturated efflux processes. Overall, the solubility-permeability interplay cannot be ignored when using solubility-enabling formulations; looking solely at the solubility may be misleading with regards to absorption predictions, and hence, the solubility-permeability interplay must be taken into account to strike the optimal solubility–permeability balance, in order to maximize the overall absorption.
Keynote Forum
Howayda Ezz El Din Gomaa
National Research Centre- Cairo-Egypt
Keynote: Impact of HLA-class I alleles on response to HCV treatment in a cohort of Egyptian patients
Time : 11:10-11:50
Biography:
Howayda Ezz El Din Gomaa has completed her M.D. in Clinical and Chemical Pathology from Faculty of Medicine –Cairo University –Egypt and postdoctoral studies in microbiology , immunology of infectious diseases from the National Research Centre (Egypt).She published more than 30 papers and serves as a reviewer in scientific journals and in the scientific committee of the National Research Centre (Egypt).Presently , she is Professor of Clinical and Chemical Pathology - Clinical and Chemical Pathology Department - NRC-Egypt
Abstract:
Extensive allele diversity is observed in HLA associations with response to HCV combined therapy (pegylated interferon+ ribavirin) in different populations. The aim of the study is to assess the frequency and association of certain HLA-class I alleles in Egyptian persons with persistent HCV and others with sustained viral response (SVR). The study was a retrospective cohort study that included 246 HCV patients who received combined therapy; 106 cases responded to treatment (SVR) and 140 individuals did not respond to treatment (persistent HCV infection). Both groups are subjected to genotyping for HLA-class I. According to logistic regression analysis, Cw17 was considered as the most predictor allele as it was the highest significant allele (OR =16.70; 95% CI: 2.64–105.58; P = 0.003), whereas the presence of the HLA-B45 and HLA-B27 alleles has a 19.35-fold risk and 15.7 fold risk, respectively of non-response to interferon therapy in chronic HCV patients (OR= 19.35; 95% CI: 1.05–357.24; P = 0.04) and (OR= 15.69; 95% CI: 1.179–208.9; P =0.04) can act also as high predictor alleles, and the lowest significant predictor allele was B44 (OR = 6.535; 95% CI: 1.55–27.63; P = 0.01). The presence of the HLA-A alleles might have a limited role in prediction for the non-responders, as the A32 was significantly higher among the SVR patients, but, it cannot have a predictor role (OR: 0.161, CI: 0.03–1.056, P = 0.049).Conclusion: Cw17, HLA-B45, and HLA-B27 alleles can predict the no responders to HCV combined therapy.
Keynote Forum
Moses S S Chow
Western University of Health Sciences, USA
Keynote: Personalized medicine for resistant cancer-a potential new role for herbal medicine.
Time : 11:50-12:30
Biography:
Dr. Moses S S Chow graduated from University of California and currently is Professor of Pharmacy Practice and Director, Center for Advancement of Drug Research and Evaluation (CADRE) at the College of Pharmacy, Western University of Health Sciences, Pomona, California. His previous academic appointments included professor, University of Connecticut School of Pharmacy and Director, Chinese University of Hong Kong. He has supervised/co-supervised over 40 Masters and Ph.D. degree students and post-doctoral fellows. He has published as author/co-author over 300 hundred articles, book chapters, monographs in pharmacokinetic studies, translational research and development of new drugs, including Chinese medicine. He has served as a consultant to NIH and USPs as well as visiting professor to a number of Pharmacy Schools in Asia. He has served as Board member and Secretary of the American College of Clinical Pharmacology, President of American Chinese Pharmaceutical Association and Founding President and Board member of Asian Association of Schools of Pharmacy (AASP).
Abstract:
Cancer is currently the number one killer of all diseases worldwide. One important factor for this high mortality is the development of chemotherapy resistance due to genetic heterogeneity and tumour physiology (environment). Despite advances in modern technique of developing new medicinal entities by targeting the mechanisms one site with one single drug at a time, such approach has not resulted in major impact of cancer mortality as of to date. Herbal medicine (HM) usually contains multiple components some of which can possess anticancer properties capable of targeting multiple mechanisms. Thus HM can offer a new opportunity to overcome drug resistance and/or improving efficacy, especially when combined with conventional anticancer agents and applied to individual patients via a personalized medicine approach. The steps required for successful implementation of combined herb-drug approach for personalized treatment of resistant cancer is challenging and will be presented and discussed.
- Industrial Pharmacy | Pharmacological Sciences | Pharma Manufacturing | Pharmaceutical Chemistry | Types Of Pharmaceutical Formulation
Chair
Moses S S Chow
Western University of Health Sciences, USA
Co-Chair
Anna Szemic-Hojniak
University of Wroclaw, Poland
Session Introduction
Walid El Azab
Technical Services Manager for STERIS Life Sciences
Title: EU GMP changes – impact on cleaning and process validation
Time : 12:30-12:50
Biography:
Walid El Azab is a Technical Services Manager for the Life Sciences Division of STERIS Corporation. He currently provides technical support related to cleaning chemistries, disinfectants and sterility assurance products and their application and validation. His areas of expertise include both upstream and downstream biopharmaceutical operation and validation. Walid has held various positions including Project Manager, Inspection Readiness Manager, Quality and Regulatory Manager, and Qualified Person (QP). Walid’s responsibilities and experience have also included handling deviations and complaints, releasing raw materials and drug products, conducting external audits of suppliers, and leading customer and regulatory (FDA, EMA…) audits. Walid earned a Master’s degree in Industrial Pharmaceutical Sciences from the University of Liège, Belgium and is a certified Lean Six Sigma green belt. Walid also gives Industrial Pharmaceutical Sciences Master courses at the University of Liège (Belgium). Finally, Walid is an active member of the PDA, ISPE, Pharmaprocess, ECA, A3P and is Secretary of the Belgium Qualified Person (UPIP-VAPI) association.
Abstract:
The presentation will shed light on the current European GMP changes and how these changes are now linked to each other. The presentation will also detail and explain the changes of recently effective and draft documents as the annex 15, annex 16, chapter 2, chapter 3, chapter 5 and finally the EMA guidance on setting limit. Following that, the presentation will explain the impact of these changes on cleaning, process validation and how senior management and the qualified person need to ensure compliance. In addition, the presentations will deep dive on how to assess setting limits in cleaning validation and explain the difference with the ISPE and EMA guidance. Finally, the presentation will share common questions asked by manufacturers on cleaning and process validation in Europe and what regulatory agencies are expecting to be in place.
Suad Yousif Abdalla Alkarib
University of Karary, Sudan
Title: Gum Arabic Acacia for Manufacturing of Hard & Soft empty capsule shell in Sudan 2011
Biography:
Suad Yousif Abdalla Alkarib has completed her PhD at the age of 37 years from University of Khartoum. She is the founder of College of Pharmacy in Karary University. Before she was a Director General Manager for the “Wafrapharma Laboratories Ltd. She is the Member of the Sudanese Medical Council. She is the Member of Scientific Researches committee in Gum Arabic Board(Sudan). She is the Member of the Arab Administrative Development Organization(League of Arab States). She is the Rapporteur of the Industrial Pharmacy Committee in the Pan Arab Colleges of Pharmacy.(October-2012) . She is the Member of the proposed fellowship in Technology of Industrial Pharmacy. (Council of pharmaceutical specialties-Sudan). She has got a Certificate of honor as a leader in the field of pharmacy, and the first female major-general (Jan-2011) Sudan. She has got a MAJOR AWARDS AND DECORATIONS in Competency - Duty - The national Rescue - Golden defence. She has published more than ten papers in deferent Journals and Conferences.
Abstract:
Gum is a dried exudate from stems and branches of acacia senegle linne willdenow and other related African species of acacia Family Leguminosae. It is a safe nontoxic material utilized in production of capsule shell compared to the gelatin. Capsule hardness and elasticity are influenced by changes in gum: water: plasticizer ratio. This study described the use of gum Arabic in the manufacturing of capsules, using water and plasticizer to fine-tune the elasticity. Hand pick gum Arabic grinded and treated by adding glycerine B.P, polyethylene B.P glycol, sorbitol and purified water in a ratio of 5:2:1 per volume in Wafrapharma industry. A flexible sheet was produced from the mucilage to confirm the formula reliability. Then after capsules shells were produced by process of dipping molds in the mucilage and let to dry. The influence of gum: water: plasticizer ratio on capsule formulation showed the difference in ratio of gum solution formula affects the elasticity degree of the sheet. When the quantity of the plasticizer is increased, the ratio of water: plasticizer decreased. Gum Arabic is a stable suitable natural material to be used in capsule shell production in Sudan. Both gum solution and plasticizer loading level were found to influence the initial rate of elasticity. Elasticity shown to be controlled by the added quantity of plasticizer.
Yahdiana Harahap
Universitas Indonesia, Indonesia
Title: Analysis of Valproic Acid with Dried Blood Spot Method by Ultra Performance Liquid Chromatography – Mass Spectrometer
Time : 13:50-14:10
Biography:
Yahdiana harahap has completed her PhD at the age of 39 from Department of Pharmacy, Institute Technology Bandung, Indonesia. Now she is the Head of Bio availability and Bioequivalence laboratory Faculty of Pharmacy, Universitas Indonesia. Prior to this position, she was the Dean of Faculty of Pharmacy, Universitas Indonesia. She has published 40 papers published in both International and National Journals. She has been invited to be the speakers in many international conference, especially in the field of BA/BE and Bioanalysis technique. She currently serves as an expert at Indonesia National Agency of Drug and Food Control, specifically in BA/BE evaluation.
Abstract:
Valproic Acid is an anticonvulsant, which can be used to treat all types of epilepsy and has also been developed to be used as an adjuvant therapy for bipolar disorder. Valproic acid has narrow therapy index therefore it needs therapeutic drug monitoring with dried blood spot method which is simple, easy, and accurate. The objective of this research is to obtain optimum and validated method of Valproic acid in whole blood as Dried Blood Spot (DBS) using Ultra Performance Liquid Chromatography – tandem mass spectrometry (UPLC-MS/MS). The quality control and calibration samples were obtained by pipetting as much as 20 µL blood sample onto CAMAG DBS paper and then left to dry at room temperature for 1 hour. Then the disc was transferred into micro tube and added 200 µL extraction solution (acetonitrile – methanol mixed solution (1:3) containing benzoic acid as internal standard with concentration of 1000 µg/mL. Chromatographic separation was conducted using Waters Acquity UPLC Class BEH C18 1.7 µm (2.1 x 100 mm) with mobile phase of 0.1% acetic acid - acetonitrile (40-60) under isocratic elution and flow rate of 0.4 mL/minute. Mass detection was performed with an Electrospray Ionization (ESI) source at negative ion mode in the Multiple Reaction Monitoring. Detection of Valproic acid was performed at m/z 142.95 > 142.95 value; and benzoic acid was at m/z 121.1 > 77.1. This method was linear on range concentration of 0.5 – 100 µg/mL with r > 0.9991. Dried Blood Spot sample was stable for minimum of 16 days in room temperature and the validated analysis method was applied on one healthy subject.
Hiwa K. Saaed
University of Sulaimani KRG-Iraq
Title: QRT-AAGEL-Quantitative Real Time PCR Analysis of Apoptotic Gene Expression In Chronic Lymphocytic Leukemia Patients and Their Relationships With Chemosensitivity
Time : 14:10-14:30
Biography:
Hiwa K Saaed currently the Dean of The School of Pharmacy, Faculty of Medical Sciences at the University of Sulaimani since 2010, where he has been a faculty member since 2007. He is currently a lecturer of Pharmacology, Toxicology, and Communication skills in Pharmacy Practice. Hiwa K Saaed received his B.Sc in pharmacy and a Higher Diploma in Clinical Pharmacy from the College of Pharmacy and M.Sc and Ph.D. (1st Rank) in Clinical Pharmacology and Toxicology from the College of Medicine University of Baghdad. He has over 20 years of experience in Pharmacy practice/ Hospital and Community settings. He is a director of Joint Higher Diploma (in Clinical Pharmacy) Studies with Ministry of Health KRG-Iraq, since 2010. His academic research explores the different aspects of Pharmacodynamics and –kinetics; permeability of Hydatid (Echinococcus granulosus) Cyst to drugs, GABA Receptor, Apoptotic gene expression in Leukemic patients... etc. He is supervising several postgraduate students in the area of clinical and basic pharmacology leading to MSc in Pharmacology and higher Diploma in Clinical Pharmacy. He is a member of the University Council of Sulaimani, Scientific Promotion Committee of Faculty of Medical Sciences, Federal International Pharmacist Society, Royal Pharmaceutical Society, Syndicate of Iraqi Pharmacists and Kurdistan Pharmacists Associations and Faculty Affiliate of College of Pharmacy at Belmont University, Tennessee USA
Abstract:
To determine the role of Bcl-2 and p53 apoptosis related genes expressions in chronic lymphocytic leukaemia (CLL) patients concerning the response to different chemotherapy regimens and number of treatment courses. The study conducted on 55 CLL patients (44 CLL and 11 CLL/SLL; small lymphocytic leukaemia) and forty healthy individuals as control, at Hiwa Hospital of oncology & haematology in Sulaimaniyah during three-month period, October 1st- Dec 13th 2013. The RNA was extracted by exploitation total RNA extraction kit, treated with DNAse, then cDNA was synthesized and qRT-PCR used to analyse anti-apoptotic Bcl-2 and tumour suppresser p53 gene expressions. CLL/SLL showed higher Bcl-2 and p53 gene expression than CLL. CLL patients showed one-third increase in Bcl-2 gene expression compared to healthy controls (p<0.05), and one-half decrease in p53 gene expressions (p<0.05). Bcl-2 gene expression was higher, particularly, for those who were treated with higher range of treatment courses and fludarabine cyclophosphamide rituximab (FCR) regimen. P53 gene expression reciprocally related with Bcl-2 and vice versa. In conclusion, the results of this study indicated that both of the anti-apoptotic Bcl-2 family members and additionally the tumour suppresser p53 may be thought-about as a result of the key choices of cancer and significantly contributes to the impact of current treatment modalities on cancer cells. Moreover, a marked role for p53 gene in the chlorambucil resistance in CLL is elucidated.
Shinya Uchida
University of Shizuoka, Japan
Title: Evaluation of the ease of taking mini-tablets compared with other tablet formulations in healthy volunteers
Time : 14:30-14:50
Biography:
Shinya Uchida, PhD, received his Ph.D. degree from University of Shizuoka in 1999. Dr. Uchida served as a clinical pharmacist at University Hospital of Hamamatsu School of Medicine. He is associate professor at University of Shizuoka and his major interests include clinical pharmaceutical science, clinical pharmacology and pharmacokinetics. He has published more than 50 papers in reputed journals.
Abstract:
Tablets are the most widely used drug formulation. However, problems may arise in paediatric or elderly patients, whose swallowing functions are inferior. Mini-tablets (MTs) are considered easier to swallow than conventionally sized tablets (CTs). Although several trials suggest that MTs are the most acceptable oral formulation, reports comparing MTs with other tablet formulations and quantitative data for the ease of intake of a unit of several tablets are lacking. We aimed to evaluate the ease of taking MTs in comparison with that of other tablet formulations, as well as to evaluate the ease of taking different numbers of MTs. We prepared 4 types of tablets in 2 diameters (3 mm for MTs and orally disintegrating mini-tablets (ODMTs) vs 8 mm for CTs and orally disintegrating tablets, ODTs) and two formulations (MTs and CTs vs ODMTs and ODTs). Our randomized crossover trial in 18 healthy volunteers indicated that the visual analogue scale (VAS) score for the ease and amount of water required for intake of MTs was significantly lower than those of CTs. An ODMT required the least amount of water and smallest VAS score for ease of taking a tablet. The advantages of MTs, namely the ease of intake and the low amount of water required, were the most prominent for a unit comprising < 5 tablets. In conclusion, MTs could reduce the problems and risks associated with taking tablets and improve patient adherence, especially in paediatric and geriatric patients who have difficulty with taking CTs.
Arik Dahan
Ben-Gurion University of the Negev, Israel
Title: Implications of Segmental-Dependent Intestinal Permeability in Oral Drug Delivery
Time : 14:50-15-10
Biography:
Arik Dahan is an Associate Professor of Pharmaceutics and Biopharmaceutics at the Department of Clinical Pharmacology and the School of Pharmacy, Ben-Gurion University of the Negev in Beer-Sheva, Israel. He is also an Adjunct Professor of Pharmaceutical Sciences at the College of Pharmacy, University of Michigan. Dr. Dahan received his Ph.D. (2007) from the Hebrew University of Jerusalem. He was a Post-Doctoral Research Fellow at the University of Michigan (2007-2010) with Professor Gordon Amidon. Dr. Dahan's research interest is the integration of up-to-date molecular/cellular mechanistic investigations of drug disposition in the context of the human body. In implementing this molecular biopharmaceutical approach to ADME research, Dr. Dahan is seeking to enable mechanistic-based successful solutions to drug delivery/therapy, in challenging scenarios e.g. low-solubility, low-permeability, extensive metabolism, poor site targeting, various pathophysiological conditions, and paediatrics. He has published over 60 top-notch Journal papers
Abstract:
On several levels, the dissolution and the permeability are related and should maintain a certain relationship between them. For instance, Tsume and Amidon (Mol Pharmaceutics 2010) have shown that the higher the permeability is, the more lax the dissolution criterion for granting a bio waiver can be. In this talk, regional-dependent intestinal permeability will be discussed, including dissolution aspects, as well as pathophysiological conditions. Permeability is location dependent, and pertains to each point throughout the gastrointestinal tract. A drug may exhibit significantly different intestinal permeability not only between the small and large intestine, but even within the small intestine, i.e. between the proximal jejunum and the distal ileum. The asymmetrical pH profile throughout the small intestine may be the underling mechanism for such segmental-dependent permeability of certain ionisable drugs. An asymmetrical expression pattern of different transporters throughout the intestinal tract may also cause such regional-dependent permeability. Asymmetrical intestinal enzymes expression may significantly influence the systemic bioavailability of a drug, although not necessarily affect the permeability. In these cases, rapid vs. sustained dissolving drug products may result unexpectedly different systemic drug levels. In conclusion, it is prudent to consider the intestinal permeability pattern when deciding on a certain dissolution profile.
Biography:
Dr Pierre Lutgen was born 1940 in Luxembourg, studied at the University of Louvain in Belgium and obtained diplomas in chemistry, social sciences and philosophy. He worked during 25 years for the Dupont CY, in research, and during 8 years in the steel industry, mainly in the environmental field. Since his retirement he worked as consultant for health and environment as invited professor at the University in Medellin and for the European Communities in several countries. Over the last ten years he has organized the association IFBV-BELHERB studying and fighting tropical diseases with some 30 academic and medical partners in Africa, South America and Europe. Numerous peer reviewed papers have been published by this team, mainly on herbal medicine.
Abstract:
A team of medical doctors in R.D.Congo, Jerome Munyangi and Michel Idumbo, have run randomized clinical trials in Maniema province with the participation of some 1000 malaria infected patients. The trials were run in conformity with the WHO procedures. For all the parameters tested herbal treatment was significantly better than ACTs. The efficiency was equivalent for Artemisia annua and Artemisia afra. More important even is the observation for the total absence of gametocytes after 7 days treatment with the herb. A tremendous hope for malaria eradication. The results have been communicated to the local health authorities, and to the Ministries of Health and Research in the RD Congo who were supportive of these trials. The draft of a paper is almost ready and will be submitted to a peer reviewed scientific journal. The large scale trials confirm those of Dr Constant Kansango in Katanga who had found in a trial with 44 Plasmodium falciparum infected patients that after 7 days of treatment with 20 gr of capsules containing a afra powder the gametocytes had completely disappeared, except for one patient. Artemisia afra does not contain artemisinin. The best explanation available is the high arginine content of Artemisia plants (see "Arginine, a deadly weapon against gametocytes" on malariaworld.org). In 2012 already Dr Saint-Hillier worked with capsules containing powdered leaves from the French Artemisia annua genotype with a content of 0.1 % artemisinin only. A total of 40 000 capsules containing one gram was administered, to adults, children, but also to neonates and pregnant women. The therapeutic effect of the capsules against fever and other clinical signs of malaria are always very fast. These results confirm results obtained by the association IFBV-Belherb and her partners in many small scale trials in several African countries. Therapeutic efficiency always was > 95% and prophylaxy was noticed and documented. The abstracts or peer reviewed papers of all these trials are available on request.
- Young Researchers Forum
Session Introduction
Noor Mohammed
University of Birmingham School of Bioscience, UK
Title: Regucalcin protects HepG2 cells from Doxorubicin-induced apoptosis and Autophagy
Time : 15:50-16:05
Biography:
Noor has completed her master degree (MSc) in Histology on March 2010 from university of Duhok (Kurdistan Region Government of Iraq) and has published her master thesis as two papers in local university journal. Noor worked as an assistant lecturer in biology department, university of Duhok since 2010 then she started her PhD on September 2013 focusing on the mechanism effect of chemotherapy drugs on liver and kidney cell line.
Abstract:
Regucalcin (RGN) is a cytosolic Ca2+-binding protein that was discovered in 1978 and is known to be a multi-functional protein involved in number of cellular processes including – calcium homeostasis by regulating Ca²+ binding protein activity such as Ca2+-ATPases, calmodulin kinase and PKC. This protein is mostly found in liver and kidney tissues. Furthermore, RGN also plays a defence role in Ca2+-mediated stress protection and apoptosis. Doxorubicin (DOX) is a potent anti-cancer drug that is used either in isolation or in combination with other drugs for treating variety of cancers. Several studies have shown that DOX induces p53 activation leading to apoptosis in both normal and tumour endothelial cardiomyocytes cells; by causing cytochrome c release from the mitochondria, resulting in caspase 3 activation and induction of apoptosis. Moreover, this drug has the ability to damage DNA by producing reactive oxygen species. A major problem of DOX treatment is that it is highly cardio- and hepato-toxic. In the current study we have investigated the molecular mechanisms of DOX-induced hepatic cell death and show that DOX can induce cell death in human HepG2 liver cells through a number of different mechanisms including; apoptosis, DNA damage and autophagy. However, necrosis does not appear to be involved in this process. Furthermore, over-expression of RGN in HepG2 cells was found to protect against the toxicity by DOX. Therefore increased expression of RGN in the liver could be a mechanism for protection against DOX-induced toxicity.
Juan Wang
Jilin University, China
Title: MUC1-MBP/BCG anti-tumor vaccine, an attractive anti-tumor vaccine
Time : 16:05-16:20
Biography:
Juan Wang is a Ph.D student, whose supervisor is professor Guixiang Tai from Department of Immunology, College of Basic Medical Sciences, Jilin University. Hers research is focus on the biological function of MUC1 and the therapy of cancer by targeting MUC1. She has participated in several projects, including the China National Natural Science Foundation and the Major Development Programs for New Drugs of the Chinese Academy of Sciences during the 12th Five-Year Plan Period . To date, she has been published 4 SCI indexed papers
Abstract:
Mucin 1 (MUC1), as an oncogene, plays a key role in the progression and tumorigenesis of many human adenocarcinomas and is an attractive target in tumour immunotherapy. To develop an effective anti-tumour vaccine for the treatment of MUC1-expressing human tumours, our research group generated a recombinant MUC1-MBP fusion protein combined with Bacillus Calmette-Guerin (MUC1-MBP/BCG) anti-tumour vaccine, the repeated animal experiments demonstrated that MUC1-MBP/BCG anti-tumour vaccine not only induced the release of MUC1-specific antibody and a MUC1-specific Th1-dominant immune response, but also enhanced the cytotoxic T lymphocyte killing activity and the activation of macrophage and NK cells. Furthermore, the results from tumour-bearing nude mouse model revealed that MUC1-MBP/BCG anti-tumor vaccine significantly inhibited the growth of Lewis lung cancer, B16-MUC1 (MUC1+) and human breast cancer cells. To help move the vaccine into a Phase I clinical trial, the pilot production process and quality control standard of pharmaceutical research have been accomplished, and a majority of pharmacodynamics, pharmaceutical and toxicology pre-clinical studies have been accomplished as well. A pre-clinical toxicity evaluation that comprised of a single-dose acute toxicity study in mice, repeat-dose chronic toxicity and immunogenicity studies in rats, and pilot toxicity and immunogenicity studies in cynomolgus monkeys showed that treatment with the MUC1-MBP/BCG anti-tumour vaccine did not cause any organ toxicity. Collectively, these data are beneficial to move the MUC1-MBP/BCG anti-tumour vaccine into a Phase I clinical trial, and suggesting that MUC1-MBP/BCG vaccine is an attractive anti-tumour vaccine.
Lanja Ibrahim Saeed
University of Sulaimani School of Pharmacy, KRG-Iraq
Title: T-VDMS- Therapeutic Potential of Vitamin D3 as an add on to Interferon Beta in Patients with Multiple Sclerosis in Sulaimaniyah, KRG-Iraq
Biography:
Lanja Ibrahim Saeed recently graduated from Master Degree, she is currently in charge of Multiple sclerosis pharmacy at Multiple Sclerosis Center at Shar Hospital of Sulaimaniyah. Lanja Ibrahim Saeed received her B.Sc in pharmacy and M.Sc in Clinical Pharmacology from the College of Pharmacy University of Sulaimani. She has 12 months of experience in Hospital as clinical pharmacist / 2 years of experience in hospital pharmacy management and 5 years of experience in Pharmacy practice and Community pharmacy. She is a member of the Syndicate of Iraqi Pharmacists and Kurdistan Pharmacists Associations
Abstract:
Treatment of Multiple Sclerosis (MS) has received substantial attention due to devastating symptoms, disability progression, mental health and cost of polytherapy. To investigate the effect of vitamin D supplementation as an add on to interferon beta on immunological, biochemical, radiological and clinical outcomes. Patients and methods: Double-blind, placebo-controlled, randomized study conducted in 54 MS patients on interferon beta at MS Center in Sulaimaniyah City, KRG-Iraq. Total of 43 patients completed the study. On vitamin D3 arm 13 patients received 10000 IU/day, 14 patients received 5000IU/day and on placebo arm 16 patients treated with placebo. Serum cytokines IL-2 and TGF-βâ‚ were measured. Modified Fatigue Impact Scale, cognition (MFIS), Expanded Disability Status Scale (EDSS), 9-hole peg test, 25-foot walk, lesion numbers at T2 and T1 enhancing lesion, brain atrophy, relapse occurrences were assessed twice for every patient at baseline and after six months of treatment. Results: after six months of treatment; serum vitamin D level significantly increased MFIS, EDSS and cognition function improved significantly, relapse rate reduced very significantly, TGF-βâ‚ serum level increased, IL-2 level and MS Functional Composite changed but not significantly, Gadolinium-enhancing lesions reduced significantly compared to placebo. Conclusions: Vitamin D deficiency is considered as both risk factor and consequences of MS. The optimum serum vitamin D level (40ng/ml) can be achieved faster by 10000IU vitamin D3/daily which can be considered as a loading dose, also favoured for prevention of relapse occurrences this level can be maintained by 5000IU vitamin D3/daily and keeping its therapeutic potential without causing hyperkalaemia.
Maria Sala-Cîrtog
University of Medicine and Pharmacy “Victor Babesâ€, Timisoara, Romania
Title: Identification of potentially conserved microRNAs in Calendula officinalis using homology-based approaches
Time : 16:35-16:50
Biography:
Maria Sala-Cîrtog is a third year PhD student at the University of Medicine and Pharmacy "Victor Babes", Timisoara (Romania) where she works as an Assistant professor in the Department of Biochemistry and Pharmacology. She is also a Pharmacy resident at the Clinical Municipal Hospital, Timisoara. In the last year, she received a grand from the Ministry of European Funds.
Abstract:
MicroRNAs (miRNAs) are a group of small, noncoding endogenous RNA (21-25 nucleotides long) with an important role in gene expression regulation by targeting specific mRNAs in plants, animals and humans. To date, no miRNAs from marigold (Calendula officinalis), one of the best known medicinal plants, have been identified. This may be due to the lack of genome data regarding Calendula off. because the majority of available miRNA identification tools require a reference such as EST database or genomic sequence to discover novel miRNAs. Materials and Methods: - Certified plant material (Calendulae flos) and standard growth conditions - Plant small RNA isolation and extraction - Sequencing data analysis and plant miRNA identification Results: The cDNA libraries of two tissues from Calendula (petals and inflorescence) were prepared and small RNA-seq were conducted according to Illumina's protocols. To identify potential miRNAs, previously known miRNAs from Arabidopsis thaliana, Ricinus Communis, Linum Usitatissimum and Physcomitrella patens were downloaded from MirBase. The reference set miRNAs were compared against Calendula small RNA sequences using homology approaches. A total of 3 miRNAs, with 0 mismatches, (mir166a, lus-mir166e, ppt-mir894 and ath-mir8175), were identified based on their sequence complementarities. Conclusion: The potentially conserved miRNAs from Calendula were identified only in the inflorescence, which is the part used for medicinal purposes. This could lead to a better understanding of the relationship between plant exogenous genetic material and the changes in mammal upon oral ingestion. Acknowledgement: We would like to thank for financial support received from the Romanian Ministry of Education and Research (Grant PN-II-PT-PCCA-2013-4 No 165/2014)
- Poster Presentation