15^th Annual European Pharma Congress May 07-09, 2018 Frankfurt, Germany

Biography:

Kell Cannon has an MBA degree and a BS degree in Microbiology and has more than 20 years of US and global lifecycle and pharmaceutical marketing expertise to 3D's clients. He uses his analytical and organizational skills to help clients identify the strengths and weaknesses in their data and define their competitive differentiation. He has developed rigorous processes to help clients analyze and prepare their regulatory submissions and FDA advisory committee presentations. This assistance enables companies to win approval, expedite product access, and achieve competitive reimbursement. He has held leading positions at Roche, Novartis, Ciba, and Merck in clinical trial strategy, label negotiations, brand positioning, and advocacy development.

Abstract:

Getting a product approved by the European Medicines Agency (EMA) can be daunting, especially for companies that have little experience with this unique and complex process. Within the EMA, the Committee for Medicinal Products for Human Use (CHMP) conducts a scientific data review and recommends whether or not the drug or biologic should receive marketing authorization. The CHMP holds meetings to get input and scientific advice to inform its decision and/or to discuss objections that might prevent or delay approval. For applicants, the goal is clear: get a positive majority vote for marketing authorization. However, multiple hurdles exist that can make preparing for these meetings quite challenging. Firstly, CHMP meetings are not public; they’re held behind closed doors, and even the applicant is not present for much of the discussion. The CHMP typically makes its own presentation to the regulatory or scientific experts before the applicant is allowed in the room. Thus, when applicants present their data and answer questions, they don’t know what has already been discussed. In addition, the applicant has only one hour to make a core presentation AND answer the panel’s questions. In addition, applicants are allowed only a very limited number of people in the room, meaning they have to face tough Q&A without much backup from internal or external experts. After the applicant’s hour is up, they are dismissed from the room; the ensuing deliberations and voting are private. With such a limited amount of time to state their case, applicants’ messages must be clear, compelling and memorable. Another major hurdle is the limited preparation timeline. While the applicant may have an early indication based on the Day 80 rapporteurs review or the Day 120 list of questions, the need for a CHMP meeting only becomes certain when they receive the Day 180 assessment. That leaves the applicant with one to three months to prepare a briefing document, core presentation, and answers to difficult questions. The information must be presented clearly and concisely to overcome CHMP objections within the very limited timeframe of one hour, and to ensure that the voting participants retain the information up until the vote. This presentation will walk you through how to prepare for, and manage, CHMP meetings to achieve a positive recommendation for your product. Learning objectives of this presentation will be as follows: understand the EMA review timeline; learn how to prepare for the four different types of CHMP meetings you may face (Expert Group meeting, Scientific Advisory Group (SAG) meeting, oral explanation, and PRAC meeting); be introduced to the technology and support needed to successfully manage Q&A in the meetings.

Biography:

Caroline Kersten is a partner with Leverage HR, where they focus on transitioning talented women to the top, and developing and implementing solutions to create diverse leadership teams (www.leveragehr.com). She has trained and coached countless women and consulted with some of the most notable Fortune 500/1000 organizations across the US and Europe. She has over 20 years of experience as a business strategy consultant and HR leader in (non-)profit organizations, and draws on a wide variety of skills and experiences when working with clients. She has lived and worked in the Netherlands, France, Belgium, and currently Germany.

Abstract:

CEOs consistently identify “having the talent I need to drive my business” as one of their top three imperatives. To achieve business goals, you need the best men and women leaders. While women represent over half the available talent pool, organizations struggle to retain and grow talented women. The key question is therefore: what is stopping women in your organization from moving into leadership roles and what can managers/leaders do about it? Reinforcing enablers? Yes! Reducing barriers? Absolutely! Plus one key element that is often overlooked: building trust. Building (gender) diverse teams requires more than respecting and valuing differences. It requires trust. Trust creates an environment where each individual feels uninhibited and can show his/her authentic self. Each individual will be stronger, and the team will be more effective and cohesive. It will create a strong foundation for all future diversity initiatives. Join me in this interactive session where I will — Highlight results of global research on enablers encouraging women to pursue leadership roles and barriers preventing women from taking on next level roles; create an understanding of why trust is required for any diversity initiative to be successful and show three tactical ways managers/leaders can build trust that is needed to unleash the power of diversity.

Biography:

Djebbar Atmani is a Senior Lecturer at the Faculty of Nature and Life Sciences, University of Bejaia (Algeria). He obtained his Master of Science Degree from California State University, Los Angeles (USA) in 1987 and his PhD from the University of Sétif (Algeria) in 2004. His research interest lies in natural products from medicinal plants. He has published more than 30 papers in high impact scientific journals, attended several seminars and symposia worldwide and supervised many Doctoral theses besides reviewing many high impact journals

Abstract:

Phytochemicals, including phenolic compounds present in many plants have received much attention in recent years due to their health benefits. This study was conducted to investigate the anti-diabetic and anti-inflammatory activities of Pistacia and Fraxinus angustifolia, two plants traditionally used in Algerian folk medicine. The results indicated that P. lentiscus and F. angustifolia extracts, exhibited a promising anti-diabetic activity in streptozotocin (STZ)-induced diabetic rats, by a significant reduction (55%) of blood glucose level, a result confirmed by the inhibition of alpha-amylase activity (65%). The results of the anti-inflammatory activity of P. lentiscus and F. angustifolia showed significant reduction of the paw edema induced by carrageenan. Furthermore, P. lentiscus extracts showed a significant reduction of pro-inflammatory cytokines (IL-1β) in activated macrophages. Moreover, the extracts of F. angustifolia, significantly inhibited ear edema induced by single and multiple doses of 12-O-tetradecanoylphorbol 13-acetate (TPA) and suppressed the cellular infiltration. In vivo, the vesicles loaded with the crude extract of F. angustifolia and especially penetration enhancer-containing vesicles (PEV) inhibited oxidative stress in human keratinocytes against H₂O₂ and attenuated edema and leukocyte infiltration by stimulating the repair of TPA-induced skin damage. Chromatographic and spectroscopic analysis allowed the identification of known and new phenolic compounds, some of which are endowed with biological activities.

Biography:

Atmani-Kilani Dina has obtained her BS Degree in Biology from the American University of Beirut, Lebanon, Master’s Degree in Biology from California State University, LA, USA and her PhD from the University of Bejaia, Algeria. Her teaching activities in the field of Molecular Biology and Genetics since 1990 in the University of Bejaia have provided her with a lot of experience. Furthermore, her implication in research in the field of medicinal plants with collaboration of her colleagues has allowed many PhD students to obtain their degrees and resulted in many international publications. As her conviction that medicinal plants research will lead to the development of novel drugs with better efficiency than synthetic medicines, she hopes that her contribution will be fruitful.

Abstract:

Gastric ulcer (GU) and recto colitis (RC) are prevalent diseases that can become chronic and fatal. Therapeutic strategies have to focus on the inflammatory character of both diseases, by reducing myeloperoxidase (MPO), an enzyme activated by infiltrated neutrophils. Reactive oxygen species (ROS) generated by this enzyme aggravate the ulcer symptoms. Clematis flammula (CF) leaves are widely used in Algeria to treat inflammatory-related disorders. The inhibition of this enzyme by CF ethanolic extract was tested in mice suffering from GC or RC, induced respectively by ethanol and intra-colon injection of acetic acid (3%). Our findings indicated that MPO activity was significantly (p<0.05) increased in ethanol-treated mice, indicating infiltration and activation of neutrophils in the acute ulcerated gastric mucosa, while pre-treatment with CF (25, 50, and 100 mg/kg) as well as the drug pantoprazole (40 mg /kg) led to a marked (pË‚0.05) decrease in MPO activity, compared to the control group with respective values of 16.06±4.13, 6.92±0.68, 6.13±0.74, and 65.40±9.67 U/g tissue, indicating that CF significantly repressed MPO activity at the site of inflammation (ulcer). On the other hand, concerning RC, the administration of CF ethanolic extract attenuated the MPO activity with 38.11±7.61, 25.85±4.39 and 14.35±7.50 U/g tissue at concentrations of 25, 50 and 100 mg/kg, respectively. The known anti-RC drug sulfasalazine (100 mg/kg) was significantly less effective (47.62±4.05 U/g of tissue) than the extract. Histologic analysis has confirmed our results, which validates the use of this plant for ulcer conditions especially for RC.

Biography:

Sergey Suchkov received his MD from Astrakhan State Medical University. In 1985, he received his PhD from the I M Sechenov Moscow Medical Academy and in 2001, his Doctorship Degree at the Nat Institute of Immunology, Russia. From 1987 through 1989, he was a Senior Researcher, Koltzov Institute of Developmental Biology. From 1989 through 1995, he was a Head of the Lab of Clinical Immunology, Helmholtz Eye Research Institute in Moscow. From 1995 through 2004, he was the Chair of the Department of Clinical Immunology, Moscow Clinical Research Institute. He was an Exe Secretary-in-Chief of the Editorial Board of Biomedical Science, an international journal published jointly by the USSR Academy of Sciences and the Royal Society of Chemistry, UK. At present, he is a Chair at the Department for Personalized and Translational Medicine, I M Sechenov First Moscow State Medical University. He is a Member of the New York Academy of Sciences, USA; American Chemical Society (ACS), USA; American Heart Association (AHA), USA; EPMA (European Association for Predictive, Preventive and Personalized Medicine), Brussels, EU; ARVO (American Association for Research in Vision and Ophthalmology); ISER (International Society for Eye Research) and PMC (Personalized Medicine Coalition), Washington, USA.

Abstract:

Catalytic Abs (catAbs) is multivalent immunoglobulin (Igs) with a capacity to hydrolyze the antigenic (Ag) substrate. In this sense, proteolytic Abs (Ab-proteases) represents Abs to provide proteolytic effects. Abs against myelin basic protein/MBP with proteolytic activity exhibiting sequence-specific cleavage of MBP is of great value to monitor demyelination whilst in MS. The activity of Ab-proteases was first registered at the subclinical stages, 1–2 years prior to the clinical illness. The activity of the Ab-proteases revealed significant correlation with scales of demyelination and the disability of the patients as well. So, the activity of Ab-proteases and its dynamics tested would confirm a high subclinical and predictive (translational) value of the tools as applicable for personalized monitoring protocols. Of tremendous value are Ab-proteases directly affecting remodeling of tissues with multilevel architectonics, for instance, myelin. By changing sequence specificity, one may reach reduction of a density of the negative proteolytic effects within the myelin sheath and thus minimizing scales of demyelination. Ab-proteases can be programmed and re-programmed to suit the needs of the body metabolism or could be designed for the development of new catalysts with no natural counterparts. Further studies are needed to secure artificial or edited Ab-proteases as translational tools of the newest generation to diagnose, to monitor, to control and to treat and rehabilitate MS patients at clinical stages and to prevent the disorder at subclinical stages in persons-at-risks.

Biography:

Abstract:

Inter-individual variations in the body's response and tolerance to drugs can be attributed to genetic polymorphisms, among others. A good example is dihydropyrimidine dehydrogenase gene (DPYD) single nucleotide polymorphisms (SNPs). DPYD encoding dihydropyrimidine dehydrogenase (DPD) is the first rate-limiting enzyme in the catabolic pathway of 5-fluorouracil (5-FU) and pyrimidines. A tolerable therapeutic dose of 5-FU for a DPD-normal patient can make a DPD-deficient patient intolerable. To save a patient's life and money, health professionals need a convenient and reliable way to find out a patient’s tolerance to 5-FU prior to clinical trials or 5-FU therapy. In this talk, I present a simple, easy and fast way to predict an individual’s intolerance to 5-FU using the secondary structure prediction programs, YASPIN, PSIPRED and JPred 3, freely available to anyone. These programs predict the DPD secondary structure with and without mutation(s) within DPYD, so that impact of the mutation-induced structural changes on functional sites of human DPD domains can be deduced. Among 11 SNPs analyzed as samples, two missense mutations, D949V (SNP A2846T) and C953S (SNP G2858C), in the DPD domain V are predicted to cause disruption of the domain core responsible for [4Fe-4S] clusters. Furthermore, a point mutation in a splicing region (14 G1A) in DPYD is predicted to produce truncated DPD mRNAs (exon 14 skipping) and disabled DPD proteins (missing 55 amino acids from D581 to N635) which cause a complete loss of DPD activity. SWISS-MODEL predicts significant change in the 3D structures of human DPD in the presence of exon 14 skipping, D949V and C953S mutation. Thus, prediction by these secondary structure prediction programs provides useful and reliable information about toxicity associated 5-FU due to mutation (s) in DPYD.

Biography:

Masaki Otagiri is currently a Professor and Dean of Faculty of Pharmaceutical Sciences, Sojo University. He graduated from Nagoya City University with a PhD Degree in 1975. In 1980, he joined the Pharmaceutics Department of Faculty of Pharmaceutical Sciences, Kumamoto University as an Associate Professor and then promoted to Professor of Biopharmaceutics Department, Kumamoto University in 1983. After his retirement from Kumamoto University in 2009, he was appointed as Professor of Faculty of Pharmaceutical Sciences, Sojo University, Kumamoto, Japan.

Abstract:

Sodium 4-phenylbutyrate (PB) is phenyl-substituted fatty acid derivative that is clinically used for the treatment of urea cycle disorders by its ammonium scavenging activity. PB has also other pharmacological activities such as an inhibitor of endoplasmic reticulum stress and histone deacetylases. However, the binding of PB to plasma protein is not fully understood. Thus, we investigate the binding of PB to plasma protein in detail. Binding experiments showed that PB mainly binds to human serum albumin (HSA) with a single high affinity site, site 2. Moreover, the hydrophobic and electrostatic interactions play an important role on the binding based on structure-activity relationship and thermodynamic analysis. In addition, Tyr411 and Arg410 were involved in the binding of PB to site 2, from the binding experiments using chemically modified HSAs and mutant HSAs. These findings were confirmed by X-ray crystallographic analysis: the carboxylate group of PB hydrogen-bonded to Arg410, Tyr411 and Ser489, and the alkyl chain, including the phenyl group of PB, occupies the hydrophobic cavity of drug site 2. Next, we examined binding properties of PB to mammalian serum albumin. PB was also found to interact with one high affinity site, which corresponds to site 2 of HSA and several number of low affinity binding sites in all albumins. The affinities of PB to human and bovine albumins were higher than those to rabbit and rat albumin, and that to rabbit was the lowest. Binding and molecular docking studies using structurally related compounds of PB suggested that species differences in the affinity are attributed to differences in the structural feature of PB-binding sites on albumins (e.g. charge distribution, hydrophobicity, shape, or size). The findings presented herewith will be useful for understanding the pharmacokinetics and the pharmacological effects of PB.

Biography:

Yasin I Tayem completed his MD from Al-Quds University School of Medicine, Palestine in 2001 and PhD in Clinical Sciences from the University of London, United Kingdom in 2006. From 2006 to 2013, he worked as an Assistant Professor of Pharmacology at the Al-Quds University School of Medicine. He has also been active in undertaking research, especially in collaboration with many international institutions including Mayo Clinic (USA), Gothenburg University (Sweden), Birmingham University (UK) and Kuwait University (Kuwait). From 2012 to 2013, he held the position of a Postdoctoral Research Fellow at the National Institutes of Child Health and Human Development (NICHD), Maryland, USA. Since 2013, he has been working as an Assistant Professor of Pharmacology and Therapeutics at the Arabian Guild University, Manama, Bahrain.

Abstract:

Statement of the Problem: Drug-drug interactions (DDIs) represent a significant cause of patient’s morbidity and mortality. The rate of DDIs is rapidly increasing worldwide with the increasing proportion of ageing population and frequent requirement of polypharmacy prescription of multiple drugs to treat comorbidities. Prescribing physicians are responsible for checking their prescriptions for the presence and severity of DDIs. However, since a large number of new drugs are approved and marketed every year, new interactions between medications are increasingly reported. Consequently, it is no longer practical for physicians to rely only upon their previous knowledge of medicine to avoid potential DDIs. The aim of this study is to explore the perceptions of physicians working at primary healthcare centres in Bahrain towards DDIs and how they manage them during their practice.

Methodology & Theoretical Orientation: In this cross-sectional study, physicians working at all governmental primary healthcare centres in Bahrain were invited to voluntarily, privately and anonymously respond to a self-administered questionnaire. The questionnaire aimed to assess their self-reported knowledge of DDIs and how they check for them in their practice. The participants were requested to provide socio demographic data and information related to their attitudes towards DDIs including strategies they employ for detecting and managing them, and their awareness of drugs which commonly cause DDIs. At the end of the questionnaire, an open-ended item was added to allow participants to further add any comments.

Findings: The study is going on currently and the results will be presented in the conference.

Conclusion & Significance: The conclusions will be presented in the conference since the study is still going on.

Biography:

Nuriye Korkmaz has her expertise in Biochemistry and Phytoteraphy studying enyzme activities, isolations, HPLC analysis, in vivo and in vitro studies on wound healing and anti obesity mechanisms.

Abstract:

Traditional uses of plants are guiding the development of new drugs. Determining the biological activity of plants which have been popularly used for many years and the identification of effective compounds in plants are essential factors in drug development. While wound healing is a normal biological process in the human body, non-healing wounds are an important global health care problem. Plants belonging to the family Asteraceae exhibit antioxidant, wound healing, antibacterial, antifungal, anti-inflammatory, antitumor, antiseptic effects. P. hoppeana is a folk medicinal plant known for its anti-inflammatory potential in Balıkesir for many years. The purpose of the study was to evaluate the wound healing activity of the methanolic extract of P. hoppeana, traditionally used in skin diseases, with its biological activity and antimicrobial properties and examine levels of TNF-α, IL-1β, IL-10 and MMP-9 in rat tissues. A circular excision wound was created by excising the skin in the dorsal interscapular region. Animals in the positive and experimental group were topically treated with Madecassol, and pomade prepared from the extract, respectively. At the end of the experiment, biological activity was studied, and PCR analyses were performed on skin samples. The antimicrobial activity of the methanol extract of the plant was also investigated. Rat groups treated with methanol extract and Madecassol exhibited wound contraction compared with the control group. Antioxidant, anti-inflammatory and hydroxyproline values were high in the extract group. Strong antimicrobial activity of the plant was observed. The plant exhibited its wound healing effect by increasing mRNA expression of TNF-α, IL-1β, IL-10 and MMP-9 genes. This study shows that P. hoppeana exhibits healing activity in a rat wound model. Considering all these results together, a drug with effective wound healing properties might be developed from the plant.

Biography:

Sila Özlem Åžener has her expertise in Pharmacognosy and Phytoteraphy, studying enyzme activities, isolations, HPLC analysis, in vivo and in vitro studies on wound healing and anti obesity mechanisms.

Abstract:

Obesity is a serious and chronic health problem that is the basis of many diseases such as cardiovascular diseases, certain types of cancer, osteoarthritis and diabetes. Cirsium (Asteraceae) genus is represented by 67 species (79 taxa, 32 endemic) in Turkey. Cirsium genus have been used as anti-inflamatory, diuretics and venoactive remedies, traditionally. The goal of the present study is to evaluate antiobesity effect of the methanolic extracts of some Cirsium species in normal and high fat diet (HFD) induced obese rats. Male Spraque Dawley rats were divided into seven groups. HFD induced obese rats were treated with methanolic extract (200 mg/kg) and orlistat (5 mg/kg) orally, besides non-obese control group were treated with normal diet for eight weeks. At the end of the experimental duration, to interpret antiobesity activity, body weight was measured per week for eight weeks and serum samples were obtained for lipid profile analysis. Serum samples from rats were analyzed in terms of some biochemial parameters, low density lipoprotein (LDL), high density lipoprotein (HDL), triglycerides (TG), leptin and adiponectin. Oral administration of the extracts and positive control orlistat reduced body weight (p<0.005). Morever, the treatments resulted in increased serum HDL (p≤0.05) and adiponectin (p≤0.05); decreased in LDL (p≤0.05), TG (p≤0.05) and leptin (p≤0.05). According to results, the methanolic extracts of some Cirsium species displayed antiobesity activity. Thus, the Cirsium species can be a potential source of herbal medicine for obesity and its complications. Further investigations and human trials are required for understanding the therapeutic effects of Cirsium species for the global health problem.

Biography:

Bimal Krishna is currently Professor and Director of Pharmacology at the College of Osteopathic Medicine, Touro University in Nevada. He obtained a Bachelor of Science (First Class Honors) in Pharmacology and Physiology and a Doctor of Philosophy, Medicine (OB/GYN/Pharmacology) from Monash University in Australia. He also teaches for the Step 1 USMLE and COMLEX reviews for Kaplan Medical throughout the United States and in UAE, Europe, Saudi Arabia, India, Mexico and the Caribbean. He has been teaching online for Kaplan University for over seven years. He has contributed to numerous publications and is a Member of a number of organizations including Fellow of American College of Clinical Pharmacology. His research background is in Maternal and Neonatal Pharmacology, specifically looking at materno-fetal transfer utilizing the perfused human placental and cultured syncytiotrophoblast model. Complementary and Alternative Medicine is another area of interest.

Abstract:

During pregnancy and the post-partum period, significant physiological changes occur to meet the demands of the fetus. These changes typically peak in the second trimester. Maternal plasma volume, cardiac output and glomerular filtration increase up to 50%. Increasing body fat increases the volume of distribution of highly lipid soluble drugs. Nausea, vomiting and delayed gastric emptying may impact drug absorption. The placenta plays a significant role in nourishing and maintaining fetal integrity along with the amniotic fluid. The placenta is fundamentally the exchange organ for nutrients and gaseous substances and drugs. Essentially drugs with low molecular weight and high lipid solubility will traverse the placenta. Hence, placental insult will have significant impact on the fetus. Pre-conception planning is essential, particularly in high risk patients. During pregnancy, nausea, vomiting, constipation and gastroesophageal reflux disease (GERD) are likely to occur and can be treated with therapeutic and non-therapeutic approaches. Thereafter, pregnancy-influenced issues, acute-care issues and chronic illnesses require immediate therapeutic intervention. Pre-eclampsia, seizures, HIV, STDs can certainly pose serious adverse consequences for the fetus. Drugs of abuse are a concern as they rapidly traverse the placenta and are responsible for IUGR, fetal death in utero, carcinogenic effects and placental abruption. This presentation addresses the current therapeutic trends in pregnancy and contraindicated drugs. It also covers optimizing medication use in pregnancy and effects of drug abuse.

Biography:

Leszek Paczek, Head of the Department of Immunology, Transplant Medicine and Internal Diseases at the Warsaw Medical University, is an expert in Transplant Medicine and Nephrology. He has authored over 400 journal articles and given lectures and presentations on numerous international and national congresses. Among numerous scientific interests, he is devoted to research on the determinants of side effects and toxicity of immunosuppressive drugs with an emphasis on the role of metabolites of immunosuppressive agents. His ongoing and future projects are aimed at the development of procedures allowing the individualization of immunosuppression after solid organ transplantation.

Abstract:

Statement of the Problem: The immunosuppressive drugs and their metabolites may often be toxic. Advances in laboratory methods enable measurement of real levels of both; a specific immunosuppressive drug and their metabolites. Older, but still widely used immunoassays yield fluctuating results and what is more, results that are often about 25-30% higher than the actual levels. On the other side, novel liquid chromatography combined with mass spectrometry (LC/MS) method obtains accurate drug level measurements.

Methodology & Theoretical Orientation: LC/MS and immunoassays (IA) were applied to assess levels of both parent drugs and its metabolites in the cohort of 834 patients after kidney transplantation (KTX), mean age: 49.13 years, median: 64.95 months after KTX. 256 (30.7%) patients were treated with cyclosporine A (CsA) and 449 (53.8%) patients were given tacrolimus (Tac).

Findings: Results of analyses of immunosuppressive drugs and their metabolites as well as differences between IA and LC/MS are presented in Table 1. Tac LC/MS to IA mean difference was 1.78 ng/ml; 89.9% of IA results overestimated real Tac levels. CsA LC/MS to IA mean was 28.8 ng/ml; 94.3% of IA results overestimated real CsA levels.

Conclusion & Significance: This preliminary study warrants the initiation of multi-centre studies of serum drug levels and metabolite pharmacokinetics. Future studies should include the analysis of large data sets, as well as long-term follow-up of patients and grafts.

Biography:

Taishi Higashi took part in a half-year internship of Evonik Röhm GmbH & Co., Darmstadt, Germany in 2008. Then, he obtained PhD (Pharmaceutical Sciences) at Kumamoto University, Japan in 2009. In 2009-2011, he became a Research Scientist of Taisho Pharmaceutical Co., Ltd, Japan, and engaged self-medication business such as oral solid formulation. From 2011, he works as a Research Associate in the Department of Physical Pharmaceutics, Graduate School of Pharmaceutical Sciences at Kumamoto University, Japan. In 2013-2014, he became a Guest Researcher at Faculty of Engineering, National University of Singapore. From 2016, he holds the additional post as a Technical Adviser in CyDing Co., Ltd. His research topic is “supramolecular pharmaceutical sciences” which combines Pharmaceutical Sciences and Supramolecular Chemistry.

Abstract:

Polyethylene glycol (PEG) modification (PEGylation) is one of the best approaches to improve the stabilities and blood half-lives of protein drugs; however, PEGylation dramatically reduces the bioactivities of protein drugs. Here, we present “self-assembly PEGylation retaining activity” (SPRA) technology via a host–guest interaction between PEGylated b-cyclodextrin (PEG-b-CyD) and adamantane-appended (Ad)-proteins. Firstly, we prepared SPRA-insulin and SPRA-lysozyme. Both SPRA-proteins showed high stability against heat and trypsin digest, comparable with that of covalently PEGylated protein equivalents. Importantly, the SPRA-lysozyme possessed ca. 100% lytic activity, whereas the activity of the covalently PEGylated lysozyme was ca. 23%. Additionally, SPRA-insulin provided a prolonged and peak-less blood glucose profile when compared with insulin glargine. It also showed no loss of activity. In contrast, the covalently PEGylated insulin showed a negligible hypoglycemic effect. Next, we prepared SPRA-bromelain, because bromelain is known to degrade the extracellular matrix (ECM) in pancreatic cancer and increase the penetration of antitumor agents, although the blood half-life of bromelain is short. SPRA-bromelain showed high in vitro ECM-degrading activity, and enhanced not only the accumulation of FITC-dextran (2 MDa) in the tumor, but also the in vivo antitumor activities of doxorubicin and DOXIL. These findings indicate that SPRA technology has the potential as a generic method, surpassing conventional PEGylation methods for proteins.

Biography:

Eriona Petro received her Master’s Degree in Pharmacy (MPharm) from the University of Tirana, Albania. She worked for two years as a Community Pharmacist following her position as Sales and Application Manager for the representative office of Siemens Healthcare in Albania. She has been working as the Vice Technical Director of the Regional Directory of Health in the District of Durres since 2016 and has been a part-time Lecturer at “Aleksander Moisiu” University, Durres, Albania since 2012.

Abstract:

Statement of the Problem: Pharmaceutical expenditures make up an increasing percentage of healthcare costs. One strategy in cost minimizing without compromising quality of medications is switching brand-name drugs to generics. Eventhough generics are comparable in terms of efficacy, safety and quality with their original drugs and can be used interchangeably, there are still concerns regarding their usage. Understanding physicians’ knowledge and attitude about generics may help ensure more cost-effective treatments. The market share of generic drugs in Albania is considerable. This study aimed to investigate the perceptions of physicians towards generic drug prescribing.

Methodology & Theoretical Orientation: Physicians from 18 primary healthcare centers in the district of Durres, Albania participated in the study conducted in January 2018. A paper-based questionnaire was used to assess their knowledge and attitude towards use of generic drugs. The study was approved by the Regional Directory of Health, Durres. Descriptive statistical analysis was used to examine the results.

Findings: 60% of 109 physicians that participated in the study declared to have very good knowledge of the term ‘‘generic drug’’. The majority of them (70%) prescribed generics daily. However, no correlation between years of experience and frequency of prescribing generics was reported (p>0.05). Approximately, 42% of the physicians responded that the price difference between brand and generic drugs was one of the influential factors when deciding the right medication for treatment. Only 11% of the physicians reported generics as being less safe and effective compared to the original drugs.

Conclusion & Significance: Although it appeared that physicians are well informed about generic drugs, they still have concerns about their quality and safety. The results of this study highlight the need in suggesting the implementation of a national educational program about generics for physicians in order to overcome barriers towards generic prescribing.

Biography:

Ladislav Novotny got his PharmD from Charles University and his PhD from Czechoslovak Academy of Sciences in Prague, Czech Republic. He obtained his Specialization in the field of Pharmacology and Toxicology of Drugs. He received a Doctor of Sciences at Slovak Academy of Sciences. He worked at the Czech Academy of Sciences in Prague, at Comenius University in Bratislava and at the Cancer Research Institute of the Slovak Academy of Sciences in Bratislava. He spent a substantial amount of time at M D Anderson Cancer Center in Houston, USA. He served as a Dean at the Faculty of Pharmacy, Kuwait University from 2003 to 2014. He has authored more than 120 original scientific papers, 36 reviews and 7 patents. His scientific work is in the area of anticancer agents, experimental cancer therapy and in the area of studying physico-chemical and biological properties of various natural and synthetic compounds.

Abstract:

Cadmium (Cd) is a toxic heavy metal and industrial pollutant of the environment. Its biological half-life in humans is approximately 30 years. The flavonoid, quercetin (QE) is distributed in plants and is a part of human diet. Many studies demonstrated potential therapeutic effects of QE. Additionally, some studies demonstrated protective effects of QE against Cd-induced toxicity in healthy intact animals. The aim of our study was to investigate the effect of QE and Cd on proliferation in already cancerous cells. Human cancer cells of astrocytoma 1321N1 served as our experimental model. The simultaneous exposure of the cells to QE and Cd (16 μM), significantly reduced cell viability to 21% and 7% at 100 and 200 µM QE, respectively, compared to viability decrease by Cd alone to 81% (48-hours exposure). Other experiments with QE pre-treatment and Cd exposure or co-exposure with QE were performed. The observed effects were time and concentration-dependent. In general, these experiments show the ability of QE to induce cytotoxicity in an in vitro model of cancer cells that may undergo further carcinogenic transformation due to exposure to Cd. Cd alone was less cytotoxic in 1321N1 cells and cells did not benefit from QE presence in the medium. In general, a synergetic anti-proliferative interaction of Cd and QE in malignantly transformed cells was shown. This may represent a novel aspect of QE protective effects on organisms that are exposed to toxic agents as it would not only protect normal cells from toxicity of these toxic agents but would contribute to removal of already malignantly transformed cells from the system or removal of any cell undergoing malignant transformation.

Biography:

Abstract:

Traditional Chinese medicine is an ancient remedy with a long history of thousands of years in China. The application experiences of Chinese medicines (CMs) have been recorded in a large number of ancient and current literatures, but the mechanism of its treatment is not clear. Impacted by modern medical research in recent decades, the chemical composition and therapeutic mechanism of CMs have been studied, so as to develop many new drugs with better curative effects. In China, CMs are the important ways to develop new drugs. The development of artemisinin and arsenic preparations are the typical examples. In the 70s of last century, Prof. Tu Youyou led a research team that aimed to discover antimalarial drugs. When they retrieved the Chinese ancient medical literatures, they found that southernwood appeared in the prescriptions for malaria treatment with highest frequency. After determination of the plant origin of southernwood by textual research, they tested the extract of Artemisia annua Linn for anti-malaria effect on animal malaria models. The initial experiments were not optimistic in antimalarial activity. By reviewing an ancient medical book "zhou Hou Bei Ji Fang”which was written by Ge Hong, a Chinese ancient doctor in one thousand and eight hundred years ago, Prof. Tu was enlightened by the preparation method  recorded in this book in which southernwood was prepared as fresh juice and oral administered to treat malaria. She changed the preparation methods from hot extraction to merceration, and successfully found Artemisinin, a powerful anti-malaria lead compound. Artemisinin was approved to market in China in 1986. Since then, various derivatives of artemisinin have been marketed and benefited hundreds of millions of people. Another example is the development of arsenic preparations in the treatment of acute myeloid leukemia. Arsenics have been used in Chinese traditional medicine for more than 2000 years. Although arsenics have been abandoned in clinic worldwide because of consideration of their toxicity in the last few decades, they are always in use in China until now. In 1970s, Chinese doctors noticed that a formula containing three toxic Chinese materia medica, arsenic, calomel and venenum bufonis，was very popular in cancer patient which was used in a folk clinic. The doctors processed this formula to be a compound injection and used it for the treatment of leukaemia. Surprisingly, it had a good effect. Subsequently, they screened the efficacy of each ingredient in the formula and found that arsenic trioxide had the best effect on leukemia with a good tolerance in patients. Science then, various clinical studies have shown that arsenic trioxide had a prominent targeted efficacy for acute promyelocytic leukemia (APL). Now, FDA already approved the first line treatment of arsenic trioxide combined with retinoic acid for treatment of APL with t (15, 17) translocation or PML/RAR alpha gene expression. Today, prognoses in the treatment of APL have drastically improved. A standard treatment of ATRA in combination with arsenic trioxide can result in a clinical remission in approximately 90% of patients. In addition, a formula, Compound Huang Dai tablets containing realgar has also been used to treat leukemia for more than 40 years in China. It also shows good curative effect. From the examples mentioned above we can conclude that traditional Chinese medicine is a valuable source for new drug discovery, because there are plenty of clinical and pharmaceutical experiences to support the efficacy and safety. It should be a cost saving and effective way to develop new drugs.

Biography:

Jafari S received her Master’s Degree in Analytical Chemistry from the University of Tabriz and is currently pursuing her Doctorate of Chemistry in the Analytical Area at Imam Khomeini International University. In addition to her Master’s Degree, she has well travelled during her schooling and as such has acquired a wide range of different chemistry techniques. With this experience, she gleaned and culminated a wide scope of techniques to develop a novel method for targeting various cancers efficiently with relatively low costs as compared to customized patient medicines. With a generic customized cancer drug delivery system as described in her work, a new field of focus is presented that can make large strides in the fight against breast cancer.

Abstract:

Polyurethanes have great variety of physical and chemical properties due to different building blocks in their structure which makes it possible to be used for different biomedical and pharmaceutical applications. The most important application of these polymers is as a biocompatible, smart and controllable drug carrier, which directs the anticancer drugs sufficiently to the cancerous cells for solving the problem of inadequate drug cargo with fewer side effects to the cancerous tissue cells. In this article, a new drug delivery system is introduced which is a smart, controllable (pH-sensitive), multifunctional, magnetic polyurethane (SCMMP) nano composite composed of isocyanate as a main chain and cyclodextrin as a chain extender with magnetic nano particles in their structure. Then consequently, the bulk structure, size and morphology and magnetic characteristic of the synthetic nano-composite was characterized through different accepted analytical techniques such as FT-IR, TGA, XRD, TEM, SEM, DLS and VSM, respectively. The SCMMP was used for loading tow effects, currently used pharmaceutical cancer agents of metatroxate and doxorubicin with high loading efficiency of 87% and 89%, respectively. Dual drug loaded nano composite release behaviour was investigated in three different pHs of 4.5, 5.4 and 7.4. According to the concentration profile, low release percentage in the pH of 7.4 for long term circulation and good stability in blood stream and high release in pH of 4.5 and 5.4 for improving vast variety of cancerous cells in physiological media were observed. Thereupon, new drug carrier systems have great efficacy for cancer therapy. The MTT calorimetric method was used to track the presented nano composite eligibility as a polymer based drug delivery system. Different cellular tests of MTT assay, DAPI staining, cellular uptake and cell cycle was done on Nan composite/DOX/MX combination vs. free DOX/MX to validate it as a nano carrier. Biocompatibility of the nano carrier was done using hemolysis assay through checking on human red blood cells (HRBCs) with very fine results. According to the results, the introduced system is very effectible in delivering synchronous therapeutic agents of DOX and MX to the cancerous cells and on other hand for in vivo usage in the future.

Biography:

Parnia Mobasheran graduated from IAUPS with PharmD in Pharmaceutical Science in 2017. She ranked 7^th in the Nationwide Basic Science Exam. At present she is studying German language and completing her Internship at Alborz Health Center. She defended her PharmD thesis based on the effect of sumatriptan administration on renal ischemia reperfusion injury in rat. She has participated in several scientific conferences in the field of Pharmacy and has also attended two summer schools on the topics, Pharmacology and Clinical Pharmacy. She is very interested in pursuing her educational goals and conducting more research in the field of Pharmacology.

Abstract:

Aim: Ischemic/reperfusion injury is the common cause for acute kidney injury. The aim of the present study is to investigate the effect of 5HT_1B/1D agonist on the renal ischemic injury in rats.

Method: Ischemia/reperfusion injury was induced by a 45-minute occlusion of the bilateral renal pedicles and a 24-hour reperfusion. Our experimental groups consist of sham, control, and treatments that received three doses of sumatriptan (5, 10, 20 mg/kg). Nitric oxide kit, selective and non-selective inhibitor of nitric oxide synthase (NOS), aminoguanidine, and L-NAME were used to determine the role of Nitric oxide system. Superoxide dismutase (SOD) and malondialdehyde (MDA) of the tissue were measured to investigate the role of inflammation. Histopathological study of the kidney was performed too.

Result: Serum creatinine (Cr) and blood urea nitrogen (BUN) were measured after 24 hours of reperfusion. Sumatriptan in doses of 10, 20 mg/kg increased Cr and BUN significantly. There was a significant increase (P<0.05) of nitric oxide (NO) level in the treatment group compared with the level of the control group. Comparing to sumatriptan alone, the result of aminoguanidine administration showed a significant decrease (P<0.01) in BUN and (P<0.05) Cr. Besides, there was a significant increase (P<0.05) in BUN level, but not in Cr level when both L-NAME and sumatriptan administered within one hour. We also observed a reduction of SOD level (P<0.05) and increased serum level of MDA (P<0.001); furthermore, the histopathological result indicates kidney damage.

Conclusion: The study conducted showed an increase in kidney damage due to use of sumatriptan. We proved that NO plays a significant role in this injury. Also, decreased levels of creatinine and blood urea nitrogen in response to the aminoguanidine injection showed that inducible NO was involved in this injury.