Scientific Program

Conference Series Ltd invites all the participants across the globe to attend 12th World Drug Delivery Summit Chicago, USA.

Day 14 :

  • Sessions: Drug Discovery and Development | Patient-Centric Clinical Trials | Polymer–Peptide Conjugates | Medicinal Chemistry and Drug Discovery | Drug Delivery Systems | Patient-Centric Clinical Trials | Globalization of Clinical Trials
Location: Chicago, IL, USA
Speaker

Chair

Edwin G Moore

University of Illinois, Urbana

Speaker

Co-Chair

Panayiotis P Constantinides

Biopharmaceutical & Drug Delivery Consulting LLC, USA

Speaker
Biography:

Navaneetha Nambigari, Assistant Professor, Department of Chemistry, University College of Science, Saifabad, Osmania University, Hyderabad. She has done PhD in Bio-Inorganic Chemistry and Post Doctoral work in Computational Chemistry. Her core research areas are Spectroscopic Investigations of Metal Complexes and Their Applications (Bioinorganic chemistry) and in silico Drug designing techniques, based on targeted approaches. Drug designing with special reference for identifying New leads against cancer and rheumatoid arthritis. She has several awards to her credit “Best Presentation Award” at Drug Design 2017, JNU Convention Centre, New Delhi, India, and April 2017 and at recent advances in applied nano materials, Osmania University, Hyderabad (2016). “Young Faculty Award” by Venus International Foundation, Chennai. (2015) and “Young Chemist Award”, by Royal Society of Chemistry, London, UK at 42nd IUPAC Conference, “Chemistry Solutions”, Glasgow, UK (2009). She has 13 years of teaching and 16 years of research experience with 5 Graduate students and 6 PhD scholars working for their thesis dissertation.

Abstract:

Cancer is a major public health problem worldwide and is the second leading cause of death in the United States. The discovery and ontogenesis of small molecule inhibitors of cancer have been remodeled with technological innovation. The application of computational techniques has been quickly ratified by the scientists in the field of targeted drug designing. The pharmacokinetic parameters (ADME) are important for the designing as well as targeted delivery to the site of infection/disease. The highly expressed proteins phenotypes in cancer are targeted through signaling pathways, leading to gene expression. In the present study computer-aided drug designing techniques are used to design drugs and potential binding affinities to understand the pharmacokinetic aspects of the lead i.e., ADME. Successful case studies will be discussed to understand the target specificity and site specificity. Bioinformatic tools are used for refining the 3D structure of the target protein, validation of the active site, virtual screening carried out to identify the leads (inhibitors), and synthesis of leads, in vitro and in vivo studies.

Biography:

Brandon Furr, CCRP, is a Senior Coordinator of Sponsored Programs, at Neurosciences Institute-Neurology, Atrium Health. He has completed his B.S. in Finance from the University of North Carolina at Charlotte. He is a SOCRA-Certified Clinical Research Professional with six years of clinical research experience in both industry and federal grant projects. He is a member of the Executive Leadership Research Committee at Atrium Health’s-Neurology which is comprised of a variety of medical professionals who address higher level research-related issues and leverage resources across the enterprise. He has successfully negotiated budgets and contracts, managed revenues and billing for numerous Phase I-IV clinical trials. More recently, he has been focused on developing new applications with Atrium Health’s Sponsored Programs Administration to help strengthen the relationship between the research site and off-site financial administration offices.

 

Abstract:

Financial management of clinical research throughout its life cycle is comprised of various disciplines across the healthcare field. Leadership which utilizes the strengths of each of these areas can result in successful budgeting, and subsequently lay the foundation for the management of crucial milestones. A clinical trial’s life cycle can be separated into two phases: pre-award & post-award. The pre-award phase of strategic financial management requires the analysis of projected personnel salary costs and protocol-required procedures. Effective post-award management involves contrasting actual expenses with the original projected budget, and reporting it regularly to recognize discrepancies that may be negatively impacting financial accounts. Correcting these issues involves careful monitoring of fluctuations in salary costs, as well as an understanding of interim short-term deficits and whether any future budget amendments are necessary. It is also important to recognize the critical balance of a project’s assignment of administrative personnel versus clinicians, which can intrinsically create communication barriers and logistical difficulties. The identification of deficiencies along this workflow can only be obtained by implementing a strategic management approach that highlights the relationship between clinical practices/procedures and their financial counterpart. This session will identify common financial issues that occur during the life cycle of a clinical trial, and propose strategies to mitigate these issues in both the pre-award budgeting and negotiation phase, as well as the post-award project management phase. It will also provide tools necessary for the analysis of this data and discuss the application of this methodology across differing structural department arrangements. 

Biography:

To date, over 800 lipophilic alkaloids representing more than 20 structural classes have been detected from the skin extracts of neotropical poison frogs. The 2,5-disubstituted decahydroquinolines are represented one of the major classes, and the structural diversity and pharmacological activity associated with this class of alkaloids have stimulated synthetic activity in numerous groups. We report here the first total synthesis of the decahydroquinoline type poison-frog alkaloid cis-211A along with ent-cis-195A. The synthesis began with known piperidine 16, which was converted to aminoester 2 in 3 steps. Michael-type conjugate addition reaction of 2 provided the adduct 3 in high yield as a single stereoisomer. The ester 3 was transformed into the keto-aldehyde 4, which was subjected to an intermolecular aldol-type cyclization to afford the cis-fused enone 5 as a single isomer. The conjugate addition reaction of 5 followed by treatment of the resulting enolate with Comins’ reagent gave rise to the common and key intermediate of enol triflates 6. Synthesis of ent-cis-195A was achieved from 6 in 2 steps, and the first total synthesis of cis-211A was also completed from 6 in 5 steps as shown in Scheme1. Details of the synthetic process synthesis and their evaluation of the nicotinic acetylcholine receptors and inhibitory effect on [3H] nicotine uptake by TR-BBB13 cells of both synthetic alkaloids will be reported. 

Abstract:

Naoki Toyooka has done B. S. in Pharmaceutical Sciences from Kinki University, March 1984. He completed his Ph. D. in Pharmaceutical Sciences from Kinki University, March 1989. He earned his Postdoctoral Research in department of chemistry from North Carolina State University with Professor Daniel L. Comins, 1997. From April 1989-March 2001 he worked as Research Associate, Toyama Medical & Pharmaceutical University. From April 2001-March 2006, he served as an Associate Professor, Toyama Medical & Pharmaceutical University. From April 2006-March 2010, he joined as an Associate Professor, University of Toyama. Currently, he is the Full Professor in University of Toyama since April 2010. Also, he is the Dean of Graduate School of Innovative Life Science, University of Toyama since April 2017.

Biography:

Bijoy K Kuanr received the PhD degree in "Microwave materials & Devices" in Electronic in 1993. He has more than 20 years of research experience in India as well as in various laboratories in Germany and USA. From 1994-96, he joined the Microwave Laboratory of Professor Dr. Guther Nimtz at University of Koeln, Germany as a Post-Doctoral Researcher. From 1999-2001 he worked with Professor Dr. Peter Grünberg - (Nobel Laureate - Physics 2007) as a guest scientist in GMR-Sensor project. In 2002 he joined University of Colorado at Colorado Springs as a senior Researcher till 2013. His main research deals with electromagnetic theory and measurement techniques applied to materials, devices, and circuits at microwave, millimeter-wave.

Abstract:

Cancer is one of the biggest curse on humanity, causes almost 8.2 million deaths annually. In past decades, many conventional therapies including radiation and chemotherapy have been employed for the treatment of cancer. However, conventional chemotherapy and radiotherapy methods for cancer treatment are associated with the severe side effect. In comparison to the traditional method, Magnetic Hyperthermia (MHT) is a promising non-invasive way to cure cancer. The localized magnetic materials (act as heating source) into the tumor tissue produce heat by oscillating their magnetic moments, thereby efficiently destroying tumor cells without much damage to surrounding healthy cells. Cancer cells are typically more susceptible to mild heat than the healthy cells because of compactly disorganized blood vessels that reduce blood flow in a tumor which limits the heat dissipation to the surrounding area. Magnetic nanoparticle have been widely used in biomedical applications such as targeted drug delivery, hyperthermia treatment of cancer and magnetic resonance imaging contrast enhancement, based on their inherent magnetic property, high Specific Absorption Rate (SAR) and low cytotoxicity profile. In this work for cancer treatment using MHT, we have used surface modified iron oxide nanoparticles (Fe3O4) and Fe3O4 decorated graphene oxide. We demonstrated the high colloidal stability and high heating efficiency of surface modified iron oxide nanoparticles (Fe3O4) and Fe3O4 decorated graphene oxide. We also performed an in-vitro hyperthermia experiment in the range of 41 to 43⁰C for three different time interval to treat cancer cells. Our results revealed maximum cancer cell death occur at 43⁰C for 60 min of hyperthermia treatment. 

Ebtisam A Aldaais

Imam Abdulrahamn Bin Faisal University, Saudi Arabia

Title: The power of theory in developing the design of targeted nanoparticles
Biography:

Ebtisam Aldaais is one of the first Saudi women that have a PhD in Biomedical Engineering. She earned her PhD degree in 2016 from the University of South Carolina. In 2012, she got her Master’s degree in Physics. She has more than 18 years of experience in teaching, developing material courses, research, performing quality assurance for LINAC machines, and modeling polymeric biomaterials and drug delivery systems. She works as an assistant professor at the biomedical engineering department at Imam Abdulrahman Bin Faisal University, as well as a visiting assistant professor at the department of physics & astronomy at University of South Carolina.  

Abstract:

In nano-medicine, designing therapeutic nanoparticles has undergone an enormous development in the last few decades. These therapeutic designs focus on developing several features to illuminate inflammations, protect the drug, and enhance the targeted delivery. While the choice of materials affects the efficiency of the design, pondering the intermolecular interactions in a system that is composed of a nanoparticle and cell at a biological environment is vital to stabilize the design and improve targeting. Such a system is usually subject to steric, Van der Waals, and electrostatic interaction, and in the case of magnetic nanoparticles, to electromagnetic interactions. Thus, developing a theory that can predict and/or interpret the nanoparticle behavior at altered biological and design parameters is sufficient. The biological parameters include temperature, salt concentration, pH, and an external electromagnetic field, while the choice of polymers, their functional groups, and density are considered as design parameters. The theory defines the molecular reorganization that can form microgel or micelle, prevent drug leakage, extend mono or dual-ligands toward the targeted cell. Using the theory to stimulate the system and predict the molecular reorganization and correspondingly the nanoparticles behavior should illuminate material and time loss. Then, combining the theory with several experimental data can lead to a new machine learning technique to post the arena of designing smart therapeutic nanoparticles.

 

Biography:

Takuya Okada have completed master of Graduate School of Science and Engineering, University of Toyama in 2016. Then, he entered Graduate School of
Innovative Life Science, University of Toyama, and going to get PhD in 2019.

Abstract:

Neuropathic pain such as postherpetic neuralgia is a chronic pain characterized by severe spontaneous pain and allodynia. However, the mechanisms of such a pain are unclear. Previously, our research group has demonstrated that stimulation of PAC1 receptor elicits long-lasting mechanical allodynia in mice, suggesting the important roles of the PAC1 receptor and its ligand PACAP in chronic pain. Currently, there are no small-molecule antagonists for PAC1 receptor aimed at developing an oral drug. Recently, we have discovered a novel small-molecule antagonist of the PAC1 receptor (named PA-8) by in silico screening followed by in vitro/vivo pharmacological assays. On the basis of the structure of PA-8, we aimed at synthesizing novel compounds having more potent antagonistic activity. We synthesized over twenty derivatives and evaluated their antagonistic activities for the PAC1 receptor. Among them, two more potently derivatives (PA-810 and PA-81004) inhibited PACAP-induced phosphorylation of CREB in the PAC1 receptor-expressing CHO cells than PA-8. Intrathecal injection of both derivatives inhibited PACAP-induced nociceptive behavior and mechanical allodynia in mice. Further, the oral administration of these compounds inhibited nociceptive behavior in neuropathic pain model mice.

 

  • Clinical Research & Clinical Trials | Computer Aided Drug Designing | Drug Delivery Systems| Nanotechnology in Drug Delivery | Clinical Trial Forecasting, Budgeting and Contracting| Drug Discovery and Development| Patient-Centric Clinical Trials| Clinical Trial Site Selection and Management| Pharmaceutical Nanotechnology |Drug Delivery Technology
Location: Chicago, IL, USA
Speaker

Chair

Arwyn T Jones

Cardiff University, UK

Speaker

Co-Chair

Tatsuya Takagi

Osaka University, Japan

Biography:

Mohammad Tauseef is an Assistant Professor of Pharmaceutical Sciences at Chicago State University College of Pharmacy, Chicago IL. He completed his postdoctoral training from Department of Pharmacology, the University of Illinois at Chicago IL. He performs his biomedical research to investigate the role of calcium signaling in the regulation of vascular endothelial hyperpermeability and inflammation. He regularly presents his research findings in various national and international scientific meetings such as Federations of America Society of Experimental Biology (FASEB), American Heart Association (AHA), etc. He is the recipient of several awards for his research presentations including Research Recognition Award from American Physiological Society (APS), Young Investigator Award by American Society for Pharmacology and Experimental Therapeutics (ASPET). He is an active member of the American Association of College of Pharmacy (AACP) and American Association of Pharmacology and Experimental Therapeutics. He has published his research work in the top tier, peer-reviewed international journals, such as Circulation Research, Journal of Experimental Medicine, The FASEB Journal.

Abstract:

Despite the great strides have been made in treating hyperglycemia-induced vascular endothelial barrier dysfunction, current treatments have shown limited success in reversing vascular pathologies. During inflammatory conditions, such as diabetes mellitus, endothelial cell-cell junctions start to disrupt because of the internalization of the junctional proteins, such as Vascular Endothelial (VE) cadherin. This leads to the formation of minute inter-endothelial gaps, and the infiltration of protein-rich fluid and immune cells in the interstitial space. If remaining unchecked, the persistent buildup of edema underlying the endothelial lining sets the stage for the serious life-threatening complications. Wound healing impairment is also increasingly recognized to be a consequence of hyperglycemia-induced dysfunction of endothelium in type 2 diabetes mellitus (T2DM). Metformin, an oral antihyperglycemic agent, is the first line drug in the clinic for patients with T2DM. We hypothesized that the metformin prevents high glucose-induced endothelial barrier dysfunction and accelerates the wound healing process in human coronary endothelial cells (HCAE) via preventing the destabilization of junctional protein, VE-cadherin. Endothelial permeability and wound healing process were evaluated by using state of the art Electric Cell-Substrate Impedance Sensing (ECIS) mechanism. Our data show that high glucose concentration increased endothelial permeability and abrogated the wound healing process. Metformin significantly prevented the alteration of endothelial barrier function and enhances the wound healing process. Metformin also prevented Myosin Light Chain Kinase (MYLK) phosphorylation and increased in VE-cadherin expression in presence of high glucose concentration in HCAE. In conclusion, metformin is emerging as a potential therapeutic treatment for improving endothelial barrier function to prevent and treat coronary artery disease in diabetes mellitus.

 

Rama Mishra

Northern Western University, USA

Title: Drug discovery research in academia
Biography:

Rama K Mishra has been working for more than two decades in drug discovery and the molecular pharmacology of novel therapeutics at the pre-clinical levels. He has worked in different industries and academia, applying his expertise in computer-assisted drug design with an emphasis in screening and designing of small molecule ligands for various disease targets. He has established a novel in silico drug discovery platform at Northwestern University. He is an inventor of 7 published US patents and 14 filed patent applications. He has more than 70 peer-reviewed publications in reputed journals..

Abstract:

The most challenging issues facing the biopharmaceutical industry are the expiration of profitable drug patents, overreliance on blockbuster-type products, low numbers of new drugs being approved each year, and the increased costs associated with developing new drugs. At the same time, unprecedented advances in genomics, proteomics, molecular biology, and informatics have provided tremendous insights into the biological underpinnings of many diseases. The result is that there are increasing numbers of new drug targets against which to develop new therapeutics. However, given the rapidly increasing costs associated with developing new drugs, the drug discovery scientists have decreasing resources available to carry out the work. Unfortunately, the way in which new drugs are discovered is still carried out largely the same way it has been for the last 20-30 years. This process typically involves screening many thousands or millions of compounds in a high-throughput screen (HTS) to discover “hit” compounds for different disease targets. The HTS requires screening millions of compounds and the maintenance of vast compound libraries in facilities dedicated to their storage and use. These efforts are enormously resource and infrastructure-intensive and necessitate a large research overhead. Hit compounds found in this manner typically require substantial investments of time and money to optimize using medicinal chemistry to achieve a necessary level of potency, selectivity, and other properties consistent with an effective therapeutic. The main challenge in this field is developing drug candidates quickly, efficiently, and cost-effectively so that new drug targets can be validated and increased value can be realized. At Northwestern’s Center for Molecular Innovation and Drug Discovery (CMIDD), we have developed a novel strategy based on computational methodologies that efficiently identifies unique bioactive compounds possessing excellent drug-like characteristics without the burdens associated with large screening campaigns. This approach leverages recent advances in computational chemistry with unique methods to evaluate potential bioactive compounds using in silico tools. We have successfully used the novel in silico approach to discover new bioactive molecules for over few dozens of potential new drug targets. This strategy has the potential to shift the current drug discovery paradigm away from traditional in vitro HTS to the in silico approach CMIDD is pioneering. Furthermore, it will greatly accelerate the drug discovery process and increase the efficiency with which new drugs are developed. This is particularly important in an academic environment such as Northwestern University because this new strategy requires far less infrastructure and is much less costly than traditional HTS.

 

Biography:

Dr. hab. eng. MirosÅ‚aw Kwiatkowski in 2004 obtained PhD degree from the Faculty of Energy and Fuels at the AGH University of Science and Technology in Kraków (Poland), and in 2018 D.Sc. degree from the Faculty of Chemistry at the WrocÅ‚aw University of Technology (Poland) in the discipline: chemical technology. In addition, he obtained a certificate of completion of postgraduate studies: Professional Research and Development Project Manager at the Krakow University of Agriculture (Poland), Research and Development Project Manager at the University of Economics and Innovation in Lublin (Poland), and Electrical Energy Markets from the Faculty of Electrical Engineering, Automatics, Computer Science and Biomedical Engineering at the AGH University of Science and Technology in Krakow (Poland). His published work includes more than 45 papers in reputable international journals and 80 conference proceedings. He is the editor in chief of The International Journal of System Modeling and Simulation (United Arab Emirates), an associate editor of Micro & Nano Letters Journal (United Kingdom) and a member of the many editorial board of international journals as well as a member of the organizing and scientific committees international conferences in Europe, Asia and United States of America.

Abstract:

The optimal selection of the methods and conditions for the production of adsorbents and catalysts requires the reliable and accurate description of the parameters of the heterogeneous surfaces and physicochemical processes occurring on them. Many theories of the adsorption processes were developed in the past century, which assume different mechanisms of physicochemical processes and various simplifications. This work presents the results of the application of new mathematical models with the unique numerical fast multivariate numerical identification procedure as the universal tool for analyzing the heterogeneous surfaces. The proposed method yield a broader range of reliable information on the surface structure of the analyzed material, which is particularly useful for the assessment of the impact of production process conditions and modifications on the development of both geometrical and energetic properties of the surface of heterogeneous catalysts.

 

Biography:

Disruption of the regulation of normal tumor suppressor genes and activation of oncogenes lead to abnormal growth i.e., development of cancer. Platinum complexes represent one of the most successful families of clinically used metal-based anticancer drugs; other transition metal complexes such as ruthenium complexes generate interest as antitumor agents. Ruthenium complexes have shown great potential and remain the subject of extensive drug discovery efforts. Transition metals can provide several interesting complex structures capable of apoptosis & forms an interesting area of research. The present work focuses on a series of mononuclear ruthenium (ii) polypyridyl complexes with n, n-donor ligands (then = 1, 10 phenanthroline, bpy = 2, 2’ bipyridine, dmb = 4, 4’-dimethyl 2, 2’ bipyridine and an intercalating ligands (bnpip= 2-(4-butoxy- 3-nitrophenyl)-1h-imidazo [4, 5-f][1, 10] phenanthroline, synthesized and characterized. The binding abilities of ruthenium complexes were investigated using UV-visible and fluorescence studies. The mode of binding was confirmed by viscosity experiment. Experimental results suggested that they can bind through intercalative mode with DNA having different binding constant. The in vitro assays were used to determine the cytotoxicity and apoptotic activities of the complexes. The significant in vitro activity observed for these complexes show promising findings for future in vivo cytotoxicity and anti-proliferative evaluation. 

Abstract:

Navaneetha Nambigari, assistant professor, department of chemistry, University College of science, saifabad, Osmania University, Hyderabad. She has done PhD in bio-inorganic chemistry and post-doctoral work in computational chemistry. Her core research areas are spectroscopic investigations of metal complexes and their applications (bioinorganic chemistry) and in silico drug designing techniques, based on targeted approaches. Drug designing with special reference for identifying new leads against cancer and rheumatoid arthritis. She has several awards to her credit “best presentation award” at drug design 2017, jnu convention center, New Delhi, India, and April 2017 and at recent advances in applied nano materials, Osmania University, Hyderabad (2016). “Young faculty award” by venus international foundation, Chennai. (2015) and “young chemist award”, by royal society of chemistry, London, UK at 42nd iupac conference, “chemistry solutions”, Glasgow, UK (2009). She has 13 years of teaching and 16 years of research experience with 5 graduate students and 6 phd scholars working for their thesis dissertation.  

Biography:

Sajid Ali was born in Pakistan. He has completed Pharm D and M Phil from Pakistan. He completed his Master’s thesis on the enhancement of drug permeation through the transdermal drug delivery system. He also worked with Nano and microparticles loaded transdermal patches. As a teacher, he taught Pharmaceutical technology to Pharm D students for 4 years. He got an HEC/DAAD scholarship to pursue his PhD in Germany. He is currently working as a PhD at the Department of Pharmaceutical Technology and Biopharmaceutics, Marburg, Germany. His areas of interest are the formulation of Nanocarrier based polymeric and liposomal systems targeting cancer therapy, cell culture studies and Atomic force microscopy. Currently, he is working on a combination of Nanocarrier systems (lipid coated polymeric systems) for synergistic photodynamic-chemotherapy and antibacterial therapy.

Abstract:

Background: Photodynamic Therapy (PDT) is a clinically approved therapeutic modality for the treatment of various diseases including cancers. It predominantly utilizes biocompatible photosensitizer and light energy of optimal wavelength to initiate photochemical reactions, triggering the photosensitizer, converting tissue oxygen (O2) to highly reactive oxygen species (ROS). This ROS induces oxidative damage to bio-organic molecules including proteins, nucleic acids, carbohydrates, and lipids consequently leading to the destruction and of targeted cancer cells. The present study aims to develop a novel nanocarrier for the photodynamic treatment of cancer.

Methodology: Liposomes containing mTHPC (Meta-tetra (hydroxyphenyl) chlorin) were prepared by the thin film hydration method using different lipid combinations. These liposomes were subsequently extruded with Avanti Polar extruder using polycarbonate membranes above the phase transition temperature of lipids. These extruded liposomes were characterized for size distribution, polydispersity index, zeta potential, encapsulation efficiency and morphological studies using dynamic light scattering, laser doppler velocimetry, ultracentrifugation, and atomic force microscopy. These liposomes were further evaluated with cell culture studies utilizing HT-29 cell line including in vitro cytotoxicity, photodynamic & antibacterial therapy, intracellular localization with CLSM, haemocompatibility assay and in vivo CAM model.

Results: All liposomal formulations ranged from 99 nm to 125nm in size with the PDI less than 0.2 and surface charge from -18 to +15mV. Photodynamic studies showed a dose-dependent effect with no cytotoxicity in dark. mTHPC was mainly localized in the perinuclear region with no internalization in the nucleus. In vivo CAM model displayed a strong occlusion of blood vessels while haemocompatibility studies demonstrated no toxicity to the blood cells.

Conclusion: Present study concludes that mTHPC liposomes can be formulated with different lipid combinations. These systems are not only biocompatible and less toxic but also effective against different cancer and bacterial infections. 

Sedegheh Malek Mohammadi

Orthotics and Prosthetics Research Clinic, Iran

Title: Tribology in phantom pain in upper limb amputees
Biography:

I am a faculty of orthotics and prosthetics. My experience in the area of research, teaching in University, clinical experiments and measuring is more than 20 years. I have done research in the area of plantar fascia qualities and its connection with the ankle and foot structure and function in living individual. (My PhD) I have experience of working with Ultrasound machine. I have presented my papers internationally since 2004. Some of my papers have been published, also. I have written five books in the area of orthotics and prosthetics in Persian. I have been chief guest editor in the American Journal of Medical Sciences and Medicine (Special Issue) up to March 01; 2015 and guest editor in the American Journal of Sports Science and Medicine (Special Issue) up to April 10, 2018.

Abstract:

The purpose of this research is to study phantom pain feeling in upper limb amputees using the prosthesis. It is believed recent prostheses can be substituted for the lost function. 44 subjects were studied. All of them were men and acquired amputees. The youngest was 8 and the eldest was 50 years old. 11 subjects were the bilateral amputee and 33subjects were the unilateral amputee. Data was collected via the PEQ standard questionnaire. An analysis was done by Spss software. The statistical method was linear regression model. In descriptive statistics table, minimum, maximum, mean and standard deviation of quantitative questions were studied one by one. To study the relation between phantom pain and other variables, the regression model was used. To omit colinearity among independent variables, a stepwise model was used. (R2 =66.4) It was found there was a direct relation between a)feeling pain in shoulder area and phantom pain (p-value=0.014), b) stump perspiration and phantom pain (p-value= 0.00), c) easy donning /doffing of the prosthesis and phantom pain (p-value=0.007), d) comfortable using of the prosthesis in sitting position and phantom pain (p-value=0.00). There was reverse relation between e) using prosthesis to don / doff clothes and phantom pain (p-value=0.00), f) stump contact with the inner wall of the socket and phantom pain (p-value= 0.00) Appropriately, 1) weight reduction of the prosthesis is required, 2) prosthesis can be more beneficial for amputees with long stump 3) humidity affects the efficiency of the electrodes, 4) suspension system has to support the function of the prosthesis, 5) prosthesis should not be exposed to the external waves, 6) adequate pulse of the amputated muscle should be received with the electrodes. 

Biography:

Rubina Fatima was graduated in Bachelors of Pharmacy (B Pham) from MRM Collage of Pharmacy in 2012 and during her studies she got an opportunity from her institute to work as a “Trainee” in Quality control at Dr Reddy Laboratory. During her bachelor's she have successfully worked on project “Formulation and evaluation of mouth are dissolving tablet donepezil with superdisingredents” After her first achievement, she received her Pharmacy license from Pharmacy council of India (PCI). Later she moves forward in her career to pursue her Master in Pharmacy with a major in Pharmaceutics and successfully completed the same with a distinction in 2015. She is an Assistant Professor in MRM Collage of Pharmacy affiliated to JNTUH. She is an active researcher, a teacher of pharmaceutical and Alliance healthcare professional member.

Abstract:

In the present work, mouth dissolving tablet of donepezil was designed with a view to enhancing patient compliance, by direct compression. In this method, crospovidone and croscarmellose were used in combination as super disintegrants. The different formulations of tablets were evaluated for hardness, friability, drug content uniformity, wetting time, water absorption ratio, in vitro dispersion time. Out of all the formulations the drug with combination 4% of the super disintegrants found to be high dissolving tablet than other formulations. These formulations were tested for in vitro drug release pattern (pH 6.8 phosphate buffer). Among these formulations, only one show an excellent result with a free drug release, this is prepared by direct compression method. The stability studies prove that there are no greater significant changes in drug content and in vitro dispersion time. The results show that donepezil is a safe and effective with the combination of super disintegrants in the treatment of Alzheimer's disease. 

Biography:

Ochieng O Anthony studied pure and applied chemistry, a PhD scholar, the senior chemistry lecturer at Faculty of Science, Sumait University in Tanzania. He is also a co-author of determination of acidic pharmaceutical components in an analgesic drug. His research focuses on natural products and evaluating their medicinal values, pharmaceutics, cosmetology, education chemistry, macrocyclic compounds and their applications in drug design and using statistical thermodynamics in evaluating acidic constants. He is a member of Kenya Chemical Society, American Chemical Society, Royal Society of Chemistry &GNDU Chemical Society. He has 7 years working in pharmaceutical and cosmetic industrial sectors, 3 publications in reputable journals and 15 years lecturing chemistry in higher institutions of learning.

Abstract:

Malaria is one of the most important infectious diseases worldwide where in Africa the disease is mostly endemic. The choices for the treatment are highly limited, and prolonged with minimum dose goes for 10- 14days. Over forty different medicinal plant species from East Africa regions are commonly used by the local traditional healers for the treatment of malaria. Among them, the stem barks and soft roots from Azadirachta indica, Cissampelos mucronata, Zanthoxylum chalybeum, Entandrophragma congolense, Picralima nitida, Toddalia esiratica, Tamarindus indica, Maytenus senegalensis, and Dodonaea angustifolia are commonly used traditionally for antimalaria. A total of nine aqueous crude plants extracts from the said traditional medicine were evaluated for their in vivo antimalarial activity using Plasmodium berghei infected swiss mice and for their acute toxicity using brine shrimp lethality test and the locally available chloroquine was used as an anti-malaria drug. The plants extract had a LC50> 750μg/ml thus non-toxic.The aqueous extract significantly reduced parasitemia by an average of 35.4% at a dose of 200 mg/kg incomparable to chloroquine after 48 hours as a monotherapy showing the significant difference from that of chloroquine(P≤0.07). This suggests synergism of phytoconstituents and efficacy of crude extracts against specific drug chloroquine in suppressing the parasitemia thus ascertaining the ethnopharmacological claims

  • Poster Presentation
Location: Chicago, IL, USA
Biography:

Chalachew Alemayehu is a PhD candidate in Medical Science in School of Medicine, University of Queensland, Australia. His PhD is on the role of N-of-1 Trials in the Clinical Care of Developing Countries. He is a primary care medical practitioner in Ethiopia. He has published more than 10 research papers and is a peer reviewer of International Journal for Equity in Health.

Abstract:

Due to lack of bioequivalence-data, additional assurance tests are needed to build trust in cheaper locally made drugs in Ethiopia. N-of-1 therapeutic equivalence trials can improve the quality of care provided to patients by improving healthcare providers practice in ways most beneficial to patients under the prevailing circumstances. By establishing bioequivalence information on local drugs, N-of-1 trials have the potential to promote patient-centred, quality use of medicine. The objective of this study is to assess whether it is acceptable to use N-of-1 tests to evaluate local-drugs in a resource-limited clinical practice setting. A descriptive qualitative study, using focus group discussions and key informant interviews, was conducted. Five key informant interviews (two senior regulatory authority members and 3 institutional review board members), as well as 4 focus group discussions (2 with physicians and 2 with patients), were held. The interviews were audiotaped and transcribed verbatim. Data were analyzed using an inductive, thematic process. Five major themes were identified in this study; (1) Opinions about using N-of-1 tests to test the therapeutic equivalence of local drugs, (2) N-of-1 therapeutic equivalence tests: clinical care vs research, (3) Ethical and regulatory requirements, (4) Barriers to imp mention the study and (5) Possible solutions to address challenges. Overall, this qualitative study showed that N-of-1 tests are acceptable as a strategy to assess therapeutic interchangeability of local generics in Ethiopia. However, key informants of the regulatory authority didn’t support additional tests on local drugs. Regarding ethical requirements, while the IRB members believed that IRB approval sufficed to conduct N-of-1 tests, the regulatory members reported that N-of-1 tests require approval at the regulatory level. Not only access but quality should be a top priority in health and this requires the development of policies and regulations on evidence-based, patient-centered clinical care. 

Chih-Hung Wang

Tri-Service General Hospital, National Defense Medical Center, Taiwan

Title: Enhanced inner ear drug delivery assisted by ultrasound-aided microbubbles
Biography:

Chih-Hung Wang is a professor of Otolaryngology-Head and Neck Surgery at the National Defense Medical Center, Taipei, Taiwan. He received his MD and PhD degrees from the National Defense Medical Center. After completing his doctoral degree, he completed a postdoctoral course with Prof Yehoash Raphael at Kresge Hearing Research Institute and a visiting fellowship course with Dr Steven A Telian at the Department of Otolaryngology-Head and Neck Surgery, University of Michigan, in 2003–2004. His main research interest is in otology, focusing on developing strategies for inner ear protection and repair, including stem cell and gene therapy topics. He has also previously served as the director of the Department of Otolaryngology-Head and Neck Surgery, Tri-Service General Hospital, Taipei, Taiwan. He was promoted to major general on 1st July 2016 and served as the director of Medical Affairs Division, Army Logistics Command, and ROCA...

Abstract:

Sensorineural Hearing Loss (SNHL) can result from multiple causes, including aging, infection, noise exposure, ototoxic drugs, and immune-mediated inflammation. Clinical therapeutic strategies for SNHL may involve pharmaceutical medications, acoustic sound amplification, or implantable surgical devices. Pharmaceutical approaches are always considered as the first choice in treating hearing disorders, and most of them are prescribed as systemic delivery. However, the systemic medication route has limitations because the blood–cochlea barrier can limit inner ear drug absorption or penetration and because undesirable systemic side effects are possible. One alternative to the systemic route is delivered via the Round Window Membrane (RWM), which, because of its exposure to the middle ear, can serve as a viable route for delivery of therapeutic medications to the inner ear via middle ear applications. Intratympanic injection therapies are now widely applied for the treatment of several hearing disorders; however, the therapeutic responses vary for ambiguous reasons. We have targeted the practical application of Ultrasound Microbubbles (US-MBs) to increase the RWM permeability, thereby facilitating medication delivery to the inner ear. Using guinea pigs as animal models, we showed that US-MB exposure can provide a 38-fold improvement of the inner ear absorption of biotin–FITC applied through the RWM when compared to spontaneous absorption. Cochlear hair cell uptake of gentamicin was also significantly enhanced using US-MBs. We also confirmed an increased permeability of the RWM in response to the acoustic cavitation effects of MBs by showing the passage of the tracer through the three-layered structure of the RWM. The US-MB approach did not damage the integrity of the RWM or cause any deterioration of the hearing thresholds, indicating a good safety margin. Our recent work now focuses on facilitating inner ear gene delivery using US-MBs. We believe that US-MB-mediated techniques have great potential for use in delivery of therapeutic medication or genes to the inner ear in future clinical applications.

 

Biography:

Sid Chowdhury has completed his Bachelors in Pharmacy at the age of 22 years from Mumbai University, Mumbai and Masters of Science (MS) from Northeastern University, College of Professional Studies, Boston, MA. He is the Study Start-Up lead for Alkermes, a premier pharmaceutical company based out of the Boston metro area. He has been managing Study Start-Up for global Phase III CNS studies for more than 3 years and has been serving as a Clinical Trial Manager, Global Clinical Services....

Abstract:

Starting a global multicenter phase III study in Schizophrenia is challenging for many reasons. Understanding the patient population, regulatory landscape, access to clinics/physicians, study drug import/export permit and legal requirements are key during the planning phase of a global study. Selecting clinical trial sites are often a cumbersome process and traditional ways of conducting site feasibility are neither user friendly nor time sensitive. In such situations, it is very important to be creative on finding ways to collect the same information in a time and cost effective manner while ensuring the quality is not compromised. We at Alkermes came up with creative methods of conducting site feasibility and selection which in return reduced our site selection timeline during conferences and investigator meetings. Negotiating clinical trial agreements and budgets could easily take months to finalize. Using tools such as smart budgets, grant plan parameters for fair market value have allowed Alkermes to expedite the budget negotiation process. Similarly, liaising directly with clinical trial sites that are huge academic institutions have reduced contract negotiation timelines. Revising requirement for site essential documents and using online cloud based portals for document collection, tracking and tracking has improved site selection and start up. Use of technology such as remote study drug adherence or electronic-consents will reduce time lost and maintain. This presentation will showcase individual case studies of Study Start Up challenges and ways to overcome them maintain quality, time and costs. 

Biography:

Dr. Yoriko Harigaya is a clinical pharmacologist at the Division of Bioequivalence, the Office of Generic Drug, FDA. After receiving her Doctor of Pharmacy from the University at Buffalo, School of Pharmacy, New York, she completed a drug development fellowship at Glaxo SmithKline. Prior to joining the Division of Bioequivalence, she also served at the Office of Clinical Pharmacology, the Office of Translational Sciences, FDA.

Abstract:

Product-Specific Guidances (PSGs) for generic drugs recommend evaluation of Aqueous Humor (AH) Pharmacokinetics (PK) with or without in vitro studies of Physicochemical Properties (PCP) for biowaivers to establish bioequivalence for OCS. However, the relationships among PCP, AH PK, and patient demographics are not well understood. The objective of this research is to provide an overview of the in vivo human AH studies submitted to the FDA for OCS and to investigate the impact of patient demographics on the human AH PK. We summarized demographic data, PCP, PK parameters, sampling time points, and sample size per time point to investigate correlations in the studies submitted to the FDA. In the evaluation of patient-specific covariates, the Area Under The Concentration-time curves (AUC) and maximum concentrations (Cmax) were significantly different among ethnicities and age groups, which suggests that the ocular anatomical and physiological differences in various ethnicities and ages of the study population play an important role in the AH PK profiles of OCS. Gender was not primarily associated with differences in AH PK. Considering patient-specific covariate effects in designing bioequivalence studies with AH PK endpoints could reduce bias from covariate imbalance and help identify true effects of formulation differences

Biography:

Luke S Fisher brings twenty years of experience in scientific informatics solutions. Managing Pre-Sales, Post-Sales and working in Account Management has expanded my domain knowledge of scientific informatics and provided me the ability to maintain a successful track record. He have covered a broad range of clients including the world’s leading pharmaceutical, biotech, agricultural, chemicals, academic and government labs. He have extensive experience in scientific software solutions from the smaller scale deployment of point solutions like molecular modeling packages to the larger enterprise scale of ELNs, scientific workflow technologies, data content, analysis and visualization. It also includes managing the support complexity of software integration strategies based on numerous mergers and acquisitions..

Abstract:

Bioassay protocols are conspicuously absent from the informatics of drug discovery: Current best practices have not progressed beyond using scientific English text, which is intractable to software. We will present our solution which draws from the rich semantic web vocabularies of the BioAssay Ontology, Drug Target Ontology, Gene Ontology, and others. On their own, these ontologies are not friendly to experimental scientists, and so we have created the Common Assay Template, which turns the massive hierarchies of the underlying ontologies into useful guidelines. This has been supplemented by machine learning infrastructure to help translate existing text into suggestions, with the help of natural language analysis. Using our new web-based interface, a small team of biologists was able to annotate 3500 MLPCN screening assays that were extracted from the PubChem database, which consumed approximately 3 weeks FTE. These semantically annotated protocols are fully machine-readable, which imparts many new capabilities, which apply at all scales. Searching can be done using precise specific terms, which is far more effective than keyword searching. In conjunction with electronic lab notebooks, the annotations serve as a facile way to classify and organize experiments and keep tabs on the activities of colleagues. These well-defined annotations can also serve as an alternative to long-winded text. Applied to a large scale, the machine readability of these annotations enables a diverse array of algorithms to be applied to assay databases, such as clustering and selection of groups of compatible assays for model building, or analysis of the protocol designs and their effects on structure-activity relationships. Large numbers of annotated assay protocols from open data such as PubChem and ChEMBL are available for novel analyses for big Pharma, biotechnology companies, academics, and consortia. We have explored a number of techniques for utilizing large quantities of data, including the development of searching interfaces, visualization modes, and methods for extracting related data and creating models. We have also studied specific trends within public screening data which we have eludicated with the help of our own curated content, and investigated some of the characteristics of specific projects, such as the NIH molecular libraries probes, which can be analyzed retrospectively given the much larger amount of information that is now available. 

Biography:

Luke S Fisher brings twenty years of experience in scientific informatics solutions. Managing Pre-Sales, Post-Sales and working in Account Management has expanded my domain knowledge of scientific informatics and provided me the ability to maintain a successful track record. He have covered a broad range of clients including the world’s leading pharmaceutical, biotech, agricultural, chemicals, academic and government labs. He have extensive experience in scientific software solutions from the smaller scale deployment of point solutions like molecular modeling packages to the larger enterprise scale of ELNs, scientific workflow technologies, data content, analysis and visualization. It also includes managing the support complexity of software integration strategies based on numerous mergers and acquisitions...

Abstract:

Currently, infectious diseases of the developing world (e.g., malaria, tuberculosis) represent a global health challenge of the 21st century and require new approaches that would allow scientists to do research more effectively. As a result of the development of web-database technologies (CDD Vault®), a collaborative approach to research on antibiotics and infectious diseases for global health has emerged. The major components of effective scientific-community based research include: (1) unifying goal or focus on common therapeutic areas/diseases; (2) multiple research areas/expertise; (3) uniform database platform for effective data accumulation and management; (4) easy access and sharing of information; (5) potential for unlimited growth. The Collaborative Drug Discovery (CDD) Vault® was built by utilizing innovative web technologies in order to provide a platform that allows scientists to archive, mine, and securely share research data with a focus on global collaborative R&D. This new collaborative technology allows researchers to build up networks of technical experts around therapeutic or target areas thus advancing research facilitating the discovery of new drug candidates. It also allows scientists to speed up research by sharing unpublished data providing new hope in the race to overcome drug resistance. An example illustrating how potential chemosensitizers that address chloroquine resistance could be identified by using the CDD Vault® database platform is presented. 

Biography:

Amal Abdulrahman has completed her Bachelor's Degree from King Khalid University in Saudi Arabia, and Master degree from Clark Atlanta in the USA. She has worked as a teaching assistant at King Khalid University, Clark Atlanta University, and Spelman College. Currently, she is pursuing her PhD degree with guidelines of her advisor: Dr. Ishrat Khan. She was invited to write a review paper on drug delivery using host-guest interactions through cyclodextrins

Abstract:

In literature, there is a disagreement regarding whether or not β-CD forms inclusion complexes with Polyethylene Glycol (PEG). In a publication in 1993 Harada et al. reported the complexation between CDs with several polymers including PEG. They reported PEG forms inclusion complexes with α-CD and γ-CD; however, it does not form such complexes with the β-CD. Researchers still agree and cite this article to continue the classification of PEG as being impenetrable within the β-CD cavity. However, there is one communication in 2000 reported the formation of the crystalline complex between PEG and β-CD demonstrating this via a single crystal preparation. However, this work did not report the used molecular weights of PEG/PEO. Furthermore, most PEGs/PEOs have a distribution of molecular weight suggesting that preparing a single crystal for a mixture of molecular weights would be difficult. One plausible explanation for β-CD/PEG single crystal formation is the complexation method. As a next step to our report on the inclusion complexes of β-CD with β-sitosterol, we prepared β-CD crystalline inclusion complexes with different molecular weights of PEG. The suggestion of the formation of β-CD/PEG inclusion complexes was supported by NMR, FTIR, X-Ray diffraction, and SEM. The study clearly demonstrated the formation of crystalline inclusion complexes in the solid state, and via 2-D NMR spectroscopy, in the solution state, that the methylene protons of the PEG repeat units interact with both the internal and external protons of the β-CDs. The examination of drugs solubility in water is as an example of our future work. 

  • Clinical Trial Forecasting, Budgeting and Contracting | Novel Drug Delivery Systems| Drug Delivery Technology | Pharmaceutical Nanotechnology
Location: Chicago, IL, USA
Speaker

Chair

Prakash V Diwan

National Institute of Pharmaceutical Education and Research, India

Session Introduction

Rubina Fatima

MRM College of Pharmacy, India

Title: Advance microneedles integrated transdermal patch for fast onset of Ivermectin
Biography:

Rubina Fatima was graduated in Bachelors of Pharmacy (B Pham) from MRM Collage of Pharmacy in 2012 and during her studies she got an opportunity from her institute to work as a “Trainee” in Quality control at Dr Reddy Laboratory. During her bachelor's she have successfully worked on project “Formulation and evaluation of mouth are dissolving tablet donepezil with superdisingredents” After her first achievement, she received her Pharmacy license from Pharmacy council of India (PCI). Later she moves forward in her career to pursue her Master in Pharmacy with a major in Pharmaceutics and successfully completed the same with a distinction in 2015. She is an Assistant Professor in MRM Collage of Pharmacy affiliated to JNTUH. She is an active researcher, a teacher of pharmaceutical and Alliance healthcare professional member

Abstract:

The purpose of the study is to prepare an advanced transdermal delivery system contribution to medical practice; it has yet to fully achieve its potential as an alternative to oral, delivery and hypodermic injections. The importance of a transdermal delivery patch essentially provides rapid action with advance microneedles using photolithography based process, in which microneedles create micrometer-sized channels in the skin to deliver Ivermectin rapidly. While the reservoir patch holding the bulk of drug enables the higher drug loading and carries on to release the drug for a prolonged period. There are no significant changes in the physicochemical evaluation, in vitro drug release was studied by flow through diffusion cell with microneedles, horizontal type skin permeation, and skin irritation was performed in hairless albino rats. The formulation with Polyvinylpyrrolidone (PVP) shows a desirable result with fast release of Ivermectin. The results show that Ivermectin is safe and effective with advance microneedles integrated transdermal patch in the treatment of rosacea with few side-effects and good compliance with long-term efficacy

Biography:

Muhammad Umair Amin is Pharmacist by profession and has done his Master in Pharmaceutics. Currently he is doing PhD under DAAD/HEC Pakistan Scholarship program, in the supervision of Prof Dr Udo Bakowsky at Department of Pharmaceutics and Biopharmaceutics, Philipps University Marburg, Marburg, Germany. The major area of interest is development of drug carrier systems and characterization. Primary research goals are directed toward the fabrication of mesoporous inorganic drug delivery system and targeting of mesoporous nanoparticles loaded with anti-cancer drugs to resistant hypoxic tumor cells. Development of combine dosage form of Enzyme inhibitors and chemotherapeutic agent based mesoporous silica nanoparticles as a dosage form for better drug uptake, decreased tumor invasiveness and increased cytotoxic effects. He has an experience in research, teaching and administration in education institutions.

Abstract:

Delivery of chemotherapeutics, in higher doses to specific sites of action without side effects, is a big challenge. Recent developments in the field of nanotechnology, including the use of inorganic materials, have opened up new dimensions. Mesoporous silica nanoparticles as drug carrier address many problems related to chemotherapeutic targeting and delivery. Larger surface area and higher drug loading capacity, mechanical strength and stability, entrapping both hydrophilic and hydrophobic drugs, tailorable pore size and pore volume, inner and outer surface for modification and drug attachment, controlled particle size and distribution, lipid coating and gene delivery, make them a suitable candidate as a drug carrier. Hexagonal micelles of surfactants (CTAB: Cetyltrimethylammonium bromide) interact with silica source (TEOS: Tetraethylorthosilicate) to form a firm silica structure. Then removal of micelles leaves behind mesoporous silica nanoparticles. Mesoporous silica nanoparticle fabrication is based on hydrolysis and condensation reaction in a basic environment and a specific surfactant/silica molar mass ratio is crucial for the preparation of particles. Surfactant removal was confirmed by elemental analysis and the porous structure was confirmed by TEM images. Pore size was in the range of 2-3nm. Our studies have shown the high entrapment of doxorubicin in particles due to the availability of porous structure. Lipid coating of drug-loaded particles not only protects the drug from premature release in circulation but also due to the compatibility of a lipid bilayer with the cellular membrane, lipid-coated mesoporous silica nanoparticles enhance the cellular uptake of doxorubicin. In our studies, the lipid-coated silica nanoparticles have shown higher cellular toxicity as compared to non-lipid coated particles. Drug release profile and increase in cytotoxicity with time, support the hypothesis of sustained release of drug from lipid coated mesoporous silica nanoparticles

Biography:

Jalpa Suthar did her B.Pharm and M.Pharm from A R College of Pharmacy and completed Ph D in 2015 in Clinical Pharmacy from Charotar University of Science And Technology (CHARUSAT) Changa, Gujarat, INDIA. She is currently working as Assistant Professor, Department of Clinical Pharmacy & Pharmacology, Ramanbhai Patel College of Pharmacy, Charusat University.  

Abstract:

Several tools have been introduced to evaluate the quality of prescribing. Study aim was to determine the quality of prescribing in hypertension and bronchial asthma in primary, secondary and tertiary health care setting using the new Prescription Quality Index (PQI) tool and to assess the reliability of this tool. A prospective cross-sectional study was carried out at selected PHCs, SHCs and THC facility for chronic conditions Patients with hypertension and bronchial asthma, attending out-patient departments of each health care facility for at least 3 months were included. Complete medical history and prescriptions were noted. Total and criteria wise PQI scores were derived for each prescription and prescriptions were categorized as poor, medium and high quality. A total 356 patients was included. Mean age was 57.7±14.7years (range 4–87 years) with 36% patients above 65 years of age. Mean total PQI score was 28.9±8.1. Of 356 prescriptions, 138 (38.8%) prescriptions were of high quality with PQI score ≥34. Prescribing quality in terms of PQI score showed significant difference between PHC, SHC and THC (P<0.0001). The prescribing quality between PHCs and SHCs did not differ significantly (P>0.05). The value of Cronbach’s α for the entire 22 criteria of PQI was between 0.68 to 0.89. As evaluated by PQI tool, the quality of prescribing at THC was better as compared to SHCs & PHCs. PQI was found to be a reliable tool for assessment of prescribing quality in chronic diseases.

 

Biography:

Sid Chowdhury has completed his Bachelors in Pharmacy at the age of 22 years from Mumbai University, Mumbai and Masters of Science (MS) from Northeastern University, College of Professional Studies, Boston, MA. He is the Study Start-Up lead for Alkermes, a premier pharmaceutical company based out of the Boston metro area. He has been managing Study Start-Up for global Phase III CNS studies for more than 3 years and has been serving as a Clinical Trial Manager, Global Clinical Services.

Abstract:

What is Fair Market Value? Fair Market Value (FMV) means paying a legitimate and reasonable market price to conduct studies per “industry standards” to limit bias into clinical trials. A grant plan is a benchmarking tool to inform a FMV decision. Grant plan is a representation of average fair market value costs. As a pharmaceutical company, we must ensure that payments for our clinical studies should align with FMV for necessary services. Now there are many factors that affect the grant plan globally. A comparison on cost per patient between US and Ex-US sites show that it is more expensive to do clinical trials in the US. Likewise, a comparison between Western European and Eastern European countries reveal that it Western Europe is more expensive to do business. Geographic location, study indication, and design all attribute to a variation in the costs of doing business. How does a pharmaceutical sponsor company stay compliant with FMV? This presentation will explain grant plan parameters and smart budgets to negotiate clinical site budgets. A comparative case study(s) of Alkermes trials and the factors that impacts site budgets or cost of doing business will be discussed along with measures Alkermes took to stay compliant with FMV. 

Biography:

Saad Ikram graduated among the top ten in his class from Baqai Medical University Karachi Pakistan in 2012. He then moved to the United Kingdom to pursue a career in surgery where he is now working as a Trust Grade Core-surgical Trainee level doctor under Mr. SM Ahmad(Consultant Colo-rectal Surgeon). Still, in his early years since graduation, he has developed a passion for the surgical sciences and has multiple case reports, clinical audits, literature reviews and poster presentations to his name and is actively involved in retrograde studies at his institution at present. Now looking for opportunities for oral and poster presentations at an international level.

Abstract:

Colonic polyps have widely been resected using endoscopic techniques which remains one of the most commonly employed therapeutic colonoscopic procedure. Other procedures namely Endoscopic Mucosal Resection (EMR), snare polypectomies and laparoscopic or open colonic resections for the larger polyps are all well documented in the literature and are in common use. With traditional methods such as simple polypectomies and EMR, documented complication rates among the vast literature, remains low and varies between 0 to 3.3%, however such methods are not suitable for polyps with a broad base and can be dangerous with higher rates of complications reported for polyps >3cm in size and when located in the thin-walled caecum. Further such techniques always carry a risk of incomplete resection. Recently, however, combined laparoscopic and endoscopic techniques have emerged for polyps not suitable for resection by endoscopy alone, advocating shorter hospital stay and lower risk of complications when compared to segmental colonic resections which were traditionally the treatment of choice for such polyps and involved a major procedure with high risks of complications. The laparoscopy-assisted colonoscopic resection of polyps is seen time and time again in the literature which involves assistance from a laparoscope while the polyp is removed via a snare by the endoscopist. This technique, although largely documented to be safer and less invasive when compared to segmental resections, also employs removal of the polyp in piecemeal making histological analysis of clear margins difficult and an added risk of delayed perforation due to diathermy injury. We describe a similar but alternative method involving wedge resection using a linear laparoscopic stapler with colonoscopic assistance which can ensure complete excision under direct vision and achieve similar complications rates. Following strict indications, we feel that this technique provides an excellent, safe and definitive excision method for such polyps.

 

Biography:

Mouloud Kecha was awarded a PhD from the University of Setif, Algeria in 2007. He spent two years during his doctoral research in Reims University (France); Laboratory of Industrial Microbiology (LMI) before starting his position of Senior Lecturer and then Professor in the University A.MIRA of Bejaia, Algeria. He has published more than 23 papers in different journals and has been serving as an editorial board member and reviewer

Abstract:

Four polyketides were isolated from the algal-derived endophytic actinomycete Streptomyces sundarbansensis, which represents the lacking member in the recently reported series of phaeochromycins A–E. We also proposed a method based on the comparison of experimental IR spectra with the DFT ones calculated in order to establish the tautomeric forms for these metabolites. The results indicated a γ-pyrone structure for these compounds, in analogy to the related polyketides mutactin and SEK34. Due to this study, it is possible to suggest that also the known phaeochromycins were isolated mainly in this tautomeric form, differently by the structures reported until now. Evaluation of IC50 values on the pure and structurally defined metabolites as inhibitors of gram-positive and gram-negative bacteria, from where the new compound showed the highest and selective antibacterial activity against MRSA.