Day 1 :
Keynote Forum
John D Higgins
Merck Research Labs, USA
Keynote: A new and versatile method for preparing crystalline drug nanoparticle formulations
Time : 09:50-10:30
Biography:
John Higgins, PhD, received a BS in biochemistry from Albright College and his PhD in synthetic organic chemistry from Brown University. After completing a Postdoctoral Fellowship at the Sloan-Kettering Cancer Institute in NYC in the departments of Positron Emission Tomography and Neurology, he joined the Medicinal Chemistry Discovery group at Johnson Matthey Biomedical. There he worked on Pt-based antitumor drugs and diagnostic radio-imaging agents. He later moved on to drug development, in positions of increasing responsibility at Johnson & Johnson and Sanofi Aventis. For the past 15 years he and his teams have specialized in the areas of drug delivery and solid state chemistry, focused at the interface of drug discovery and development. His specific expertise in drug delivery focuses in the area of enhancing the solubility of insoluble compounds, where he has successfully introduced a wide range of methods into drug discovery space. More recently, he has been active in the design of prodrugs for improving physicochemical properties or targeting for specific disease states. Dr Higgins currently is a Senior Director and Global Technology Lead in the Discovery Pharmaceutical Sciences department at Merck Research Labs as well as an Adjunct Professor at the University of Pennsylvania School of Medicine, Dept. of Systems Pharmacology and Translational Therapeutics. Spanning his 28 year career, he is co-inventor on 13 US Patents and author of numerous publications and book chapters in the fields of organic, solid state & medicinal chemistry and drug delivery.
Abstract:
The birth of the nanoparticle (nanos) drug delivery field was seen over 20 years ago with the advent and application of simple oral crystalline nanoparticle formulations. This effective approach for enhancing oral absorption using aqueous suspensions of drug particles milled to sub-micron size is now employed in several marketed drug products. Originally, relatively large amounts of drug were required to make even prototype nano formulations. This made it difficult to investigate nanos in drug discovery or even early development space, where available drug quantities are limited. At Merck we have developed an innovative new method for generating nanos, using a LabRam high-frequency resonant mixer. This unique application of a LabRam allows us to prepare nanos at a wide range of scales, from stabilizer high throughput screen quantities in a 96 well plate format to liters. With this capability, we can now test nanos during the drug discovery lead optimization stages all the way to the preparation of long-term toxicology supplies and even clinical supplies. This lecture describes this new preparation method, which also has further applications to other formulation methodologies such as liposomes and nanoemulsions.
Keynote Forum
David H Thompson
Purdue University, USA
Keynote: Peptide-targeted immunotherapeutic nanoparticles for intravesical treatment of bladder cancer
Time : 10:30-11:10
Biography:
David H Thompson received Bachelor Degree in Chemistry and Biology from the University of Missouri and a PhD Degree in Organic Chemistry from Colorado State University. After Postdoctoral studies at the Oregon Health and Sciences University, he joined the department of Chemical & Biological Sciences at the same institution as an Assistant Professor during 1987-1994 before moving to Purdue University where, he is currently a Professor of Chemistry and Head of the Medicinal Chemistry Group, Purdue Center for Cancer Research. He has published over 145 papers, many focused on the area of bioresponsive material development for drug delivery.
Abstract:
Bladder carcinoma is the most expensive tumor type to treat on a cost per patient basis from diagnosis to death. Intravesical bacillus Calmette Guerin (BCG) instillation is the only approved immunotherapy for treatment of superficial bladder carcinoma. Unfortunately, frequent relapses, high local morbidity and the risk of systemic mycobacterial infection are significant limitations of this therapeutic approach. BCG utilizes an adhesin protein known as fibronectin attachment protein that contains a critical peptide sequence for binding to bladder tumor cells. Previously, we have shown that multivalent peptide targeted liposomes promote fibronectin-integrin microaggregation and internalization via a caveolae dependent mechanism with a strict ï‚£70 nm size cutoff. Microfluidics offers the potential of formulating scale size controlled nanoparticles in a reproducible manner. Using a chemtrix flow reactor system, we have developed pH sensitive CpG lipid nanoparticles and organic solvent purified elastin like peptide complexes for targeted delivery of these oligonucleotides to activate cells expressing toll like receptor 9 (TLR)9 to mount an innate immune response characterized by the production of Th1 and proinflammatory cytokines. Since (TLR)9 receptors are located within intracellular acidic compartments, such as endosomes and lysosomes, these vehicles have been designed to release their CpG cargo after internalization. Data showing that these peptide targeted nanoparticles specifically bind to and are internalized by bladder tumor cells will be presented. Confocal studies have also been performed to track the cellular fate of these targeted carrier systems. Our findings show that only the pH-sensitive formulations are capable of releasing their payload after 12 h and stimulating a cytokine response. Collectively, our findings suggest that these peptide targeted immunostimulatory complexes may be at low-risk, highly efficient alternative to BCG immunotherapy.
Keynote Forum
Ewa J Kleczyk
Symphony Health, USA
Keynote: Is your machine learning algorithm worth the pharmaceutical industry?
Time : 11:35-12:15
Biography:
Dr Ewa Kleczyk is a Vice President leading the Client Analytics group at Symphony Health. Ewa has more than 15 years of experience in pharmaceutical market research, having worked on both primary & secondary side of the market research area. With her broad experience in commercial effectiveness, digital & media analytics, as well as forecasting & promotional impact measurement, she is one of the industry recognized leaders in the pharmaceutical marketing research area. Ewa is also a highly sought-after conference speaker with her experience speaking at the leading industry conferences, including PMSA, PMRG & DTC Perspectives. She also has published in multiple academic & industry journals and is a board member of several peer-reviewed publications, including the PMSA Journal. Ewa has been an active advocate of mentoring future women leaders of the pharma industry for which she has been recognized with multiple leadership awards, including HBA’s ‘Rising Star’ & ‘Luminary’ recognitions. Ewa has earned her PhD in Economics from Virginia Tech and has been a part-time graduate faculty in the School of Economics at the University of Maine.
Abstract:
Keynote Forum
Ewa J Kleczyk
Symphony Health, USA
Keynote: Is your machine learning algorithm worth the pharmaceutical industry?
Time : 09:00-09:30
Biography:
Dr Ewa Kleczyk is a Vice President leading the Client Analytics group at Symphony Health. Ewa has more than 15 years of experience in pharmaceutical market research, having worked on both primary & secondary side of the market research area. With her broad experience in commercial effectiveness, digital & media analytics, as well as forecasting & promotional impact measurement, she is one of the industry recognized leaders in the pharmaceutical marketing research area. Ewa is also a highly sought-after conference speaker with her experience speaking at the leading industry conferences, including PMSA, PMRG & DTC Perspectives. She also has published in multiple academic & industry journals and is a board member of several peer-reviewed publications, including the PMSA Journal. Ewa has been an active advocate of mentoring future women leaders of the pharma industry for which she has been recognized with multiple leadership awards, including HBA’s ‘Rising Star’ & ‘Luminary’ recognitions. Ewa has earned her PhD in Economics from Virginia Tech and has been a part-time graduate faculty in the School of Economics at the University of Maine.
Abstract:
- Bio-Pharmaceutics | Pharmaceutical Formulation | Smart Drug Delivery Systems | Novel Drug Delivery Systems | Pharmaceutical Nanotechnology
Location: Edinburgh, Scotland
Chair
John D Higgins
Merck Research Labs, USA
Session Introduction
Tirasak Pasharawipas
Rangsit University, Thailand
Title: The keys to manufacturing viral vaccines for individual human population
Time : 12:15-12:45
Biography:
Tirasak Pasharawipas completed his PhD from Faculty of Microbiology, Mahidol University, Bangkok, Thailand. He has his Postdoctoral training at Neuro Virology and Cancer biology Center, Temple University, Philadelphia. At present, he is a Full Professor in Microbiology and Immunology, Graduate Program of Medical Technology, Rangsit University, Thailand. He is interested in various academic subjects of science and liberal arts in addition to music and sports. His scientific fields mainly focus in viral and cellular interaction, bacteriophage and viral diseases in invertebrate animals. However, his research interests expand to viral vaccines, autoimmune disease and cancer biology including the relationship of MHC molecules to some specific diseases and viral vaccines. He enjoys being a reviewer for several journals and an advisor to develop young medical scientists with the wish that they would co-operate and succeed to solve all the problematic diseases, now and then, in a proper way with genuine scientific thinking.
Abstract:
The success to use subunit viral vaccine to prevent a particular viral infection is very limit. This is different from the time when the entire Cowpox virus was originally used for vaccination to prevent the smallpox viral epidemic over a thousand years ago in China before approved in a scientific way by Edward Jenner although immunity was not known. Knowledge of immunology has been profoundly discovered now-a-days. With a thought of safety reason to prevent side effects, subunit viral vaccine becomes the major choice for manufacturing viral vaccine. However, many kinds of viral vaccines could not reach our accomplishment. There is a question why viral vaccines cannot be effective for everybody. This is a question that we need to revise our knowledge and manipulate in the right direction for the viral vaccine production. To prevent a viral infection, a body must produce a protective antibody to prevent the particular viral particle to attach the viral receptor on a target cell. Theoretically, adaptive immunity needs induction not only by a particular antigen but also our cellular molecule called major histocompatibility complex (MHC) to form a complex molecule with its appropriate epitope to activate a specific receptor of T cell. There are two classes of MHC molecules called class I and class II. MHC class I is required for inducing cytotoxic T cell while MHC class II is for helper T cell. Helper T cell plays a key role to induce an effective stage of acquired immunity including a specific protective antibody. To produce the viral-specific antibody, MHC class II plays a key role to induce helper T cell and then B cell to synthesize a specific antibody. Since the MHC gene alleles are highly polymorphic so the possibility that individuals have the same gene alleles might be one in a million which, mostly, can be found in those who are an identical twin. Accordingly, a subunit viral vaccine, which contains a limit number of epitopes, would reduce a capacity of an antigen presenting cell, such as a dendritic cell, to process some epitopes to induce the particular helper T cell clones. Subsequently, in some people, the corresponding B cell clones cannot synthesize the specific antibody to neutralize the particular infectious viral particle. Moreover, the success of vaccination might require other different thoughts. We might need to understand more about the viral receptor on the target cells. There was a proposal of an inducible viral receptor concept which can be applied to protect viral infection as an additional strategy to produce the effective viral vaccines. Accordingly, this presentation will present the novel approach to develop the viral vaccine for everybody.
Samer Adwan
Zarqa University, Jordan
Title: Fractional ER: YAG laser as a novel method for enhancing ocular drug permeation
Time : 12:45-13:15
Biography:
Adwan S has completed his PhD from Queens University Belfast School of Pharmacy. He is working as Assistant Professor at Zarqa University School of Pharmacy. His research interest involves investigation of novel technologies and drug delivery systems for the treatment of otic and ophthalmic diseases.
Abstract:
Ocular drug delivery is currently one of the most challenging areas in modern drug delivery due to the unique anatomy and physiology of the eye and the presence of the ocular barriers. Accordingly, novel drug delivery methods have been investigated to enhance ocular drug permeation and increase the intraocular bioavailability. In this project, P.L.E.A.S.E. (Precise Laser Epidermal System; Pantec Biosolutions AG) laser technology was investigated, for the first time, to enhance ocular drug permeation. Two effects were revealed after laser treatment of ocular tissues. At high fluenes, micropores were created with scare formation around the pores due to the photo thermal effect of laser radiation. Lower fluences showed the formation of shallow pores and the disruption of the collagenous structure of ocular tissues. The effect of increasing the fluence and density of applied laser was investigated. Confocal microscopy studies revealed more intense dye distribution of rhodamine B, FITC-Dextran 70 kDa and FITC-Dextran 150 kDa after laser application. The transscleral and transcorneal permeation of rhodamine B was increased after laser application of 8.9 J/cm2 fluence and increasing the density of laser application. The transscleral water loss studies showed increased water loss after laser application which was decreased after 6 hours of application. As a conclusion, fractional ER: YAG laser is a promising and safe microporation technique that can be used to enhance the permeation of topically applied drugs. Tissue imaging, permeation, distribution studies and transscleral water loss studies showed that the laser application at low energies is promising for enhancing ocular drug permeation.
Dimitrios A Lamprou
Queen’s University Belfast, UK
Title: A new chapter in pharmaceutical manufacturing: 3D-printed and electrospun drug delivery systems
Time : 14:15-15:15
Biography:
Dimitrios A Lamprou is reader in Pharmaceutical Engineering and MSc Programme Director at the School of Pharmacy at Queen's University Belfast (UK) and Visiting Researcher at University of Strathclyde (Glasgow, UK). He has experience of teaching in higher education, conducting research and has 60+ publications, 200+ conference abstracts, 70+ oral/invited presentations) and securing national and international funding (£2M+). He is Secretary at the United Kingdom and Ireland Controlled Release Society (UKICRS), external PhD viva examiner for UK and International Institutions, and referees for journals, publishers and research funding bodies. His group is applying aspects of Pharmaceutical Technology to a range of areas such as cancer, antimicrobial resistance and nanomedicine development. The group research interests focused on four distinct areas like biosurface engineering, electrospinning, microfluidics and pharmaceutical 3D printing and bioprinting.
Abstract:
The talk will cover the challenges and opportunities in pharmaceutics by adopting new formulation technologies to bring new products into the market. 3D printing and electrospinning are an example of technologies that have been widely used in other industries, however are new to pharmaceutical manufacturing. Therefore, the use of these techniques in drug delivery and tissue engineering applications, including the use of state of the art techniques (e.g. FastScan AFM, ToF-SIMS, nanoCT) will be discussed. The first part will focus on the preparation of drug-loaded polymeric electrospun nanofibers. The purpose of this study is to examine any potential effects, chemical and mechanical, of drug loaded electrospun nano fiber scaffolds. Biodegradable polyesters that commonly used in biomedical applications for controlled release and targeted drug delivery was loaded and electrospun with different types of drugs. The electrospun fibres were characterised through various methods in order to measure the drug efficacy, antibacterial properties and drug-polymer interactions. There are a number of different applications within medicine that require materials to be developed with the optimal characteristics, such as their strength, rate of degradation and porosity as well as their shapes and sizes. 3D printing process was patented in 1986, however only recently have been utilised in the field of pharmaceutical printing. Therefore, in the second part, 3D printed systems (e.g. microneedles, rings and tablets) of various designs with high drug payloads that have been formulated using advanced additive technologies and characterised using advanced characterisation techniques will be discussed.
Faongchat Jarintanan
Rangsit University, Thailand
Title: Terrein from Aspergillus terreus induced cytotoxic and nuclear changes on human colon cancer COLO205 cells
Time : 15:15-15:45
Biography:
Faongchat Jarintanan has completed her PhD from Srinakharinwirot University at Thailand in 2010. During the academic year 1998-2018, she is the Lecturer in Molecular Genetic and Hematology at Faculty of Medical Technology, Rangsit University. She got grant for research at Hiroshima University to study development of production system for foreign protein by exploiting transgenic green algae in 2003. She has research focuses on natural product, cell culture, bioprinting with cells and SNPs gene of Alzheimer's disease.
Abstract:
Colon cancer is the most common cancer worldwide. Recently, natural products have been used for the treatment of cancer and becoming an important research area for drug discovery. Terrein, a fungal metabolite derived from Aspergillus terreus, has been shown to have a variety of biological activities to exhibit selective anticancer activity in human including colon cancer. However, cytotoxic effects of terrrein against human colon cancer cell lines have never been studied. Therefore, the present study was observed the cytotoxic effects of terrein by using the MTT assay. The sensitivity was evaluated by comparing the effect to COLO205 cells with vero cells for 24h. The results of MTT assay showed that terrein was cytotoxic to COLO205 with IC50 at 0.05 mM, but not to normal Vero epithelial cell line. The induction of cell death was further investigated by observing the cellular morphology of nuclei using Hoechst 33342 staining, a DNA specific dye. The result showed that the treated cancer cells had increased of nuclear condensation and fragmentation with 0.05, 0.15, 0.2, 0.25, 0.3 mM at 6 h by observing under the phase contrast inverted microscopy. These data supported that the mode of cell death induction of terrein possibly activated via apotosis mechanism. Thus, terrein is an interesting compound that might be a development for colon cancer treatment. However, investigation through the mechanism of action is needed.
Julia Matsuieva
University of Wroclaw, Poland
Title: Current aspects of Polish pharmaceutical market advertisement ban as a factor affecting pharmaceutical market (The Polish case)
Time : 15:45-16:15
Biography:
Julia Matsuieva is a PhD researcher at the University of Wroclaw, Poland. Her scientific interests are on pricing strategies on the pharmaceutical market, local legal requirement for drug pricing, access to the medicines, quality life of people, generic medicines. She is the author of scientific publications in Poland, Ukraine and Slovakia. Her Doctoral thesis is dedicated to the consumer’s behavior in the Polish pharmaceutical market.
Abstract:
Tirasak Pasharawipas
Rangsit University, Thailand
Title: Future approaches concerning vitamin B12 deficiency in elderly
Time : 16:35-17:05
Biography:
Tirasak Pasharawipas completed his PhD from Faculty of Microbiology, Mahidol University, Bangkok, Thailand. He has his Postdoctoral training at Neuro Virology and Cancer biology Center, Temple University, Philadelphia. At present, he is a Full Professor in Microbiology and Immunology, Graduate Program of Medical Technology, Rangsit University, Thailand. He is interested in various academic subjects of science and liberal arts in addition to music and sports. His scientific fields mainly focus in viral and cellular interaction, bacteriophage and viral diseases in invertebrate animals. However, his research interests expand to viral vaccines, autoimmune disease and cancer biology including the relationship of MHC molecules to some specific diseases and viral vaccines. He enjoys being a reviewer for several journals and an advisor to develop young medical scientists with the wish that they would co-operate and succeed to solve all the problematic diseases, now and then, in a proper way with genuine scientific thinking.
Abstract:
Vitamin B12 or cobalamin is essential for the major parts of the human body which are nerves, blood, and skeletal system. The major source of vitamin B12 is animal products. Vitamin B12 deficiency is common in vegan and vegetarians but the reports also become increased in elderly while human-life span keeps proliferating. There are more than 20 forms of vitamin B12 analogues but only two forms account as the natural active forms in the human body. Besides insufficient consumption of the vitamin B12, ingestion, transportation and the activity of the cobalamin in a body are also the causes of the deficiency. This presentation will give an overview concerning vitamin B12 and the known causes of its deficiency. However, the mechanism and homeostasis of vitamin B12 are truly complicated. Accordingly, the opinions for future approaches to study for developing the key information of the vitamin B12 for the general application in public health care will be proposed.
- Poster Presentations
Location: Edinburgh, Scotland
Session Introduction
Andrea Gelain
Freund-Vector European Lab, Italy
Title: Top spray granulation PAT monitoring by NIR: Calibration vs PCA trend approach
Biography:
Andrea Gelain took a master degree in Pharmacy and a master degree in Chemistry and Pharmaceutical Technologies. Worked for three years as a Pharmaceutical technologies researcher in Pharmaceutical Technologies department of the Milan Università degli Studi upon the formulation and preformulation of new conventional release and modified release solid dosage forms. Since 2016 works as Process Development Scientist and in R&D department in Freund-Vector Corporation.
Abstract:
Statement of the Problem: One of the main points of investigation to optimize a granulation is to precisely determine and monitor the process trend and the endpoint of each phase. The PAT systems give the possibility to operate a continuous, real-time process monitoring correlating the online response with the real measured parameters without the necessity of taking and separately analyze samples during process. The aim of this study was the feasibility to apply a NIR device to a fluid bed top spray granulation process to investigate the possibility to correlate the same NIR response to the moisture content and to the particle size distribution.
Methods: A placebo formulation was granulated by top spray using a fluid bed (Freund-Vector VFC-Lab3) equipped with a Viavi MicroNIR PAT-U device. The spectrophotometer is connected to the fluid bed with a welded flange. Two runs were performed. The load of dry blend was adjusted for the equipment capacity to achieve appropriate product movement. LOD was determined at regular intervals (5 min) using a thermobalance (Mettler Toledo MJ33). Particle size distribution was also determined using a graphical imaging device (Sympatec QicPic). Data were analyzed starting with the principal component analysis to locate the process trend, then the values were correlated to the samples collected to produce a calibration curve. The correlation proved to be very strong.
Conclusion & Significance: This study demonstrated the possibility to follow the process trend and to determine the phase endpoints both for moisture content and for particle size growth using a single PAT device. This could open up the possibility to apply this technology to other techniques, such as Wurster coating, fluid bed rotor powder layering and high shear granulation, and to implement a full integration of the NIR device with the machine software to get a complete automatic process control.
Qufshe Bardar Oais Fazlul Baqui
Army Medical College Bogra, Bangladesh
Title: Self-medication practices among the tribal people of Rangamati: A questionnairebased study
Biography:
Abstract:
In developing countries, self-medication is commonly practiced. Current study was conducted in Rangamati, southern part of Bangladesh with the attempt to explore the practice of self-medication among the tribal people. Previously briefed 4th year medical students of Prime Medical College, Rangpur, Bangladesh, using a structured questionnaire, carried out the study on 88 respondents. 47.2% of studied population was Chakma. Out of 88, 53 respondents (60.1%) had taken some kind of self-medication in the 6-month period preceding the study. 102 drugs were consumed by 53 respondents and average number of drugs consumed by 53 respondents was 1.9 drugs per person. The common reasons given for self-medication were headache and fever. Paracetamol was the most commonly used drug for self-medication (43.4%). A significantly higher proportion of young (<40 years) male respondents had used self-medication than other groups. The study revealed that practice of self-medications common among the tribal population of the Rangamati. Patient education on self-medication is the need of the hour for ensuring rational use of drugs.
Dóra Farkas
Semmelweis University, Hungary
Title: Development and evaluation of propellant free pharmaceutical foam formulations
Biography:
Dóra Farkas has obtained her MSc Degree as a Pharmacist at Semmelweis University Budapest, Hungary. Currently, she is doing her PhD in Pharmaceutical Technology at the Department of Pharmaceutics (Semmelweis University). She is doing researches in the field of pharmaceutical foams.
Abstract:
Pharmaceutical foams are active ingredients bearing colloid systems, where gas is dispersed in the continuous liquid phase. They are designed mainly for dermal application and several foam formulations are available also for vaginal and rectal use. Numerous advantages are attached to foams when compared to traditional vehicles, resulting in increased patient compliance. Amongst others, the suitable composition contributes to quick, oily residue-free and convenient application even on large or hairy areas, as well as for good drug transfer rate. While in aerosol cans creamy foams are formulated with propellant from emulsions, propellant free pump devices which enable the production of light textured foams from microemulsions. Aerosol foams can be evaluated by pharmacopoeial tests (Ph. Eur.), amongst which relative foam density determination is the only applicable for microemulsion foams. Aside from the traditional methods, based on physicochemical characterization (eg. density, viscosity, morphology), image analysis provides a new aspect for the classification of foams based on their structure. Photos taken after actuation hold information on bubble size and shape that can be used in the development of foam formulations. Bubble size is influenced by several parameters, like the composition of the foam formulation, the type and amount of surface active agent and also the liquid phase viscosity.
Jorge Galvez
University of Valencia, Spain
Title: Novel antifungal drugs design by molecular topology
Biography:
Jorge Galvez is Full Professor in Physical Chemistry and Director of the Molecular Topology and Drug Design Research Unit at the University of Valencia (Spain). He authored over 200 articles, 100 communications and 6 patents of new drugs designed or selected by molecular topology. He is member of the Spanish Royal Society of Chemistry, the Academy of Medicine of Valencia, the International Academy of Mathematical Chemistry (Founder Member), the European Academy of Mathematical Chemistry (Founder Member) and the Spanish Society of Green Chemistry. He has leaded the discovery of some 200 new hit-lead compounds in cancer, Alzheimer, malaria, etc.
Abstract:
Some species of fungi act as pathogens against both mammals and plants. The search for new effective antifungals against these pathogenic strains constitutes one of the priority objectives of the pharmaceutical and phyto sanitary industry, since deadly diseases may arise. However, the problems of the antifungals and fungicides currently available are basically two: On the one hand they are not exempt from toxicity to the host and on the other they generate resistance in more or less long terms. The objective of the present work is the search for new antifungals that follow new, more effective mechanisms of action with lower toxicity. This search is done by molecular topology, a method that has shown extraordinary efficacy in the design of new drugs. In this sense, the MOAs related to the inhibition of chitin formation of fungi are very attractive, among other reasons because some of them stimulate the immune system of the host, which is thus able to defend the host against the fungus. In addition, said MOAs are less susceptible to the development of resistance by fungi. As a result, a set of compounds potentially effective in the inhibition of chitin formation and of possible future utility as drugs and/or phyto sanitary products is proposed.