Scientific Program

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

Day 2 :

Keynote Forum

Matt Cavallo

Patient Activation Network, USA

Keynote: The dog story: A patient’s perspective on research and healthcare
Conference Series Drug Delivery 2018 International Conference Keynote Speaker Matt Cavallo photo
Biography:

Matt Cavallo, MPH is the founder and Chief Empathy Officer of the Patient Activation Network. He is a patient experience thought the leader who has been a keynote speaker for healthcare events across the country. He has been named among The Top 10 Social HealthMakers by WCG and his blog was selected as one of Healthline’s Top Healthcare Blogs. His story of being diagnosed and overcoming the physical and emotional challenges associated with having a chronic disease can be read in his memoir, The Dog Story: A Journey into a New Life with Multiple Sclerosis

Abstract:

At twenty-eight years old, Matt Cavallo, MPH was diagnosed with Multiple Sclerosis. Seemingly overnight he went from a fully-functioning, healthy man to someone who was paralyzed from the waist down and unable to walk. His story of being diagnosed and overcoming the physical and emotional challenges associated with having a chronic disease will be presented from the onset of symptoms and hospitalization to the decision to try a black-box therapy. He will discuss the successful outcomes he experienced because of the decision to advocate for himself based on the clinical trial research. Matt will also discuss the emotional and physical toll that it took on him, his wife and their young family. During this lecture, Matt will talk about the importance of participating in clinical trials from the patient perspective. He will discuss the resistance he faced from his care team because of his decision to try a newly approved, but risky therapy option, and how he overcame those objections. Matt has presented on this topic to top researchers and scientists in the field inspiring them with his compelling personal patient experience story. His authenticity and ability to be vulnerable on stage will make this presentation one that your audience will talk about long after the conference has ended. Matt will make your audience laugh, cry, and in the end, inspire hope.

Learning Objectives

                        The World Health Organization recognizes therapeutic patient education and patient experience as clinical education. Content within the lecture is relevant to healthcare and the designated audiences in the following four areas:

                        The patient adaptation process including coping with the disease, loss of control, health beliefs and sociocultural perceptions.

                        Subjective and objective needs of the patient, whether expressed or not, as an integral part of treatment and care

                        Concerns about the patient’s daily life and psychosocial environment, as well as, the patient’s family and other close relatives and friends.

                        A disease as a continuous process, which has to be adaptive over the course of the disease and to the patient and patient’s way of life as part of a long-term care of the patient. 

Conference Series Drug Delivery 2018 International Conference Keynote Speaker Tatsuya Takagi photo
Biography:

Tatsuya Takagi has completed his PhD at the age of 32 from Osaka University. At that time, he had been an Assistant Professor of School of Pharmaceutical Sciences, Osaka University for 5 years. Then, since 1993, he had worked for the Genome Information Research Center, Osaka University as an Associate Professor until he became a Professor of Graduate School of Pharmaceutical Sciences, Osaka University in 1998. He has published more than 150 papers in reputed journals and had served as Chairman of Division of Structure-Activity Relationship of the Pharmaceutical Society of Japan for three years (until March 2017).

Abstract:

 MDM2 (Mouse double minute 2 homolog) is known as a protein which is a significant negative regulator of p53. MDM2 is also considered to be E3 ubiquitin-protein ligase recognizing the N-terminal TAD (Transactivation Domain). Thus, MDM2-p53 interactions are proposed to be a promising therapeutic strategy for tumors. Previously, we reported a part of the FMO (Fragment Molecular Orbital) calculation results of MDM2 and its inhibitors at the 11th China-Japan Joint Symposium on Drug Design and Development. Although we showed a satisfactory result, we also thought the result could be improved using PIEDA (Pair Interaction Energy Decomposition Analysis). In this study, we added some FMO results and tried to obtain a better correlation using data mining methods, such as PLS. First, we selected significant 18 IFIE (Inter Fragment Interaction Energy) values and 45 electrostatic interaction energies as the results of PIEDA from 84 ones. Then we obtained two latent variables as the results of PLS and cross validations. Resulted scatter plot of the two latent variables. In this case, the best-squared correlation coefficient values between observed and calculated pIC50 of MDM2, 0.924, was obtained. FMO calculation results between β-secretase and inhibitors also will be shown.

Conference Series Drug Delivery 2018 International Conference Keynote Speaker Guiyong (Nick) Song photo
Biography:

Nick Song has completed his PhD from The University of Missouri and his MBA from Purdue University. He is a technical manager of the Science & Technology organization at Abbvie Inc, where he leads the modeling and simulation of drug delivery devices and systems. He previously completed numerous technical consulting projects on drug delivery and medical devices with major medical companies, as a consultant at the world leading simulation solutions company Dassault Systemes (previously ABAQUS Inc.) He has published more than 20 papers in reputed journals and conferences.

Abstract:

Drug delivery devices and drug-device combination products involve complex working mechanisms, nonlinear materials with complex mechanical behaviors, and interactions between fluids and structures. The development and manufacturing of combination products entail the deep understanding of the design, manufacturability, and reliability, where modeling and simulation offer unparalleled capabilities and complement testing based on physical prototypes. This presentation will provide a few case studies of device and combination products modeling at Abbvie. Bio-compatible polymers including thermoplastic polyurethane and thermoplastic elastomer are commonly used in medical devices such as drug delivery tubing and connectors. They provide excellent durability and resistance against oils and chemicals. Their mechanical properties are complex, exhibiting nonlinear large strain nonlinearity, hysteresis, and permanent set under cyclic loading. Hi-fidelity finite element modeling was utilized to study the performance of a delivery system under various conditions. Results showed the high margin of safety. Auto-injector is a combination of drug and device. A syringe pre-filled with a drug is installed into a spring-loaded pen device to achieve automatic subcutaneous drug delivery. Finite element simulations of the firing/activation process provided deep insights into the working mechanism that were not known from prior experiments. An infusion pump is an electro-mechanical device used to deliver the drug into the human body at large volumes and over the long period of time. Simulations showed the working mechanism of the complex device that includes components made from nonlinear silicone rubber and thermoplastic polyurethane materials. Multiphysics modeling of auto-injector provided deep insights into the drug solution fluid flow driven by the device which was not easily measurable.

Conference Series Drug Delivery 2018 International Conference Keynote Speaker Rahul R Panchal photo
Biography:

Rahul R. Panchal has completed his M.S. (2005) and PhD (2009) in plastics Engineering and Polymer Science from University of Massachusetts, Lowell. He has B.S. in Mechanical Engineering from Gujarat University, India (1998). He has extensive background and expertise in medical device design & manufacturing, polymer injection molding, statistics, multivariate analysis, in-mold sensing technology etc. He is an inventor of the patented in-mold sensor having the capability to measure in-mold shrinkage realtime. He currently works at AbbVie as a Principle Scientist Engineering, Combination Products and transitioning into entrepreneurship. He is also founder and president of Leonine Technologies Inc. which mainly focused on new technology development for injection molding, medical device, as well as training and consultation.

Abstract:

Due to the increased health care costs, patients are looking for self-administration drug delivery devices where the drug can be packaged within the device. Because of this many pharmaceutical companies are moving towards drug and device combination for many drugs and reformulating their drugs so they can pack into the delivery device as a combination product like autoinjectors, infusion pumps, nebulizers etc. The delivery device is mainly made of injection molded plastics parts. The self-drug delivery systems have helped the patients a lot without relying on medical practitioners for drug delivery or taking frequent oral doses. However, pharmaceutical companies are still in denial to accept the importance of drug delivery devices as a part of their product portfolio, maybe they are worried about being subjected to medical device regulations which are not their core business. Hence, all major pharmaceutical companies rely on third-party device designers and manufacturers. In general, pharmaceutical companies select the device for a specific drug and conduct the patient survey by showing the device prototype via focus groups or patient experience studies. The risk behind this approach is that the patient creates own bias immediately after looking at the prototype and over 50% of patients do not provide honest feedback. Hence, the majority of patients requirements are not being translated to the device design. Any device failure will lead to patient complaints towards the pharmaceutical company even though the company is making the best drug ever available in the market. Another issue, majority of device developers are mechanical designers with little or no knowledge of plastics product design and manufacturing thus they fail in differentiating between plastics and non-plastics (metal) design concepts. Because of this, the majority of the device available in the market are designed having components with complex features not suitable for plastics materials or with the wrong material selection. This has resulted over a 30% increase in manufacturing cost and time. Therefore, it is very important to understand the importance of customer feedback even before starting the device design as well the science behind plastics product design and manufacturing, related technological innovations.

Keynote Forum

Prakash V Diwan

National Institute of Pharmaceutical Education and Research, India

Keynote: Wonders and worries of nanotechnology in healthcare

Time : 11:30-12:00

Conference Series Drug Delivery 2018 International Conference Keynote Speaker Prakash V Diwan photo
Biography:

Prakash V Diwan obtained his PhD from Postgraduate Institute of Medical Education and Research, Chandigarh, India. Contributed in the areas of Novel Drug Delivery systems & drug discovery. Published over 200 papers in pre-reviewed journals. He delivered guest lectures in India and abroad. He has many awards instituted by Indian Pharmacological Society. He has served as founder Director of NIPER, Hyderabad and fellow of the Royal Society of London, FRSC (London). Presently working as Technical Advisor, Indian Pharmacopeia Commission, Government of India, Director School of Pharmacy, and Hyderabad. Director, CRL, Maratha Mandal Group of Institutions, Belgaum, and Consultant for Indian Institute of Technology, Hyderabad

Abstract:

From science fiction to reality: Nano medicine Brings fresh hope to the medical world. Nanomedicine is an offshoot of nanotechnologies. Medical applications, dominate today's market, with sales of $19.1 billion. Emerging nanomedicine technologies could dramatically transform medical science today with their potential to address unmet medical needs and provide targeted therapy. Nanomedicine can offer impressive resolutions for various life-threatening diseases including effective drug delivery systems, drug discovery, and development, medical diagnosis, and devices. The advent of nanomedicine and techniques for the early diagnosis of diseases could usher in a new era of superior prophylactic or preventive medicine. By using preventive medicine, treatment for diseases could be initiated even before preliminary symptoms appear.

Medical Advantages

Nanotechnology has the potential to bring major advances in medicine.

Nanobots could be sent into a patient's arteries to clear away blockages.

Surgeries could become much faster and more accurate.

Injuries could be repaired cell-by-cell.

It may even become possible to heal genetic conditions by fixing the damaged genes. Cancer treatment, drug delivery, drug development, medical tools diagnostic tests, imaging

Novel drug delivery systems of herbal drugs using nanotechnology: Have a potential future

 

Nanomedicine technology faces biggest challenges such as scalability. This perceived difficulty is attributed to the fact that manufacturing standards for nanomaterials and components are yet to evolve. Therefore, there is an urgent need for standardized manufacturing techniques; only then can nanotechnology become ubiquitous in everyday applications. Furthermore, since the characteristics of nanoscale matter are very different owing to their unique nature, there is a need for appropriate quality control measures. Concerns about the potential ill effects of engineered nanomaterials such as nanotubes through inhalation, ingestion, or absorption through the skin are increasing.

Challenges

The exact usage and quality of materials? strategy,

Research is motivated by immediate profits, more concentration on commercial products,

Are nanotechnology inventions required by the society?

What about nanotoxicity? Are products commercially viable?

In the longer term, perhaps 10–20 years from today, the earliest molecular machine systems and nanorobots may join the medical armamentarium, finally giving physicians the most potent tools imaginable to conquer human disease, ill-health, and aging.

 

Keynote Forum

Vinod Labhasetwar

Lerner Research Institute, USA

Keynote: Simple is better in nanomedicine
Conference Series Drug Delivery 2018 International Conference Keynote Speaker Vinod Labhasetwar photo
Biography:

Vinod Labhasetwar, Ph.D., is a Professor of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, both in Cleveland, Ohio, USA. The primary research focus of his laboratory over the past 25+ years has been on nanoparticle-mediated drug delivery in the context of translational and clinical medicine, particularly focusing on disease conditions where no effective treatments yet exist. His team’s specific interests are in developing effective approaches to cancer therapy (against drug resistance and metastasis), cardiovascular diseases (particularly inhibition of restenosis), and facilitating neuromuscular repair mechanisms in stroke and spinal cord injury. Recently, his group’s efforts have been expanding into two new areas: retinitis pigmentosa, with the goal of slowing the progression of photoreceptor degeneration; and transplantation research, with the objective of extending the critical window of time for organ preservation. He has published over 180 peer-reviewed articles and book chapters. He is listed among the 2014 and 2015 Highly Cited Researchers by Thomson Reuters, based on the top 1% of citations during the past 10 years. He has over 25 issued US and international patents and 4 provisional the US patents filed/pending. He is Editor-in-Chief of Drug Delivery and Translational Research, an official journal of the Controlled Release Society.

Abstract:

Nanoparticle-based drug delivery systems can potentially overcome several barriers to drug delivery, reduce toxicity to the patient, and thus improve therapeutic outcomes. Over time, nanoparticles have undergone evolution from simple to more complex systems, yet the nanoparticle formulations developed as “nanomedicine” for clinical use remain quite simple. Our laboratory research has shown that simple nanoparticle formulations, developed with a solid rationale, are very effective in treating complex conditions. This overview will describe nanoparticles that are straightforward in design yet effective in treating complex diseases in animal models. One example is a formulation that successfully treats bone metastasis, considered the primary cause of death in many types of cancers but more particularly in prostate and breast cancers. A second example is a formulation that effectively modifies the after-effects of stroke. This presentation will also define the challenges in moving complex nanoparticles through regulatory pathways and the scale-up process toward eventual commercialization.

  • 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.