Day 1 :
Biography:
John J Seman began his career in global life science corporations working for E. R. Squibb & Sons and Johnson & Johnson, holding various management positions in sales, marketing and business development. The past 20 years have been spent in entrepreneurial startups where he built an innovative technology based company, Avantec; tripled revenue, and sold a reimbursement services company, HealthBridge, secured initial funding from angel investors for a preclinical research company, PhysioGenix,; founded an innovative dental pain management company, Amorsus Pharma; secured $7.3 million in funding within first 12 months to support entrepreneurial efforts for Launch NY,; and founded an early stage biotech company, ZOETIC Pharmaceuticals, targeting auto immune diseases. Mr. Seman holds a Bachelor of Science degree in Pharmacy, and a Master’s degree, with honors, in Pharmaceutical Economics and Business Administration, from the Massachusetts College of Pharmacy. He is active in industry associations, frequently asked to present at national conferences.
Abstract:
Academic-industry partnering trends reveal a shift in the direction of more openness and cooperation for both academic research institutes and the pharmaceutical industry. Two main factors driving this trend is the emergence of financial pressures on academic institutions and a growing understanding of the increased complexity of developing new innovative therapies.
Keynote Forum
Kishor K Chakraborty
Julphar, Saudi Arabia
Keynote: Thinking beyond QbD: Accelerating risk smart development & technology transfer
Biography:
Kishor K Chakraborty is a professional (M Pharm. PhD, MBA) having more than 30 years of diverse global exposure in various research and development assignments with Lederle (a division of American Cyanamid company), Hindustan Antibiotics, Concept Pharma (a farmer subsidiary of Lupin Pharma), Riyadhpharma and currently has been serving as Head – R&D in Julphar Saudi (A leading pharmaceutical company in GCC). He has published & delivered over 20 manuscripts and lectures respectively.
Abstract:
A risk-smart QbD-based methodology driven by improved Informatics goes beyond tactical & reactive development and streamlining standards-based Technology Transfer by capturing mechanistic understanding to support the probabilistic modeling approach from early ideation through research, development, optimization, and scale-up as well as integrating standards (ISA-88 and ISA-95) and structuring data in a fully searchable format. Moreover, the recognition of lean QbD risk assessment through process knowledge is a product lifecycle issue as opposed to a once and done aspect of development is a good first step. That recognition shall catalyze organizational development whose ultimate goal is a broad organizational understanding and competence in QbD concepts and tools, focusing on top-down approach of technology transfer beyond Product Development to include Operations, Engineering, QA, Regulatory Affairs and even Finance. A DIbD (Data-integrating-based-design) supported QbD strategy that expands Research, Development and Manufacturing enables seamless information from across the organization to support continuous product and process improvement. It offers significant opportunities to accelerates products to market, reduces compliance costs and improves product quality by reducing the number of experiment cycles, speeding individual cycles and facilitating technology transfer between cycles. Consistency and standards driven through informatics enable rapid technology transfer between scientists and systems, while Cloud-based software deployments enable remote organizations to collaborate in the QbD process.
- Pharmaceutical Technology and Development | Drug Discovery, Design & Development | Nanotechnology in Pharmaceuticals |Pharmacovigilance and Risk Management | Nanotechnology in Pharmaceuticals | Drug Discovery, Design & Development: Challenges and Approaches |Novel Drug Delivery Systems
Chair
Syed Iftikhar Hussain Shah
Biotroll (pvt.), Pakistan
Session Introduction
Viola Tokarova,
McGill University, Canada
Title: Microfluidics platform for nanoparticles synthesis
Biography:
Viola Tokarova completed her PhD in 2014 at the Department of Chemical Engineering at UCT Prague. She spent two years as a PostDoc at the Biological Microfluidics Laboratory at McGill University. In 2017, she established the Biomimetic Engineering Laboratory at UCT Prague (http://biomimetic-lab.vscht.cz/). The laboratory is focused on preparation and testing of variously structured nano- and micro-objects and surfaces inspired by nature
Abstract:
The increasing demand for nanoparticles with well-defined uniform properties applied in various technical fields is nowadays limited by available fabrication techniques. The presented work is based on the microfluidic system, which greatly increases the effectiveness of nanoparticles production and characterization, decreases the unwanted by-products, as well as saves time compared to standard wet chemical batch procedures. Nanoparticles prepared using microfluidics platforms are designed for the biomedical application. Among the most important parameters of nanoparticles belong their hydrodynamic diameter, particle size distribution, surface properties and morphology. The main aim of this work is to use microfluidics in the synthesis of nanoparticles with high control over the reaction and process parameters compared to standard wet chemical batch procedures. A single droplet of dispersed phase formed inside the microfluidic chip represents a reaction vessel for nanoparticle synthesis where all reactants are effectively mixed. The surface of the nanoparticles is modified with a specific antibody IgG-M75 and an adhesion to a specific target, a trans-membrane protein over-expressed in a wide variety of tumor cells, carbonic anhydrase IX is tested inside a perfusion system. In this work, we employed CFD simulation of two-phase flow in order to design a microfluidic chip and study governing physical parameters and their influence on droplet formation process and mixing efficiency. Results of nanoparticle synthesis in the microfluidic system and their surface modification will be presented and discussed.
Taisa Busaranho Franchin,
Sao Paulo State University, Brazil
Title: Caco-2 permeability studies and prospects of in vivo absorption
Biography:
Taisa Busaranho Franchin in Pharmacy-Biochemistry from the Sao Paulo State University "Julio de Mesquita Filho", Araraquara - SP. Currently in Master's degree in Pharmaceutical Sciences at the School of Pharmaceutical Sciences of Sao Paulo State University, Araraquara-UNESP in the Laboratory of Toxicology of the Department of Natural Active Principles and Toxicology (PANT) with emphasis on Pharmacokinetics and Toxicology of new substances and medicines. Her scientific initiation was with tuberculosis drug, following the same line in the master's degree, is also, part of this, the implementation of the in vitro laboratory
Abstract:
Introduction: The development of new drugs is a complex process, in which favorable pharmacokinetics is crucial for success. Information obtained from in vitro assays improve the process, aiding in the understanding of pharmacokinetic phenomena. Caco-2 cells form monolayers that exhibit morphological and functional similarities to enterocytes, their use in permeability studies have been shown to be excellent indicators of absorption after oral administration, with a high correlation with in vivo absorption. In this study, we evaluated apparent permeability (Papp) of new drug candidates and compared with in vivo uptake.
Methodology: The Thiazolidinediones GQ-2, 11, 19 and 177 and the phthalimide derivatives SCD-03 and 04 were submitted to the Caco-2 monolayer system in Hanks buffer. The Papp was quantified by UHPLC, with previously validated methods. Fluorescein and Amphotericin B were used as low permeability controls and Verapamil and Benznidazole as high permeability. These compounds were also administered orally to Wistar rats.
Results: The controls were adequate, indicating the integrity of the monolayer and the validity of the assay. GQ-19 presented Papp of 16.6x10-6, and although this is a moderate permeability value, the compound was shown to be highly unstable in rat plasma, with no significant plasma levels obtained in the in vivo studies with oral administration. Papp of SCD-03 was 9.57x10- 6 and of SCD-04 was 2.33x10-6 cm/s and after the oral administration of SCD-03, a bioavailability of 6% was obtained. For the others thiazolidinediones, there was no permeability in Caco-2 monolayers and no significant plasma levels after oral administration in Wistar rats.
Conclusion: The permeability assay demonstrated a good correlation with the in vivo findings, however, the evaluation of other characteristics of a compound, like stability in different pHs and matrices assists the understanding of the results and in the planning of next steps.
Ondrej Kaspar,
University of Chemistry and Technology,Czech Republic
Title: Allium sativum: Sustainable natural self-defense system as an alternative to modern antibiotics
Biography:
Ondrej Kaspar is an Assistant Professor at the University of Chemistry and Technology (UCT) Prague. He spent two years as a post-doc at McGill University in the research group of Prof. Dan V. Nicolau involved in the newly emerging field of bio-computation and bio-simulation research. After his return to the Czech Republic, he joined the Laboratory of Biomimetic Engineering at UCT Prague. Nowadays, he is involved in research topics focused on mimicking of natural antibacterial solutions, encapsulation of active substances and preparation of nanoparticles via microfluidics
Abstract:
Garlic among other plants in genus Allium is well-known for its beneficial properties for thousands of years. The favorable effect is attributed to the sulfur-containing substance called allicin. Allicin, volatile compound having typical garlic odor, is produced enzymatically from alliin (a substrate) and alliinase (an enzyme) when inner cell structure is compromised (e.g. by cutting). The system producing active compound “on-demand” is very effective and protects the whole plant only when it is needed. Moreover, high allicin reactivity, short half-time (less than few minutes) and no accumulation in the environment make it very difficult for bacteria to develop effective resistance. The aim of this work is to extract and stabilize enzyme and to prepare antimicrobial particles in a dry and hydrated form based on a similar principle as garlic cell in terms of allicin biosynthesis. Since the enzymatic activity of the isolated enzyme is the most important factor governing allicin production, its stability under different conditions is experimentally investigated. Alliinase was extracted from garlic cloves. The purity of the enzyme was determined by SDS-PAGE. Alliinase activity was assayed using a coupled reaction method, which is based on the reaction of enzymatically produced pyruvate, as a by-product of allicin formation, with NADH. Chitosan and alginate, both biodegradable polymers were used as an enzyme-substrate carrier. Spray drying, co-flow encapsulation, and microfluidic droplet generation were employed to produce particles with different internal structure, mean size and morphology where both substrate and enzyme are separated in different compartments of one or more carriers. We believe, that mimicking of nature-proved sustainable concepts can contribute to the reduction of the annually increasing number of bacterial infections caused by multi-drug resistant bacteria.
Syed Hadi Hasan,
Indian Institute of Technology, India
Title: Studies on the synthesis and characterization of nanosuspension of hydrophobicdrugs, particularly Nimesulide, to increase their gastrointestinal solubility
Biography:
Syed Hadi Hasan joined Department of Chemistry, Institute of Technology (BHU) as a Lecturer in 1993. He became Sr.Lecturer in 1997 and Associate Professor in 2002. Since 2008, he is a full time Professor at IIT-BHU. He has published close to 100 research papers and several Book Chapters in journals of international reputation. His also has around 50 publications in Conferences & Seminars of International and National reputation. He also serves as a reviewer for many reputed journals including Elsevier and Springer. He has supervised to completion seven PhD fellows and thirteen M. Tech students.
Abstract:
Nearly 40% of the new drug entities synthesized by the pharmaceutical industry is mostly insoluble in water. Thus the patients are forced to take drugs in high doses and more frequently to attain the desired bioavailability of the drug. Hence gastrointestinal (GI)solubility is an essential parameter in the development of a new drug. Much research has been done on this field aiming at increasing the kinetic as well as the absolute solubility ofthe drug. Methods like complexation of the drug with hydrophiles /amphiphiles, crystalengineering, and freeze-drying are the significant methods adopted. In addition to these methods, particle size reduction, in particular, synthesis of nanosuspension or nanodispersion of the drug is a very practical and economical method. The particle size is reduced either by milling or by the preparation of nanosuspension. This work focusses onthe preparation and characterization of Nimesulide nanosuspension by high-pressure homogenization ofthe drug-surfactant mixture. Nimesulide is NSAID which works by the inhibition of proinflammatory COX-2 enzymes. The drug has been shown to cause severe liver damage andsometimes death due to its high dosage and residence time in the liver. Nanosuspension of Nimesulide is prepared by combining it with different stabilizers (steric andelectrostatic). The stability of the drug nanosuspension is determined by measuring theagglomeration of the nanoparticle. The size, morphology and homogeneity of the nanosuspension is characterized by electron microscopy.
Syed Iftikhar Hussain Shah
Biotroll (pvt.), Pakistan
Title: Joining hands in order to accelerate and improve the world’s health system
Biography:
Syed Iftikhar Hussain Shah completed his M.Phil in Medicinal Biochemistry with publication in 1989 from Pakistan council of scientific and industrial research complex under B. Z.University. He worked as Technical officer in Glaxo for manufacturing of Griseofulvin antibiotic by fermentation, worked as Production Manager in Wyeth Laboratories. He worked as Production Expat in Addis Pharmaceutical Factory, Ethiopia, Africa, worked for 13 years in Retail Marketing in Pakistan as CEO in Rocks International. 10 years as Retail consultant in Salam General Hospital and Polyclinic in Kingdom of Saudi Arabia for 2 years. He visited China, Thailand and UAE as Pharma consultant. He is a Member of Federation of Pharmacists Association (FAPA) since 1992 and also a Member of Chungba Consulties as Pharma Expat in CPEC projects, Life Member Pakistan Pharmacists Association, Cheif Electoral Convener
Abstract:
The main purpose of addressing this conference is to focus some innovative recommendations in order to develop the professional span of pharmacist’s community in existing global health system. It will give hopes to the community in our region for eliminating the diseases encountered every day, effectively and efficiently. As Pakistan has and is improving its Pharmaceutical sector countrywide and internationally, by the help of both government and private sectors, we are confident and hopeful to overcome the problems encountered by Pakistani market. Pakistan is a land of opportunities with one of the most fertile soils and six seasons countrywide over the year, with some collaborative help and insight we can create many medicinal plants and develop new strategies that may promise to deal with both common and rare diseases. Young Pharmacists are encouraged and are focused to develop their research capabilities for developing new and effective medicinal products. World Pharma congress should create some initiatives and support for the students and trainees. Pakistani market has shown promise and a safe environment for foreign visitors and is collaborating for the opportunity of hosting the world Pharma conference in Pakistan.
Harvinderpal Singh Walia
Government College Kapurthla, India
Title: To describe my invention is “Piles Patronageâ€: About Hemorrhoids or Piles
Biography:
Harvinderpal Singh Walia has done their post graduation in mathematics and graduation with science. He was teaching subjects chemistry and mathematics to the students. Besides that, he served many medicines for the number of patients from more than 25 years. He started his journey to give a treatment for Hemorrhoids in 1992. He never tried to get highlight their invention before. He served medicine through Doctors, direct contacts and on medical camps. He got 100% results till date and found his own registered pharmaceuticals company in 2016. Currently, he is a managing director of his company
Abstract:
It is very common anorectal disease. It is defined as the symptomatic enlargement and/or distal displacement of anal cushion which are, prominence of anal mucosa formed by loose connective tissues, smooth muscle, arterial and venous vessels. True prevalence/expansion of Hemorrhoids is not known so far. On the basis of epidemiologic study in U.S in 1990 it was estimated that 25% of British people and 75% of American citizens would face this disease in their life particularly in their old age or during their pregnancy. In Google Zeitgeist 2012 Hemorrhoids/Piles was the top trending health issue in U.S. only. Ahead of gastro esophageal reflux disease and sexually transmitted disease. Unfortunately the quality of information about Hemorrhoids/Piles treatment on internet and on various websites is of very poor quality. There is no permanent cure of this disease even after surgery which is known as last way out to cure this disease. This article deals with some fundamental knowledge and prevailing ways to treat uncomplicated and complicated Hemorrhoids/Piles.
Taisa Busaranho Franchin,
Sao Paulo State University, Brazil
Title: Metabolic stability in vitro assay of new drug candidates for Tuberculosis
Biography:
Taisa Busaranho Franchin graduated in Pharmacy-Biochemistry from the São Paulo State University "Júlio de Mesquita Filho", Araraquara - SP. Currently in Master's degree in Pharmaceutical Sciences at the School of Pharmaceutical Sciences of Sao Paulo State University, Araraquara-UNESP in the Laboratory of Toxicology of the Department of Natural Active Principles and Toxicology (PANT) with emphasis on Pharmacokinetics and Toxicology of new substances and medicines. Her scientific initiation was with tuberculosis drug, following the same line in the master's degree, is also, part of this, the implementation of the in vitro laboratory.
Abstract:
Introduction: The development of new drugs is a complex process, with only 0.027% of newly synthesized molecules being approved by regulatory agencies. Inadequate pharmacokinetic properties and toxicity are responsible for half of the failures in this process and the in vitro screening of new molecules assists in the selection of the best candidates and to understand the results of in the in vivo studies. In the metabolic stability assay, the molecules are submitted to a microsomal system to evaluate their degradation by the microsomal enzymes. Considering that Tuberculosis is still responsible for millions of deaths and cases of bacterial resistance to the drugs used in the treatment only increase, esters of pyrazinoic acid, the active metabolite of pyrazinamide, have been developed as a novel alternative for this treatment, and the present work aimed to evaluate the metabolic stability of POAEt POAEtPOA and POAMe.
Methodology: The compounds were incubated with 0.5mg/mL rat microsome for up to 120 minutes in buffer, with and without NADPH regenerating system. They were tested in concentrations of 2, 5 and 10μM. The samples were quantified by UHPLC, with previously developed methods. Diclofenac was used as a control of the system.
Results: The control was adequate, indicating the system operation, showing a half-life of 33 minutes. The quantification was not possible in the 2μM, while the concentrations of 5 and 10μM presented the same profile, thus, the concentration of 5μM was chosen to perform the experiment. The compounds showed no decay in any of the situations referred to it, making it impossible to calculate the elimination half-life, and therefore the extrapolated clearance.
Conclusion: It was observed that the three molecules were stable in this system and there was no activity of the microsomal enzymes on these compounds.
Alia Moosavian
Mashhad university of medical science, Iran
Title: Decrease Doxorubicin resistance in breast cancer cell line by Anti-FOXM1 aptamer
Biography:
Alia Moosavian is an assistant professor of pharmaceutical nanotechnology at Mashhad University of medical science. she completed her PhD and Pharm.D at Mashhad University of medical science. Her research interests lie in the area of target delivery in cancer treatment, liposomal formulations, and design aptamers against new targets. Her secondary field is designing formulation to topical treatment of dermal diseases
Abstract:
The transcription factor Forkhead box M1 (FOXM1) is a key regulator of cell proliferation and is over-expressed in many forms of primary cancers, leading to uncontrolled cell division and genomic instability. FOXM1 is the top-ranked survival-associated transcription factor in patients with triple-negative breast cancer. Previous studies showed, silencing FOXM1 expression led to breast cancer cells to become more sensitive to Doxorubicin (Dox). The aim of this study was an improvement of therapeutic efficacy of Doxorubicin by co-delivery of FOXM1 and AS1411 aptamers in the liposomal formulation. The synergist effect of encapsulated aptamers in liposomes and Doxorubicin was studied by MTT and Annexin PI test. Combination of FOXM1 aptamer and Doxorubicin significantly improved therapeutic efficacy of Doxorubicin and lessened the required amount of Doxorubicin. The results of the MTT assay exhibited that combination therapy significantly decreased cell viability in MDA-MB-231, MCF-7, and 4T1 cells compared to CHO cells, which significantly preserved their viability. The Annexin PI test also showed FOXM1 aptamer increases apoptosis effect of Doxorubicin. In vivo findings confirmed that synergistic combination of FOXM1 aptamer and Dox enhanced antitumor effectiveness and reduced toxicity toward nontarget cells, opening up new insights into cancer treatment.
Sagaram Sudhakar
Wollega University, Ethiopia
Title: The challenges in documentation and data in the global pharmaceutical sector & their impact in regulatory management
Biography:
Sudhakar Sagaram pursued his PhD in the concentration of Organic Chemistry from Gujarat University, India. He is a reputed official with extensive knowledge in Pharmaceutics and also known for scientific publishing in the respective field. It was his contemplating thought process that channeled his innovative ideas towards the integration of improved quality management systems with regulatory compliances in polymer and Pharmaceutical sectors. His area of expertise also includes certifications from the International register of certified auditors (ISRA) and International Organization for Standardization (ISO). As a credible individual, Dr. Sagaram has functioned the role of a lead auditor for a range of large-scale pharmaceutical sectors in the speciality of Quality Management Systems (QMS) of which, Orchid Chemicals and Pharmaceuticals, Hospira Healthcare, and Pfizer limited. can be referred to few of his associations, at which he contributed his skills and made sure of their accountability. As of now, he is working the position of Associated professor in the Department of Pharmacy, College of Health Science, Wollega University, Ethiopia.
Abstract:
It is very interesting to reflect up on the fact that the recent regulatory observations reveal that most of the observations were deficient of understanding and implementing of the correct documentation and quality and authenticated data collection reporting system. In every sector documentation is playing a very critical role. The criticality lies in designing, adopting, training, executing and making the people to realise their accountability and finally monitoring the effectiveness of the document. The documents are the excellent tools to control the procedures which ultimately lead to control over the quality. The consistent process control leads to the consistence in the quality of product and this is possible only through good documentation practice. Documentation play the critical role for maintaining the sustain growth in global regulatory market the Prompt, transparent and detailed technical documentation only the ultimate tool even to handle the regulatory audits. Health care industries play very critical role in the people’s progress, happiness and the growth of every nation. Global regulatory requirements are changing spontaneously to strengthen the security and safety of the patients and the Small and Medium Business Units (SMBU) across the globe are continuously under pressure to execute and achieve the global regulatory requirement. The gaps between SMBU and the regulatory expectations are communication, understanding and proper execution of global regulatory agencies expectations. The quality assurance, Compliance and regulatory professionals must lead the situation in confidential manner to support the SMBU”s Growth and to sustain the global pharmaceutical business competition. In this presentation we discuss how to initiate the practice of good documentation practices. In this regard the quality of the data is also play a very critical role how we can maintain authentic, genuine and quality of data and traceability of data these are the critical things which play very important role during the handling regulatory matters
Jorg Bampfer
Anton Paar GmbH, Germany
Title: Compliance to national and international standards, traceability and data integrity
Biography:
Abstract:
Data security, integrity and traceability play’s an ever-increasing role for both, users and suppliers of analytical instrumentation. Today, this is particularly driven by pharmaceutical regulations, whose main aim is to make substances entering the human body as safe as possible. Also in food-, flavor- and fragrance applications traceability quickly gains importance. In polarimetry and refractometry, the foundation to quantitative analysis and common standards has been laid by sugar industry associations in close cooperation with national metrological institutes, primarily ICUMSA International Commission for Uniform Methods of Sugar Analysis, NIST National Institute of Standards and Technology, agency of U.S. Department of Commerce, Gaithersburg, USA and PTB Physikalisch-Technische Bundesanstalt, Braunschweig / Berlin, Germany. Calibration with a reference standard is only meaningful if the standard can be traced back to a national standard or normal, cf. VIM: Traceability is “the property of the result of a measurement or the value of a standard whereby it can be related to stated references, usually national or international standards, through an unbroken chain of comparisons all having stated uncertainties.” Additionally, the instrument used for the analysis should offer more than only the required compliance, as still human errors during the instrument use, could have a major impact on the quality of the results and their traceability.