Day :
Biography:
Rashid Mahmood has a master’s degree in Analytical Chemistry and an MS in Total Quality Management. He has 15 years of experience of Pharmaceutical Quality Operations and has participated in many international conferences as a keynote speaker. He has presented various talks in the USA & China on Cleaning Validation, cGMP Guidelines, Quality Risk Management, and Role of Mass Spectrometry in Pharmaceuticals and on new Drug Delivery Systems. Currently, he is working as a Senior Executive Manager Quality Operations for Surge Lab. (Manufacturer of Microencapsulated APIs, Liquid & Dry Powder Parenteral) which is the best export-oriented company of Pakistan.
Abstract:
Hot melt extrusion (HME) is emerging technology which is gaining high importance in the pharmaceutical industry as a novel technique for the preparation of various dosage forms and drug delivery systems, for example, granules and sustained-release tablets. It is a fast-growing technology platform that is utilized to solve difficult formulation challenges, primarily in the area of solubilization. Due to fast processing, a high degree of automation, absence of solvents, simple and continuous operation and ability to process poorly compactable material into tablet form are some of the main advantages offered over conventional processing by this emerging technique. Applications of HME in the pharmaceutical industry continue to grow and the recent success of this technique has made it a useful tool of consideration as a drug delivery solution. The use of hot-melt extrusion within the pharmaceutical industry is steadily increasing, due to its proven ability to efficiently manufacture novel products. HME involves the application of heat, pressure, and agitation through an extrusion channel to mix materials together, and subsequently forcing them out through a die. Twin-screw extruders are most popular in solid dosage form development as it impacts both dispersive and distributive mixing. It blends materials while also imparting high shear to break-up particles and disperse them. HME extrusion has been shown to molecularly disperse poorly soluble drugs in a polymer carrier, increasing dissolution rates and bioavailability.
Chair
Sangram Raut,
University of North Texas Health Science Center, USA
Session Introduction
Sangram Raut,
University of North Texas Health Science Center, USA
Title: rHDL: A versatile drug/biologic delivery platform
Time : 11:30-12:00
Biography:
Sangram Raut has been working with different types of nanoparticulate systems including polymeric, metallic and lipid nanoparticles. His Ph.D. and postdoctoral research further provided him with fluorescence probe development, fluorescence spectroscopy and optical imaging experience which he is combining now to develop rHDL based therapeutics in several directions. He is working on several projects related to drug delivery aspect for pediatric and solid tumors. He has published more than 40 peer-reviewed research articles, 2 book chapters, and several conference abstract/proceedings. He has been serving as a reviewer for more than 10 peer-reviewed journals in the area of nanotechnology and fluorescence spectroscopy. He enjoys playing table-tennis and photography in his free time.
Abstract:
Lipoprotein-based technologies could address many of the concerns of traditional chemotherapy via their ability to selectively deliver their payload to cancer cells and tumors via a receptor-mediated mechanism. Moreover, they have been shown to be equally effective for targeted diagnostic imaging. Specifically, it has been shown that malignant cells consistently overexpress Scavenger receptor class B type 1 (SR-B1) receptors compared to normal cells which are the receptor for lipoprotein based nanoparticles. The therapeutic index of many cytotoxic drugs can thus be significantly improved by enhancing the selective delivery and accumulation of the therapeutic agent in malignant cells and tumors vs. healthy cells and tissue, thus avoiding toxic side effects. Lipoprotein-based nanoparticles have the potential to perform tumor selective delivery and thus overcome these limitations. We will present some of our recent findings and progress in the area of lipoprotein drug delivery. Consequently, reconstituted (synthetic) lipoproteins have proven to be a superior biocompatible drug-delivery platform and thus have great potential for cancer theranostics.
Ruttiros Khonkarn,
Chiang Mai University, Thailand
Title: Overcoming multidrug resistant cancer cells with polymeric micelles of the flavonoids of the Zingiberaceae
Time : 12:00-12:30
Biography:
Ruttiros Khonkarn has completed her Ph.D. from Chiang Mai University since 2012. She also has research working experience from Institut de Biologie et Chimie des Protéines (Université Lyon 1), Utrecht Institute for Pharmaceutical Sciences (Utrecht University) and Institute of Pharmaceutical Technology and Biopharmaceutics (University of Vienna). At present, she is a lecturer at the Department of Pharmaceutical Science, Faculty of Pharmacy, Chiang Mai University, Thailand. She has published 12 papers in reputed journals.
Abstract:
Zingiberaceous plants have been used in traditional medicines throughout the tropical countries. The Zingiberaceae is rich in flavonoids especially quercetin and its derivatives. Flavonoids are potent antioxidant compounds with excellent anticancer activity. Inhibition of multidrug resistant cancer cell growth and MDR transporter by flavonoids has been reported. In this study, the water-insoluble quercetin was loaded into mPEG-b-OCL-Bz micelles. The average particle size of quercetin-loaded mPEG-b-OCL-Bz micelles was around 14-20nm with a maximum loading capacity of 7.3%. Besides, quercetin incorporated polymeric micelles are stable for 14 days at 37℃. The cytotoxicity results of this study reveal that the similar cell growth inhibition on sensitive and resistant leukemia cells was found from both free quercetin and quercetin loaded micelles which suggested that free quercetin and quercetin-loaded micelles were not transported by P-glycoprotein. Interestingly, QCT-loaded micelles increased the efficacy of the cytotoxicity of chemotherapeutic drugs (doxorubicin and daunorubicin) indicating that QCT-loaded micelle can reverse the function of P-glycoprotein. Finally, the determination of the kinetics of P-glycoprotein found that the efflux of pirarubicin was modulated by quercetin-loaded micelles in a dose-dependent manner and non-competitive mechanism. These results demonstrated that mPEG-b-OCL-Bz micelles are a promising carrier for overcoming multidrug resistance cancer.
Julio Cesar Fernandez Travieso,
National Centre for Scientific Research, Cuba
Title: A preliminary retrospective analysis of the effects of policosanol on ischemic stroke patients
Time : 12:30-13:00
Biography:
Julio Cesar Fernandez Travieso is a Senior Investigator in the Clinical Trials Unit, National Centre for Scientific Research, Havana, Cuba. He has completed his B.Sc. in Pharmaceutical Sciences from Havana University, Cuba in 1996. He was awarded Ph.D. in Pharmaceutical Sciences in 2003. He has published more than 140 publications and presented more than 110 papers in various scientific events. His research interest mainly focuses on clinical trials phase I-IV of different natural products: Policosanol, Abexol, Prevenox, and Palmex.
Abstract:
Introduction: Stroke is one of the leading causes of mortality and disability. Clinical studies conducted in patients with a recent ischemic stroke and treated with policosanol (20mg/day)+standard aspirin (AS) (125mg/day) therapy have shown benefits versus placebo+AS to patients with recent ischemic stroke.
Objectives: The objective of the present paper is to a preliminary retrospective analysis of the policosanol treatment effects in the patients included in ischemic stroke recovery trials.
Methods: This report analyzed the records of all patients included in four ischemic stroke recovery studies. Patients with a modified Rankin Scale score (mRSs) 2 to 4 were randomized, within 30 days of onset, to policosanol+AS or placebo+AS, for 6 and 12 months. The primary outcome was an mRSs reduction. Decreases on low-density lipoprotein-cholesterol (LDL-C), total cholesterol and increases on high-density lipoprotein-cholesterol (HDL-C) were secondary outcomes.
Results: Two hundred and seventy-one patients (mean age: 67 years) were included in the analysis. At the six months more policosanol+AS (117/136, 86%) than placebo+AS patients (10/135, 7.3%) achieved mRSs goals. In correspondence, at the 12 months of the study more policosanol+AS (50/59, 84.7%) than placebo+AS patients (5/59, 8.5%) achieved mRSs goals. Treatment with policosanol+AS significantly decreased mean mRSs from the first interim check-up. The treatment effect did not wear off, even improved, after 6 and 12 months therapy when the net decrease versus placebo+AS was 56% and 70.8%, respectively. In addition, policosanol+AS reduced significantly LDL-C (21.6%) and total cholesterol (12.5%), and increased HDL-C (6.3%). Treatments were safe and well tolerated. Eight patients reported serious adverse events (6 placebo+AS, 2 policosanol+AS) and other 13 patients (8 placebo+AS, 5 policosanol+AS) reported moderate or mild adverse events.
Conclusions: The preliminary retrospective analysis of the effects of policosanol+AS on ischemic stroke patients indicate that this treatment for 6 and 12 months proved to be more effective than the placebo+AS treatment in the functional recovery of these patients.
Said Abasse Kassim,
Southeast University, China
Title: Design synthesis and evaluation of a novel DNA nanothread based Cisplatin delivery system through scavenger receptors for high-efficiency anti-cancer therapy
Time : 14:00-14:30
Biography:
Said Abasse Kassim has completed his Ph.D. in Pharmacoeconomics from China Pharmaceutical University and postdoctoral studies from Southeast University School of Public Health. His evaluation of expertise and passion for improving health and wellbeing motivated him to create innovative pathways for improving healthcare. He has published several papers in reputed journals and has been serving as a reviewer of various journals including Applied Pharmaceutical Science, Cancer Epidemiology, Biomarkers & Prevention, ACS Applied Materials & Interfaces, etc.
Abstract:
To develop nucleic-acid based nanocarrier for cytotoxic-drug through self-assembly of designed sequences of artificial DNA-strands. Cisplatin having DNA binding ability is loaded in DNA-NT with the aim to achieve enhanced cytotoxicity and cell-internalization mediated by scavenger receptors targeted into Human cervical cancer cells (Hela). DNA nanothread (NT) synthesized by self-assembly of triangular-tiles made from annealing staple-strands with the circularized scaffold-strand. DNA-NT structures and integrity characterized by AFM and Native-PAGE. Cisplatin binding to the DNA-NT confirmed by UV-shift. The biocompatibility of DNA-NT and in-vitro cytotoxic studies of Cisplatin/DNA-NT assessed by MTT. Flow cytometry to quantify the effects of Cisplatin/DNA on cell-cycle phase arrest and apoptosis. The internalization of Cisplatin/DNA-NT in the cells was imaged by confocal microscopy. AFM results showed uniform DNA nanothread structures with a diameter ranging from 50 to 150nm with 300 to 600nm length. Strength/integrity of DNA nanothread was evaluated through PAGE (native), DNA nanothread being stable structure did not split into constituting strands. The results of cell viability confirmed that blank DNA-NT had the least cytotoxicity at the highest concentration with the retained value of 92% as evidence to be biocompatible nanocarrier for drug delivery. While in-vitro cytotoxicity assessment of Cisplatin/DNA-NT displayed increased anticancer activity. Flow cytometry experiments with the Cisplatin/DNA-NT increased the percentage of apoptotic cells significantly in a dose-dependent manner. Moreover, in Confocal microscopy assay, Cisplatin loaded DNA nanothread seems to efficiently deliver Cisplatin to the Hela cell nuclei. Circular DNA nanotechnology is a tool to design architects with stiffer topology and geometry based on Watson-Crick base pairing for potential applications including drug delivery. We find that being poly-anionic nature, Cisplatin/DNA-NT show enhanced endocytosis via scavenger receptors causing intracellular drug release and enhanced cytotoxicity, which boost the cancer targeting and therapy.
Yavuz Selim Silay
Istanbul Consulting Group, Turkey
Title: The critical importance of new generation government engagement navigating government healthcare reforms and their impact in the USA, Europe, Turkey, and emerging markets
Time : 14:30-15:00
Biography:
Yavuz Selim Silay is the Chairman of Istanbul Consulting Group. ICG was founded in 2013 and provided guidance to the Turkish ministry of health as part of a World Bank project. He is currently a Co-Founder of BioCube Ä°stanbul Bioentrepreneurship & Innovation Center and Corporate Communication Director of Sumitomo Group/Expel Ä°laç Archem Diagnostices Endmed and Diagen. He previously managed the largest distributor of Siemens Healthcare in Turkey managing 250 employees and director of Avcılar Hospital R&D Center, Chief Medical Officer of Lifematrix GmbH. Previously he worked as the Market Access & Health Policy Director for AIFD in Turkey. Previously he worked as the Vice-President of Ipsen pharmaceutical and Director of Teva pharmaceutical in the USA managing large clinical trials as well as Investigator Initiated Trials and developing relationships with Key Opinion Leaders. Previously, he was the Associate Director at KV Pharmaceuticals and Director in Clinical Development department at Forest Laboratories. He earned his MD from the Faculty of Medicine, the University of Ankara in Ankara, Turkey. He completed a clinical internship at Baylor College of Medicine in Houston, followed by continued research training at The University of Texas MD Anderson Cancer Center in Houston. He recently completed his Executive MBA at the Olin Business School at Washington University in St. Louis.
Abstract:
Pharmaceutical, Biotech, and Medical Device companies are constantly evaluating how decisions at the US, Europe, Turkey, and emerging markets are taken at the federal and state level and how it will impact provider and patient access and coverage to their therapies. To gain these critical insights, Government Affairs & Medical affairs teams require speaking with those on the frontlines of healthcare delivery - physicians, allied healthcare professionals, payers, and patients. New generation government engagement and commercial diplomacy approach developed by ICG ( Istanbul Consulting Group) will be provided with unique cases. Yavuz Selim Silay a global leader and seasoned expert in Government engagement, Commercial Diplomacy, Corporate Communications, Government Affairs & Medical Affairs will discuss how companies utilizing Government Affairs and Medical affairs teams should engage decision makers, payers, physicians and acquire these insights in a convenient, cost-effective, and compliant manner in this current changing global regulatory landscape.
Sonia Dhiman,
Chitkara University, India
Title: Sulfated-modified Cordia myxa gum as sustained-release and mucoadhesive excipient in Losartan Potassium tablet formulation
Time : 15:00-15:30
Biography:
Sonia Dhiman has completed her Ph.D. (Pharmaceutical Sciences) in the year 2017 from MM College of Pharmacy, Maharishi Markandeshwar University, Ambala, India, and Masters of Pharmacy (Pharmaceutics) in 2009 from Institute of Pharmaceutical Sciences, Kurukshetra University, Kurukshetra, Haryana, India. With more than 9 years’ experience in teaching & research, about 25 research (international) publications, 06 book chapters, filed 7 patents and more than 60 paper presentations in national and international conferences and has supervised 6 M. Pharmacy students for research work and authored one international book entitled “Amyotrophic Lateral Sclerosis-Motor Neuron Disease: An Insight” under publication house OmniScriptum GmbH & Co. KG, Germany.
Abstract:
Native gums may be limited in function, but modification may improve their activity. The objective of the present study was to evaluate the native and modified form of Cordia myxa gum for its sustained release and mucoadhesive properties. Modification of natural Cordia myxa polysaccharide was done using sulfation technique. The modified polymer was evaluated for mucoadhesive characteristics with systematic optimization by central composite experimental designing. The tablets prepared with modified polymer were compared with native polymer and Carbopol 934. The mucoadhesive tablets of Losartan Potassium were evaluated for various parameters such as weight variation, hardness, friability, drug content, content uniformity, mucoadhesion strength, in-vitro release characteristics and in-vivo gastric retention study. Modification improved the gum's flow properties, resulting in Carr's index and Hausner's ratio lower than 15% and 1.25, respectively. Swelling studies showed that modified gum had lower water absorption capacity and swelling index values while packing properties improved upon sulfation, indicated by lower tapped density values. Modification of the gum was confirmed by FTIR, DSC and 1H NMR. The gum's mucoadhesive properties were improved and sustained release action of 24h was obtained. Sulfation of native Cordia myxa gum improved the flow, mechanical and sustained-release properties of Losartan Potassium tablets. The results suggested that sulfation of Cordia myxa gum proved to be a successfully employed method for formulation of mucoadhesive drug delivery systems to alleviate the drawbacks of the conventional delivery of the drugs in the management of hypertension thereby improving the patient compliance.
Location: Montreal, Canada
Chair
Said Abasse Kassim,
Southeast University, China