9^th World Drug Delivery Summit June 30-July 02, 2016 New Orleans, Louisiana, USA

Pieter R. Cullis, Ph.D. Director, Life Sciences Institute, University of British Columbia; Chair, Personalized Medicine Initiative; Professor, Department of Biochemistry and Molecular Biology, Director, NanoMedicines Research Group, UBC. Dr. Cullis and co-workers have been responsible for fundamental advances in the generation, loading and targeting of lipid nanoparticle (LNP) systems for intravenous delivery of small molecule drugs and macromolecular drugs such as small interfering RNA (siRNA). This work has contributed to three LNP products that have been approved by regulatory agencies in the U.S. and Europe for the treatment of cancer and its complications and six more that have finished Phase I clinical studies. Dr. Cullis co-founded Lipex Biomembranes Inc., Tekmira Pharmaceuticals, Northern Lipids Inc., and, most recently, Acuitas Therapeutics and Precision NanoSystems. In addition, he co-founded and was Scientific Director of the Centre for Drug Research and Development (CDRD) 2004-2010. He has published over 300 scientific articles and is an inventor on over 40 patents. Dr. Cullis has received many awards, including the B.C. Science Council Gold Medal for Health Sciences in 1991, the Alec D. Bangham Award for contributions to liposome science and technology in 2000 and the B.C. Biotechnology Association award for Innovation and Achievement in 2002. He was elected a Fellow of the Royal Society of Canada in 2004, received the Leadership Award of the Canadian Society of Pharmaceutical Scientists in 2010 and was awarded the Prix Galien, Canada’s premier prize for achievements in pharmaceutical R&D, in 2011.

My research interests are focused on the roles of lipids in biological membranes and the use of lipid nanoparticle (LNP) systems to deliver drugs. Regarding the functional roles of lipids I am interested in the widespread ability of membrane lipids to adopt non-bilayer structures and the roles of such structures in processes such as membrane fusion, transport processes across bilayer lipid systems induced by ion gradients and the development of increasingly sophisticated model membrane systems that more accurately reflect biological membranes. My interests in LNP drug delivery systems concern first the in vivo delivery of small molecules, particularly drugs used in cancer chemotherapy, with the aim of increasing efficacy and reducing toxicity. In this work the aim is to take advantage of the proclivity of long-circulating LNP systems to accumulate at sites of disease such as tumour sites and sites of inflammation to maximize the benefits inherent in providing local sustained release of drugs at sites of disease. A second area concerns the design of LNP systems that are able to effectively deliver their contents into the cytoplasm of target cells following i.v. administration, thus enabling the therapeutic use of macromolecular genetic drugs such as siRNA, antisense oligonucleotides, mRNA and plasmids for gene therapy. In all, these efforts have led to 10 LNP drugs that have been approved for clinical use or are in clinical testing.

Professor Istvan Toth PhD, DSc is a Chemical Engineer, ARC Australia Professorial Fellow, Chair in Biological Chemistry and Professor of Pharmacy at the University of Queensland. His major research interest these days is drug, vaccine and gene delivery. He is active in research commercialisation as one of the key founders of Alchemia (ASX listed), Implicit Bioscience, Neurotide and TetraQ. He has more than 300 peer-reviewed publications and 43 patents. He is the Editor-in-Chief of Current Drug Delivery, and Drug Delivery Letters. He is a Fellow of the Royal Australian Chemical Institute (FRACI) and the Queensland Academy of Science and Art (FQA).

Professor Toth works to develop synthetic peptide- and nanoparticle-based vaccines including the development of delivery platforms and safe synthetic adjuvants. These vaccines target group A streptococcus, tropical diseases like malaria, hookworm and blood flukes, and the treatment of established tumors like those caused by human papilloma virus infection. Professor Toth also works to improve the stability and delivery route of existing medicines or promising drug leads. Recent drugs of interest have been the natural pain peptides Enkephalin and Endomorphin-1, an orally available version of reproductive hormone Gonadotropin Hormone Releasing Hormone, and combination antibiotics that reduce bacterial resistance.

Gjumrakch Aliev, MD, PhD, President “GALLY” International Biomedical Research Institute Inc., San Antonio, Texas, USA. He also hold appointment with the University of Atlanta, Atlanta, Georgia, USA as a Professor of Cardiovascular, Neuropathology, Gerontology, Health Science and Healthcare Administration. He received his MD in 1982, from the Baku Medical University (former USSR) with cum laude. Then he accomplished his PhD in Cardiovascular Diseases from the prestigious Russian Academy of the Medical Sciences, Moscow, Russia in 1988 with cum laude. He received postdoctoral training with Professor G. Burnstock in the University College of the London. He authored and coauthored more than 500 publications in the fields of neurodegenerative diseases research (Alzheimer disease), as well as cardio- and cerebrovascular disease, cancer, and electron microscopy. He is an outstanding teacher, scholar, and a renowned scientist in the area of cellular molecular physiology, and cardiovascular, and neurodegeneration-mediated pathologies and drug development including Alzheimer disease (AD). He is nationally and internationally reputed in his area.

Aliev’s accomplishments in the area of biochemistry and cellular biology have tremendous implications for drug design towards CNS Neurological Disorders, AD, cancer, and cerebrovascular and neurodegeneration related pathologies. He is world-renowned expert in electron microscopy. His work has been published in numerous prestigious journals such as Nature Clinical Cardiology, J. Neuroscience, Circulation Research, New England journal of Medicine, Blood, J. Cellular and Molecular Medicine, Atherosclerosis, CNS Neurological Disorders & Drug Targets, International J. Biochemistry and Cell Biology, Scientific Reports, and many others which reflect his leading role in his research areas. He is currently the Editor in Chiefs for “Central Nervous System Agents in Medicinal Chemistry”, “Applied Cell Biology”, “World Journal of Neuroscience”, “Open Journal of Psychiatry” and “Journal of Aging Science”, Cardiovascular & Hematological Agents in Medicinal Chemistry as well as which by itself shows the voluminous and outstanding work he has accomplished in the area of cellular and molecular biology as well as aged associated clinical sciences. He is one of most cited authors in his fields with high impact factors.

Dr. Irach B. Taraporewala has over 30 years’ experiece in drug discovery/drug development R&D. He currently is President of the Sitara Pharmaceutical Consulting Group. He previously served as founder, CEO, President and Chief Technology Officer, and on the Board of Directors of OHR Pharmaceutical, Inc. an ophthalmology drug development company, and as a Drug Development consultant at PAREXEL Consulting. Dr. Taraporewala has published papers in drug development and delivery in reputed journals and has lectured extensively. He received a Ph.D. in Medicinal Chemistry from the Philadelpjhia College of Pharmacy and Science, and has been Principal Investigator on several NIH/DoD biomedical research grants.

Consulting on Pharmaceutical Company start-up and phased growth strategic planning, Drug Development and Regulatory Strategy, Risk management, CMC Regulatory Affairs, CMC Module 2 and 3 CTD submissions and review, Drug Master File submissions for APIs, GMP, Medicinal Chemistry, Drug Design, Organic Synthesis, Drug Discovery and Development, Quality Assurance, Quality Systems, Technology/intellectual Property Due Diigence for Mergers and Acquisitions, Pharmaceutical Portfolio Assessment , Formulation Development, Sustained Release Pharmaceuticals, Drug-Device Combination Products, SBIR/STTR Grants and IP Evaluations. Specialist on guiding success-driven strategy and regulatory pathway development to small and mid-sized pharmaceutical and biotech companies transitioning from the R&D stage to preclinical and clinical phases of drug development. Consultant services for strategic partnerships, due diligence for technology/IP evaluation on Mergers & Acquisitions, and on portfolio companies for venture firms.

Dr. Hiroshi Maeda is a world renowned expert in macromolecular therapeutics. He was successful in creating the world first polymeric drug, SMANCS, approved for treatment of hepatoma in Japan. Consequently, he discovered the concept of EPR effect of macromolecular-drugs, ubiquitous mechanism for solid tumor selective targeting of polymeric drugs. He received MS, University of California, Fulbright Fellow, and Ph.D., M.D., Tohoku University. He published more than 450 papers in reputed journals. He was awarded Lifetime-Achievement-Award at Royal-Pharmaceutical-Society, Princess-Takamatsu-Award in Cancer Research, Tomizo-Yoshida-Award, highest award of JCA, and also selected as most cited influential scientist in pharmacology by Thomson Reuters 2014.

Formulation and Development, Drug Delivery, Pharmaceutical Industry, Drug Delivery Technology, Pharmaceutical Nanotechnology, Peptide and Protein Drug Delivery, Drug Discovery and Drug Development.

Hajime Mori has completed his PhD at the age of 26 years from Nagoya University and postdoctoral studies from The National Institute of Agrobiological Sciences. He is a trustee and vice-president, and also professor of Kyoto Institute of Technology. He has published more than 90 papers in reputed journals and has been serving as the editor of Journal of Insect Biotechnology and Sericology

Hajime Mori has completed his PhD at the age of 26 years from Nagoya University and postdoctoral studies from The National Institute of Agrobiological Sciences. He is a trustee and vice-president, and also professor of Kyoto Institute of Technology. He has published more than 90 papers in reputed journals and has been serving as the editor of Journal of Insect Biotechnology and Sericology

Christophe is Professor at the University of Strasbourg teaching at the European School of Chemistry, Polymers and Materials Science (ECPM). He received his MS and PhD degrees in chemical engineering from the National Engineering School of the Chemical Industries (Nancy) and Paul Sabatier University (Toulouse), respectively. His researches concern the development of intensified and integrated microfluidic-assisted polymer processes for the synthesis of architecture-controlled polymers and functional microstructured polymer particles

Microencapsulation is used for the protection of drug, controlled release, reduced administration frequency, patient comfort and compliance. In comparison with conventional techniques for encapsulation, microfluidics offers a new route to precisely control over microcarriers’ size, shape, morphology, composition and thus release properties. Continuous-flow off-the-shelves capillaries-based microfluidic droplet generators, assembled within minutes, were used to produce size-controlled and drug-loaded plain, core-shell, Janus and Trojan polymeric microcarriers. A single capillary-based device was employed to obtained either poly(ethyl acrylate) plain microparticles or poly(acrylamide) Trojan microparticles embedded with drug-loaded poly(ethyl acrylate) nanoparticles previously obtained from the nanoemulsification of the monomer phase within an elongation flow micromixer. On the opposite, a two capillaries-based device was employed to prepare poly(acrylamide)/poly(methyl acrylate) core-shell and Janus microparticles from the emulsification into droplets of two immiscible monomer phases that were downstream polymerized by UV irradiation at 365 nm far away from maximum absorption wave length of drugs thus insuring their integrity.

Chauhan has completed his PhD at the age of 27 years from Central Drug Research Institute (CDRI), Lucknow, India and recieved postdoctoral training from University of Nebraska Medical Center (UNMC), Omaha, NE.. Currently he is serving as a Professor of Pharmaceutical sciences at Yniversity of Tennessee Health Science Center (UTHSC), Memphis, TN, a premier educational institution. He has published more than 85 papers in reputed journals and has been serving as an editorial board member for sevral journals of international repute.

Pancreatic cancer (PanCa), is the fourth leading cause of cancer related deaths in the United States due to the lack of early diagnosis and poor response to available therapeutics. Thus, identification of newer therapeutic approaches that can aid current therapeutics is highly desirable. We have defined multidimensional roles of MUC13 mucin in the pathogenesis and therapeutics/imaging of PanCa. We have reported that MUC13 is highly expressed in human pancreatic tumors but not in normal pancreas and its expression progressively increases with disease stage and metastasis. MUC13 enhances tumorigenesis through modulation of multiple oncogenes (HER2, PAK1, ERK, metastasin/S100A4, TERT, sonic hedgehog (SHH), GATA-1) associated with tumorigenesis/metastasis and desmoplasia. We have also observed a functional interaction of MUC13 and HER2 in PanCa cells and identified miR-145 as a tumor suppressor and a novel regulator of MUC13 in PanCa. Additionally, we have identified drugs that inhibit tumor desmoplasia (targets SHH pathway) and enhances therapeutic response of gemcitabine, thus, can be of therapeutic benefit for PanCa. Moreover, we have generated unique anti-MUC13 mouse monoclonal (MAb) and recombinant humanized (HuAb) antibodies that can efficiently target pancreatic tumors. Furthermore, we have successfully generated multiple patented nanoparticle formulations for antibody guided tumor specific targeted drug delivery and imaging. Taken together, our data suggest a crucial role of MUC13 in PanCa pathogenesis. Utilization of a novel anti-MUC13 monoclonal antibody can be used for the targeted tumor specific delivery of novel nanoparticle formulations in pancreatic tumors. This research will establish the multifaceted role of MUC13 in pathogenesis of PanCa and advance diagnosis and therapy of PanCa to reduce the morbidity and mortality caused by this devastating disease.

Rajiv Nayar is Founder and President of HTD Biosystems. Previously, Dr. Nayar was at Bayer where he established the formulation and drug delivery Group in the biotechnology division and was responsible for managing the formulation and drug delivery activities within the global Bayer network on protein/peptide based drugs. He was a recipient of 3 consecutive Presidential Achievement Awards at Bayer for implementing Continuous Improvement Processes in pharmaceutical development. He is an inventor on 15 patents and has authored over 70 publications. He is the inventor the Bayer’s albumin-free Factor VIII formulation (Kogenate® FS). Prior to Bayer, he was at the Canadian Liposome Company and involved in the development of liposomal doxorubicin (Caelyx®, Myocet®). Dr. Nayar received his Ph.D. (Biochemistry) from University of British Columbia and was a MRC fellow at M.D Anderson Tumor Institute.

Formulation, Development of liposomal doxorubicin, Drug Delivery, Pharmaceutical Industry.

Ãœlo Langel is a Professor at the Department of Neurochemistry, Stockholm University, and at the Institute of Technology, Tartu University. Prof. Langel has been selected as a Fellow Member of International Neuropeptide Society (1995), and is a member of Academia Europeaea. He is a coauthor of more than 400 scientific articles and 20 approved patents or patent applications.

Introduction of PepFect and NickFect technologies for oligonucleotide transfection by transportan-based cell-penetrating peptides in vitro and in vivo is described. Recent data on mechanisms and applications of PepFect strategies are summarized on the variety of different cargoes including plasmid, antisense and siRNA oligonucleotides.

Kim is Founder and former Co-Chairman for the International Symposium on Recent Advances in Drug Delivery, which is held biennially in Salt Lake City since 1983. He is on the Editorial Board of the Journal of Controlled Release, Pharmaceutical Research, Journal of Biomedical Materials Science, and Biomaterials Science journals. He is a Fellow in the AAPS, Biomaterials Society, and the AIMBE societies. Dr. Sung Wan Kim is currently a Distinguished Professor of Pharmaceutics and Pharmaceutical Chemistry, Distinguished Professor of Bioengineering. He received his B.S. and M.S. at Seoul National University in 1963 and 1965, respectively, and his Ph.D. in Physical Chemistry at the University of Utah in 1969 (under Professor Henry Eyring).

Dr. Kim is a pioneer and has been engaged in drug delivery research since 1974 in the areas of hydrogels, biodegradable drug conjugates, self-regulating drug delivery and stimuli sensitive polymers. He has also worked extensively in medical polymers, especially blood compatible polymers. Dr. Kim\'s present research includes design of novel polymers for the delivery of protein drugs, cells and genes.

Saha received my PhD degree in Bioinformatics jointly from the University of Arkansas for Medical Sciences University of Arkansas at Little Rock, in Little Rock, Arkansas. Early in my life, I obtained a Bachelor of Science degree in Chemistry from The University of Calcutta in Kolkata, India and in 2006, I completed my Master of Science degree in Bioinformatics from The West Bengal University of Technology in Kolkata, India I have established a scientific profile through high-caliber publications in peer-reviewed journals and conference presentations throughout my career so far. Presently, I am a Senior Scientist in Computational Biologist at GlaxoSmithKline (GSK) pharmaceuticals working in the area of microbiome. My interests lie broadly in the area of Computational Biology, Computational and Structural Chemistry, Structure based drug design, Immuno-informatics and Microbiome research.

Tumor associated carbohydrate antigens (TACAs, Computational Biology, Computational and Structural Chemistry, Structure based drug design, Immuno-informatics and Microbiome research.

Omathanu Perumal is a Professor and Head of Department of Pharmaceutical Sciences at South Dakota State University. He has over 18 years of experience in developing new drug delivery systems. His group has developed natural protein based drug delivery platform for various drug delivery applications. In addition his group has developed novel topical and transdermal drug delivery approaches. Dr. Perumal has published close to 50 peer reviewed publications, and delivered over 100 presentations. He has four issued patents and two pending patent applications. Dr. Perumal is the founder and Chief Scientific Officer of Tranzderm Solutions Inc. He serves as the editor-in-chief of Journal of Biomedical Nanotechnology (Impact factor: 5.338). He is the recipient of Patricia Walker Skin Cancer Research Award from Skin Cancer Foundation, F.O. Butler Award for excellence in research, Distinguished Researcher award and Intellectual Property & Commercialization award from South Dakota State University.

Drug Delivery, nanoparticulate Systems, Topical Drug Delivery, drug bioavailability and drug administration

Dr. Abagyan’s research focuses on the development of novel technologies for structure based drug discovery and optimization, structural systems biology for target finding and protein modeling. We screen specific biomedical targets to discover new drug leads, and validate them experimentally. The applications include antibiotics, cancer, neuro-degeneration, viral and endocrine diseases. To extend the reach of docking we model alternative functional states and allosteric pockets of the kinases, GPCRs and Nuclear Receptors. We derived comprehensive sets of ligand pockets (the Pocketome) competing for ligands and metabolites in different organisms. These data are used for target identification and polypharmacology profiling. We dock drugs, leads and environmental chemicals to the ‘anti-target’ models to predict endocrine disruption and other adverse effects.

Structure Based Drug Discovery, Toxicology, Protein Modeling and Design

M. A. Mateescu (PhD from Bucharest Polytechnic University and receiver of a “Honorary Laurea” from Rome University “La Sapienza”) is full Professor at UQAM since 1994. His research relates to Multifunctional Proteins and to Drug Targeting. Co-inventor of more than 30 patents covering therapeutic enzymes and new excipients for drug delivery, Dr Mateescu developed fruitful collaborations with pharmaceutical companies and was involved in several technological transfers. He published more than 130 papers in reputed journals, one book, 8 book-chapters. He is holder of Bombardier Prize (1999) for Technological Innovation, of Venezia Prize (Italian Chamber of Commerce, 2012), of Research-Career Prize (UQAM, 2014).

The continuous improvements of pharmaceutical formulations have been achieved by means of hydrogels, in particular environmentally sensitive hydrogels, considered as smart delivery systems able to release the drug at the appropriate time and site in response to specific physiological triggers. The rich panoply of their structures and properties highly recommend the starch derivatives as excipients for drug sustained release or for chrono-delivery systems.