Scientific Program

Conference Series Ltd invites all the participants across the globe to attend 2nd International Conference and Expo on Biopharmaceutics and Biologic Drugs San Antonio, USA.

Day 1 :

Keynote Forum

Monica C. Chuong

MCPHS University- USA

Keynote: Biopharmaceutics in drug-device combination products

Time : 10:30-11:00 AM

Conference Series Biopharma 2016 International Conference Keynote Speaker Monica C. Chuong photo
Biography:

Dr. Monica C Chuong from Massachusetts College of Pharmacy & Health Sciences University, USA

Abstract:

Combination products demonstrate their clinical importance and success and are now being regarded strategies to overcome some long-standing clinical problems. They are mainly drug-device combination applications, drug enhanced devices and device-based drug delivery systems. This presentation elucidates pacemaker, different generations of drug eluting coronary stents, antibiotic-loaded bone cements, collagen-based dressings as therapeutic agents for wound healing, drug-device combination products for ocular applications, including molecularly imprinted hydrogel contact lenses.

Keynote Forum

Arie Regev

Eli Lilly, USA

Keynote: Hepatotoxicity due to Cancer immunotherapy targeting immune checkpoints

Time : 10:00-10:30 AM

Conference Series Biopharma 2016 International Conference Keynote Speaker Arie Regev photo
Biography:

Dr. Regev received his M.D. degree from the Hebrew University in Jerusalem, Israel. He completed residency in Medicine and fellowship in gastroenterology at Rabin Medical Center and Tel Aviv University and clinical fellowship in Hepatology and Transplant Hepatology at the University of Miami (UM), Florida. He continued working at UM as Associate Professor of Medicine and director of the hepatology fellowship program until 2007. He joined Eli Lilly in 2007, and currently heads Eli Lilly’s Safety Advisory Hub and chairs Eli Lilly’s Liver and GI Safety Committee. Dr. Regev is the author of numerous publications in major medical Journals and several chapters in major medical textbooks. He is also an Associate Professor of Medicine at the Division of Gastroenterology and Hepatology of Indiana University School of Medicine.

Abstract:

Immunotherapy is a rapidly developing treatment modality for cancer. Of the broad range of immunotherapies presently in clinical development and clinical use those targeting T cell inhibitor receptors, referred to as “checkpoints”, are the most advanced. They include monoclonal antibodies directed against cytotoxic T-lymphocyte antigen-4 (CTLA-4) and programmed cell death‑1 (PD-1). Activation of the immune system by inhibiting T-cell checkpoints may cause immune-mediated toxicity, which may be serious and potentially fatal. Abnormal hepatic biochemical tests have been reported in as many as 8% of patients receiving immunotherapy, while clinically significant immune-mediate liver injury has been reported in about 1.5%. In some cases severe liver injury has occurred and cases of acute liver failure leading to death have been reported. Presently there is no reliable method to predict which patients will develop immune-mediated liver injury, and there is no dependable way to identify patients who will develop severe liver injury or liver failure. Although most patients respond to corticosteroid therapy, in some cases additional immunosuppressive agents have been used with varying results. Approaches to monitoring and therapy of such patients are still evolving, and may require studies of large cross-pharma databases, to enable better understanding of the natural history and response to therapy of this potentially lethal complication.

  • Herbal Drug Interactions
Location: Hilton San Antonio Airport
Speaker
Biography:

Hiroyuki Matsuda has completed his PhD at the age of 29 years from Nihon University. His research field is chemical engineering thermodynamics. He is the associate professor of Nihon University. He has published more than 30 papers in reputed journals.

Abstract:

The object of this study is to search a suitable co-solvent of poorly water-soluble bioactive compounds in natural products on the basis of the solubility measurements. In this study, curcumin (diferuloymethane), the Indian solid gold, the major active component of turmetic, was selected as a model bioactive compound. Curcumin is used as a spice in curry and as a coloring agent in yellow mustards, cosmetics, and pharmaceuticals. It has attracted great interest because of its antioxidant, anti-inflammatory, and potential cancer chemopreventive activities. However, the major problem with curcumin is its extremely low solubility in aquous solution and poor bioavailability. If addition of a suitable co-solvent makes an enhancement of solubilities of curcumin, it would be useful for the development of drug or functional food which an efficient systemic absorption is available. In this work, several β-CD derivatives, e.g., 2-hydroxypropyl- (2-HP-), sulfobutyl ether (SBE-), and methyl- (M-) β-CDs, were investigated as a co-solvent. The solubilities of curcumin in water + CD mixed solvents, and a suitable co-solvent for an enhancement of the solubilities in curcumin was examined. The solubilities of curcumin in water + CD mixed solvents at 298.15 K were determined using high-performance liquid chromatography (HPLC). Enhancement in the solubility of curcumin could be achieved in all β-CD derivatives. Maximum solubilization shows M-β-CD, and follows SBE-β-CD and 2-HP-β-CD. Stability constants kc were evaluated by Takeru Higuchi-Konnors solubility method. The order of the determined stability constants were M-β-CD > SBE-β-CD > 2-HP-β-CD.

Speaker
Biography:

Matteo Micucci has completed his PhD at the age of 29 years from Bologna University and he carries on his research focused on Medicinal Chemisrty and Nutraceuticals at Department of Pharmacy and Biotechnology, University of Bologna. He spent a three months period, as visiting PhD Student, in the Research Laboratory of Medicinal Chemistry of De Montfort University (DMU), Leicester, UK. He has published 19 papers in reputed journals and he is Science Adviser, in the field of Nutraceuticals, Alternative and Complementary Medicines, at Segreteria Particolare of a Senator of the Italian Republic, from October 12th, 2015 to date.

Abstract:

Gastro-intestinal infections constitute important emerging and re-emerging infective worldwide diseases. They are mostly endemic and show a heterogeneous aetiology. Most water-borne diseases caused by microorganisms induce diarrhoea and determine about 5 million deaths per year. The research on anti-diarrheal tools should be focused on the evaluation of substances and chemically charachterized phytocomplexes able to affect intestinal motility and to exert a prebiotic action. Several plants, such as Castanea sativa Mill., Sanseviera liberica Gerome & Labroy, have been shown to inhibit gut peristalsis, through several mechanisms. Furthermore, disparate classes of natural compounds including hydrolysable tannins and flavonoids, restore intestinal functionality, affecting different molecular networks influencing each other’s. Acacia catechu Willd extract (ACE) has been used in Indian Traditional Medicine to manage several diseases including diarrhoea and other gastrointestinal ailments. This extract was shown to contain high amounts of flavonoids, in particular flavan-3-ols. Furthermore, in vitro biological assays were exerted, using tissues from guinea pigs, to assess ACE effects towards induced and spontaneous intestinal smooth muscle contractility. The results demonstrated that ACE reducecs spontaneous and induced colon and ileal smooth muscle contractility via inhibiting muscarinic and histaminergic receptors. Also ACE effects against several pathogenic and non pathogenic bacteria were tested, showing a selective antibacterial activity towards pathogenic strains including, Staphylococcus aureus, Gram-negative Escherichia coli, Salmonella spp, Campilobacter, without inhibiting. These findings suggest that Acacia may represent a nutraceutical option to manage diarrheal infectious and non infectious disesases

Kala D

Govt Medical College, Thiruvananthapuram, India

Title: Budesonide Microspheres for Colon Targeting
Speaker
Biography:

working as Associate professor of Pharmaceutics, College of Pharmaceutical Sciences , Govt Medical College, Thiruvananthapuram, Kerala, India. 28 years of teaching and research experience. Regarding Colon targeting two articles were published in the international journals (one in press). Formulation and in vitro evaluation of Budesonide microspheres for colon targeting vol 7, issue 2, February 2016.IJPSR. In vivo evaluation of Budesonide microspheres for colon specific drug delivery. Vol 8, issue 4, April 2016 IJPPS.

Abstract:

A number of colonic diseases could be treated more efficiently by delivering the drug locally in the colon. For the management of active, mild to moderate ulcerative colitis, an oral preparation of topical corticosteroid with reduced systemic exposure is preferred. Budesonide, a synthetic non-halogenated potent corticosteroid with high topical anti-inflammatory effect was selected as model drug.The polymer selected; chitosan is biocompatible, non-toxic and can be biodegraded by the microflora present in the human colon. Budesonide microspheres were prepared by ionotropic gelation process and were coated with eudragit S-100 polymer to prevent drug release in the stomach. The effect of concentration of polymer chitosan and cross linking agent TPP on drug entrapment efficiency, particle size and release profile were investigated. To assess the biodegradability of chitosan by the colonic microorganism, in vitro release studies in presence of rat caecal content were also performed. In vivo therapeutic experiment was done using TNBS induced colitis in rats. The therapeutic effect was assessed by determining the damage score, clinical activity score, C/B weight ratio and MPO activity measurement. The study showed that oral administration of budesonide microspheres exerted an affirmative impact on the colonic ulcer healing by decreasing the area of ulceration, reducing the mass of colon by improving the symptoms of colitis. The designed system was highly promising for potential targeting of budesonide to the colonic region with inconsiderable drug release under simulated gastric condition.

Speaker
Biography:

Kissi Mudie has completed his MSc in medical biochemistry from Addis Ababa University, School of Medicine. He is the director of National clinical chemistry laboratory, Ethiopian Public Health Institute. He has published more than 14 papers in reputed journals and has been serving as an associate researcher.

Abstract:

The safe use of medicines is a critical issue for all health care professionals, Background: Cancer refers to a group of diseases that are associated with a disturbance in the control of cell growth and metabolism. Indeed, the unbalanced control of cellular proliferation is a primary characteristic of cancer cells and, as such, any molecule capable of inhibiting cancer cell proliferation may also be useful as a potential chemo-preventive agent. Throughout history, antioxidants have been the most significant source of anticancer and chemopreventing agents. More than 1,000 different phytochemicals are already proved to possess interesting chemopreventing activities. Antioxidants consist of a wide variety of biologically active phytochemicals including phenolics, flavonoids, carotenoids, etc. that have been shown to suppress early and late stages of carcinogenesis. Objective: To review recent biochemical and molecular mechanisms, in relation to natural and synthetic chemopreventing substances (antioxidants) for cancer control and management. Major findings: Antioxidants exert anticancer effects via a variety of mechanisms, including removal of carcinogenic agents, modulation of cancer cell signaling and cell cycle progression, promotion of apoptosis and modulation of enzymatic activities. Conclusion: This review provides an updated and comprehensive overview on the anticancer effects of antioxidants in-vitro and in-vivo animal models including recent intervention studies. Finally, possible mechanisms of action involving antioxidant and pro-oxidant activity as well as interference with cellular functions are discussed.

Speaker
Biography:

Dr. R.K.Purohit at present working as Professor of Zoology in Govt. Dungar College, Bikaner (Rajasthan), India. He has 25 five years of teaching and research experience. He has published around 40 research papers in journals of international repute. He has attended dozens of national and International conferences and presented his papers. He has also chaired the sessions in many international conferences. Dr. Purohit has produced 19 Ph.Ds. and 20 M.Phil. scholars under his able supervision. He has visited Singapore, Malaysia and Japan. He is the recipient of many national and international awards. Dr. Purohit has organized one National conference on herbal radioprotection in the year 2004 (October 17=-19, 2004) and an International conference during the January, 2012 (January 24-25, 2012). He is the life member of many academic societies. At present he is holding the prestigious status of National Secretary, Indian Society for Radiation Biology who is specially working in the field of herbal radioprotection.

Abstract:

In today’s changing global scenario, ionizing radiation is considered as most potent cause of oxidative stress mediated by free radical flux which induces severe damage at various hierarchical levels in the organization in the living organisms. Testis is a highly prolific tissue with fast cellular renewal and poor antioxidant defense; therefore, it becomes an easy target for the radiation- induced free radicals that have long been suggested as major cause of male infertility. Radiation causes deleterious effects in all forms of life due to increasing utilization and production of modern technology, a simultaneous exposure of organisms to heavy metals is also unavoidable. These heavy metals become toxic when present in large quantities, with increasing the industrial revolution and industrial waste, the emission of lead has increased into the environment. Thus concomitant exposure to lead acetate and ionizing radiation might produce deleterious effect upon biological system. The total environmental burden of toxicants may have greater effect as against their individual impact as expected by their nature. So interaction between radiation and other toxicants represents a field of great potential importance. In the recent years, immense interest has been developed in the field of chemoprotection against radiation and heavy metals induced changes. In view of the potential for practical application, a variety of compounds are being tested for their radioprotective activities. Among these, Emblica holds a great promise. In light of the above, the present study was aimed to evaluate the protective effect of Emblica officinalis extract (ECE) against radiation and lead induced qualitative, quantitative and biochemical alterations in the testes of Swiss albino mice. The animals were exposed to 3.0 and 6.0 Gy of gamma rays with or without lead acetate treatment.. The Emblica was administered seven days prior to irradiation or lead acetate treatment. The animals were divided into seven groups. The non drug treated control groups were administered lead acetate and exposed to irradiation whereas the experimental groups were given Emblica seven days prior to irradiation or lead acetate treatment. Irradiation resulted into significant decrease in the frequency of different spermatogenic cell counts along with severe histo-pathological lesions up to 14th day in control animals and day-14 in experimental animals thereafter, recovery followed towards the normal architecture. ECE pre- treatment effectively prevented radiation induced end of experimentation. Furthermore, ECE administration inhibited radiation and lead induced changes in the testes of mice. These observations signify that the Emblica officinalis extract can be used as an efficient radio- protector against radiation mediated qualitative, quantitative and biochemical alterations in testes.

Jeanne Leblond

Université de Montréal, Canada

Title: Switchable lipids for pH-sensitive siRNA delivery
Speaker
Biography:

Jeanne Leblond has completed his PhD at the age of 26 years from Université Paris VI and postdoctoral studies from faculty of Pharmacy of University of Montréal. She is assistant professor at the faculty of pharmacy since 2011. She is the director of the research axis “Drug Formulaiton and Analysis” and has trained over 20 students in 5 years. She has published 13 research articles, 1 book chapter, most of them in journal with IF higher than 4.5.

Abstract:

RNA interference provides a targeted approach for silencing gene expression that may prove beneficial in the treatment of diseases such as cancer and genetic disorders. To ensure effective knockdown, siRNA must be entrapped and efficiently conveyed into the cytoplasm of cells. These hydrophilic nucleic acids have to cross the lipid-rich plasmatic and/or endosomal membrane, without being degraded into lysosomes. We have developed new pH-sensitive lipids able to change conformation upon protonation at endosomal pH values, leading to the disruption of the lipidic bilayer and thus to the fast release of the nucleic acids into the cytosol. The objective of this work was to design a fast-responding system at pH 5 while remaining stable at blood pH value and during storage. This was achieved by the design and synthesis of a series of switchable lipids, and their incorporation into lipid nanoparticle (LNP) composition. LNP complexed with siRNA exhibited high silencing efficiency, reaching up to 10% on HeLa cells, very similar to a commercial agent, with lower toxicity. Negative controls demonstrated that the improved efficiency was due to the conformational switch of the lipids. In vitro transfection potential was confirmed on various cells lines (HeLa, A549, Huh-7) and siRNA targets (GFP, PCSK9, survivin). In vivo applications are currently focused on liver disease, such as hypercholesterolemia. Indeed, liver targeting has been shown in mice by fluorescence imaging. This system has recently been able to reduce the LDL as well as HDL cholesterol blood levels of mice after a single i.v. injection of LNP/siRNA.

Jeanne Leblond

Université de Montréal, Canada

Title: Switchable lipids for pH-sensitive siRNA delivery
Speaker
Biography:

Jeanne Leblond has completed his PhD from Université Paris VI and Post-doctoral studies from faculty of Pharmacy of University of Montréal. She is Assistant Professor at the Faculty of Pharmacy since 2011. She is the Director of the research axis “Drug Formulation and Analysis” and has trained over 20 students in 5 years. She has published 13 research articles, 1 book chapter, most of them in journal with IF higher than 4.5.

Abstract:

RNA interference provides a targeted approach for silencing gene expression that may prove beneficial in the treatment of diseases such as cancer and genetic disorders. To ensure effective knockdown, siRNA must be entrapped and efficiently conveyed into the cytoplasm of cells. These hydrophilic nucleic acids have to cross the lipid-rich plasmatic and/or endosomal membrane, without being degraded into lysosomes. We have developed new pH-sensitive lipids able to change conformation upon protonation at endosomal pH values, leading to the disruption of the lipidic bilayer and thus to the fast release of the nucleic acids into the cytosol. The objective of this work was to design a fast-responding system at pH 5 while remaining stable at blood pH value and during storage. This was achieved by the design and synthesis of a series of switchable lipids, and their incorporation into lipid nano-particle (LNP) composition. LNP complexed with siRNA exhibited high silencing efficiency, reaching up to 10% on HeLa cells, very similar to a commercial agent, with lower toxicity. Negative controls demonstrated that the improved efficiency was due to the conformational switch of the lipids. In vitro transfection potential was confirmed on various cells lines (HeLa, A549, Huh-7) and siRNA targets (GFP, PCSK9, survivin). In vivo applications are currently focused on liver disease, such as hypercholesterolemia. Indeed, liver targeting has been shown in mice by fluorescence imaging. This system has recently been able to reduce the LDL as well as HDL cholesterol blood levels of mice aft er a single I.V. injection of LNP/siRNA.

Teimuraz Lezhava

Head of the Department of Genetics, Director of Institute of Genetics, Tbilisi State University,Georgia

Title: Epigenetic change of genome by peptide bioregulators in extreme old age
Speaker
Biography:

Professor T. Lezhava's scientific works are generally dedicated to the problem genetics of aging. He has discovered that the progressive heterochromatinization occurs in aging. Professor T. Lezhava is delivering lectures in Genetics, Human Genetics with the Fundamentals of Molecular Genetics, Medicine Genetics and Evolution of Genome.  Professor T. Lezhava is a member of editorial board of Journals:“Georgian medical News”; “Gerontology and Geriatric Research“ (NJ, USA); Jacobs Journal of Gerontology (Texas, USA); Edition “Inter ging” and Journal of Deutscher Wissenschaftsherold” (Germany); Journal of “Biomedicina»(Russia). Professor T. Lezhava is a member of the International Association and USA of Biomedical Gerontology, President of Georgian Gerontology Association,

Head of Georgian Human Genetic Association and member of several local and foreign Scientific Academies.

Abstract:

The object of present investigation is to the study modification of chromosome (total heterochromatin, constitutive and facultative heterochromatin) under  the influence of peptide bioregulators (Ala-Glu-Asp-Gly, Ala -Glu-Asp-Pro, Lus-Glu-Asp-Ala and Lys-Glu) and heavy metal  in cultured lymphocytes derived from old individuals 

Methods: The level of total heterochromatin identified by the method of differential scanning microcalorimetry;  the level of facultative heterochromatin – by the method of sister chromatid exchanges (SCE), level of satellite stalk and C-heterochromatin   under  the combined effect of  bioregulators  and Co Cl2 have been studied in lymphocyte cultures from individuals at the age of 80 and over.

Results: The results showed that: 1) epigenetics processes – progressive heterochromatinization of total, constitutive (pericentromeric, telomeric and NOR heterochromatin) and facultative heterochromatin occurred with aging; 2)peptide  bioregulators induce deheterochromatinization of chromosomes in old age;3) higher level of   SCEs (deheterochromatinization) were registered in precentromeric and  telomeric heterochromatin upon  combined effect of Co ions and peptide bioregulators.

Conclusions:  The proposed genetic mechanism responsible for constitutive and  facultative heterochromatin epigenetic change (hetero- and deheterochromatinization pericentromeric and  telomeric region) of old age  may lead to the development of therapeutic treat.

Upendra L Patel

Arihant School of Pharmacy and Bio-Research Institute, India

Title: Design and evaluation of press coated pulsatile release tablets of Prednisolone
Speaker
Biography:

Upendra L Patel has completed his PhD from Sardar Patel University, Anand, Gujarat, India in 2010. He is the Head of Department & Associate Professor in Department of Pharmaceutics & Pharmaceutical Technology in Arihant School of Pharmacy & BRI, Gujarat, India. His area of research is formulation and evaluation of controlled drug delivery formulations. He has guided more than 25 MPharm students. He has published more than 40 papers in reputed journals and one book “Dispensing Pharmacy & Drug Store Management”. He is life time member of Gujarat Pharmacy Teacher Associations.

Abstract:

To formulate and evaluate a press coated pulsatile release tablets of prednisolone using an admixture of hydrophilic polymer, i.e., low substituted hydroxy propyl cellulose (L-HPC) and hydrophobic polymer, i.e., ethyl cellulose (Ethocel 10 cps) in order to achieve a pre-determined lag time for chronotherapy of rheumatoid arthritis. Th e press coated pulsatile tablets containing prednisolone in the inner core were prepared by compression coating with L-HPC and Ethocel 10 cps as the outer layer in different ratios. The effect of polymer ratio and weight gain of the outer layer on lag time of drug release was investigated using 32 full factorial design. The parameters determined were tablet hardness, friability, drug content, lag time, in vitro dissolution. The release profile of the press coated tablet exhibited a distinct lag time before burst release of prednisolone. Lag time was dependent on the ratio of L-HPC/Ethocel 10 cps and weight gain in outer shell. The lag time was from 1 to 10 hr and could be modulated as it decreased as the amount of L-HPC in the outer layer increased. A surface plots are also presented to graphically represent the effect of independent variables on the lag time. The validity of generated mathematical model was tested by preparing checkpoint formulation. Formulation PCPT7 with L-HPC/Ethocel 10 cps (10:90) and weight gain 300 mg showing predetermined lag time of 5 hr prior to burst release of the drug from the press coated tablet was taken as the optimized formulation.