Scientific Program

Conference Series Ltd invites all the participants across the globe to attend 4th International Conference and Exhibition on Biologics and Biosimilars Baltimore, USA.

Day 3 :

  • BCS & IVIVC Based Biowaivers
    Pharmacovigilance and its Challenges
    Plant Produced Biosimilar Products

Session Introduction

Gene M. Ransom, III

University of Maryland and University of Baltimore School of Law, USA

Title: A review of the how State regulators are dealing with biosimlairs. A case study of the Maryland policy debate and legislation.
Speaker
Biography:

Gene M. Ransom, III is CEO of the largest physician organization in Maryland, MedChi, The Maryland State Medical Society. As MedChi executive, Ransom implements MedChi’s mission as an advocate for physicians, patients, and the public health of Maryland. MedChi currently represents over 7,500 Maryland physicians, created several Accountable Care Organizations, and operates one of Maryland’s largest Insurance Agencies. Ransom has worked hard on key public health issues like protecting Medicaid, promoting public health programs, and insurance reform in his role as director. Ransom is a life-long resident of the Delmarva Peninsula and was elected to the Queen Anne's County Commission in November 2002. Ransom was the only incumbent County Commissioner re-elected in the 2006 election. Ransom graduated from The University of Maryland with honors in economics and the University of Baltimore School of Law. When elected, at thirty-one, Ransom made history as the youngest Commissioner ever to serve Queen Anne's County. During his term as Commissioner he fought for fiscal responsibility, managing a budget of over 100 million dollars and voting for a balanced budget every year in office while reducing the Queen Anne’s property tax rate by over twenty cents during his two terms. Ransom was an instrumental part of a bipartisan effort to bring the first full service twenty four hour emergency room to Queen Anne’s County.

Abstract:

Speaker
Biography:

Gordon T Bolger received his BSc in Biochemistry from McGill University and a PhD degree in Molecular Pharmacology from the State University of New York. He then held key positions at the National Institutes of Health as Assistant Professor at Memorial University of Newfoundland and with Boehringer Ingelheim Research and Development, Canada. He possesses extensive experience in the preclinical drug development area with key expertise in evaluating the pharmacodynamics and pharmacokinetics of candidate drug molecules. He has authored /co-authored 95 publications and 53 scientific communications. Presently, he is a Senior Scientist / Study Director at Nucro- Technics, a pharmaceutical contract research organization.

Abstract:

This study utilized safety, pharmacodynamic and pharmacokinetic data to compare the biosimilarity of the human recombinant erythropoietin (EPO) products ior®EPOCIM and Eprex® following a 28-day repeated intravenous dose administration in male and female Sprague-Dawley rats with a 14-day recovery period. Safety profiling was based on clinical observations, clinical pathology and pathology findings for control rats dosed with vehicle and rats dosed either with 30, 300 and 600 I.U./kg of ior®EPOCIM or 600 I.U. of Eprex®. Adverse findings for both ior®EPOCIM and Eprex® were similar and were a consequence of thrombotic events (ulcerative skin lesions, swollen hock joints/lameness, stomach ulcers) and decreased body weight gains, all known adverse reactions to this class of drug in rats. With the exception of stomach ulcers, all other adverse findings were fully reversible with a similar time course for both products. Neither drug stimulated the production of anti-drug antibodies. As expected, iorEPOCIM® and Eprex® both increased reticulocyte, red blood cell, hemoglobin, and hematocrit levels in rats to a similar extent. The pharmacokinetics of EPO following dosing with either ior®EPOCIM or Eprex was well behaved, displayed bioequivalence and was consistent with the literature. The results of this study imply that ior®EPOCIM and Eprex® had safety profiles, pharmacodynamic responses and toxicokinetic profiles that were consistent with biosimilarity for both products.

Manjunath Ajanal

Rajiv Gandhi Educational Society's Ayurvedic Medical College, India

Title: Conception of Ayurveda Adverse Drug Reaction and Pharmacovigilance: An overview
Speaker
Biography:

Dr.Manjunath is a Research Scholar at the Department of Dravyaguna KLEUs BMK Ayurveda medical college Belgaum, India. His research interests include drugs derived from plant and other natural sources and their adverse drug reactions.

Abstract:

Drug safety is a very basic and fundamental concept in medical practice. ADRs play an important role in assessing patient safety in any system of medicine. Pharmacovigilance study is thus significant to understand treatment outcomes. Current raised issue with respect to complementary and alternative system medicine (CAM) like Ayurveda is increased in number of safety reports along with report misinterpretation; this generates the negative impact on system. Although, Ayurveda which is holistic system of medicine from India has elaborated the causes and methods of drug induced consequences along with preventive measures the available data in classical texts is scattered. The compilation and analysis along with modern concept drug safety is need of the hour. Present literature review was conducted from various compendium of Ayurveda and electronic data base with search terms of ‘Vyapad’, ‘Viruddha’, ‘Ahita’, ‘herb-herb interaction’, ‘idiosyncrasy’, ‘Prakritiviruddha’ etc. The reported information was analyzed for the possible correlation on concept of ADR and Pharmacovigilance of current science. Overall review demonstrated that drug interaction, iatrogenic, over dose, administration of unsuitable drugs, reprehensive drug administration with respect to disease, complication from five procedural therapies (Panchakarma) and reprehensible preparation of mineral drug are nearer to the modern causes of ADR. Thus, concept of drug safety and ADR is not new to the Ayurveda. The concept “Drug which is not appropriate to be used as medicine”(Abheshaja) of Ayurveda sounds similar as that of modern pharmacovigilance.

Speaker
Biography:

Adetunji, Olawale is a Ph.D. holder, Medical Microbiologist and Chief Lecturer at the Osun State Polytechnic, Iree. Nigeria. His research activities include; Medical Bacteriology, Environmental Microbiology and Public Health Microbiology. He has made some modest contributions in these major areas of Microbiology with notable publications in peer reviewed learned national and international journals. His current publication include; Olawale, A. K., David, O.M., Oluyege, A.O., Osuntoyinbo, R.T, Laleye, S.A. and Famurewa, O. (2015). Histopathological changes induced in animal model by potentially pathogenic Enterococcus faecalis strains recovered from ready-to-eat food outlets in Osun State, Nigeria. Infection and Drug Resistance, 8: 181-187.

Abstract:

Biocides are an essential part of infection control practices and aid in the prevention of bacterial infections. This work investigates the antibacterial effectiveness of four brands each of disinfectants, antiseptic and ordinary soaps purchased from different supermarkets in Osogbo and Ado-Ekiti, Nigeria against selected Enterococcus faecalis strains, using standard methods. The disinfectants include; Septol, Dettol, Purit and Izal. The soaps assessed were: Medisoft, Robert, Tetmosol, Tura, Lux, Morning fresh, Mama- gold, and Canoe. Two of the disinfectants (Septol and Purit) had the highest growth inhibition of the test isolates (55% and 65% respectively). Antibacterial effectiveness of ordinary soaps; Mama-gold, Morning-fresh, Premier and Lux were recorded as 10%, 15%, 15% and 20% respectively, followed by antiseptic soaps (Medisoft 30%, Tura40%, Robbert 35% and Tetmosol 50%). The effect of holding time on the rate of kill of soaps and disinfectants does not show any significant difference except in Purit with highest at 100 seconds. This research concludes that disinfectants have higher prevention potency on enterococcal pathogens with high records of inhibition (55% and 65%) of Septol and Purit on Enterococcus faecalis strains as against the inhibition of antiseptic soap, Tetmosol (50%) and ordinary soap, Lux (20%). Hence, the use of disinfectants and antiseptic soaps should be encouraged in our food canteens, to prevent the spread of enterococcal infections.

Speaker
Biography:

Neha Gulati has completed her M.Pharm in 2011 and pursuing PhD from IFTM University in Pharmaceutics. She has been awarded silver medal in B.Pharm and Academic Excellence Award. She has published more than 25 papers in journals of repute and has been serving as an editorial board member of repute.

Abstract:

In the biopharmaceutical market, therapeutic recombinant proteins are the noteworthy and rapidly inflating segment. Molecular types of these recombinant proteins can basically comprises of anticoagulants, blood factors, engineered protein scaffolds, enzymes, growth factors, hormones, interferons and interleukins. These are fabricated in bacteria, yeast, filamentous fungi, insect cells, mammalian cells and transgenic plants. Foremost manufacture of 38 percent recombinant proteins is achieved by E. coli, 36 per cent by CHO cells, 16 per cent by yeasts, 12 per cent by other mammalian systems. In the breakthrough, recombinant protein drugs have upheaval the future for the therapy of several types of cancer and rheumatic conditions. The significant techniques adopted for the manufacture of protein products includes reformulation, pegylation and other forms of modification. Bottom-up and top-down approach are major for the fabrication of recombinant proteins. The potential business of therapeutic proteins have stated a major change with improved efficacy, greater safety, and reduced immunogenicity. The conventional pharmaceutical manufacturers will have to concentrate for these future biologic products. It will be a big assessment to bring about the innovation, to achieve untained, secure, cost effective and high yielding recombinant human therapeutic proteins with superiority.

Speaker
Biography:

Dr Manjeeta Gupta, is currently a third year postgraduate student pursuing MD Pharmacology at MIMER Medical College Talegaon Dabhade Pune, Maharashtra, India. She has completed her Bachelor in Medicine Bachelor in Surgery (MBBS) in 2010 from BVP Deemed University, Pune, Maharashtra, India. She has also done a one month internship (February 2015 - March 2015) at National AIDS Research Institute, Pune, India. She was awarded third prize in Oral Presentation on “Newer drug delivery systems in geriatric age group” in GERICON 2014, Lonavala, Maharashtra, India.

Abstract:

Background: Drug-drug interaction (DDI) is a specific type of adverse event, which develops due to multiple drug therapy, especially in critically ill-patients. Aim: To study the prevalence of potential DDI, their severity, clinical significance, and their association with patient characteristics in Intensive Care Unit (ICU) patients in a tertiary care hospital. Material and Methods: A prospective, observational study was conducted for a period of 3 months (July 2014 -September 2014) to assess the potential DDIs using Medscape Drug Checker Software and Lexi-Comp, Inc. Version: 2.7.5. drug interact android mobile application. Results: A total of 180 patients, majority of which were suffering from cardiovascular conditions (30%) were included in the study with a prevalence of 77.78% potential DDIs. In those with hospital admission more than five days, 65.73% had potential DDIs. There were 229 potentially interacting drug pairs with corticosteroids, aspirin, beta blockers, and diuretics being commonly involved in potential drug interactions. A total of 2336 interactions were observed with an occurrence rate of 3.08 DDI per patient. Severity was moderate in 64.63%, pharmacodynamics mechanism in 72.49%, and 60.26% had risk rating category C. Conclusions: The present study showed high concomitant drug administration of potentially interacting drugs. The prevalence confirmed the association of polypharmacy and duration of hospital stay. Vigilant prescribing approach is needed to prevent hazardous outcomes of DDIs.

  • Biosimilar Analytical Strategies.
Speaker
Biography:

Afshin Safavi, PhD, Founder and CSO at BioAgilytix, is a veteran biochemist with extensive experience in establishing and leading bioanalytical teams in support of the development of biological products in preclinical and clinical-trial laboratories. Prior to founding BioAgilytix Labs, he was the Director of Ligand Binding and Immunoassay. At Grifols, he led the Preclinical and Clinical Assay Development team, building on his experience as a senior scientist at Nobex Corporation, GlaxoSmithKline and IGEN International. He is considered an expert in the area of immunoassay with a wide working knowledge of various platforms.

Abstract:

Biosimilars are entering the landscape as patents for major branded large molecule products start to expire over the next few years. This rapid drive is fueled by the potential to reduce treatment costs and increase the accessibility of treatments for everyone around the world. However, generation and approval of biosimilars are not trivial as a biosimilar medicine is essentially a new biological product that is similar (not identical) to a medicine that has already been authorized to be marketed. In this presentation, I will review the bioanalytical challenges and solutions that apply specifically to the analysis of biosimilars in biological samples with a focus on the PK, immunogenicity, biomarker and cell-based assays.

Mariana Babayeva

Touro College Of Pharmacy, USA

Title: Protein Binding Drug-Drug Interaction
Speaker
Biography:

Mariana Babayeva MD, PhD is an Associate Professor at Touro College of Pharmacy, New York, NY. In addition to her role at Touro, Dr. Babayeva is also an Adjunct Professor at RockefellerUniversity and Visiting Scientist at Arnold and Marie Schwartz School of Pharmacy of LIU.Dr. Babayeva has over 10 years of experience in clinical practice. She is recognized for her expertise in the pharmacokinetics and the use of animal and organ models. Dr. Babayeva has conducted several international research projects. Dr. Babayeva has been published in peer-reviewed journals and serving as an editorial board member of repute.

Abstract:

The effect of protein binding interaction may result in clinically significant changes in the pharmacokinetics and pharmacodynamics of a drug.A goal of this investigation was to evaluate the potential for inhibition of warfarin plasma protein binding by tizoxanide.Warfarin is a widely used anticoagulant and has a narrow therapeutic index. Tizoxanide is an active metabolite of a rapidly hydrolyzedanti-infectiveprodrug nitazoxanide. Warfarin and tizoxanideare highly bound to plasma albumins. Nitazoxanide is a compound that expected to be co-administered with warfarin and have the potential to alter warfarin protein binding. Such protein binding interaction can result in displacement of warfarin from the protein binding site, increase free plasma concentrations and raise the risk of bleeding. Plasma protein binding of warfarin was evaluated using ultrafiltration. The studies were divided into two phases. Phase I studies generated baseline protein binding values for warfarin. Phase II studies was conducted to assess the effect of tizoxanide on warfarin protein binding. Experiments were conducted over a range of warfarin concentrations. Studies were carried out at physiologic temperature and pH.Samples were analyzed by HPLC. The warfarin fractions unbound were significantly higher in the interaction studies (Phase II) compared to the values of the warfarin alone studies (Phase I). Mean fraction unbound of warfarin in Phase I studies was 0.012, in Phase II studies 0.31. Coadministration of tizoxanide significantly increased free fraction of warfarin for all concentrations tested. This interaction might increase the risk of side effects associated with warfarin administration.

Speaker
Biography:

Andy was a founding member of BioOutsource having a fundamental role in the concept of the business, Andy has developed since 2003 an in-depth knowledge of Bioassays gained from his current position at BioOutsource as Head of the Research and Development and also Custom projects and from his previous position as Study Director with Covance Laboratories in Harrogate Yorkshire where he had a leading role in the Bioassay group. Andy holds a BSc (Hons) degree in Biochemistry and an MSc in Neuroscience. His vast experience of different molecules has given him an expert knowledge on the analysis of Biological potency assays for batch release and the detection of Anti-drug Antibodies. Andy also plays a key role in the marketing strategy for the company.

Abstract:

The model for bringing a biosimilar drug to market is evolving; the regulations have required manufacturers to establish similarity based on multiple analytical methods - comparing this to the Reference Medicinal Product (RMP). However looking forward the FDA have introduced the concept; "highly similar with finger-print like similarity”, as the “gold standard” for similarity and will be viewed in a crowded market of many different biosimilars, as key to successful uptake of the drug by clinicians and patients. For manufacturers of biosimilar monoclonal antibodies, one of the greatest obstacles to meeting fingerprint like similarity is the creation of a product with the desired ADCC (Antibody-Dependent Cell–Mediated Cytotoxicity) profile, the recent approvals for Remsima demonstrates this is a continuing issue. Measuring ADCC activity relies on mimicking in vitro, the activation of innate constituents of the immune system, this is a complex stepwise series of events that can be influenced by a multitude of factors. The importance of these constituents of these steps in the immune system are slowly becoming more understood and with recent improvements in analytical methodologies we are now able to tease apart the individual interactions and better understand the ADCC potential of biosimilar monoclonal antibodies. Using ADCC data obtained from a comparison of Remicade and Remsima, this presentation will highlight the requirement for a suite of highly sensitive, orthogonal methods that can be applied at varying stages of development that allow identification of potential differences between biosimilar and RMP, prior to the application of methods with increased biological relevance to determine the potential impact on clinical efficacy or safety.

Speaker
Biography:

Dr Samantha Little is a Lead Scientist within the BioPharmaceutical CMC Solutions Division at Covance, a global drug development company, where she has worked since 2009. She has experience in CMC methodologies to support drug development of Biologics including ADCs and Biosimilars and has been a member of the Global Bioanalysis Consortium Harmonisation Team for Large Molecule Run Acceptance. Previous to Covance, Samantha worked as a Senior Scientist for a biodefense company and a post-doctoral fellow at the Hull York Medical School researching proteomics and angiogenesis. Samantha has a PhD in analytical chemistry.

Abstract:

To support a claim of Biosimilarity, the EMA and FDA are interested in the ‘totality of evidence’ where the molecule and its physicochemical and biological attributes are assessed from the perspective of clinical relevance. The assays used in these assessments need to have the ability to identify where changes in the molecule are key to clinical efficacy. There is no type of assessment which alone is capable of verifying biosimilarity. As such an orthogonal approach combining physicochemical and functional analysis is required. Results from this approach should be reflective of a molecules critical quality attributes and should hopefully minimize the extent of any clinical studies required for verification of biosimilarity, safety and efficacy. A large challenge for Biosimilars is understanding the structural function association as it relates to the activity of the antibody. Characterisation of IgG1 glycosylation has been shown to be of utmost importance, as it can impact the mode of action. We present a case study which exemplifies how identification of critical quality attributes linked to the known mode of action could have mitigated risk to a Biosimilar development program at the CMC characterisation stage. A CMC strategy has been employed to link quantitification of glycosylation with the mode of action.

Speaker
Biography:

Mario DiPaola is CSO and co-founder of Blue Stream Laboratories, Inc. He holds a PhD in chemistry and also an MBA and has been in the biopharmaceutical industry for 20 + years in various roles from scientist to company executive.

Abstract:

Glatiramer acetate, the active ingredient in the multiple sclerosis drug, CopaxoneTM, developed by Teva is a complex mixture of synthetically produced polypeptides composed of four amino acids, which include glutamic acid, alanine, tyrosine and lysine at a molar ratio of 0.141, 0.427, 0.095, 0.338. Initiation of the synthesis of the polypeptides requires the addition of diethylamine which results in the partial capping of the carboxy-termini. Blue Stream Laboratories has developed a series of analytical and mass spectrometric approaches to analyze the heterogeneity of the carboxy-termini of glatiramer acetate. Such methods and the analysis of several lots of glatiramer acetate to assess comparability between originator and biosimilar lots by these methods will be discussed.

Biography:

Dr Brijesh Kumar has completed his Ph.D from Central Drug Research Institute, Lucknow (Dr RML Avadh University Faizabad, UP. He is the Senior Principal Scientist and Facility In-charge of sophisticated analytical Instruments facility CSIR-CDRI, Lucknow, a premier drug research organization. He has published more than 81 papers in reputed journals. His current area of research is application of Mass Spectrometry tools (DARTMS/Q-TOF LCMS/4000 Q Trap LCMS/Orbitral LCMS) for qualitative and quantitative evaluation of known and unknown small molecules for quality control and authentication of Indian Medicinal Plant/parts. He is also involved in identification of marker compounds using statistical software.

Abstract:

Herbal medicines, also known as botanical medicines or phytomedicines, refer to the medicinal products of plant roots, leaves, barks, seeds, berries or flowers that can be used to promote health and treat diseases. Today, a vast range of drugs are either natural products or have been derived from them. Moreover increasing sales of herbal products indicate a worldwide concurrent surge of natural product use. Chemical fingerprinting has been demonstrated to be a powerful technique for the quality control of herbal medicines. A chemical fingerprint is a unique pattern that indicates the presence of multiple chemical markers within a sample. Similarly Natural products containing inherently large structural diversity are still a major source of bioactive agents. However many bioactive compounds have been re-discovered from new sources of natural products. To avoid it the identification of known leads at the early discovery step is highly desirable, a process known as dereplication. This method provides an efficient tool for rapid and precise identification of molecular formula of small molecules, with some characterization of sub structures, without a cumbersome process of compound isolation. Application of HRMS and hyphenated LCMS techniques for qualitative and quantitative study of bioactive phyto constituents in Indian Medicinal Plants/parts/products ( P.betle, A.paniculata, Ocimum and Rauvolfia ), with their variations and identification of makers will be discussed during the seminar.

Biography:

Dr.Dineshkumar has completed his Ph.D at the age of 31 from Vellore Institute of Technology, also he was a Junior Research Fellow (DST-Funded). His Ph.D thesis on Studies on snake venom of Indian cobra and Drug Discovery and JRF topic was Exploring the structure and functional relationship of basic poly peptides from Elapidae venom. He has handled all chromatography techniques, Circular Dichrosim etc. After his Ph.D, he had joined as Senior Scientist in Virchow Biotech Pvt Ltd in India and involved in Research& Development for process development and technology transfer for the production of recombinant Urate Oxidase for Gout disorder. Later he Joined Micro therapeutic Research Lab Pvt, India and he developed recombinant human parathyroid peptide for osteoporosis disorder. Finally he worked and developed technology transfer for the production of recombinant Streptokinase for Myocardial Infarction.

Abstract:

Native streptokinase is usually prepared from culture of Streptococcus equisimilisfor therapeutic purpose of intravenous thrombolytic agent for the treatment of myocardial infarction. The N-terminal amino acid of native streptokinase starts with Isoleucine (I), Alanine (A), Glycine (G) and followed by Proline (P) etc. The first of amino acid of Isoleucine is playing an important role for the catalytic activity of streptokinase is binding towards inactive plasminogen to activate plasminogen. The specific activity of native streptokinase is 100000 IU/mg with the initial N- terminal isoleucine amino acid. Despite the recombinant streptokinase of N-terminal amino acid begins with methionine and it is a proteinogenic for E.Coli expression. Comparison for specific activity of recombinant streptokinase shows only 85000IU/mg than 100000IU/mg native streptokinase. The reason behind this objective is that there are two forms (Isomers) of streptokinase are expressed in E.Coli which was analysed by RP-HPLC and chromogenic assay. We have found that this variation is formed by isomer-1 has 85% of Streptokinase expressed without methionine (85000IU/mg) and Isomer-2 has 15% of streptokinase expressed with methionine (nil activity) in E.Coli. This Phenomena is clearly demonstrating that the presence and absence of methionine in isomers are varying the streptokinase activity. Hence the methionine alters the streptokinase catalytic activity and is an important role for both activity and immunogenic. This is the first attempt to explore the methionine variation by our method development on RP-HPLC and chromogenic assay for improving the suppression of risk management of myocardial infarction.

Speaker
Biography:

Francesco Marchesi is a renowned scientist at the Regina Elena National Cancer Institute , Italy. His research interests are as that of biosimilars and follow-on-biologics.

Abstract:

Only limited data have been so far published about the use of biosimilar filgrastim in hematologic recovery after ASCT. The aim of this study was to compare the biosimilar filgrastim Zarzio® with the other available formulations of G-CSF in terms of efficacy and safety. From March 2013 to June 2014 we used in our Institution biosimilar filgrastim (Zarzio®, Sandoz Industrial Products Spa, Rovereto, Italy) at dosage of 5 mcg/Kg daily given from day 3 after stem cell infusion for febrile neutropenia prophylaxis and haematologic recovery in 64 consecutive adult patients who underwent ASCT. These patients were retrospectively compared with three historical cohorts: a) 99 consecutive adult patients treated with lenograstim (Myelostim®, Italfarmaco Spa, Milano, Italy) at same dosage and timing in our Institution from January 2009 to February 2013; b) 60 consecutive adult patients treated with peg-filgrastim (Neulasta®, Amgen Spa, Milano, Italy) at dosage of 6 mg single dose at day 3 after stem cell infusion in our Institution from March 2006 to December 2008; c) 79 consecutive adult patients treated with originator filgrastim (Granulokine®, Amgen Spa, Milano, Italy) at dosage of 5 mcg/Kg daily given from day 3 after stem cell infusion in Haematology Unit of Campus Bio-Medico University from May 2008 to June 2014. There is not any statistically significant difference among the four patient cohorts. We analyzed the time of hematologic recovery after stem cell infusion (defined as an absolute neutrophilis count upper than 0.5 x 109/L and a platelets count upper than 20 x 109/L), the occurrence of fever of unknown origin (FUO) in neutropenia, documented infectious episodes and needing of intravenous antibiotic treatment, the number of red blood and platelet transfusions, the days of hospitalization and the transplant-related mortality (TRM). We observed a significantly shorter time to neutrophilis and platelet recovery (P=0.001 and P=0.007, respectively) with a consequent lower median number of platelet transfusions (P=0.001) in the cohort of patients treated with Neulasta®, whereas no difference was observed among the other three groups. Moreover, we did not observe any significant difference among the four patient cohorts for all the other analyzed parameters. No difference in terms of drug-related adverse events was observed in the four patient cohorts with no serious adverse events. Considering the median days of G-CSF injections and assuming a patient median body weight of 60 Kg, the estimated cost for each patient was significantly lower in the Zarzio® group (approximately 73€) when compared with the other groups (approximately 732€ for Myelostim®, 649€ for Granulokine® and 660€ for Neulasta®; P<0.0001). Biosimilar filgrastim (Zarzio®) seems to be substantially equivalent in terms of efficacy and safety to the other G-CSF formulations when used for febrile neutropenia prophylaxis and hematologic recovery after ASCT. However, the use of biosimilar filgrastim consents to significantly limit the costs in this setting of utilization. Further prospective randomized studies are warrant to confirm these results.

Biography:

Vikas Bajpai is pursuing his PhD from CSIR- Central Drug Research Institute, Lucknow. He is senior research fellow (Council of Scientific and Industrial Research, New Delhi). He has more than six years’ experience in working and handling with many hyphenated mass spectrometric techniques. Currently he is engaged with the development of mass spectral fingerprints of natural products to check the different level of variations, adulteration from intact plant part using variousmass spectrometric techniques.

Abstract:

Thalictrum (Ranunculaceae) is very widely distributed genus of medicinal plants in India and has been reported to have many therapeutic properties like diuretic, stomachic, antiseptic, aperient etc. Approximately 290 alkaloids were reported from the 80 species of the genus Thalictrum. Alkaloids from Thalictrum are reported to exhibit various pharmacological activities like antiamebic, antimicrobial, antitumour and antiviral. Protoberberine and aporphine alkaloids are reported the major components in this plant In present study, we present simultaneous quantification of some alkaloids in Thalictrumreniformeusing ultra performance liquid chromatography coupled to hybrid triple quadrupole/linear ion trap mass spectrometry (UPLC-QqQLIT-MS) operated in the multiple reactions monitoring acquisition. The separation was achieved on an ACQUITY UPLC CSHâ„¢ C18 column using a gradient mobile phase at flow rate of 0.3 mL/min. Stock solutions of standards were prepared in methanol within the ranges from 0.5 to 1500 ng/mL.The calibration curves were constructed by plotting the peak areas versus the concentrations of each analyte. Five PBAs were quantified in which Berberine, Jatrorrhizine and Palmatine were detected in significant amount.

Biography:

Dr. Imran Ali Khan has completed his Ph.D at the age of 27 years from Osmania University and presently joined as postdoctoral studies in King Saud University. He has published more than 47 publications in reputed journals. Presently, he is working with multiple projects on relationship between consanguinity and metabolic disorders.

Abstract:

The paraoxonase 1 (PON1) gene polymorphism Q192R has been found to be consistent with multiple metabolic diseases comprising type 2 diabetes mellitus (T2DM). The R allele has been found to be associated with coronary artery disease and gestational diabetes in a Saudi population. Therefore, we attempted to determine the association between Q192R and T2DM in a Saudi population. Eight hundred subjects were enrolled in this case-control study, including T2DM patients (n = 400) and control individuals (n = 400). Epidemiological, clinical, and Q192R genotype data were obtained from all the subjects included in this study. Genotyping was performed by PCR-RFLP analysis followed by 12% polyacrylamide agarose gel electrophoresis. Most of the clinical characteristics of T2DM were associated with controls, having positive association with allele and genotype frequencies between the T2DM cases and controls (p < 0.05). Multiple regression analysis showed positive correlation of lipid profile with genotype (p < 0.05). The present findings provide robust evidence of PON1 Q192R polymorphism being associated with T2DM in a Saudi population.