16^th Annual Medicinal & Pharmaceutical Sciences Congress October 16-17, 2017 Seoul, South Korea

Biography:

Dr. Sunil S. Iyer is Associate Vice President & Head of the Department of Clinical Research and Biopharmaceutics at Mankind Pharma Limited, India. He provides leadership on Clinical, Biopharmaceutical and Bioanalytical activities based out of the company’s R&D Centre at Manesar, Haryana and serves as the Scientific Point- of-Contact for conceptualization, planning, design and execution of Bioavailability and Bioequivalence studies for drug product development and registrations. He is additionally responsible for providing critical biopharmaceutical inputs on formulation development and bio-waiver assessments. Dr. Iyer’s team specializes in design and interpretation of complex pharmacokinetic modeling and simulation activities, inclusive of PK/PD analyses, In vitro-In vivo Correlations, Population Pharmacokinetic Analyses and In vitro Release/Penetration studies on Oral and Non-oral dosage forms.

Dr. Iyer was previously employed at Sun Pharmaceutical Industries Limited (erstwhile Ranbaxy Labs) and at an academic CRO in the USA, where he held positions of increasing responsibility.

Subsequent to his Ph.D. degree in Pharmaceutical Sciences from Virginia Commonwealth University (VCU), Richmond VA USA, he was engaged in Postdoctoral research work with Dr. William H. Barr. He had earlier completed his Master’s degree in Pharmaceutics from Birla Institute of Technology, Ranchi, India. Dr. Iyer has been a recipient of several awards during his illustrious career, serves as a reviewer for reputed international journals and is a member of professional pharmaceutical organizations.

Abstract:

Methods for evaluating bioequivalence (BE) of oral dosage  forms have been implemented for decades now. Scientific and commercial interests however are leaning towards generic development of non-oral products, primarily owing to enhanced efforts at catering to unmet medical needs through alternate drug delivery routes and a decrease  in “blockbuster” oral molecules. Though core principles remain the same, the approaches to establish  equivalence  vary significantly for non-oral  dosage  forms and have presented  formidable challenges, as opposed  to oral drug products. In most cases, a ‘case-to-case’ approach  has been the need, more so if specific regulatory guidelines have not been published. While few products do have pharmacokinetic end-points governing BE criteria, most involve clinical end-point BE studies. However, the latter are difficult to conduct and even upon completion, the clinical end point studies do not necessarily ensure accuracy in differentiating formulation performance. Above reasons have in effect pushed the scientific and regulatory communities to evaluate in vitro options to establish equivalence, an essential factor in most cases being that the formulation composition   is at  least needed  to be  qualitatively and  quantitatively similar to the reference listed drug product. A multidisciplinary  approach to establish bioequivalence involving amalgamation of formulation, analytical, pharmacokinetic and statistical principles  is utmost necessary for successful generic development based on Q3 (microstructure) based equivalence methods.

This presentation will highlight  approaches  to establish bioequivalence for non-oral dosage  forms, with an emphasis on ophthalmic, nasal and topical products.

Biography:

 Dr. Tulika Prasad is Assistant Professor in Jawaharlal Nehru University (JNU), New Delhi, India and teaches Nanobiotechnology and Nanomedicine at Special Centre for Nano Sciences. She is one of the founder faculty members of AIRF-JNU, a State of Art Research Laboratory. She works on Nanomedicine, Infectious Disease Biology and Multi Drug Resistance (MDR) especially in Candida albicans (a fungal pathogen) and Mycobacterium tuberculosis (Tuberculosis causing bacteria). She has a research group of 6 PhD students and two postdoctoral fellows.

       She did graduation in Biological Sciences from Presidency College, Calcutta, India, Masters from Calcutta University and carried out Ph.D. at School of Life Sciences, JNU, New Delhi working on identification of novel drug targets and functional significance of membrane lipids in MDR and morphogenesis in pathogenic yeast, C. albicans. She received Postdoctoral Fellowships from DBT and CSIR and worked at Special Centre for Molecular Medicine, JNU to successfully demonstrate iron as a novel modulator of drug resistance and morphogenesis. She received NIH Visiting Fellowship at Liver Diseases Branch, NIDDK, NIH, Bethesda, Maryland, USA for the year 2008-09.

          Dr. Tulika has published around 40 original papers and book chapters in reputed peer-reviewed international journals and books. Her work has been awarded at several national and international conferences. She is recipient of Several Young Scientists Awards and received Ranbaxy Young Science Scholar Award for 2008 in the field of Medical Sciences by Ranbaxy Science Foundation and Innovative Young Biotechnologist Award, 2008 by Department of Biotechnology, Govt. of India. She received Best Hall Presentation Award in Young Scientist Conclave at India International Science Festival (IISF)-2016 by Ministry of Science and Technology and Ministry of Earth Sciences, Govt. of India for her work “Combating Multi Drug Resistance in Candida: a nano-based approach”.

Abstract:

Nanomedicine, an offshoot of nanotechnology has made a rapid and broad impact on healthcare. Various nanostructures and their combination with existing drugs have shown promising potential to improve the diagnostics and therapeutics for infectious diseases and combat the microbial drug resistance. More than 200 nanomedicine products are either in approval process or under clinical investigations, but their successful clinical translation is still challenging. There is only 10% success rate eventually in approval for nanotherapeutics entering Phase I clinical trials. Therefore, a combinatorial approach is required for translational research to develop a successful strategy for fast Food and Drug Administration (FDA) approval e.g. repurposing of drugs, use of FDA approved nanoparticles platform with existing drugs. Various nanoparticles such as Silver (Ag), Gold (Au), Zinc oxide (ZnO), Iron oxide (Fe3O4), Titanium oxide (TiO2), Zirconium oxide (ZrO2) and combinations of nanomaterials like Chitosan/Guanidine Functionalized Graphene Oxide, Chitosan − Iron Oxide Coated Graphene Oxide have exhibited antimicrobial activity. But the mechanism of antimicrobial activity of these nanomaterials or nanomedicines is still debatable and their safer medical adoption requires detailed investigations on the biological entities.

Among many nanomaterials, silver nanoparticles (AgNps) known for their antimicrobial properties and higher microbial toxicity have gained more impetus in biomedical and industrial applications than other metal nanoparticles. However, safer clinical applications of AgNps still require more clinical trials and research at the level of molecular biology to delineate the intracellular pathways involved before evaluating its potential host toxicity. My presentation will be towards the effect of AgNp on drug efflux pump proteins and evaluation of synergistic potential of AgNp with other antifungals against opportunistic pathogen, Candida albicans. Our findings showed that ‘nanosilver-based drug combinations’ has the potential to address the challenges of multi-drug resistance (MDR) and fungal therapeutics by favoring broad spectrum activity, multiple cellular targets and minimal host toxicity. This paves the way for development of silver-based nano-biopolymer composites having enhanced antifungal activity when combined with other drugs potentiating: i) enhanced cellular effect of otherwise less effective drugs, enabling the use of drugs in lower doses (reduction in doses ranging between 4 times to 200 times for drugs tested), thus, reducing their side effects ii) development as biofilm inhibitors. The clinical benefits of nanoformulations of existing drugs have been realized through their decreased toxicity and improved efficacy.

Dr. Tulika Prasad is Assistant Professor in Jawaharlal Nehru University (JNU), New Delhi, India and teaches Nanobiotechnology and Nanomedicine at Special Centre for Nano Sciences. She is one of the founder faculty members of AIRF-JNU, a State of Art Research Laboratory. She works on Nanomedicine, Infectious Disease Biology and Multi Drug Resistance (MDR) especially in Candida albicans (a fungal pathogen) and Mycobacterium tuberculosis (Tuberculosis causing bacteria). She has a research group of 6 PhD students and two postdoctoral fellows.

               She did graduation in Biological Sciences from Presidency College, Calcutta, India, Masters from Calcutta University and carried out Ph.D. at School of Life Sciences, JNU, New Delhi working on identification of novel drug targets and functional significance of membrane lipids in MDR and morphogenesis in pathogenic yeast, C. albicans. She received Postdoctoral Fellowships from DBT and CSIR and worked at Special Centre for Molecular Medicine, JNU to successfully demonstrate iron as a novel modulator of drug resistance and morphogenesis. She received NIH Visiting Fellowship at Liver Diseases Branch, NIDDK, NIH, Bethesda, Maryland, USA for the year 2008-09.

Dr. Tulika has published around 40 original papers and book chapters in reputed peer-reviewed international journals and books. Her work has been awarded at several national and international conferences. She is recipient of Several Young Scientists Awards and received Ranbaxy Young Science Scholar Award for 2008 in the field of Medical Sciences by Ranbaxy Science Foundation and Innovative Young Biotechnologist Award, 2008 by Department of Biotechnology, Govt. of India. She received Best Hall Presentation Award in Young Scientist Conclave at India International Science Festival (IISF)-2016 by Ministry of Science and Technology and Ministry of Earth Sciences, Govt. of India for her work “Combating Multi Drug Resistance in Candida: a nano-based approach”.

Biography:

Prof. Mulayam S. Gaur has his expertise in chemical synthesis, biosynthesis, characterization of nanomaterial and their application to develop nanobiosensor and nanomedicine. He has focused on multidisciplinary research such as polymer nanocomposites and their applications, biosensor based on nanomaterial  for detection of blood TSH (i.e. blood harmones), pesticides, heavy metals etc. He is having 25 year teaching and academic administration experience. He is having joint research project with National Centre of Biotechnology, Moscow (Russia).He has published 75 research papers in International reputed Journals and guided 10 Ph.D. He was the group leader of pesticide awareness programme ( i.e in north India) of Department of Science and Technology, Government of India during 2008-2009. He has received Bharat Shikshha Ratan Award in 2004. He is actively engaged alongwith team to popularize the science at gross root level.  Currently he is holding the position of Dean R&D and looking after the research programme. He has elected as a President of Nano and Molecular Society (India) (http://www.nmsindia.net).

Abstract:

The aptamers have potential to create new binding sites, if nanoparticles are functionalized by suitable way. The functionalization of nanoparticles is serious issue among the scientists. The attraction on aptamers is because of their stability, low molecular weight, and their rapid and reliable synthesis and production.  The interaction of aptamers with nanoparticles provides the more and more binding sites for target molecules and increases the sensitivity of aptasensor system. Gold and silver nanoparticles and their alloy are one of the most interesting sensing materials because of their unique size and shape dependent properties, high surface energy and surface-to-volume ratio, and tunable surface properties. Aptamers are oligonucleotides that can bind their target ligands with high affinity. The use of these particle that are bioconjugated with aptamers for selective and sensitive detection of analytes such as small molecules and metal ions, has been demonstrated.

In this work Au, Ag and their alloy nanoparticles were prepared by chemical synthesis method and characterize by Zeta potential and TEM.

The aptasensor were developed and applied for detection of arsenic (III), cobalt (II), lead (II), mercury (II) in real water samples. 

The several experiments were carried out with the variation of different parameters such as pH, concentration of nanoparticles and aptamers. We found that Ag-Au alloy NPs have very good efficiency towards detection of heavy metals. Analytical parameters and kinetics will be described in detail to know the nature and working mechanism of aptasensor. This presentation focuses on recent progress in the design and development of nanobiosensors based on aptamers (i.e. aptasensor) integrating functional aptamers with nanoparticles. Different aptasensor (i.e.Colorimetry, fluorescence, amperometry, surface plasmon resonance etc) for detection of heavy metals with high sensitivity and selectivity will be described.