Theme: Discoveries in Prediction of Toxicity and Drug Monitoring

Toxicogenomics 2015

Renowned Speakers

Toxicogenomics 2015

Toxicogenomics-2015 is a remarkable event which brings together a unique and International mix of large and medium pharmaceutical, biotech and diagnostics companies, leading universities and clinical research institutions making the Symposium a perfect platform to share experience, foster collaborations across industry and academia, and evaluate emerging technologies across the globe.

Toxicogenomics-2015 anticipates more than 600 thought provoking presentations and eminent Keynote lectures. The attending delegates include Editorial Board Members of featured OMICS Group Journals. This is an excellent opportunity for the participants from Universities, Institutes and other Private Organizations to interact with the World class Scientists and renowned speakers.

The global Toxicogenomics market is estimated to reach $17,227 million by 2018 at a CAGR of 13.5% during the forecast period (2013–2018). The market will witness a double-digit growth attributed to the increasing acceptance of in vitro methods over in vivo ones. Government support to stop animal testing, new and promising technologies, and advancement in new approaches are significant factors forcing the market in the forecast period. Initiation of Tox 21, government programs by the U.S. government and growing number of drug discoveries and innovations globally represent an opportunity for the growth of the market.

 

Detection of the toxic effects much earlier in the development stage, the pharmaceutical industry adapted to in vitro methods apart from the rising pressure to reduce the drug attrition rates to control the drug development costs and time line. The pharmaceutical industry has been witnessing a enormous growth as a result of government initiatives such as AXLR8 program that was initiated by the European Union. Geographic analysis reveals that Europe was the largest contributor to the global Toxicogenomics market in 2013. It will also be the fastest growing region till 2018.

 

OMICS International Organises 300+ Conferences Every Year across USA, Europe & Asia with support from 1000 more scientific societies and Publishes 400+ Open access journals which contains over 30000 eminent personalities, reputed scientists as editorial board members.

 

For more information on Market Analysisis Please visit: Toxicogenomics Market Analysis

Track 1: Toxicology Approaches:

Toxicology is the branch of sciences which studies the symptoms, mechanisms, treatments and detection of poisoning when living organisms are treated with chemicals. The relationship between dose and its effects on the exposed organism is of high significance in toxicology.

Toxicology approaches inclulde toxicogenomics which means, applying molecular profiling approaches to the study of toxicology.
 
Toxicology can be divided into standard disciplines, such as clinical, forensic, investigative and regulatory toxicology; toxicology can be considered by target organ system or process, such as immunotoxicology or genetic toxicology; toxicology can be presented in functional terms, such as research, testing and risk assessment.
Toxicity experiments may be conducted in vivo (using the whole animal) or in vitro (testing on isolated cells or tissues), or in silico (in a computer simulation)In vivo (Using the whole animal) or In vitro (testing on isolated cells or tissues), there are both ethical and technical concerns. So an alternate modeling has to be used instead of animal modelingIn Silico (in a computer simulation), Quantitative Structure Activity Relationships (QSARs) are mathematical models that are used to predict measures of toxicity from physical characteristics of the structure of chemicals (known as molecular descriptors).
 
 
Toxicogenomics is defined as the application of genomic technologies (for example, genetics, genome sequence analysis, gene expression profiling, proteomics, metabolomics, and related approaches) to study the adverse effects of environmental and pharmaceutical chemicals on human health and the environment. Toxicogenomics combines toxicology with information-dense1 genomic technologies to integrate toxicant-specific alterations in gene, protein, and metabolite expression patterns with phenotypic2 responses of cells, tissues, and organisms. Toxicogenomics can be studied by using Basic Cellular Models and Molecular mechanisms.
Genotoxicity and carcinogenesis
 
Pharmacogenomics and Drug Safety: Pharmacogenomics is the study of inherited genetic differences in drug metabolic pathways which can affect individual responses to drugs, both in terms of therapeutic effect as well as adverse effects.
 
 
Genomic technologies encompass both genome sequencing technologies, which derive DNA sequences from genes and other regions of DNA, and genotype analysis, which detects sequence variations between individuals in individual genes.The convergence of genome sequencing and genotyping technologies will eventually enable whole-genome sequences of individuals to be analyzed. Advances in genotyping technologies allow the simultaneous assessment of multiple variants across the whole genome in large populations rather than just single or several gene polymorphisms.
 
Gene expression profiling is the measurement of the activity (the expression) of thousands of genes at once, to create a global picture of cellular function. These profiles can, for example, distinguish between cells that are actively dividing, or show how the cells react to a particular treatment. Many experiments of this sort measure an entire genome simultaneously, that is, every gene present in a particular cell.
 
In spite of the recent advances in technology to optimize the absorption, distribution, metabolism and elimination (ADME) properties of new and promising medicinal products to reduce clinical failures, the investigation of drug disposition in the pediatric and elderly populations continues to be under evaluated. With the increasing prevalence of aging populations world-wide, there is a growing concern from health care providers, regulators and the general public that drug delivery is still less than optimal for the vulnerable patient populations likely to be more sensitive to adverse effects of the new investigational drugs. This Translational Investigation of Drug Disposition in Children  is not known.
 
Omics based technologies for drug discovery and toxicity assessment (or gene expression profiling) measure mRNA expression in a highly parallel assay system, usually using microarrays. As the first widely available method for global analysis of gene expression, DNA microarrays are the emblematic technology of the post-genomic era. Microarray technology for transcriptomics has enabled the analysis of complex, multigene systems and their responses to environmental perturbations.
 
Oxidative stress, DNA damage and repair and biological considerations is an inevitable consequence of cellular metabolism, with a propensity for increased levels following toxic insult. 
 
 
The use of genome-scale mRNA expression profiling to monitor responses to adverse xenobiotic exposure. Toxicogenomics is being investigated for use in the triage of compounds through predicting potential toxicity, defining mechanisms of toxicity, and Biomarker Identification with toxicogenomics. Whereas various approaches have been reported for the development of algorithms predictive of toxicity and for the interpretation of gene expression data for deriving mechanisms of toxicity, there are no clearly defined methods for the discovery of biomarkers using gene expression technologies. Ways in which toxicogenomics may be used for biomarker discovery include analysis of large databases of gene expression profiles followed by in silico mining of the database for differentially expressed genes; the analysis of gene expression data from preclinical studies to find differentially expressed genes that correlate with pathology (coincident biomarker) or precede pathology (leading biomarker) within a lead series; or gene expression profiling can be performed directly on the blood from preclinical studies or clinical trials to find biomarkers that can be obtained noninvasively. Applying toxicogenomics to biomarker discovery is the Chronic biomarkers in disease screening and monitoring. Later the discovery of biomarkers gives the Functional biomarkers in major therapeutic areas which can be concluded after following the Regulatory guidance for biomarkers
 
Track 5 : Drug monitoring
 
Drug monitoring is a branch of clinical chemistry and clinical pharmacology that specializes in the measurement of medication concentrations in blood. Its main focus is on drugs with a narrow therapeutic range, i.e. drugs that can easily be under- or overdosed.  TDM aims at improving patient care by individually adjusting the dose of drugs for which clinical experience or clinical trials have shown it improved outcome in the general or special populations. Toxicogenomics, as a predictive tool gives the therapeutic range for a patient.
 
Stages of Drug Discovery : 
High-content screening (HCS), also known as high-content analysis (HCA) or cellomics, is a method that is used in biological research and drug discovery to identify substances such as small molecules, peptides, or RNAi that alter thephenotype of a cell in a desired manner. Hence high content screening is a type of phenotypic screen conducted in cells. Phenotypic changes may include increases or decreases in the production of cellular products such as proteins and/or changes in the morphology (visual appearance) of the cell. High content screening includes any method used to analyze whole cells or components of cells with simultaneous readout of several parameters. Hence the name "high content screening". 
 
New Therapeutic Targets in Drug Design/Discovery : Initially drugs were discovered through identifying the active ingredient from traditional remedies or by serendipitous discovery. Later synthetic small molecules, natural products or extracts were screened in intact cells or whole organisms to identify substances that have a desirable therapeutic effect in a process known as classical pharmacology. Since sequencing of the human genome which allowed rapid cloning and synthesis of large quantities of purified proteins, it has become common practice to use high throughput screening of large compounds libraries against isolated biological targets which are hypothesized to be disease modifying in a process known as reverse pharmacology. 
 
Application of Pharmacokinetic / Pharmacodynamic Principles in optimizing drug delivery  is the final stage in Drug discovery and the Stem cells (ECS & IPCS)in Drug Discovery and Toxicity Testing are done prior to its approval.
 
 
The ADME/TOX studies in the early stages are carried in Human Micro dosing and Beyond and later Mechanistic Model of Drug-Induced Liver Injury in Predictive Toxicology as used for ADME/TOX. Predictive toxicology is a critical area for improvement in drug discovery in order to avoid expensive late-stage clinical failures and the damaging consequences of withdrawing market approved drugs. This helps in High Content Analysis and Predictive Toxicity testing
 
Drug cardiotoxicity is one of the leading causes of drug attrition and withdrawal. According to the ICH guideline E14, all drugs with systemic exposure must undergo a Thorough QT study to investigate QTc prolongation in healthy volunteers at supratherapeutic doses. In recent years, development of many drugs may have been needlessly stopped as companies routinely terminate candidates showing hERG inhibition, without even preliminary assessment of the drugs’ clinical profile.The Cardiac Safety Simulator can help to overcome this challenge by supporting early assessment of a drugs pro-arrhythmic risk based on in vitro data. The Cardiac Safety Simulator integrates mechanistic PBPK modeling and simulation via the Simcyp Simulator with a cardiomyocyte based heart model to predict the cardiac effects of drugs, using available in vitro data to simulate in vivo effects.
 
 
Predictive toxicology describes the study of how toxic effects observed in humans or model systems can be used to predict pathogenesis, assess risk, and prevent human disease. Predictive toxicology includes, but is not limited to, risk assessment, the practical facilitation of decision making with scientific information. The predictions in toxicology helps in assessing Applying Toxicogenomics in Pharmaceutical Safety Assessment.
Predictive toxicology can be used to predict the Tissue specific transcriptional responses to alkylating agents which gives the effects when Humans are Exposed to alkylating agents.
 
Applications of Toxicogenomic Technologies to Predictive Toxicology and Risk Assessment has Integrated Toxicogenomics into predictive & discovery toxicology.The application of these technologies to toxicology has ushered in an era when genotypes and toxicant-induced genome expression, protein, and metabolite patterns can be used to screen compounds for hazard identification, to monitor individuals’ exposure to toxicants, to track cellular responses to different doses, to assess mechanisms of action, and to predict individual variability in sensitivity to toxicants. These detailed studies can help Genomic studies in evaluating mechanisms of genotoxicity and carcinogenicity.
 
Human organ slices, an in vitro model representing the multicellular and functional features of in vivo tissue, is a promising model for characterizing mechanisms of drug-induced organ injury and for identifying biomarkers of organ injury. Target organ injury is a significant clinical issue. In vitro models, which compare human and animal tissue to improve the extrapolation of animal in vivo studies for predicting human outcome, will contribute to improving drug candidate selection and to defining species susceptibilities in drug discovery and development programs. A critical aspect to the performance and outcome of human organ slice studies is the use of high quality tissue, and the use of culture conditions that support optimum organ slice survivability, in order to accurately reproduce mechanisms of organ injury in vitro gives the importance of Organ slices for the evaluation of human drug toxicity.
 
 
Metrics of Quantitative Approach of Genotoxicity has need for quantitative dose–response analysis of genetic toxicology data, the existence and appropriate evaluation of threshold responses, and methods to analyze exposure-response relationships and derive points of departure (PoDs) from which acceptable exposure levels could be determined which forms the basis for Quantitative Approach of Genotoxicity for Risk Assessment. This helps in predicting the Genetic Susceptibility to Disease  and Genetic toxicity assays are used to screen chemicals for their ability to cause mutations or other types of genetic damage. This information may then be used to determine the potential of a chemical to induce human carcinogenicity. This provides the information on Level of Concern for Genotoxic Carcinogens at Human Relevant Exposure.
 
 
Introduction and Overview of AOPs : Adverse Outcome Pathway (AOP) is an analytical construct that describes a sequential chain of causally linked events at different levels of biological organisation that lead to an adverse health or ecotoxicological effect. AOP concept can be used to guide research aimed at improving both our understanding of chronic toxicity, including delayed toxicity as well as epigenetic and transgenerational effects of chemicals, and our ability to predict adverse outcomes. A better understanding of the influence of subtle toxicity on individual and population fitness would support a broader integration of sublethal endpoints into risk assessment frameworks. Detailed mechanistic knowledge of Development, Testing, and Applying AOPs to Risk Assessment would facilitate the development of alternative testing methods as well as help prioritize higher tier toxicity testing. We argue that targeted development of AOPs supports both of these aspects by promoting the elucidation of molecular mechanisms and their contribution to relevant toxicity outcomes across biological scales. The extended AOP framework can serve as a venue for integration of knowledge derived from various sources, including empirical data as well as molecular, quantitative and evolutionary-based models describing species responses to toxicants. This will allow a more efficient application of AOP knowledge for quantitative chemical- and site-specific risk assessment as well as for extrapolation across species in the future. AOP are also studied mainly in Mutagenic Mode-of-Action in Cancer. 
 
 
Bioinformatics is a branch of computational biology focused on applying advanced computational techniques to the collection, management, and analysis of numerical biologic data. Elements of bioinformatics are essential to the practice of all genomic technologies. Bioinformatics also encompasses the integration of data across genomic technologies, the integration of genomic data with data from other observations and measurements, and the integration of all these data in databases and related information resources. It is helpful to think of bioinformatics not as a separate discipline but as the universal means of analyzing and integrating information in biology.
 
 
Environmental genomics helps to study the molecular basis of adverse effects of environmental toxicants. It affords efficient and high-throughput means to delineate mechanisms of action, risk assessment, identify and understand basic pathogenic mechanisms that are critical to disease progression, predict toxicity of unknown agents and to more precisely phenotype disease subtypes. The potential of environmental genomics in a toxicant exposure model and, perhaps, this might become a crucial tool in biological response marker or biomarker discovery. Environmental Toxicogenomics is a post-genomic approach to analyse the biological responses to environmental toxins. 
 
 
Toxicogenomic technologies ultimately depends on how reliable, reproducible, and generalizable the results are from a particular study or individual method of analysis. Moving beyond laboratory assays to more widespread use requires some level of validation, which can be defined as the process of ensuring that a test reliably measures and reports the determined end point(s) and encompasses both technical and platform qualification in addition to biologic qualification. Distinct issues arise from the use of any novel technology in a regulatory context. Therefore validation is an integral part of the more general process of developing and applying toxicogenomic methodology. Hence Validating Toxicogenomics Assays is important
Toxicology experiments may be conducted in vivo (using the whole animal) or in vitro (testing on isolated cells or tissues).For these experiments various kinds of animals are used which include : Translational Models I, Aquatic Model Genomes, Regenerative Models, Cancer Models, Developmental Disease Models, Infectious Disease Models, Models of Aging, Metabolic Disease Models
 
 
Comparative Toxicogenomics Database (CTD) is a public website and research tool that curates scientific data describing relationships between chemicals/drugs, genes/proteins, diseases, taxa, phenotypes, GO annotations, pathways, and interaction modules.The primary goals of CTD is to advance the understanding of the effects of environmental chemicals on human health.

Conference Highlights

  • Toxicology Approaches
  • Concept of Toxicogenomics
  • Omics Technologies in Toxicogenomics
  • Biomarkers in Toxicogenomics
  • Drug monitoring
  • Predictive Human Toxicity and ADME/Tox Studies
  • Genomic Approaches to Predictive Toxicology
  • PK and PD Tools for DNA-Damage Pathways
  • Adverse Outcome Pathways
  • Bioinformatics in Toxicogenomics
  • Environmental Toxicogenomics
  • Animal Modeling in Toxicogenomics and Toxicoprotenomics
  • Comparative Toxicogenomics

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Conference Date August 25-27, 2015
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