Prioritizing the Toxicity Testing of Environmental Chemicals at EPA
|
|
- Josephine Lindsey
- 5 years ago
- Views:
Transcription
1 Prioritizing the Toxicity Testing of Environmental s at EPA George Gray, Ph.D. Assistant Administrator
2 Ranking and Prioritizing s Ranking for further testing Identify compounds of greatest concern Focus testing efforts Ranking for decision making Challenge of consistent methods vs. chemical specific information Differential uncertainty 1
3 ToxCast TM Addresses the Critical Need for Prioritization Too Many s Too High a Cost Pesticides HPV Actives Inerts DW Cancer ReproTox DevTox NeuroTox ImmunoTox $20M 2 IUR (5375) HPV (3548) HPV Challenge (1973) Pesticides (3448) Pesticides (Actives Supported) (1082) Pesticide (Food Use Actives) (336) AntiMicrobial (754) AntiMicrobial (Food Use) (26) Inerts (3305) Inerts (List 1) (8) Inerts (List 2) (96) Toxic Release Inventory (563) CCL (41)
4 ToxCast Merges HTS and Genomics Technologies with Traditional Toxicology Quantitative Biology (HTS) Toxicogenomics ToxCast Toxicology Systems Biology 3
5 4
6 High-Throughput Screening Assays batch testing of chemicals for pharmacological/toxicological endpoints using automated liquid handling, detectors, and data acquisition LTS MTS HTS uhts Gene-expression 1000s/day 10s-100s/yr 10s-100s/day 10,000s- 100,000s/day Human Relevance/ Cost/Complexity Throughput/ Simplicity 5
7 ToxCast TM will identify classifiers or signatures from HTS, HCS and genomics assays to predict hazard $20K Cancer ReproTox DevTox NeuroTox ImmunoTox and prioritize further testing of chemicals. 6
8 Examples of ToxCast Assays Biochemical Target Profiling High Content Cytotoxicity Assessment Transcription Factor Activity Profiling Gene Expression Profiling by Microarray and PCR 7
9 Pesticides as Proof of Concept ~800 Registered in the United States Wealth of Toxicological Information (~$19m) Developmental, reproductive, chronic, etc Represent broad range of chemistries Azoles, carbamates, pyrethroids, triazines, etc. Designed with biological activity in mind Receptor binding, enzyme inhibition, cytoskeletal, etc. 8
10 340 Candidate s for ToxCast Phase pesticidal active ingredients with complete animal toxicity datasets - 7 metabolites 6 pesticidal inerts 17 industrial chemicals - 16 HPV (11 HPVchallenge) 9
11 Correlating HTS to Toxicity CellularAssays Profile Matching Physical chemical properties Biochemical Assays Genomic Signatures Toxicology Endpoints 10
12 Finding Tests For Toxicity - Classification Goal: Find classifiers that accurately predict endpoints Use all available data ToxCast TM & public sources HTS, HCS, genomics, physicochemical properties, calculated properties Properties of an ideal classifier Accurate (low false positive & false negative rates) Inexpensive and easy to measure for new chemicals Easy to interpret provides biological insight ToxCast TM 11
13 Difficult Issues (the usual suspects) Endpoint data Extent to which concentration-response information is acquired (versus use of only single concentration) Ability to detect protoxicants Solubility How many assays are needed? How many assays are affordable? Ability to cover many mechanisms of toxicity 12
14 Phased Development of ToxCast Phase I Proof of Concept: derivation of first-generation ToxCast signatures based on known toxicity of 300 pesticide actives Phase II: Expansion and validation of ToxCast signatures with >1000 additional chemicals, most with partially characterized toxicity. Phase III: Application to thousands of environmental chemicals. Delivering affordable, science-based system for categorizing chemicals Increasing confidence as database grows Identify potential mechanisms of action Refine and reduce use of animals in hazard identification and risk assessment ToxCast ToxCast Assays Assays NO Hazard ToxCast Further Prediction Database Screening And YES Testing No Further Testing Prioritize HIGH Office of Research and LOW Development MEDIUM Programs OPP- inerts, antimicrobials OPPT- HPV, TRI, IUR OSCP- EDC OW- CCL 13
15 Phased Development of ToxCast Phase Number of s Purpose I >300 Training and Cross-Validation II >1000 Validation and Prediction III thousands Prediction and Prioritization ToxCast ToxCast Assays Assays NO ToxCast Database No Further Testing LOW Hazard Prediction YES Prioritize MEDIUM HIGH Further Screening And Testing 14
16 Roles for ToxCast TM in Prioritization and Risk Assessment Risk Assessment Hazard Dose Response Exposure Assessment ID Mode of Action Mechanism of Action Mode of Action Mechanism of Action Genotox Carc. Non-genotox Carc. ReproTox DevTox NeuroTox ToxCast TM ToxCast TM 15
17 Summary Prioritization for testing is important goal for EPA ToxCast is structured approach to developing a prioritization tool using modern biological and information management approaches Still need solid data on endpoints and analytic tools to inform decisions 16
18 Thank You! 17
Risk Management under the Chemicals Management Plan
Risk Management under the Chemicals Management Plan Hazard Characterization and Tools for Health Risk Assessment under CMP Stakeholder Advisory Council meeting Health Canada PAHO Workshop Lima, Peru November
More informationA Strategy for Reducing Animal Use in the U.S. EPA's Endocrine Disruption Screening Program
A Strategy for Reducing Animal Use in the U.S. EPA's Endocrine Disruption Screening Program Catherine Willett, PhD Science Policy Advisor Patricia Bishop, M.S. Research Associate Kristie Sullivan, MPH
More informationToxCast TM : Developing predictive signatures for chemical toxicity
AATEX 14, Special Issue, 623-627 Proc. 6th World Congress on Alternatives & Animal Use in the Life Sciences August 21-25, 2007, Tokyo, Japan ToxCast TM : Developing predictive signatures for chemical toxicity
More informationTox21: Opportunities& Challenges. Richard A. Becker Ph.D., DABT American Chemistry Council
Tox21: Opportunities& Challenges Richard A. Becker Ph.D., DABT American Chemistry Council October 21, 2010 Opportunities and Challenges The manifest challenge is to develop in vitro and in silico approaches
More informationMoving Towards Version 2.0 of Toxicity Testing in the 21 st Century and Application to Regulatory Decision Making
Moving Towards Version 2.0 of Toxicity Testing in the 21 st Century and Application to Regulatory Decision Making ECHA Topical Scientific Workshop on New Approach Methodologies April 20, 2016 Rusty Thomas
More informationProgress and Future Directions in Integrated Systems Toxicology. Mary McBride Agilent Technologies
Progress and Future Directions in Integrated Systems Toxicology Mary McBride Agilent Technologies 1 Toxicity testing tools of the late 20 th century Patchwork approach to testing dates back to the 1930
More informationAcceptance of New Technology. Richard Phillips, ExxonMobil Petroleum & Chemical CEFIC LRI 11th Annual Workshop, 19 November 2009
Acceptance of New Technology Richard Phillips, ExxonMobil Petroleum & Chemical CEFIC LRI 11th Annual Workshop, 19 November 2009 Overview Acceptance of New Technology Within LRI Nanotechnology New Approaches
More informationILSI AGRICULTURAL CHEMICAL SAFETY ASSESSMENT (ACSA) PROJECT: A TIERED TESTING APPROACH. November 18, 2005
ILSI AGRICULTURAL CHEMICAL SAFETY ASSESSMENT (ACSA) PROJECT: A TIERED TESTING APPROACH Ann Blacker, PhD, DABT Head of Regulatory Toxicology Bayer CropScience November 18, 2005 HESI ACSA Technical Committee
More informationTHE SYSTEMATIC REVIEW OF MECHANISTIC DATA IN IRIS ASSESSMENTS
THE SYSTEMATIC REVIEW OF MECHANISTIC DATA IN IRIS ASSESSMENTS Catherine Gibbons, Ph.D. U.S. EPA The views expressed in this presentation are those of the author and do not necessarily reflect the views
More informationNCCT Project Descriptions BOSC Review, December Project Title: Information Management for Computational Toxicology
NCCT Project Descriptions BOSC Review, December 17-18 2007 Project Title: Information Management for Computational Toxicology Lead Investigator: Richard Judson Key Participants: NCCT: Ann Richard, Matt
More informationAn NGO Perspective on Regulatory Acceptance of Non-animal Data and Related Issues. Martin Stephens, Ph.D. The Humane Society of the United States
An NGO Perspective on Regulatory Acceptance of Non-animal Data and Related Issues Martin Stephens, Ph.D. The Humane Society of the United States Animal Use Numbers Rabbits 222,167 Guinea pigs 203,098 Hamsters
More informationGlyphosate Research Scoping
Glyphosate Research Scoping Stephanie L. Smith-Roe, Ph.D. Biomolecular Screening Branch National Institute of Environmental Health Sciences NTP Board of Scientific Counselors Meeting June 15 16, 2016 Glyphosate
More informationCommitted since 2002 to ensuring that Europe s food is safe. David Gott. Chair & Rapporteur - WG Guidance on Food Additives
Committed since 2002 to ensuring that Europe s food is safe Risk assessment paradigm David Gott Vice-chair chair of the ANS Panel Chair & Rapporteur - WG Guidance on Food Additives Stakeholders workshop
More informationToxicity testing in the 21st Century: Challenges and Opportunities
Toxicity testing in the 21st Century: Challenges and Opportunities Alan R Boobis Imperial College London a.boobis@imperial.ac.uk 10 th CONCAWE Symposium 26 th February, 2013 Brussels, Belgium Risk assessment
More informationFrom Discovery to Development of new Drugs. and pitfalls along the way. by Kim Dekermendjian, PhD in Medicine BD & Key Account manager
From Discovery to Development of new Drugs. and pitfalls along the way by Kim Dekermendjian, PhD in Medicine BD & Key Account manager The roots of Drug Discovery Before 20 th century the term didn't exists,
More informationSTUDIES TO EVALUATE THE SAFETY OF RESIDUES OF VETERINARY DRUGS IN HUMAN FOOD: GENERAL APPROACH TO TESTING
VICH GL33 (SAFETY: GENERAL APPROACH) October 2002 For implementation at Step 7 - Final STUDIES TO EVALUATE THE SAFETY OF RESIDUES OF VETERINARY DRUGS IN HUMAN FOOD: GENERAL APPROACH TO TESTING Recommended
More informationSetting Limits in Shared Facilities
Setting Limits in Shared Facilities The New Scientific Approach 27 h September 2012 Sarah O Meara, Ph.D. Non-clinical Assessor & SWP Delegate, Irish Medicines Board Slide 1 Principles of Pharmacology and
More informationHazard identification Dose-response assessment Exposure assessment Risk characterization In vivo animal experiments Endpoint assays (mortality) Epidemiological studies Environmental monitoring Extrapolation
More informationCosmetics Europe LRSS Programme
Cosmetics Europe LRSS Programme 2016-20 Rob Taalman Objectives of CE Research To deliver tools & strategies for animal-free safety assessment Accurate Robust Efficient ultimately accepted by regulators
More informationGUIDELINES. Framework for Assessing the Human Safety of Microbial Pesticides CropLife International s Guidelines, established January 2018
GUIDELINES Framework for Assessing the Human Safety of Microbial Pesticides CropLife International s Guidelines, established January 2018 1 Contents Background 3 Purpose 3 Scope 3 Regulatory requirements
More informationBiostimulants, Beneficial Substances & Plant Regulators: An EPA Perspective
AAPFCO Industry Regulatory Council Meeting Denver, CO, 7August 2015 Biostimulants, Beneficial Substances & Plant Regulators: An EPA Perspective Russell S. Jones, Ph.D., Senior Biologist Chair, Biochemical
More informationPathway-based Approaches to Safety Assessment: development and use
Pathway-based Approaches to Safety Assessment: development and use Molecular initiating event Intermediary steps Adverse Outcome Catherine Willett, PhD Director, Regulatory Testing Risk Assessment and
More informationProblem Formulation: Lessons and Tools from Practical Applications Involving Systematic Review of Mechanistic Data
Problem Formulation: Lessons and Tools from Practical Applications Involving Systematic Review of Mechanistic Data Dr. Daniele Wikoff Health Sciences Practice Director Innovative Solutions Sound Science
More informationIntroduction to Drug Design and Discovery
Introduction to Drug Design and Discovery Course: Drug Design Course code: 0510412 Dr. Balakumar Chandrasekaran Dr. Bilal Al-Jaidi Assistant Professors, Pharmaceutical Medicinal Chemistry, Faculty of Pharmacy,
More informationSYSTEMATIC APPROACH TO THE SAFETY ASSESSMENT OF NATURALS FOR USE IN CONSUMER PRODUCTS
SYSTEMATIC APPROACH TO THE SAFETY ASSESSMENT OF NATURALS FOR USE IN CONSUMER PRODUCTS SIVARAM TK SAFETY & ENVIRONMENTAL ASSURANCE CENTRE, UNILEVER R&D, INDIA NATURALS Natural substances are substances
More informationThe Role of Chemistry in Adverse Outcome Pathways. Paul Russell & Steve Gutsell Safety and Environmental Assurance Centre, Unilever April 2013
The Role of Chemistry in Adverse Outcome Pathways Paul Russell & Steve Gutsell Safety and Environmental Assurance Centre, Unilever April 2013 Contents Background Risk Assessment in FMCG industry Drivers
More informationIntegration of FDSS7000 into a modular robotic system for Open Innovation drug discovery
Integration of FDSS7000 into a modular robotic system for Open Innovation drug discovery José Manuel Brea & María Isabel Loza BioFarma, Santiago de Compostela DRUG DISCOVERY OPEN INNOVATION CLOSED innovation
More informationUnited States Environmental Protection Agency (EPA) Office of Pesticide Programs (OPP): The Vision for Global Pesticide Reviews
2009/SOM2/SCSC/WKSP2/011 United States Environmental Protection Agency (EPA) Office of Pesticide Programs (OPP): The Vision for Global Pesticide Reviews Submitted by: United States Examination of Hot Issues
More informationMolecular Mechanisms of Food Contaminants Toxicity
Molecular Mechanisms of Food Contaminants Toxicity Course Leader: Joseph Rafter Department of Medical Nutrition, Karolinska Institutet, Stockholm, Sweden 09.00 09.15 Introduction Joseph Rafter, Professor,
More informationTSCA Work Plan Methodology and Chemicals
TSCA Work Plan Methodology and Chemicals Maria Doa, Director Chemical Control Division Office of Pollution Prevention and Toxics US Environmental Protection Agency October 1, 2014 TSCA Work Plan Chemicals
More informationMaximizing opportunities towards achieving clinical success D R U G D I S C O V E R Y. Report Price Publication date
F o r a c l e a r e r m a r k e t p e r s p e c t i v e Early Stage Drug Safety Strategies & Risk Management Maximizing opportunities towards achieving clinical success D R U G D I S C O V E R Y Report
More informationNuclear Receptor Bio-Assays
Nuclear Receptor Bio-Assays Kun Bi, Ph.D. Senior Staff Scientist Gerry Pelanek Associate Director New Markets & Business Development Joint Meeting of California and Water Reuse Research Foundation Project
More informationGene Expression on the Fluidigm BioMark HD
Gene Expression on the Fluidigm BioMark HD Overview Introduction to Fluidigm James Miller Advantages of the technology Running a Fluidigm gene expression project Paul Lacaze Assay design, chemistry, experimental
More information158W Implementation Update. Pat Jennings Environmental Engineer EPA/OCSPP/OPP/AD/RASSB March 11, 2015
158W Implementation Update Pat Jennings Environmental Engineer EPA/OCSPP/OPP/AD/RASSB March 11, 2015 AGENDA Overview of the Final Rule: Data Requirements for Antimicrobial Pesticides 158W Implementation
More informationIntroduction to Assay Development
Introduction to Assay Development A poorly designed assay can derail a drug discovery program before it gets off the ground. While traditional bench-top assays are suitable for basic research and target
More informationThe Viability of Cancerous vs. Non-cancerous Cells
THE JOURNAL OF UNDERGRADUATE RESEARCH University of Kansas Fall 2009 The Viability of Cancerous vs. Non-cancerous Cells Lung cancer is a disease that affects a number of human beings in the world each
More informationAssociation of American Pesticide Control Officials Alexandria, VA, 9 March 2016 Biostimulants & Biopesticides
Association of American Pesticide Control Officials Alexandria, VA, 9 March 2016 Biostimulants & Biopesticides Russell S. Jones, Ph.D., Senior Biologist Biochemical Pesticides Branch Biopesticides & Pollution
More informationUsing 21 st Century Science for Risk-related evaluations: An Overview of the NAS Risk21 Report
Using 21 st Century Science for Risk-related evaluations: An Overview of the NAS Risk21 Report Committee on Incorporating 21st Century Science into Risk-Based Evaluations Board on Environmental Studies
More informationPharmaceutical LC/MS Solutions from Agilent Technologies
Pharmaceutical LC/MS Solutions from Agilent Technologies Application Compendium Overview LC/MS plays a key role in the drug discovery and drug development process. Since the introduction of electrospray
More informationDevelopments in Chemical Toxicity Testing
Developments in Chemical Toxicity Testing EPA relies on toxicology studies for its regulatory decision making, but traditional toxicology testing has led to slow and expensive chemical-bychemical analysis.
More informationGuide to the City of San Francisco s Reduced Risk Pesticide List Revised February 2013
Guide to the City of San Francisco s Reduced Risk Pesticide List Revised February 2013 Introduction The City of San Francisco Department of the Environment s (SFE) Reduced-Risk Pesticide List is the result
More informationBilateral technical meeting between the EFSA Panel on Genetically Modified Organisms and AFSSA
Bilateral technical meeting between the EFSA Panel on Genetically Modified Organisms and AFSSA AFSSA-EFSA Milan 10 december 2008 AFSSA working group on 2000 2000: Working group establishing GMO risk assessment
More informationSpecies Considerations for Predictive and Mechanistic Modeling
Species Considerations for Predictive and Mechanistic Modeling Thomas B. Knudsen National Center for Computational Toxicology This work was reviewed by EPA and approved for presentation but does not necessarily
More informationDosing for Controlled Exposure (DoCE): Dosing strategies for characterising in vitro dose-responses with increased relevance for in vivo extrapolation
Dosing for Controlled Exposure (DoCE): Dosing strategies for characterising in vitro dose-responses with increased relevance for in vivo extrapolation Background Chemical safety assessments continue to
More informationUpdate of the WHO/IPCS Mode of Action Framework
Update of the WHO/IPCS Mode of Action Framework ECETOC/WHO/IPCS Mode of Action Workshop Vienna, February 21 st 22 nd, 2013 Presented by: M.E. (Bette) Meek University of Ottawa bmeek@uottawa.ca Outline
More informationStudent Research Opportunities at the Institute for Risk Analysis and Risk Communication
Student Research Opportunities at the Institute for Risk Analysis and Risk Communication About IRARC Founded in 1997, the Institute for Risk Analysis and Risk Communication (IRARC) is committed to improving
More informationDevelopment of Crop Protection Products: An Industry Perspective. Keith S. Rucker Technical Service Specialist
Development of Crop Protection Products: An Industry Perspective Keith S. Rucker Technical Service Specialist Need for Continued Crop Protection Product Development Wild oats White Mold on Peanuts Treated
More informationIPA Advanced Training Course
IPA Advanced Training Course Academia Sinica 2015 Oct Gene( 陳冠文 ) Supervisor and IPA certified analyst 1 Review for Introductory Training course Searching Building a Pathway Editing a Pathway for Publication
More informationThe WHO Framework for Combined Exposures and MOA/AOP Analysis; Implications for Euromix. Euromix Kick Off Meeting
The WHO Framework for Combined Exposures and MOA/AOP Analysis; Implications for Euromix Euromix Kick Off Meeting M.E. (Bette) Meek University of Ottawa bmeek@uottawa.ca Contents of the WHO IPCS Framework
More informationBR-10455A. Automated Multiplexed Gene Expression Profiling Process Solutions. Multiplex Quantitative High-throughput
BR-10455A Automated Multiplexed Gene Expression Profiling Process Solutions Multiplex Quantitative High-throughput As a scientist, you understand the challenges of working with limited amounts of sample,
More informationSEURAT-1: Why predictive safety science is important to regulatory acceptance of alternative methods
1 SEURAT-1: Why predictive safety science is important to regulatory acceptance of alternative methods Ian A Cotgreave Swedish Toxicology Sciences Research Center On behalf of all SEURAT-1 partners 10
More informationFRCaST peer review summary
FRCaST peer review summary 1. The EPA has sought on its FRCaST (Flexible Reassessment Categorisation Screening Tool) approach to prioritisation of chemicals for reassessment. This exercise was considered
More informationData analysis in cell-based functional assay
02.02.2005 Florian Hahne Molecular Genome Analysis Data analysis in cell-based functional assay Tools for automated pre-processing, analysis and visualization of high throughput FACS data Overview Challenge
More informationFuture Directions. Steven Russell. EPA HPV Data Users Conference December 13, 2006
Views on Success and Future Directions Steven Russell Senior Director, American Chemistry Council EPA HPV Data Users Conference December 13, 2006 American Chemistry Council 130 chemistry companies and
More informationIntegrating Molecular Toxicology Earlier in the Drug Development Process
Integrating Molecular Toxicology Earlier in the Drug Development Process Jonathan Hitchcock Molecular Toxicology, Drug Safety R&D Pfizer Global Research & Development Sandwich, Kent UK 4.5 4.0 3.5 3.0
More informationProteomics. Manickam Sugumaran. Department of Biology University of Massachusetts Boston, MA 02125
Proteomics Manickam Sugumaran Department of Biology University of Massachusetts Boston, MA 02125 Genomic studies produced more than 75,000 potential gene sequence targets. (The number may be even higher
More informationPublic Interest Incorporated Foundation BioSafety Research Center
Public Interest Incorporated Foundation BioSafety Research Center http://www.anpyo.or.jp Ver. 201801 Building #1(Test and research annex) Building #2 (Administrat ion office) Building #3 (Toxicity test
More informationHow to use ANOVA in Qlucore Omics Explorer
How to use ANOVA in Qlucore Omics Explorer Content 1 Introduction... 3 2 Introduction to ANOVA... 3 2.1 Model A: Independent measures, single factor design... 3 2.2 Model B: Independent measures, factorial
More informationClass 3: Identifying a Green Chemistry Project
Class 3: Identifying a Green Chemistry Project Goals 1. Provide a structured interdisciplinary dialog among the students and faculty. 2. Provide an application focus for the Green Chemistry theory presented
More informationChemicals, Drinking Water, Risk and Regulation
Chemicals, Drinking Water, Risk and Regulation Brian G. Bearden, P.E. Mariana Islands Water Operators Association February 5, 2014 NPR Story: The Big Impact Of A Little-Known Chemical In W.Va. Spill http://www.npr.org/2014/01/13/262185930/mysteries-persist-surrounding-west-virginiachemical-spill
More informationSGN-6106 Computational Systems Biology I
SGN-6106 Computational Systems Biology I A View of Modern Measurement Systems in Cell Biology Kaisa-Leena Taattola 21.2.2007 1 The cell a complex system (Source: Lehninger Principles of Biochemistry 4th
More informationGreenScreen for Safer Chemicals and LEED v4 Material Ingredient Credits March 6, 2014 Webinar
GreenScreen for Safer Chemicals and LEED v4 Material Ingredient Credits March 6, 2014 Webinar Lauren Heine, Ph.D., Co-Director Clean Production Action Director GreenScreen Program lauren@cleanproduction.org
More informationLessons from the Human Genome Project that may be applicable to the Exposome Endeavor
Lessons from the Human Genome Project that may be applicable to the Exposome Endeavor Christopher P. Austin. M.D. Director, NIH Chemical Genomics Center Senior Advisor to the NHGRI Director for Translational
More informationProduct Stewardship Summary
Product Stewardship Summary Sodium xylene sulfonate General Statement Sodium xylene sulfonate is a hydrotrope, an organic compound that increases the ability of water to dissolve other molecules. Sodium
More informationMB Expands Capabilities Adds Ames Test, MTD and Range Finding
What's New @ MB? MB Expands Capabilities - Ames, PK, MTD, Range Finding New! - PorCORA - Non-Animal Ocular Irritation/Reversibility Test Under Development - PorFocal - Low-Level Ocular Irritation Screening
More informationECO-PHARMACO- STEWARDSHIP (EPS) PILLAR 1 - RESEARCH & DEVELOPMENT: INTELLIGENCE-LED ASSESSMENT OF PHARMACEUTICALS IN THE ENVIRONMENT (ipie)
ECO-PHARMACO- STEWARDSHIP (EPS) PILLAR 1 - RESEARCH & DEVELOPMENT: INTELLIGENCE-LED ASSESSMENT OF PHARMACEUTICALS IN THE ENVIRONMENT (ipie) PILLAR 1 - RESEARCH & DEVELOPMENT: INTELLIGENCE-LED ASSESSMENT
More informationScientific ifi Confidence Framework: 1) Analytical validation. 3) Utilization 4) Explicit documentation
A Framework for Building Scientific Confidence in Tox21 and Risk21 Methods Richard A. Becker Ph.D. DABT September 18, 2015 Scientific confidence is a necessity: must have confidence to rely on ToxCast,
More informationPUBLIC CONSULTATION AT STEP 4 OF THE VICH PROCEDURE OVERVIEW OF COMMENTS RECEIVED
VICH/12/056 FINAL PUBLIC CONSULTATION AT STEP 4 OF THE VICH PROCEDURE OVERVIEW OF COMMENTS RECEIVED VICH draft Guideline 54 - Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food:
More informationBayer Pharma s High Tech Platform integrates technology experts worldwide establishing one of the leading drug discovery research platforms
Bayer Pharma s High Tech Platform integrates technology experts worldwide establishing one of the leading drug discovery research platforms Genomics Bioinformatics HTS Combinatorial chemistry Protein drugs
More informationAn Automated, Cell-based Platform for the Rapid Detection of Novel Androgen Receptor Modulators
A p p l i c a t i o n N o t e An Automated, Cell-based Platform for the Rapid Detection of Novel Androgen Receptor Modulators Brad Larson and Peter Banks, BioTek Instruments, Inc., Winooski, VT Bruce Sherf,
More informationQuo vadis Drug Discovery
Quo vadis Drug Discovery Donatella Verbanac, Dubravko Jelić, Sanja Koštrun, Višnja Stepanić, Dinko Žiher PLIVA - Research Institute, Ltd. Prilaz baruna Filipovića 29, 10000 Zagreb, CROATIA The Pharmaceutical
More informationWP3: Database, statistical analysis, assay automation (P4, P10, P17, P19, and P26)
WP3: Database, statistical analysis, assay automation (P4, P10, P17, P19, and P26) Establishment of AcutoxBase (P4, P19) AcutoxBase is a unique database that combines in vivo, in vitro and in silico data
More informationModernizing Approaches to Chemical Risk Assessment
L R I R E S E A R C H S T R A T E G Y 2009-2015 Modernizing Approaches to Chemical Risk Assessment The American Chemistry Council represents the companies that make the products that make modern life
More informationValidation of the 21 st Century Toxicology Toolbox: Challenges, Opportunities, and the Way Forward
Validation of the 21 st Century Toxicology Toolbox: Challenges, Opportunities, and the Way Forward William S. Stokes 1, Judy Strickland 2, and Warren Casey 1 1 National Toxicology Program Interagency Center
More informationThermo Scientific TSQ Quantum Access MAX
www.ietltd.com Proudly serving laboratories worldwide since 1979 CALL +847.913.0777 for Refurbished & Certified Lab Equipment Thermo Scientific TSQ Quantum Access MAX UNSURPASSED PRICE TO PERFORMANCE Superior
More informationNew York State Department of Environmental Conservation
New York State Department of Environmental Conservation Division of Solid & Hazardous Materials Bureau of Pesticides Management 625 Broadway, Albany, New York 12233-7254 Phone: 518-402-8788 FAX: 518-402-9024
More informationRegistration Decision. Noviflumuron
Registration Decision RD2016-03 Noviflumuron (publié aussi en français) 5 February 2016 This document is published by the Health Canada Pest Management Regulatory Agency. For further information, please
More informationTiered Evaluation Strategies: An Animal Protection Perspective. Martin Stephens, Ph.D. The Humane Society of the United States
Tiered Evaluation Strategies: An Animal Protection Perspective Martin Stephens, Ph.D. The Humane Society of the United States 2 ISRTP Workshop, Baltimore, Nov. 18-19, 2005 3 ISRTP Workshop, Baltimore,
More informationGene expression connectivity mapping and its application to Cat-App
Gene expression connectivity mapping and its application to Cat-App Shu-Dong Zhang Northern Ireland Centre for Stratified Medicine University of Ulster Outline TITLE OF THE PRESENTATION Gene expression
More informationSubcommittee on Distinguishing Adverse from Non-Adverse and Adaptive Effects
Subcommittee on Distinguishing Adverse from Non-Adverse and Adaptive Effects DOUGLAS A. KELLER, PhD (sanofi-aventis US) Subcommittee Co-Chair HESI Annual Meeting Reston, VA May 13, 2010 1 The issue Advances
More informationOur Business. in vitro / in vivo. in vitro / in vivo ADME. in vitro / in vivo. Toxicology. Cell Battery V79. Analytical Services. Service.
GenPharmTox is one of the few CROs who can guarantee the success of our project within the given time framework and on the terms agreed. Dr. Michael Runkel, Apogepha GmbH 3 3 In vitro 3.1. Phototoxicity
More informationPrioritising chemicals of emerging concern: some approaches being used in Canada and the USA
Prioritising chemicals of emerging concern: some approaches being used in Canada and the USA Derek Muir 1,2 and Phil Howard 3 1 Dept of Chemistry, University of Toronto, Toronto ON 2 Environment Canada,
More informationCASE STUDYS: APPLYING ALTERNATIVE APPROACHES
CASE STUDYS: APPLYING ALTERNATIVE APPRACHES Dr. Wera Teubner, BASF Schweiz AG 12th Stakeholders` Day, April 5th, 2017 at ECHA, Helsinki, Finnland 1 Case study 1: In-vitro methods Alternative methods have
More informationThe Human Toxome Project a test case for pathway identification by multiomics. Thomas Hartung
The Human Toxome Project a test case for pathway identification by multiomics integration Thomas Hartung Mechanistic & evidence-based toxicology 2 Level of resolution Current state of the art Perturbed
More informationLARGE-SCALE PROTEIN INTERACTOMICS. Karl Frontzek Institute of Neuropathology
LARGE-SCALE PROTEIN INTERACTOMICS Karl Frontzek Institute of Neuropathology STUDYING THE INTERACTOME A yeast 2 hybrid (DB: DNA binding domain, AD: activation domain) B tandem affinity purification (dashed
More informationClassification of Chemicals Based on Structured Toxicity Information. Matthew T. Martin
Classification of Chemicals Based on Structured Toxicity Information Matthew T. Martin A thesis submitted to the faculty of the University of North Carolina at Chapel Hill in partial fulfillment of the
More informationCENTER FOR BIOTECHNOLOGY
CENTER FOR BIOTECHNOLOGY Keith A. McGee, Ph.D., Program Director Math and Science Building, 3 rd Floor 1000 ASU Drive #870 Phone: 601-877-6198 FAX: 601-877-2328 Degree Offered Required Admission Test M.
More informationLecture 23: Clinical and Biomedical Applications of Proteomics; Proteomics Industry
Lecture 23: Clinical and Biomedical Applications of Proteomics; Proteomics Industry Clinical proteomics is the application of proteomic approach to the field of medicine. Proteome of an organism changes
More informationCOMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON THE NON-CLINICAL DEVELOPMENT OF FIXED COMBINATIONS OF MEDICINAL PRODUCTS
European Medicines Agency London, 24 January 2008 Doc. Ref. EMEA/CHMP/SWP/258498/2005 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON THE NON-CLINICAL DEVELOPMENT OF FIXED COMBINATIONS
More informationCase Study: USEPA Benthic Invertebrate Risk Assessment for Endosulfan
U.S. Environmental Protection Agency 1 Case Study: USEPA Benthic Invertebrate Risk Assessment for Endosulfan Presentation to: European Chemicals Agency Topical Scientific Workshop: Risk Assessment for
More informationSupplementary Figure 1. Details of the component modelling and steps in generating and validating a PTGS. The steps (boxes) and the flow of
Supplementary Figure 1. Details of the component modelling and steps in generating and validating a PTGS. The steps (boxes) and the flow of information (arrows) through the modelling process, including
More informationGENE EXPRESSION REAGENTS MARKETS (SAMPLE COPY, NOT FOR RESALE)
TriMark Publications April 2007 Volume: TMRGER07-0401 GENE EXPRESSION REAGENTS MARKETS (SAMPLE COPY, NOT FOR RESALE) Trends, Industry Participants, Product Overviews and Market Drivers TABLE OF CONTENTS
More informationDISCOVER OUR SEGMENT REGULATORY SCIENCE
DISCOVER OUR SEGMENT REGULATORY SCIENCE Our focus In the demanding regulatory environment of the EU, expert knowledge is essential to gaining approval for substances and products. That is why the scientific
More informationNew Approaches to Chemical Risk Assessment
New Approaches to Chemical Risk Assessment Wednesday, 11 May, 13.30-15.00 IAFP s European Symposium on Food Safety 2016, Athens, Greece New Approaches in Chemical Risk Assessment Dr Ans Punt RIKILT Wageningen
More informationWhat is the mechanism of 2,4-D? Abstract
What is the mechanism of 2,4-D? Abstract In 2000, Schreinemachers published a paper showing an increased risk for certain types of cancers such as reticulum cell sarcoma, prostate, and pancreatic cancers
More informationThe OECD activities on biocides and IATA
The OECD activities on biocides and IATA Sylvie Poret & Joop de Knecht OECD Secretariat 18-20 November 2013, Vienna Presentation Outline What is OECD? The OECD Biocides Programme The OECD framework for
More informationACVM - REGISTRATION STANDARD FOR TOXICOLOGY AND ENVIRONMENTAL TOXICOLOGY
ACVMS 9.1 Ministry of Agriculture and Forestry Post Office Box 2526 WELLINGTON, NEW ZEALAND ACVM - REGISTRATION STANDARD FOR TOXICOLOGY AND ENVIRONMENTAL TOXICOLOGY This document may be altered at any
More informationIN VITRO TOXICITY TESTING: TECHNOLOGIES AND GLOBAL MARKETS
IN VITRO TOXICITY TESTING: TECHNOLOGIES AND GLOBAL MARKETS PHM017E January 2014 Robert Hunter Project Analyst ISBN: 1-56965-661-4 BCC Research 49 Walnut Park, Building 2 Wellesley, MA 02481 USA 866-285-7215
More informationPrioritization of biomarkers in the French human biomonitoring programme
Prioritization of biomarkers in the French human biomonitoring programme Nadine Fréry, Clémence Fillol, Stéphanie Vandentorren French Institute for Public Health Surveillance (InVS) Context A French national
More informationBiocompatibility Testing for Medical Devices
Biocompatibility Testing for Medical Devices *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER TODAY! The medical device field is one of the most heavily regulated industries, for obvious
More information