Tox21: Opportunities& Challenges. Richard A. Becker Ph.D., DABT American Chemistry Council
|
|
- Arron Tyler
- 6 years ago
- Views:
Transcription
1 Tox21: Opportunities& Challenges Richard A. Becker Ph.D., DABT American Chemistry Council October 21, 2010
2 Opportunities and Challenges The manifest challenge is to develop in vitro and in silico approaches that adequately address the range and complexity of biological processes and can predict toxicity responses How can these new technologies be used with requisite degree of scientific confidence in regulatory & product stewardship chemical management programs? 2
3 Prioritization Opportunities: Prioritization Biological profiling to develop information on activity of chemicals in pathways related to toxicity responses Link with indicators of exposure Risk based priority setting 3
4 Opportunities: Grouping Chemicals in Categories Category = a group of chemicals whose physicochemical and toxicological properties are likely to be similar. Permits interpolation of responses from one member to another HTS (and other similar approaches) could be used to develop &/or justify a category based on the pattern of activity of chemicals in pathways related to toxicity responses Within structurally related compounds, ID subcategory based on biological responses: C1R C2R and C7R C12R exhibit different profile from C4R C6R 4
5 Opportunities: Guide Tox Study Design What does the biological profile indicate re: activity of a chemical in pathways related to toxicity responses? Can one deduce potential mode(s) of action based on HTS and other molecular profiling studies? Based on what is known about that mode of action, how should a tox study be designed? Dose levels Animal model most relevant Endpoints to measure Satellite groups specialized studies Test the hypothesis of particular mode of action 5
6 Opportunities: Screening Level Risk Appraisal As a key element of an Integrated Testing and Assessment Framework A framework that utilizes relevant information from multiple sources including predictive computer models, chemical categories, and in vitro assays with information/results from traditional tox studies to evaluate potential hazards Initial hazard characterization) and derive a tox point of departure (NOAEL/BMD/BMDL) Look at use and exposure scenarios and develop quantitative metrics of exposure Then combine hazard with exposure to yield screening level risk characterization (Margin of Exposure) 6
7 Challenges To predict toxicity will require extensive collaborative research to forge the solid scientific foundation for developing prediction models using QSAR, genomics profiling and High Throughput Screening methods All need to have confidence in the models regulators, industry and the public If the models are to be used in place of traditional tox testing can we have confidence they ll provide results that will be valid? Health protective?
8 Challenges Recurrent theme need to understand what the biological profiles indicate re: activity of a chemical in pathways related to toxicity responses Necessary to evaluate relevance, reliability, sensitivity and specificity of advanced high throughput molecular screening and computational profiling methods prior to regulatory acceptance so that regulatory agencies, the regulated community and the public have sufficient confidence in the decisions based on such methods. Toxicity Testing in the 21 st Century: A View from the Chemical Industry Bus and Becker, (2009) TOXICOLOGICAL SCIENCES 112(2), (2009 8
9 Toxicological Sciences Bringing the Vision to Life Andersen and Krewski Toxicol. Sci..2009:107: Pragmatic Challenges for the Vision of Toxicity Testing in the 21 st Century in a Regulatory Context: Another Ames Test?...or a New Edition of "the Red Book"? Meek and Doull Toxicol. Sci..2009: 108:19 21 Mapping the Road Ahead Hartung Toxicol. Sci..2009: 109: View from the Pharmaceutical Industry MacDonald and Robertson Toxicol. Sci..2009: 110: View from the Chemical Industry Bus and Becker Toxicol. Sci.2009: 112, Biologically relevant exposure science for the 21st century Hubal, Toxicol. Sci. 2009: 111, Endless possibilities: stem cells and the vision for toxicity testing in the 21st century Chapin and Stedman, Toxicol. Sci. 2009: 112, Toxicity testing in the 21st century: using the new toxicity testing paradigm to create a taxonomy of adverse effects Boekelheide and Campion, Toxicol. Sci : The Vision of Toxicity Testing in the 21st Century: Moving from Discussion to Action Andersen and Krewski Toxicol. Sci : 17 24
10 Challenges A shotgun approach generating large quantities of data and applying informatics to develop correlations will not be very fruitful in developing the models we need Need a thoughtful approach to develop models that are relevant to extrapolating to humans We need to be careful that such approaches as ToxCast don t just lead us to re discover what we already know about toxicity: metabolism is critical, dose is critical, effects at doses which have saturated detoxification systems are not very relevant for extrapolating to low, environmentally relevant levels of exposures to humans
11 Agent Release Transport/ Transformation Exposure Monitoring Indicators Exposure/Effect Discontinuum Exposure/ Contact Entry & Distribution in Body = Dose No Health Effects Dose Below Threshold or Homeostatic Response Effect Altered Structure/ Function Biomon itoring Indicators Health Outcome Indicators Adverse Health Outcomes Mortality Morbidity
12 Toxicity Pathway Exposure Effect Discontinuum Response is Dependent on Dose: Not All Exposures Will Produce Adverse Effects Higher Dose Leads to Altered Organ Structure / Function Adverse Health Outcome Response Adaptive Responses Higher Dose Leads to Altered Organ Structure / Function No Adverse Outcomes Higher Dose Leads to Altered Physiology: Adaptive Response No Adverse Outcomes Homeostasis Increasing Dose Higher Dose Elicits Homeostatic Response No Adverse Outcome Chemical Properties Protein binding DNA Binding Receptor Binding Gene Expression Protein Production Altered Signaling Dose Below Threshold No Adverse Outcomes Toxicant Toxicity Pathway Interaction with macromolecules Cellular Responses Effects Organism Responses
13 Exposure Effect Discontinuum: Illustrated in Graphic from NRC Toxicity Testing in the 21 st Century 2007
14 Challenge and Opportunity Develop Predictive Models from HTS and Genomic Data That are Fully Transparent Shared Responsibility: Use knowledge of biological pathways and dose response. Predictive models must have: 1)Mechanistic interpretation: MOA, Bio.Pathway, DR 2)Defined endpoint 3)Unambiguous algorithm 4)Defined domain of applicability 5)Appropriate measures of goodness of fit, robustness and predictivity
Acceptance 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 informationIdentification and Characterization of Adverse Effects in 21 st Century Toxicology and Risk Assessment
Identification and Characterization of Adverse Effects in 21 st Century Toxicology and Risk Assessment Daland R. Juberg, PhD Dow AgroSciences Douglas A. Keller, PhD Sanofi US 13 June 2012 SOT Risk Assessment
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 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 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 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 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 informationSafety Assessment in the 21 st Century
Safety Assessment in the 21 st Century PCPC Legal & Regulatory Conference 6 May 2016 Donald L. Bjerke, PhD, DABT The Procter & Gamble Company Outline Common ground Safety assessment basic principles Safety
More informationCatherine Willett, Humane Society of the United States, Humane Society International
The Use of Adverse Outcome Pathways (AOPs) to Support Chemical Safety Decisions within the Context of Integrated Approaches to Testing and Assessment (IATA) Catherine Willett, Humane Society of the United
More informationUse of Adverse Outcome Pathways (AOPs) to reduce uncertainty and animal use in chemical hazard and risk assessment
Use of Adverse Outcome Pathways (AOPs) to reduce uncertainty and animal use in chemical hazard and risk assessment MatTek, Inc. MatTek, Inc. Reinnervate, Inc. Molecular initiating event Intermediate Events
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 informationRisk 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 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 informationIntroduction to Adverse Outcome Pathways and the AOP Wiki
Introduction to Adverse Outcome Pathways and the AOP Wiki Sunday July 20, 2017 10:00 AM - 12:00 PM Sheraton Seattle, Aspen Room 10:00: Introduction to the OECD AOP Programme and Online Training course
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 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 informationPrioritizing the Toxicity Testing of Environmental Chemicals at EPA
Prioritizing the Toxicity Testing of Environmental s at EPA George Gray, Ph.D. Assistant Administrator Ranking and Prioritizing s Ranking for further testing Identify compounds of greatest concern Focus
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 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 informationDISTINGUISHING ADVERSE FROM NON-ADVERSE/ADAPTIVE EFFECTS PROJECT COMMITTEE
DISTINGUISHING ADVERSE FROM NON-ADVERSE/ADAPTIVE EFFECTS PROJECT COMMITTEE Mission The mission of the Project Committee on Distinguishing Adverse from Non-Adverse/Adaptive Effects is to develop an approach
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 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 informationProgress in the Toxicity Testing in the 21 st Century (TT21C) Proposal
Progress in the Toxicity Testing in the 21 st Century (TT21C) Proposal AXLR8 Workshop 2011 Berlin-Dahlem, Germany May 24-26, 2011 Harvey Clewell Director, Center for Human Health Assessment The Hamner
More informationFORUM SERIES - PART IX Toxicity Testing in the 21st Century: Using the New Toxicity Testing Paradigm to Create a Taxonomy of Adverse Effects
TOXICOLOGICAL SCIENCES 114(1), 20 24 (2010) doi:10.1093/toxsci/kfp307 Advance Access publication December 21, 2009 FORUM SERIES - PART IX Toxicity Testing in the 21st Century: Using the New Toxicity Testing
More informationFORUM SERIES PART VIII Toxicity Testing in the 21st Century: A View from the Chemical Industry
TOXICOLOGICAL SCIENCES 112(2), 297 302 (2009) doi:10.1093/toxsci/kfp234 Advance Access publication October 4, 2009 FORUM SERIES PART VIII Toxicity Testing in the 21st Century: A View from the Chemical
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 informationNanoparticle risk assessment. practical solutions. systems toxicology
Nanoparticle risk assessment practical solutions systems toxicology Mathematical Models for Analyzing Genomic Data Sets: From Equations to Diagnosis? FU Berlin, Germany Outline My background Paradigm shift
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 informationUse of (Q)SAR to Evaluate Potential Genotoxic Impurities
Use of (Q)SAR to Evaluate Potential Genotoxic Impurities Naomi Kruhlak, PhD Lead, Chemical Informatics Program Division of Applied Regulatory Science Office of Clinical Pharmacology Office of Translational
More informationIntegrated Approaches to Testing and Assessment (IATA) ex. Skin Sensitisation
Integrated Approaches to Testing and Assessment (IATA) ex. Skin Sensitisation João Barroso 10 th EPAA Annual Conference Brussels, 2014 Conventional Toxicology Chemical Animal model Pancreatic tumor Observe
More informationHazard identification Dose-response assessment Exposure assessment Risk characterization In vivo animal experiments Endpoint assays (mortality) Epidemiological studies Environmental monitoring Extrapolation
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 informationTHE FUTURE OF IN VITRO SCREENING IN THE DEVELOPMENT OF NEW DRUGS. Hajime Kojima, JaCVAM, NIHS, Japan
THE FUTURE OF IN VITRO SCREENING IN THE DEVELOPMENT OF NEW DRUGS Hajime Kojima, JaCVAM, NIHS, Japan 1 3Rs of animal use (Russel and Burch 1959) Reduction (of animal use) Refinement (to lessen pain or distress
More informationEvolving approaches to AOP development: observations from MOA frameworks to systems biology
Evolving approaches to AOP development: observations from MOA frameworks to systems biology Molecular ini'a'ng event Intermediary steps Adverse Outcome Catherine WilleI, PhD Director, Regulatory Tes'ng
More informationTHE OECD PROGRAM ON ADVERSE OUTCOME PATHWAYS (AOP)
THE OECD PROGRAM ON ADVERSE OUTCOME PATHWAYS (AOP) WC-9 Satellite meeting AOP 101 24 August 2014 Anne Gourmelon Principal Administrator OECD Test Guidelines Programme Environmental, Health and Safety Division
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 informationsignificant concerns no or very low predictive power
Your feedback Citizens concerns should be considered How to ensure ethical concerns are harnessed to drive change? Don t separate Non-animal and animal approaches they are integrated Avoid overstating
More informationHarnessing Toxicity Testing in the 21 st Century to Help Train Chemists
Harnessing Toxicity Testing in the 21 st Century to Help Train Chemists John Jack R. Fowle III, Ph.D., D.A.B.T. Science to Inform, (US EPA, ret d) Presented to ACS Toxicology and Environmental Impact in
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 informationMutagenic impurities: predicting alerting structures using in silico tools
Mutagenic impurities: predicting alerting structures using in silico tools Richard Williams Senior Principal Scientist, Lhasa Limited About Lhasa Limited Not-for-profit company and educational charity
More informationAN INTERNATIONAL COALITION ADVANCING A NEW PARADIGM FOR CHEMICAL SAFETY TESTING
AN INTERNATIONAL COALITION ADVANCING A NEW PARADIGM FOR CHEMICAL SAFETY TESTING READING REFERENCE: 1. Krewski D. 2010. Toxicity testing in the 21st century: a vision and a strategy. J Toxicol Environ Health
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 informationHow to bring your registration dossier in compliance with REACH Tips and Hints - Part 5
How to bring your registration dossier in compliance with REACH Tips and Hints - Part 5 Read-across Niklas Andersson 12 February Read-across - Definition Read-across is a technique for predicting endpoint
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 informationThe Dose: Toxicokinetics for Human Health Risk Assessment
The Dose: Toxicokinetics for Human Health Risk Assessment John C. Lipscomb, PhD, DABT, ATS U.S. Environmental Protection Agency Office of Research and Development National Center for Environmental Assessment
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 informationIntroduction and Overview of a Biological Pathway-Based Approach to Disease and Drug Discovery
Introduction and Overview of a Biological Pathway-Based Approach to Disease and Drug Discovery Catherine Willett Coordinator, Human Toxicology Project Consortium Director, Regulatory Toxicology, Risk Assessment
More informationEndocrine disruptors: EURL ECVAM activities related to validation
The European Commission s science and knowledge service Joint Research Centre Endocrine disruptors: EURL ECVAM activities related to validation Elise Grignard 1 EU legislative background on endocrine disruptors
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 informationEPAA STEM CELLS PROJECT
EPAA STEM CELLS PROJECT Belén Tornesi AbbVie - EPAA Platform on Science - Stem Cells Forum Platform on Science 1 Platform on Science Shifting from the traditional paradigm Not looking for an 1:1 replacement
More informationCurrent State of the Science in Chemical Risk Assessment
Current State of the Science in Chemical Risk Assessment M.E. (Bette) Meek McLaughlin Centre University of Ottawa, Ottawa, Canada Email:bmeek@uottawa.ca Outline The Evolution of Regulatory Mandates & Implications
More informationCurrent challenges from Evaluation point of view - Introduction case studies
Current challenges from Evaluation point of view - Introduction case studies Expert Workshop Dealing with Uncertainty of Non-Test Methods under REACH 23-24 September 2010 Wim De Coen ECHA Evaluation I
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 informationDEVELOPMENT OF INTEGRATED APPROACHES TO TESTING AND ASSESSMENT AT OECD
DEVELOPMENT OF INTEGRATED APPROACHES TO TESTING AND ASSESSMENT AT OECD Joint Cefic LRI/Cosmetics Europe/EPAA workshop 23-24 April 2015 Promoting the regulatory use of alternative test methods The OECD
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 informationExtrapolation of in vitro effects to in vivo embryotoxicity Basic requirements for prediction model development. Han van de Sandt, PhD
Extrapolation of in vitro effects to in vivo embryotoxicity Basic requirements for prediction model development Han van de Sandt, PhD TNO: Netherlands Organisation for Applied Scientific Research Established
More informationProgress Made on Tox21: A Framework for the Next Generation of Risk Science
Progress Made on Tox21: A Framework for the Next Generation of Risk Science Daniel Krewski, PhD, MHA Professor and Director McLaughlin Centre for Population Heath Risk Assessment & Risk Sciences International
More informationThe Long Range Science Strategy (LRSS) of Cosmetics Europe
The Long Range Science Strategy (LRSS) of Cosmetics Europe Repeated dose systemic toxicity 2016 Bas Blaauboer Aim of LRSS: Development of a strategy to determine safety of cosmetic ingredients and products
More informationLong-Range Research Initiative Global Research Strategy
Long-Range Research Initiative Global Research Strategy Advancing Chemical Safety Assessment for the 21st Century Around the world, the chemical industry currently faces multiple challenges. Sound science
More informationLONG-RANGE RESEARCH INITIATIVE Global Research Strategy ADVANCING CHEMICAL SAFETY ASSESSMENT FOR THE 21ST CENTURY
LONG-RANGE RESEARCH INITIATIVE Global Research Strategy ADVANCING CHEMICAL SAFETY ASSESSMENT FOR THE 21ST CENTURY AROUND THE WORLD, THE CHEMICAL INDUSTRY CURRENTLY FACES MULTIPLE CHALLENGES. SOUND SCIENCE
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 informationADVERSE OUTCOME PATHWAYS: WHERE DO YOU START?
ADVERSE OUTCOME PATHWAYS: WHERE DO YOU START? Terry Schultz Presented at: Adverse Outcome Pathways 101: The How and Why of Development and Use. Phoenix, AZ 25 March 2014 THE AIM OF MY PRESENTATION is to
More informationNON-ANIMAL APPROACHES TO SAFETY ASSESSMENT OF COSMETIC PRODUCTS. Cutting-Edge Science and Constant Innovation: The Keys to Success
NON-ANIMAL APPROACHES TO SAFETY ASSESSMENT OF COSMETIC PRODUCTS Cutting-Edge Science and Constant Innovation: The Keys to Success 2 NON-ANIMAL APPROACHES TO SAFETY ASSESSMENT OF COSMETIC PRODUCTS Cutting-Edge
More informationThe Role of Mode of Action in Dose-Response Assessments: Recommendations from 2009 NRC Science and Decisions
The Role of Mode of Action in Dose-Response Assessments: Recommendations from 2009 NRC Science and Decisions January 25, 2016 The Role of Mode of Action in Dose- Response Assessments: Recommendations from
More informationFrumkin, 2e Part 1: Methods and Paradigms. Chapter 6: Genetics and Environmental Health
Frumkin, 2e Part 1: Methods and Paradigms Chapter 6: Genetics and Environmental Health Genetics Genetics, the study of individual genes, has expanded to include genomics, which is the study of all the
More informationPanama City, Panama April, 12-15, Marcelo Mario Matos Moreira. The Brazilian Health Surveillance Agency (ANVISA)
DIA Latin American Regulatory Conference Panama City, Panama April, 12-15, 2011 Biosimilars/Biotechnology Marcelo Mario Matos Moreira Coordinator Office of Biological Products The Brazilian Health Surveillance
More informationApplicability of the AOP for Assessing Causality of Observations in Epidemiological Studies
Applicability of the AOP for Assessing Causality of Observations in Epidemiological Studies Presented by: M.E. Meek, University of Ottawa bmeek@uottawa.ca 2 Outline Background on Adverse Outcome Pathways
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 informationNew Risk Assessment Methodologies
New Risk Assessment Methodologies in the development of Food Safety Systems Roy Kirby, Peter McClure and Natalie Thatcher Food Industry Context Business Risk Management ISO 31010/9001 (guidance on selection
More informationRecent advances in estimating real world chemical interactions. 21st Century Toxicology. The Promise and Challenges of
The Promise and Challenges of 21st Century Toxicology by Terry Shistar, Ph.D. Recent advances in estimating real world chemical interactions and exposure through computer models, known as computational
More informationFast Track Drug Development The Clinical (Caleidoscopic) Perspective
20 Years AGAH, Annual Meeting, Hamburg 21.-23. February 2010 Fast Track Drug Development The Clinical (Caleidoscopic) Perspective Fritz R. Bühler, MD ECPM, University of Basel European Innovative Medicine
More informationTESTIMONY OF THE PHYSICIANS COMMITTEE FOR RESPONSIBLE MEDICINE AND PEOPLE FOR THE ETHICAL TREATMENT OF ANIMALS ON THE TOXIC SUBSTANCES CONTROL ACT
TESTIMONY OF THE PHYSICIANS COMMITTEE FOR RESPONSIBLE MEDICINE AND PEOPLE FOR THE ETHICAL TREATMENT OF ANIMALS BEFORE THE HOUSE COMMITTEE ON ENERGY AND COMMERCE SUBCOMMITTEE ON COMMERCE, TRADE AND CONSUMER
More informationPathway-Based Regulatory Toxicology and Alternatives to Animal Testing
Pathway-Based Regulatory Toxicology and Alternatives to Animal Testing Thomas Hartung Doerenkamp-Zbinden Professor and Chair for Evidence-based Toxicology, EHS Director, Center for Alternatives to Animal
More informationProtecting Children from Harmful Chemicals -Dr. Joshua Lederberg, Nobel Laureate in Medicine
Protecting Children from Harmful Chemicals An Effective Approach to Toxic Chemicals Reform It is simply not possible with all the animals in the world to go through chemicals in the blind way we have at
More informationQSAR and Read-Across Approaches using in silico Tools in Food Ingredient/Contaminant Safety Assessments at the U.S. Food & Drug Administration
QSAR and Read-Across Approaches using in silico Tools in Food Ingredient/Contaminant Safety Assessments at the U.S. Food & Drug Administration Kirk B. Arvidson, Ph.D. U.S. Food and Drug Administration
More informationINDUSTRY S NEEDS FOR 21 ST CENTURY SAFETY SCIENCE & NON-ANIMAL APPROACHES: A UNILEVER PERSPECTIVE
INDUSTRY S NEEDS FOR 21 ST CENTURY SAFETY SCIENCE & NON-ANIMAL APPROACHES: A UNILEVER PERSPECTIVE JULIA FENTEM & GAVIN MAXWELL UNILEVER R&D SAFETY & ENVIRONMENTAL ASSURANCE CENTRE (SEAC) CONTEXT - 1 Our
More informationEURL ECVAM. A broader role for greater impact. Maurice Whelan. Head of Systems Toxicology Unit and EURL ECVAM
EURL ECVAM A broader role for greater impact Maurice Whelan Head of Systems Toxicology Unit and EURL ECVAM Institute for Health and Consumer Protection DG Joint Research Centre Meeting of the EP Intergroup
More informationNew methods: miniorgans
New methods: miniorgans C. Rovida CAAT-Europe, University of Konstanz 16 maggio 2018 Parma Summer School 2018 Emerging Risks for Food Safety and Public Perception 1981 2010 www.ecopa.eu 2012 Stakeholder
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 informationOrganisation de Coopération et de Développement Économiques Organisation for Economic Co-operation and Development
Unclassified ENV/JM/MONO(2016)48 ENV/JM/MONO(2016)48 Unclassified Organisation de Coopération et de Développement Économiques Organisation for Economic Co-operation and Development 12-Sep-2016 English
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 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 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 informationAdvancing Risk Analysis for Nanomaterials and Nanotechnologies
Advancing Risk Analysis for Nanomaterials and Nanotechnologies Jo Anne Shatkin, Ph.D. Managing Director CLF Ventures, Inc. Boston, Massachusetts November 19, 2008 Society for Risk Analysis New England
More informationJSAAE & JaCVAM Joint Workshop International Trends on 3Rs in Animal Experiments 14 February 2011, Tokyo
JSAAE & JaCVAM Joint Workshop International Trends on 3Rs in Animal Experiments 14 February 2011, Tokyo The FP7 Project AXLR8 Accelerating the transition to a toxicity pathway-based paradigm for chemical
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 informationEPAA 3Rs Science Award 2012
EPAA 3Rs Science Award 2012 Systematic approach to investigate outliers of the fish embryo test to increase its predictive capacity and applicability domain for acute fish toxicity and beyond Nils Klüver,
More informationin Toxicity Testing NAS Systems Biology-Informed Risk Assessment Workshop Kim Boekelheide, M.D., Ph.D.
The Process of Transformation in Toxicity Testing NAS Systems Biology-Informed Risk Assessment Workshop Kim Boekelheide, M.D., Ph.D. Professor, Department of Pathology & Lab Medicine, Brown University
More informationOpportunities to integrate recent advances in toxicology to promote green chemistry. Traditional whole animal-based studies present barriers
Application of Rapid In Vivo Approaches to Green Chemistry Robert Tanguay Oregon State University Department of Environmental and Molecular Toxicology Sinnhuber Aquatic Research Laboratory Environmental
More informationGuideline for the quality, safety and efficacy of follow-on biological medicinal products
Guideline for the quality, safety and efficacy of follow-on biological medicinal products 1. Introduction A follow-on biological medicinal product (hereinafter referred to as FOBMP) is considered as a
More informationQuestions and answers on the 'Guideline on the limits of genotoxic impurities'
23 September 2010 EMA/CHMP/SWP/431994/2007 Rev. 3 Committee for Medicinal Products for Human Use (CHMP) Safety Working Party (SWP) Questions and answers on the 'Guideline on the limits of genotoxic impurities'
More informationKey Aspects of Non-Clinical Pharmacology and Pharmacokinetics in the Evaluation of Safety
Safeguarding public health Key Aspects of Non-Clinical Pharmacology and Pharmacokinetics in the Evaluation of Safety David R Jones (david.jones@mhra.gsi.gov.uk) Expert Pharmacotoxicologist, Medicines and
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 informationAgreed with W. Cornell Graduate Program and Tri-I
Drug Development Course From Molecule to Prescription Weill Cornell Graduate School - Tri-Institutional Therapeutics Discovery Institute ABOUT THIS COURSE This course has been designed in collaboration
More informationDetection of toxicity to reproduction for human pharmaceuticals. Explanatory slides agreed by EWG members
Detection of toxicity to reproduction for human pharmaceuticals Explanatory slides agreed by EWG members 2 October 2017 International Council for Harmonisation of Technical Requirements for Pharmaceuticals
More informationCombining Large Animal IND Enabling Toxicology and CV Sph Studies- PRO
Safety Pharmacology Endpoints: Integration into Toxicology Studies Combining Large Animal IND Enabling Toxicology and CV Sph Studies- PRO Marc Bailie DVM, PhD Director In Vivo Facility Michigan State University,
More informationEcotoxicology Studies To Evaluate Adverse Impacts On Non Target Organisms
Ecotoxicology Studies To Evaluate Adverse Impacts On Non Target Organisms Chad Boeckman Research Scientist-Environmental Risk Assessment DuPont Pioneer Joe Huesing, PhD Senior Biotechnology Advisor USAID
More informationHow Targets Are Chosen. Chris Wayman 12 th April 2012
How Targets Are Chosen Chris Wayman 12 th April 2012 A few questions How many ideas does it take to make a medicine? 10 20 20-50 50-100 A few questions How long does it take to bring a product from bench
More informationDariusz Leszczynski & Martin L. Meltz March 15 th, 2006 ****************************************************************************************
Dariusz Leszczynski & Martin L. Meltz Rapporteurs Report WORKSHOP Application of Proteomics and Transcriptomics in EMF Research October 30 November 1, 2005 STUK - Radiation and Nuclear Safety Authority,
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 information