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McKim Workshop on Data Redundancy in Cancer Assessment, Duluth, MN, May 19-21, 2010

Duluth

The McKim Conferences on Predictive Toxicology will host a special workshop on opportunities for streamlining the array of toxicity tests used in assessments of carcinogenicity.  Evaluating short-term in vitro and in vivo data often assumes that alternative test methods have global chemical domains, and the resulting ambiguities tend to propel testing toward the expensive, long-term rodent carcinogen assay.  This retreat will consider a hypothesis-testing framework for organizing short-term evidence of low-incident in vivo risks and more efficient cancer assessments. Participation will be by invitation only, but registration for a limited number of observers will begin in March.

Workshop Goals

The McKim Conferences on Predictive Toxicology are convened to discuss the scientific barriers associated the paradigm shift to a more efficient hypothesis-driven testing paradigm as well as critical paths to overcome those barriers.  A conceptual framework centered on adverse outcome pathways serves to integrate QSAR models and a wide variety of in vitro and in vivo test endpoints, and provides a logical structure for assembling and interpreting safety assessments of in vivo risks.  Improved predictions for many short-term assessment endpoints are already being demonstrated by many regulatory agencies.

While the prediction of low-incident toxic effects such as cancer in populations still has many uncertainties, the assessment of chemical carcinogenicity, potency and susceptibility factors are routinely conducted by panels of experts even without the rodent carcinogenicity assay.  This workshop will reinterpret the supporting evidence for carcinogenicity using more rigorous QSAR–based chemical categories which collate chemical on a basis of molecular initiations with DNA and other macromolecules.  Once categorized, the in vitro and in vivo evidence coming soon can be arrayed along adverse outcome pathways to the assessment endpoints used by regulatory authorities.

 

Agenda

Tuesday May 18
18h30-20h30 With a number of participants are arriving Monday and early Tuesday, we will host an informal get-acquainted social near the lobby of the Canal Park Lodge

Wednesday May 19
09h00 Welcome & Introductions
09h15 Review of purpose and the agenda - Gilman Veith, IQF, Two Harbors
09h50 Levels of Assessment in the Canadian Environmental Protection Act – Kathy Hughes, Health Canada, Ottawa
10h30 Coffee
10h45 In silico, in vitro, and in vivo methods as alternatives to the carcinogenicity bioassay – Romualdo Benigni, Instituto Superiore di Sanita, Rome, Italy
11h30 Predicting cancer endpoints using MultiCase – Gilles Klopman, MultiCase Inc, Cleveland
12h15 Catered Lunch


13h15 Identifying genotoxic and nongenotoxic carcinogens with cell transformation assays – Paule Vasseur, Laboratoire Interactions, Ecotoxicologie, Biodiversité, Ecosystèmes, University of Metz, France
14h00 Identifying major stress pathways - Ram Ramabhadran, Integrative Systems Toxicology, USEPA, RTP
14h45 Identifying carcinogens using Oncologic – Yin-tak Woo, USEPA, Washington DC
15h30 Break
15h45 In Silico Methods for Predicting Chromasomal Endpoints - Jay Niemela, National Food Institute, Technical University of Denmark
16h30 Integrating Adverse Outcome Pathways into the OECD (Q)SAR Application Toolbox – Terry Schultz, OECD, Paris
17h15 Adjourn
19h00 Dinner after a short walk to Bellisio’s – (Order off the regular menu)

Thursday May 20
09h00 Forming Chemical Categories for Cancer Endpoints – Ovanes Mekenyan, Laboratory of Mathematical Chemistry, Bourgas
09h45 Discussion of grouping methods that combine structural alerts and reactivity models
10h30 Coffee
10h45 Discussion of the predictability of metabolism, mutagenicity and cell transformation within chemical categories
12h15 Catered Lunch


13h15 Discussion of approaches for identifying nongenotoxic pathways to carcinogenesis
15h15 Break
15h30 Discussion of “negative carcinogens” in the assessment process (QSAR boundaries for the precautionary principle in multiple pathways
17h00 Adjourn

Dinner in Small Groups

Friday May 21

09h00 Discussion of approaches for bridging the in vitro/in vivo gap
10h30 Coffee
10h45 Workshop summary and implementing next steps
12h00 Adjourn

The workshop is 15-20 minutes from the airport and we will arrange transportation for the early afternoon flights

Last Updated (Monday, 14 June 2010 08:10)

 

Participants

Hristo Aladjov Bulgarian Academy of Sciences,Sofia, Bulgaria

Gary Ankley Senior Scientist,US EPA Duluth, MN

Subhash Basak Natural Resources Research Institute,Duluth, MN

Romualdo Benigni Instituto Superiore di Sanita,Rome, Italy

Steve Enoch Liverpool John Moores University,Liverpool UK

Michael Hornung Senior Scientist,US EPA Duluth, MN

Kathy Hughes Senior Science Advisor,Health Canada, Ottawa

Gilles Klopman CEO MultiCase Inc.,Cleveland, OH

Marie-Alaine Maire Laboratoire Interactions, Ecotoxicologie, Biodiversité, Ecosystèmes,University of Metz, France
Ovanes Mekenyan Head, Laboratory of Mathematical Chemistry,Bourgas, Bugaria

Jay Niemela National Food Institute,Copenhagen, Denmark

Rich Purdy Retired,River Falls, WI

Terry Schultz OECD, Paris, U of Tennessee Emeritus,Knoxville, TN

Ram Ramabhadran Director, Integrative Systems Toxicology,USEPA, RTP-NC

Kristie Sullivan Scientific and Policy Advisor,Physicians Committee for Responsible Medicine

Kendall Wallace U of M Medical School,CEO Stratatox, LLC

Yin-tak Woo Office of Pollution Prevention and Toxics,USEPA, Washington DC

Paule Vasseur Laboratoire Interactions, Ecotoxicologie, Biodiversité, Ecosystèmes,University of Metz, France
Judy Vee IQF Conference Coordinator,Duluth, MN

Gilman Veith Int QSAR Foundation,Two Harbors, MN

Last Updated (Tuesday, 22 June 2010 07:17)

 

Presentations

Wednesday May 19
Review of purpose and the agenda Gil Veith ppt
Levels of Assessment in the Canadian Environmental Protection Act Kathy Hughes ppt
In silico, in vitro, and in vivo methods as alternatives to the carcinogenicity bioassay Romualdo Benigni ppt
Predicting cancer endpoints using MultiCase Gilles Klopman ppt
Identifying genotoxic and nongenotoxic carcinogens with cell transformation assays Paule Vasseur ppt
Identifying major stress pathways Ram Ramabhadran ppt
Identifying carcinogens using Oncologic Yin-tak Woo ppt
In Silico Methods for Predicting Chromasomal Endpoints Jay Niemela ppt
Integrating Adverse Outcome Pathways into the OECD (Q)SAR Application Toolbox Terry Schultz ppt
Thursday May 20
Summary of Day One and Agenda Gil Veith ppt
Forming Chemical Categories for Cancer Endpoints Ovanes Mekenyan pptx
Modulation of QSAR sensitivity / specificity Romualdo Benigni ppt

Simulating of in vivo metabolism taking into account detoxification logics

Ovanes Mekenyan ppt
Friday May 21
Discussion of approaches for bridging the in vitro/in vivo gap Romualdo Benigni ppt

Last Updated (Monday, 14 June 2010 09:19)