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2019 Winter Meeting Agenda

The Program Planning Committee is pleased to present a varied scientific program emphasizing dialogue on a number of complex topics in toxicology. Bringing together scientists from industry, government, academia, and interest groups, the goal of the meeting is to build a better understanding through dialogue in a collegial and engaging environment for all participants.

Program Structure: After each presentation, there will be approximately 5-10 minutes for specific dialogue on the presentation such as clarifying questions regarding the content. Additionally, each session concludes with a moderated panel discussion that allows audience members and speakers alike to address the central questions of the session, address research gaps, and help advance science-based decision making.


Detailed Program by Day                


Monday, January 28, 2019


8:00 AM–10:00 AM

Risk Assessment Communications—Perspectives from Different Sectors
This session is supported via the David Miller Traveling Scholar Award Funds

This session is intended to give the audience a factual understanding of the goals and processes of risk communication in the various sectors. A moderated panel discussion among speakers and attendees (approximately 30 minutes – 1 hour) will follow the presentations. Opportunities for collaboration and similarities among the sectors will be highlighted, along with potential differences and how they might be better understood and potentially overcome.

Elisabeth Anderson, Michigan State University
Monica Linnenbrink, US EPA/ORD
Lisa Navarro, Givaudan


10:30 AM–12:30 PM

SESSION: Safety Assessment of Genetically Engineered Food Crops: Screening Methods, Safety Concerns, and Current US Regulation

Moderated by Grace Chappell, ToxStrategies, Inc.


10:30 AM–11:00 AM
Agricultural Biotechnology, Food Safety, and the US FDA
Patrick Cournoyer, US FDA

  11:00 AM–11:30 AM
Evaluating Real and Potential Risks of Allergy or Celiac Disease from Genetically Engineered Crops
Rick Goodman, University of Nebraska

  11:30 AM–12:00 Noon
The Use of Human Intestinal Epithelial Cell Line Monolayers for In Vitro Protein Hazard Characterization
Bryan Delaney, Independent Consultant

  12:00 Noon–12:30 PM
Moderated Panel Discussion
All Session Speakers


12:30 PM–1:30 PM
Attendee Luncheon
(Included with Registration)


1:30 PM–5:30 PM
SESSION: Non-Genotoxic Impurities in Pharmaceuticals—Is it Time to Review Acceptance Levels, Specifications and Toxicology Qualification?
Moderated by Timothy Hart, GlaxoSmithKline, plc


1:30 PM–1:55 PM
The Challenges with Existing Impurities Guidelines and Why Recrystallisation Isn’t a Cure All Approach
Andy Teasdale, AstraZeneca

1:55 PM–2:20 PM

Scientific Justification for (Higher) Impurity Levels in Early Clinical Trials
James Harvey, GlaxoSmithKline

2:20 PM–2:45 PM

Initiatives of the Drug Impurities Working Group to Clarify Aspects of Impurity Qualification
Joel Bercu, Gilead

2:45 PM–3:15 PM BREAK 3:15 PM–3:40 PM

Regulatory Perspective of Impurity Levels in Drug Substance/Drug Products
Timothy McGovern, US FDA/CDER

3:40 PM–4:05 PM

A European Regulatory Perspective on the Qualification of Non-Genotoxic Impurities in Drug Substance/Drug Products
Leon van Aerts, Medicines Evaluation Board

4:05 PM–4:30 PM

A Health Canada Regulatory Perspective on the Qualification of Non-Genotoxic Impurities in Drug Substance/Drug Products
Alisa Vespa, Health Canada

4:30 PM–5:30 PM

Round Table Discussion
All Speakers with additional panelists including: John Nicolette–Abbvie, Aisar Atrakchi–US FDA, Stephen Miller–US FDA, Krista Dobo–Pfizer, Inc., and Mark Powley–Merck & Co., Inc.


5:45 PM–7:30 PM Welcome Reception


Tuesday, January 29, 2019


8:00 AM–11:30 AM

Mixtures Toxicology: Moving from Addition to Prediction 

Moderated by Christopher Borgert, Applied Pharmacology and Toxicology, Inc.

8:00 AM–8:15 AM

Introduction and Background: Limitations of Current Approaches to Mixtures Testing and Modeling
Christopher Borgert, Applied Pharmacology and Toxicology, Inc.

8:15 AM–8:40 AM

Considerations on Quantification of Uncertainty in Mixtures Studies
Claudio Fuentes, Oregon State University

8:00 AM–9:05 AM

Using Mechanistic Information to Inform the Design, Analysis and Interpretation of Potential Toxicological Interactions: The Case of Insecticidal DvSnf7 dsRNA and Cry3Bb1
Steven Levine, Monsanto Company

9:05 AM–9:30 AM

Understanding the Biological Integration of Mixture Exposures
Jonathan Boyd, West Virginia University

9:30 AM–10:00 AM


10:00 AM–10:25 AM

Options for Decision Making in Face of Uncertainties in Mixtures Modeling
Edward Odenkirchen, US EPA

10:25 AM–10:50 AM

Better Mixtures Living through Biochemistry: Using Biochemical Modeling to Better Understand What Chemicals Are Doing in Mixtures
Lyle Burgoon, US Army Corp of Engineers

10:50 AM–11:30AM

Moderated Panel Discussion
All Speakers

11:30 AM–12:30 PM

Review of the Evidence for Thresholds for DNA-Reactive and Epigenetic Experimental Chemical Carcinogens
Gary Williams and Tetyana Kobets, New York Medical College

12:30 PM–1:30 PM Attendee Luncheon
(Included with registration) 1:30 PM2:00 PM

Philippe Shubik Award Lecture
Awardee: Robert Kavlock

2:00 PM–5:30 PM

SESSION: Deciphering Different Approaches to Benchmark Dose Methodologies

Moderated by Brian Hughes, NSF International and Michael Dourson, Toxicology for Excellence in Risk Assessment (TERA)

2:00 PM–2:30 PM

Modeling:  Issues and Controversies from a Biologist’s Perspective
Lynne Haber, University of Cincinnati

2:30 PM–3:00 PM EFSA and US EPA BMD Guidance: Understanding the Different Approaches and Underlying Arguments
Matthew Wheeler, NIOSH
3:00 PM–3:30 PM BREAK 3:30 PM–4:00 PM Importance of Utilizing BMD Approaches for Risk Assessment and Risk Communication
Kimberly Wise White, American Chemistry Council
4:00 PM–4:30 PM

Practical Examples of Modeling Choices and Their Consequences for Risk Assessment
Allen Davis, US EPA

4:30 PM–5:30 PM Moderated Panel Discussion
6:00 PM–7:00 PM Attendee Reception
(Included with Registration) 


Wednesday, January 30, 2019


8:00 AM–10:00 AM

SESSION: The Re-Emergence of Cannabis: New Frontiers in the Potentials and Pitfalls of Inhalation and Oral Exposures

Moderated by Roger Clemens, University of Southern California

8:00 AM–8:20 AM

History of Cannabis and Introduction to the Spectrum of Cannabinoids Toxicology
A. Wallace Hayes, University of South Florida

8:20 AM–8:40 AM

Cannabis in our Food Supply: The Importance of Updating and Implementing the Supply Chain, Manufacturing Practices and Specifications, and Regulatory Oversight
Roger Clemens, University of Southern California

8:40 AM–9:00 AM

Cannabis: A Re-Emerging Public Health Issue as Reflected in the Clinic—Therapeutics, Pathophysiology, and Endocannabinoid Research and Development
Peter Pressman, Polyscience Consulting and The Daedalus Foundation

9:00 AM–9:20 AM

Overview and Update on Cannabis Regulations
Claire Kruger, ChromaDex

9:20 AM–10:00 AM

Moderated Panel Discussion

10:00 AM–10:30 AM BREAK 10:30 AM–2:00 PM

SESSION: Hazard Identification: Is Hazard Classification Valid without Context of Exposure?

Moderated by Susan Borghoff, ToxStrategies, Inc, and Susan Felter, Procter & Gamble Company

10:30 AM–11:00 AM

Hazard Identification and Classification, Historical Perspective, and Impact
Rita Schoeny, Consultant/Retired from US EPA

11:00 AM–11:30 AM

High-Dose Hazard Testing at Concentrations That Exceed Kinetically Derived Maximum Doses: Implication of Saturation of Kinetic Pathways
Jeanne Domoradzki, Corteva AgriScience

11:30 AM–12:00 Noon

Nongenotoxic Carcinogens in Our Food: Time to Banish the Delaney Clause?
Susan Felter, Procter & Gamble Company

12:00 Noon–12:30 PM


12:30 PM–1:00 PM

Identification of Endocrine Disruptors: Implications of Hazard Classification without Considering Exposure and Potency
Susan Borghoff, ToxStrategies, Inc.

1:00 PM–1:30 PM

Use of New Approach Methodologies (NAMs) for Integration into Risk Assessment
Tala Henry, US EPA

1:30 PM–2:00 PM

Moderated Panel Discussion