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

Contemporary Hot-Topics in Toxicology

This session will be announced as we approach the meeting and is dedicated to addressing issues that are current or have newly arisen within the past few months.

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, DuPont Pioneer

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–2:00 PM

The Challenges with Existing Impurities Guidelines and Why Recrystallisation Isn’t a Cure All Approach
Andy Teasdale, AstraZeneca

2:00–2:30 PM

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

2:30 PM–3:00 PM

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

3:00 PM–3:30 PM BREAK
3:30 PM–4:00 PM

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

4:00 PM–4:30 PM

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

4:30 PM–5:30 PM

Round Table Discussion
All Speakers with additional panelists including: John Nicolette–Abbvie, Aisar Atrakchi–US FDA, Steven 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

Concentration Addition As a Proxy for Reality—How Relevant Is it?
Heli Miriam Hollnagel, Dow Europe GmbH

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: TBA

2:00 PM–5:30 PM

SESSION: Deciphering Different Approaches to Benchmark Dose Methodologies

Moderated by Brian Hughes, NSF International

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 Practical Examples of Modeling Choices and Their Consequences for Risk Assessment
Allen Davis, US EPA
4:00 PM–4:30 PM

Importance of Utilizing BMD Approaches for Risk Assessment and Risk Communication
Kimberly Wise White, American Chemistry Council

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

Case Study: Hazard Classification of Non-Genotoxic Carcinogens
Susan Felter, Procter & Gamble Company

12:00 Noon–12:30 PM


12:30 PM–1:00 PM

Case Study: Hazard Classification of Endocrine Disruptors: Implication for Lack of Consideration of Potency
Susan Borghoff, ToxStrategies, Inc.

1:00 PM–1:30 PM

Future Use of New Approach Methodologies (NAMS) for Hazard Identification
Louis Scarano, US EPA

1:30 PM–2:00 PM

Moderated Panel Discussion