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2018 Summer Meeting Agenda



Organizing Committee Members


Bethany Hannas, Dow Chemical Company (Chair)
John Wambaugh, US EPA (Co-Chair)
Susan Borghoff, ToxStrategies, Inc.
Chris Bowman, Pfizer, Inc.
Wolfgang Dekant, University of Würzburg
Xiao Pan, Mars, Inc.
Nisha Sipes, NIEHS/NTP
Kimberly Wise White, American Chemistry Council
Janet Zang, US FDA-CFSAN


Detailed Program Schedule By Day



Monday, July 9


8:00 AM–9:00 AM

Computational Toxicology in Pharmaceuticals—Perspectives from Industry and Government on Its Use and Potential Areas of Collaboration between Sectors
Speakers: Matthew Martin, Pfizer, Inc. and Naomi Kruhlak, US FDA-CDER

9:00 AM–12:30 PM

SESSION: Use of Alternative Liver Models for Hepatotoxicity and Disease Progression—The Future of Practical Applications for Evaluating Compound Efficacy and Toxicity

Moderated by Esther Haugabrooks, Physician's Council for Responsible Medicine and Rebecca Clewell, ToxStrategies, Inc.

9:00 AM–9:30 AM

In Silico Modeling of Liver Toxicity—Where Are We Now?
Mark Hewitt, Wolverhampton University

9:30 AM–10:00 AM

Biologics of 3D and Other In Vitro Liver Models Used for Hepatotoxicity Prediction—Insight to Regulatory Application
Valery Shevchenko, Biopredic International

10:00 AM–10:30 AM


10:30 AM–11:00 AM

Biokinetic Modeling and IVIVE to Interpret the Results from Advanced In Vitro Liver Models for Safety and Efficacy Testing
Rebecca Clewell and Miyoung Yoon, ToxStrategies, Inc.

11:00 AM–11:30 AM

Predictive Toxicology with High-Throughput Transcriptomics and Organotypic In Vitro Liver Models
Stephen Ferguson, NIEHS/NTP

11:30 AM–12:00 Noon

Adverse Outcome Pathways As Tools to Predict Liver Toxicity in In Vitro Models
Mathieu Vinken, Vrije Universiteit Brussels

12:00 Noon–12:30 PM

Moderated Panel Discussion
All Session Speakers + Paul Brown US FDA-CDER, Andre Kleensang, CAAT
Moderated by Esther Haugabrooks, Physician's Council for Responsible Medicine and Rebecca Clewell, ToxStrategies, Inc. 

12:30 PM–1:30 PM

Attendee Luncheon
(Included with Registration)

1:30 PM–2:00 PM

Annual Business Meeting
All Attendees Welcome—Learn more about The Forum and how you can help drive the dialogue

2:00 PM–3:00 PM

Update Presentation: Hexabromocyclododecane (HBCD): A Case Study Applying Tiered Testing for Human Health Risk Assessment
Carole Yauk, Health Canada

3:00 PM–3:30 PM


3:30 PM–5:30 PM

SESSION: Building on the Science: Possible Opportunities to Reduce Toxicity Testing and Better Allocate Resources for Evaluating Ecological Risk

Moderated by Thomas Steeger, US EPA

3:30 PM–3:45 PM

The Adverse Outcome Pathway: A Framework Supporting 21st Century Toxicology
Gary Ankley, US EPA-ORD

3:45–4:00 PM

Opportunities to Improve Ecological Risk Assessment Through New Approaches—An Industry Perspective
Suzanne Hartigan, American Chemistry Council

4:00 PM–4:15 PM

Performance-Based Measures on Which EPA Relies in Determining the Utility of Data Using Clearly Defined Acceptance Criteria
Ed Odenkirchen, US EPA-OPP

4:15 PM–4:30 PM

Examination of the Acute Oral versus Acute Dietary Testing in Avian Risk Assessment Conclusions
Gina Hilton, PETA International Science Consortium

4:30 PM–4:45 PM Using New Approach Methodologies Under the Toxic Substances Control Act (TSCA)
Karen Eisenreich and Kara Koehrn, US EPA-OPPT
4:45 PM–5:00 PM Overview of the Pivot in US EPA’s Endocrine Disruptor Screening Program (EDSP) with an Emphasis on High-Throughput and Computational Approaches
Seema Schappelle and Stan Barone, US EPA-OSCP

5:00 PM–5:30 PM

Moderated Panel Discussion

Moderated by Thomas Steeger, US EPA

5:45 PM–7:30 PM Welcome Reception


Tuesday, July 10


8:00 AM–10:00 AM

David Miller Traveling Scholars Session: Adverse Effects As the Basis for Regulatory Decisions: What Is Adverse?

Moderated by Wolfgang Dekant, University of Würzburg

8:00 AM–8:20 AM

Defining Points-of-Departure from New Approach Methods
Katie Paul Friedman, US EPA-NCCT

8:20 AM–8:40 AM

A View on Adverse Effects and Decision Making at US FDA-CFSAN
Antonia Mattia, US FDA-CFSAN

8:40 AM–9:00 AM

Adversity in the Light of REACH
Helmut Greim, Technical University of Munich

9:00 AM–9:20 AM

A Perspective from Industry
Rebecca Clewell, ToxStrategies, Inc.

9:20 AM–10:00 AM

Moderated Panel Discussion
Moderated by Wolfgang Dekant, University of Würzburg

10:00 AM–10:30 AM BREAK
10:30 AM–12:30 PM

SESSION: From Bio-Concentration in Aquatic Organisms to Bio-Accumulation in Humans: How the Use of Bio-Concentration Factors (Bcfs) Underestimate PFAS Bio-Accumulation Risks to Humans

Moderated by Jamie DeWitt, East Carolina University 

10:30 AM–11:00 AM

Chemical-Physical Properties of PFASs That Make Them Persistent
Shawn Gannon, Chemours Company

11:00 AM–11:30 AM

Bioaccumulation of PFASs in Terrestrial Species and Marine Mammals: Canadian Regulatory Perspective
Jessy Kurias, Environment and Climate Change Canada

11:30 AM–12:00 Noon Relevance of Wildlife Bioaccumulation Data to Human Health Protection
Susanne Brander, Oregon State University
12:00 Noon–12:30 PM

Moderated Panel Discussion

Moderated by Jamie DeWitt, East Carolina University

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

George H. Scott Award Lecture
Awardee: Jeffrey Peters, Penn State University

2:00 PM–5:30 PM

SESSION: Integration of Toxicokinetics and the Kinetically-Derived Maximum Dose into Toxicity Testing and Risk Assessment

Moderated by Jeanne Domoradzki, Dow AgroSciences and Shakil Saghir, Smiters-Avanza

2:00 PM–2:30 PM

The Mechanistic Basis of Non-Proportionate Systemic Doses in Toxicology Studies and Implications for Chemical Risk Assessment
Jeanne Domoradzki, Dow AgroSciences

2:30 PM–3:00 PM Kinetically-Derived Maximum Dose (KMD) for Dose-Level Selection and Interpretation of Toxicity Studies
Shakil Saghir, Smithers-Avanza
3:00 PM–3:30 PM BREAK
3:30 PM–4:00 PM Kinetically-Derived Maximum Dose: A Key Initiating Event Impacting Need for Mode of Action Investigations of High-Dose Specific Toxicity
Susan Borghoff, ToxStrategies, Inc.
4:00 PM–4:30 PM

Regulatory Perspectives on the Use of Toxicokinetic Data in Human Risk Assessment
Monique Perron, US EPA-OPP

4:30 PM–5:30 PM Moderated Panel Discussion
(Included with Registration) 


Wednesday, July 11


8:00 AM–10:00 AM

SESSION: Food Contact Material Risk Assessment: Perspectives on the Science

Moderated by Marusia Popovech, ExxonMobil Biomedical Sciences

8:00 AM8:30 AM

Scientific Challenges in the Risk Assessment of Food Contact Materials
Maricel Maffini, Independent Consultant

8:30 AM–9:00 AM

New Developments in Toxicology
Margaret Whittaker, ToxServices, LLC

9:00 AM–9:30 AM

Food Contact Materials Risk Assessment: An Industry Perspective
Edwin Bisinger, Akzo Nobel Chemicals

9:30 AM–10:00 AM

Moderated Panel Discussion

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

SESSION: US FDA’s Predictive Toxicology Road Map—A Six-Part Framework for Integrating Predictive Toxicology Methods into Safety and Risk Assessments 

Moderated by Suzanne Fitzpatrick, US FDA-CFSAN and Ronald Brown, US FDA-CDRH

10:30 AM–11:00 AM Introducing the FDA Predictive Toxicology Road Map
Suzanne Fitzpatrick, US FDA-CFSAN

11:00 AM–11:30 AM Examples of the Value of Partnering with the US FDA in Toxicology
Paul Brown, US FDA-CDER
11:30 AM–12:00 Noon

The US FDA-CDRH Guidance on Biocompatibility—Integrating Alternatives Methods for Safety Assessment
Ronald Brown, US FDA-CDRH

12:00 Noon–12:30 PM BREAK  

12:30 PM–1:00 PM Guidance for Partnering with US FDA to Advance Predictive Toxicology
Alice Welch, US FDA (Office of the Commissioner)
1:00 PM–2:00 PM Moderated Panel Discussion
All Speakers + Heidi Bialk, PepsiCo, and Kelly Coleman Medtronic, plc