The Toxicology Forum — 44th Annual Summer Meeting — Program

THE TOXICOLOGY FORUM 44th Annual Summer Meeting July 9–11, 2018 Loews Annapolis Hotel Annapolis, MD

www.toxforum.org

2018 Corporate Sponsors

Platinum The Coca-Cola Company

Mars, Inc.

ExxonMobil Biomedical Sciences, Inc.

PepsiCo

Frimenich

Procter & Gamble

Silver Cargill Merck, Inc.

Bronze American Beverage Association

NSF International

American Chemistry Council

ToxStrategies, Inc.

Intertek Scientific & Regulatory

Your organization’s sponsorship allows The Forum to build a better understanding through dialogue, helps lower attendee costs at its meetings, and greatly increases the meeting’s impact.

AGENDA

2018

All Sessions will be held in the Regatta Ballroom.

All Breaks and Attendee Luncheons will be held in the Annapolis Atrium.

Reception locations are included in the reception listings wihtin the daily agenda.

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 Miyoung Yoon, ToxStrategies, Inc.

9:00 AM–9:30 AM

9:30 AM–10:00 AM

10:00 AM–10:30 AM

BREAK

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 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

In Silico Modeling of Liver Toxicity—Where Are We Now? Mark Hewitt, Wolverhampton University Biologics of 3D and Other In Vitro Liver Models Used for Hepatotoxicity Prediction—Insight to Regulatory Application Valery Shevchenko, Biopredic International

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 + Suzanne Fitzpatrick US FDA-CFSAN, Andre Kleensang, CAAT Moderated by Esther Haugabrooks, Physician’s Council for Responsible Medicine and Miyoung Yoon, 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.

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2018

AGENDA

Monday, July 9 (Continued)

2:00 PM–3:00 PM

UPDATE PRESENTATION—Progress Made in BMD Modeling of Toxicoepigenomics for Risk Assessment—Hexabromocyclododecane (HBCD): A Case Study Applying Tiered Testing for Human Health Risk Assessment Carole Yauk, Health Canada

3:00 PM–3:30 PM

BREAK

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 PM–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 (Included with Registration) Location: Mainsail/Spinnaker Room

Other Opportunities to Connect The Toxicology Forum aspires to provide attendees with opportunities to network and socialize, which is why the Forum has setup courtesy dinner reservations at local area restaurants, including BarOak located in the Loews Annapolis Hotel, for Monday and Tuesday evening. Guests will be responsible for settling their own tabs. Please stop by the registration desk for additional restaurant details and to sign up.

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AGENDA

2018

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

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

Moderated Panel Discussion Moderated by Wolfgang Dekant, University of Würzburg

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

ATTENDEE LUNCHEON (Included with Registration)

12:30 PM–1:30 PM

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2018

AGENDA

Tuesday, July 10 (Continued)

1:30 PM–2:00 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

6:00 PM–7:00 PM

ATTENDEE RECEPTION (Included with Registration) Location: Annapolis Atrium

Other Opportunities to Connect The Toxicology Forum aspires to provide attendees with opportunities to network and socialize, which is why the Forum has setup courtesy dinner reservations at local area restaurants, including BarOak located in the Loews Annapolis Hotel, for Monday and Tuesday evening. Guests will be responsible for settling their own tabs. Please stop by the registration desk for additional restaurant details and to sign up.

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AGENDA

2018

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 AM–8:30 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

10:00 AM–10:30 AM

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

Moderated Panel Discussion BREAK

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

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2018

AWARDS

Session Descriptions AWARD LECTURE Presented by the George H. Scott Distinguished Scientist Award Winner on a topic of their choosing.

KEYNOTE LECTURE Invited lecture and discussion session intended to generate thought and discussion among the audience on topics not typically covered at a “toxicology meeting.”

SCIENTIFIC SESSIONS Typically 2 or 3.5 hours in length depending on the topic. Sessions provide a balanced slate of presentations to drive a better understanding through dialogue for audience members and presenters alike.

DAVID MILLER TRAVELING SCHOLAR SESSION Through the support of a generous donor, the David Miller Traveling Scholar Session brings in noted experts on a topic of high-interest to Toxicology Forum attendees.

UPDATE SESSIONS 30 minute presentations on a timely, discussion provoking topic from a single speaker. Engaged audience dialogue is encouraged.

Discussion Guidance At the end of each presentation, at the discretion of the moderator or presenter there will be a short time for questions. Please limit questions during this time to brief, clarifying questions about the presentation.

Each session has a built in moderated panel discussion. Please allow the dialogue to develop naturally among the speakers and audience participants and avoid asking additional questions until other audience members have been able to contribute to the current line of dialogue. The goal of The Toxicology Forum is to build a better understanding through dialogue for all attendees.

Code of Conduct The Toxicology Forum (“The Forum”) hosts some of the most respected meetings of toxicologists in the science community. The Forum is committed to providing a safe, productive, and welcoming environment for all participants. It is the stated policy of The Forum that all participants, attendees, staff, and stakeholders will conduct themselves in a professional manner that encourages scientific debate while maintaining a welcoming environment.

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AWARDS

2018

George H. Scott Memorial Award George H. Scott, a Procter & Gamble scientist, who gained worldwide respect for his tireless efforts and contributions in the fields of human and environmental toxicology is remembered through an annual award established by The Toxicology Forum in 1983. His unfailing support of The Forum in its early days played a major role in its success. The award is given to those who have demonstrated an outstanding role in developing and applying the science of toxicology, and honors the memory of George H. Scott.

2018 Recipient: J effrey M. Peters, PhD, ATS Dr. Peters’ 20+ years career as an academic researcher includes numerous contributions to the science of toxicology, along with the selfless service, education, and mentoring that continues to advance not only the science, but the people that help increase the impact and utilization of toxicology. Best known for his studies in the field of PPAR-mediated mechanisms and carcinogenesis, Dr. Peters’ studies have demonstrated that PPARα is required to mediate the physiological and hepatocarcinogenic effects of PPARα agonists in rodents.

Dr. Peters’ leadership, teaching, and mentorship at Penn State University, along with his high-impact publication record and volunteer service in the toxicology community, make him a deserving recipient of the George H. Scott Memorial Award.

The George H. Scott Memorial Award Recipients Norbert Kaminski, PhD—2017 Michigan State University East Lansing, MI Wolfgang Dekant, PhD—2016 University of Würzburg Germany Serrine S. Lau, PhD—2015 University of Arizona Tucson, AZ William Slikker Jr., PhD, ATS—2014 US FDA Jefferson, AR James S. Bus, PhD, DABT, ATS—2013 Exponent, Inc. Midland, MI Samuel Cohen, MD, PhD, ATS, DABP—2012 University of Nebraska Medical Center Omaha, NE Lewis Smith, PhD—2011 University of Leicester, Leicester United Kingdom Curtis D. Klaassen, PhD, DABT, ATS—2010 University of Kansas Medical Center Kansas City, KS

James E. Klaunig, PhD, ATS, IATP—2009 Indiana University School of Medicine Indianapolis, IN

Diether Neubert, PhD—2000 Free University Berlin Berlin, Germany

Ronald Estabrook, MD, DSc, PhD—1999 George P. Daston, PhD—2008 University of Texas at Dallas Procter & Gamble Dallas, TX Mason, OH J. David Miller, PhD—1998 Jay I. Goodman, PhD —2007 Carleton University Michigan State University Ontario, Canada East Lansing, MI Jerry M. Rice, PhD—1997 Lois Lehman-McKeeman, International Agency for PhD, ATS—2006 Research on Cancer Bristol-Myers Squibb Lyon, France Princeton, NJ Charles C. Capen, Raymond W. DVM, PhD—1996 Tennant, PhD—2005 Ohio State University National Institute of Columbus, OH Environmental Health Sciences Frank Gonzalez, PhD—1995 Research Triangle Park, NC National Cancer Institute Benjamin F. Trump, MD—2004 Bethesda, MD University of F. Peter Guengerich, PhD—1994 Maryland, Baltimore Vanderbilt University Baltimore, MD Nashville, TN Gerald N. Wogan, PhD—2003 Melvin Andersen, PhD, DABT, Massachusetts Institute of CIH, ATS—1993 Technology US EPA Cambridge, MA Research Triangle Park, NC Andrew Renwick, PhD—2002 James A. Popp, DVM, PhD—1992 University of Southampton Chemical Industry Institute Southampton, United Kingdom of Toxicology, Emil Poulsen, DVM, DVSc—2001 Research Triangle Park, NC Copenhagen, Denmark

Curtis C. Harris, MD—1991 National Cancer Institute Bethesda, MD James A. Swenberg, PhD—1990 University of North Carolina Chapel Hill, NC David B. Clayson, PhD—1989 Health and Welfare Canada Ottawa, Canada W. Gary Flamm, PhD—1988 Flamm Associates Reston, VA Perry J. Gehring, DVM, PhD, ATS—1987 Dow Chemical Company Midland, MI Herbert Blumenthal, PhD—1986 US FDA Silver Spring, MD Robert Neal, PhD—1985 Chemical Industry Institute of Toxicology Research Triangle Park, NC Carroll S. Weil, MA—1984 Union Carbide Danbury, CT Leon Goldberg, DSc, PhD—1983 Duke University Medical Center, Durham, NC

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LEADERSHIP

2018 Officers Vice President Cody Wilson Coca-Cola Company

Treasurer illiam Hanneman W Colorado State University

Past President J ames Klaunig * Indiana University

Secretary J ay Goodman * Michigan State University

A. Wallace Hayes* University of South Florida & Michigan State University

David Tonucci* Tate & Lyle

President Robert Barter ExxonMobil Biomedical Sciences, Inc.

Directors Heidi Bialk PepsiCo Christine Crincoli Cargill Laurie Haws* ToxStrategies, Inc.

Mark Miller NIEHS/NIH

Thomas Vollmuth* Vollmuth & Associates, LLC Kimberly Wise White* American Chemistry Council

Incoming Board of Directors The Toxicology Forum would like to welcome its newly-elected leaders to its Board of Directors, effective September 1, 2018.

Vice President A. Wallace Hayes University of South Florida & Michigan State University

Secretary L aurie Haws ToxStrategies, Inc.

Director Edward Ohanian US EPA

Director Suzanne Fitzpatrick US FDA

Director eza Rasoulpour R Corteva Agrisciences

*Indicates a term expiration date of August 31, 2018.

Program Planning Committee The Toxicology Forum would like to thank the members of the Program Planning Committee for their hard work and dedication.

Chair ethany Hannas B Dow Chemical Company S usan Borghoff ToxStrategies, Inc.

Committee Members Xiao Pan Mars, Inc.

Kimberly Wise White American Chemistry Council

Chris Bowman Pfizer, Inc.

Nisha Sipes NIEHS/NTP

Janet Zang US FDA-CFSAN

Wolfgang Dekant University of WĂźrzburg

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Co-Chair John Wambaugh US EPA

ATTENDEE ROSTER

2018 As of June 19, 2018

Attendees Roster Usage Guidelines The 2018 Summer Toxicology Forum attendees roster/list is provided for the convince of the meeting attendees’ use. The list is owned by the Toxicology Forum and may not be used for solicitation purposes.

Please contact the Toxicology Forum Headquarters if you have any questions.

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NOTES

EUROPEAN MEETING

The Toxicology Forum is pleased to announce the organization of a special European Workshop entitled...

Determining Relevant Low Level Chemical Exposures for Safety Assessments of Consumer Products May 13–15, 2019 The Hotel Brussels Brussels, Belgium

Planned as a 2.5-day workshop, organized under the principles and with the assistance of The Toxicology Forum, this meeting intends to progress towards a broadly-accepted framework to assess and position the safety of trace chemicals exposure from consumer products, and in particular, from articles and assembled consumer goods.

Both experimental-analytical and computational approaches, and how their respective exposure data are realistic and relevant for safety assessments, will be in scope.

Call for presentations and call for abstract opportunities will be available!

Watch your email and check www.toxforum.org for updates.

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TERUNDERSTANDING CONSENSUSBUILDING WORD BANK ENVIRONMENTALISSUES Better Understanding High Impact Issues HIMPACTISSUES HEALTHAGENCIES Consensus Building Health Agencies HS OPENDIALOGUE David Miller Award Key Decision Makers ATIONSHIPBUILDING RISKASSESSMENT EPA NIEHS TOXICOLOGYFORUM TOXICOLOGY Environmental Issues

Open Dialogue

FDA

Philippe Shubik Award

DAVIDMILLERAWARD FDA Relationship Building KEYDECISIONMAKERS Risk Assessment PHILIPPESHUBIKAWARD Scientific Challenges SCIENTIFICCHALLENGES The Toxicology Forum WASHINGTONDCJANUAR Toxicology

Washington DC January

Toxicology Forum Sponsorship Building Understanding through Dialogue

Sponsorship Levels Platinum Sponsorship $10,000 per annum

Yearly membership dues are waived for up to five individuals and the company receives eight–50% reduced price meeting registrations.

Gold Sponsorship $7,500 per annum

Yearly membership dues are waived for up to three individuals and the company receives six–50% reduced price meeting registrations.

Silver Sponsorship

Bronze Sponsorship

Yearly membership dues are waived for up to two individuals and the company receives four–50% reduced price meeting registrations.

Yearly membership dues are waived for one individual and the company receives two– 25% reduced price meeting registrations.

$5,000 per annum

$1,500 per annum

For more information on sponsorship of The Toxicology Forum, please contact Kevin Merritt (info@toxforum.org).

www.toxforum.org 703.547.0876 *The Toxicology Forum reserves the right to refuse the acceptance of funds from any organization whose goals, objectives, or past actions are deemed counterproductive to those of The Forum. The Toxicology Forum does not accept sponsorship from tobacco companies.

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2018 Summer Meeting Sponsors The Toxicology Forum would like to thank the Lilly Grant Office and the National Institute of Environmental Health Sciences, Office of the Director for their generous support through the Conference Support Funds program.

The Toxicology Forum welcomes meeting support from all organizations that seek to help build a better understanding through dialogue. Support is used to offset the cost of meeting expenses and help to keep registration fees modest to attract greater attendance.

Smile!

The Toxicology Forum is here to help you build a better understanding through dialogue with those around you. Hopefully, you will have plenty to smile about.

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Toxicology Forum Membership Building Understanding through Dialogue Overview The Toxicology Forum is a nonprofit organization dedicated to facilitating open, transparent dialogue among leading scientists concerned with current challenges in toxicology, environmental and public health. The objective of The Toxicology Forum’s meetings is to discuss and better understand the science that leads to more effective future research as well as a sound basis for good regulatory decisions affecting human health. Each scientific session provides an opportunity to develop a common understanding of the latest scientific data, its interpretation, and policy implications. Through a carefully balanced approached that acknowledges the diversity of opinion within each session topic, various sides of an issue are presented—with ample opportunity for constructive dialogue on all sides. The open and diverse meetings of The Forum provide an unmatched opportunity to engage key decision makers in conversation and gain insight on cutting-edge scientific presentations.

Membership Requirements_____

Benefits of Membership ______

Membership Dues: $200 Full members must fulfill one of the following requirements:

• Attend Forum meetings and events at discounted costs to share your viewpoints and network with a diverse group of toxicology professionals from industry, academia, and government on the issues that matter to you.

1) Bachelor’s degree and eight years of experience in toxicology; 2) Master’s degree and six years of experience in toxicology; or: 3) PhD and three years of post-doctoral experience in toxicology.

Additional requirements include: • Sponsorship by two toxicologists, at least one of whom must be a full member of The Forum.

• Evidence of peer-reviewed publications and presentations in toxicology or related sciences.

• Submission of a CV

www.toxforum.org 703.547.0876

• Ability to submit session proposals for consideration by the Program Planning Committee as well as propose and develop special meetings of The Forum • Access to meeting materials and archives.

• Participate in various Committees (Program Planning, Membership, Awards)

Mark Your Calendar THE TOXICOLOGY FORUM 43rd Annual Winter Meeting

January 28–30, 2019 | Ritz-Carlton | Pentagon City, VA

Submit a Proposal Today!

Deadline to Submit a Session Proposal: July 30 dialogue.toxforum.org/submit All text and graphics are © 2018 by The Toxicology Forum. All rights reserved. No text or graphics may be copied or used without written permission from The Toxicology Forum. For further information, please contact The Toxicology Forum Headquarters.