Futuretox: Building the Road for 21St Century Toxicology and Risk Assessment Practices

FutureTox: Building the Road for 21st Century Toxicology and Risk Assessment Practices

October 18–19, 2012
Arlington, Virginia

Index

Accommodations / Organizing Committee
General Information / Registration Information
Program / Sponsors

Background

FutureTox will address the challenges and opportunities associated with effective and efficient implementation of the explosion of 21st century toxicity testing technologies and tools into improved, science-informed hazard prediction and risk assessment. There is a common desire to use 21st century tools and approaches in hazard identification, and risk assessment. As of yet no one roadmap exists for coalescing disparate approaches into a consistent and coherent strategy. The workshop will have four major themes, starting with a review and discussion of the various strategies being considered as potential roads to the desired destination. This opening session will promote identification of common themes and key considerations and requirements essential to an ordered and rational implementation of the road design. The following three session themes are intended to stimulate more detailed dialog and understanding of “what, when and how” considerations whereby newly emerging technologies can be most constructively engaged in transitioning to the future vision. The themes will discuss (a) Toxicology testing in the 21st Century (TT21c) approaches for safety assessments and expectations for effective and efficient integration into and potential transition of existing safety assessment practices (b) TT21c approaches for exposure assessments and links to toxicity test dosimetry, with a particular focus on relationships to contextual dose-exposure considerations associated with high throughput in vitro evaluation systems; and finally (c) Reframing risk assessment practices, with an emphasis on how emerging science can best impact and reshape current risk assessment practice.

Products

FutureTox will be in a workshop format in order to encourage active dialog among attendees about the technically complex, and interdisciplinary landscape of new technologies available to toxicology. The intent is to identify productive avenues for implementation of this exciting new science into future toxicity testing and risk assessment practice; thus, each major topic area includes a Roundtable Discussion. The meeting sessions and roundtable discussions will be summarized in a publication.

Program

(Reflects Invited Speakers)

October 18, 2012

8:30 AM–8:45 AM / Welcoming
James S. Bus, PhD, DABT, ATS, The Dow Chemical Company, Midland, MI, United States
8:45 AM–9:30 AM / Plenary: The Need for a Roadmap for Using Tox21 Methods in Risk Assessment: A Practitioner’s Perspective
Thomas Hartung, MD, PhD, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States
9:30 AM–9:35 AM / First Session: Risk Assessment Roadmaps and Methods for Using 21st Century Methods
Chair: Michael L. Dourson, PhD, DABT, ATS, Toxicology Excellence for Risk Assessment, Cincinnati, OH, United States
9:35 AM–10:00 AM / Transitioning from the Current Practice to the Next Generation Risk Assessment
Ila Cote, PhD, US EPA, Washington, DC, United States
10:00 AM–10:25 AM / European Perspectives
Maurice Whelan, PhD, Institute for Health and Consumer Protection, European Commission Joint Research Centre, Ispra, Italy
10:25 AM–10:40 AM / Break
10:40 AM–11:05 AM / HESI-Risk21 Perspectives
Timothy P. Pastoor, PhD, DABT, Syngenta Crop Protection Inc., Greensboro, NC, United States
11:05 AM–11:30 AM / FDA Perspectives
Speaker to be confirmed
11:30 AM–12:05 PM / Roundtable Discussion
Chair: Michael L. Dourson, PhD, DABT, ATS, Toxicology Excellence for Risk Assessment, Cincinnati, OH, United States
Panelists: Ila Cote, PhD; Maurice Whelan, PhD; Timothy P. Pastoor, PhD (affiliations noted above)
Additional Panelists:
Richard A. Becker, PhD, DABT, American Chemistry Council, Washington, DC United States
Suzanne Compton Fitzpatrick, PhD, DABT, US FDA, Silver Spring, MD, United States
Martin Stephens, PhD, Senior Research Associate, Johns Hopkins University Center for Alternatives to Animal Testing (CAAT)
Kim Boekelheide, MD, PhD, Brown University, Providence, RI, United States
12:05 PM–1:30 PM / Lunch
1:30 PM–1:35 PM / Second Session: TT21c Approaches for Safety Assessments
Chair: Ray Tice, PhD, NIEHS-NTP, Research Triangle Park, NC, United States
1:35 PM–2:00 PM / Application of TT21c Approaches to High Throughput Risk Assessments: The ToxCast Approach
Richard Judson, BA, PhD, US EPA, NCCT, Research Triangle Park, NC, United States
2:00 PM–2:25 PM / Incorporating New Technologies and Approaches in Toxicity Testing and Risk Assessment: Moving from 21st Century Vision to Data-Driven Reality
Rusty Thomas, MS, PhD, The Hamner Institutes for Health Sciences, Research Triangle Park, NC, United States
2:25 PM–2:50 PM / Utilizing TT21c Approaches in an Intelligent Testing Strategy
Richard A. Becker, PhD, DABT, American Chemistry Council, Washington, DC, United States
2:50 PM–3:05 PM / Break
3:05 PM–3:30 PM / How to Qualify Drug Development Tools for Regulatory Decisions
Shashi Amur, PhD, US FDA-CDER, Silver Spring, MD, United States
3:35 PM–4:00 PM / Practical Experience of Toxicity Predictions in Drug Discovery Space; A Pfizer Perspective
William Pennie, PhD, Executive Director of Compound Safety Prediction, Pfizer Global Research and Development
4:00 PM–4:35 PM / Roundtable Discussion
Chair: Raymond R. Tice, PhD, NIEHS-NTP, Research Triangle Park, NC, United States
Panelists: Richard Judson, BA, PhD; Russell S. Thomas, MS, PhD; Richard A. Becker, PhD, DABT; Shashi Amur, PhD; William Pennie, PhD (affiliations noted above)
Additional Panelist:
Edward W. Carney, PhD, The Dow Chemical Company, Midland, MI, United States
4:35 PM–5:15 PM / US FDA-DARPA-NIH Collaboration
William Slikker Jr., PhD, Director, US FDA-NCTR, Jefferson, AR, United States
5:15 PM–6:30 PM / Social Reception

October 19, 2012

8:30 AM–8:40 AM / Welcoming
James S. Bus, PhD, DABT, ATS, The Dow Chemical Company, Midland, MI, United States
8:40 AM–8:45 AM / Third Session: TT21c Approaches for Exposure Assessments
Chair: Mike Dellarco, DrPH, National Children’s Study, Washington, DC, United States
8:45 AM–9:10 AM / Exposure Science for TT21
Elaine Cohen-Hubal, MS, PhD, NCCT/US EPA, Research Triangle Park, NC, United States
9:10 AM–9:35 AM / Reverse Dosimetry—In Vitro to In Vivo Extrapolation
Harvey J. Clewell III, PhD, DABT, The Hamner Institutes for Health Sciences, Research Triangle Park, NC, United States
9:35 AM–10:00 AM / Population-Based PK Modeling and Simulation
AminRostami-Hodjegan, PharmD, PhD, FCP, University of Manchester, and Simcyp Limited, Sheffield, United Kingdom
10:00 AM–10:15 AM / Break
10:15 AM–10:40 AM / Opportunities to Utilize Current Understanding of Dosimetry for the Future
James S. Bus, PhD, ATS, DABT, The Dow Chemical Company, Midland, MI, United States
10:40 AM–11:25 AM / Exposure Assessments
Speaker to be confirmed
11:25 AM–12:00 Noon / Roundtable Discussion
Chair: Mike Dellarco, DrPH, National Children’s Study, Washington, DC, United States
Speakers: Elaine Cohen-Hubal, MS, PhD; Harvey J. Clewell III, PhD; AminRostami-Hodjegan, PharmD, PhD, FCP, DABT
James S. Bus, PhD, DABT, ATS, The Dow Chemical Company, Midland, MI, United States
12:00 Noon–1:30 PM / Lunch
1:30 PM–1:55 PM / TT21c: Funding the Science
Linda S. Birnbaum, PhD, DABT, ATS, NIEHS, Research Triangle Park, NC, United States
1:55 PM–2:00 PM / Fourth Session: Reframing Risk Assessment Practices
Laurie Haws, PhD, DABT, ToxStrategies Inc., Austin, TX, United States
2:00 PM–2:25 PM / Improving Current Practices through Problem Formulation and Mode of Action
Bette Meek, PhD, University of Ottawa, OT, Canada
2:25 PM–2:50 PM / Utilizing New Technologies and Approaches for Revealing Toxicant Mode of Action
Craig Rowlands, PhD, DABT, The Dow Chemical Company, Midland, MI, United States
2:50 PM–3:05 PM / Break
3:05 PM–3:30 PM / Utilizing New Technologies and Approaches to Understand Individual and Population Susceptibility
Ivan Rusyn, MD, PhD, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States
3:30 PM–3:55 PM / Reducing Uncertainty through Virtual Organs
Paul Watkins, MD, University of North Carolina and The Hamner Institutes for Health Sciences General Clinical Research Center, Research Triangle Park, NC, United States
3:55 PM–4:20 PM / Roundtable Discussion
Chair: Laurie C. Haws, PhD, DABT, ToxStrategies Inc., Austin, TX, United States
Panelists: Bette Meek, PhD; Craig Rowlands, PhD, DABT; Ivan Rusyn, MD, PhD; Paul Watkins, MD (affiliations noted above)
Additional Panelist:
Alan Boobis, OBE, BSc, PhD, CBiolFIBiol, Imperial College, London
4:20 PM–5:00 PM / Wrap-Up Reports and Concluding Remarks
George P. Daston, PhD, Procter & Gamble, Cincinnati, OH, United States
5:00 PM / Meeting Ends

Organizing Committee

• Craig Rowlands, The Dow Chemical Company
• James S. Bus, The Dow Chemical Company
• Kim Boekelheide, Brown University
• Russell S. Thomas, The Hamner Institutes for Health Sciences
• Vicki L. Dellarco, US Environmental Protection Agency
• Marty Stephens, Human Toxicology Project Consortium
• George P. Daston, Procter & Gamble
• Suzanne Compton Fitzpatrick, US Food and Drug Administration
• Raymond R. Tice, National Institute of Environmental Health Sciences
• Robert J. Kavlock, US Environmental Protection Agency
• Laurie C. Haws, ToxStrategies

Contact Information

SOT Headquarters
1821 Michael Faraday Drive, Suite 300
Reston, VA 20190
USA
Tel: 703.438.3115
Fax: 703.438.3113
Email:

Sponsors

The Society of Toxicology

ILSI-HESI Risk21

Human Toxicology Project Consortium

National Institute of Environmental Health Sciences

Sponsorship Information

Sponsorship serves as visible evidence of an organization’s commitment to the Society’s mission of “creating a safer and healthier world by advancing the science of toxicology.” Moreover, sponsorship provides an opportunity for private, public, and not-for-profit organizations to increase overall awareness of their services and programs to SOT members and CCT meeting attendees.

Sponsors are listed in publications related to the FutureTox meeting, including the on-site Program, pre- and post- meeting announcements and articles. In addition, FutureTox Sponsors are listed on the FutureTox website, an essential go-to source of information for all registrants. During the FutureTox meeting, acknowledgement signs, which group sponsors by the level of giving, are displayed prominently at many of the session.

The levels of sponsorship are:

• Gold Level—$10,000: Website, Opening and Closing Slides, Program, and have the option to distribute literature at the meeting
• Silver Level—$5,000: Website, Opening and Closing Slides, Program
• Bronze Level—$2,500: Website, Opening and Closing Slides

To become a FutureTox Sponsor or for more sponsorship information, please contact Clarissa Russell Wilson.

Invitation to FutureTox Meeting

The FutureTox meeting welcomes all participants interested in the evolving area of science. To meeting is open to all paid attendees. If for Visa purposes, you need a formal Letter of Invitation to the meeting, please contact SOT Headquarters.

Registration Information

Conference Fees

Registration Type / Early Bird / Advanced / On-Site
June 30, 2012 / July 1–
September 10, 2012 / After
September 10, 2012
SOT Member / $300 / $375 / $450
Non-Member / $400 / $475 / $550
Student/Postdoc
Member / $150 / $200 / $250
Student/Postdoc
Non-Member / $200 / $250 / $300

Fees include all general sessions, program materials, morning refreshments, breaks, and the opening reception. Attendees will be provided access to a secure website to access all the meeting materials.

Registration fees may be paid by check (please list all registrants on the check stub), money order, credit card (Visa, MasterCard, Diner’s Club, or American Express), or by a US Government Purchase Order (check must be drawn from the US Department of Treasury). Please use the registration form. All wire transfers should include an additional $40 processing fee.

No telephone registrations will be accepted.

Online Registration

Registration Form

To register, please send the registration form and payment or credit card information by one of the following methods:

1. Mail/USPS Express packages:
   FutureTox CCT, Society of Toxicology
   1821 Michael Faraday Drive, Suite 300
   Reston, VA 20190
2. Fax: 703.438.3113

NOTE: To prevent double-billing, if you are registering by fax, DO NOT mail your original registration form. SOT only needs one copy for processing.

Registration Deadline: After September 10, 2012, you must register on-site.

Registration Cancellation Refund Policy: All requests for cancellations and/or refunds must be received in writing to SOT Headquarters by September 28, 2012. These refunds will be processed, less a $30 fee, following the Meeting.

For individuals who are not members of SOT, participation in SOT’s Annual Meeting and ToxExpo is available only to bona fide individuals who are engaged in or promote the field of toxicology or biotechnology research and support the growth and development of the toxicology field. For organizations participation in the SOT’s Annual Meeting and ToxExpo is available only to bona fide organizations with public policy positions and business practices that are generally consistent with SOT’s mission, goals, reputation and its policies and principles as determined by SOT. SOT reserves the right to review applications for participation at SOT’s Annual Meeting and ToxExpo to confirm that the applicant meets these criteria and may, at SOT’s sole discretion, reject a registration by any individual or business or withdraw registration privileges at any time if any individual or organization is found to be inconsistent with SOT’s principles and interests.

Meeting Fees

Paid registrants will have the right to participate in all the scientific programs held over October 18–19, 2012. Registrants will have access to a secure website with real-time meeting content that includes the scientific program, and attendee list. In an effort to be environmentally conscious, registrants are encouraged to use the online FutureTox resources to view conference materials.

All registrants are welcome to partake in the morning coffee served prior to the start of the meeting and during the morning and afternoon refreshment break times. There are several affordable restaurants near the hotel.

Registrants will receive an attendee badge upon arrival at the meeting (see Program for registration hours).

Accommodations

The Westin Arlington Gateway Hotel for the Workshop and meeting functions. One of the newest hotels in the Washington DC area, The Westin Arlington Gateway enjoys prime access to its surrounding area. In the active Ballston area of Arlington, and just a short walk from the Ballston Metro Station, guests have the option of exploring Arlington, Virginia or venturing into the nation’s capital.
The Westin Arlington Gateway
801 North Glebe Road
Arlington, VA 22203
Tel: 703.717.6200
Fax: 703.717.6204

The Society of Toxicology has reserved a block of rooms at a discounted rate at the Westin Arlington Gateway Hotel. The room rate is $229 Single/Double. There is an additional $25 for a third and fourth person. The room tax is 10.5%. Deadline: The Housing Deadline is September 15, 2012. Please make your hotel reservation prior to September 15 in order to receive the SOT discounted rate.

Attire

The official attire for the PRA Meeting is business casual. No coats or ties are required! We encourage you to bring comfortable clothing and extra shoes.

Transportation

Airports

There are three airports in and around the metropolitan DC area: Reagan National Airport (DC), Dulles International Airport (VA) and Baltimore Washington International Airport (MD).

Airline Information

To book your flights, you may contact SOT’s travel agents via email or telephone:

American Express Travel, 800.872.9954, direct 410.772.8500, or Carlson Wagonlit 800.5250.6061, direct 703.276.2030.

• Expedia
• Priceline
• Travelocity
• AirTran
• American Airlines
• US Airways
• American West Airlines
• Continental Airlines
• United Airlines
• Delta

Car

By car, the Northern Virginia/Capital Region is easily accessible from the I-95 corridor which dissects the area. I-95 becomes I-495 (The Capital Beltway) and encircles Washington, DC and the inner suburbs of Virginia and Maryland. From I-95 (Northbound) approaching from south of Washington, DC, I-395 runs from the Capital Beltway into downtown Washington, DC through the portions of Virginia. From the West, I-66 runs from the intersection of I-81 in the northwestern area of Virginia near Front Royal, through the Northern Virginia suburbs to across the Potomac River terminating near the Lincoln Memorial on Constitution Avenue in downtown Washington, DC. Access to the area is also provided by US Routes 50 and 29 from the East and West and US Route 1 form North to South. It is highly recommended that visitors avoid these roads during rush hours during the week.

Driving Direction from Airports

• From East—Take State Route 50 to Interstate 495 (Outerloop/Exit 7B). Continue on I-495 to State Route 267 (Exit 45B) which joins with Interstate 66 East. Continue on I-66 to North Fairfax Drive (Exit 71). Proceed pass the light and turn right on Vermont Avenue.
• From North—Take Interstate 95 or Interstate 270 to Interstate 495 (Outerloop). Follow I-495 to State Route 267 (Exit 45B).SR-267 joins with Interstate 66 East. Continue on I-66 East and exit onto North Fairfax Drive (Exit 71).Proceed pass the light and turn right on Vermont Avenue.
• From West—Take Interstate 66 and exit onto North Fairfax Drive (Exit 71). Proceed pass the light and turn right on Vermont Avenue. The hotel is 1 block further on the left.
• From South—Take Interstate 95 North to Interstate 395. Continue on I-395 to State Route 120 (Exit 7B/South Glebe Road). Continue on SR-120 North for 3.2 miles, the hotel is located on the right.

Train/Bus

Amtrak and Greyhound Bus run through DC’s Union Station; from Union Station you can take the Metro to the Westin Gateway Hotel. Visit or call 800.USA.RAIL for Amtrak reservations. Visit or call 800.231.2222 for Greyhound reservations.

Transportation Around Town

Public transportation is encouraged when exploring Northern Virginia and Washington, DC to avoid parking problems. Northern Virginia/Washington DC have an excellent subway train system called “Metro” or “MetroRail” and a bus “Metro Bus.” Metrorail and Metrobus provide the safest, cleanest and most efficient way of getting around Northern Virginia and Washington, DC. Five rail lines and an extensive bus system connect DC with the Maryland and Virginia suburbs. Train lines are named for colors. Station entrances are marked by brown pylons, capped with the letter “M” and colored stripes indicate which lines are available. For more information on using Metro and a map of its destinations, visit

General Information

About the Area

Arlington, Virginia
Arlington, Virginia lies across the Potomac River from Washington, DC and is part of the Metropolitan DC area. Rich in history, immersed in tradition, and painted with the colors, culture, and art of neighboring Washington, DC, Northern Virginia captures your heart and soul with its breathtaking countryside, heart-stopping monuments to courage, inspiring world of arts and antiquities, and tempting palette of regional cuisines. There are many attractions close at hand to Arlington, Virginia. One of the most well known attraction is the Arlington National Cemetery. America’s most hallowed site and resting place for thousands of heroes and casualties-of-war, from Civil War times until the present. The 612-acre site along the Potomac River includes such famed monuments as: the Tomb of the Unknowns, the Confederate Monument, and the Custis-Lee Mansion. Catch one of the public daily tours and see the Pentagon, headquarters of the United States Department of Defense and the nerve center for command and control, the Pentagon is a virtual city within itself. To learn more about Arlington, Virginia, please visit