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SOT Contemporary Concepts In Toxicology (CCT) Workshop

 

Hemangiosarcoma in Rodents:
Mode-of-Action Evaluation and Human Relevance Workshop
Society of Toxicology—Current Concepts in Toxicology

December 4–5, 2008
Westin Arlington Gateway Hotel, Arlington, Virginia

HR-COF Meeting Presentations (Presentations accessible only to Registrants)

Early Registration Deadline:  July 31, 2008
Abstract Submission Deadline (Poster Session):  October 15, 2008

Registration Form
CCT Flyer
CCT Program (updated meeting materials)
Poster Instructions

Index:

Abstract/Poster	Airline Information
Program	Transportation
Sponsors	About Location
Organizing Committee	Touring Programs
Registration Information	Previous SOT CCT Meetings
Hotel Information

Purpose and Objectives of the SOT-CCT Workshop: 
The purpose of the workshop is to explore the modes of action (MOAs) and human relevance of hemangiosarcoma induced in rodents by various classes of compounds.

Background:
Hemangiosarcoma is a malignant tumor of endothelial cells that is rare in humans, but common in certain breeds of dogs. In carcinogenicity studies conducted for safety assessment, nongenotoxic agents typically induce hemangiosarcoma in mice but not rats, and the most common target organs are the liver, spleen, and bone marrow. To date, the MOA for hemangiosarcoma induction by nongenotoxic compounds is not known, nor is the human relevance of these tumors understood.

Ojectives: 
The objectives of the workshop are to 1) summarize current understanding of MOAs for various compound classes, 2) share data and information with the scientific and regulatory communities to promote and guide future research on nongenotoxic MOAs for hemangiosarcoma in rodents, and 3) identify research tools and approaches to studying hemangiosarcoma and related vascular lesions.

Product:
A report summarizing the workshop presentations and discussions will be submitted for publication in Toxicological Sciences.

Abstracts and Poster Presentations:
Individuals conducting research/testing on key events leading to induction of hemangiosarcoma in animals or humans, evaluating the pathology and/or histopathology of hemangiosarcoma or its precursor cells, or conducting research in other areas that shed light on the MOA and human relevance of hemangiosarcoma are encouraged to submit abstracts for presentation during the December 4–5, 2008, Poster Session.  Abstract submission will close on October 17, 2008. Approximately 20–25 posters will be displayed. Please submit according to the instructions below.

Abstract Instructions:

1. Each Abstract is limited to 400 words.
2. Complete abstracts using Times New Roman, 12 point text. Format abstracts using Microsoft Word. All formatting should be single spaced. Title, authors, affiliations, and body of the abstract should be separated by a paragraph break. Do not include figures or tables. The following example can be used as a guide: Example Abstract
3. The title should be as brief as possible, but long enough to indicate clearly the nature of the study. Titles should be formatted in bold caps, 12-point Arial. No full stop at the end.
4. Authors, affiliations, and body of the abstract should be formatted in regular 12-point Times New Roman. For authors, provide first name, middle initial(s), and last name. For affiliations, provide institution, department, and city, state/province, and country. Use superscript numbers to distinguish author affiliations. Separate three or more authors with a comma, and separate affiliations with semicolon(s).
5. Abstract text should state briefly and clearly the purpose, methods, results, and conclusions of the work.
• Papers may be submitted even if previously presented at a national/international meeting.
• Completed abstracts should be e-mailed to Clarissa Wilson at clarissa@toxicology.org.
• A confirmation of receipt will be sent to submitters within one week of submission. Following review by the Organizing Committee, a confirmation of acceptance will be sent.
• Abstract submitter must register for the meeting using the regular registration process.
• Questions should be e-mailed to Clarissa Wilson at clarissa@toxicology.org.
6. Poster Presentation Information

Program:

Hemangiosarcoma in Rodents:
Mode-of-Action Evaluation and Human Relevance

December 4–5, 2008
Westin Arlington Gateway Hotel
Arlington, Virginia

PROGRAM

Workshop Co-Chairs:
Samuel M. Cohen (University of Nebraska Medical Center, Omaha, NE)
Jon C. Cook (Pfizer Inc., Groton, CT)

Day 1
Thursday, December 4, 2008

Session One: Welcome

Session Co-Chairs: Samuel M. Cohen (University of Nebraska Medical Center, Omaha, NE) and Jon C. Cook (Pfizer Inc., Groton, CT)

Time	Topic	Speaker
7:00 AM–8:00 AM	Open registration
8:00 AM–8:05 AM	Welcome	George B. Corcoran, Wayne State University, Detroit, MI
8:05 AM–8:15 AM	Welcoming Remarks; Workshop Objectives	Jon C. Cook, Pfizer Inc, Groton, CT, and Samuel M. Cohen, University of Nebraska Medical Center, Omaha, NE

Session Two: Pathology and Biology

Session Co-Chairs: Richard D. Storer (Merck Research Laboratories, West Point, PA) and David E. Malarkey (NIEHS National Toxicology Program, Research Triangle Park, NC)

Time	Topic	Speaker
8:15 AM–8:30 AM	Speaker Introductions	Richard D. Storer, Merck Research Laboratories, West Point, PA
8:30 AM–9:15 AM	Trivial to Catastrophic, Necessary to Deadly: Vascular Proliferations and Malignancies in Humans and Animals	Professor Sir Colin Berry, Queen Mary, University of London, London, United Kingdom
9:15 AM–10:00 AM	Pathology of Treatment-Induced Hemangiosarcoma in NTP Studies	David E. Malarkey, NIEHS National Toxicology Program, Research Triangle Park, NC
10:00 AM–10:15 AM	BREAK
10:15 AM–11:00 AM	The Effect of Genetic Diversity on Angiogenesis	Michael S. Rogers, Harvard Medical School, Boston, MA
11:00 AM–11:45 AM	Barking Up the Right Tree: Uncovering the Influence of Heritable Factors on Canine Hemangiosarcoma	Jaime F. Modiano, University of Minnesota, Minneapolis, MN
11:45 AM–2:00 PM	LUNCH AND POSTER VIEWING

Session Three: Hemangiosarcoma Induced by Non-Pharmaceuticals

Session Co-Chairs: James E. Klaunig (Indiana University School of Medicine, Indianapolis, IN) and James A. Swenberg (University of North Carolina at Chapel Hill, Chapel Hill, NC)

Time	Topic	Speaker
2:00 PM–2:15 PM	Speaker Introductions	James E. Klaunig, Indiana University School of Medicine, Indianapolis, IN
2:15 PM–2:45 PM	Using Mode-of-Action Data to Assess the Human Relevance of Animal Tumors	Vicki L. Dellarco, Office of Pesticide Programs, U.S. Environmental Protection Agency, Washington, DC
2:45 PM–3:15 PM	Mode of Action of Vinyl Chloride-Induced Hepatic Hemangiosarcoma	James A. Swenberg, University of North Carolina at Chapel Hill, Chapel Hill, NC
3:15 PM–3:30 PM	BREAK
3:30 PM–4:00 PM	Vascular Tumor Potential of Carbaryl in the Heterozygous p53 Knockout Mouse Model	Dominique Lasserre-Bigot, Bayer CropScience, Sophia Antipolis, France
4:00 PM–4:30 PM	Nongenotoxic Agents: Studies with 2-Butoxyethanol	James E. Klaunig, Indiana University School of Medicine, Indianapolis, IN
4:30 PM–5:00 PM	Comments and Questions	Jon C. Cook, Pfizer Inc., Groton, CT
5:00 PM	ADJOURN DAY ONE (dinner on your own)

Day 2
Friday, December 5, 2008

Time	Topic	Speaker
7:00 AM–8:00 AM	Open registration

Session Four: Hemangiosarcoma Induced by PPAR Agonists—HESI Initiative

Session Co-Chairs: Samuel M. Cohen (University of Nebraska Medical Center, Omaha, NE) and Jon C. Cook (Pfizer Inc., Groton, CT)

Time	Topic	Speaker
8:00 AM–8:10 AM	Speaker Introductions	Samuel M. Cohen, University of Nebraska Medical Center, Omaha, NE
8:10 AM–8:45 AM	Angiogenesis and Adipogenesis	Keith L. March, Indiana University School of Medicine, Indianapolis, IN
8:45 AM–9:20 AM	Troglitazone: An Illustration of the HESI Mode-of-Action Framework for PPAR Gamma-Induced Hemangiosarcoma	Jon C. Cook, Pfizer Inc., Groton, CT
9:20 AM–9:55 AM	Troglitazone Effects on Endothelial Cells In Vivo and In Vitro: Differences between Mice and Humans	Samuel M. Cohen, University of Nebraska Medical Center, Omaha, NE
9:55 AM–10:15 AM	BREAK

Session Five: Hemangiosarcoma Induced by Other Pharmaceuticals

Session Co-Chairs: Samuel M. Cohen (University of Nebraska Medical Center, Omaha, NE)
and Jon C. Cook (Pfizer Inc., Groton, CT)

Time	Topic	Speaker
10:15 AM–10:25 AM	Speaker Introductions	Jon C. Cook, Pfizer Inc., Groton, CT
10:25 AM–11:00 AM	Retinoid-Induced Hemangiosarcoma in Mice:  Potential Insight from In Vivo and In Vitro Studies	Timothy E. Johnson, Merck Research Laboratories, West Point, PA
11:00 AM–11:35 AM	Epigenetic Mode of Action Associated with Induction of Hemangiosarcoma in Mice Treated with Pregabalin	Kay A. Criswell, Pfizer Global Research and Development, Ann Arbor, MI, Groton, CT
11:35 AM–12:45 PM	LUNCH (on your own)

Session Six: Regulatory Perspectives on Data Gaps

Session Co-Chairs: Vicki L. Dellarco, Office of Pesticide Programs, U.S. Environmental Protection Agency, Washington, DC and Abigail C. Jacobs, U.S. FDA, Center for Drug Evaluation and Research, Silver Spring, MD

Time	Topic	Speaker
12:45 PM–1:00 PM	Speaker Introductions	Vicki L. Dellarco, Office of Pesticide Programs, U.S. Environmental Protection Agency, Washington, DC
1:00 PM–1:10 PM	EPA Perspectives	Vicki L. Dellarco, Office of Pesticide Programs, U.S. Environmental Protection Agency, Washington, DC
1:10 PM–1:35 PM	Hemangiosarcoma and Pharmaceuticals: An FDA Perspective	Abigail C. Jacobs, U.S. FDA Center for Drug Evaluation and Research, Silver Spring, MD
1:35 PM–2:00 PM	European Perspectives on Carcinogenicity Testing	Jan Willem van der Laan, National Institute of Public Health and the Environment (RIVM), Bilthoven, The Netherlands

Session Seven: Mode(s) of Action for Hemangiosarcoma Induction

Session Co-Chairs: Samuel M. Cohen (University of Nebraska Medical Center, Omaha, NE) and Jon C. Cook (Pfizer Inc., Groton, CT)

Time	Topic	Speaker
2:00 PM–3:00 PM	Panel-Led Forum:  Open Discussion	Moderators: Samuel M. Cohen (University of Nebraska Medical Center, Omaha, NE) and Jon C. Cook (Pfizer Inc., Groton, CT)
3:00 PM–3:15 PM	Closing Comments	Jon C. Cook, Pfizer Inc., Groton, CT
3:15 PM	ADJOURN

Sponsors:

The Society of Toxicology

ILSI Health and Environmental Sciences Institute

Aclairo Pharmaceutical Development Group

AstraZeneca

Daiichi-Sankyo

GlaxoSmithKline

Merck Research Laboratories

Pfizer, Inc

sanofi-aventis

Society of Toxicologic Pathology

SOT Regulatory and Safety Evaluation Specialty Section

Takeda Pharmaceutical Company

 

Organizing Committee:

Co-Chairpersons:

• Samuel M. Cohen, M.D., Ph.D., ATS—Professor, Department of Pathology and Microbiology, Havlik-Wall Professor of Oncology, University of Nebraska Medical Center, Omaha, NE, United States
• Jon C. Cook, Ph.D., DABT—Senior Director, Investigative Toxicology, Pfizer Inc., Groton, CT, United States

Members:

• Neil G. Carmichael, Ph.D.—Secretary General, ECETOC AISBL, Brussels, Belgium
• Vicki L. Dellarco, Ph.D.—Senior Science Advisor, Office of Pesticide Programs, U.S. Environmental Protection Agency, Health Effects Division, Washington, DC,
  United States
• Nancy G. Doerrer, M.S.—Associate Director, Scientifific Program Stewardship, ILSI Health and Environmental Sciences Institute, Washington, DC, United States
• Tim G. Hammond—Vice President, Safety Assessment UK, AstraZeneca R&D, United Kingdom
• Jerry F. Hardisty, D.V.M., DACVP—Experimental Pathology Laboratories, Inc., Research Triangle Park, NC, United States
• Heike Hellmold, Ph.D.—Principal Scientist and Associate Director Molecular Toxicology, Safety Assessment, AstraZeneca R&D Sweden, Sweden
• Abigail C. Jacobs, Ph.D.—Associate Director, Pharmacology/Toxicology, Center for Drug Evaluation and Research, ONDIO, U.S. Food and Drug Administration, Silver Spring, MD, United States
• David Jacobson-Kram, Ph.D., DABT—Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD,
  United States
• James E. Klaunig, Ph.D., ATS—Robert B. Forney Professor of Toxicology, Director, Center for Environmental Health, Indiana University School of Medicine, Indianapolis, IN, United States
• Martin A. Philbert, Ph.D.—Professor of Toxicology, University of Michigan, Toxicology Program, School of Public Health, Ann Arbor, MI, United States
• Christopher J. Powell, D.Sc., FRCPath—Director, Safety Assessment Europe, GlaxoSmithKline R&D, United Kingdom
• Richard D. Storer, Ph.D.—Senior Scientific Director, Department of Laboratory Sciences and Investigative Toxicology, Merck Research Laboratories, West Point, PA, United States
• James A. Swenberg, D.V.M., Ph.D., DACVP—Director, Curriculum in Toxicology, University of North Carolina at Chapel Hill, School of Health and Medicine, Chapel Hill, NC, United States
• Clarissa Wilson—Society of Toxicology

Registration Information:

Hemangiosarcoma in Rodents: Mode-of-Action Evaluation and Human Relevance Workshop to be held at the Westin Arlington Gateway Hotel on December 4–5, 2008.

Registration fees:

Registration Type	Early Bird	Advance	On-Site
	July 31, 2008	August 1– November 14, 2008	November 15– December 4, 2008
Industry/Consultants	$350	$400	$450
Academia/Government	$125	$150	$175
Student	$75	$75	$75

Make payment to:
Hemangiosarcoma CCT, Society of Toxicology
1821 Michael Faraday Drive, Suite 300
Reston, VA 20190

Fees include all general sessions, program materials, continental breakfasts, breaks, and lunch on day one.

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 U.S. Government Purchase Orders (check must be drawn from the U.S. Department of Treasury). Please use the registration form.

No telephone registrations will be accepted.

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

1–Mail/USPS Express packages:
Hemangiosarcoma CCT, Society of Toxicology
1821 Michael Faraday Drive, Suite 300
Reston, VA 20190

Tel: (703) 438-3115

2–Fax: (703) 438-3113

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

DEADLINE:  After November 14, 2008, you must register on-site.

CANCELLATION REFUND POLICY: All requests for cancellations and/or refunds must be received in writing to SOT Headquarters by November 20, 2008. These refunds will be processed, less a $30 fee, following the Workshop.

Hotel Information

The Workshop will be held at The Westin Arlington Gateway Hotel. One of the newest hotels in the Washington D.C. 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, Virginia 22203
United States
Phone: (703) 717-6200
Fax: (703) 717-6260

The Society of Toxicology has reserved a block of rooms at a discounted rate at the Westin Arlington Gateway Hotel. The room rate is $239 Single / Double. There is an additional $25 charge for a third and fourth person in the room. The room tax is 12.25%. To make a reservation please call (888) 627-7076 and be sure to mention that you are with the Society of Toxicology Meeting in order to receive the discounted rate OR you can make reservations on-line at http://www.starwoodmeeting.com/StarGroupsWeb/res?id=0802280886&key=3A81E

Deadline: The Housing Deadline is November 11. Please make your hotel reservation prior to November 11 in order to receive the SOT discounted rate.

Attire
The official attire for the 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) & Baltimore/Washington International Airport (MD).

Airline Information
To book your flights, you may contact SOT's travel agents:
American Express Travel, (800) 872-9954, columbiamdctn@aexp.com  or Carlson Wagonlit, (800) 525-6061, direct (703) 276-2040, NMarkun@carlsonwagonlit.com.

Expedia: www.expedia.com
Priceline: www.priceline.com
Travelocity: www.travelocity.com
AirTran: www.airtran.com
American Airlines: www.aa.com
US Airways: www.usair.com
American West Airlines: www.americanwest.com
Continental Airlines: www.continental.com
United Airlines: www.united.com
Delta: www.delta.com/home/index.jsp

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 U.S. Routes 50 and 29 from the East and West and U.S. Route 1 from North to South. It is highly recommended that visitors avoid these roads during rush hours during the week.

Driving Directions 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 & Greyhound Bus run through DC's Union Station; from Union Station you can take the Metro to the Westin Gateway Hotel. Visit www.amtrak.com or call (800) USA-RAIL for Amtrak reservations. Visit www.greyhound.com 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" & 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 & a map of its destinations, visit www.wmata.com.

About the Area

About 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 attractions 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 www.arlingtonvirginia.com.

About Washington, DC
Washington, DC lies in the center of the Eastern Seaboard, about 90 miles from the coast and is nestled between Maryland and Virginia. Located midway along the eastern seaboard of the United States, south of Maryland, north of Virginia and 233 miles south of New York City, the Washington, DC metropolitan area refers to the District of Columbia, plus 7 Maryland counties, 5 Virginia counties, and 6 Virginia cities. The District of Columbia is 67 square miles and divided into 4 quadrants: Northwest, Southwest, Northeast and Southeast. The U.S. Capitol building marks the center where the quadrants meet. Numbered streets run north and south. Lettered streets run east and west (there are no J, X, Y or Z streets), becoming two-syllable names, and then three-syllable names as you travel farther out from the center. Avenues named for U.S. states run diagonally, often meeting at traffic circles and squares.

Elevation
Highest is 420 feet; lowest is sea level.

Population
The population is approximately 202,000 in Arlington proper and 5.4 million for the entire metro area.

Time Zone
Arlington, Virginia is in the EST/EDT time’s zone.

Area Code
The area codes for Arlington, Virginia are (703) and (571); Washington, DC is (202).

Climate
Northern Virginia and the Washington, DC metropolitan area experience the beauty of all four seasons. Warm weather usually prevails from April until as late as October. Winters here are short, with more rain than snow. The high and low average temperature for the month of December is 48 F/28 F.

Disabled Travelers
Washington, DC is one of the most accessible cities in the world for physically-challenged visitors. Visit www.disabilityguide.org, the premier source of disability related information in the Washington, DC metro area. Please contact SOT Headquarters if you need special assistance for this meeting. SOT HQ phone number is (703) 438-3115.

International Travelers
Washington is more than just the Nation's Capital—it is also home to more than 150 embassies, chancelleries and diplomatic residences where colors, cultures and languages mix like nowhere else. The following sections contain some tips and information to make international visitors feel more at home.

Embassies
Many embassies offer guided tours with prior notification. Arrangements can also be made by some embassies to host meeting functions and private parties, offering an unmatched asset for any meeting planner. Embassy phone numbers are available by calling directory assistance at (202) 555-1212. A comprehensive listing of embassies is also available on-line at www.embassy.org.

Multilingual Services
Many of the attractions in Arlington, Virginia and in Washington, DC offer brochures in several languages. The Smithsonian Institution provides multilingual information at the visitor’s center in the Castle building. Meridian International Center offers multilingual services at its information desk at Washington Dulles International Airport, plus a telephone language bank. For details, call Meridian International Center at (202) 667-6800 or visit www.meridian.org. (See Interpreters & Translating Services section for more information.)

Electricity
The electricity used in Northern Virginia is standard electricity, which is 110 volts. European appliances will require a voltage transformer.

International Currency Exchange
You may want to visit a Customer Service Booth at the airport when you arrive into Northern Virginia, DC, or BWI. Either the customer service representative can exchange currency at the booth or direct you to a special ATM that can exchange your currency.

Touring Programs

Visit the Official Tourism Site of Washington, DC for information on touring The White House, The Capitol Building and museums and/or monuments.

For more information about Washington, DC please visit: www.washington.org. For more information about Arlington, Virginia, please visit www.arlingtonvirginia.com.

Previous SOT CCT Meetings