54th Annual Meeting Birth Defects Research (Part A) 100:319–357 (2014)

54 th Annual Meeting June 28–July 2, 2014

This event has been accredited by the McGill Center for Continuing Health Professional Education.

Bellevue

WASHINGTON Eastside of Seattle Hyatt Regency Bellevue

38th Annual Meeting of the Neurobehavioral Teratology Society (NBTS) June 28–July 2, 2014 All text and graphics are © 2014 by the Teratology Society unless noted. Some Bellevue photos are courtesy of Visit Bellevue Washington/Colin Walker and Hyatt Regency.

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54 th Annual Meeting

June 28–July 2, 2014

Bellevue, Washington Eastside of Seattle Hyatt Regency Bellevue

Pushing the Boundaries of Birth Defects Research

Program & Abstracts Birth Defects Research (Part A) 100:319–357 (2014)

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Program Overview FRIDAY, JUNE 27, 2014

3:00 PM–6:00 PM Registration 3:00 PM–6:00 PM Speaker Ready Room Open 3:00 PM–6:00 PM Council 1A Meeting SATURDAY, JUNE 28, 2014

7:00 AM–6:00 PM Registration 7:00 AM–6:00 PM Speaker Ready Room Open 7:30 AM–8:00 AM Education Course: Coffee and Continental Breakfast 8:00 AM–12:00 Noon Education Course Session 1: Frontiers in Developmental Biology 12:00 Noon–1:30 PM Student Affairs Committee Meeting 1:30 PM–5:00 PM Education Course Session 2: Mechanisms of Abnormal Embryonic Development 5:30 PM–7:30 PM Student/Postdoctoral Mixer 6:30 PM–9:30 PM Council 1B Meeting and Committee Reports/Leadership Training SUNDAY, JUNE 29, 2014

7:00 AM–6:00 PM Registration 7:00 AM–6:00 PM Speaker Ready Room Open 7:00 AM–8:00 AM Dine with a Teratology Ambassador 7:00 AM–8:00 AM Science Committee Meeting 8:00 AM–8:15 AM President’s Welcome 8:15 AM–9:00 AM Josef Warkany Lecture (Joint with NBTS): Teratology v2.0: Building a Path Forward 9:00 AM–12:00 Noon Student/Postdoctoral Fellow Platform Session 1 12:00 Noon–1:30 PM 2015 Program Committee Meeting 12:00 Noon–1:30 PM F. Clarke Fraser and Service Awards Committee Meeting

12:00 Noon–1:30 PM Student and Postdoctoral Lunch Workshop: Building a Successful Career in Developmental and Reproductive Toxicology: Part 1 1:30 PM–2:00 PM F. Clarke Fraser New Investigator Award: From Computational Approaches to an Alternative Animal Model and Epidemiology: Building a Fulfilling Research Career 2:00 PM–2:30 PM James G. Wilson Publication Award: Dihydroartemisinin (DHA) Treatment Causes an Arrest of Cell Division and Apoptosis in Rat Embryonic Erythroblasts in Whole Embryo Culture 2:30 PM–5:30 PM ILSI HESI Symposium: Cross-Industry Data Survey of the Value of Rabbit Developmental Toxicity Data in the Risk Assessment for Pharmaceutics 2:30 PM–5:30 PM TS/NBTS Joint Symposium: National Children’s Study 5:30 PM–7:30 PM TS/NBTS Welcome Reception, Silent Auction, and Exhibits Attended 7:30 PM–8:30 PM Membership Committee Meeting MONDAY, JUNE 30, 2014

7:00 AM–6:00 PM Registration 7:00 AM–6:00 PM Speaker Ready Room Open 7:00 AM–8:00 AM Dine with a Teratology Ambassador 7:00 AM–8:00 AM BDRB Editorial Board Meeting 8:00 AM–9:00 AM Special Lecture (Joint with NBTS): Systems Medicine and Proactive P4 Medicine: Revolution in Healthcare 9:00 AM–12:00 Noon March of Dimes Symposium: Advances in Early Diagnosis of Birth Defects and Adverse Perinatal Outcomes 9:00 AM–12:00 Noon Platform Session 2: Mechanisms 12:00 Noon–1:30 PM Past Presidents’ and Honorees’ Luncheon 12:00 Noon–1:30 PM Public Affairs Committee

Birth Defects Research (Part A) 100:319–357 (2014)

12:00 Noon–1:30 PM Publications Committee 1:30 PM–2:30 PM Elsevier Distinguished Lecturer (Joint with NBTS): Epigenetic Mechanisms in Intellectual Developmental Disabilities 2:30 PM–5:30 PM TS/NBTS Joint Symposium: Epigenetics 2:30 PM–3:30 PM Platform Session 3: Pregnancy Registry and Public Policy 3:45 PM–5:30 PM Hot Topic Symposium: Neural Tube Defects Cluster in Washington State 5:30 PM–7:30 PM TS/NBTS Joint Poster Session 1 and Exhibits Attended 7:30 PM–10:00 PM TS/MARTA Student Career Event TUESDAY, JULY 1, 2014

6:30 AM–7:00 AM Sunrise Mini Course: Coffee and Continental Breakfast 7:00 AM–6:00 PM Registration 7:00 AM–6:00 PM Speaker Ready Room Open 7:00 AM–8:00 AM Dine with a Teratology Ambassador 7:00 AM–8:30 AM Sunrise Mini Course: Applications of Computational Toxicology in the Study of Birth Defects 8:30 AM–9:00 AM Special Lecture (Joint with NBTS): Fetal Alcohol Syndrome 9:00 AM–12:00 Noon Testicular Dysgenesis Syndrome Symposium 12:00 Noon–1:30 PM Student and Postdoctoral Lunch Workshop: Building a Successful Career in Developmental and Reproductive Toxicology: Part 2 1:30 PM–2:30 PM TS/ETS Exchange Lecture: Is Lack of Mandatory Folic Acid Fortification Public Health Malpractice? 2:30 PM–5:30 PM Grant Officers Roundtable 2:30 PM–5:30 PM Platform Session 4: Epidemiology and Clinical Teratology 5:30 PM–7:30 PM Poster Session 2 and Exhibits Open

7:30 PM–8:30 PM Communications Working Group Meeting WEDNESDAY, JULY 2, 2014

6:30 AM–7:30 AM Teratology Society 33rd Annual Volleyball Game 7:00 AM–4:30 PM Registration 7:00 AM–4:30 PM Speaker Ready Room Open 8:00 AM–8:30 AM Robert L. Brent Lecture: Teratogen Update: Teratology and Public Health: Working Together to Make Recommendations for Pregnant Women in the Face of Uncertainty 8:30 AM–12:15 PM Wiley-Blackwell Symposium: From Fleas to Fish and Beyond: Advances in Alternative Assays to Predict Developmental Toxicity 9:40 AM–10:25 AM Warkany Tea 12:15 PM–1:30 PM BDRA Editorial Board Meeting 12:15 PM–1:30 PM Education Committee Meeting 1:30 PM–4:30 PM Public Affairs Committee Symposium: Thrombosis during Pregnancy: Risks, Prevention, and Treatment for Mother and Fetus 1:30 PM–4:30 PM Platform Session 5: In Vitro, Stem Cells, and Alternative Approaches 4:45 PM–6:15 PM Business Meeting 6:30 PM–7:30 PM Banquet Reception 7:30 PM–11:00 PM Banquet THURSDAY, JULY 3, 2014

7:00 AM–10:00 AM Council 2 Meeting

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OFFICERS (2013–2014) ELAINE Z. FRANCIS President

EDWARD W. CARNEY Past President

LUDMILA BAKHIREVA Councilor (2013–2016)

MARY ALICE SMITH Vice President

EVE MYLCHREEST Secretary

STEPHEN B. HARRIS Councilor (2012–2015)

TACEY E.K. WHITE Vice President-Elect

WAFA A. HARROUK Treasurer

EIAS A. ZAHALKA Councilor (2011–2014)

PAST PRESIDENTS OF THE SOCIETY J. WARKANY 1960–1961

J.R. MILLER 1973–1974

C.T. GRABOWSKI 1987–1988

J.M. FRIEDMAN 2001–2002

J.G. WILSON 1961–1962

E.M. JOHNSON 1974–1975

M.S. CHRISTIAN 1988–1989

W. SLIKKER JR. 2002–2003

F.C. FRASER 1962–1963

L.S. HURLEY 1975–1976

E.F. ZIMMERMAN 1989–1990

R.W. TYL 2003–2004

M.M. NELSON 1963–1964

J.L. SEVER 1976–1977

C.A. KIMMEL 1990–1991

K.L. JONES 2004–2005

D.A. KARNOFSKY 1964–1965

E.V. PERRIN 1977–1978

R.K. MILLER 1991–1992

M.S. TASSINARI 2005–2006

I.W. MONIE 1965–1966

A.R. BEAUDOIN 1978–1979

M. BARR JR. 1992–1993

E.M. FAUSTMAN 2006–2007

S.Q. COHLAN 1965–1966

R.M. HOAR 1979–1980

J.W. HANSON 1993–1994

T.B. KNUDSEN 2007–2008

M.N. RUNNER 1966–1967

C.R. SWINYARD 1980–1981

J.M. DESESSO 1994–1995

C.D. CHAMBERS 2008–2009

R.L. BRENT 1967–1968

W.J. SCOTT JR. 1981–1982

K.K. SULIK 1995–1996

B.F. HALES 2009–2010

T.H. SHEPARD 1968–1969

D.M. KOCHHAR 1982–1983

J.F. CORDERO 1996–1997

J.M. ROGERS 2010–2011

R.W. MILLER 1969–1970

R.E. STAPLES 1983–1984

P.E. MIRKES 1997–1998

J.M. GRAHAM JR. 2011–2012

J. LANGMAN 1970–1971

G.P. OAKLEY JR. 1984–1985

A.R. SCIALLI 1998–1999

E.W. CARNEY 2012–2013

A. PRUZANSKY 1971–1972

L.B. HOLMES 1985–1986

G.P. DASTON 1999–2000

D.G. TRASLER 1972–1973

A.G. HENDRICKX 1986–1987

R.J. KAVLOCK 2000–2001

HEADQUARTERS STAFF TONIA M. MASSON Executive Director BECCA ISAKOWER Program Manager

ELSA CANNON, CMP Exhibits and Meetings Manager

RACHEL WYNN FROHBERG Program Coordinator

Teratology Society

1821 Michael Faraday Drive, Suite 300 • Reston, Virginia 20190 Tel:  703.438.3104 • Fax:  703.438.3113 • Email:  [email protected]

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COMMITTEES OF THE TERATOLOGY SOCIETY (2013–2014)

AAALAC REPRESENTATION (AD HOC) Eias Zahalka, PhD, MBA Email: [email protected]

2016 Tel: 301.796.7065

COMMUNICATIONS WORKING GROUP (AD HOC)

Ludmila Bakhireva, MD, PhD, MPH Email: [email protected]

Councilor 2016 Tel: 505.272.2545

Stephen B. Harris, PhD, FATS, FSB Email: [email protected]

Councilor 2015 Tel: 619.469.7886

Eias Zahalka, PhD, MBA Email: [email protected]

Councilor 2014 Tel: 301.796.7065

Christopher Lau, PhD Email: [email protected]

Public Affairs Committee Chair Tel: 919.541.5097

L. David Wise, PhD Email: [email protected]

Publications Committee Chair Tel: 610.804.5117

Christine Perdan Curran, PhD Email: [email protected]

Co-Leader Tel: 859.572.6914

Tacey E.K. White, PhD Email: [email protected]

Co-Leader Tel: 267.216.7470

Edward W. Carney, PhD Email: [email protected]

Tel: 989.636.2580

Christina M. Carruthers, PhD Email: [email protected]

Tel: 201.427.8034

Christina D. Chambers, PhD, MPH Email: [email protected]

Carolyn Kapron, PhD Email: [email protected]

Tel: 858.246.1704

Robert G. Ellis-Hutchings, PhD Email: [email protected]

Janet R. Hardy, PhD, MSc, MPH Email: [email protected]

Secretary Tel: 508.736.7722

Tel: 989.636.1928

Janee Gelineau-van Waes, DVM, PhD Email: [email protected]

2014 Tel: 402.280.3457

Julia M. Gohlke, PhD Email: [email protected]

2016 Tel: 205.934.7060

Carolyn Kapron, PhD Email: [email protected]

Tel: 705.748.1011 (7641)

EDUCATION COMMITTEE Chair Tel: 705.748.1011 (7641)

Norbert Makori, PhD, MSc, BVM Email: [email protected]

Tel: 425.322.2404

Sarah Gloria Obican, MD Email: [email protected]

Jane Stewart, PhD Email: [email protected]

Tel: 561.289.2415

Kary Ellen Thompson, PhD Email: [email protected]

Chris J. Stodgell, PhD Email: [email protected]

2016 Tel: 585.275.1902

Tel: 732.227.5014

Ali S. Faqi, DVM, PhD, DABT, FATS Email: [email protected]

Past Chair Tel: 269.668.3336

Mary Alice Smith, PhD Email: [email protected]

Vice President Tel: 706.542.1599

Michelle Carll Helms, MSc Email: [email protected]

Ad Hoc, Student Tel: 856.981.3124

Keith J. Robinson, BSc, DABT Email: [email protected]

Ad Hoc Tel: 514.630.8204

CONSTITUTION AND BY-LAWS COMMITTEE Mark E. Hurtt, PhD Email: [email protected]

Chair Tel: 860.715.3118

Connie J. Kappeler, PhD Email: [email protected]

2016 Tel: 419.289.8700

John W. Kille, PhD, DABT Email: [email protected]

2015 Tel: 908.236.6182

Elaine Z. Francis, PhD Email: [email protected]

President Tel: 609.822.0217

Carole A. Kimmel, PhD Email: [email protected]

Past Chair Tel: 252.261.8057

COUNCIL

2015 Tel: 44 1625 513209

F. CLARKE FRASER AND SERVICE AWARDS COMMITTEE (AD HOC) Robert G. Ellis-Hutchings, PhD Email: [email protected]

Chair Tel: 989.636.1928

Eve Mylchreest, PhD Email: [email protected]

Council Liaison Tel: 205.581.2391

Elaine Z. Francis, PhD Email: [email protected]

President Tel: 609.822.0217

Peixin Yang, PhD Email: [email protected]

2015 Tel: 410.706.8402

Mary Alice Smith, PhD Email: [email protected]

Vice President Tel: 706.542.1599

Elaine Z. Francis, PhD Email: [email protected]

President Tel: 609.822.0217

Ludmila Bakhireva, MD, PhD, MPH Email: [email protected]

Past Chair Tel: 505.272.2545

Tacey E.K. White, PhD Email: [email protected]

Vice President-Elect Tel: 267.216.7470

Edward W. Carney, PhD Email: [email protected]

Past President Tel: 989.636.2580

Bruce K. Beyer, PhD, DABT Email: [email protected]

Ad Hoc Tel: 908.981.3274

Eve Mylchreest, PhD Email: [email protected]

Secretary 2015 Tel: 205.581.2391

Claudia Kappen, PhD Email: [email protected]

Ad Hoc Tel: 225.763.2781

Wafa A. Harrouk, PhD Email: [email protected]

Treasurer 2016 Tel: 301.796.0908

Joshua F. Robinson, PhD Email: [email protected]

Ad Hoc Tel: 310.883.5685

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COMMITTEES (continued)

FASEB REPRESENTATION Wafa A. Harrouk, PhD Email: [email protected] Belen Tornesi, DVM, MS Email: [email protected] Xiaoqin Ye, PhD Email: [email protected]

NOMINATIONS AND ELECTIONS COMMITTEE Science Policy Committee Tel: 301.796.0908 Board Representative Tel: 847.937.8934 Science Policy Committee Tel: 706.542.6745

FINANCE COMMITTEE Wafa A. Harrouk, PhD Email: [email protected] Ida M. Washington, DVM, PhD, DACLAM Mary Alice Smith, PhD Email: [email protected] Tonia M. Masson Email: [email protected]

Chair Tel: 301.796.0908 Past Treasurer Vice President Tel: 706.542.1599 Executive Director Tel: 703.438.3104

MEMBERSHIP COMMITTEE Linda G. Roberts, PhD, DABT Email: [email protected]

Chair Tel: 925.842.5381

Kary Ellen Thompson, PhD Email: [email protected]

Vice Chair Tel: 732.227.5014

Eve Mylchreest, PhD Email: [email protected]

Secretary Tel: 205.581.2391

Mary L. Hixon, PhD Email: [email protected]

2016 Tel: 617.395.5560

John M. Rogers, PhD Email: [email protected]

2014 Tel: 919.541.5177

Sandra L. Wood, PhD Email: [email protected]

2016 Tel: 215.652.6334

Peixin Yang, PhD Email: [email protected]

2015 Tel: 410.706.8402

Elaine Z. Francis, PhD Email: [email protected]

President Tel: 609.822.0217

Jack B. Bishop, PhD Email: [email protected]

Past Chair Tel: 919.541.1876

Rachel Wynn Frohberg Email: [email protected]

Staff Liaison Tel: 703.438.3104

NEWSLETTER EDITOR (AD HOC) Kimberly Brannen, PhD Email: [email protected]

Tel: 215.443.8710

Michael G. Narotsky, PhD Email: [email protected]

Chair Tel: 919.541.0591

Barbara F. Hales, PhD Email: [email protected]

Tel: 514.398.3610

Mary S. Marty, PhD Email: [email protected]

Tel: 989.636.6653

Michael F. O’Hara, PhD, MBA Email: [email protected]

Tel: 317.467.8480

Louise M. Winn, PhD Email: [email protected]

Tel: 613.533.6465

Sonja A. Rasmussen, MD, MS Email: [email protected]

Past Chair Tel: 404.639.2297

PROGRAM COMMITTEE (AD HOC) Mary Alice Smith, PhD Email: [email protected]

Chair Tel: 706.542.1599

Ludmila Bakhireva, MD, PhD, MPH Email: [email protected]

Tel: 505.272.2545

Thomas M. Burbacher, PhD Email: [email protected]

NBTS Organizer Tel: 206.685.7674

Christina M. Carruthers, PhD Student Affairs Committee Chair Email: [email protected] Tel: 201.427.8034 Robert M. Greene, PhD Email: [email protected]

Tel: 502.852.8304

Barbara F. Hales, PhD Email: [email protected]

Tel: 514.398.3610

Deborah K. Hansen, PhD Email: [email protected]

Tel: 870.543.7480

Alan M. Hoberman, PhD, DABT Email: [email protected] Carolyn Kapron, PhD Email: [email protected] Christopher Lau, PhD Email: [email protected]

Tel: 215.443.8710 (3705) Education Committee Chair Tel: 705.748.1011 (7641) Public Affairs Committee Chair Tel: 919.541.5097

Elise Madison Lewis, PhD Email: [email protected]

Tel: 215.443.8710

Sarah Gloria Obican, MD Email: [email protected]

Tel: 561.289.2415

Sonja A. Rasmussen, MD, MS Email: [email protected]

Tel: 404.639.2297

Michael A. Schellpfeffer, MD, MS Email: [email protected]

Tel: 262.658.2133

Susanna H. Wegner, BA Email: [email protected]

Student Tel: 503.467.6175

Tacey E.K. White, PhD Email: [email protected] L. David Wise, PhD Email: [email protected]

Vice President-Elect Tel: 267.216.7470 Publications Committee Chair Tel: 610.804.5117

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COMMITTEES (continued) Balambal Bharti, MBBS, MPH Email: [email protected]

Ad Hoc, Student Tel: 619.294.3791

Smitha K. Infante, PhD Email: [email protected]

Ad Hoc, Student Tel: 956.455.1820

Tel: 561.289.2415

Sonja A. Rasmussen, MD, MS Email: [email protected]

France-Helene Paradis, MS Email: [email protected]

Ad Hoc, Student Tel: 514.398.3634

Tel: 404.639.2297

Mary Alice Smith, PhD Email: [email protected]

Elaine Z. Francis, PhD Email: [email protected]

President Tel: 609.822.0217

Tel: 706.542.1599

Gloria D. Jahnke, DVM, MS, DABT Email: [email protected]

Past Chair Tel: 919.541.3376

PROGRAM COMMITTEE FOR CME 2013–2014 (AD HOC) Barbara F. Hales, PhD Email: [email protected]

Chair Tel: 514.398.3610

Sarah Gloria Obican, MD Email: [email protected]

PUBLIC AFFAIRS COMMITTEE Christopher Lau, PhD Email: [email protected]

Chair Tel: 919.541.5097

Suzan L. Carmichael, PhD Email: [email protected]

2015 Tel: 650.736.0735

Thomas R. Hanley Jr., MSc Email: [email protected]

2014 Tel: 336.632.6729

Deborah K. Hansen, PhD Email: [email protected]

2016 Tel: 870.543.7480

E. Sid Hunter III, PhD Email: [email protected]

2016 Tel: 919.541.3490

Susan Laessig, PhD Email: [email protected]

2016 Tel: 202.564.5232

Susan Bielmeier Laffan, PhD Email: [email protected]

2014 Tel: 610.270.7625

Susan L. Makris, MS Email: [email protected]

2014 Tel: 703.347.8522

Sarah Gloria Obican, MD Email: [email protected]

2015 Tel: 561.289.2415

Michael A. Schellpfeffer, MD, MS Email: [email protected]

2016 Tel: 262.658.2133

Evi Struble, PhD Email: [email protected]

2015 Tel: 301.451.3982

Wladimir Wertelecki, MD Email: [email protected]

2014 Tel: 251.343.6919

Daniel T. Wilson, PhD, DABT Email: [email protected]

2015 Tel: 908.981.3284

Connie L. Chen, PhD, MPH Email: [email protected]

Ad Hoc Tel: 202.659.3306 (131)

Carl L. Keen, PhD Email: [email protected]

Ad Hoc Tel: 530.681.2047

Asher Ornoy, MD Email: [email protected]

Ad Hoc Tel: 97 2267 58329

John M. Rogers, PhD Email: [email protected]

Ad Hoc Tel: 919.541.5177

Anthony R. Scialli, MD Email: [email protected]

Ad Hoc Tel: 571.527.1709

Belen Tornesi, DVM, MS Email: [email protected]

Ad Hoc Tel: 847.937.8934

Janet Uriu-Adams, PhD Email: [email protected]

Ad Hoc Tel: 530.752.4658

Birth Defects Research (Part A) 100:319–357 (2014)

PUBLICATIONS COMMITTEE L. David Wise, PhD Email: [email protected]

Chair Tel: 610.804.5117

Norbert Makori, PhD, MSc, BVM Email: [email protected]

Vice Chair Tel: 425.322.2404

Melissa J. Beck, PhD Email: [email protected]

2016 Tel: 937.766.7402

Christopher J. Bowman, PhD, DABT Email: [email protected]

2017 Tel: 860.686.2361

Anthony M. DeLise, PhD Email: [email protected]

2014 Tel: 908.619.8195

Terry C. Hrubec, DVM, PhD Email: [email protected]

2015 Tel: 540.231.1702

Russell S. Kirby, PhD, MSc, FACE Email: [email protected]

2017 Tel: 813.396.2347

Lori E. Kotch, PhD Email: [email protected]

2015

Sarah N. Mattson Email: [email protected]

2016 Tel: 619.594.7228

Elaine Z. Francis, PhD Email: [email protected]

President Tel: 609.822.0217

George P. Daston, PhD Email: [email protected]

BDRB Editor Tel: 513.622.3081

Rocky S. Tuan, PhD Email: [email protected]

BDRC Editor Tel: 412.648.2603

Michel Vekemans, MD, PhD Email: [email protected] Kevin Jeannette Email: [email protected]

BDRA Editor Tel: 33 1444 94981 Wiley Representative Tel: 201.748.7760

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COMMITTEES (continued)

SCIENCE COMMITTEE

WEB SITE COMMITTEE

Christina D. Chambers, PhD, MPH Email: [email protected]

Chair Tel: 858.246.1704

Robert M. Parker, PhD, DABT Email: [email protected]

George P. Daston, PhD Email: [email protected]

Tel: 513.622.3081

Pragati Sawhney Coder, PhD, DABT Email: [email protected]

Vice Chair Tel: 614.424.4948

John M. DeSesso, PhD Email: [email protected]

Tel: 571.227.7261

Christine Perdan Curran, PhD Email: [email protected]

2016 Tel: 859.572.6914

Elaine M. Faustman, PhD Email: [email protected]

Past Chair Tel: 206.685.2269

Anne-Lee Gustafson, MSc, PhD Email: [email protected]

Barbara F. Hales, PhD Email: [email protected]

Tel: 514.398.3610

Winnie Jeng, PhD, DABT Email: [email protected]

Wafa A. Harrouk, PhD Email: [email protected]

Tel: 301.796.0908

Seyed Adel Moallem Email: [email protected]

Anthony R. Scialli, MD Email: [email protected]

Tel: 571.527.1709

Eias Zahalka, PhD, MBA Email: [email protected]

Council Liaison Tel: 301.796.7065

Elaine Z. Francis, PhD Email: [email protected]

President Tel: 609.822.0217

Ava Schlisser, BSc Email: [email protected]

SPC Editor Tel: 514.961.0146

Kelly J. Chandler, PhD Email: [email protected]

Ad Hoc, Student Tel: 919.541.3365

Kristin R. Di Bona Email: [email protected]

Ad Hoc, Student Tel: 205.239.0219

Kimberly Brannen, PhD Email: [email protected]

Newsletter Editor Tel: 215.443.8710

Kevin H. Denny, MS, MT, MBA, DABT Email: [email protected]

Past Chair Tel: 610.738.6725

STUDENT AFFAIRS COMMITTEE Christina M. Carruthers, PhD Email: [email protected]

Chair Tel: 201.427.8034

Jason Hansen, PhD Email: [email protected]

2015 Tel: 404.727.3145

Dana L. Shuey, PhD, DABT Email: [email protected]

2016 Tel: 302.498.5721

Jeffrey H. Charlap, MS Email: [email protected]

Past Chair Tel: 419.289.8700

Stephen B. Harris, PhD, FATS, FSB Email: [email protected]

Council Liaison Tel: 619.469.7886

Tonia M. Masson Email: [email protected]

Chair Tel: 732.873.2550 (2389)

2014 2016 Tel: 908.981.3556 2015 Tel: 98 915 509 0106

Executive Director Tel: 703.438.3104

Members interested in serving on a committee should contact the leadership or staff at [email protected]

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2014 Sustaining Members (as of March 31, 2014)

The Teratology Society thanks the following Sustaining Members: PLATINUM

Charles River Pfizer Inc. WIL Research GOLD

AbbVie Inc. Chevron Corporation GlaxoSmithKline Reproductive Toxicology Center SILVER

Eli Lilly and Company Experimur Huntingdon Life Sciences SNBL USA, Ltd. The J&J Pharma R&D Companies

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2014 Annual Meeting Sponsors (as of March 31, 2014)

The Teratology Society thanks the following Sponsors: PLATINUM Birth Defects Center, University of Louisville

Charles River Covance Inc. ILSI HESI Developmental and Reproductive Toxicology (DART) Technical Committee March of Dimes Foundation Grant 4-FY13-560 MPI Research Pfizer Inc. WIL Research Wiley-Blackwell GOLD Exponent, Inc.

Lilly USA, LLC Southern Research Institute Tetra Tech Sciences SILVER Sandcastle Toxicology Associates

Sanofi US Inc. Society of Toxicology

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Pushing the Boundaries of Birth Defects Research

General Information

Photography and Recording Policy Photography, video, and/or audio recording of scientific presentations is prohibited without advance specific consent of the presenter(s)/ author(s). Session chairs are asked to strictly enforce this policy, and individuals who do not comply will be asked to leave the session. In addition, cameras and recording devices are prohibited in the Exhibit Hall.

Registration The Teratology Society Annual Meeting registration is located in the Grand Ballroom Foyer. Hours: Friday, June 27 Saturday, June 28 Sunday, June 29 Monday, June 30 Tuesday, July 1 Wednesday, July 2

3:00 PM–6:00 PM 7:00 AM–6:00 PM 7:00 AM–6:00 PM 7:00 AM–6:00 PM 7:00 AM–6:00 PM 7:00 AM–4:30 PM

What Does the Meeting Registration Fee Cover? The Teratology Society meeting registration fee covers a number of food and beverage functions as well as the administrative costs for the meeting. The functions include: • • • •

Welcome Reception on Sunday Seven refreshment breaks Two light receptions during poster sessions Two Student/Postdoctoral Fellow Lunch Workshops (Trainees only) • Student/Postdoctoral Fellow Career Event (Trainees only) • Warkany Tea on Wednesday • Banquet on Wednesday Quick options are available from Tully’s Coffee and Needs Deli for both breakfast and lunch. A complete list of dining options is located on page 335.

Hotel Map To assist you in locating the hotel registration desk, meeting rooms, and Exhibit Hall there are maps of the Hyatt Regency Bellevue located on pages 336–337.

First Aid and Security The Hyatt Regency Bellevue has house phones located throughout the hotel for use in case of an emergency. If you need medical or security assistance pick up the house phone and dial 55. The hotel operator will connect you to the correct department.

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Teratology Society Annual Meeting registrants grant the Teratology Society permission to reproduce, copy, and publish photographs taken at the Annual Meeting unless written notification by the registrant, stating otherwise, is submitted to the Teratology Society headquarters office prior to the Annual Meeting or while registering onsite.

AWARDS/LECTURES Narsingh Agnish Fellowship This award recognizes Narsingh Agnish’s contributions to the Teratology Society, particularly the implementation of the Education Course. The Narsingh Agnish Fellowship facilitates the continuing participation of senior Teratology Society members at the Annual Meeting. The 2014 recipient is John M. DeSesso, who will present on Saturday, June 28 at 8:10 am.

Josef Warkany Lecturer This award recognizes Josef Warkany’s contributions to the Teratology Society. Dr. Warkany was the first person to demonstrate that exposures to environmental chemicals are responsible for production of congenital malformation. His early studies culminated in the formulation of the scientific principles of teratology. This award recognizes a scientist who has significantly contributed to the field of teratology over his/her career. This year’s lecture will be presented by Thomas B. Knudsen, National Center for Computational Toxicology, US EPA, on Sunday, June 29 at 8:15 am.

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F. Clarke Fraser  New Investigator Award

Teratology Society  Distinguished Service Award

This award honors F. Clarke Fraser, one of the founding members of the Teratology Society, for his many contributions to the field of developmental toxicology. This year’s award recipient is Julia M. Gohlke, University of Alabama, Birmingham, who will present on Sunday, June 29 at 1:30 pm.

The Teratology Society Distinguished Service Award honors an individual who has provided exemplary service to the Society and the field of teratology. The 2014 Teratology Society Distinguished Service Award recipient is Carole A. Kimmel, Exponent. Dr. Kimmel’s extraordinary service includes leadership throughout the years as a past president and an active member of several committees. Her extraordinary service includes the establishment of the Society’s first executive office, commissioning of the 5-year Strategic Plan, and initiation of the Society’s newsletter. Through these and other numerous contributions Dr. Kimmel has left an indelible mark on the Teratology Society and the field of birth defects research at large.

James G. Wilson  Publication Award This award is presented in recognition of the best paper accepted or published in the journal Birth Defects Research. The dual purpose of the award is to provide recognition to the authors of the best paper and to encourage authors trained in various disciplines to submit high-quality papers to Birth Defects Research. The paper selected for this year’s award is “Dihydroartemisinin (DHA) Treatment Causes an Arrest of Cell Division and Apoptosis in Rat Embryonic Erythroblasts in Whole Embryo Culture.” Lorraine Posobiec, GlaxoSmithKline, will present the data on Sunday, June 29 at 2:00 pm.

Robert L. Brent Lecture This award recognizes Robert L. Brent’s contributions to the Teratology Society and particularly to the implementation of the “Teratogen Update.” The purpose of the Robert L. Brent Lecture is to facilitate the discussion of new and old teratogens during the Annual Meeting. The 2014 Robert L. Brent Lecture will be presented by Sonja A. Rasmussen, Centers for Disease Control and Prevention, on Wednesday, July 2 at 8:00 am.

Birth Defects Research  Distinguished Scholar Awards The awards recognize senior authors for the importance, impact, and relevance of their published works in the field of birth defects research. The dual purpose of the award is to provide recognition to the authors of high impact papers and to encourage authors trained in various disciplines to submit high quality papers to Birth Defects Research Part A and Birth Defects Research Part  B. The 2014 recipients of this award are Bengt Källen, Tornblad Institute, for his research investigating the potential impacts of in vitro fertilization on birth defects incidences (reference paper: In Vitro Fertilization (IVF) in Sweden: Risk for Congenital Malformations after Different IVF Methods; BDRA 73, 3: 162–169) and Anick Bérard, University of Montreal, for her research investigating the potential adverse impacts of antidepressant use during pregnancy (reference paper: First Trimester Exposure to Paroxetine and Risk of Cardiac Malformations in Infants: The Importance of Dosage; BDRB 80, 1: 18–27).

Award Nominations Nominate a deserving candidate to receive one of the Society awards. Awards nominations are due in October. Details are available on the Teratology Society website at www.teratology.org.

CONTINUING MEDICAL EDUCATION (CME) The Teratology Society is offering a CME Program to clinicians and trainees for many of the scientific sessions held during the 54th Annual Meeting. The CME Program is available on the Teratology Society website at www.teratology.org. The Society offers CME credits in an effort to broaden the audience at our scientific sessions while enhancing the professional development of clinicians who integrate the outcome of the research into everyday practice. Talks designated as part of the CME Program are identified by the CME icon in the agenda.

Teratology Society CME Program This event is approved for up to 26 credits by the Office for Continuing Health Professional Education (CHPE). The Office for CHPE, Faculty of Medicine, McGill University is fully accredited by the Committee on Accreditation of Canadian Medical Education (CACME). This event is an Accredited Group Learning Activity as defined by the Maintenance of Certification program of the Royal College of Physicians and Surgeons of Canada. Through an agreement between the Royal College of Physicians and Surgeons of Canada and the American Medical Association, physicians may convert Royal College MOC credits to AMA PRA Category 1 Credits™. Information on the process to convert Royal College MOC credit to AMA credit can be found at www.ama-assn.org/go/internationalcme. Each physician should claim only credit commensurate with the extent of their participation in the activity.

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Daily Breakdown of CME Credits

Silent Auction

The following is the daily breakdown of credits available. Each attendee is responsible for claiming credit commensurate with the extent of their participation in the scientific activities.

The Teratology Society is holding a Silent Auction during the Welcome Reception on Sunday, June 29. Bidding will start at 5:30 pm and will conclude at 7:30 pm. A list of the highest bidders will be posted in the registration area by Monday at 12:00 noon. All items must be claimed by Wednesday at 12:00 noon. The Society is unable to ship auction items to the highest bidder; unclaimed items will become property of the Society. Your generosity will help us continue our mission to support the activities of our students and postdoctoral fellows.



Saturday, June 28: 6 credits Sunday, June 29: 4.25 credits Monday, June 30: 6.5 credits Tuesday, July 1: 5.25 credits Wednesday, July 2: 4 credits

Required CME Program—Intent to Participate Teratology Society Annual Meeting attendees who wish to receive CME credits must complete the CME participation form, which is available on the Society’s website and at the registration desk.

Required Daily Sign-in Sheets Teratology Society Annual Meeting attendees who wish to receive CME credits are responsible for signing the attendance sheet each day of participation. Sign-in sheets will be located at the registration desk during registration hours. Only the current day’s sign-in sheet will be available.

CME Certificates of Participation Certificates of CME participation, based on the daily sign-in sheets, will be available at the registration desk. Attendees are required to state the number of CME credits they are claiming and sign the certificate prior to departure. Certificates will be issued until 4:00 pm on Wednesday, July 2. Certification of Continuing Medical Education credits is the responsibility of the attendee.

ACCME ACCREDITATION Disclosure of Faculty and Industry Relationships In accordance with ACCME policy, all faculty members have signed a conflict of interest statement in which they have disclosed any significant financial interests or other relationships with industry relative to topics they will discuss at this program. At the beginning of the program, faculty members are expected to disclose any such information to participants. Such disclosure allows you to better evaluate the objectivity of the information presented in lectures. Please report on your evaluation form any undisclosed conflict of interest you perceive.

HIGHLIGHTS Welcome Reception The Welcome Reception will be held in the Evergreen Ballroom on Sunday, June 29 at 5:30 pm. The reception is open to registered attendees of the Teratology Society and NBTS Annual Meetings. Please wear your badge to gain entrance to the reception.

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Exhibits Exhibits will be open in the Evergreen Ballroom to attendees Sunday through Tuesday in the evenings and will feature companies offering teratology-related products and services. Scientific posters will be displayed in the Exhibit Hall on Monday and Tuesday. Although the Exhibit Hall will be open Sunday afternoon through Tuesday evening, the exhibits will be attended only during the times listed below.

Exhibits Attended

Sunday, June 29  Monday, June 30  Tuesday, July 1 

 5:30 PM–7:30 PM  5:30 PM–7:30 PM  5:30 PM–7:30 PM

Poster Sessions The Poster Sessions will be held in the Evergreen Ballroom on Monday, June 30 and Tuesday, July 1. The session on Monday is joint with NBTS. The posters for both sessions will be on display starting at 12:30 pm. The authors will be present for discussion from 5:30 pm–7:30 pm during their assigned session.

New This Year—2014 Student Design Competition The Teratology Society is excited to present their first annual Student Competition for Technical Solutions for Preventing and Treating Birth Defects. This competition is intended to encourage engineering and other students, undergraduate and graduate, and their mentors to collaborate with researchers in the field of teratology and to challenge students to imagine novel solutions to technical problems in the study of mechanisms, prevention, and treatment of birth of defects.

Banquet and Award Presentations The Banquet will be held on Wednesday, July 2. The reception (no host bar) will be held in the Evergreen Ballroom Foyer beginning at 6:30 pm. Dinner will be served at 7:30 pm in the Evergreen Ballroom. Banquet tickets are required for this event. The tickets are included in your registration materials and are not transferable. Guest tickets can be purchased at the registration desk. Teratology Society Awards recognized during the banquet are as follows:

Travel Awards James C. Bradford Memorial Student Poster Award Wilson Presentation Awards Marie W. Taubeneck Award Birth Defects Research Part A Distinguished Scholar Award Birth Defects Research Part B Distinguished Scholar Award Distinguished Service Award Recognition of Awards Presented Throughout the Week

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33 Years of Volleyball Come one, come all, and join in the fun! The 33rd Annual Volleyball Game is scheduled for Wednesday, July 2 from 6:30 am–7:30 am at the Community Gym at Tyee Middle School located at 13630 SE Allen Road, Bellevue, WA. This is an event that you will not want to miss. Stop by the registration desk for more information on how to participate in this match—it is free and open to all attendees. If you don’t play, come out and cheer!

Student/Postdoctoral Fellow Activities Special events for student and postdoctoral attendees will occur throughout the Teratology Society meeting. These events were planned with you in mind and allow you to meet other students, postdoctoral fellows, and scientists in the field. The following special events are scheduled. Saturday Mixer—The mixer is a perfect opportunity to get acquainted or reacquainted with your fellow student and postdoctoral attendees at the beginning of the meeting. Students and postdoctoral attendees are encouraged to participate in this event at 5:30 pm on Saturday, June 28. Student/Postdoc Treasure Hunt—At this year’s annual meeting, the students and postdoctoral fellows are encouraged to participate in the first annual Teratology Society Treasure Hunt. This activity is intended to facilitate networking. All participants who complete the list will receive a prize, and there will be a random drawing for all participants who complete at least half of the list (two chances for those who complete all tasks) for a grand prize of $100. The drawing will take place at the banquet. All who participate are winners, but you must be present to collect a prize. Tasks will include interacting with various members and participating in activities over the course of the meeting. Consider the experience a human treasure hunt. It is a great opportunity to discuss your research, connect with members and attendees, learn about different career paths, and forge relationships that you will “treasure” throughout your career! Student/Postdoctoral Fellow Platform Session: Wilson Presentation Award Competition—This year’s Student/Postdoctoral Platform Session showcases the work of ten students and postdoctoral fellows. The participants in this session were selected by the Student Affairs Committee from submitted abstracts. The presenters in this session will compete for the Wilson Presentation Award.

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This award was established in honor of James G. Wilson, one of the founding members of the Teratology Society, and recognizes the work of students and postdoctoral fellows in the field of teratology. It is awarded based on the content and quality of the oral presentations. The two award recipients will be announced during the Teratology Society Banquet on Wednesday, July 2. Make plans to support the Society’s student and postdoctoral members by attending this session on Sunday, June 29 at 9:00 am. Dine with a Teratology Ambassador—The Dine with a Teratology Ambassador program is a special opportunity for small groups of students and postdoctoral fellows to meet with associate or full members of the Society for informal discussion while enjoying a light breakfast. Advance signup is required. Please stop by the registration desk for the schedule and availability. TS/MARTA Student Career Event—Take advantage of this great networking opportunity! Join MARTA and the Teratology Society for dinner and conversation at a Student Career Event in the Juniper Room on Monday, June 30 from 7:30 pm–10:00 pm. This popular event is for students and postdoctoral fellows attending the joint meetings of the Teratology Society and NBTS. As you prepare for the next phase in your professional career, we offer you this opportunity to meet with other students and postdoctoral fellows and to interact with scientists from academia, government, and industry. This is also an opportunity for you to discuss your future and the various career paths available to you. James C. Bradford Memorial Student Poster Award—This is an award for the best poster presentation by a student at the annual meetings of the Teratology Society and Neurobehavioral Teratology Society. It is jointly sponsored by the Middle Atlantic Reproduction and Teratology Association and Sanofi US. The award will be announced during the Teratology Society Banquet.

HYATT REGENCY BELLEVUE Conference Site Step into the sophisticated Hyatt Regency Bellevue on Seattle’s desirable Eastside. The hotel is just 20 minutes from the Seattle-Tacoma International Airport and nine miles east of downtown Seattle, which can be conveniently reached in 20 minutes by express buses leaving every 15 minutes ($2 fare). Stroll through connecting sky bridges and discover more than 250 shops, 45 restaurants and lounges, and plenty of entertainment options harbored inside this chic urban streetscape. The Hyatt Regency Bellevue offers room service as well as multiple dining options on the property. A complete list of dining options is available on page 335.

Business Center The Hyatt Regency Bellevue has a full-service business center open Monday through Friday, 7:30 am–10:00 pm with hours varying on Saturday and Sunday. The Front Desk will be happy to assist you after the standard hours of service.

Printing Your Boarding Pass The Hyatt Regency Bellevue offers Hyatt Fast Board™. Check in for your flight and print your boarding pass in the lobby of the hotel. The secure connection ensures your information remains private while you enjoy fast and convenient access to flight information, weather, and traffic conditions.

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Internet Access The Teratology Society understands the importance of staying connected while you are in Bellevue. The Teratology Society will have an Internet Café located in the registration area, which will be available during registration hours. The café will include several computers with Internet service. Please note that wireless access is not available in the Internet Café, in the meeting rooms, or in the meeting room foyers. You may access complimentary wireless Internet access in Tully’s café, located near the lobby, or through a free 30-minute trial in the lobby through Hyatt Regency Bellevue’s WiFi connection. The Hyatt Regency Bellevue offers a tiered price structure and multi-day options for guest room Internet (wired or wireless). The tiered price structure will be as follows:

GROUND TRANSPORTATION (All prices are subject to change.) The Hyatt Regency Bellevue is located just 20 minutes from the SeattleTacoma International Airport (SEA). Transportation options include shared-ride vans, taxis, and express bus.

Shared-Ride Van Service Shuttle Express offers a $19 one-way fare between the Seattle-Tacoma International Airport and the Hyatt Regency Bellevue, 24 hours a day. For more information and reservations, please contact them by telephone at 425.981.7000 or make your reservation online at shuttleexpress.hudsonltd.net.

Taxi

   Single-day options include:

The estimated one-way taxi fare between the resort and the SeattleTacoma Airport is approximately $45–$50 (plus tip). For a taxi from the hotel, simply contact the sky captain in the hotel lobby.

• Standard High-Speed Internet is $9.99 with a 3Mbps per-user cap • Premium High-Speed is $12.99 with a 10Mbps per-user cap    Multi-day options include: • 3-day Standard High-Speed Internet is $21.99 • 3-day Premium High-Speed Internet is $29.99 • 7-day Standard High-Speed Internet is $29.99 • 7-day Premium High-Speed Internet is $39.99 Once signed in on the guest room access, you can utilize your device in the main lobby, Eques restaurant, and StayFit Gym without having to log in again and for no additional charge. Please note that this service is not available in the meeting rooms or the meeting room foyers.

Express Bus Downtown Seattle can be conveniently reached in 20 minutes by express bus 550 leaving every 15 minutes from the Bellevue Transit Center, which is a few blocks from the Hyatt Regency hotel (fare: $2). For more information about the Seattle area public transit system please visit www.soundtransit.org.

Hotel Parking The Hyatt Regency Bellevue offers valet parking for $29 a day or self parking for $25 a day (plus applicable taxes, currently 9.5%) for Sunday-night through Thursday-night stays. Friday- and Saturdaynight parking are complimentary (8:00 pm Friday until 12:00 midnight Sunday). Please note the parking rates are subject to change.

Future Annual Meetings 55th Annual Meeting

56th Annual Meeting

57th Annual Meeting

Hilton Montreal Bonaventure Montreal, Québec, Canada June 27–July 1, 2015

Grand Hyatt San Antonio San Antonio, Texas June 25–29, 2016

Grand Hyatt Denver Denver, Colorado June 24–28, 2017

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Hyatt Regency Dining Options Eques

Joey Bellevue

A contemporary restaurant serving breakfast favorites a la carte and buffet style, with one of the most popular brunches in Bellevue.

Satisfy your appetite with a convergence of big bold flavors as well as engaging service in a hip, lively restaurant. The menu features “new world” flavors with a broad spectrum of regional entree selections as well as an accessible, unpretentious wine list, and a diverse line-up of signature cocktails.

Breakfast a la carte and buffet hours: Monday–Friday    6:30 AM–10:00 AM Saturday    7:00 AM–12:00 Noon Sunday    7:00 AM–1:30 PM  (Brunch available 9:00 AM–1:30 PM)

Daniel’s Broiler Enjoy sumptuous steaks high atop Bellevue Place on the twenty-first floor with impressive views of the Cascade Mountains and the Seattle Skyline. Reservations: 425.462.4662, [email protected] Hours: Lunch:  Monday–Friday   Dinner:  Sunday–Thursday    Friday-Saturday  

 11:30 AM–2:30 PM  5:00 PM–10:00 PM  5:00 PM–11:00 PM

Koral Bar & Kitchen The menu is a culinary adventure. Highlighting upscale appetizers, small plates, and a full menu featuring unique items with a plentiful selection of comfortable prepared foods. This is a gathering place for large groups or a cozy dinner for two. You will find a place to grab a delicious drink, share appetizers with friends, or sit down for a great dining experience. Hours: Lunch:  Monday–Friday   Dinner:  Sunday–Wednesday    Thursday–Saturday  

Reservations: 425.637.1177, [email protected] Hours: Daily 

 11:00 AM–2:00 AM

Needs Deli/Needs Mercantile Offering breakfast items as well as tasty salads and sandwiches, Needs Deli is the perfect place to grab a quick bite to eat. Hours: Monday–Friday   Saturday   Sunday  

 7:00 AM–4:00 PM  8:00 AM–2:00 PM  Closed

Tully’s Coffee Savor the flavor of Tully’s serving rich, dark 100% custom-roasted Arabica whole bean coffees, specialty coffee beverages, tea, juices, and more since 1992. Stop by and enjoy tasty pastries, breakfast breads, and bagels for an early morning quick start or an afternoon snack. Hours: Monday–Friday   Saturday   Sunday  

 5:00 AM–8:00 PM  5:30 AM–8:00 PM  5:30 AM–6:00 PM

Zen Express  11:00 AM–2:30 PM

This quick casual hotspot boasts fusion style Asian cuisine in a relaxed environment. Eat in or take out—the choice is yours.

 4:00 PM–9:00 PM  4:00 PM–10:00 PM

Hours: Monday–Friday   Saturday–Sunday  

 11:00 AM–6:30 PM  Closed

55th Annual Meeting Montréal Québec

Skyline photo courtesy of © Tourisme Montréal/Parcs Canada

Hilton Montréal Bonaventure June 27–July 1, 2015

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Hyatt Regency Bellevue Maps First Floor OLYMPIC TOWER

EVERGREEN BALLROOM I

EVERGREEN BALLROOM H

EVERGREEN BALLROOM G

ESCALATOR

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HYATT STAYFIT GYM

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Hyatt Regency Bellevue Maps Second Floor NBTS GRAND BALLROOM T

CORRIDOR GRAND BALLROOM FOYER GRAND BALLROOM E

Teratology Society

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Pushing the Boundaries of Birth Defects Research

Bellevue WASHINGTON

Program Agenda FRIDAY, JUNE 27, 2014

3:00 PM–6:00 PM

REGISTRATION—Grand Ballroom Foyer

3:00 PM–6:00 PM

SPEAKER READY ROOM OPEN—Grand Ballroom Foyer

3:00 PM–6:00 PM

COUNCIL 1A MEETING—Laurel

SATURDAY, JUNE 28, 2014

7:00 AM–6:00 PM

REGISTRATION—Grand Ballroom Foyer

7:00 AM–6:00 PM

SPEAKER READY ROOM OPEN—Grand Ballroom Foyer

7:30 AM–8:00 AM

EDUCATION COURSE: COFFEE AND CONTINENTAL BREAKFAST—Grand Ballroom A

8:00 AM–12:00 Noon

EDUCATION COURSE SESSION 1 (Separate Registration Required)—Grand Ballroom A Frontiers in Developmental Biology Organized by the Education Committee, Chairperson, Carolyn Kapron, Trent University 8:00 AM–8:10 AM 8:10 AM–8:40 AM

8:40 AM–8:45 AM 8:45 AM–9:30 AM

9:30 AM–10:15 AM

Welcome Elaine Z. Francis, Teratology Society President Narsingh Agnish Fellow Lecture Of Embryos and Tumors: The Relevance of Teratology John M. DeSesso, Exponent Course Overview Education Committee, Chairperson, Carolyn Kapron, Trent University Effects of the Microbiome on Embryonic and Postembryonic Development CME Kjersti M. Aagaard, Baylor College of Medicine Genomic Approaches to Understanding Normal and Abnormal Brain Development: From Human to Animal Models and Back CME Maximillian Muenke, National Human Genome Research Institute, NIH

10:15 AM–10:30 AM

Break

10:30 AM–11:15 AM

The Role of Cilia in Development CME Jacqui Tabler, The University of Texas, Austin The Role of Nutrition in Embryo/Fetal Development Carl L. Keen, University of California

11:15 AM–12:00 Noon

12:00 Noon–1:30 PM

LUNCH ON YOUR OWN

12:00 Noon–1:30 PM

STUDENT AFFAIRS COMMITTEE MEETING—Evergreen Ballroom G

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CME

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SATURDAY/SUNDAY



1:30 PM–5:00 PM EDUCATION COURSE SESSION 2 (Separate Registration Required)—Grand Ballroom A Mechanisms of Abnormal Embryonic Development

Organized by the Education Committee, Chairperson, Carolyn Kapron, Trent University

1:30 PM–1:35 PM

Course Overview  Education Committee, Chairperson, Carolyn Kapron, Trent University Oxidative Stress in Abnormal Embryonic and Fetal Brain Development  CME   Peter Wells, University of Toronto Epigenetics  CME   Barbara F. Hales, McGill University



1:35 PM–2:20 PM



2:20 PM–3:05 PM



3:05 PM–3:20 PM

Break



3:20 PM–4:05 PM



4:05 PM–4:50 PM



4:50 PM–5:00 PM

Cellular Signal Transduction Pathways  CME   Carolyn Kapron, Trent University Gene-Regulatory Networks  CME   Michael D. Collins, University of California, Los Angeles Discussion



5:30 PM–7:30 PM STUDENT/POSTDOCTORAL MIXER



6:30 PM–9:30 PM COUNCIL 1B MEETING AND COMMITTEE REPORTS/LEADERSHIP TRAINING—Laurel SUNDAY, JUNE 29, 2014



7:00 AM–6:00 PM REGISTRATION—Grand Ballroom Foyer



7:00 AM–6:00 PM SPEAKER READY ROOM OPEN—Grand Ballroom Foyer



7:00 AM–8:00 AM DINE WITH A TERATOLOGY AMBASSADOR (Advanced Signup Required)—Juniper



7:00 AM–8:00 AM SCIENCE COMMITTEE MEETING—Evergreen Ballroom G



8:00 AM–8:15 AM PRESIDENT’S WELCOME—Grand Ballroom E Elaine Z. Francis, Sandcastle Toxicology Associates



8:15 AM–9:00 AM JOSEF WARKANY LECTURE (JOINT WITH NBTS)—Grand Ballroom E Teratology v2.0: Building a Path Forward (L1) 

CME

Chairperson: Elaine Z. Francis, Sandcastle Toxicology Associates Lecturer: Thomas B. Knudsen, National Center for Computational Toxicology, US EPA

9:00 AM–12:00 Noon STUDENT/POSTDOCTORAL FELLOW PLATFORM SESSION 1—Grand Ballroom E Organized by the Student Affairs Committee Chairperson: Christina M. Carruthers, Forest Research Institute Presenting author is underlined.

9:00 AM–9:15 AM



9:15 AM–9:30 AM

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Introduction  Christina M. Carruthers, Forest Research Institute Antidepressant Use during Pregnancy and Risk of Autism Spectrum Disorders in Children above or beyond of Genetic Background  Boukhris T1,2, Sheehy O2, Berard A1,2. 1Faculty of Pharmacy, University of Montreal, Montreal, QC, Canada, 2Research Center, CHU-Sainte-Justine, Montreal, QC, Canada.

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SUNDAY



9:30 AM–9:45 AM

2

The Neurobehavioral Consequences of Chronic Atrazine Exposure during Early Development in Male and Female Sprague-Dawley Rats  Walters J, Burroughs R, Hunt S, Harvey E, Baker L. Western Michigan University, Kalamazoo, MI, United States. Medical History Predicts Phenotypic Differences in Autism Spectrum Disorder  Wenger TL, Parish-Morris J, DePolo L, Yerys BE, Schultz RT. Children’s Hospital of Philadelphia, Philadelphia, PA, United States. Fumonsin B1-Induced NTDs: Is Nuclear Sa1P to Blame?  Gardner NM1, Sachs AJ1, Riley RT2, Maddox JR1, Gelineau-van Waes J1. 1Dept. of Pharmacology, Creighton University, School of Medicine, Omaha, NE, United States, 2Toxicology and Mycotoxin Research Unit, USDA, ARS, Athens, GA, United States. Defining a Transcriptomic Signature for Developmental Toxicity Prediction in the Zebrafish Embryo  Hermsen SAB1,2, Pronk TE1,2, van den Brandhof EJ1, van der Ven LTM1, Piersma AH1,3. 1RIVM, Bilthoven, Netherlands, 2Maastricht University, Maastricht, Netherlands, 3Utrecht University, Utrecht, Netherlands.



9:45 AM–10:00 AM

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10:00 AM–10:15 AM

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10:15 AM–10:30 AM

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11:45 AM–12:00 Noon

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Cellular Stress, Excess Apoptosis, and the Effect of Metformin on a Mouse Model of Type 2 Diabetic Embryopathy  Wu Y, Wang F, Yang P. University of Maryland, Baltimore, MD, United States. Class-Specific Histone Deacetylase (HDAC) Inhibitors Have Differential Adverse Effects on Chondrogenesis and Early Osteogenesis in Murine Limb Buds In Vitro  Paradis FH, Hales BF. McGill University, Montreal, QC, Canada. Assessing Early Developmental and Pubertal Effects in CD-1 Mice Following In Utero Exposure to Bisphenol (BP) Analogs  Robinson D1,2, Fenton S2. 1University of North Carolina, Chapel Hill, Chapel Hill, NC, United States, 2NTP Laboratory Branch, NIEHS, Research Triangle Park, NC, United States. Valproic Acid-Induced Alterations in CBP/p300 Regulation in P19 Embryonal Carcinoma Cells  Lamparter CL1, Winn LM1,2. 1Queen’s University, Department of Biomedical and Molecular Sciences, Kingston, ON, Canada, 2Queen’s University, School of Environmental Studies, Kingston, ON, Canada. Comparing PBDE Effects across Human Embryonic and Placental In Vitro Models  Robinson JF, Larocque N, Kapidzic M, McMaster MT, Fisher SJ. University of California, San Francisco, San Francisco, CA, United States.

12:00 Noon–1:30 PM LUNCH ON YOUR OWN 12:00 Noon–1:30 PM 2015 PROGRAM COMMITTEE MEETING—Laurel 12:00 Noon–1:30 PM F. CLARKE FRASER AND SERVICE AWARDS COMMITTEE MEETING—Evergreen Ballroom G

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12:00 Noon–1:30 PM STUDENT AND POSTDOCTORAL LUNCH WORKSHOP

(Advance Registration Required)—Grand Ballroom A

Building a Successful Career in Developmental and Reproductive Toxicology: Part 1 (W1) Chairpersons: Christine P. Curran, Northern Kentucky University and Jeffery H. Charlap, WIL Research





12:00 Noon–12:15 PM



12:15 PM–12:35 PM



12:35 PM–12:55 PM



12:55 PM–1:15 PM



1:15 PM–1:30 PM

Introduction Writing Well: From Cover Letters to Major Grants  Christine P. Curran, Northern Kentucky University Tips from the Top: Getting Published in High-Impact Journals  George P. Daston, Birth Defects Research Part B Editor-in-Chief and Michel Vekemans, Birth Defects Research Part A Editor-in-Chief Finding the Perfect Match: Building Successful Mentor-Mentee Relationships  Mary Alice Smith, University of Georgia Panel Discussion

1:30 PM–2:00 PM F. CLARKE FRASER NEW INVESTIGATOR AWARD—Grand Ballroom E From Computational Approaches to an Alternative Animal Model and Epidemiology: Building a Fulfilling Research Career (L2)  CME Chairperson: Robert G. Ellis-Hutchings, The Dow Chemical Company Lecturer: Julia M. Gohlke, University of Alabama, Birmingham



2:00 PM–2:30 PM JAMES G. WILSON PUBLICATION AWARD—Grand Ballroom E Dihydroartemisinin (DHA) Treatment Causes an Arrest of Cell Division and Apoptosis in Rat Embryonic Erythroblasts in Whole Embryo Culture Chairperson: L. David Wise

Lecturer: Lorraine Posobiec, GlaxoSmithKline



2:30 PM–5:30 PM ILSI HESI SYMPOSIUM—Grand Ballroom E Cross-Industry Data Survey of the Value of Rabbit Developmental Toxicity Data in the Risk Assessment for Pharmaceutics Chairpersons: Alan M. Hoberman, Charles River; Aldert H. Piersma, National Institute for Public Health and the Environment (RIVM); and Jane Stewart, AstraZeneca Pharmaceuticals

2:30 PM–3:00 PM

S1

ICH Workshop Origins of the Survey  Jane Stewart, AstraZeneca Pharmaceuticals An Analysis of Rat and Rabbit Developmental Toxicity Studies for Pharmaceuticals: The Scientific Background  CME   Aldert H. Piersma, National Institute for Public Health (RIVM)



3:00 PM–3:30 PM

S2



3:30 PM–3:45 PM

Break



3:45 PM–4:15 PM

S3



4:15 PM–4:45 PM

S4

A Comprehensive Data Survey of the Relative Value of Rat versus Rabbit Developmental Toxicity Data in the Risk Assessment for Pharmaceuticals: Presentation of Results  CME   Peter Theunissen, National Institute for Public Health (RIVM) and University of Applied Sciences Utrecht and Aldert H. Piersma, National Institute for Public Health (RIVM) Industry Perspective: What Are the Implications to Industry of Changing the Default Paradigm of Two Species Developmental Toxicity Testing?  Alan M. Hoberman, Charles River Laboratories, Preclinical Services

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4:45 PM–5:15 PM

S5



5:15 PM–5:30 PM

Regulatory Perspective: How Might the Risk Assessment of Novel Drugs and Regulatory Decisions Profit from the Results of This Survey?  CME   Sonja Beken, Federal Agency for Medicines and Health Products, Belgium Discussion

2:30 PM–5:30 PM TS/NBTS JOINT SYMPOSIUM—Grand Ballroom I National Children’s Study

Chairperson: Elaine M. Faustman, University of Washington and Richard K. Miller, University of Rochester

2:30 PM–2:55 PM

S6



2:55 PM–3:20 PM

S7



3:20 PM–3:45 PM

S8



3:45 PM–4:00 PM



4:00 PM–4:25 PM





An Integrated Framework for Linking Exposure and Phenotypic Data in the National Children’s Study  CME   Steven Hirschfeld, National Children’s Study Streamlining the Diagnosis of Autism Spectrum Disorder for the National Children’s Study  CME   Wendy Stone, University of Washington Results of Whole-Genome Analysis from National Children’s Study (NCS)  CME   Elaine M. Faustman, University of Washington Break

S9

Novel Insights on the Molecular Targets of Environmental Exposures during Pregnancy Using Placental Multi'omics Data Integration in the National Children’s Study (NCS)  CME   Kjersti M. Aagaard, Baylor College of Medicine 4:25 PM–4:50 PM S10 Environmental Exposures during Pregnancy: US National Children’s Study Formative Research Investigation  CME   Richard K. Miller, University of Rochester 4:50 PM–5:15 PM S11 Integration of Biological Cortisol Concentrations and Stress Questionnaires As a Marker of Maternal Stress  CME   Shirley A. Beresford and Marissa N. Smith, Fred Hutchinson Cancer Research Center and University of Washington 5:15 PM–5:30 PM Discussion



5:30 PM–7:30 PM TS/NBTS WELCOME RECEPTION, SILENT AUCTION, AND EXHIBITS ATTENDED—Evergreen Ballroom



7:30 PM–8:30 PM MEMBERSHIP COMMITTEE MEETING—Evergreen Ballroom G MONDAY, JUNE 30, 2014



7:00 AM–6:00 PM REGISTRATION—Grand Ballroom Foyer



7:00 AM–6:00 PM SPEAKER READY ROOM OPEN—Grand Ballroom Foyer



7:00 AM–8:00 AM DINE WITH A TERATOLOGY AMBASSADOR (Advanced Signup Required)—Juniper



7:00 AM–8:00 AM BDRB EDITORIAL BOARD MEETING—Evergreen Ballroom G



8:00 AM–9:00 AM SPECIAL LECTURE (JOINT WITH NBTS)—Grand Ballroom E Systems Medicine and Proactive P4 Medicine: Revolution in Healthcare (L3)  Chairperson: Elaine Z. Francis, Sandcastle Toxicology Associates Lecturer: Leroy Hood, Institute for Systems Biology

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9:00 AM–12:00 Noon MARCH OF DIMES SYMPOSIUM—Grand Ballroom E Advances in Early Diagnosis of Birth Defects and Adverse Perinatal Outcomes Chairpersons: Ludmila Bakhireva, University of New Mexico and Sarah G. Obican, Columbia University



9:00 AM–9:05 AM Introduction 9:05 AM–9:40 AM S12 Smart Skin Sensors and Analytics in the Cloud to Advance the Frontiers of Wearable Health  CME   Todd P. Coleman, University of California, San Diego 9:40 AM–10:15 AM S13 Screening for Birth Defects and Teratogen Risks with Ultrasonography in Early Gestation  CME   William F. Rayburn, University of New Mexico 10:15 AM–10:30 AM

Break

10:30 AM–11:05 AM S14 The Role of the First Trimester Fetal Echocardiography in Identification of Birth Defects  CME   Lynn L. Simpson, Columbia University 11:05 AM–11:40 AM S15 Fetal MRI As an Adjunct to Second Trimester Ultrasound  Jennifer A. Jolley, University of Washington 11:40 AM–12:00 Noon Discussion

CME



9:00 AM–12:00 Noon PLATFORM SESSION 2—Grand Ballroom A Mechanisms

Chairpersons: Barbara D. Abbott, US Environmental Protection Agency and Peixin Yang, University of Maryland School of Medicine Presenting author is underlined.

9:00 AM–9:15 AM

Introduction



9:15 AM–9:30 AM

11



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12



9:45 AM–10:00 AM

13



10:00 AM–10:15 AM

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Inhibition of Valproic Acid-Induced Malformation through Nrf2 Activation  Hansen J1, Sant K2, Jilek J2, Harris C2. 1Emory University, Atlanta, GA, United States, 2University of Michigan, Ann Arbor, MI, United States. Decreased miR-322 and Increased Its Target Gene, TRAF3, a Proapoptotic Factor Leading to Caspase Activation in Diabetic Embryopathy   Gu H, Yang P. University of Maryland School of Medicine, Baltimore, MD, United States. Cdk1-Dependent Phosphorylation of Leukemia-Associated RhoGEF (LARG) during Mitosis  Helms MC1, Grabocka E1, Martz MK1, Suzuki N2, Wedegaertner PB1. 1 Thomas Jefferson University, Philadelphia, PA, United States, 2University of Tokyo, Meguro, Tokyo, Japan. Novel Mode of Defective Neural Tube Closure in the Nonobese Diabetic (NOD) Mouse Strain   Kappen C, Kruger C, Macgowan J, Herion N, Salbaum JM. Pennington Biomedical Research Center, Louisiana State University System, Baton Rouge, LA, United States.



10:15 AM–10:30 AM

Break

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10:30 AM–10:45 AM

15



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16



11:00 AM–11:15 AM

17



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11:30 AM–11:45 AM

19



11:45 AM–12:00 Noon

20

Predictive Models of Skeletal Developmental Defects from ToxCast High-Throughput Screening Data   Ahir BK1, Sipes NS1, Baker NC2, Leung MCK1, Dewoskin RS3, Spencer RM2, Judson RS1, Martin MT1, Knudsen TB1. 1National Center for Computational Toxicology, US Environmental Protection Agency, Office of Research and Development, Research Triangle Park, NC, United States, 2 Lockheed Martin, Research Triangle Park, NC, United States, 3National Center for Environmental Assessment, Research Triangle Park, NC, United States. Unique Susceptibility of the Rat to Leydig Cell Tumors Mediated by Pronamide-Induced Testosterone Metabolism   Rasoulpour RJ1,2, Andrus AK1, Marty S1, Zhang F1, Thomas J1, Lebaron MJ1, Papineni S2, Pottenger LH1, Hannas BR1, Eisenbrandt DL2. 1The Dow Chemical Company, Midland, MI, United States, 2Dow AgroSciences, Indianapolis, IN, United States. Mechanisms in Distal Reproductive Tract Development   Zhao F1, Li R1, Dudley EA1, Zhou J1, Huang S2, Ye X1. 1University of Georgia, Athens, GA, United States, 2Georgia Regents University, Augusta, GA, United States. Juvenile Toxicity Assessment of a Novel Antihyperglycemic Agent in Post-Weaned Rats   De Schaepdrijver LM1, Stannard D2, De Jonghe S1, Proctor J3, Bailey GP1, Mamidi R3, Johnson MD3. 1Preclinical Development and Safety, Janssen Research and Development, Beerse, Belgium, 2Huntingdon Life Sciences Ltd., Eye, Suffolk, United Kingdom, 3Preclinical Development and Safety, Janssen Research and Development, Raritan, United States. Epigenetic Modifications of Histone H3 in Brains of Fetal DNA Repair-Deficient Oxoguanine Glycosylase 1 (ogg1) Knockout Mice Exposed Once In Utero to Ethanol   Bhatia S1, Shapiro AM1, Wells PG1,2. 1Department of Pharmaceutical Sciences, University of Toronto, Toronto, ON, Canada, 2Department of Pharmacology and Toxicology, University of Toronto, Toronto, ON, Canada. Activation of Human Peroxisome Proliferator-Activated ReceptorGamma (PPARγ) by House Dust Extracts   Wolf CJ1, Fang M2, Stapleton HM2, Abbott BD1. 1Toxicity Assessment Division, NHEERL, ORD, US EPA, Research Triangle Park, NC, United States, 2Nicholas School of the Environment, Duke University, Durham, NC, United States.

12:00 Noon–1:30 PM LUNCH ON YOUR OWN 12:00 Noon–1:30 PM PAST PRESIDENTS’ AND HONOREES’ LUNCHEON (By Invitation Only)—Juniper 12:00 Noon–1:30 PM PUBLIC AFFAIRS COMMITTEE—Laurel 12:00 Noon–1:30 PM PUBLICATIONS COMMITTEE—Evergreen Ballroom G

1:30 PM–2:30 PM ELSEVIER DISTINGUISHED LECTURER (JOINT WITH NBTS)—Grand Ballroom E Epigenetic Mechanisms in Intellectual Developmental Disabilities (L4) 

CME

Chairpersons: Thomas M. Burbacher, University of Washington and Robert M. Greene, Birth Defects Center, University of Louisville

Lecturer: J. David Sweatt, The University of Alabama, Birmingham, School of Medicine

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2:30 PM–5:30 PM TS/NBTS JOINT SYMPOSIUM—Grand Ballroom E Epigenetics

Chairpersons: Thomas M. Burbacher, University of Washington and Robert M. Greene, Birth Defects Center, University of Louisville

2:30 PM–2:45 PM



2:45 PM–3:30 PM S16 Environmentally-Induced Epigenetic Transgenerational Inheritance of Disease: Ancestral Ghosts in Your Genome  CME   Michael K. Skinner, Washington State University



3:30 PM–3:45 PM



3:45 PM–4:30 PM S17 Chromatin Remodeling, miRNAs, and Determination of Neurogenic Cell Fate  CME   Andrew S. Yoo, Washington University School of Medicine 4:30 PM–5:15 PM S18 Mechanisms of MicroRNA Function in Fetal Neural Stem Cells: Implications for Ethanol Teratology  CME   Rajesh C. Miranda, Texas A&M Health Science Center 5:15 PM–5:30 PM Discussion





Introduction

Break

2:30 PM–3:30 PM PLATFORM SESSION 3—Grand Ballroom A Pregnancy Registry and Public Policy

Chairpersons: Marlissa A. Campbell, Office of Environmental Health Hazard Assessment and Leyla Sahin, US Food and Drug Administration Presenting author is underlined.





2:30 PM–2:45 PM

21



2:45 PM–3:00 PM

22



3:00 PM–3:15 PM

23



3:15 PM–3:30 PM

24

The Need for a Disease-Specific Prospective Pregnancy Registry for Multiple Sclerosis (MS)  Alwan S1, Chambers CD2, Sadovnick AD1. 1University of British Columbia, Vancouver, BC, Canada, 2University of California, San Diego, La Jolla, CA, United States. US FDA Systematic Review and Preliminary Analysis of Pregnancy Registries  Sahin L1, Gelperin K2, Hammad H2, Nguyen M3, Woo J3, Iyasu S2. 1US FDA, Center for Drug Evaluation and Research, Office of New Drugs, Silver Spring, MD, United States, 2US FDA, Center for Drug Evaluation and Research, Office of Surveillance and Epidemiology, Silver Spring, MD, United States, 3US FDA, Center for Biologics Evaluation and Research, Rockville, MD, United States. The Navigation Guide Systematic Review Methodology Proof of Concept: PFOA and Fetal Growth   Johnson PI1, Sutton P1, Atchley D1, Koustas E2, Lam J3, Sen S4, Robinson K5, Axelrad D6, Woodruff TJ1. 1University of California, San Francisco, CA, United States, 2Oak Ridge Institute for Science and Education (ORISE), Office of Policy, US EPA, Washington DC, United States, 3Johns Hopkins University, Health Policy and Management, Baltimore, MD, United States, 4 University of California, Epidemiology and Biostatistics, San Francisco, CA, United States, 5Johns Hopkins University, Medicine, Epidemiology, and Health Policy and Management, Baltimore, MD, United States, 6Office of Policy, US EPA, Washington DC, United States. Changing Complexion of Drug Safety Studies in Pregnancy in the Published Literature  Covington D1, Veley K1, Mcgee A2. 1PPD, Wilmington, NC, United States, 2 UNCW, Wilmington, NC, United States.

3:30 PM–3:45 PM BREAK

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3:45 PM–5:30 PM HOT TOPIC SYMPOSIUM—Grand Ballroom A Neural Tube Defects Cluster in Washington State

Chairpersons: Richard H. Finnell, The University of Texas at Austin and Janee Gelineau-van Waes, Creighton University School of Medicine This Hot Topics Symposium will describe the recent recognition of a cluster of babies born with anencephaly or spina bifida in a three county area of Washington state. Speakers will include Sara Barron a nurse who first recognized the increase in neural tube defects and other speakers invited including those who investigated this or similar clusters. Time will be allotted for discussion.



5:30 PM–7:30 PM TS/NBTS JOINT POSTER SESSION 1 AND EXHIBITS ATTENDED—Evergreen Ballroom Teratology Society Posters: P1–P26

Chairpersons: Elise Madison Lewis, Charles River Laboratories and Terry C. Hrubec, E. Via Virginia College of Osteopathic Medicine

NBTS Posters: P01–P21

7:30 PM–10:00 PM TS/MARTA STUDENT CAREER EVENT—Juniper TUESDAY, JULY 1, 2014



6:30 AM–7:00 AM SUNRISE MINI COURSE: COFFEE AND CONTINENTAL BREAKFAST—Grand Ballroom A



7:00 AM–6:00 PM REGISTRATION—Grand Ballroom Foyer



7:00 AM–6:00 PM SPEAKER READY ROOM OPEN—Grand Ballroom Foyer



7:00 AM–8:00 AM DINE WITH A TERATOLOGY AMBASSADOR (Advanced Signup Required)—Juniper



7:00 AM–8:30 AM SUNRISE MINI COURSE (Separate Registration Required)—Grand Ballroom A

(For Sunrise Mini Course Registrants)

Applications of Computational Toxicology in the Study of Birth Defects

Organized by the Education Committee, Chairperson, Carolyn Kapron, Trent University





7:00 AM–7:45 AM



7:45 AM–8:30 AM

The Use of Computational Toxicology to Identify Reproductive and Developmental Outcomes of Concern  George P. Daston, Procter & Gamble Company How Are Computational Toxicology Methods Used to Prioritize Compounds for Testing?  CME   Thomas B. Knudsen, National Center for Computational Toxicology, US EPA

8:30 AM–9:00 AM SPECIAL LECTURE (JOINT WITH NBTS)—Grand Ballroom E Fetal Alcohol Syndrome (L5) 

CME

Chairperson: Christina D. Chambers, University of California, San Diego Lecturer: Kenneth Lyons Jones, University of California, San Diego and MotherToBaby

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TUESDAY

9:00 AM–12:00 Noon TESTICULAR DYSGENESIS SYNDROME SYMPOSIUM—Grand Ballroom E Chairpersons: Barbara F. Hales, McGill University and Thomas B. Knudsen, National Center for Computational Toxicology, US EPA







9:00 AM–9:15 AM

Introduction

9:15 AM–9:45 AM S19 Genetic and Environmental Regulation of External Genital Development  CME   Martin J. Cohn, Howard Hughes Medical Institute and University of Florida 9:45 AM–10:15 AM S20 Cryptorchidism Susceptibility in Pediatric Patients and in Animal Models  CME   Julia S. Barthold, Nemours/Alfred I. duPont Hospital for Children 10:15 AM–10:30 AM

Break

10:30 AM–11:00 AM S21 Hypospadias: An Overview of Risk Factors and Etiologies  CME   Suzan L. Carmichael, Stanford University 11:00 AM–11:30 AM S22 Computational Embryology and Predictive Toxicology of Hypospadias  CME   Maxwell C. K. Leung, National Center for Computational Toxicology, US EPA 11:30 AM–12:00 Noon S23 3-D In Vitro Models and Systems Biology: The Phthalate Syndrome As a Case Example  CME   Elaine M. Faustman, University of Washington

12:00 Noon–1:30 PM STUDENT AND POSTDOCTORAL LUNCH WORKSHOP

(Advance Registration Required)—Grand Ballroom A

Building a Successful Career in Developmental and Reproductive Toxicology: Part 2 (W2) Chairpersons: Christine P. Curran, Northern Kentucky University and Jeffery H. Charlap, WIL Research

12:00 Noon–12:15 PM



12:15 PM–12:35 PM



12:35 PM–12:55 PM



12:55 PM–1:15 PM



1:15 PM–1:30 PM

Introduction Beyond the Bench: What Skills Are Needed for Next-Gen Developmental and Reproductive Toxicology?  Nisha Sipes, US Environmental Protection Agency Using Good Laboratory Practices to Get Great Data  Jeffrey H. Charlap, WIL Research Integrative Thinking  Reza J. Rasoulpour, The Dow Chemical Company Panel Discussion

12:00 Noon–1:30 PM LUNCH ON YOUR OWN

1:30 PM–2:30 PM TS/ETS EXCHANGE LECTURE—Grand Ballroom E Is Lack of Mandatory Folic Acid Fortification Public Health Malpractice? 

CME

Chairpersons: Paul C. Barrow, F. Hoffmann-La Roche and Susan L. Makris, US Environmental Protection Agency

European Teratology Society: The Impact of Spina Bifida on Individuals, Families, and Society (L6) Margo L. Whiteford, Southern General Hospital

Teratology Society: Accelerating the Pace of Preventing Spina Bifida F and Anencephaly F (L7) Godfrey P. Oakley Jr., Emory University

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2:30 PM–5:30 PM GRANT OFFICERS ROUNDTABLE—Grand Ballroom E Moderators: Jason Hansen, Emory University and Xiaoqin Ye, University of Georgia Panelists: Richard L. Callan, US Environmental Protection Agency; A. Tyl Hewitt, Eunice Kennedy Shriver National Institute of Child Health and Human Development; Susan E. Maier, Office of Research on Women’s Health, NIH; Thaddeus T. Schug, National Institute of Environmental Health Sciences; and Edward R.B. McCabe, March of Dimes Foundation



2:30 PM–5:30 PM PLATFORM SESSION 4—Grand Ballroom A Epidemiology and Clinical Teratology

Chairpersons: Suzan L. Carmichael, Stanford University and James L. Mills, Eunice Kennedy Shriver National Institute of Child Health and Human Development Presenting author is underlined.

2:30 PM–2:45 PM 2:45 PM–3:00 PM 25



3:00 PM–3:15 PM

26



3:15 PM–3:30 PM

27



3:30 PM–3:45 PM

28



3:45 PM–4:00 PM

Break



4:00 PM–4:15 PM

Oral Corticosteroid Use during Pregnancy and Risk for Preterm Birth: A Prospective Cohort Study  Palmsten K, Johnson DL, Luo Y, Torres CL, Chambers CD. University of California, San Diego, La Jolla, CA, United States.

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Introduction Disease Severity and Preterm Delivery in Women with Rheumatoid Arthritis: The Autoimmune Diseases in Pregnancy Project  Bharti B, Kopald D, Yan J, Johnson D, Chambers C. University of California, San Diego, Department of Pediatrics, Division of Dysmorphology-Teratology, La Jolla, CA, United States. Racial Disparity in Birth Defects: Who Has Higher Risk?  Ibrahim A1, Tran T2,3, Johnston J2, Richmond N2,3, Pierce D2, Berry S2,3. 1 Tulane University School of Public Health and Tropical Medicine, New Orleans, LA, United States, 2Louisiana DHH OPH Children and Youth with Special Health Needs Program, New Orleans, LA, United States, 3 LSUHSC School of Medicine, Department of Pediatrics, New Orleans, LA, United States. Novel Copy Number Variants in a Population-Based Investigation of Heterotaxy-Associated Congenital Heart Disease  Rigler S1,2, Kay D3, Sicko R3, Fan R2, Liu A2, Caggana M3, Browne M3, Druschel C3, Romitti P4, Brody L5, Mills J2. 1Naval Medical Center Portsmouth, Portsmouth, VA, United States, 2NICHD, NIH, Bethesda, MD, United States, 3New York State Department of Health, Albany, NY, United States, 4University of Iowa, Iowa City, IA, United States, 5NHGRI, NIH, Bethesda, MD, United States. Quantifying the “Anticonvulsant Face”  Nasri HZ1, Deutsch CK2, Holmes LB1. 1The Medical Genetics Unit at MassGeneral Hospital for Children, Boston, MA, United States, 2Eunice Kennedy Shriver Center, Boston, MA, United States.

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4:15 PM–4:30 PM

30



4:30 PM–4:45 PM

31



4:45 PM–5:00 PM

32



5:00 PM–5:15 PM

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Linkage of Prescription Data to Congenital Anomaly Registers to Improve Information on Maternal Medication Use: A EUROmediCAT Study  De Jonge L1, Jordan S2, Tucker D3, Thayer D4, Pierini A5, Gini R6, Garne E7, Hansen AV7,8, Neville AJ9, Puccini A10, Bakker MK1,11. 1University Medical Center Groningen, Department of Genetics, Groningen, Netherlands, 2Department of Nursing, College of Human and Health Sciences, Swansea University, Swansea, Wales, United Kingdom, 3CARIS, Public Health Wales, Swansea, Wales, United Kingdom, 4Centre for Health Information, Research and Evaluation, Swansea University, Swansea, Wales, United Kingdom, 5Institute of Clinical Physiology, National Research Council (IFC-CNR), Pisa, Italy, 6Agenzia Regionale di Sanità Della Toscana, Florence, Italy, 7Paediatric Department, Hospital Lillebaelt, Kolding, Denmark, 8Department of Public Health, University of Copenhagen, Copenhagen, Denmark, 9IMER (Emilia Romagna Registry of Birth Defects), Azienda Ospedaliero-Universitaria di Ferrara, Ferrara, Italy, 10Drug Policy Service, Emilia Romagna Region Health Authority, Bologna, Italy, 11Department of Obstetrics and Gynecology, University Medical Center Groningen, Groningen, Netherlands. The Relationship of Sociodemographic and Hispanic Acculturation Factors with Isolated Anotia/Microtia  Hoyt AT1, Canfield MA1, Shaw GM2, Waller DK3, Polen KD4, Ramadhani T5, Anderka M6, Scheuerle AE7. 1Texas Department of State Health Services, Birth Defects Epidemiology and Surveillance Branch, Austin, TX, United States, 2Department of Pediatrics, Stanford University School of Medicine, Palo Alto, CA, United States, 3University of Texas Health Science Center at Houston School of Public Health, Houston, TX, United States, 4National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention, Atlanta, GA, United States, 5Division of Research and Analysis, Texas Education Agency, Austin, TX, United States, 6Massachusetts Department of Public Health, Boston, MA, United States, 7Tesserae Genetics, Dallas, TX, United States. Early Pregnancy Agricultural Pesticide Exposures and Risk of Gastroschisis among Offspring in the San Joaquin Valley of California  Shaw GM1, Yang W1, Wolff C2, Roberts E3, Kegley SE4, Padula A1, English PB5, Carmichael SL1. 1Stanford University, Stanford, CA, United States, 2 Lobo Geo, LLC, Alameda, CA, United States, 3Public Health Institute, Oakland, CA, United States, 4Pesticide Research Institute, Berkeley, CA, United States, 5California Department of Public Health, Richmond, CA, United States. Math Dysfunction in Young Adults Exposed Prenatally to Alcohol: 20-Year Follow-Up  Coles CD, Kable JA, Lynch ME, Goldstein F. Emory University School of Medicine, Atlanta, GA, United States.

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5:15 PM–5:30 PM

34

Ovarian Stimulation Use, including Clomiphene Citrate, and Intrauterine Insemination Use and the Risk of Multiplicity and Major Congenital Malformations: A Meta-Analysis  Chaabane S1,2, Blais L2,3, Fraser W4,5, Bissonnette F9,5, Monnier P6,7, Tan S-L6,7, Trasler J7,8, Bérard A1,2. 1Research Center, CHU Ste-Justine, Montreal, QC, Canada, 2Faculty of Pharmacy, University of Montreal, Montreal, QC, Canada, 3Research Center, Sacré-Coeur Hospital, Montreal, QC, Canada, 4Department of Obstetrics and Gynecology, CHU Ste-Justine, Montreal, QC, Canada, 5Faculty of Medicine, University of Montreal, Montreal, QC, Canada, 6MUHC University Reproductive Center, Department of Obstetrics and Gynecology, Royal Victoria Hospital, Montreal, QC, Canada, 7Faculty of Medicine, McGill University, Montreal, QC, Canada, 8Montreal Children’s Hospital Research Institute, Montreal, QC, Canada, 9OVO Fertility Clinic, CHUM, Montreal, QC, Canada.

5:30 PM–7:30 PM POSTER SESSION 2 AND EXHIBITS ATTENDED—Evergreen Ballroom Teratology Society Posters P27–P61

Chairperson: Jane F. Rasco, University of Alabama



7:30 PM–8:30 PM COMMUNICATIONS WORKING GROUP MEETING—Evergreen Ballroom G WEDNESDAY, JULY 2, 2014



6:30 AM–7:30 AM TERATOLOGY SOCIETY 33RD ANNUAL VOLLEYBALL GAME—Community Gym at Tyee Middle School



7:00 AM–4:30 PM REGISTRATION—Grand Ballroom Foyer



7:00 AM–4:30 PM SPEAKER READY ROOM OPEN—Grand Ballroom Foyer



8:00 AM–8:30 AM ROBERT L. BRENT LECTURE: TERATOGEN UPDATE—Grand Ballroom E Teratology and Public Health: Working Together to Make Recommendations for Pregnant Women in the Face of Uncertainty (L8)  CME Chairperson: Mary Alice Smith, University of Georgia

Lecturer: Sonja A. Rasmussen, Centers for Disease Control and Prevention



8:30 AM–12:15 PM WILEY-BLACKWELL SYMPOSIUM—Grand Ballroom E From Fleas to Fish and Beyond: Advances in Alternative Assays to Predict Developmental Toxicity Chairpersons: Robert G. Ellis-Hutchings, The Dow Chemical Company and E. Sid Hunter III, US Environmental Protection Agency

8:30 AM–8:40 AM



8:40 AM–9:10 AM S24 Prediction of Developmental Toxicity Using Mouse Embryonic Stem Cells on Environmental Chemicals  CME   E. Sid Hunter III, US Environmental Protection Agency 9:10 AM–9:40 AM S25 Daphnia As a Whole-Animal Invertebrate Model System for Human Health Research  CME   Julia M. Gohlke, University of Alabama, Birmingham





9:40 AM–10:25 AM

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10:25 AM–10:55 AM S26 Development of a C. elegans Assay to Characterize the Effects of Toxicants on Growth, Reproduction, and Development  CME   Jonathan Freedman, National Institute of Environmental Health Sciences 10:55 AM–11:25 AM S27 Using Embryonic Zebrafish and Multidimensional Screening to Evaluate Neurobehavioral Toxicity and Teratology  CME   Robert Tanguay, Oregon State University 11:25 AM–11:55 AM S28 Applications of Multiple Developmental Toxicology Assays for Teratogenic Hazard Identification and Mechanistic Evaluation  Karen A. Augustine, Bristol Myers Squibb Research Institute 11:55 AM–12:15 PM Discussion



12:15 PM–1:30 PM LUNCH ON YOUR OWN



12:15 PM–1:30 PM BDRA EDITORIAL BOARD MEETING—Evergreen Ballroom G



12:15 PM–1:30 PM EDUCATION COMMITTEE MEETING—Evergreen Ballroom H



1:30 PM–4:30 PM PUBLIC AFFAIRS COMMITTEE SYMPOSIUM—Grand Ballroom E Thrombosis during Pregnancy: Risks, Prevention, and Treatment for Mother and Fetus Chairpersons: Emmanuel Fadiran, Office of Women’s Health, US FDA and Evi Struble, Center for Biologics Evaluation and Research, US FDA Organized by the Public Affairs Committee

1:30 PM–1:45 PM S29 Thrombosis: Molecular Mechanisms, Clinical Picture, and Treatment Options during Pregnancy: An Introduction  CME   Lisa Soule and Evi Struble, US Food and Drug Administration 1:45 PM–2:20 PM S30 Thrombosis in Pregnancy and Maternal Outcomes  CME   Andra H. James, University of Virginia 2:20 PM–2:55 PM S31 Thrombophilia in Pregnancy and Fetal Outcome: Special Emphasis on Antiphospholipid Syndrome (APLS)  CME   Sarah Gloria Obican, Columbia University and Asher Ornoy, Israel Ministry of Health and Hebrew University



2:55 PM–3:10 PM



3:10 PM–3:45 PM S32 Management of Thrombosis in Pregnancy  CME   Barbara A. Konkle, Puget Sound Blood Center and University of Washington 3:45 PM–4:20 PM S33 Harvesting the Power of 'Omic Technology, Biomarkers, and In Vitro or In Vivo Models to Facilitate the Treatment of Thrombosis  CME   Michael Paidas, Yale University 4:20 PM–4:30 PM Panel Discussion and Closing Remarks  Emmanuel Fadiran, Office of Women’s Health, US FDA and Evi Struble, Center for Biologics Evaluation and Research, US FDA



Break

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1:30 PM–4:30 PM PLATFORM SESSION 5—Grand Ballroom A In Vitro, Stem Cells, and Alternative Approaches

Chairpersons: Kimberly Brannen, Charles River Laboratories and Deborah K. Hansen, US Food and Drug Administration Presenting author is underlined.

1:30 PM–1:45 PM

Introduction



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2:45 PM–3:00 PM

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Propofol-Induced Toxicity in Embryonic Neural Stem Cells and the Potential Protective Effect of Acetyl-L-Carnitine  Slikker Jr. W, Liu F, Rainoseck SW, Sadovova N, Fogle CM, Patterson TA, Hanig JP, Paule MG, Wang C. US Food and Drug Administration, NCTR, Jefferson, AR, United States. Effect of Growth Factors on Stem Cell Transplantation in Rat Fetuses with Spina Bifida Aperta  Yuan Z, Li H, Cao S, Gu H. Shengjing Hospital, China Medical University, Shenyang, China. Short-Term Embryonic Stem Cell Exposure Assay As a Tool to Predict Developmental Toxicity  Sun Y2, Jergil M1, Stockling K3, Hellmold H3, Dencker L1, Gustafson A-L3, Salter H2, Stigson M1. 1Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden, 2AstraZeneca Translational Science Centre at the Karolinska Institutet, Solna, Sweden, 3AstraZeneca Global Safety Assessment, AstraZeneca R&D, Södertälje, Sweden. Using Human Pluripotent Cells to Detect Teratogens and Study Teratogenic Mechanisms  Flamier A1, Rasmussen T1,2,3. 1University of Connecticut, Department of Pharmaceutical Sciences, Storrs, CT, United States, 2University Connecticut Stem Cell Institute, Farmington, CT, United States, 3 University Connecticut Institute for Systems Genomics, Storrs, CT, United States. Pathway Dynamics of an Organotypic In Vitro Testicular Model Reflect Developmental Processes In Vivo   Wegner S, Harris S, Stanaway I, Pacheco S, Park J, Hong S, Faustman EM. University of Washington, Seattle, WA, United States.



3:00 PM–3:15 PM

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An In Vitro Assay As a Screening Tool for Listeria monocytogenes Invasion in Maternal and Fetal Tissues   Wadhwa DR, Amosu M, Smith MA. University of Georgia, Athens, GA, United States. The Effects of Carbamazepine and Valproic Acid on Gene Expression in a Human Embryonic Stem Cell Based Assay for NeuroDevelopmental Toxicity   Schulpen SHW1,2, De La Fonteyne LJJ1, De Klerk A1, Piersma AH1,2. 1 Centre for Health Effects Research, RIVM, Bilthoven, Netherlands, 2 Institute for Risk Assessment Sciences, Utrecht University, Utrecht, Netherlands. The Effects of the Zebrafish Chorion on the Response to Exogenous Chemicals   Gurrola-Gal MC1, Penney LC2, Macdougall J2, Clipston AS2, Brannen KC1. 1Preclinical Services, Charles River Laboratories, Horsham, PA, United States, 2Preclinical Services, Charles River Laboratories, Tranent, Edinburgh, United Kingdom.

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WEDNESDAY/THURSDAY



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Presence of Macrophages in an In Vitro Testicular Coculture Model of Male Reproductive Development Enhances Relevance to In Vivo Conditions   Pacheco SE, Wegner S, Green F, Harris S, Faustman EM. University of Washington, Seattle, WA, United States. A Novel Human Embryoid Body System (hEB) with Potential to Be Used for Screening Drug Candidates in the Field of Reproductive Toxicology  Allison T1, Powles-Glover NS2, Stewart J2, Andrews PW1. 1The University of Sheffield, Sheffield, Yorkshire, United Kingdom, 2AstraZeneca, DSM, Mereside, Alderley Edge, Cheshire, United Kingdom.



4:45 PM–6:15 PM BUSINESS MEETING—Grand Ballroom E



6:30 PM–7:30 PM BANQUET RECEPTION—Evergreen Ballroom Foyer



7:30 PM–11:00 PM BANQUET—Evergreen Ballroom Travel Awards James C. Bradford Memorial Student Poster Awards Wilson Presentation Awards Marie Taubeneck Award Birth Defects Research Part A Distinguished Scholar Award Birth Defects Research Part B Distinguished Scholar Award Distinguished Service Award Recognition of Awards Presented Throughout the Week THURSDAY, JULY 3, 2014



7:00 AM–10:00 AM C OUNCIL 2 MEETING—Laurel

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Annual Meeting Exhibitors (as of March 31, 2014)

The Teratology Society thanks these organizations for their participation in Bellevue.

ArunA Biomedical, Inc. Charles River Experimur Exponent, Inc. SAI Infusion Technologies San Diego Instruments Wiley

Birth Defects Research (Part A) 100:319–357 (2014)

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Bellevue WASHINGTON

Exhibitor Information (as of March 31, 2014) Exhibits and Posters are located in the Evergreen Ballroom. Although the Exhibit Hall will be open Sunday afternoon through Tuesday evening, the exhibits will be attended only during the times listed below. Exhibits Attended Sunday, June 29 5:30 PM–7:30 PM

Monday, June 30 5:30 PM–7:30 PM

Tuesday, July 1 5:30 PM–7:30 PM

All information printed in this exhibitor section is listed in alphabetical order and was submitted by the exhibiting company.

ARUNA BIOMEDICAL, INC. 425 River Road Athens, GA 30602 United States

Tel: 706.542.9191 Fax: 706.262.2821

Email: [email protected] Website: www.arunabiomedical.com

ArunA Biomedical provides human pluripotent stem cell (hPSC) derived products including CNS and PNS neural, germ, and muscle cells for research use. The Company’s expertise in hPSC differentiation and manufacturing enables scaled uniform production of high quality and informative hPSC cellular platforms in ready to culture formats.

CHARLES RIVER 251 Ballardvale Street Wilmington, MA 01887 United States

Tel: 877.CRIVER.1 Fax: 978.988.9236

Email: [email protected] Website: www.criver.com

Charles River provides a comprehensive service in developmental, reproductive, and juvenile toxicology for the progression of your compound. Studies are performed in multiple species using various routes of dose administration. Our range of capabilities, combined with leading scientific expertise and over 25 years of historical data, results in timely nonclinical reproductive toxicology programs with regulatory acceptance.

EXPERIMUR 4045 S. Morgan Street Chicago, IL 60609 United States

Tel: 773.254.2700 Fax: 773.254.2723

Email: [email protected] Website: www.experimur.com

Experimur is a full-service toxicology testing and research laboratory with extensive experience in the conduct of developmental (Seg I, II, and III) and reproductive (single and multigeneration) toxicity assessments, including sperm morphology and vaginal cytology, as well as general toxicity (acute, subchronic, chronic, and carcinogenicity), neurotoxicity, and pharmacokinetic/ADME studies in species ranging from rodents to primates. With an experienced and well-trained team that has worked together for over 28 years and successfully completed thousands of GLP-compliant preclinical studies, we are committed to providing our customers with top quality and unmatched service. We invite you to visit our spectacular custom-built, AAALAC-accredited, USDA-registered, 54,000 sq ft state-of-the art facility and vivarium, which includes extensive inhouse support services for histology diagnostic pathology, clinical pathology, and analytical chemistry.

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EXPONENT, INC. 1800 Diagonal Road, Suite 500 Alexandria, VA 22314 United States

    Tel: 571.227.7261     Fax: 571.227.7299

Email: [email protected] Website: www.exponent.com

Exponent’s veteran toxicologists and epidemiologists are drawn from the chemical and pharmaceutical industries, academia, and government. They have international regulatory experience in designing and interpreting developmental and reproductive toxicity (DART) and developmental neurotoxicology studies; assessing potential endocrine disruption; performing quantitative risk assessments and cancer risk assessments related to children.

SAI INFUSION TECHNOLOGIES (STRATEGIC APPLICATIONS INC) 276 Park Avenue Lake Villa, IL 60046 United States

    Tel: 847.356.0321     Fax: 847.356.0382

Email: [email protected] Website: www.sai-infusion.com

SAI Infusion Technologies designs and manufactures systems and components for preclinical infusion and sampling. SAI surgeons and scientists provide onsite comprehensive training for all our systems and products including: wireless-infusion management software, (Axios) pumps, harnesses, access ports, jackets, swivels, catheters, and DART procedure kits and products.

SAN DIEGO INSTRUMENTS 9155 Brown Deer Road, Suite 8 San Diego, CA 92121 United States

    Tel: 858.530.2600     Fax: 858.530.2646

Email: [email protected] Website: www.sandiegoinstruments.com

For more than 30 years, San Diego Instruments has served the scientific community as a comprehensive resource for the design, manufacture, and distribution of testing systems used in human and animal behavioral studies. SDI systems are utilized in laboratories worldwide with many research paper citations.

WILEY 350 Main Street Malden, MA 02148 United States

    Tel: 781.388.8544     Fax: 781.338.8544

Email: [email protected] Website: www.wiley.com

Birth Defects Research is an official publication of the Teratology Society, published in three parts: Clinical and Molecular Teratology, Developmental and Reproductive Toxicology, and Reviews. Together these form a comprehensive resource of original research and reviews in fields related to embryo-fetal development and reproduction. Wiley is the leading society publisher. We publish on behalf of more societies and membership associations than anybody else, and offer libraries and individuals 1,250 online journals, thousands of books and ebooks, reviews, reference works, databases, and more. For more information, visit www.wiley.com, or our online resource: onlinelibrary.wiley.com.

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Online Membership Application

Why you should join…

• The Society does important work. Preventing birth defects is an extremely important goal—to the families as well as to society overall. By working together in a multidisciplinary way, our members are dedicated to advancing the science of developmental and reproductive toxicology in order to eliminate or ameliorate birth defects and to providing education and training on the causes, mechanisms, treatment, and prevention of birth defects. • You have the opportunity to collaborate with like-minded professionals and to engage in leadership activities. • Members receive reduced registration rates for the Teratology Society Annual Meeting and reduced fees for the journal, Birth Defects Research. • To see different perspectives! We don’t all look at birth defects the same way—some of us are involved in diagnosing them, caring for the children affected with them, and educating the families in dealing with them; some of us are more interested in trying to find out what caused the defect and how these defects could be prevented in the future. Payment of the Nonmember registration fee for the 54th Annual Meeting includes first-year membership dues if a Regular or Associate membership application is also received by July 1. Online membership application can be done via the Teratology Society website in a matter of minutes. Apply for membership by July 1, November 1, or March 1 each year via the Teratology Society website.

www.teratology.org Birth Defects Research (Part A) 100:319–357 (2014)

Birth Defects Research (Part A) 100:358–362 (2014)

TERATOLOGY SOCIETY LECTURE ABSTRACTS

(Presenter designated by underlined author.)

Birth Defects Research (Part A) Clinical and Molecular Teratology 100:358–362 (2014)

LECTURE ABSTRACTS

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Josef Warkany Lecture (Joint with NBTS)

F. Clarke Fraser New Investigator Award

Chairperson: Elaine Z. Francis, Sandcastle Toxicology Associates

Chairperson: Robert G. Ellis-Hutchings, The Dow Chemical Company

L1

KNUDSEN TB. US Environmental Protection Agency, Research Triangle Park, NC, United States. Teratology v2.0: Building a Path Forward Unraveling the complex relationships between environmental factors and early life susceptibility in assessing the risk for adverse pregnancy outcomes requires advanced knowledge of biological systems. Large datasets and deep data-mining tools are emerging resources for predictive modeling that can be broadly applied to the analysis of developmental pathways, processes, and toxicities. For the teratologist, does this “big data” stream represent a new solution for traditional problems, or new problems for traditional solutions? Reducing a complex embryological system into simpler components on one hand may facilitate analysis, but on the other hand disrupts precisely the combination of qualities and features that makes the system complex in the first place. Multicellular interactions ultimately determine the resolution of molecular impairment(s) into critical effects that ultimately determine a developmental defect or disability. This lecture will focus on challenges and opportunities associated with utilizing complex data for predictive and mechanistic understanding of teratogenesis, strategies to interact big-data with principles of teratology for hypothesis generation and adverse outcome pathway elucidation, and spatio-temporal prediction utilizing the major organizing principles of dosimetry, criticality, and susceptibility. This abstract does not reflect US EPA policy.

L2

GOHLKE JM. University of Alabama at Birmingham (UAB), Birmingham, AL, United States. From Computational Approaches to an Alternative Animal Model and Epidemiology: Building a Fulfilling Research Career There are a host of novel data-driven methods to generate and test hypotheses in developmental and reproductive toxicology and risk assessment research. At the cellular level, the developing brain is characterized by proliferation, differentiation, and apoptotic processes that can be computationally modeled to estimate the relative effects of different modes of action. At the molecular level, the effect of exogenous substances on key regulators of proliferation and differentiation processes in the developing brain can be elucidated via gene regulatory networks. Genomic and genetic datasets can be synthesized via pathways, generating novel hypotheses of environmental associations with developmentally regulated disease. To test hypotheses generated, several alternative models systems have been developed and can serve as a relatively quick and inexpensive way to prioritize hypotheses for targeted testing in mammalian systems. D. pulex, a well characterized ecotoxicology model, is being evaluated as a whole model organism to test early life and transgenerational effects. Large amounts of data to improve characterization of exposure in humans have also been generated. For example, satellite-derived and archived weather station datasets on exposure to extreme weather events and air pollution in human populations can be coupled with archived health datasets to test for associations between environmental factors and birth outcomes. When taking a wholistic approach, each of these methodologies is useful for teasing apart the interconnecting environmental and genetic components of developmentally regulated disease. The generation and accessibility of large-scale data has created a diverse set of tools for researchers to explore these relationships in novel ways.

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Special Lecture (Joint with NBTS) Chairperson: Elaine Z. Francis, Sandcastle Toxicology Associates

L3

HOOD L. Institute for Systems Biology, Seattle, WA, United States. Systems Medicine and Proactive P4 Medicine: A Revolution in Healthcare The challenge for biology in the 21st century is the need to deal with its incredible complexity. One powerful way to think of biology is to view it as an informational science. This view leads to the conclusion that biological information is captured, mined, integrated by biological networks, and finally passed off to molecular machines for execution. Hence the challenge in understanding biological complexity is that of deciphering the operation of dynamic biological networks across the three time scales of life-evolution, development, and physiological responses. Systems approaches to biology are focused on delineating and deciphering dynamic biological networks and their interactions with simple and complex molecular machines. I will define our contemporary view of systems biology and then focus on our efforts at a systems approach to disease-looking at prion disease in mice. We have just published a study that has taken more than 5 years that lays out the principles of a systems approach to disease including dealing with the striking signal to noise problems of high-throughput biological measurements and biology itself (e.g. polymorphisms). I will also discuss the emerging technologies (measurement and visualization) that will transform biology and medicine over the next 10 years—including next generation DNA sequencing, microfluidic protein chips and single-cell analyses. I will as well discuss some of the computational and mathematical challenges that are fundamental to the revolution in biology and medicine. It appears that systems medicine, together with emerging technologies, Big Data and patient-activated social networks will transform medicine over the next 5–20 years from its currently reactive state to a mode that is predictive, personalized, preventive, and participatory (P4) medicine. I will discuss the impact P4 medicine has on society and several ISB-strategic partnerships that have been established to attack the technical and societal barriers to the realization of P4 medicine.

Birth Defects Research (Part A) 100:358–362 (2014)

Elsevier Distinguished Lecturer (Joint with NBTS) Chairpersons: Thomas M. Burbacher, University of Washington and Robert M. Greene, Birth Defects Center, University of Louisville

L4

SWEATT JD. Department of Neurobiology, UAB School of Medicine, Birmingham, AL, United States. Epigenetic Mechanisms in Intellectual Developmental Disabilities This presentation will discuss the potential role of epigenetic molecular mechanisms in intellectual disabilities and learning and memory disorders. Epigenetic mechanisms typically involve alterations in chromatin structure, which in turn regulate gene expression. “Epigenetics” is functionally equivalent to the mechanisms allowing stable maintenance of gene expression that involve physically “marking” DNA or its associated proteins through post-translational modification. Thus, regulation of chromatin structure and regulation of direct methylation of DNA are the principal mechanisms of epigenetic regulation. This presentation will address the idea that conservation of epigenetic mechanisms for information storage represents a unifying model in biology, with epigenetic mechanisms being utilized for cellular memory at levels from behavioral memory to development to cellular differentiation. Do epigenetic mechanisms operate in behavioral memory formation? We have generated several lines of evidence that support this idea that I will discuss. 1. Contextual fear conditioning triggers alterations in hippocampal DNA methylation and histone post-translational modifications. 2. Inhibitors of DNA methylation block both hippocampal long-term potentiation and associative learning in vivo. 3. Remote contextual fear memory is associated with persisting changes in DNA methylation in the Anterior Cingulate Cortex, and DNA Methyltransferase inhibition can reverse established remote memory. 4. Histone acetylation increases in memory formation, and histone deacetylase (HDAC) inhibitors enhance both memory formation and hippocampal longterm potentiation.

LECTURE ABSTRACTS

Special Lecture (Joint with NBTS)

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Chairperson: Christina D. Chambers, University of California, San Diego

TS/ETS Exchange Lecture Is Lack of Mandatory Folic Acid Fortification Public Health Malpractice?

JONES KL1,2. 1University of California, San Diego, CA, United States, 2MotherToBaby, LaJolla, CA, United States. Fetal Alcohol Syndrome

Chairpersons: Paul C. Barrow, F. Hoffmann-La Roche and Susan L. Makris, US Environmental Protection Agency

L5

The purpose of this presentation is to provide a retrospective look at 40 years of the Fetal Alcohol Syndrome (FAS). The presentation will be broken into three parts: Recognition of the disorder, Reaction to that recognition and finally, where we are today which I will refer to as Resurgence not because I think we’ve actually solved the problem, but I think we’re heading in the right direction. In 1996, the Institute of Medicine Report on Fetal Alcohol Spectrum Disorder (FASD) established the previously under-recognized concept that prenatal alcohol exposure leads to a spectrum of defects. At the most severe end of the spectrum is FAS, a pattern of malformation that includes growth deficiency, microcephaly, characteristic facial abnormalities, and neurodevelopmental defects while at the most mild end of the spectrum are children with characteristic neurodevelopmental defects who lack the pattern of structural and growth deficits. This mild end of the spectrum is referred to as Alcohol Related Neurodevelopmental Disorder (ARND). Recognition of ARND has been critical in shaping where the future lies as far as this disorder is concerned. Forty years after the recognition of this disorder, issues relating to intervention and prevention are being considered. In addition, the Interagency Coordinating Committee on FASD (ICCFASD) in collaboration with the American Academy of Pediatrics sponsored a conference entitled Recognizing ARND in Primary Health Care of Children as well as an initiative co-sponsored with the American Bar Association entitled Recognizing Alcohol Related Birth Defects and the Law. Finally, although FASD has not been included in the main part of the newly revised DSM V, Neurobehavioral Disorder Associated with Prenatal Alcohol Exposure (ND-PAE) will appear in the DSM 5 Appendix. Finally, awareness that many individuals are affected by intrauterine exposure to alcohol who lack the physical phenotype requires that a neurodevelopmental phenotype be identified.

L6

WHITEFORD ML. Southern General Hospital, Glasgow, United Kingdom. The Impact of Spina Bifida on Individuals, Families, and Society Neural tube defects, including spina bifida, are congenital malformations of the spine resulting in lifelong disability. The impact that this disability has on an individual and his or her family cannot be underestimated as they face physical, emotional, and financial hardships at all stages of life. The cost to society as a whole is also substantial. The majority of people with spina bifida require frequent admissions to hospital for medical treatment and there is an increasing need for mobility aids and home adaptations as people get older. It has been estimated that the lifetime cost of caring for an individual with spina bifida is in excess of $620,0001 if hidden costs, such as loss of employment from caregivers, is included. Since the introduction of flour fortification with folic acid in North America the birth incidence of spina bifida has significantly reduced. In most western European countries the birth incidence of spina bifida is also falling but this is due to improved prenatal diagnosis and subsequent termination of pregnancy, often in the mid-trimester. This cannot be considered to be primary prevention and whilst it may be viewed as economical by government bodies there is an enormous psychological cost, with many women remaining guilt-ridden for the rest of their lives if they “choose” to terminate their pregnancies. Despite their disabilities, many people affected by spina bifida, with the correct support and a suitable environment, can attain a good quality of life and a meaningful place in society, but, given the choice, would rather take up that place in society without their disability. With the introduction of flour fortification with folic acid on a worldwide scale this is something which is surely possible for future generations. 1Economic burden of neural tube defects and impact of prevention with folic acid: a literature review: Yunni Yi et al. Eur J Pediatr. 2011 November; 170(11): 1391–1400.

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L7 OAKLEY JR. GP. Rollins School of Public Health of Emory University, Atlanta, GA, United States. Accelerating the Pace of Preventing Spina Bifida F and Anencephaly F The Teratology Society and the European Teratology Society exist to prevent birth defects. In 1991, unambiguous evidence showed that folic acid would prevent a very large proportion of spina bifida and anencephaly (Spina Bifida F and Anencephaly F). By January 1998, all enriched cereal grains (wheat flour, corn meal, rice) sold in the United States and Canada were fortified at 1.4 ppm (USA) and 1.5 ppm (Canada). The prevention of almost all, if not all, Spina Bifida F and Anencephaly F by mandatory folic fortification is one of the great triumphs of public health of our time. In addition, mandatory folic acid fortification has prevented almost all, if not all, of folate deficiency anemia and folate deficiency in adults in North America. No European country has yet to require this simple, safe, and very inexpensive public health intervention that prevents such serious birth defects. Around the globe each year, 18 times (180,000) as many babies develop Spina Bifida F and Anencephaly F as there were ever babies affected by Thalidomide—the drug that caused major changes in drug regulation and prompted amazing growth of Teratology Society and the birth of the European Teratology Society. It is the goal of the joint Teratology, European Teratology Society presentations this year to prompt both organizations to issue policy statements recommending that all governments require folic acid fortification to prevent Spina Bifida F and Anencephaly F. It remains a tragic irony that the two randomized controlled trials that proved that folic acid prevents these birth defects were European studies and no European country has yet to require folic acid fortification. We believe that our two societies and their members can be in each country the driving force that leads to the prevention of these birth defects by mandatory folic acid fortification. Such actions by the governments of Europe are long overdue.

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Robert L. Brent Lecture Teratogen Update Chairperson: Mary Alice Smith, University of Georgia

L8

RASMUSSEN SA. Centers for Disease Control and Prevention (CDC), Atlanta, GA, United States. Teratology and Public Health: Working Together to Make Recommendations for Pregnant Women in the Face of Uncertainty Experts in teratology and public health have collaborated on several initiatives in recent years in the interest of healthier mothers and babies. Some examples of these initiatives include rubella vaccination to prevent congenital rubella syndrome, folic acid fortification of US grains to prevent neural tube defects, and 2009 H1N1 vaccination and treatment to prevent influenza-associated complications in pregnant women and their infants. In each of these initiatives, public health professionals worked closely with teratologists to weigh the benefits and risks, and recommendations were subsequently developed after a thorough analysis, despite the lack of complete data. In each of these examples, initial implementation of these initiatives was criticized because of concerns for potential adverse effects; however, retrospective review of their impact has demonstrated their net benefits to pregnant women and their babies. This presentation will provide updates on the progress of previous initiatives, discuss challenges to making public health recommendations when data on which to base recommendations are sparse, and propose approaches to weighing the risks and benefits in these situations.

Birth Defects Research (Part A) 100:363–380 (2014)

TERATOLOGY SOCIETY SYMPOSIUM ABSTRACTS

(Presenter designated by underlined author.)

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ILSI HESI Symposium Cross-Industry Data Survey of the Value of Rabbit Developmental Toxicity Data in the Risk Assessment for Pharmaceutics Chairpersons: Alan M. Hoberman, Charles River; Aldert H. Piersma, National Institute for Public Health and the Environment (RIVM); and Jane Stewart, AstraZeneca Pharmaceuticals

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STEWART J. AstraZeneca Pharmaceuticals, Macclesfield, United Kingdom. ICH Workshop Origins of the Survey In June 2010, there was a workshop “Brainstorm Reproductive Toxicity: Implementation of In Vitro Assays” at the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). EU “ReProTect” funded scientists described the progress made with in vitro assays to detect different reproductive toxicity endpoints. In addition, pharmaceutical industry speakers described efforts to use nonmammalian systems to detect developmental toxicants plus efforts to reduce the number of animals required for reproductive toxicity testing. The workshop followed the ICH M3 2009 revision which harmonized: 1) that women of child bearing potential (WOCBP) could be entered on clinical trials of limited scope and duration based on small scale “preliminary” embryo-fetal development (EFD) studies provided those women were using effective contraception. 2) WOCBP could be entered on Phase III trials with monoclonal antibodies (mAb) without having finalized EFD testing of that mAb. In addition, at the 2010 ICH meeting, the ICH S6 expert working group on Biotechnology-derived Proteins agreed that single species (EFD) testing would be acceptable where only nonhuman primates were of relevance. This regulatory background provided the impetus for challenging the default requirement to have completed EFD testing in two species prior to starting Phase III trials. The second species (typically rabbit) is often used with limited understanding of its pharmacological relevance for humans at a time when the therapeutic dose in humans is uncertain and the project is still likely to fail. Simply postponing the 2nd species EFD testing until after Phase III clinical trials have already started, could reduce animal usage substantively. The workshop issued a challenge: where “definitive” rat EFD data exist prior to Phase III AND i) rat has been shown to be pharmacologically relevant, AND ii) rat exposures are considered adequate AND iii) phase III clinical trial can maintain effective contraception, what impact would delaying the main EFD study in the (rabbit) 2nd species have on risk assessment and informed consent? The HESI DART Committee subsequently accepted the task of collecting developmental toxicity data that would address the frequency with which the 2nd species fundamentally changes the risk assessment for developmental toxicity.

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PIERSMA AH, THEUNISSEN PT. National Institute for Public Health (RIVM), Bilthoven, Netherlands. An Analysis of Rat and Rabbit Developmental Toxicity Studies for Pharmaceuticals: The Scientific Background The thalidomide tragedy not only marked the dawn of modern reproductive and developmental toxicology, it also largely determined how we currently test the safety of chemicals and pharmaceuticals in that area of toxicity testing. As the limb reduction defects, observed in children after use of the drug in their mother’s pregnancy, were reproducible to some extent in rabbits but not in rats, it was deemed important to test manmade compounds in rat and rabbit to detect possible teratogenic properties. To date, for hundreds of chemicals and pharmaceuticals, teratogenicity assays have been carried out in both species, providing a rich data source for comparing rat and rabbit. Such a comparison has become of interest in view of efforts towards reducing animal use, cost, and testing time. The question has arisen as to whether a single species for teratogenicity testing would suffice for safety assessment, or under what circumstances or for what classes of compounds a second species could be deferred. Experience in the field of chemical safety has already shed light on these questions. A current project is taking a similar database driven approach to analyze pharmaceuticals for their common and different responses in teratogenicity studies in rat versus rabbit. Issues to be addressed are, among others, the interpretation of different manifestations of developmental toxicity (be they variations, malformations, growth retardation or prenatal death in different species), the role of compound kinetics and systemic dose, and the extrapolation between species including humans in particular. The study aims at providing a clear picture of the developmental toxicity comparison between rat and rabbit using existing data, as the basis of formulating ways forward that may reduce animal testing, cost and testing time, whilst retaining the necessary information level for sound decision making in compound development.

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THEUNISSEN PT, PIERSMA AH. National Institute for Public Health (RIVM), Bilthoven, Netherlands. A Comprehensive Data Survey of the Relative Value of Rat versus Rabbit Developmental Toxicity Data in the Risk Assessment for Pharmaceuticals: Presentation of Results Industry representatives discussed the impact of testing in a second species for embryofetal developmental toxicity during a 2010 ICH Workshop in Tallinn, Estonia. It was proposed that industry review the frequency with which the results from studies in the rat and rabbit have driven the lowest observed adverse effects level (LOAEL) and exposure margins in risk assessment for pharmaceuticals. The goal of this retrospective analysis is to better understand the implications of either postponing the testing in one of the two required species or waiving the need for one of the two embryofetal toxicity testing in specific circumstances. The ILSI Health and Environmental Sciences Institute’s Developmental and Reproductive Toxicology Technical Committee (HESI-DART) organized a cross-industry data survey in which anonymized embryofetal development and toxicokinetic study data from marketed and unmarketed drugs were submitted for analysis. Additionally, compounds for which rat and rabbit data were submitted for registration on the EU market were also submitted through the Dutch Medicines Evaluation Board. The two sources have accumulated data from more than 800 studies spanning more than 400 compounds which have been entered in US EPA’s ToxRefDB database at the Dutch National Institute for Public Health and the Environment (RIVM). Fetal and maternal effect levels were determined to address fundamental questions about species sensitivity based on internal exposure. In addition, the nature and severity of embryofetal findings in the rat and rabbit is being reviewed to quantitate the frequency with which differences of embryofetal effects between species are driving risk assessment. Database structure, data analysis strategy, and preliminary results will be discussed in this presentation.

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HOBERMAN AM. Charles River, Horsham, PA, United States. Industry Perspective: What Are the Implications to Industry of Changing the Default Paradigm of Two Species Developmental Toxicity Testing? The need to determine the hazard to the embryo/fetus from exposure to a chemical or pharmaceutical drug product cannot be evaluated in clinical trials because the embryo/fetus can never provide consent. The practical issues regarding embryo/fetal developmental hazard assessments have been surmounted by conducting nonclinical tests in substitute species, including rodents and rabbits. These nonclinical studies evaluate exposure during the period of major organogenesis, and have been the standard testing paradigm for almost 50 years. History has shown that the current testing paradigm has prevented another thalidomide tragedy and has identified potential human teratogens such as all-trans retinoic acid prior to marketing. However, there are several key deficiencies in the standard design including: differences in metabolism across species; a study design that is more likely to produce reductions in fetal weight and/or embryo/fetal death rather than malformation; an incomplete understanding of developmental biology along with an incomplete knowledge of the mechanism of action of a xenobiotic. These deficiencies limit the ability of the current testing paradigm from providing a complete assessment of hazard to the human fetus. Refinements to the standard testing paradigm have allowed cross species comparisons based on exposure levels, and molecular based in vitro tests, and nonmammalian models, are proving useful in providing information on the mechanism of action of a particular drug and potential adverse outcome pathways (AOPs). However, until we have a complete understanding of developmental biology and can model both the on-target and off-target mechanisms of action of a drug, nonclinical testing in animal models will remain paramount in the drug development process. Over the last decade there has been a heightened awareness in the drug development community to align with the 3Rs (reduce, refine, and replace). While there has been a steady momentum to use less animals and speed up the drug development process, more efforts could be made to refine how we conduct our hazard evaluations prior to marketing. Changes in timing of testing relative to clinical trials and marketing, and applying information on AOPs will gradually improve our efforts to use fewer animals and provide a better assessment of hazard.

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BEKEN S. Federal Agency for Medicines and Health Products (FAMHP), Brussels, Belgium. Regulatory Perspective: How Might the Risk Assessment of Novel Drugs and Regulatory Decisions Profit from the Results of This Survey? The S5(R2) Guideline on Reproductive Toxicity was written some 20 years ago, and in line with its recommendations, the information on the potential adverse effects of new medicinal products on embryofetal development (EFD) comes from generally two animal species, i.e. rat and rabbit. Over the past years, multiple in vitro and nonmammalian in vivo methods for EFD testing were developed and validated by the European Centre for the Validation of Alternative Methods (EURL ECVAM). As such the mouse embryonic stem cell test was concluded to be most suitable for regulatory use within an integrated testing strategy. Several recommendations of a postvalidation workshop were taken up by the EU FP6 Project “ReProTect” (www.reprotect.eu); the results of which were largely discussed at an ICH Brainstorming Meeting on reproduction toxicity (June 2010, Tallinn, EU). Follow-up discussions held in Europe (DIA Workshop, October 2011) and the USA (US FDA Public Workshop, April 2012) indicated that the assessment of the value of rat versus rabbit EFD data was paramount to evolve towards a novel testing strategy. The compilation and analysis of a database that allows for the comparison of the value of rat versus rabbit EFD data (cfr ILSI HESI DART 2nd species working group), will allow for the determination of an approach to select the most appropriate species to use for specific classes of compounds. Progress has been reported to the ICH SC (November 2012, San Diego, US) and at the same time a preliminary discussion was held on the possible design of a novel strategy for EFD testing. The reproductive toxicity project was proposed for consideration at the ICH Safety Brainstorming Meeting in Osaka, Japan (November 2013) and was supported by the ICH SC. As such, a Concept Paper to initiate the revision of ICH S5(R2) has been drafted and will be discussed at the ICH SC meeting of June 2014 (Minneapolis, US). The purpose of this revision is to implement a novel strategy for EFD testing taking into account the current advances in the field in order to increase predictive power whilst implementing the 3Rs (Replacement, Reduction and Refinement) to the greatest feasible extent.

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TS/NBTS Joint Symposium National Children’s Study Chairpersons: Elaine M. Faustman, University of Washington and Richard K. Miller, University of Rochester

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HIRSCHFELD S. National Children’s Study, Bethesda, MD, United States. An Integrated Framework for Linking Exposure and Phenotypic Data in the National Children’s Study The integration of exposure and outcome data remains challenging. The National Children’s Study, a large national birth cohort study, developed an approach that begins with a model of health that has four dimensions of performance, experience, adaptability, and potential. These dimensions are characterized by the composite of many specific items organized into domains. In addition to a theoretical framework, the NCS developed Use Cases to frame data collection temporally. Organizing the data collection based on the data source of whether the resulting data refer to individual phenotypic data or environmental exposure data and then integrating the data source within the framework provides a functional methodology to describe potential associations between exposure and outcome systematically for a wide range of both exposures and outcomes.

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STONE WL1, IBANEZ L1, NEWSCHAFFER C2, ROHLOFF E2, ABDULLAH M3, BURKOM D4, CLARKE N4, DURKIN M5, GOLDEN A6, KUO A7, LAKES K3, LAMBERT B8, LANDA R9, MESSINGER D8, PATERSON S10, WARREN Z11, BURBACHER TM1, FAUSTMAN EM1. 1University of Washington, Seattle, WA, United States, 2Drexel University, Philadelphia, PA, United States, 3 University of California, Irvine, CA, United States, 4Battelle Memorial Institute, Baltimore, MD, United States, 5University of Wisconsin, Madison, Madison, WI, United States, 6Icahn School of Medicine at Mount Sinai, New York, NY, United States, 7University of California, Los Angeles, Los Angeles, CA, United States, 8 University of Miami, Miami, FL, United States, 9Kennedy Krieger Institute, Baltimore, MD, United States, 10University of Pennsylvania, Philadelphia, PA, United States, 11Vanderbilt University, Nashville, TN, United States. Streamlining the Diagnosis of Autism Spectrum Disorder for the National Children’s Study Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder defined by impairments in social interaction, communication, and behavioral functioning. The demonstrated benefits of early-specialized intervention for young children with ASD have highlighted the importance of early detection, and the National Children’s Study (NCS) protocol includes routine screening at 24 months with the Modified Checklist for Autism in Toddlers-Revised (M-CHAT-R; Robins et al. 2014). However, the current gold-standard assessments used for ASD diagnostic confirmation are costly and time-intensive, creating the need for a more streamlined approach that can be employed by NCS staff without specialized expertise in ASD. The purpose of the present study was to develop and evaluate a novel assessment battery for potential use in ASD case confirmation during children’s 36-month NCS clinic visits. The battery was designed to minimize the burden on participant time, NCS resources, and examiner training, and comprises three separate measures: 1) a video-guided parent self-report measure, 2) a direct observation measure adapted from the Screening Tool for Autism in Toddlers (Stone et al. 2004; STAT-NCS), and 3) a parent interview adapted from the Autism Diagnostic Interview (Kim et al. 2012; ADI-S). Training on the measures can be completed online in less than eight hours, and completion of the battery takes about 1.5 hours. Nine NCS field sites, including the Pacific Northwest Center for the National Children’s Study, have been involved in data collection to examine the criterion validity of these three measures. Participants are 24–39 month old children with suspected ASD or developmental delay who have recently completed, or are scheduled for, a gold-standard diagnostic evaluation. At each site, children and parents receive the streamlined assessment battery, and information from their gold-standard evaluation is abstracted from clinical records. More than185 children have been seen to date, and data collection is ongoing. Analyses will focus on identifying cutpoints or critical items for each measure, and identifying overall sensitivity and specificity relative to the gold standard diagnosis. Positive results will yield a streamlined toolkit of field-tested instruments for the diagnosis of ASD that can be used in the NCS and other community settings.

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S8 FAUSTMAN EM. School of Public Health, University of Washington, Seattle, WA, United States. Results of Whole-Genome Analysis from National Children’s Study (NCS) In collaboration with other NCS study centers (University of California, Irvine; South Dakota State University and University of Iowa); the Pacific Northwest Center for the National Children’s Study developed a feasibility project to evaluate Genomic capabilities. The goal of the study was to combine experiences to build capacity and test feasibility of including next-generation (next-gen) genomics in the NCS. This project included capacity building and developing a genomic infrastructure, as well as demonstration projects. An example of the demonstration projects was the Trios research initiative with a goal to better characterize the full spectrum of variation in the human genome (nucleotide as well as structural variation) and to provide some details about two sources of this variation (the inherited as well as the noninherited de novo components). The Trios project was able to characterize 30 trios. Approximately 3.8–4.4 million single nucleotide substitutions per genome were identified. The collaborative group published two papers in The American Journal of Human Genetics (2013 vol. 92): Below et al. (2013) and McMillin et al. (2013). The Below et al. publication used linkage analysis and whole-genome sequencing of a consanguineous trio to discover mutations in inositol polyphosphate phosphatase-like 1 (INPPL1). An evaluation of 12 families with opsismodysplasia revealed that INPPL1 mutations explain ~60% of cases overall, including both of the families in the cohort with more than one affected child and 50% of the simplex cases. The McMillin et al. publication used linkage analysis and whole-genome sequencing of the consanguineous trio to study Distal Arthrogryposis (DA). DA is a group of at least ten disorders characterized by nonprogressive, congenital contractures that typically affect the hands, feet, wrists, and ankles. The trio whole genome sequencing analysis demonstrated that mutations in ECEL1 cause DA5D and explain ~70% of cases in the cohort. These two examples illustrate the amazing power of including next-gen sequencing within the NCS structure. This research was funded by National Institute of Child Health and Human Development, NIH, DHHS, under Contract No. HHSN267200700023C with support from The NIEHS, US EPA funded Center for Children’s Environmental Health Risks Research (RD-83170901, ES-09601).

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AAGAARD KM1, MILLER RK2, CHEN J3, STODGELL C2, DUDLEY J3, SCHADT E, THE NATIONAL CHILDREN’S STUDY PLACENTA CONSORTIUM4. 1Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, Baylor College of Medicine, Houston, TX, United States; 2Obstetrics and Gynecology, University of Rochester School of Medicine, Rochester, NY; United States; 3Genetics and Genomics Science, Icahn School of Medicine at Mount Sinai, New York City, NY, United States; 4National Institutes of Health Sciences, Bethesda, MD, United States. Novel Insights on the Molecular Targets of Environmental Exposures during Pregnancy Using Placental Multi'omics Data Integration in the National Children’s Study (NCS) Objective: Though epidemiologic studies have demonstrated associations between exposure to environmental pollutants and perinatal morbidity and mortality, establishing a causal relationship has been problematic. Unbiased high-throughput discovery-based data sets (collectively referred to as multi'omics) can infer causality when integrated with expanded clinical and environmental exposure data. Our aims were to integrate high-dimensional placental multi'omics data sets with measured environmental contaminants and pregnancy outcome data. Study Design: As part of the NCS Main Study, 210 placentas from 10 regional centers were uniformly collected and stored with a priori protocols designed to preserve biologic material for future 'omics research. Subsequent DNA/ RNA/miRNA/methylated DNA analysis, analytic chemistry for environmental exposures, and 3-D placental imaging and mapping were conducted by established experts from over 20 collaborating centers. High-dimensional data sets were reduced and integrative analysis to determine the interrelationships among biologic measures was undertaken. RNA levels for all annotated transcripts (UCSC & Ensembl) were normalized to construct a weighted coexpression gene network. Leveraged variant information derived from placental RNA sequencing enabled construction of a weighted gene network of 20,000 most variable gene expression traits. 1 million SNPs and SNPs from 1,000 genomes (14 million SNP genotypes per sample) were imputed across all samples, and placental eQTL were mapped to identify enriched loci at p

Abstracts of the 54th Annual Teratology Society Meeting, June 28-July 2, 2014, Bellevue, Washington.

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