##### ONCOLOGIC DRUGS ADVISORY COMMITTEE

###### PEDIATRIC SUBCOMMITTEE

####### November 28, 2001

####### **ODAC MEMBERS**

Stephen L. George, Ph.D. 6/30/05

Professor of Biostatistics

Department of Biostatistics and Bioinformatics

Box 3958

Hanes House, Room 219

Trent Drive at Erwin Road

Duke University Medical Center

Durham, NC 27710

Donna Przepiorka, MD, PhD 6/30/04

Associate Professor of Medicine

Center for Cell and Gene Therapy

Baylor College of Medicine

6565 Fannin Street, M964

Houston, Texas 77030

**EXECUTIVE SECRETARY (Acting)**

Kimberly L. Topper, MS

Advisors & Consultants Staff, HFD-21

Food and Drug Administration

5600 Fishers Lane

Rockville, Maryland 20857

\(301\) 827-7001 FAX (301) 827-6776

<Topperk@cder.fda.gov>

**[Consumer Representative]{.underline}**

Jody L. Pelusi, F.N.P., Ph.D. 6/30/03

Phoenix Indian Medical Center

4212 North 16^th^ Street

Phoenix, AZ 85016

#### AD HOC MEMBERS

**CHAIRMAN**

Victor M. Santana, MD

Associate Professor

Department of Hematology/Oncology

# The University of Tennessee

St. Jude Children's Research Hospital

332 North Lauderdale

Memphis, Tennessee 38101

James M. Boyett, Ph.D.

Chair, Dept. of Biostatistics & Epidemiology

St. Jude Children's Research Hospital

332 North Lauderdale Street

Memphis, Tennessee 38105

Susan L. Cohn, MD

Associate Professor of Pediatrics

Northwestern University Medical School

Box 30, 2300 Children's Place

Chicago, Illinois 60614

Alice Ettinger, MSN, RN, CPON, CPNP

St. Peter's University Hospital

254 Easton Avenue

New Brunswick, New Jersey 08901

Jerry Z. Finklestein, MD

Clinical Professor of Pediatrics/UCLA

Jonathan Jacques Children's Cancer Center

Long Beach Memorial Cancer Center

2653 Elm Avenue, Suite 200

Long Beach, California 90801

Henry S. Friedman, MD

James B. Powell, Jr. Professor of Neurosurgery

Duke University Medical Center

Trent Drive, Baker House, Room 047

Durham, North Carolina 27710

C. Patrick Reynolds, MD, PhD

Professor of Pediatrics

Division of Hematology/Oncology

Children's Hospital of Los Angeles

4650 Sunset Boulevard

Los Angeles, California 90801

#### PATIENT ADVOCATES

Nancy Keene

4167 Elizabeth Lane

Annandale, Virginia 22003

Susan L.Weiner, PhD

The Children's Cause, Inc.

1010 Wayne Avenue, Suite 505

Silver Spring, Maryland 20910

##### 

##### 

##### ONCOLOGIC DRUGS ADVISORY COMMITTEE

###### PEDIATRIC SUBCOMMITTEE

####### November 28, 2001

###### Consultant (voting)

###### Peter C. Adamson, MD

###### Children\'s Hospital of Philadelphia

###### 3516 Civic Center Blvd.

###### Abramson Bldg, Room 907

###### Philadelphia, PA 19104

###### 

###### Guest Speakers (non-voting)

Steven Goodman, MD, MHS, Ph.D.

Associate Professor of Oncology, Pediatrics, Epidemiology and
Biostatistics

Department of Oncology, Division of Biostatistics

Johns Hopkins School of Medicine

550 N. Broadway, Suite 1103

Baltimore, MD 21205

J. Steven Leeder, Pharm.D., Ph.D.

Chief, Section of Developmental Pharmacology and Experimental
Therapeutics

Division of Clinical Pharmacology and Toxicology

Children\'s Mercy Hospital and Clinics

2401 Gillham Road

Kansas City, MO 64108

Mary V. Relling

Member, Department of Pharmaceutical Sciences

St. Jude Children\'s Research Hospital

332 N. Lauderdale

Memphis, TN 38101

Clinton F. Stewart, Pharm.D.

Associate Member

Department of Pharmaceutical Sciences

332 N. Lauderdale

St. Jude Children\'s Research Hospital

Memphis, TN 38105

#######  

######  Guests (non-voting)

Dr. Mark Bernstein

Hematology

St. Justine Hospital

3175 Cote St. Catherine Road

Montreal, Quebec

Canada H3T 1C5

Charles A. Coltman, Jr. M.D.

President and C.E.O

Cancer Therapy Research Center

8122 Datapoint Dr., Suite 600

San Antonio, TX 78229-3219

Edward L. Korn, Ph.D.

Head, Clinical Trial Section

Biometrics Research Branch

Executive Plaza North, Room 8128

National Cancer Institute

Bethesda, MD 20892

##### ONCOLOGIC DRUGS ADVISORY COMMITTEE

###### PEDIATRIC SUBCOMMITTEE

####### November 28, 2001

**Guests (non-voting) Cont.**

Malcon Smith, M.D., Ph.D.

Rm. 741

Executive Park North

Bethesda, MD 20892

Eric Kodish, MD. Ph.D.

Director, Rainbow Center for Pediatric Ethics

Associate Professor

Pediatrics, Oncology and Biomedical Ethics

Rainbow Babies and Children\'s Hospital Room 340

11100 Euclid Avenue

Cleveland, OH 44106-6054

Frank Balis, MD

Mailing Address: Pediatric

National Cancer Institute , NIH

10 Center Drive, Bldg. 10/Rm. 13N240

Bethesda, MD 20892-1928

Eric Keith Rowinsky, M.D.

Director, Clinical Research

Institute for Drug Development

Cancer Therapy and Research Center

8122 Datapoint Drive, Suite 700

San Antonio, Texas 78229

**INDUSTRY GUESTS (non-voting)**

Wayne Rackoff, M.D.

Jansen Research Foundation

1125 Trenton-Harbourton Road

Room E-31908

Titusville, New Jersey 08560

Martine F. Bayssas, M.D.

DEBIOPHARM S.A.

17, rue des Terreaux

1000 Lausanne 9

Switzerland

**FDA Presenters**

Steven Hirschfeld, M.D.

Food and Drug Administration

5600 Fishers Lane

Rockville, MD 20857

Richard Pazdur, M.D.

Food and Drug Administration

5600 Fishers Lane

Rockville, MD 20857