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Slides for the December 15, 2009 Meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee

 

Morning Session

 

FDA

 

Karen D. Weiss, M.D.  (pdf)

Associate Director for Medical Affairs

Office of the Center Director, CDER, FDA

 

Brian Booth, Ph.D.  (pdf)

Deputy Director, Division of Clinical Pharmacology V

Office of Clinical Pharmacology (OCP) Office of Translational Science (OTS), CDER, FDA

 

Shrikant (Suresh) Pagay, Ph.D., R.Ph.  (pdf)

Chemistry Manufacturing and Controls (CMC) Reviewer, Division of Pre-Marketing Assessment II, Office of New Drug Quality Assessment, Office of Pharmaceutical Science, CDER, FDA

 

Guest Speakers

 

Persons with disabilities having problems accessing the PDF file(s) below may call (301) 796-3634 for assistance

 

Anne Zajicek, M.D., Pharm.D.  (pdf)

Acting Branch Chief, Obstetric and Pediatric Pharmacology Branch

Center for Research for Mothers and Children

The Eunice Kennedy Shriver National Institute of Child Health and Human Development

National Institutes of Health

 

Stephen R. Byrn, Ph.D.  (pdf)

Charles B. Jordan Professor of Medicinal Chemistry

Department of Industrial and Physical Pharmacy

Purdue University

 

Peter C. Adamson, M.D.  (pdf)

Director, Office of Clinical and Translational

Chief, Division of Clinical Pharmacology &

Therapeutics, the Children's Hospital of Philadelphia

 

Malcolm Smith, M.D., Ph.D.  (pdf)

Associate Branch Chief, Pediatrics

Cancer Therapy Evaluation Program

National Cancer Institute

National Institutes of Health

&

Ravie Kem, Pharm.D.  

Senior Clinical Research Pharmacist

National Cancer Institute

National Institutes of Health

 

Sponsor

 

Persons with disabilities having problems accessing the PDF file(s) below may call (301) 796-3634 for assistance

 

Debra L. Pereira, R.Ph.  (pdf)

Director, Parenteral Center of Emphasis

Worldwide Pharmaceutical Sciences

Pfizer Global Research and Development


 

 Afternoon Session

 

Amir Shahlaee, M.D.  (pdf)

Medical Officer, Division of Drug Oncology

Products (DDOP), Office of Oncology Drug

Products (OODP), CDER, FDA

 

Qi Liu, Ph.D. (pdf)

Clinical Pharmacology Team Leader – Drug Oncology

Division of Clinical Pharmacology V

OCP, OTS, CDER, FDA

 

Jean Temeck, M.D. (pdf)

Lead Medical Officer

Office of Pediatric Therapeutics (OPT)

Office of International and Special Programs (OISP)

Office of the Commissioner (OC), FDA

 

Gregory H. Reaman, M.D. (pdf)

Professor of Pediatrics

The George Washington University

School of Medicine and Health Sciences

Chair, Children's Oncology Group

 

Jeffrey S. Barrett, Ph.D. (pdf)

Associate Professor, Pediatrics

Children’s Hospital of Philadelphia

Abramson Research Center