DEVELOPMENT OF T-ALL IN TWO SUBJECTS

IN

A GENE TRANSFER CLINICAL TRIAL FOR X-SCID

NIH RECOMBINANT DNA ADVISORY COMMITTEE MEETING

A Gene Transfer Safety Symposium

 

February 10, 2003

 

 

List of Presenters

Slide Show (hyperlink)

 

 

Case Presentation and Molecular Analyses

 

Title:                       Analysis of Serious Adverse Events in                                            the Gene Therapy of SCID-X1

Speaker:                Christof von Kalle, M.D.
                                Cincinnati Children’s Hospital Research                                       Foundation

NIH Videocast Only (*)
(*) Requires RealPlayer

http://videocast.nih.gov/ram/rac021003.ram
Start Time: 0:23:00 / 6:49:32 (total run time)

 

 

Pediatric T - ALL

 

Title:                       T-cell ALL in Childhood and Adolescence

Speaker:                Gregory Reaman, M.D.

                                Executive Director, The Center of Cancer
                                 and Blood Disorders,
                                The Children's National Medical Center

 

PDF:                      T_cell_ALL_Reaman.pdf

 

 

 

Retroviruses and Insertional Mutagenesis

 

Title:                       Retroviruses and Insertional Mutagenesis

Speaker:                Naomi Rosenberg, Ph.D.
                                Tufts University

PDF:                      Retro_Mutagenesis_NRosenberg.pdf

 

 

LMO Genes in Leukemogenesis

 

Title:                       LMO-1 and LMO-2

Speaker:                Peter Aplan, M.D.
                                National Cancer Institute, NIH

PDF:                      LMO1_2_Aplan.pdf

 

 

Defective Cytokine Signaling in X-linked SCID

 

Title:                       Defective Cytokine Signaling in X-linked SCID

Speaker:                Warren Leonard, M.D.
                                National Heart, Lung and Blood Institute, NIH

PDF:                      Cytokine_Signaling_Leonard.pdf

 

FDA Actions in Response to the Second X-SCID Serious Adverse Event

 

Title:                       FDA Actions

Speaker:                Philip Noguchi, M.D., Acting Director

                                The Office of Cellular, Tissues, and Gene                                    Therapies, CBER, FDA

 

PDF:                      FDA_Actions_Noguchi.pdf

 

 

Points to Consider

 

Speaker:                Stephen Rose, Ph.D.

                                Executive Secretary,
                                Recombinant DNA Advisory Committee,
                                Office of Biotechnology Activities, NIH

 

PDF:                      PTC_X_SCID_Rose.pdf

 

 

Public Questions and Comments

 

 

 

Title:                       Use of Retroviral Vectors for the Experimental                                 Treatment of Melanoma

Speaker:                Steven Rosenberg, M.D., Chief of Surgery
                                National Cancer Institute, NIH

 

PDF:      Retrovectors_for_Melanoma_SRosenberg.pdf

 

 

Title:                       Regulatory recommendations in Germany                                    concerning the use of retrovirally modified cells

Speaker:                Klaus Cichutek, Ph.D.
                                Vice-President, Paul-Ehrlich-Institut, Langen
                                Chair, Commission for Somatic Gene Therapy
                                Chair, Ad hoc Gene Therapy Expert Group, EMEA

 

PDF:                      Regulatory_Germany_Cichutek.pdf

 

About Slides:  The slide presentations above were converted from PowerPoint to HTML and PDF formats for access by a wider viewing audience.  The Netscape browser cannot interpret the scripting in the HTML files; please use Internet Explorer 6.0 (.htm) or Acrobat Reader (.pdf).  Note that all presentations are also viewable in the videocast at the following URL:  [http://videocast.nih.gov/ram/rac021003.ram ].