Food & Drug Administration

 

Center for Biologics Evaluation & Research

 

Vaccines and Related Biological Products Advisory Committee

 

November 16-17, 2005

 

Consultants

 

DAY 1

 

James Cook, M.D.  ***                                            Robin Robinson, Ph.D.  ***

Chief, Section of Infectious Diseases                                   Senior Project Officer for the

Department of Medicine                                              Office of Research and Development

University of Illinois at Chicago                                      Coordination in the Office Emergency

808 S. Wood Street                                                     Preparedness, HHS/OPHEP/ORDC

Chicago, IL  60612                                                  200 Independence Avenue, S.W.

                                                                                    Humphrey Bldg., Rm. 638G

Seth Hetherington, M.D.  **                                              Washington, DC  20201

Chief, Medical Officer

VP Clinical Development

Inhibitex, Inc.

1165 Sanctuary Pkwy., Suite 400

Alpharetta, GA  30004

 

Pamela McInnes, D.D.S.  ***                                        

National Institute of Allergy and Infectious                     

Diseases (NIAID)                                                          

Deputy Director, Division of Microbiology

  and Infectious Diseases (DMID)                                              

National Institutes of Health                                     

6610 Rockledge Drive, Room 6113                           

Bethesda, MD  20892 

 

Philip Minor, Ph.D.  ***

Head, Division of Virology

National Institute for Biological Standards

  and Control

Blanch Lane, South Mimms, Potters Bar

Hertfordshire EN6 3QG

England

 

 

 

 

 

 

**  Acting Industry Representative

***  Temporary Voting Members

 

Food & Drug Administration

 

Center for Biologics Evaluation & Research

 

Vaccines & Related Biological Products Advisory Committee

 

November 16-17, 2005

 

Speakers

 

Day 1

 

Rino Rappuoli, Ph.D.

Chiron Corporation

Chief Scientific Officer for Chiron

Bell Atlantic Tower

1717 Arch Street, 28th Fl.

Philadelphia, PA  19103

 

Jeroen Medema

Solvay Pharmaceuticals, Inc.

Senior Scientist, Vaccines

901 Sawyer Road

Marietta, GA  30062

 

FDA Participants

 

Philip Krause, M.D.                                                    Keith Peden, Ph.D.               

Head, Unit of Viral Latency                                        Senior Investigator

Laboratory of DNA Viruses                                       Laboratory of Retrovirus Research

Division of Viral Products                                      Division of Viral Products

OVRR/CBER                                                              OVRR/CBER

1401 Rockville Pike, HFM-457                              1401 Rockville Pike, HFM-454

Rockville, MD  20852                                                  Rockville, MD  20852

 

Andrew Lewis, Ph.D.

Chief, Laboratory of DNA Viruses

Head, Unit on Cell Substrates and

  Adventitious Agents

Division of Viral Products

OVRR/CBER

1401 Rockville Pike, HFM-457

Rockville, MD  20852

 

Arifa Khan, Ph.D.

Section Chief

Laboratory of Retrovirus Research

Division of Viral Products

OVRR/CBER

1401 Rockville Pike, HFM454

Rockville, MD  20852

 

Food & Drug Administration

 

Center for Biologics Evaluation & Research

 

Vaccines and Related Biological Products Advisory Committee

 

November 16-17, 2005

 

Consultants

 

DAY 2

 

Seth Hetherington, M.D. **                                               Mark Steinhoff, M.D.  ***

Chief, Medical Officer                                      Professor

VP Clinical Development                                        International Health and Epidemiology

Inhibitex, Inc.                                                                Bloomberg School of Public Health

1165 Sanctuary Pkwy., Suite 400                                    Johns Hopkins University

Alpharetta, GA  30004                                                  615 N. Wolfe Street

                                                                                    Baltimore, MD  21205

Lisa Jackson, M.D., M.P.H.  ***                             

Senior Science Investigator                                           Melinda Wharton, M.D., M.P.H.  ***   

Center for Health Studies                                      Acting Deputy Director of the

Group Health Cooperative                                         National Immunization Program

1730 Minor Avenue, Suite 1600                            Centers for Disease Control and     

Seattle, WA  98101                                                    Prevention

                                                                                    1600 Clifton Road, N.E. (MS E61)

Pamela McInnes, D.D.S.  ***                                         Atlanta, GA  30333                              

National Institute of Allergy and Infectious                     

Diseases (NIAID)          

Deputy Director Division of Microbiology               

  and Infectious Diseases (DMID)                                  

National Institutes of Health                                     

6610 Rockledge Drive, Room 6113   

Bethesda, MD  20892 

                                                           

Steven Piantadosi, M.D., Ph.D.  ***

Director of Oncology

Biostatistics

Johns Hopkins Oncology Center

550 North Broadway, Suite 1103

Baltimore, MD  21205

 

Robin Robinson, Ph.D.  ***

Senior Project Officer for the

Office of Research and Development

  Coordination in the Office of Public

Health Emergency Preparedness

HHS/OPHEP/ORDC

200 Independence Avenue, S.W.

Humphrey Bldg., Rm. 638G

Washington, DC  20201

 

**  Acting Industry Representative

***  Temporary Voting Members

 

 

Food & Drug Administration

 

Center for Biologics Evaluation & Research

 

Vaccines & Related Biological Products Advisory Committee

 

November 16-17, 2005

 

Speakers

Day 2

 

Sandra Steiner, Ph.D.

Microbiologist/Immunologist

Respiratory Diseases Branch, Immunology Laboratory

Division of Bacterial and Mycotic Diseases

Centers for Disease Control and Prevention

1600 Clifton Road, NE (MS A-36)

Atlanta, GA  30333

 

Matthew R. Moore, M.D., M.P.H.

Commander, USPHS

Centers for Disease Control and Prevention

1600 Clifton Road, NE

Atlanta, GA  30333

 

Jan Poolman, Ph.D.

Director, Bacterial Vaccine R&D

GlaxoSmithKline, Inc.

2301 Renaissance Blvd.

Bldg. 510, PO Box 6154

King of Prussia, PA  19406

 

George Siber, M.D.

Executive Vice President and

Chief Executive Officer

Wyeth

401 North Middleton Road

Pearl River, NY  10965

 

Louis Fries, M.D.

Vice President, Clinical and Medical Affairs

ID Biomedical Corporation

Suite 103

6996 Columbia Gateway Drive

Columbia, MD  21045

FDA Participants

 

Douglas Pratt, M.D., M.P.H.                                      Marion Gruber, Ph.D.

Chief, Clinical Trials Branch                                        Associate Director for Regulatory

Division of Vaccines and Related                         Policy

Products Applications                                                     OVRR/CBER

OVRR/CBER                                                              1401 Rockville Pike, HFM-481

1401 Rockville Pike, HFM-485                              Rockville, MD  20852

Rockville, MD  20852