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NIAID/NIH - CBER/FDA TB Vaccine Regulatory Workshop

Fernwood Building
10401 Fernwood Road
NIAID Suite 250, Conference Room 2C13
Bethesda, MD
December 9, 2003

Click here to download the meeting transcript.

Tuberculosis

Tuberculosis vaccine

Registration

Logistics

Agenda

Related Material

 

Registration

This Workshop will be limited to a maximum of 70 attendees on a first come/first serve basis.

All those interested in participating must register by November 14, 2003. No inquiries after that date will be accepted.

To register, please contact Christine Sizemore at cs390s@nih.gov or 301-435-2857.

Logistics

Meeting Date/Time: Tuesday, December 9, 2003
8:30 am to 5:30 pm
Meeting Location: Fernwood Building
10401 Fernwood Road
NIAID Suite 250, Conference Room 2C13
Bethesda, MD
Accommodations: Hyatt Regency Bethesda
One Bethesda Metro Center
Bethesda, MD 20814
Tel: 301-657-1234
Fax: 301-657-6453
Hotel Information: A block of rooms has been reserved at the government rate of $150.00 + 12% tax (total $168.00) at the Hyatt Regency Bethesda. Participants may contact the in-house reservations department at (301) 657-1234 to secure a room. Participants should reference the NIH/NIAID "TB Vaccine Meeting" room block.

All hotel reservations must be made by the registration deadline of November 14. No reservations at the government rate will be available after that date.

Check in time is 3:00 p.m. and check out time is 12:00 p.m.

*Note: Those participants requiring financial assistance should contact Christine Sizemore at cs390s@nih.gov or 301-435-2857.

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Meeting Agenda
(Download .doc)


Welcome and Introductions - Goal of Meeting 8:30 - 8:45
  Christine Sizemore - NIH
Michael Brennan - FDA
All Presentations will be 15 min. each plus 5 min. discussion  
Session I. Overview Of The USFDA Regulatory Process 8:45 - 9:45
General IND issues Julienne Vaillancourt – FDA
GMP Manufacturing & Preclinical testing Sheldon Morris – FDA
Toxicology/Adjuvants Marion Gruber – FDA
Session II. Vaccine Development: From The Laboratory To FDA - Two Perspectives: 9:45 -10:25
NIAID/NIH Lydia Falk - NIH
The Biologics Consulting Group James Kenimer - TBCG
Break 10:25 – 10:45
Session III. Clinical Trial Issues 10:45 – 12:30
Basics of phase I/II clinical trials Steve Rosenthal - FDA
Phase II feasibility trials of TB vaccines for Targeted Populations:  
Manufacturers perspectives Ripley Ballou – GSK
FDA perspectives Douglas Pratt - FDA
Rosemarie Tiernan - FDA
Ann Schwartz - FDA
Leonard Sacks - FDA
Clinical endpoints in TB vaccine studies Christopher Whalen – CWRU
Immunological assays in TB vaccine studies Daniel Hoft - SLU
Lunch 12:30 – 1:30
Lunch Presentation: A TB vaccine study in the UK Adrian Hill - OxU
Session IV. Specific Vaccine Issues 1:30 – 2:50
DNA vaccines Dennis Klinman – FDA
Peptide vaccines Hana Golding – FDA
Live vaccines Karen Elkins – FDA
Subunit/Recombinant vaccines Sheldon Morris - FDA
Session V. Open Discussion 2:50 – 3:30
Break 3:30 - 4:00
Session VI. Meeting Summary 4:00 – 5:30
  Norman Baylor – FDA
Richard Walker - FDA

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Related Material

*Note: A meeting summary and additional presentation slides will be posted on this page following the Workshop.

Available Slideshow Presentations:

  1. Welcome and Introduction - Christine Sizemore
  2. General IND Issues - Julienne Vaillancourt
  3. Subunit Vaccines - Inactivated Vaccines - Sheldon Morris
  4. Toxicology/Adjuvants - Marion Gruber
  5. DMID Perspective for Conducting Clinical Trials - Lydia Falk
  6. Vaccine Development: From the Laboratory to the FDA - James G. Kenimer
  7. Clinical Issues to Consider in the Development of New Vaccines - Steven Rosenthal
  8. Feasibility Trials for TB Vaccines: An Industry Perspective - Ripley Ballou
  9. Tuberculosis Vaccines -FDA Perspective on Phase 2 Clinical Trials - Rosemary Tiernan
  10. Phase I/II Tuberculosis Vaccine Trials - Christopher Whalen
  11. Immunoassays in Phase I/II Trials of New TB Vaccines - D.F. Hoft
  12. MVA85A - Progress with phase I studies and some regulatory and safety aspects - Adrian V. S. Hill
  13. DNA Vaccine Development: Practical Regulatory Aspects - Dennis Klinman
  14. Multi-epitope vaccines:Potency assays - Hana Golding
  15. Challenges Inherent in Developing Live Attenuated Bacterial Vaccines - Karen Elkins
  16. Regulatory Issues in the Manufacture and Pre-clinical Testing of New Vaccines - Sheldon Morris

Related Sites:

Center for Biologics and Evaluation Research

Information on Submitting an Investigational New Drug Application for a Biological Product

CBER Guidances / Guidelines / Points to Consider

Summary Workshop on Counter Terrorism Products Regulated by the Center for Biologics Evaluation and Research: See pdf files for Effective Strategies to Assist in Product Development - 10/23-24/2003

The Jordan Report 20th Anniversary: Accelerated Development of Vaccines 2002

Fourth World Conference on Tuberculosis Proceedings

NIAID Global Health Plan

Blueprint for TB Vaccine Development

NIAID Statement on World TB Day

TB Vaccines – State of the Science

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