NIAID/NIH—CBER/FDA TB Vaccine Regulatory Workshop
Fernwood Building
10401 Fernwood Road
NIAID Suite 250, Conference Room 2C13
Bethesda, MD
December 9, 2003
Download the meeting transcript.
Download the meeting agenda
Available Presentations
- Welcome and Introduction—Christine Sizemore
- General IND Issues—Julienne Vaillancourt
- Subunit Vaccines - Inactivated Vaccines—Sheldon Morris
- Toxicology/Adjuvants—Marion Gruber
- DMID Perspective for Conducting Clinical Trials—Lydia Falk
- Vaccine Development: From the Laboratory to the FDA—James G. Kenimer
- Clinical Issues to Consider in the Development of New Vaccines—Steven Rosenthal
- Feasibility Trials for TB Vaccines: An Industry Perspective—Ripley Ballou
- Tuberculosis Vaccines - FDA Perspective on Phase 2 Clinical Trials—Rosemary Tiernan
- Phase I/II Tuberculosis Vaccine Trials—Christopher Whalen
- Immunoassays in Phase I/II Trials of New TB Vaccines—D.F. Hoft
- MVA85A - Progress with Phase I Studies and Some Regulatory and Safety Aspects—Adrian V. S. Hill
- DNA Vaccine Development: Practical Regulatory Aspects—Dennis Klinman
- Multi-Epitope Vaccines: Potency Assays—Hana Golding
- Challenges Inherent in Developing Live Attenuated Bacterial Vaccines—Karen Elkins
- Regulatory Issues in the Manufacture and Pre-clinical Testing of New Vaccines—Sheldon Morris
Related Links
Government
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
NIAID Global Health Plan
Blueprint for TB Vaccine Development
NIAID Statement on World TB Day
Non-Government
Fourth World Conference on Tuberculosis Proceedings
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