This document provides a high-level overview of the vaccine development process from research and testing in animals through clinical trials in humans and regulatory approval. It discusses key stages including preclinical research in animal models to test safety and efficacy, phases of human clinical trials, requirements for good manufacturing practices and regulatory compliance, and the role of quality assurance. It also provides examples of DVC's experience developing vaccines for biodefense threats like anthrax, smallpox, and plague.

1. Vaccine 101 July 22, 2009 DynPort Vaccine Company LLC, A CSC Company

3. Vaccine 101 Vaccines and How They Work

6. Vaccine 101 Making a Vaccine

7. From Test Tube to FDA Review Source: CDER Handbook, FDA 3/16/98, http://www.fda.gov/cder/handbook/

22. 2005: DVC receives first-ever FDA licensure for a biodefense product (VIGIV) 2008: DVC and Quintiles win $32M NIAID Phase 1 clinical trial unit contract DVC biodefense milestone Emerging diseases / services milestone 2003-2009: DVC completes six Phase 1 clinical trials for biological and chemical defense countermeasures 2008: DoD plague RAD allocates all future DoD plague vaccine funding to existing DVC contract 2005-ongoing: DVC initiates and manages Phase 2 clinical trials for botulinum neurotoxin and plague vaccines 2006: DVC and Baxter win $242 M HHS award to develop seasonal and pandemic influenza vaccines DVC Milestones Throughout the Product Development Life Cycle

23. Vaccine 101 Vaccine Manufacturing

27. Vaccine 101 Putting Things Together

35. Vaccine 101 Biodefense and Vaccines

37. Questions?