Title: Regulatory Approval Pathways for Vaccines and Antivirals: Laying the Groundwork
Location: MassBio, 300 Technology Square, 8th Floor, Cambridge MA, 02139
Date/Time: Tuesday, September 25, 2018
Registration: 11 am
Lunch/presentation begins: 11:30 am
Robert O. Baker, PhD, Assistant Vice President and Microbiology and Molecular Biology Division Manager, IITRI
The race to develop vaccines and antiinfectives against emerging new pathogens (e.g., Zika, Ebola) and long-standing infectious diseases (e.g., influenza, tuberculosis) is accelerating due to innovations in vaccine technologies and therapeutic strategies. Yet, once the potential of a new vaccine or treatment is confirmed in vitro, researchers who are unfamiliar with the in vivo challenge and GLP toxicology studies required for IND submissions may be unclear on how to proceed. This talk will present an overview of the path from research to FDA approval for vaccines and anti-infectives to provide a framework for planning IND-enabling programs, along with specific details on study requirements. Specialized topics such as the following will be highlighted:
- What information should challenge studies provide for toxicology studies?
- What GLP-compliant studies are required?
- What defines a pivotal toxicology study for vaccines?
- What are Animal Rule studies and what is their purpose?
- What is the advantage of partnering with a CRO for these studies?
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