Microbiology and Infectious Diseases Resources

Microbiology and Infectious Diseases Resources—Vaccines

Discovery and IND-Enabling Activities

Develop targets

• Genome sequencing
• Identify protein biomarkers
• Data and analysis
• Structural genomics
• Systems biology

Assess in vitro efficacy

Assess activity in vivo (pathogens, all types)

Assess in vivo efficacy

• Pathogens (all types)
• Malaria

Develop preclinical planning and evaluation

• Pathogens (all types)
• Malaria

Develop lead candidates

• Pathogens (all types)
• Malaria

Develop Assays

• Pathogens (all types)
• Malaria

Assess immunogenicity

• Pathogens (all types)
• Malaria

Evaluate toxicology

• Pathogens (all types)
• Malaria

Refine animal models

• Pathogens (all types)
• Malaria

Process development

• Pathogens (all types)

Formulate and produce pilot lots

• Pathogens (all types)
• Malaria

cGMP manufacturing

• Pathogens (all types)

Obtain regulatory support for compiling documentation necessary for submission of an Investigational New Drug (IND) application and/or Master Files to the Food and Drug Administration (FDA).

• Malaria