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Contact Info

Beth Spinelli  
Project Officer, Drug Development Section
Office of Biodefense Research Affairs
spinellb@niaid.nih.gov

Microbiology and Infectious Diseases Resources

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Examples of Services by Category

Lead Identification and Development

  • Design lead optimization schemes (LOS) and generate chemical analogues
  • Synthesize, resynthesize, or acquire compounds/interventional agents or chemical analogues for in vitro and in vivo studies
  • Analyze structure activity relationships (SAR)
  • Custom synthesize radio labeled compounds for in vitro and in vivo studies
  • Optimize lead series to improve specific physiochemical or pharmacological properties
  • Synthesize prodrug derivative(s.

Chemistry and Manufacturing

  • Develop analytical methods to characterize interventional agents
  • Develop and manufacture cGMP-qualified materials for preclinical and Phase I/II clinical use
  • Conduct formulation studies
  • Support cGMP-compliant stability program

In Vitro and In Vivo Preclinical Safety, Toxicology, and Biokinetics

  • Develop analytical methods to characterize interventional agents
  • Perform preclinical microbiological, safety, biokinetics and toxicity studies, such as in vitro microbiological assays
  • Perform in vitro and In vivo pre-clinical safety, toxicology, and biokinetics studies, including
    • maximum tolerated dose and no observed adverse effect levels (NOAEL)
    • acute and sub chronic toxicity
    • PK, Bioavailability, ADME
    • Genotoxicity, carcinogenicity, reproductive toxicity testing
    • Biotransformation assays conducted in vitro
    • Cytotoxicity, immunotoxicity
    • Behavioral pharmacology Cell permeability

Preclinical Development, Planning, and Evaluation

  • Develop preclinical and/or product development plans

Last Updated March 05, 2014