Science and Technology

Overview: The “One-Stop” Solution

The ITI has been created to industrialize what have been traditional academic, foundation and small biotechnology clinical research approaches to allow for more effective, efficient and robust mechanism-based clinical development. 

ITI’s dedicated research facility – the Center for Critical Path Immunology – will encompass state-of-the-art technology platforms in cytomics (immune phenotyping using multi-parameter flow cytometry and techniques for intracellular staining and multiplex secreted cytokine detection), cell-based immune function, and genomics (gene expression and genotype analyses). 

ITI's technology platforms are being deployed in a rigorously standardized, efficient fashion to perform a comprehensive set of cellular, molecular, and immunological assays on specimens obtained from patients during clinical trials of emerging immunotherapeutics.

The mechanistic data that are generated will be analyzed in parallel with clinical safety and efficacy data using cutting-edge bioinformatic approaches that leverage new insights at the nexus of emerging life science and information technologies.
This global approach will:

  1. Interrogate immune system function in therapeutic settings, correlating clinical outcomes with underlying disease mechanisms and generating an enhanced understanding of the complex relationship between gene expression and function in disease.
  2. Provide biological data more proximal to disease pathology, advancing discovery of novel immune biomarkers that predict disease course and drug efficacy and safety.
  3. Accelerate the development of first-in-class drugs for immune system-related diseases.

Quality and Cost-Effectiveness

ITI will perform all discovery and production assays under “Good Clinical and Laboratory Practice” (GCLP) – to ensure the quality and reproducibility of data necessary to support development of biomarkers/diagnostics that meet FDA requirements for product approvals.  Certain types of programs will require Clinical Laboratory Improvement Amendments (CLIA) certification and ITI will be incorporating this capability as needed.

Automation through robotic technologies will improve the quality of the data, enhance capacity and reproducibility, minimize human error and reduce costs.  Immunological assay analysis is very sensitive to issues of reproducibility, which have limited the general utility of data generated from many studies in the past.