Vision: To provide infrastructure, methods and technology to facilitate efficient translation of targeted approaches to the treatment of human disease.
UC San Diego Clinical and Translational Research Institute (ACTRI) Center for Accelerating Drug Development (CADD) integrates our biomarker laboratory, computational biology, and phase I unit to facilitate novel early stage clinical trials.
There is a pressing need to accelerate the early stages of drug development. Given the high attrition rate for drugs in clinical development, with estimates of successful phase I therapeutics gaining regulatory approval as low as 8 percent, improved drug development methods that provide data for rapid “go/no-go” decisions are required. Biomarkers can potentially be used to achieve this goal, particularly in phase I drug studies, by improving the speed and accuracy of drug safety, efficacy and dosing assessments.
The CADD combines resources and expertise to support early evaluation of therapeutic agents and enhanced multi-center clinical trials capabilities, providing a development pathway from initial drug assessment to registration. The focus of studies we support is first-in-disease rather than healthy human volunteers. This takes advantage of our clinical registries and provides early access of treatments to patients.
The CADD brings together three key elements of early drug development: the ACTRI Biomarker Laboratory; the ACTRI Phase I Unit; and the Center for Computational Biology and Bioinformatics (CCBB). The biomarker lab designs and validates assays; the phase I unit and project management team execute the study; and the biomarker lab performs assays on the biosamples. The CCBB assists with analysis of data generated by the Biomarker Laboratory and other omics technologies, and correlates with clinical and laboratory data from the research participants.
Our focus is to support early clinical studies that integrate high content nucleic acid-based omics analysis. We can provide integrated services from study design to analysis or a la cart support depending on investigator need.
Services available include clinical study design and performance, assay development and biospecimen measurement, large data set analysis and data integration.
A systems biology approach is employed to assess how changes in biomarker data correlate with response to therapy. Based on these assessments, the CADD determines the likelihood for a positive outcome using traditional clinical endpoints.
The three CADD components – clinic, lab and informatics – are designed to work together so that investigators can use all or some of these services, seamlessly weaving in and out of the process as needed.
To find out more about CADD and how the Center can support your research, please submit the attached form.