Program in Regulatory Science

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Mission and Approach

The mission of the Program in Regulatory Science (PRS) is to generate novel approaches for the development of therapeutics and biomarkers through preclinical and clinical trial designs, pipeline modeling, and scientific contributions in regulatory science.

The development and translation of effective precision medicines requires generation of information regarding both efficacious therapeutics and putative biomarkers that predict that efficacy. The exponential increase in potential biomarker information that is available for any given patient or disease, including genomic biomarkers, has created challenges with respect to the best methods to support both the scientific development and the regulatory decision-making required to bring new medicines to clinic. The Program in Regulatory Science develops new approaches and quantitative methods to support the discovery of new treatments in precision medicine and collaborates with groups at Dana-Farber in the development of innovative clinical trials.

Clinical Trial Design

The Program in Regulatory Science focuses on three major areas of clinical trial design:

  • Design and implementation of biomarker-based platform trials in oncology.
  • Development of novel algorithmic or model-based approaches to phase I and II studies.
  • Biomarker-driven subgroup analyses in clinical trials.

Pipeline Modeling

The PRS models the therapeutic development pipelines in oncology, using data from published sources and commercially available databases. This modeling approach is used to evaluate the utility of various sources of information, such as preclinical models or specific trial designs.