The US Food and Drug Administration (FDA) has reaffirmed a Public-Private Partnership (PPP) with Project Data Sphere (PDS). Scientific engagement with the FDA has been foundational to PDS and the PPP dates back at least 5 years.
Through our seven-year FDA-PDS symposium series, we have identified a number of areas at the frontier of analytics and regulatory science that PDS has developed into multi-institutional research programs.
In addition to our data sharing platform and collaborative analytics workspace, hosted by SAS, PDS has run five different research programs as a result of member engagement following these FDA-PDS workshops.
- The Prostate DREAM challenge – a crowd-sourced challenge to use emerging analytics approaches to identify biomarkers to aid in the management of patients with castrate-resistant metastatic prostate cancer.
- The External Control Arm program – a series of methods to construct and use existing patient performance data on standard-of-care therapy to supplement the control arm of a clinical trial, streamline evidence generation, and honor patient contributions to science.
- The Rare Tumor Registries program – a focused effort in Merkel Cell Carcinoma to demonstrate how high quality, longitudinal clinical data can transform patient care and inform the development of the next generation of medicines.
- The Immune-Related Adverse Events (irAE) program – a crowd-sourced challenge to establish clinical definitions of dozens of tissue-/organ-specific adverse events that occur in a small fraction of patients receiving immuno-oncology treatments. With these definitions in hand for a number of tissues and organs, we are now embarking on several additional projects (biomarkers, genomics, and digital health) that can improve patient management practices to keep patients on life-saving therapies.
- The autoRECIST program – a consortium-supported radiomics project where state-of-the-art machine learning techniques are being applied to medical images to ascertain whether a patient with advanced cancer has responded to therapy. This program has reported substantial progress on quantifying liver metastases and has pilot work demonstrating that these approaches can quantify metastatic lesions in lung and lymph nodes as well.
In the new iteration of the PPP, the FDA and PDS will be focusing on our data sharing platform, the irAE program, and autoRECIST. This focus highlights the necessity for continued work in these areas to establish widely adopted best practices. Our other research programs are undergoing lifecycle review with the Life Sciences Council (PDS’ scientific advisory board) and will continue in some fashion, though without the formal engagement with FDA.
Program lifecycle management also allows us to more thoroughly evaluate new research proposals and bring them before our membership. Our current portfolio of research proposals includes: digital pathology, pediatric oncology, cellular therapy, and developing tools to support the community of scholars across our partner HBCUs. This research portfolio is in review by the Life Sciences Council and potential funders.