The Translational Oncology Partnership Program aims to accelerate the development and regulatory approval of biomarker assays and technologies. These rapidly evolving tools, which can be used for a range of cancer types, enable more informed medical decision-making.
They also allow clinicians to take great strides forward in addressing obstacles in the optimization of patient care. These obstacles include:
- late diagnosis of disease
- inability to select the best treatment for each individual patient’s tumor
- delays in translating therapeutic innovations from the laboratory (bench) to clinical practice (bedside)
To address these challenges, we have changed the paradigm of collaborative biomarker development. Our approach is to treat biomarker development the same way we do drug development.
This includes requiring that each device or assay is “fit for the purpose” in which it will be studied. This is followed by a sequence of clinical trials to support and justify regulatory approvals and coverage by third-party payers. These steps are essential to ensure that the biomarker test can be used in routine practice.
In the era of precision medicine, where decisions to improve patient outcomes are based on the biologic profile of an individual patient’s tumor, we are creating novel solutions for the complex challenges of assay development. Additional areas of focus include:
MSK Liquid Biopsy for Interception of Cancer (MSK-LINC)
MSK-LINC is a large-scale, cross-disciplinary research initiative aimed at advancing the understanding and clinical application of circulating biomarkers, including circulating tumor DNA (ctDNA), in oncology.
MSK-LINC is a hypothesis-driven, faculty-led translational platform focused on developing and clinically validating advanced ctDNA technologies and leveraging longitudinal molecular monitoring. The platform generates high-resolution insights into tumor dynamics, treatment response, tumor evolution, and the mechanisms of resistance in both early-stage and metastatic settings.
MSK Program for Research in Early Cancer Identification through Scientific Engagement
This broad initiative, led by. Dr. Luke Pike, addresses the unmet need for effective, scalable, and noninvasive early cancer detection and screening tools. To accelerate the research and development of liquid biopsy biomarker assays for early cancer detection, the program leads several industry-sponsored, multi-institutional early detection trials. It also focuses on internal discovery and validation work.
Through this program, we investigat eassays that use techniques such as fragmentomics, methylomics, artificial intelligence, and machine learning to examine changes in cell-free DNA and other circulating biomarkers reflected in early oncogenesis. Our initiative provides the infrastructure necessary to support pan-cancer investigations and enables systematic exploration of early-detection biomarkers across diverse tumor types.
Working With Stakeholders
Across our initiatives, we engage with a diverse range of stakeholders including:
- Laboratory and clinical scientists
- Drug and assay developers
- Biotechnology and pharmaceutical companies
- Computational biologists
- Statisticians
- Regulators
Our platform allows us to identify and vet promising state-of-the-art technologies and innovations and establish truly collaborative research partnerships for biomarker development.
These projects must meet the following criteria before they are eligible for incorporation into our platform. Requirements are:
- They must be a technology-based platform.
- They must have an expectation of cost-effectiveness.
- They must be translational in nature (bench to bedside).
- They must have the potential to create clinical and economic value.
- They must be an equitable collaboration between academia and industry.