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White House Unveils ADAPT Program to Advance Biomarker-Guided Cancer Treatment

NEW YORK – The Biden Administration on Thursday unveiled a new program aimed at advancing precision oncology biomarkers and clinical trial design.

The program, dubbed ADvanced Analysis for Precision cancer Therapy (ADAPT), is part of the new funding agency, the Advanced Research Projects Agency for Health (ARPA-H), which launched in 2022. ARPA-H technically sits within the National Institutes of Health, though it operates as a separate agency. Its director reports directly to the secretary of the US Department of Health and Human Services.

The new ADAPT program will fund projects meant to guide advanced cancer treatment in real time as tumor biology changes while also supporting the development of new clinical trial approaches to help bring these biomarker strategies into the clinic.

The funding awarded through ADAPT will fall into three buckets. The first will be for projects developing new approaches to guiding treatment decisions. Examples include those using multimodal data fusion, resistant trait modeling, and new biomarker approaches to predict drug response.

The second bucket will fund projects focused on an evolutionary clinical trial design that adapts to patients' treatment approach over the course of therapy based on how their tumor biology changes. The clinical trial approach is meant to track longitudinal changes in patients' tumor traits, in turn leading to new data-driven biomarkers that can point oncologists toward the best sequence of therapies for a patient.

Finally, the third funding bucket will go toward projects that encourage collaboration between researchers and clinicians using a shared treatment and analysis platform capable of updating patient- and biomarker-level data in real time. ADAPT's goal with this bucket is to establish a centralized space for clinicians and researchers to access data and resources in real time.

The overarching goal of the ADAPT program, through these three buckets, is to improve advanced cancer outcomes by predicting which patients will respond to which therapies.

The government agency believes that the new ADAPT program is distinct from other existing efforts in that it's focused on developing sophisticated biomarkers, including projects that use machine learning, statistical, mechanistic methods, and state-of-the-art tumor measurement techniques that can help shift treatment approaches as patients' cancers change.

"Biomarkers, developed from comprehensive tumor biology measurements and advanced computational approaches, will enable adaptation of treatments based on real-time identification of tumor traits," ADAPT Program Manager Andrea Bild said in a statement announcing the new initiative. "Patients participate in an evolutionary clinical trial, ensuring a personalized approach to combating treatment resistance. Through ADAPT, we aim to improve patient response to therapy and increase survival time."

The program will be soliciting project proposals in the three technical areas — new biomarkers, longitudinal clinical trial design, and real-time data-sharing — though it has not revealed the amount of funding these areas will receive or the factors that will play into which projects are selected.