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Leveraging digital innovations to support the development of CRS de-risking products

Today, Cytokine Release Syndrome (CRS) requires regular clinical oversight through extended hospitalizations, creating barriers to care and limiting patient access to vital immunotherapies. Digital health technologies (DHTs) have matured to a point where we can—and should—rely on them to detect the onset of CRS, enabling monitoring and risk prediction beyond the clinic.

To support, DATAcc by DiMe has developed resources to support the development of trustworthy CRS de-risking products that can enable earlier detection and management, empowering oncologists to improve patient outcomes globally.

Immunotherapies have emerged as promising treatments for devastating hematological cancers like leukemias, lymphomas, and multiple myeloma. They offer targeted, better-tolerated options with promising results, such as improved survival rates and quality of life.

Cytokine Release Syndrome (CRS) can be a side effect of these immunotherapies and has become a significant risk for drug developers, healthcare providers, payors, regulators, and, most importantly, patients. It can threaten patients’ lives if the onset is not closely monitored and managed.

Who will benefit from these resources?

Developers

Build products that address a growing unmet need for providers, patients, or both.

Providers

Improve immunotherapy access, optimize your workflows, and minimize hospital resource use.

Patients

Gain access to state-of-the-art treatment options and reduce the need for long hospitalizations so you can spend more time at home.

Building CRS De-risking Products: A Practical Guide for Developers

The guide provides you with actionable recommendations for developing CRS de-risking products, outlining the value proposition and key development milestones for bringing a safe and effective product to market.

Additional resources to support your success

Digital clinical measures

Use these digital clinical measures to gather high-quality datasets, gain insights into CRS onset and progression, and support the development of data-driven solutions that reduce risks for immunotherapy patients.

Innovation roadmap

By using this roadmap, you’ll explore important milestones that inform the development of your CRS de-risking product—thereby enhancing patient outcomes, optimizing care, and accelerating drug development.

Navigating CRS: The patient journey

The visual highlights Alexandra’s challenges and shows how a CRS de-risking product could have been used to improve her patient journey.

As immunotherapies, including those in development, become available sooner and indications expand, more patients like Alexandra will become eligible, challenging clinical staff to keep up with the growing demand for care.

Only 20% of eligible patients, like Alexandra, receive this therapy due to the complex logistics, toxicity concerns, and financial burden.

Her vitals are collected every four hours as standard of care.

Using DHTs could’ve enabled her CRS detection up to two hours earlier and supported monitoring in an outpatient setting.

Advanced CRS de-risking products could assess whether her CRS event would progress, allowing her team to manage the CRS event in the appropriate setting.

CRS de-risking products could allow Alexandra to safely distance herself from the clinic, potentially even returning home several hours away.

Our partners

Partners also include the National Cancer Institute

Discover how others are using these resources

Leveraging DATAcc by DiMe’s ontology for data transfer specifications development for early detection of CRS in CAR-T and BiTE therapy patients
Melinda Chen & Erik Koenig | Takeda
Milos Todorovic | Director of Biomedical and Clinical Engineering Analog Devices, Inc.
Optimizing sepsis and CRS detection: A data-driven approach to improve patient outcomes
Lavi Kwiatkowsky | Founder & CEO, Canopy
Premal Kamdar | Director, Digital Health Product Management, Bristol Myers Squibb
Michael Pettinati | Senior Data Scientist, ActiGraph

    More about this project

    Moving the bar(rier) forward: the benefits of de-risking cytokine release syndrome

    Advancing CRS care: Blue Spark Technologies’ role in early detection and innovation with DATAcc

    Get involved

    Explore opportunities to collaborate, share insights, and develop innovative solutions that drive progress and set new best practices for our ecosystem.

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    Get the DiMe Seal to show your digital health product meets rigorous standards in evidence, privacy, security, usability, and equity.

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    Pediatric Rare Disease: Digital Measures Development

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