As obesity and related metabolic disorder research and development continues to grow, the need for evidence on health benefits beyond weight loss, as well as improved clinical trial design, will be critical to optimize program success, differentiate treatments, and support payer negotiations. Wearables can capture real-life mobility, physical activity, and sleep measures with minimal burden, and are crucial to support the next generation of novel treatments.
The DECODE CRS Coalition has been jointly established by Ametris and the Digital Medicine (DiMe) Society to accelerate the development of scalable, clinically meaningful approaches to CRS detection and management.
The DECODE CRS Consortium has been jointly established by Ametris and the Digital Medicine (DiMe) Society to accelerate the development of scalable, clinically meaningful approaches to CRS detection and management.
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Patient access to CAR-T and T‑cell engager (TCE) therapies remains limited despite their transformative clinical potential. A key bottleneck is Cytokine Release Syndrome (CRS), a frequent but increasingly manageable inflammatory response associated with CAR‑T and TCEs. Concern over CRS severity has driven highly conservative care models, requiring inpatient administration, specialized centers, and intensive monitoring. As a result, CRS functions less as a safety issue and more as a system‑level barrier that restricts where and how therapy can be delivered.
Expanding access to immunotherapy depends on de‑risking CRS in outpatient and community settings, enabling decentralized care models, lower cost of delivery, and broader physician participation. Technologies and approaches that improve CRS predictability, early detection, and standardized management are critical enablers of scale. By reducing uncertainty around adverse event management, they unlock outpatient administration, increase center capacity, and significantly expand the addressable patient population.
To address this shared industry-wide challenge, the DECODE CRS Coalition has been jointly established by Ametris and the Digital Medicine (DiMe) Society, with leading pharmaceutical organizations across oncology and immunology. This pre-competitive initiative brings together clinical trial sponsors, clinicians, regulators, payors, patients, technology developers, and healthcare systems to accelerate the development of scalable, clinically meaningful approaches to better understand patients’ immunotherapy experiences across real-world care settings to increase access and improve outcomes.
DECODE CRS is a system-level effort to build shared evidence that no single organization can generate alone.
CRS remains a significant clinical barrier to expanding access to CAR-T and bispecific TCE immunotherapies.
Several key challenges limit progress:
These challenges are not confined to a single therapy or sponsor, but rather they are a shared constraint across the immunotherapy ecosystem. A coordinated, cross-sector solution is needed to generate clinically meaningful evidence that satisfies regulatory oversight and is applicable across modalities.
DECODE CRS
Pre-Competitive, System-Level Approach to Accelerate Immunotherapy Access
Building on DiMe’s original CRS digital measures work, DECODE CRS combines Ametris’ expertise in continuous sensor-based data collection and DiMe’s cross-sector leadership with global immunotherapy development experience from leading biopharma sponsors.
DECODE CRS consists of two workstreams:
Workstream #1:
We are pleased to share that Workstream 1 (WS1) is now complete! Through structured interviews, workshops, and cross-sector collaboration, the DECODE CRS coalition established:
Workstream #2:
Although prior studies have demonstrated that wearables can detect CRS onset signals earlier than conventional approaches, translating those signals into actionable alerts has remained a challenge. Workstream 2 (WS2) addresses this gap through a prospective study of 150+ patients receiving approved CAR-T and T-cell engager (TCE) therapies. Building on WS1 deliverables, the study will generate the data needed to develop and validate an early warning model focused on delivering actionable, clinically meaningful CRS alerts.
WS2 partners will play a key role in defining alerting strategies and clinical guidance for standardized adverse event management, gaining access to the study dataset, the resulting CRS monitoring algorithm, and representation in health authority interactions. Don't miss this opportunity to help shape the future of CRS monitoring and expand patient access to immunotherapies.
Contact us to learn more about WS2 partnership opportunities.
DECODE CRS aims to develop a clinically appropriate, regulatory-ready, and commercially viable monitoring solution to enable:
DECODE CRS seeks to accelerate progress at a pace and level of rigor that individual efforts cannot achieve alone.
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Find more information below about how to become involved in the project and access related resources.
Ametris and DiMe continue to welcome additional partners to the DECODE CRS Coalition.
Participation Provides the Opportunity to:
CRS is a shared barrier to immunotherapy access. Through pre-competitive collaboration, we can create shared solutions that expand safe, equitable access to life-saving immunotherapies.
Contact us for more information about joining the coalition.
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