HARMONY Alliance Foundation participating in European projects

After the end of the IHI-funded phase in March 2024, the HARMONY Alliance has already become a full-fledged foundation, that is able and open to participate in European projects and any kind of collaborative research, offering its resources and know how.

So far, the HARMONY Alliance Foundation has been included as a partner in the two European initiatives: RESOLVE and IMPACT.

RESOLVE: The RESOLVE Consortium will leverage numerous existing expert networks and patient advocacy partnerships to establish the predictive value of MRD in AML/CLL patients, with the expectation that this affordable, minimally-invasive biomarker can be imminently used to guide the intensity of consolidation therapy, improve quality of life (QoL), and reduce costs. This is achieved through 1) the development of a real-world patient registry and data platform (RESOLVE registry); 2) the establishment of standardized, decentralized MRD analysis across Europe; and 3) a randomized, controlled pragmatic trial (RESOLVE trial) based on the hypothesis that treatment intensity can be safely reduced in MRD negative AML/CLL patients, to provide evidence for the clinical, personal and societal impact of MRD-guided therapy.

The HARMONY Alliance has generated the largest data collection of patients with hematologic malignancies and established structures to maintain data privacy. The HARMONY Alliance will support RESOLVE with aspects regarding data privacy, GDPR, data management, and ethical issues. At the same time, the HARMONY Alliance will promote data accesibility and reusability by making RESOLVE clinical data accessible after project ends in March 2029.

IMPACT-AML: The project "Master framework and pragmatic clinical trial for relapse or refractory acute myeloid leukemia (IMPACT- AML)" is a multidisciplinary consortium that integrates clinical scientists, pediatricians, health and humanity experts, statisticians and technical experts from partner organizations. IMPACT-AML, represents a model of high-impact disease, in which no standard of care exists, and where there is an urgent need for new evidence on possible therapies; AML offers the setting in which methodological innovation will combine powerful instruments of clinical trials with personalized medicine through academic efforts. The project proposes to create an inclusive master framework for relapsed or refractory acute myeloid leukemia (STREAM) to include patients with R/R AML across Europe proficiently acquire an unselected population for clinical trials and monitor outcomes including neglected cohorts. The project ends in March 2028.

The experience of the HARMONY Alliance in the genomic characterizations of adults and pediatric AML will provide additional information and interpretation of big data.

The HARMONY Alliance Foundation aims to transform high-quality data into meaningful evidence.

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Public-private partnership for Big Data in Hematology

HARMONY and HARMONY PLUS are funded through the Innovative Medicines Initiative (IMI), Europe's largest public-private initiative aiming to speed up the development of better and safer medicines for patients. Funding is received from the IMI 2 Joint Undertaking and is listed under grant agreement for HARMONY No. 116026 and grant agreement for HARMONY PLUS No. 945406. This Joint Undertaking receives support from the European Union’s Horizon 2020 Research and Innovation Programme and the European Federation of Pharmaceutical Industries and Associations (EFPIA).