Report

Teaser, summary, work performed and final results

Periodic Reporting for period 2 - HARMONY (Healthcare Alliance for Resourceful Medicines Offensive against Neoplasms in HematologY - Sofia ref.: 116026)

Teaser

Over the last 25 years, academic and pharmaceutical research has made significant progress, increasing Hematologic Malignancies (HM) patients’ survival rates and improving quality of life. However, a substantial proportion of patients with HM still have a poor prognosis due...

Summary

Over the last 25 years, academic and pharmaceutical research has made significant progress, increasing Hematologic Malignancies (HM) patients’ survival rates and improving quality of life. However, a substantial proportion of patients with HM still have a poor prognosis due to relapse and refractory disease. In many cases, potentially life-saving treatment decisions need to be made quickly, hence current decision-making processes need to be speeded up.
In addition, the advances in the molecular characterization of HMs achieved in the past years have revealed them to be genetically complex and heterogeneous diseases, translating into highly-divergent clinical behavior. This heterogeneity of HMs makes improving patients’ outcome even more challenging.
Progress along these lines is further complicated by the heterogeneity and diversity among European healthcare systems and oncology practices across the EU. This results in differences in the treatment of patients throughout Europe and limits the direct comparability of the clinical and non-clinical data on HMs that are being collected.
Therefore, there is an unmet need to harmonize outcome measures and endpoint definitions for HMs and their collection at the European level. HARMONY is designed to achieve this by uniting and aligning all European stakeholders.
The HARMONY Alliance is the the largest Innovative Medicines Initiative (IMI) European public-private partnership aiming to improve outcomes of patients with hematological malignancies (HMs) by establishing consensus outcomes among all stakeholders through the analysis of data on a large “Big Data” platform. HARMONY is composed of 53 partners from 11 countries including the pharmaceutical industry, hospitals, academic, research institutions, regulatory agencies, health technology assessment bodies, and patients’ organizations. HMs within scope are acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), multiple myeloma (MM), myelodysplastic syndrome (MDS), non-Hodgkin lymphoma (NHL) and pediatric HMs.
By creating a “big data platform”, the project aims to improve the access to a repository of relevant Data from HM patients. The magnitude of the data in this unique repository will help to represent the diversity of HM diseases in relation to their pathological, medical, epidemiological, healthcare and societal scope. The platform provides the technological requirements and governance to allow these data sets to be shared and queried by medical and non-medical experts involved in the healthcare provision and management of HMs, thus enhancing their value.

Work performed

HARMONY has implemented standardized operating procedures and a de-facto anonymization process for data intake, quality evaluation, storage, and analysis compliant with the European General Data Protection Regulation. As a result, a Big Data Platform allowing analysis, and interpretation of data from different sources to answer the most challenging research questions is now in place. Data to be included in HARMONY comprise clinical and biological variables, treatment, omics data, quality of life, patient-reported outcomes, and health economics.
During 2008, research projects are already underway for all HMs, with the first AML pilot study acting as the “proof of principle” study for HARMONY. This study, aimed to identifying the relevance on outcomes of gene-gene interactions, already includes data from >3,000 patients, being 5,000 more expected in the coming months. Datasets come from cooperative AML groups from the German and Austrian AML Study Group (AMLSG) and Haemato Oncology Foundation for Adults in the Netherland (HOVON) as well as from the NOVARTIS RATIFY clinical trial. The combination of academic and Pharmaceutical Industry data is a key step for HARMONY. The consortium has identified >15,000 high-quality patient records, from public and private partners which are expected to be added to the platform soon.
The number of Associated Members has raised from 15 in 2017 to 27 in 2018, being their main role providing data to integrate into the HARMONY’s database.

The project has defined the HARMONY identity and brand and created a sound foundation for internal and external communications/dissemination:
• HARMONY website: www.harmony-alliance.eu, which includes a newsletter section and a Community Platform for internal communication.
• Twitter: https://twitter.com/HarmonynetEU
• LinkedIn: https://www.linkedin.com/company/17987398/
• YouTube: https://www.youtube.com/channel/UCTOHQVjSs0Ee1g4cD8FAbwg

Final results

HARMONY aims to establish the efficacy and safety of the early diagnostics and clinical stratification, and the impact that it would have on response to therapy, patient survival and quality of life.
HARMONY will impact on distinct levels:
- The patients and patient advocacy organizations
Patients shall benefit from: i) linking diagnostic and molecular profiling platforms and ongoing trials to facilitate enrollment into specific clinical trials; ii) faster access to innovative diagnostics and treatments; iii) early and precise diagnosis and accurate risk assessment through better-defined outcomes based on patients’ unmet needs.
- Medical and scientific community
Improved management of patients due to the enhanced ability to select the “right” therapy for each individual on the basis of the disease profile, by applying the HARMONY selected outcomes measures and defined models to improve patient stratification.
- Market access decision-makers: regulatory agencies, HTA
The rational and analytical framework provided by HARMONY supports harmonization on decision-making for regulatory approval and reimbursement, policy and process developments on an international level, and provides tools and techniques to guarantee the efficient collection and analysis of hematologic data.
- European market
Europe shall benefit strengthening its profile as a business location and leading geographical area in the pharmaceutical and medical/healthcare industry.
Pharmaceutical and diagnostics industry shall benefit from: i) models generating a benefit through a personalized HM approach; ii) a better understanding of patient stratification, and validation of novel endpoints that will increase efficiency in R&D.
- Socio-economics
Socio-economic benefits achieved by: i) proving the value of innovative HM therapies for the healthcare system; ii) the cost savings through better identifying appropriate patients for treatment; iii) improved decision-making in the selection of therapies which can lead to improved treatment outcomes with a focus on supporting quality of life of patients.

Website & more info

More info: https://www.harmony-alliance.eu/.