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HARMONY: THE INNOVATIVE MEDICINES INITIATIVE

The Innovative Medicines Initiative (IMI) is Europe's largest public-private initiative aiming to speed up the development of better and safer medicines for patients. IMI supports collaborative research projects and builds networks of industrial and academic experts in order to boost pharmaceutical innovation in Europe. IMI is a joint undertaking between the European Union and the pharmaceutical industry association EFPIA.

Link to the IMI web site: www.imi.europa.eu

Link to HARMONY at the IMI website: www.imi.europa.eu/projects-results/project-factsheets/harmony



HARMONY

Healthcare Alliance for Resourceful Medicines Offensive against Neoplasms in HematologY

 

The HARMONY Alliance is a European Network of excellence that captures, integrates, analyzes and harmonizes Big Data from high-quality multidisciplinary sources for the purpose of acquiring valuable knowledge across the spectrum of blood cancers i.e. hematologic malignancies (HMs).

 

HARMONY is made up of 53 Partners and 27 Associated Members: 72 participants from 15 European countries and 8 pharmaceutical companies. The highly multidisciplinary project brings together key stakeholders in the clinical, academic, patients, Health Technology Assessment, regulatory, economic, ethical, ICT, and pharmaceutical fields.

 

The main goal of the HARMONY project is to develop a HM-specific Big Data platform, to enable the rapid definition of promising treatment strategies, and prediction of adverse events likely to be associated with such strategies. This platform represents a tool to determine treatment options for the individual patient, and will take into account demographic differences, genomic information as well as the needs of the individual patient. To improve reliability, and therefore the value of the data, HARMONY will specifically address the need to define standard sets of outcome measures that are relevant to all stakeholders, and that will help monitor treatment.

 

HARMONY aims to establish a more efficient process of treatment development and regulatory evaluation: this can only be achieved by the concerted action of a multidisciplinary partnership, which includes institutions, industry, hospitals, HTA, payers, and organizations with the required know-how and a proven track-record of excellence.

 

HARMONY will uniquely enable all key healthcare system stakeholders to assemble, connect, analyze and interpret Big Data, and to define standard sets of HM outcome indicators that are relevant and meaningful to all stakeholders, thus harmonizing a pan-European approach towards the measurement-based decision-making in HMs at all levels of the healthcare system.

HARMONY constitutes a powerful representative European Network of Excellence to address these challenges and thereby improve both the treatment outlook and health-related quality of life (QoL) for patients with HMs.

HARMONY Alliance is 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. HARMONY has received funding from IMI 2 Joint Undertaking and is listed under grant agreement No. 116026. 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). IMI supports collaborative research projects and builds networks of industrial and academic experts to boost pharmaceutical innovation in Europe.

 

HARMONY activities and related tasks officially started in January, 2017 and will be accomplished within 60 months. HARMONY is structured in 8 distinct, highly interconnected work packages (WPs). HARMONY will focus on 7 blood cancers, HMs: Acute lymphoblastic leukemia, Acute Myeloid Leukemia, Chronic Lymphocytic Leukemia, Myelodysplastic Syndromes, Non-Hodgkin’s Lymphoma, Multiple Myeloma and Pediatric Hematologic Malignancies.

OBJECTIVES - IMPLEMENTATION

The HARMONY Alliance will produce the following outputs:



  • The creation of a comprehensive data-sharing platform

  • The publication of a defined set of outcomes and the development of a set of specific biomarkers to better define outcome parameters

  • The development of analytical tools for complex data sets; the harmonization of clinical endpoints and methods to implement clinical interventions in a common pan-European database

  • The integration of “real-life” clinical data together with “omics” data into drug development


HARMONY output will bring meaningful patient relevant outcomes and will align with regulators and health technology assessment bodies. Moreover HARMONY will facilitate close collaboration between academics and stakeholders in HMs, leading epidemiologists, clinicians and bioinformatics groups, to foster European excellence in the study of HMs. HARMONY’s overall scientific and action governance will be accomplished by creating a well-defined management and decision-making structures with clear accountabilities and decision rules.


HARMONY has been designed as a technological ecosystem for the analysis of large volumes of clinical information; the project architecture supports the optimization of data collection and the creation of a high-quality HM data repository with data analysis tools to provide a continuously up-dated outcomes-based HM data platform. This work, concentrated in WPs 2-6, is supported by efficiently structured project management (WP1), external dissemination and communication activities (WP7), and by provision of a framework for legal, ethical and governance aspects relating to data handling (WP8).

MENARINI CONTRIBUTION

The Clinical Science of Menarini is leading the Data Analytics Work Package (WP5).


WP5 activity is centered on the description, analysis and modeling of the data collected, stored and generated into a personalized medicine framework. It will implement tools and models able to answer the most important disease-specific questions and will be applicable to cross-disease analyses, including data-, biomarker- and outcome-driven analyses. In particular WP5 will work on statistical harmonization of data, outcome modeling, assessment of economic and societal impact of therapies and cost effectiveness analyses. It will also provide in silico prediction of therapeutic response and it will provide a holistic
The WP5 aims to:



  • Harmonizing data according to their heterogeneity and complexity, with a special emphasis on statistical data cleaning (which identifies and corrects any abnormalities in the data) and statistical harmonization (normalization);

  • Characterizing any variables that impact the data collected;

  • Describing and modeling outcomes, particularly those related to disease progression, responder/non-responder factors, quality of life, healthcare resource use, and cost;

  • Using economic analysis tools to identify and compare the value of HM care;

  • Integrating data to create a holistic approach in a personalized medicine framework;

  • Reporting on the cost-effectiveness of therapies and their societal value (including information on the quality of life).