Innovation & Research

The Healthcare Alliance for Resourceful Medicines Offensive against Neoplasms in HematologY

The HARMONY Alliance is a Public Private Partnership that captures, integrates, analyzes and harmonizes Big Data from high-quality sources with the aim to improve the treatment of blood cancers i.e. Hematologic Malignancies (HMs). 

HARMONY was launched in 2017 and consists of 53 Partners and 43 Associated Members from 17 European countries, including 8 pharmaceutical companies. The highly multidisciplinary project assembles key stakeholders in the clinical, academic, patient advocacy, Health Technology Assessment (HTA), regulatory, economic, ethical, ICT, and pharmaceutical fields.
 

HARMONY’S Objectives

The main goal of the HARMONY Alliance is to develop a Big Data platform for HMs, to enable clinicians to rapidly define promising treatment strategies, and predict potential adverse events. This Platform represents a tool to determine treatment options for the individual patient, taking into account demographic characteristics, genomic information, and the needs of the individual patient. To improve comparability between future clinical trials, HARMONY will also develop standard sets of outcome measures that are relevant to all stakeholders. 

HARMONY aims to establish a more efficient process of drug discovery and regulatory evaluation. This can only be achieved by the concerted action of a strong multidisciplinary partnership, which includes academic institutions, pharmaceutical companies, hospitals, HTA and regulatory bodies, payers, and patient organizations, each with the required know-how and a proven track-record of excellence. 

HARMONY will uniquely enable these key stakeholders to assemble, connect, analyze and interpret Big Data, and to define standard sets of outcomes that are relevant and meaningful to all stakeholders. This will facilitate a harmonized pan-European approach towards evidence-based decision-making in HM management at all levels of the healthcare system. HARMONY constitutes a powerful European Network of Excellence that is fully equipped to address the challenges and improve the treatment options and health-related quality of life for patients with HMs.

Deep Dive into the Structure

HARMONY’s activities officially started in January 2017 and will be accomplished within 60 months. The project is structured in eight highly interconnected work packages and will focus on seven HMs: Acute lymphoblastic leukemia, Acute Myeloid Leukemia, Chronic Lymphocytic Leukemia, Myelodysplastic Syndromes, Non-Hodgkin’s Lymphoma, Multiple Myeloma and Pediatric Hematologic Malignancies.

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 is supported by efficiently structured project management, external dissemination and communication activities, and by a framework for legal, ethical and governance aspects relating to data handling. 

Introducing HARMONY PLUS

In the past four years, since 2017, the HARMONY Alliance has created a powerful European network, developed a unique Big Data Platform, already identified 60,000 data sets from patients with HMs, developed state-of-the art Big Data analytics solutions, launched several blood cancer Research Projects, and generated valuable novel insights. Capitalizing on these accomplishments, the Alliance has launched a follow-up IMI project called ‘HARMONY PLUS’ in October 2020. This project will address additional types of blood cancer, expanding the scope to the complete range of acute leukemias, chronic leukemias, lymphomas, and monoclonal gammopathies. In addition, HARMONY PLUS will apply advanced techniques to model disease progression, identify new markers, and perform risk stratification based on Artificial Intelligence (AI), and transform the HARMONY Big Data Platform into an Integrated Services Platform.

HARMONY and HARMONY PLUS: Expected Output

HARMONY and HARMONY PLUS will empower clinicians, patients, and policy stakeholders to improve decision-making procedures and identify appropriate treatments for patients with blood cancers. This will foster European excellence in the study of HMs, through a powerful and constantly growing European network that have joined forces to improve the quality of life of blood cancer patients.

Goals:

• creation of a comprehensive data-sharing platform;
• publication of a defined set of outcomes and the development of a set of specific biomarkers to better define outcome parameters;
• 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;
• integration of “real-life” clinical data together with “omics” data into drug development.
   

HARMONY PLUS will leverage the lessons learned, the scientific knowledge and the technological platform developed in HARMONY to unlock a greater potential of Big Data and the application of Artificial Intelligence (AI) to healthcare challenges. 

Menarini for HARMONY

We are fully involved in the activities of the HARMONY Projects, with our Clinical Sciences Unit leading the Data Analytics Work Packages of HARMONY. Our tasks include the description, analysis and modeling of the data collected, stored and generated into a personalized medicine framework. Tools and models are used to answer the most important disease-specific questions and to conduct cross-disease analyses, including data-, biomarker- and outcome-driven analyses. In detail, the HARMONY Data Analytics teams 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 approach in a personalized medicine framework. 

Goals:

• 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).

Our commitment in the HARMONY Alliance is not limited to the Data Analytics Work Packages, but also encompasses additional tasks related to Clinical Sciences and to Payers/Providers/HTAs, EMA Alignment and Optimization.
Look at the interview with Menarini’s Dr. Simone Baldini to hear more details about this! 

HARMONY in Florence: the General Assembly 2019

Menarini was honored to host the 4th General Assembly of the HARMONY Alliance in Florence on 26^th and 27^th September 2019. 

The 4^th General Assembly helped to foster the collaboration of the HARMONY leaders, Partners, Associated Members and Patient Cluster. The program celebrated the success of HARMONY at its mid-point and used innovative ‘research-a-thons’ to kick-start HARMONY’s second wave of research projects across seven Hematologic Malignancies.
In addition, several plenary presentations and panel discussions took place. These delivered key progress updates on HARMONY’s ongoing research efforts and gave attendees the opportunity to learn more about the value of HARMONY from experts in the field. View the highlights of the HARMONY's 4^th General Assembly at the HARMONY website.

Disclaimer

This webpage reflects only the view of Menarini; the IMI 2 Joint Undertaking is not responsible for any use that may be made of the information it contains.

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).
 

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 and HARMONY PLUS at the IMI website: 
•    www.imi.europa.eu/projects-results/project-factsheets/harmony
•    www.imi.europa.eu/projects-results/project-factsheets/harmony-plus