HARMONY: a big data project to improve disease classification, identify prognostic factors and monitor outcomes

Updated: 13th March, 2019

Moving Forward: First Data Transferred Into The HARMONY Big Data Platform

An important step in search of new methods of treatment of Hematological Malignancies: HARMONY Partners Ulm University, Novartis and Erasmus University Medical Center uploaded research data into the HARMONY Big Data Platform.
More Partners and Associated Members announce their readiness to contribute data from their sources. The HARMONY Alliance is a large public-private European Network of Excellence for Big Data in Hematology, established in January 2017
and funded by the Innovative Medicines Initiative (IMI).

Although the cytogenetic heterogeneity of AML has been recognized for many decades, the molecular heterogeneity of the disease has been identified only over the past 15 years. The prognostic value of the heterogeneity is widely accepted. However, translation of this molecular information into improved therapeutic regimes is slow.

In its first pilot project, HARMONY is combining patient information from the German Austrian AML Study Group (AMLSG) and the HOVON – the Haemato Oncology Foundation for Adults in the Netherlands- registries with the aim to further improve disease classification and better understand the genomic context, to identify other prognostic factors and to monitor outcomes with current treatment and new therapies in different subtypes of adult AML.

In this context, Novartis has provided anonymized data from the RATIFY trial.

“HARMONY will become an invaluable tool to better understand the heterogeneity of hematologic malignancies and to move big data analysis to the next level”, says Hartmut Döhner from HARMONY Partner Ulm University Hospital and chair of the German-Austrian AML Study Group (AMLSG). Ulm University Hospital provided 1540 datasets.

Novartis shared data from the Rydapt (midostaurin) RATIFY study, the largest clinical trial in FLT3-mutated AML to date, performed to determine the effect of adding midostaurin, a multitargeted kinase inhibitor, to standard chemotherapy in patients with AML and a FLT3 mutation. This data, which was anonymized before transfer, will be integrated and analyzed along with data from a number of other high-quality sources within HARMONY, to help define clinical endpoints and outcomes for AML. The Phase III RATIFY trial was run in collaboration with the Alliance for Clinical Trials in Oncology (CALGB). It included 717 study participants from around the world. The full results, which showed significant overall survival benefit for FLT3+ AML patients consistently across FLT3 mutation subgroups, were published in the New England Journal of Medicine in June 2017 under the senior authorship of the HARMONY Key Opinion Leader Hartmut Döhner (ref Stone RM et al. N Engl J Med. 2017 Aug 3;377(5):454-464). Based on data from RATIFY, The National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology for AML now include the use of midostaurin in FLT3-mutated AML.

“With such positive efforts in sharing aggregated data of hundreds of patients into the HARMONY platform, the hope is that other data custodians across industry and academia will also be inspired to join the HARMONY Alliance. In the future, the aspiration is that the HARMONY Alliance model will allow us to create a blueprint that can be applied to future projects in other disease areas, ultimately benefiting many more patients in Europe and well beyond”, states Mirko Vukcevic from Novartis and HARMONY Project Lead.

Other datasets (680) come from the Erasmus University Medical Center in Rotterdam. The department of Hematology has been engaged in the collection of genomics data sets of clinically well-annotated patients enrolled in the international multicenter HOVON-SAKK AML trials. This way they will contribute the published data sets – which include gene expression data (Affy), copy number data (Affy), and targeted NGS data of AML – to HARMONY.

“This data will give better insight into the heterogeneous disease AML”, adds Dr. Peter Valk from Erasmus MC, HARMONY Partner, who focuses in his research on the molecular analyses of various hematologic malignancies, mainly acute myeloid and lymphoblastic leukemias.

In the next generation sequencing era, large data sets of (subset of) acute myeloid and lymphoid leukemias of patients enrolled in the HOVON-SAKK clinical trials will be generated. These data sets currently comprise targeted gene panels on AML cases at diagnosis and after high dose induction treatment but will also include whole exome and whole genome data in the future. They will also be contributed to the HARMONY Alliance. The first three data sources are just the beginning. More HARMONY Partners and Associated Members are getting ready to upload their anonymized data from clinical trials or other research projects to the HARMONY Big Data Platform. Furthermore, it is not a one-off process with a specified end. Big Data analysis will be carried out over a long period of time. Alongside the gradually added and upgraded data sets and rising amounts of information, a data mining process will enable us to make new discoveries in the connected databases.

The HARMONY Big Data Platform: Algorithms to transform knowledge into better medicine outcomes for hematology patients.
Read more >

The HARMONY Anonymization Concept reconciles data quality, safety, and privacy.
Read more >

London – November 23/24, 2017

On 23 and 24 November 2017 the HARMONY Alliance organized a workshop on the definition of meaningful outcomes for hematological malignancies.

We were invited as patients advocates, together with 60 stakeholders to discuss outcomes relevant to all stakeholders across all haematological malignancies.

Brussels/Salamanca – January 9, 2017

The Innovative Medicines Initiative (IMI) has approved HARMONY, a project that aims to foster better access and care for patients with various hematologic malignancies (HM) with the use of big data. The project is made up of 51 partners from 11 European countries, including 7 pharmaceutical companies.

Other organisations such as Myeloma Patients Europe (MPE), Lymphoma Coalition, MDS Alliance and CLL Advocate will be involved in this project as well in order to provide the patient perspective.

MDS Alliance will attend the kick-off meeting in mid-January 2017, together with the other patient advocacy groups and all stake-holders.

More news to follow soon.

PRESS RELEASE

INNOVATIVE MEDICINES INITIATIVE APPROVES

€ 40 million PROJECT FOR BETTER CARE OF PATIENTS WITH HEMATOLOGIC MALIGNANCIES

Brussels/Salamanca, January 9, 2017. The Innovative Medicines Initiative (IMI) has approved HARMONY, a project that aims to foster better access and care for patients with various hematologic malignancies (HM) with the use of big data. The project is made up of 51 partners from 11 European countries, including 7 pharmaceutical companies.

HARMONY will capture, integrate, analyze and harmonize anonymous patient data from high-quality multidisciplinary sources to unlock valuable knowledge on multiple myeloma (MM), acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), non-Hodgkins lymphoma (NHL), myelodysplastic syndromes (MDS) and pediatric HMs.

Building on pre-existing, long-lasting collaborations between Academic institutes and the pharmaceutical industry, the HARMONY project shall further advance HM management through a more efficient process of treatment development and rapid decision-making. The expected outcome will be better prognosis and quicker life-saving decisions, important for patients suffering from these hematological diseases.

The project brings together key stakeholders in the clinical, academic, patient, HTA (health technology assessment), regulatory, economical, ethical and pharmaceutical fields to:

  • Developing a data sharing platform that empowers clinicians and policy stakeholders to improve decision-making
  • Establishing a network reflecting the European HMs landscape
  • Defining clinical endpoints and standard outcomes in ALL (paediatric & adult), NHL, MM, AML, CLL, MDS
  • Alignment of key stakeholders on relevance of these outcomes (policy makers, payers, patients)
  • Providing means for analysing complex data sets comprising different layers of information
  • Identifying specific markers for early registration of innovative and effective therapies for HMs

The HARMONY project’s final deliverable is a big data platform which integrates outcome measures and endpoint definitions for HMs. HARMONY will achieve this from a pan-European perspective by uniting and aligning European stakeholders and key opinion leaders in the field. The 5-year project will start in January 2017 and 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 is coordinated by two public leads: Prof. Dr. Jesús Marïa Hernández from Instituto de Investigación Biomédica de Salamanca, Spain, and Dr. Guillermo Sanz from Instituto de Investigación Sanitaria del Hospital La Fe de Valencia, Spain, and by two EFPIA leads, Tayyab Salimullah from Novartis Oncology and Pam Bacon from Celgene International.

Contact information: Harmonyoffice@ibsal.es

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.

Disclaimer
It should be made clear in the text and layout that the communication reflects the author’s view and that neither IMI nor the European Union, EFPIA, or any Associated Partners are responsible for any use that may be made of the information contained therein.

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Partners in HARMONY

Project management

  • Instituto de Investigación Biomédica de Salamanca (IBSAL), Spain
  • Instituto de Investigación Sanitaria del Hospital La Fe de Valencia (HULAFE), Spain
  • Celgene International II SARL, Switzerland
  • Novartis, Switzerland
  • Synapse Research Management Partners, S.L. (SYNAPSE), Spain

Partners

  • Universitaet Ulm (UULM), Germany*
  • Alma Mater Studiorum – Università di Bologna (UNIBO), Italy*
  • European Hematology Association (EHA), The Netherlands*
  • ELN Foundation (ELN), Germany*
  • GMV Soluciones Globales Internet S.A.U. (GMV), Spain*
  • European Alliance for Personalised Medicine (EAPM), Belgium
  • Medizinische Universitaet – Wien (MUW), Austria*
  • Erasmus Universiteit Medisch Centrum Rotterdam (EMC), The Netherlands
  • University of Navarra (UNAV), Spain
  • Università degli Studi di Torino (UNITO), Italy
  • Stichting VUmc, The Netherlands
  • The Chancellor, Masters and Scholars of the University of Cambridge (UCAM), United Kingdom
  • University of Rome ‘Tor Vergata’ (URTV), Italy
  • Goethe University Frankfurt (GUF), Germany
  • Group for Research on Adult Acute Lymphoblastic Leukemia (GRAALL), France
  • Jose Carreras Leukaemia Research Institute (IJC), Spain
  • European Research Initiative on CLL e.v. (ERIC), Germany
  • Masaryk University (MU), Czech Republic
  • Fundacio privada Institut D’investigacio Oncologica de Vall-Hebron (VHIO), Spain
  • The Lymphoma Scientific Association (LYSA), France
  • Ludwig-Maximilians-Universitaet – Muenchen (LMU-Muenchen), Germany
  • Barts Health NHS Trust (BHT), United Kingdom
  • Groupe Francophone des Myélodysplasies (GFM), France
  • Heinrich-Heine-Universitaet – Duesseldorf (UDUS), Germany
  • Fondazione Italiana per lo studio delle sindromi mielodisplastiche onlus (FISMonlus), Italy
  • University of Newcastle upon Tyne (UNEW), United Kingdom
  • German Society of Pediatric Oncology-Hematology GmbH gemeinnützig (GPOH), Germany
  • Ospedale Pediatrico Bambino Gesù (OPBG), Italy
  • University of York (UoY), United Kingdom
  • European Organisation for Research and Treatment of Cancer (EORTC), Belgium
  • European Society for Blood and Marrow Transplantation (EBMT), The Netherlands
  • Flanders Institute of Biotechnology (VIB), Belgium
  • University of Helsinki (UH), Finland
  • Assistance Publique – Hôpitaux de Paris (AP-HP), France
  • Genome Research Limited (GRL-SANGER), United Kingdom
  • MediSapiens Ltd (MS), Finland
  • MLL Munich Leukemia Laboratory GmbH (MLL), Germany
  • LeukaNET (LeNET), Germany*
  • National Institute for Health and Care Excellence (NICE), United Kingdom
  • Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), Spain
  • Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Germany
  • Amgen, United Kingdom*
  • Janssen Pharmaceutica NV, Belgium*
  • Bayer Aktiengesellschaft, Germany*
  • Menarini Ricerche S.p.A., Italy*
  • Takeda, United Kingdom*

*Work package leaders and co-leaders

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