The collaborative endeavor of European hematologists, scientists, drug companies, and patient organizations called ‘HARMONY’ has launched an innovative big data platform. By 2019, the platform will contain de-identified and anonymized data from thousands of European patients with cancers that affect the blood and lymphatic system (hematologic malignancies, HMs). Scientists can use this unique resource to characterize the molecular landscape of HMs, understand their pathophysiology, and identify novel drug targets. Ultimately, clinicians should be able to use the platform to rapidly select the most promising treatment for a particular patient: personalized medicine.
Over the last 25 years, scientific research has made significant progress, increasing HM patient survival rates and improving patients’ quality of life. However, a substantial proportion of HM patients still have a poor prognosis. Taken together, HMs rank third after lung cancer and colorectal cancer in terms of age-adjusted mortality in Europe. In addition, they strongly contribute to loss of productivity. Hence, there is an urgent need to develop innovative therapeutic approaches for HM patients, especially those with high-risk profiles and resistance to conventional therapies.
The HARMONY Alliance is a unique public-private partnership of clinicians, scientists, drug companies, and patient organizations: 53 partners from 11 European countries. HARMONY uses big data technologies to improve the treatment of the following hematologic malignancies:
To meet the needs of HM patients, we require targeted treatments based on molecular data, therapies to eradicate minimal residual malignant disease (MRD), cellular immunotherapies, combination treatments, improved hematopoietic stem cell therapies, and treatments that are better tolerated by elderly patients. These needs can only be addressed by studying large numbers of patients. Therefore, HARMONY has generated a harmonized European clinical data platform that will gather data from completed and future clinical trials. Later, data from population-based cohorts will be added. By 2019, the platform will contain de-identified and anonymized data from thousands of European patients with cancers that affect the blood and lymphatic system (hematologic malignancies), including clinical information, treatment details, molecular data (i.e., genomic, transcriptional, epigenetic, proteomic, and metabolomics data), patient information on quality of life & life style, and health system information.
The HARMONY Data Platform
Jesús María Hernández Rivas, HARMONY Project Coordinator, based at the Institute of Biomedical Research of Salamanca: “The HARMONY Alliance launched its big data platform several months ago. We uploaded some public repository datasets from HM patients as a proof of concept. HARMONY uses state-of-the-art technologies to ensure the platform’s compliance with legal and ethical rules, most notably the GDPR that recently took effect. We obtained external legal advice to achieve this. HARMONY uses advanced big data technologies to enable stakeholders to share, connect, analyze, and interpret the data. For instance, we have recently implemented the so-called OMOP tool, which is a system to harmonize the data entrance in the platform by using the same units. This supporting big data infrastructure is unparalleled in the field of hematology. We are now ready to transfer clinical trial datasets to the platform. At the EHA conference, we want to connect with new data partners and collaborators.”
Lars Bullinger, Leader of HARMONY Work Package 2 Definition of Outcomes and Professor in Personalized Medicine at Charité in Berlin:
The AML research groups involved in HARMONY are about to sign the data transfer agreement. In June 2018, we will start transferring the datasets to the platform. I expect that we will have gathered data of around 5.000 patients in 6-12 months from now. These data will be provided by public research institutions as well as pharmaceutical companies; I think this is unique.”
Gert Ossenkoppele, Professor of Hematology at VU University Medical Center in Amsterdam, adds:
“Then, we can start analyzing the data. We aim to identify molecular profiles that can predict clinical course and drug response in AML patients, facilitating personalized patient management. A key question that we will address first is ‘How do combinations of genetic mutations relate to AML disease course and treatment response?”
Paolo Ghia, Associate Professor of Internal Medicine at Università Vita-Salute San Raffaele in Milano:
“Things are really moving now. The CLL research groups are signing the data transfer agreement and I expect that we will start transferring CLL datasets to the platform after the EHA conference. By combining data of thousands of CLL patients, we aspire to identify robust prognostic markers for clinical course and drug response. These markers may constitute patient characteristics (e.g., age, fitness), genetic variables (e.g., TP53 mutation status), and other molecular data (e.g., minimal residual disease, MRD). Like the AML groups, we are interested in the relationship between combinations of genetic mutations and disease course and treatment response.
Jan Geissler: Leader of HARMONY Work Package 6: Payers/Providers/HTAs, EMA Alignment/ Optimization and founder and CEO of LeukaNET:
“Importantly, HARMONY gathers a variety of stakeholders. So, not only hematologists and scientists, but also patient organizations, pharmaceutical companies, HTA agencies and regulators. Thus, the patient perspective is truly considered. One of our work packages focuses on defining relevant outcomes for each type of HM, including both classical clinical outcome measures and measures that are relevant for patients and caregivers such as a reliable quality of life measure.
Mirko Vukcevic: HARMONY Project Leader, based at Novartis:
“Building on pre-existing, long-lasting collaborations between Academic institutes and the pharmaceutical industry, the HARMONY project shall further advance Hematologic Malignancies (HM) management through a more efficient process of treatment development and rapid decision-making of clinicians and policy makers. The expected outcome will be better prognosis and more personalized 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. 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 HARMONY data platform will revolutionize the treatment of HMs in several ways:
Are you interested to learn more about the HARMONY Alliance, our projects and Work Packages, please contact us.
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