WP6 will group stakeholders into clusters and will be working to identify and address any evidence gaps which might delay decision-making by regulatory agencies, HTA bodies, and payers. Such activities will identify those factors which prevent patient access to innovative treatments for HM. The group’s work, building upon previously gained experience and other EU-funded projects and international initiatives, will lead to consensus-based decisions and facilitate interaction and consultation between all the relevant stakeholders.
Objectives
- Providing support and advice to other WPs to ensure that all relevant perspectives (from HTA bodies, patients, regulators, policy-makers, etc.) are reflected;
- Engaging all stakeholders to collect input and ensure the long-term implementation of the project’s outcomes;
- Creating an evidence framework to enhance decision-making processes, thereby facilitating centralized regulatory approval and national/regional HTA;
- Developing a clinical value framework to assess how effective new clinical interventions are and to assess their relative therapeutic value;
- Inviting input in terms of multiple viewpoints and requirements on the part of stakeholders;
- Fostering consensus among the stakeholders, thus facilitating the development of and access to innovative solutions and therapies for HMs;
- Integrating stakeholder participation and evidence;
- Providing guidance on methodologies for evidence generation and analysis of real-life evidence.
Work Package Partners
AEMPS, Amgen, Bayer, BFArM, Celgene, EHA, HULAFE, IBSAL, Janssen, Leukanet, MediUni Wien, Menarini, NICE, Novartis, Synapse, University of York.
Work Package Leadership
“HARMONY helps improve the prognosis and outcome of patients with hematological cancers, driven by knowledge derived from the combination and analysis of complex data. This will only make a difference to real patients if the evidence, findings and outcomes of the project are meaningful and relevant to patients, next to other stakeholders. Through its Stakeholder Forum, HARMONY will collect input from patient organisations and all other stakeholders to discuss needs, gaps, opportunities and barriers, informing the implementation of the project across work packages.”
Jan Geissler, Founder and CEO, LeukaNET
WP6 Leader
“Big Data and Advanced Analytics provide an opportunity to look for dynamic patterns and predict accurate and timely diagnosis in rare diseases such as Hematology. Big Data in Hematology will ideally allow a more refined phenotyping that eventually prolong and improve the patients´ live”
Sofia Iqbal, Real World Evidence Partnerships Lead, EMEA, Janssen Health Economics, Market Access and Reimbursement
WP6 Leader
” “HARMONY is one of the major initiatives in Europe focused on patient unmet need in Haematology. It is a critical collaborative effort between public and private stakeholders using the most advanced Big Data platform. HARMONY will contribute to innovation for patients, through this major collaboration in Europe, with clinicians, patients, cooperative group, regulatory authorities, HTA bodies and the pharmaceutical industry.””
Yann Guillevic, External Collaborations & Partnership Lead, Celgene, a Bristol Myers Squibb company
HARMONY Co-Lead