Celgene is the EFPIA co-lead in the HARMONY project and so Celgene will be leading along with Novartis, with Salamanca and Valencia the Executive Committee and we’re delighted to be involved in this very important project for the haematological community. My role in Celgene is I’m Executive Director of Medical Affairs; I work in haematology oncology and I have a broad role looking across all sorts of clinical trials, observational research, medical information and training, multiple aspects of the medical affairs world that Celgene works in. So Celgene is very keen to be involved in this project because we have a very long heritage in treating haematological cancers. We’ve been involved with Revlimid, of course, in myeloma and through collaborations already over the last ten years or so really changed the landscape in myeloma. This project is a unique opportunity to not only look at myeloma but also multiple other diseases in the haem space to try and find ways collaboratively to find improvements in treatment, in diagnosis and in outcomes for patients. So I’m very enthusiastic about the chances it gives us to really try and move the treatment for patients forward in a cross-functional way to help all sorts of stakeholders – patients, regulatory authorities, HTA bodies and, of course, very importantly, the physicians who treat the patients.

How did Celgene become involved?

So the industry met a long time ago after hearing suggestions from the academics that a haematological project could be very interesting to work on within the IMI framework. EFPIA companies joined together then to form and create a first short proposal to explain what this project would be about and then put it out for the core process of IMI to invite academic institutions to join, to form consortiums to try and take on this project. The HARMONY consortium was successful and then we jointly as EFPIA and the public side of HARMONY merged into one and now together we’re going to move the whole project forward, bringing in multiple other stakeholders such as the regulators, the HEA bodies, the patients, to ensure we can cross-functionally achieve this project.

What are the main goals?

This project is a five year project and there are many, many deliverables we plan to try and achieve in this project across the seven different disease areas we’re going to work in. Very importantly short-term is to prove we can do this. So we want to try and bring together large datasets to analyse the key open questions in each disease. We’re going to start with AML first of all as a pilot to try and make the proof of principle, show how you can merge data, how you can analyse data and, hopefully, then publish some important outcomes that can immediately try and improve the treatment of AML patients and then from that develop the project across all seven diseases over the next five years.

The consortium is very concerned to ensure all data protection measures, all patient confidentiality are addressed. We have a whole work package dedicated just to the legal aspects of how to manage and combine, anonymise and use data because obviously, as you know, in the European environment data protection is a very important point. So we have, as I said, a whole work package who will work very closely with the colleagues who are going to work on identifying data and analysing data to make sure all those aspects are fully covered and fully transparently managed.

Will you have any input on any of the work packages?

The Executive Committee are overseeing the whole organisation and also we lead work package 1. Work package 1 is very much the project management aspect, so it’s making sure operationally the project moves forward, all the IMI requirements are fulfilled, reporting, the financial aspects etc. So one of the biggest challenges for this project is going to make it achieve outcomes in a timely fashion and involve as many people as we can to make it really a pan-European successful project. We have lots of partners, 51 partners currently, but also another 60 plus associate members. We’re very keen to involve anybody, collaborative groups, universities, other companies, who have data that could be contributed to this project to ensure we all work together on this to make the most positive and successful project possible.