Bringing personalised medicine to citizens
As a Joint Undertaking between the EU and the pharmaceutical industry association EFPIA, the Innovative Medicines Initiative (IMI) is Europe’s largest public private initiative. With a €2bn budget, it aims to speed up the development of better and safer medicines for patients by supporting collaborative research projects and building networks of industrial and academic experts in order to boost pharmaceutical innovation in Europe.
The IMI is headed by executive director Joint Undertaking , Professor of Immunology at the Faculty of Medicine of the Université Libre de Bruxelles in Belgium. He outlines the obstacles to personalised medicine, his thoughts on the FET Flagship Human Brain Project and the evolution of the public private initiative.
What are the biggest barriers to personalised medicine and what changes are necessary for personalised medicine to become a success in Europe’s healthcare systems?
There are a series of barriers facing the successful development and implementation of personalised medicine and these do not just occur in Europe. The first of these hurdles is scientific in nature, in that it is of fundamental importance that we generate a much better understanding of the molecular basis of disease – in the current system we still classify diseases by the names of the clinicians who made the initial description, but this does not tell you anything about the molecular basis of Alzheimer’s or Parkinson’s, for instance. What this comes down to is the very real need for a new taxonomy of disease.
Once this new nomenclature has been developed, it will then be necessary to identify biomarkers in order to use this taxonomy and thus classify patients. What is more, these biomarkers must then be agreed upon by the relevant regulatory agency.
The creation of a new system of disease classification is already underway at the Innovative Medicines Initiative, where we have begun to develop a taxonomy of asthma, and we plan to do the same for Type 2 diabetes, rheumatoid arthritis, and Alzheimer’s.
Thus, the scientific challenges facing personalised medicine could be summed up as: understand the disease; classify the patient; and develop the biomarkers.
It is then that the regulatory challenges will come in to play, because if new classifications and biomarkers have been developed and identified, it is then necessary for the regulator to accept them, and, moreover, to consider them in their own decisions.
The regulators need to agree that a drug is appropriate for a particular subset of patients for this new classification of disease for instance, and, indeed, they will need to agree that a specific biomarker, if it is positive, will give the green light for the drugs in question.
It is not enough to just have the science in place; the regulators must also embrace the concept.
Once these things have been achieved, the unavoidable economic challenges must then be faced; even if a new drug has been accepted by the regulators as having a good profile, it must then be funded.
As such, it is necessary to consider the approaches taken by financers, and a way in which this could be done is through a re-visiting of the way drugs access the market, perhaps via new forms of drug adaptive licensing.
In addition to the scientific, the regulatory and the economical, the implementation of personalised medicine will also face cultural challenges, and, in this sense, it will be necessary to foster a paradigm shift in the way in which many stakeholders view the drug development process; they need to realise that things are evolving, and that does not only relate to the way in which science is progressing, but also the way healthcare is organised, and so this requires a change in the mindset in order to foster an increasing amount of collaboration.
What are your views on the FET Human Brain Project and what are your hopes for personalised medicine generally?
The Human Brain Project is very important for the future of medicine in a very general sense, not least for the way in which it will enable us to learn so much more about the brain and the way it works and, by extension, about the ways in which drugs act on the brain.
Brain disease is a significant focus of the work that we do at the IMI, and we certainly hope to take advantage of the Human Brain FET flagship project by working collaboratively with those involved.
It is also of crucial importance that such large and long-term projects as this are being developed in Europe because they will play a fundamental part of what is needed to build the science I have referred to already, and thus will help to further the implementation of a truly personalised medicine.
How will the IMI continue to work towards the successful development and implementation of personalised medicine?
The IMI’s most recent call for proposals specifically addresses the issue of the taxonomy of disease, generating new classifications for Alzheimer’s, Parkinson’s, rheumatoid arthritis and lupus, and we plan to launch a huge project on induced pluripotent stem cells. The idea here is to use stem cells from patients to reproduce the disease process and, from there, to test new therapies which will be tailored to the needs of the different forms of the disease.
Public private partnerships are an ideal tool for driving the development of personalised medicines in diverse areas. How would you like to see the EU focus on this type of partnership evolve?
In Europe, I believe that we now have a strong basis for PPPs to continue, but there is more that can be done, and I hope that we can also come to do even more for SMEs and develop an even more patient-centric approach to medicine.
This will mean that a greater emphasis will need to be placed on the role of patients, care givers, and healthcare organisations, whilst also ensuring a strong collaboration with regulators.
Professor Michel Goldman
