February 2012: Lunch debate on "IMI in the spotlight" and "Speeding up drug discovery for Alzheimer’s disease: the PharmaCog project"
On 28 February 2012, Alzheimer Europe organised its 12th lunch debate in the European Parliament. The debate focused on how to speed up drug discovery for Alzheimer’s disease within the framework of the Innovative Medicines Initiative and the PharmaCog project.
Elisabeth Morin-Chartier, MEP (France) opened the debate on behalf of host, Françoise Grossetête, MEP (France), by explaining that in Europe there are some 7.3 million people who live with dementia of which around 75% have Alzheimer’s disease. Ms Morin-Chartier highlighted the research programme and innovation partnerships as ways in which Europe can aim to improve the quality of life. Emphasising the need for Europe to face challenges together, Ms Morin-Chartier spoke of the Horizon 2020 programme (which has been assigned EUR 80 billion) and the need for world leaders to be driving the research agenda.
Dr. Elisabetta Vaudano, Principal Scientific Manager, Innovative Medicines Initiative (IMI), European Commission, presented the current challenges: (1) There are some 35.6 million people with dementia in the world and by 2050 this is expected to rise to 115.4 million; (2) the societal cost of Alzheimer’s disease in the world is calculated to currently be EUR 72 billion, but by 2040 it will be EUR 144 billion; (3) there is no cure for dementia. Despite vast amounts of work being carried out to develop new treatments, the reality is that the last drug approval was nearly a decade ago (memantine, 2003). Of the drugs which have been developed it is found that they work only in some of the people with the conditions and (4) there is need for greater collaboration and funding in dementia research. Dr. Vaudano illustrated the stark contrast between research for dementia and other areas of research such as nuclear fusion for example. At the moment, spending and coordination for research on dementia is low and fragmented, whereas research into nuclear fusion enjoys strong funding and collaboration and the research effort is not fragmented.
To overcome such barriers, Dr. Vaudano said that there is a real need for innovation, with new research models which involve all stakeholders. The idea behind the IMI was to do exactly this by having the public sector (represented by the European Commission and a budget of EUR 1 billion) and the private sector (represented by the pharmaceutical industry and matching a budget of EUR 1 billion) work together in a non-competitive environment in order to develop a new way forward. Dr Vaudano said that we need to realise the aim of finding the “right drug, for the right patient, at the right time and with the right dose”.
Currently, IMI is financing 30 projects of which the ‘Prediction of cognitive properties of new drug candidates for neurodegenerative diseases in early clinical development’ (PharmaCog) project is one. Alzheimer’s disease is still high in the agenda for future IMI initiatives and there will be the launch in 2013 of a new project (EMIF-AD) part of the EMIF (European Medical Information Framework). At this stage, said Dr. Vaudano, the opportunity to use the information received has not yet been fully realised as each country records data differently and has varying standards. However, an opportunity for future research could arise once the harmonisation process of data has taken place.
The PharmaCog project was presented by Dr. Jill Richardson, GSK R&D China, EFPIA coordinator together with Dr. Alexandra Auffret, PharmaCog Academic Coordinator, Marseilles University, France. Dr. Richardson said that the main issue, despite years of research, is that we still do not really understand how neurodegenerative diseases manifest themselves and we don’t know which are the best targets to pursue. Therefore, there is an urgent need for good tools which provide objective measures to enable diagnosis of patient populations, classification of disease severity, prediction of treatment outcome and drug response.
Dr. Richardson explained that PharmaCog aims to take a very broad approach to drug development and, in so doing, addresses some of the reasons why late stage trials for Alzheimer’s disease had not been successful. These included an over-focusing on the lowering of amyloid, a lack of harmonisation of protocols and data, a failure to identify relevant and accepted endpoints and a lack of clarity on how biomarkers translate into clinical benefit. In addition drugs had been targeted at a late stage in the disease, leading to poor results. It is now thought that amyloid lowering agents should be given much earlier. The cost of trials may also hinder progress of drug development. Long trials are required for dementia drugs (two years or more) and the cost for this is around EUR 20 million.
Dr. Auffret presented how the PharmaCog project works in practice. Launched in 2010, this five-year project has five objectives:
- To develop and validate pre-clinical and clinical models with greater predictive capacity to increase the effectiveness of the drug discovery process in Alzheimer’s disease
- Develop and validate translatable pharmacodynamics markers to support dose selection
- Identify and validate markers of disease progression and patient stratification
- Gain industry and regulatory acceptance of models and markers
- Develop a pan European network of experts in technologies fully translatable from animal to human, experts in translational medicine, drug discovery and mathematical modelling.
To carry out these objectives, there are 32 partners across Europe providing expertise: academic institutions (advice on science and technology), EFPIA companies (Alzheimer’s disease drug discovery, archived data, pharmacology expertise, harmonisation and statistics), SMEs (innovative biomarkers and clinical trial authorisation procedures), the European Medicines Agency (advice and information on clinical trials) and Alzheimer Europe (communication of results and work on ethical issues). Dr. Auffret said that whilst the project is indeed a massive challenge, it is also an opportunity to share a vast amount of expertise and avoid duplication. Innovation, translation and harmonisation are, said Dr. Auffret, key words of this project.
Teams collaborate on the ten work packages and research is ongoing covering topics such as induced cognitive deficit, intensity of cognitive deficit, prediction and dose effect, touchscreen technology and identification of best markers. All studies are designed to improve the ability to identify successful new medicines and to stop the development of those medicines destined to fail as early as possible.
Ms Brepoels, MEP (Belgium) asked what we could learn from the investment levels on dementia research in the US. Ms Vaudano explained that whilst investment in the US appeared higher, the scope of work is often wider in Europe. She said that in some areas the US was actually learning from how Europe works and had been surprised that in Europe people from different disciplines can work together in a collaborative way.
Elizabeth Morin-Chartier mentioned the role of technology in Alzheimer’s disease treatment and referred to the European discussions on the use of MRI and the exemption of MRI from the limit values of the revised Directive on Electromagnetic Fields. She insisted that it was our responsibility to strive towards a European legislation that will allow MRI to be performed in the same way across all Members States to avoid inequalities and ensure people with dementia can be diagnosed properly. Dr. Auffret added that in France there is a lack of federal facilities for research and that access to MRI is a challenge.
Heike von Lützau-Hohlbein, Chairperson of Alzheimer Europe, reflected that Alzheimer Europe had highlighted the importance and need for increased funding for research and greater research collaboration in the 2006 Paris Declaration. She said that she was delighted to see a concrete example of how Europe had responded to this call by supporting this coordinated research effort and she hoped it would result in the development of new treatments slowing down the progression of Alzheimer’s disease. . Ms Lützau-Hohlbein thanked the speakers and said that on a personal note that she had appreciated finding out what is happening in the area of research as both her mother and her mother-in-law had lived with dementia.
Ms Morin-Chartier thanked her colleagues who help to put dementia on the European agenda and stressed the importance of policy makers making sure they were engaged to try and understand the disease and to help carers. Support at all levels was evident at the debate by the attendance of nearly 50 people including MEPs [Heinz Becker (Austria), Frieda Brepoels (Belgium), Sean Kelly (Ireland), Astrid Lulling (Luxembourg) and Marina Yannakoudakis (UK)], MEPs’ assistants, national policy makers and representatives from the European Commission, Alzheimer associations and pharmaceutical companies.
Closing the debate, Ms Morin-Chartier said that the need to develop partnerships between researchers in all countries was clear and she thanked the researchers for the work they carry out.
Last Updated: Monday 02 July 2012