February 2014: "The Innovative Medicines Initiative: improving drug discovery for Alzheimer’s disease"
Françoise Grossetête, MEP (France) and Chair of the European Alzheimer’s Alliance (EAA) hosted an Alzheimer Europe lunch debate focusing on the activities of IMI, the Innovative Medicines Initiative.
MEP Grossetête welcomed the participants and thanked Michel Goldman, IMI’s Executive Director, for taking the time to present the workings of the public-private partnership. She also gave a short overview of IMI - whose funding phase has now ended - and an update on “IMI 2”, for which she is the shadow rapporteur for the EPP group in the European Parliament. As rapporteur for the first IMI, she was also keen to stress that no other European or national programme had led to such comprehensive collaboration between pharmaceutical companies.
IMI is a public-private partnership between the EU and EFPIA, the European Federation of Pharmaceutical Industries and Associations. EFPIA brings together 33 European national pharmaceutical industry associations as well as 40 leading companies undertaking research, development and the manufacture in Europe of medicinal products for human use.
IMI received EUR 2 billion in financing over its 2008-2013 lifetime, evenly split between the EU and EFPIA. These monies have so far funded 46 medical research programmes, including EUR 167 million for four Alzheimer’s disease projects. Alzheimer Europe (AE) is participating in all of them: AETIONOMY, EMIF and PharmaCog are already underway and EPOC-AD will begin in 2014.
In January 2014, the Industry Committee of the European Parliament approved the text for IMI 2, which will operate during 2014-2025 with a budget of over EUR 3 billion. The new initiative will fund, among other things, research on healthy ageing and speeding up the identification of new treatments. According to Ms Grossetête, dementia research will be a priority, especially the development of new diagnostic tools. [Editor’s note: the IMI 2 text was approved in a plenary session of the European Parliament on 16 April.]
Ms Grossetête concluded her presentation with the hope that IMI will help lead to a cure for Alzheimer’s disease by creating new synergies among public and private research bodies. Cooperation and sharing will continue to be essential in eliminating the fragmentation of research efforts.
Professor Goldman thanked MEP Grossetête for her efforts to shepherd the IMI 2 bill through the Parliament’s administrative process. He specifically noted that her work had helped the Industry Committee to see beyond the traditional funding models of previous research programmes.
An engine for therapeutic innovation
Prof. Goldman began his presentation by explaining that IMI is above all else a collaborative effort. To illustrate this, he quoted Dr Elias Zerhouni, medical researcher and former Director of the U.S. National Institutes of Health: “Deciphering the complexity of human diseases and finding safe, cost-effective solutions that help people live healthier lives requires collaboration across scientific and medical communities throughout the health care ecosystem. Indeed, we must acknowledge that no single institution, company, university, country, or government has a monopoly on innovation.”
By mid-2013, IMI projects involved more than 6,000 people from 650 academic and research teams, 409 EFPIA teams, 120 SMEs, 25 patient organisations and 17 regulatory agencies. This unique blend of public and private skills has led to the development of a collective intelligence network that will inevitably grow - and continue to operate beyond the lifetime of the IMI projects. In addition, the EFPIA pharmaceutical companies are seeing improved research and development productivity. The result is a series of innovative approaches for unmet public health needs.
Prof. Goldman also showed that scientific papers published by IMI partners during 2010-2012 were consistently rated higher than non-IMI publications. This was especially true for papers about psychiatry, clinical neurology and neuroscience research. He firmly believes that better cooperation between academia and the pharmaceutical industry will always lead to better science.
Addressing the specific challenges of dementia
In the first IMI programme, around 10% of the total budget has been allocated to brain disorders. This is more than the funding for any single disease and a clear indication of the urgent need for therapeutic strategies. Prof. Goldman pointed out that EUR ten billion has been spent on beta amyloid research without any real results. This is partly due to the way clinical trials are conducted today, as they do not allow to adequately establish the efficiency of a drug. The overhaul of clinical trial design is one the principal aims of IMI: Prof. Goldman referred to a January 2014 paper in Nature Medicine where drug companies are teaming up to run clinical trials in many different disease areas.
Currently, four IMI projects are addressing dementia-specific topics: the complexity of brain pathology, patient heterogeneity and the lack of validated markers for disease activity.
- PharmaCog(2010-2015) is developing models to predict the efficacy of drug candidates by combining past and current data to define a series of biomarkers of dementia progression.
- EMIF(2013-2018) is connecting data on 40 million individuals to decipher links between genetic background, biological abnormalities, brain imaging changes, mental symptoms and disease progression.
- AETIONOMY(2014-2019) is identifying subgroups of dementia and Parkinson’s disease, based on the underlying genetic or molecular causes of the variants, in order to allow tailored therapies.
- EPOC-ADwill launch in 2014 with the aim to accelerate drug development by helping pharmaceutical companies share resources in the early phases of drug testing. According to Prof. Goldman, 18 companies have agreed to cooperate in this project.
He also explained that IMI supports the PROTECT project, which aims to improve the benefit-risk assessment methods used by the EMA (European Medicines Agency) to authorise the use of new drugs in Europe. Prof. Goldman’s presentation was followed by a discussion period where various issues were addressed:
Involvement of people with dementia: all IMI project planners are strongly encouraged to include patient groups as active partners and this is already the case for many projects. Jean Georges, Executive Director of Alzheimer Europe, explained how AE represents the interests of people with dementia in the IMI projects listed above.
Alcoholism and dementia: replying to Hiltrud Breyer, MEP (Germany), Prof. Goldman agreed that more research is needed to differentiate the causes of dementia, including the effects of alcoholism. He noted that the AETIONOMY project is specifically tasked to identify these underlying causes.
Parliament Dementia Envoy: Mr Georges suggested that the European Parliament appoint a dementia envoy to ensure that all scientific and social research efforts are coordinated. Prof. Goldman commented that the OECD and the G8 Dementia Challenge are also working to enhance research activities.
Geographical inequity: Prof. Goldman said that IMI projects are reaching a growing number of countries in Europe, including the eastern and southern regions. A basic tenet of IMI is to involve as many organisations in as many countries as possible. In addition, patients need to be considered as active players in drug development by all the research and government agencies involved.
Alzheimer Europe presents 2013 reports
The lunch debate was followed by a presentation of Alzheimer Europe’s 2013 research reports by Heike von Lützau-Hohlbein, Chairperson of Alzheimer Europe.
2013 Dementia in Europe Yearbook
The new yearbook contains the results of a survey on national policies relating to the care and support of people with dementia and their carers. The report also features dementia prevalence figures in 33 European countries.
More specifically, the yearbook details the provision of care, the training of health and social care professionals and support in the home, the community and in nursing homes. For each country, the report includes details of the national dementia strategy and/or any related policy provisions.
In addition, there is a section on the services and types of support provided by the national Alzheimer association. The country reports also include comparative tables that show the prevalence of dementia by sex and age group, as well as the various services offered by the associations.
2013 Ethics report
This report, entitled “The ethical issues linked to the perceptions and portrayal of dementia and people with dementia”, looks at the many different ways that people make sense of dementia. It covers perceptions associated with the experience of dementia, the cause of dementia and the possible implications of dementia on individuals and society.
There are also sections on the use of metaphor and on the portrayal of dementia in the media and in films. Each section details the reflection by the multi-disciplinary working group on the ethical implications for people with dementia of being perceived and portrayed in a particular way.
The report also considers how people with dementia feel about dementia and about the way they are perceived and portrayed within society. The report ends with a set of guidelines on things to consider when writing about or portraying dementia and people with dementia.
Following this presentation, Françoise Grossetête and Heike von Lützau-Hohlbein thanked Michel Goldman and all the participants for their attendance and active participation.
Delegates at the lunch debate included MEPs Hiltrud Breyer (Germany), Sirpa Pietikäinen (Finland), Angelika Werthmann (Austria) and Marina Yannakoudakis (UK). Other participants included representatives from the European Commission, the pharmaceutical industry and representatives from 19 Alzheimer Europe member associations.
Last Updated: Monday 15 September 2014