IMI Stakeholder Forum 2015 – Save the date!
The IMI Stakeholder Forum 2015 will take place on Monday 15 June in Brussels, Belgium. Every year, the IMI Stakeholder Forum gathers together IMI’s stakeholders in health and medicines R&D and provides them with an opportunity to learn about and discuss IMI's latest activities and plans. This year's event will focus on the following questions:
- How far has IMI come since its start in 2008?
- One year on from the launch of IMI2, how has IMI evolved into its second phase?
- And how it can further develop in the future to meet its ambitious goals of speeding up the development of, and patient access to, innovative medicines?
All stakeholders in health and medicines research and drug development are welcome: policy makers, academia, pharmaceutical industry and other sectors in healthcare, small and medium-sized enterprises (SMEs) and mid-sized enterprises, patient representatives and regulators, representatives of other public-private partnerships and research funding organisations. Registration will open in the coming weeks.
Ipsen’s Marc de Garidel elected Chair of IMI Governing Board
Marc de Garidel of Ipsen has been named as the new chair of the Innovative Medicines Initiative (IMI) Governing Board. Mr de Garidel is Chairman and Chief Executive Officer of French pharmaceutical company Ipsen, which specialises in neurology, endocrinology and urology-oncology. The Governing Board is the main decision-making body of IMI, carrying overall responsibility for the operations of the organisation and overseeing the implementation of its activities. The make-up of the 10-strong Governing Board reflects the equal nature of the partnership; 5 members come from the European Commission, and 5 come from the European pharmaceutical industry. Rudolf Strohmeier of the European Commission is Deputy Chair of the Board.
- Read the IMI press release
IMI Alzheimer’s projects unite to form platform
IMI and its AETIONOMY, EMIF and EPAD projects have announced the creation of the IMI Alzheimer’s Disease Research Platform. The platform will facilitate collaboration between the three projects, helping them to deliver results faster. At the same time, IMI and the Global Alzheimer’s Platform (GAP) announced their plans to sign a Memorandum of Understanding to accelerate Alzheimer’s drug development by building a global, standing, trial-ready platform for Alzheimer’s drug development. The announcements came during a symposium held at the 12th International Conference on Alzheimer's and Parkinson's Diseases and Related Neurological Disorders (AD/PD 2015), and in the wake of a major World Health Organization (WHO) conference on dementia. Dementia already affects over 35 million people globally, and places a huge and growing burden on health and social care systems and on the families and carers of those affected. There is still neither treatment nor cure for the disease. The three projects in the new IMI Alzheimer’s Disease Research Platform have a combined budget of €138 million and address complementary areas of Alzheimer’s disease research.
- Read about the IMI Alzheimer’s disease platform in a letter in the journal Alzheimer’s & Dementia
- View the presentations from the projects’ joint symposium at AD/PD2015
FLUCOP project gets underway
FLUCOP, IMI’s new project on seasonal flu vaccines, has got underway. The focus of the project is on ‘correlates of protection’ of flu vaccines – markers that indicate the level of protection offered by a vaccine. FLUCOP will provide the seasonal influenza vaccine community with improved or new tools to evaluate the vaccine’s ability to raise an immune response, allowing the comparability of clinical data across laboratories, and paving the way for establishing improved and/or novel correlates of protection. The harmonisation of laboratory tests will ultimately contribute to increase the transparency of the results and therefore the public trust in seasonal flu vaccination programmes. FLUCOP has 22 partners, including vaccine manufacturers, small and medium sized enterprises, major academic institutions, public health governmental institutions, and non-governmental organisations.
- Read the project’s press release
IMI antimicrobial resistance programme expands with new project
IMI’s antimicrobial resistance programme New Drugs for Bad Bugs has acquired a new project with the launch of COMBACTE-CARE. With 18 academic partners and 3 pharmaceutical companies , the project will bring highly innovative studies and activities related to the treatment of patients with infections caused by Carbapenem-Resistant Enterobacteriaceae (CRE). Tough to treat and sometimes deadly, CRE are considered to be one of the most dangerous resistant bacteria in the world. Specifically, the €83 million project aims to understand how patients with CRE infections are managed, with a focus on best available treatment and clinical outcomes. The project will develop new tools to detect CRE and conduct clinical trials with AstraZeneca’s antibiotic combination product Aztreonam-Avibactam (ATM-AVI), in development for the treatment of serious infections due to a difficulty to treat sub-type of CRE infections called metallo‐β‐lactamase producing Gram‐negative pathogens. All clinical and microbiological studies will be conducted in South-Eastern Europe, where infection rates with MDR-GNB are expected to be high. The phase III study is intended to include investigation sites outside Europe to ensure the global assessment of the ATI-AVI combination product.
- Read the project’s press release
News from the projects
COMBACTE open call for clinical trial programmes/studies - deadline 29 April
COMBACTE has launched an open call for clinical trial programmes or studies to join the project. The open call aims to identify potential replacement antimicrobial agents or approaches developed by EFPIA companies that could fulfil the overall objectives of the project i.e. to conduct prospective clinical trials with novel trial designs to deliver safety, pharmacology, and proof of efficacy data for novel agents directed towards treatment, prevention or sequelae of infections due to priority pathogens. COMBACTE is one of the first IMI projects to be launched under the ND4BB programme with the aim of developing a broad European network of fully capable and Good Clinical Practice (GCP) compliant clinical investigation sites associated to microbiological labs to execute clinical trials enabling the registration of novel agents to be used in the treatment of patients with bacterial infections. Following the early termination of development of GSK1322322, the first novel agent to be developed within COMBACTE, there is now opportunity for other clinical trial programmes or studies to join the COMBACTE project. A webinar on the open call is planned - details will be published on the COMBACTE website.
- Deadline for submissions: 29 April 2015 at 19:00 Central European Summer Time (CEST).
- Read the open call protocol and guidelines for submitting proposals
- Download the proposal submission template and evaluation criteria
Join EUPATI for an interactive workshop on 22 April
Join the patient education project EUPATI in Dublin, Ireland on 22 April for the workshop ‘EUPATI Taking off in Your Country – an Interactive Workshop on Implementing EUPATI in Your Country’. The project is in an exciting phase, as its training courses and materials are coming to life and going online. The challenge for the project now is to spread the word to patient advocates, patient representatives, and patients, as well as to the project’s academic and industry partners, all at a more local level. The goal of the Dublin workshop is to help identify how to move forward on this, and participants will have an opportunity to discuss, together with consortium members, the current and future strategy for the implementation of EUPATI at the national level. The workshop is open to all stakeholder groups that have a role in the medicines development process - patients, citizens, industry, academia, ethics committees, regulators, medical professionals, journalists, etc. Participation in the workshop is free.
- For further details and registration, visit the event website
PreDiCT-TB marks World TB Day
Tuberculosis (TB) project PreDiCT-TB marked World TB Day on 24 March with a series of articles, videos and tweets on its activities. TB is an infectious bacterial disease. Although it is both preventable and treatable, in 2013, 9 million people fell ill with TB and 1.5 million died. The goal of PreDiCT-TB is to find the most rapid and reliable ways of identifying the most potent combinations of new drugs and hasten their arrival in the clinic. Material released on World TB Day included:
- An article on the University of St Andrews’s work in the project. The team looks at ways of detecting TB bacteria that are naturally resistant to current treatment and using this information to understand and predict the effect of current and future treatment regimens.
- Videos from the team at the University of Liverpool, including an overview of the project and a discussion on historical clinical trial data.
- A day in the life of Sanofi’s Lucie Eckenberg-Friedlander, who heads up the project’s work package on data management.
- An article on the team at École Polytechnique Fédérale de Lausanne (EPFL), which is developing tools to assess the efficacy of TB drugs.
- An interview with the project’s academic coordinator, Dr Gerry Davies of the University of Liverpool.
Sign up for the SUMMIT symposium on diabetes complications
Diabetes project SUMMIT will hold a symposium entitled ‘A leap forwards for diabetes complications’ in Malmö, Sweden on 22 April 2015. SUMMIT is working to improve our ability to identify and treat diabetes patients at greatest risk of diabetes complications such as eye, kidney, and cardiovascular disease. At the symposium, members of the SUMMIT team will present highlights from their research, while speakers from outside the project will put SUMMIT’s findings into a broader context. Participation in the symposium is free but registration is obligatory.
- Download the agenda (which also includes information on registration).