IMI Newsletter: Stakeholder Forum, advanced therapies consultation, project news

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58th Edition – June 2016

  IMI Stakeholder Forum 2016 – Save the date!   IMI at BIO 2016   IMI cited in Council conclusions on AMR   IMI consultation on advanced therapies – have your say   Next deadline approaching for IMI’s open Call on Ebola   New VAC2VAC project to develop non-animal methods for vaccine testing   News from the projects   IMI statement on the outcome of the referendum of the UK's membership of the EU

IMI Stakeholder Forum 2016 – Save the date!

The IMI Stakeholder Forum 2016 will take place on Wednesday 28 and Thursday 29 September at the Hotel Crown Plaza - Le Palace in Brussels, Belgium. Raju Kucherlapati, Paul C. Cabot Professor of Genetics and Professor of Medicine at the Harvard Medical School, will provide the keynote speech.
Held annually, the IMI Stakeholder Forum gathers 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.

The event will start after lunch on Wednesday 28 September. The afternoon programme will focus on IMI's latest initiatives and introduce the topics of the upcoming Call for proposals and facilitate partnering opportunities for applicants.
On Thursday 29 September, parallel consultative workshops on strategic research areas will bring together IMI stakeholders to shape together the future of IMI’s programme. The event will draw to a close at 17:00.

IMI at BIO 2016

IMI’s first participation in the BIO International Convention was a success, with excellent attendance at its conference sessions. Over 200 people came to a workshop co-organised by IMI that was dedicated to novel antibiotics and antimicrobial resistance (AMR) innovation. Specifically, it showcased global research programmes supporting the development of novel anti-infectives as well as 10 innovative small companies from around the world that are pioneers in the development of new antibiotics. A session organised by IMI in the brain health track of the BIO educational programme attracted over 160 attendees. Despite decades of research, there is still neither treatment nor cure for Alzheimer’s disease and success in clinical trials remains elusive. Pioneering projects on both sides of the Atlantic are working together to turn this situation around by running adaptive clinical trials – a first in Alzheimer’s research. In this session, leading dementia experts, including from IMI's EPAD project, shared their experiences and discussed how best to overcome the challenges to delivering successful clinical trials for much-needed Alzheimer’s treatments. IMI was also present at the European Commission’s booth at the BIO Exhibition. BIO 2016 was held in San Francisco in early June. The event attracted over 15 000 biotechnology and pharma leaders.

Presentations from IMI’s conference sessions can be downloaded from the IMI website.

IMI cited in Council conclusions on AMR

EU health ministers meeting in Brussels highlighted the work of IMI’s antimicrobial resistance (AMR) project DRIVE-AB in their Council conclusions on antimicrobial resistance. In the document, the ministers describe AMR as a ‘global public health concern’ and note that it kills 700 000 people globally every year. The Council also ‘underlines that in order to stimulate the development of new antimicrobials, alternative therapies and (rapid) diagnostics, EU and global coordination and cooperation on research programmes and incentives are needed and recognises the work done by the Innovative Medicines Initiative (IMI) project DRIVE-AB (Driving reinvestment in research and development and responsible antibiotic use), the proposals of the Antimicrobial Resistance Review team and the Joint Programming Initiative on Antimicrobial Resistance among others’. IMI’s AMR programme was born out of the European Commission’s 2011 action plan on AMR, and the ministers Call on the Member States and Commission to develop a new, comprehensive action plan. For their part, DRIVE-AB comments: ‘To be acknowledged by the EU Council is an exceptional and outstanding achievement, and the consortium is very pleased to receive such recognition for its work. The group looks forward to continuing to work with global stakeholders to develop and implement new, feasible reward models to drive investment into antimicrobial research and development.’

IMI consultation on advanced therapies – have your say

The field of advanced therapy medicinal products (ATMP) is scientifically progressing at a very fast pace, as demonstrated by the number and variety of clinical trials conducted over the last five years, yet there are numerous factors that have complicated the translation from research into patient access.
IMI, in collaboration with key stakeholders, has developed a concept paper on advanced therapies which we are posting for public consultation. The aim of the concept paper is to identify the potential of IMI as a platform for enhancing ATMP research and development.
Contributors who wish to submit comments on the concept paper are encouraged to consider in particular the following questions:

Have the key challenges that can be addressed through collaborative, public-private initiatives been properly identified? Which of the proposed potential initiatives should be prioritised? Are any areas missing? What are the key European or national initiatives that IMI should synergise with?

Deadline for submitting comments: 25 July 2016
More information on the consultation, including details of how to submit comments, can be found on the IMI website.

Next deadline approaching for IMI’s open Call on Ebola

The next cut-off date for submitting proposals for IMI’s open Call on Ebola and related diseases (IMI 2 - Call 8) is 15 September 2016. Following the first cut-off date in March of this year, €55 million is left in the pot for future projects. The Call was launched to capture emerging scientific advances and to progress those rapidly into health care interventions. Projects funded under this Call should ensure fast development and a wide deployment of sustainable innovative solutions that will result in an increased readiness to respond to future outbreaks. Applicants should pay particular attention to exploiting support from different stakeholders, including the mobilisation of funds through the inclusion of contributing partners under the IMI scheme of public-private consortia. Proposals may address aspects of pre-clinical development and/or clinical development of vaccines, treatments and diagnosis of Ebola or other filovirus infections. Manufacturing strategies, vaccine stability during transport and storage, and/or deployment of vaccines and treatments are also in scope. There are a number of cut-off dates for this open Call, with the final cut-off date set for March 2018.

All Call documents and details of how to apply can be found on the Call 8 page Read IMI’s press release Read our tips for applicants and find partners View the webinar on the Call

New VAC2VAC project to develop non-animal methods for vaccine testing

Developing and validating alternative, non-animal testing approaches for both human and veterinary vaccines is the main goal of a newly-launched IMI project called VAC2VAC. In routine vaccine production, the current quality control approach requires large numbers of laboratory animals. The new IMI project aims to provide data to support the ‘consistency approach’ for quality control that promotes the use of in vitro, analytical, non-animal based systems. VAC2VAC is a public-private consortium of 20 partners from 7 different countries, bringing together both the human and veterinary pharmaceutical industry along with academia and regulators. VAC2VAC started on 1 March 2016 and has a total budget of €15.98 million. Half of this comes from the EU’s Horizon 2020 programme; the other half comes in the form of in-kind contributions from the EFPIA companies.

News from the projects

European Lead Factory sets sights on neglected tropical diseases
In a bid to contribute to the development of treatments for neglected tropical diseases (NTDs), IMI’s European Lead Factory project is waiving certain fees for drug discovery programmes in the area. The waiver applies specifically to non-profit programmes on diseases on the World Health Organization list of NTDs. The diseases on the list, which includes sleeping sickness, rabies, leprosy, and dengue fever, are found in 149 (mainly tropical and sub-tropical) countries and affect one billion people worldwide.
‘For drug target programmes relating to the pathogens on the WHO list of neglected tropical diseases, clinical or diagnostic milestone payments will be waived, thereby freeing charities and other organisations from financial obligations in their pursuit of new therapies for patients in the least developed countries,’ said the project in a statement.
The European Lead Factory allows researchers to propose drug targets for screening against the project’s 400 000-strong compound collection. The project also offers assistance with the follow-up of results generated through the project. Achim Schnaufer of University of Edinburgh recently drew on the project for his research. ‘The compounds that were identified by the European Lead Factory have really promising properties and we look forward to building on these discoveries,’ he said. ‘We are very grateful for European Lead Factory's support for our efforts to develop new therapies for African sleeping sickness and other related diseases.’
GetReal and ADAPT-SMART launch glossaries
Information on drug development is often filled with jargon. Now IMI’s GetReal and ADAPT SMART projects  have released new/updated glossaries to facilitate discussions in their respective subject areas.
GetReal is investigating how to best incorporate ‘real world evidence’ into drug development. Its updated glossary, which was the subject of a consultation, also includes a more detailed discussion on questions such as the difference between ‘efficacy’ and ‘effectiveness’.
ADAPT SMART was set up (among other things) to coordinate IMI activities in the area of MAPPs (medicines adaptive pathways to patients). Many of the items in its glossary are drawn from the GetReal glossary. The project welcomes feedback on the glossary.


DRIVE-AB discusses proposals on economic models for antibiotic innovation
IMI project DRIVE-AB is working to define new, alternative economic models for antibiotic development that balance the need to reward those who develop new antibiotics with the need to use new antibiotics only when absolutely necessary. Now the project has shared its preliminary ideas with 180 high-level experts at a conference in Amsterdam, the Netherlands on 2 June. Some key points arising from discussions at the event include:

Hospital stewardship programmes and antibiotic regulation are either lacking or insufficient in many parts of the world. Efforts to address antibiotic resistance should be coordinated globally. Reward models for antibiotics should align with sustainable use policies and delink the volume of sales from return on investment. New reward models should be piloted in appropriate settings as soon as possible, with support from pharmaceutical companies. Innovation and sustainable use are only part of the equation for addressing antibiotic resistance. Infection prevention and control, vaccine use and a One Health approach are necessary as well. There is a need for coordinated global public investment, which should direct antibiotic research and development to meet public health needs that are defined by a global body.

IMI statement on the outcome of the referendum of the UK's membership of the EU

Following the result of the United Kingdom’s referendum on its membership of the European Union, the Innovative Medicines Initiative (IMI) will continue to implement its work programme as planned with the mission of improving health by speeding up the development of, and patient access to, the next generation of medicines, particularly in areas where there is an unmet medical or social need.

The vote does not mean that the UK will cease to be a member of the EU with immediate effect; therefore IMI will continue to operate under the current rules until the negotiations between the UK government and the European Union are concluded.

IMI consortia, as well as potential applicants to IMI Calls for proposals, should operate in a ‘business as usual’ mode. IMI is part of Horizon 2020, and as such IMI’s position will remain closely aligned with the position of the European Commission and other institutions relating to Horizon 2020. Meanwhile IMI will continue to communicate on the impacts on its stakeholders and activities as and when necessary.

Read the statement online

The Innovative Medicines Initiative is the largest public-private partnership aiming to boost pharmaceutical innovation in Europe and to speed up the development of better and safer medicines for patients. IMI is a joint undertaking between the European Union and the pharmaceutical industry association EFPIA.
www.imi.europa.eu

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