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A great occasion to get to know more on three Alzheimer’s Disease IMI (Innovative Medicines Initiative) projects, was at the 27^th Alzheimer Europe Conference (#27AEC), held in Berlin from 2-4 October. At a symposium convened by Eli Lilly, entitled: “Engaging with patient organisations within IMI consortia to inform quality, relevance and value in Alzheimer’s research – insights from MOPEAD, EPAD and ROADMAP”, the attendees were able to explore how these three initiatives are tackling AD across the disease continuum. The panelists provided their perspectives regarding the rationale for each project, engaging in a discussion on the concrete multipronged actions to improve timely diagnosis through citizens’ participation, pioneering novel approaches to clinical trials and providing evidence regarding the value of new medications. The first panelist was Mercé Boada, she is co-founder of Fundació ACE and Project Coordinator of the MOPEAD (Models of Patient Engagement for Alzheimer’s Disease). Her presentation was followed by an introduction to the EPAD (European Prevention of Alzheimer’s Disease) project by Craig Ritchie (pictured) Director of the Centre for Dementia Prevention. The presentations were rounded off by Catherine Reed principal research scientist at Eli Lilly who introduced ROADMAP (Real world Outcomes across the AD spectrum for better care: Multi-modal data Access Platform) and how real-world evidence may be used to address specific healthcare challenges. One of the highlights of the following discussions was the engagement of Pierre Meulien Executive Director of the IMI at the end of the symposium.

Watch the EPAD presentation on Engaging with patient organisations within IMI consortia to inform quality, relevance and value in Alzheimer’s research “ insights from MOPEAD, EPAD and ROADMAP” here.

In September 2017, two articles about the EPAD project appeared in the media.

On 19 September, the Italian newspaper “la Repubblica” published an article entitled “L’Alzheimer si combatte giocando d’anticipo” including an interview and quotes from Prof. Giovanni Frisoni from the University of Geneva. He highlighted the EPAD project and described it as “il piu grande al mondo sull’Alzheimer”. The article can be read on the journal website.

On 21 September, the Journal of mHealth released its latest issue (August/September 2017 Edition). Pamela Brankin, Head of Marketing and Communications at Aridhia, wrote an article entitled “Transforming trials – why data-driven drug development is critical to gaining competitive advantage” where EPAD was featured as a project exemplifying the benefits to use adaptive trials in research. The article can be read on the Journal of mHealth website.

The EPAD family bids a fond farewell to Lennert Steukers. Lennert worked full time as project manager for Janssen on the IMI-EPAD project and provided the overall management to the project. In this role, he notably supported the coordinator, executive committee and the WP leaders in day-to-day management. He was also involved in EPAD’s internal and external communication activities.

All the EPAD family would like to thank him for his many outstanding contributions and his dedication throughout the past 2.5 years. Lennert will be taking a new position of a Clinical Scientist, Experimental Medicine Neuroscience in Janssen. We wish him every success in the future.

The EPAD project reached the halfway of the project in June 2017. Given that all IMI projects are subject to an official Mid Term Review, EPAD held its IMI Mid-Term Review meeting on 15 September 2017 in Brussels, Belgium.

The WP leads presented their work and the overall project progress to an independent expert panel. They gave impressive presentations, which were followed by fruitful discussions. The Mid-Term Review performed by IMI and a group of external experts went very well. Indeed, the evaluators were pleased with the project, its progress and contingency plans we have in place.  It was a successful Mid-Term Review meeting with very positive feedbacks.  The EPAD project was congratulated for what it has achieved so far. The review panel suggested some improvements for the next two years and the final report with the recommendations from IMI are expecting by the end of October.

On 7 September, the European Federation of Pharmaceutical Industries and Associations (EFPIA) held an event under the banner “Unlocking tomorrow’s cures” in Brussels, Belgium. The EFPIA Rentrée 2017 gathered six scientists working on groundbreaking, innovative and life-changing therapies:

1. Dr Frank Bähner, Area Head Prophylactic Vaccines at Curevac, explained the advantages of mRNA vaccines where pandemics arise.
2. Serge Van der Geyten (pictured), Director Neuroscience External Affairs at Janssen Pharmaceutical, presented EPAD with a talk entitled “Prevention of Alzheimer’s Dementia in Europe – the EPAD project”. He described the EPAD initiative, its aims and its progress to date.
3. Alain Munafo, Global Head of Quantative Pharmacology at Merck explained the use of clinical trials in Multiple Sclerosis.
4. Dr Alastair Coupe from Pfizer UK described the challenge of formulating better medicines for children.
5. Ana Isabel Jiménez, Director of R&D at Sylentis, highlighted that oligonucleotides represent a novel approach to discovering new therapeutic agents.
6. Luc Uylenbroeck, Head of New Patient Solutions and Portfolio Management at UCB, described how his company is able to create value for patients.

More information on the EFPIA Rentrée 2017: https://efpia.eu/news-events/the-efpia-view/blog-articles/07092017-efpia-s-rentree-2017-unlocking-tomorrow-s-cures/

On 31 July, The Times Scotland published an article entitled: “Everyday pill to stop dementia in its tracks is tested in Scotland” where the EPAD project was featured.

In this great article wrote by Helen Puttick, the health reporter for The Times in Scotland, Prof Craig Ritchie, EPAD co-coordinator, explained dementia prevention and mentioned that changes in the brain may precede symptoms of Alzheimer’s dementia by many years or even decades. He said: “The problem is, a lot of the drugs that have been failed, almost definitely because they were given too late”.

Dr Rosa Sancho, head of research at Alzheimer’s Research, UK, said: “It’s great to see innovative new dementia studies such as EPAD, which are taking on board many of the lessons learnt over recent years. By studying people at risk of Alzheimer’s but before they develop symptoms, researchers have the opportunity to develop approaches to stop the diseases in its tracks.”

The article is available here: https://www.thetimes.co.uk/edition/scotland/everyday-pill-to-stop-dementia-in-its-tracks-is-tested-in-scotland-0xxz6tnhq

What is your current role in EPAD?

I am a biostatistician and therefore my key role is in the statistical work package (WP2). I have mostly been involved in writing the protocol for the proof-of-concept study, which has been evolving since I joined EPAD in February 2016. WP2 is also responsible for statistical modelling of the disease progression, which will contribute to our disease understanding.

What did you do prior to joining EPAD?

My education includes a PhD in statistics followed by a degree as Doctor of Science based on a thesis on frailty models (which is a kind of models used in survival data). I have worked in the pharmaceutical industry for almost my entire career (32 years!), first NovoNordisk and, now, Lundbeck, where I have a specialist position at the VP level. EPAD is only one of my duties. I also have a responsibility for scientific activities and help and advice my colleagues across all the company projects. I have recently finished being supervisor for an EU-funded PhD student working on adaptive dose-finding studies and this knowledge is helpful for the planning of the EPAD POC study. I also have an affiliation with the University of Southern Denmark as external professor.

Tell us a bit about the institution/company/organisation you work for.

Lundbeck is a pharmaceutical company focusing development on four diseases within psychiatry and neurology (depression, schizophrenia, Parkinson and Alzheimer’s). We market a range of products within the four indications as well as other CNS indications. Our vision is to strive for global leadership in psychiatry and neurology by improving the lives of patients. Lundbeck has around 5000 employees and is headquartered in Copenhagen, Denmark but is selling the products globally.

What are your expectations from the EPAD project?

With the aging population, our society has a big need both for preventing and treating Alzheimer’s disease. However, experience has shown that drug development in Alzheimer’s disease is very difficult, for several reasons. Going into preventive treatments makes this even more difficult, so tackling drug development in this domain is a complex task. My expectation is that EPAD can make this drug development easier than it would be in a single company setup. While we are still working on getting the POC study up and running, my long-term expectation is that doing proof-of-concept in this way will be better and faster than alternative solutions.

What is your current role in EPAD?

I work as a clinical project manager in the Gérontopôle team at Toulouse University Hospital coordinated by Pr Bruno Vellas who is the EPAD National Lead for France. I was designated to be the national study coordinator for EPAD project in 2015. We are involved in two major Work Packages: WP3 for the Registry and WP4 for the longitudinal cohort study (LCS). My role is to manage the implementation of both EPAD Registry and EPAD LCS study in our site and in the French participating sites. In France, as source of recruitment for EPAD LCS study, we connected subjects from the French Alzheimer research registry, which was initially developed by our team in order to improve recruitment in clinical trials in the field of Alzheimer’s disease. We have now 4 French sites connected to PREPAD (Toulouse, Lille, Nantes and Montpellier). In July 2016, we obtained all the regulatory authorizations for starting the EPAD LCS study in France. The first subject was recruited in September 2016 in our clinical research center, coordinated by Dr Pierre Jean Ousset, and we screened more than 50 subjects until now. During the autumn, 5 French sites should be active for the EPAD LCS study (Lille, Nantes, Montpellier, Paris Lariboisière and Paris La Pitié Salpetrière).

What did you do prior to joining EPAD?

I have a PhD and a postdoctoral fellowship in Biology of Aging. My research interests were always focused on aging, memory and prevention. Thanks to my experience in the pharmaceutical industry at the preclinical level, I learned a lot in the development of drugs against Alzheimer’s disease. Ten years ago, I joined the clinical research team of Pr Bruno Vellas, for the coordination of an important preventive trial: the MAPT study (Multidomain Alzheimer Preventive Trial). It was a very rewarding experience because the study was conducted in 13 sites in France, and 1,680 participants were recruited and followed during 3 years (Andrieu et al. Lancet Neurol, 2017). Since 2014, I had the chance to be involved in the coordination of the therapeutic assays in the field of Alzheimer’s disease with Dr Pierre Jean Ousset, and together, we have the pleasure to lead the national Alzheimer Research Network.

Tell us a bit about the institution/company/organisation you work for.

The “Gérontopôle” of the Toulouse University Hospital was created in 2007 and was the first French center to have obtained this label from the French Ministry of Health for which it was commissioned to conduct research and develop actions on prevention in the field of aging. One of the main areas of work concerns the prevention of disability and our aim is to promote multi-disciplinary research in relation with high quality care. The 3 strategic axes of the Gérontopôle are: (1) Alzheimer’s disease with the development of research programs relevant to prevention, therapeutics and biomarkers; (2) Frailty and maintaining autonomy; (3) Clinical research in nursing homes.

What are your expectations from the EPAD project?

In my opinion, the EPAD project is a project full of hope above all for the patients but also for the families and the health professionals. Through follow – up in the EPAD Longitudinal Cohort, we can offer participants an assessment of their risk of developing AD, and, for those at risk, the opportunity of benefiting from therapeutic prevention trials. Thus, our participation in the EPAD project is an important issue because it should allow the implementation of therapeutic trials at a very early stage of Alzheimer’s disease.

The European Prevention of Alzheimer’s Dementia Consortium (EPAD) seeks a Global Trial Leader. 

There have been no new treatments for Alzheimer’s Dementia for over 15 years and there are no interventions on the market at all for disease modification or prevention. EPAD is the world’s largest ever dedicated platform for testing new interventions to prevent Alzheimer’s Dementia.

The EPAD project is funded from a comprehensive public:private partnership of Europe’s leading academic centres and pharmaceutical companies, dedicated to the development of new therapies to prevent the progression of Alzheimer’s Disease. A key part of the project is the development and maintenance of a virtual pipeline of interventions to be implemented in the EPAD Proof of Concept study. As this trial is a ‘platform trial’, with a single protocol and several appendices, not only do we need an innovative and exciting pipeline, we also need to make sure we achieve seamless integration of each new therapy into the study.

The role of the Global Trial Leader (GTL) for EPAD will be both pivotal and crucial to the project’s success. With a minimum of eight years’ clinical trial experience from the pharmaceutical industry or a CRO, this person will have first-class leadership, negotiation and conflict resolution skills, as well as the ability to influence without clear reporting authority. The successful applicant will bring experience of leading global or regional teams in a virtual environment, with a proven track record of developing creative solutions and meeting project objectives. Ultimately, EPAD’s new GTL will combine in-depth clinical research operational knowledge with strong strategic thinking, commercial acumen and the ability to lead and develop a multi-disciplinary team.

This appointment will be made on a consultant contract of 12 months, with the possibility of renewal.

Download the Global Trial Leader information pack here

How to Apply:

Enquiries or applications can be made, in confidence, to Mary Comer on +44 7408 850797 or email maryc@wittkiefferccentric.com quoting job reference 15817

The EPAD consortium is increasing in optimism regarding the success of its project that had some great media coverage during the summer.

On 20 July, research in dementia prevention was covered in BBC on its main 6 o’clock news bulletin (see link at bottom – from 19 min 50 sec) and on BBC Radio 4 (see link at bottom – from 17 min 10 sec). Prof Craig Ritchie, EPAD co-coordinator, was interviewed by the BBC and talked about both the PREVENT Dementia study and the EPAD project, led from the University of Edinburgh Centre for Dementia Prevention.

BBC TV news bulletin: http://www.bbc.co.uk/programmes/b08xd148

BBC radio 4 segment: http://www.bbc.co.uk/programmes/b08xxdq7

The EPAD project has received support from the Innovative Medicines Initiative Joint Undertaking under grant agreement n° 115736, resources of which are composed of financial contribution from the European Union’s Seventh Framework Programme (FP7/2007-2013) and EFPIA companies’ in kind contribution.