This document discusses post-Brexit implications for research and cooperation in Europe. It outlines how Brexit may impact the movement of staff in research and health industries, future data protection and clinical trial frameworks, and authorization of new medicines. It also summarizes several ongoing EU research initiatives on neurodegenerative diseases, including the Joint Programme for Neurodegenerative Disease Research (JPND) and Innovative Medicines Initiative (IMI), and EU Joint Actions on Dementia.

1. Post Brexit implications for
research and cooperation in Europe
Edinburgh – 2 June 2017
Jean Georges, Executive Director
@JeanGeorgesAE

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4. Agenda
• Movement of staff in research and health industry
• Future data protection and clinical trial frameworks
• Authorisation of new medicines
• Collaboration on EU research initiatives
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6. Data protection at EU level
• Regulation (EU) 2016/679 of the European
Parliament and of the Council of 27 April 2016 on the
protection of natural persons with regard to the
processing of personal data and on the free
movement of such data
– A single set of rules on data protection, valid
across the EU.
– Unnecessary administrative requirements will be
removed.
– Increased responsibility and accountability for
those processing personal data.
– People will have easier access to their own data
– A ‘right to be forgotten’ will help people better
manage data protection risks online 6

7. Clinical trials at EU level
• Regulation (EU) No 536/2014 of the European
Parliament and of the Council of 16 April 2014 on
clinical trials on medicinal products for human use
– Streamlined application procedure via a single
entry point, the EU portal
– Single set of documents to be prepared and
submitted
– Harmonised procedure for assessment of
applications
– Simplified reporting procedures
– Increased transparency as regards clinical trials and
their outcomes.
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8. Clinical trials
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Numberofpoints
Countries (n=36)
Clinical Trials
Aducanumab Brexipiprazole CAD106 Crenezumab Idalopirdine JNJ-54861911 LY3314814 RVT-101 Verubecestat
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11. JPND (Joint programme ND research)
• Common vision, strategic research agenda and
management structure for joint programming of
research in neurodegenerative diseases
• 30 participating countries (including Australia, Albania,
Canada, Israel, Norway, Switzerland, Turkey)
• Joint European priorities and evaluation but national
funding
• 15 ongoing projects (2011-2014) for EUR 68.5 million
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12. Innovative Medicines Initiative
• EUR 168.8 million funding under IMI 1
– PharmaCog - Prediction of cognitive properties of new drug candidates
for neurodegenerative diseases in early clinical development
– EMIF - European Medical Information Framework
– AETIONOMY - Organising mechanistic knowledge about
neurodegenerative diseases for the improvement of drug development
and therapy
– EPAD - European Prevention of Alzheimer’s dementia
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13. Innovative Medicines Initiative
• EUR 80.4 million funding under IMI 2
– ADAPTED - Alzheimer's disease apolipoprotein pathology for treatment
elucidation and development
– AMYPAD - Amyloid imaging to prevent Alzheimer’s disease
– MOPEAD - Models of patient engagement for Alzheimer’s disease
– PHAGO - Inflammation and AD: modulating microglia function - focussing on
TREM2 and CD33
– PRISM - Psychiatric Ratings using Intermediate Stratified Markers
– ROADMAP - Real world outcomes across the AD spectrum for better care:
multi-modal data access platform
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14. EU Joint Actions on Dementia
• ALCOVE: ALzheimer COoperative Valuation in Europe
(2011-2013)
– Models for timely diagnosis, Prevalence of dementia in Europe,
Support systems for behavioural and psychological symptoms in
dementia, Toolbox for reduction of anti-psychotics in dementia,
Advance directives and competence assessment
• DEM2: Act on Dementia – (2016-2018)
– Timely diagnosis and post-diagnostic support; Crisis and care
coordination; Residential care; Dementia-friendly communities
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15. 15
Alzheimer Europe
39 associations in 34
countries