Hugh Laverty

5th July 2017, IMI-ECSEL Workshop

The Innovative Medicines Initiative Project Portfolio

IMI1 budget distribution per disease area

IMI2 budget distribution per disease area

Cross-project communication & collaboration

ND4BB Information Centre

All data generated is submitted and made accessible to all partners

TRANS-

LOCATION

Research on

penetration

& efflux in

Gram-

negatives

Data hub &

learning from

R&D

experience

ENABLE

Discovery &

development

of new drugs

combatting

Gram-

negative

infections

COMBACTE

Enabling

clinical

collaboration

& refining

clinical trial

design

Clinical

development

of

compounds

for Gram

positives

COMBACTE-

CARE

Clinical

development

of

antibacterial

agents for

Gram-

negative,

antibiotic

resistant

pathogens

COMBACTE-

MAGNET

Systemic

molecules

against

healthcare-

associated

infections

DRIVE-AB

Driving

reinvestment

in R&D &

responsible

use of

antibiotics

iABC

Inhaled

antibact-

erials in

bronchiec-

tasis and

cystic

fibrosis

Drug

discovery

New Drugs for Bad Bugs (ND4BB)

Drug

development

(Gram-

positives)

Drug

development

(Gram-

negatives)

Economics &

stewardship

Ebola+ programme overview

EBOVAC1

EBOVAC2

EBOMAN

Total

budget:

€ 215 million

EBODAC EbolaMoDRAD

FILODIAG

Mofina

VSV-EBOVAC

Mofina

Objectives

Develop a diagnostic for Ebola Virus Disease with the following

characteristics:

Very high sensitivity and specificity

Ability to be deployed in resource-limited settings

Minimal training required to operate

Capability of multiplexing in order to include different ebola

strains

Time to result 15-30 minutes (desirable) – 3 hours (acceptable)

Sample type for intake: blood (capillary fingerstick desirable),

other less invasive sample types (urine, etc.)

Key Achievements

Successfully miniaturised Altona Realstar

Filovirus assay to fit Alere Q automated

PCR system.

Tested in West Africa

Registrations for CE-IVD (Conformité

Européene) & FDA in progress

IMI actions on Neurodegeneration

IMPRiND

Data Quality

Consortium

Big Data for

Better

Outcomes

Programme

(BD4BO)

Remote

Assessment

of Disease

and Relapse

Programme

(RADAR)

EHR4CR

Electronic Health Records 4 Clinical Research Current medical needs, the growth of targeted therapies and

personalised medicines coupled with escalating R&D costs result

in formidable cost pressures on healthcare and pharmaceutical

industry. By developing and integrating EHR for medical research

it is possible to:

Enable substantial efficiency gains

Make Europe more attractive for R&D investment

Provide patients better access to innovative medicines and improved

healthcare outcomes.

EHR4CR aimed to develop a platform to use advanced EHR

systems within healthcare networks to address this issue

The EHR4CR project has developed a robust and scalable platform that can

utilise de-identified data from hospital EHR systems, in full compliance with the

ethical, regulatory and data protection policies and requirements of each

participating country.

The EHR4CR platform supports distributed querying to assist in clinical trials

feasibility assessment and patient recruitment.

Contrary to other initiatives, EHR4CR designed a solution which is compliant to

EU legislation and respects the position of hospitals and patients. One of the key

aspects is that patient level data never leaves the connected hospitals.

Sustained through http://www.i-hd.eu/

Key Achievements

The European Institute for Innovation

through Health Data

Other DKM projects

European Medical Information Framework - EMIF-Platform: Developed an IT platform allowing access to multiple, diverse data sources to

leverage data on approx 40 Million European adults and children by means of

federation of healthcare databases. Piloted in AD and obesity.

Open PHACTS - Built a freely available discovery platform integrating

pharmacological data from a variety of information sources in an integrated,

interoperable infrastructure. It contains all the data sources already used by

researchers, integrated and linked together so that you can easily see the

relationships between compounds, targets, pathways, diseases and tissues.

eTRIKS - Developed, deployed and hosts the eTRIKS platform as an open

source/open license Translation Research KM technology stack with analytics

methods and tools. For use by IMI and other projects with KM needs

WEB-RADR

WEB-RADR: Overall objectives

Investigate the potential for publicly available social media data for

identifying drug safety issues.

Develop mobile apps for patients and healthcare professionals to

report suspected adverse drug reactions to national EU regulators

Key Achievements

Mobile ADR Reporting Apps

3 apps delivered: UK, NL, HR

Off the shelf app ‘toolbox’ ready for other countries – to be piloted

for malaria treatment ADR reporting

Social media monitoring

Large database of social media posts curated to MEDRA preferred

terms.

Evaluation ongoing

RADAR-CNS

Challenges in Managing Chronic Disease Today Physician visits are time-limited evaluations based on subjective observations of both

the patient and the physician or psychiatrist

Changes in disease state can occur on timescales much shorter than the interval

between physician visits

Opportunity from new technology

Through technological advances over the last decade it is now possible to objectively,

remotely, and continuously measure aspects of patient physiology, behavior and

symptoms

Methodology

Recruit patients in three diseases

Depression

Multiple Sclerosis

Epilepsy

Monitor each patient via wearable & smart phone

Follow-up with doctor visits

Compare data from wearables with doctor visits to see if wearable

data is useful

BD4BO Programme

Big Data 4 Better Outcomes Programme

The BD4BO platform aims to maximise the potential of the large

amount of data that is available

In order to do this key enablers are required:

Definition of outcome metrics

Protocols, processes and tools to access high quality data

Methodologies and analytics to drive improvements

Digital and other solutions that increase patient engagement

The programme is composed of several topics which address key

enablers for the transition of healthcare systems including:

An overarching coordination structure

Key structural and technology components

Several disease specific topics

Design sets of

standard outcomes

and demonstrate

value

• Sets of outcomes

• Clinical endpoints

• Alignment of HC

stakeholders on the

outcomes

Increase access

to high quality

outcomes data

• Mapping of data

sources and methods

for harmonization

• Governance and

technical standards

Use data to

improve value of HC

delivery

• Drivers of outcomes

variation

• Best clinical practices

• Methodologies to

predict outcomes

Increase patient

engagement through

digital solutions

• Patient Reported

Outcomes

opportunities

• Profiling patients

behaviors

• Tools to increase

patient engagement

BD4BO Programme Objectives

1 2 3 4

The Big Data for Better Outcomes programme at a glance

IMAGING

AMYPAD - Amyloid imaging to prevent Alzheimer’s disease

QuIC-ConCePT - Quantitative Imaging in Cancer: Connecting Cellular Processes with Therapy

TRISTAN - Translational Imaging in Drug Safety Assessment

Diagnostics

RAPP-ID – Development of rapid point-of-care test platforms for infectious diseases

Patient Reported Outcomes

PRO-ACTIVE - Physical Activity as a Crucial Patient Reported Outcome in COPD (qualified for use as exploratory endpoints – EMA)

Other IMI projects

Technology has the potential to transform all stages of pharmaceutical R&D and the delivery of healthcare

Point-of-care diagnostics

Sensors enabling collection of real world evidence

Novel imaging approaches

Patient reported outcomes

Platforms to enable the integration and interrogation of diverse data sets

All will become increasingly important

Conclusion

Thank you

Hugh Laverty • Head of Scientific Operations

Hugh.Laverty@imi.europa.eu