Pavadinimas
Translational
approaches
to disease
modifying
therapy of
Type 1
Diabetes
Mellitus
(T1DM)
Discovery
and
validation of
novel
endpoints in
dry agerelated
macular
degeneration
and diabetic
retinopathy
Projekto aprašymas
The project should help
to gain an improved
molecular understanding
of the T1DM patients,
deliver insights into
the disease heterogeneity
and provide tools for
identification of high-risk
patients. Ultimately the
outcome will be the
definition and refinement
of T1DM disease
taxonomy which could
create a foundation for
personalised therapy of
T1DM patients.
clinicians and researchers
from the areas
of immunology, beta cell
biology, and biomarker
research from academia
and industry
Dalyviai
Academic endocrine clinics
and associated supporting
departments
The project should
provide generation of
adequate data resulting
from robust retrospective
and/or prospective
studies in patients that
could serve as basis for
initial discussion with
regulatory agencies
and/or HTA-bodies for
acceptance of the
resulting outcomes as
endpoints for future
clinical programmes
Pharmaceutical companies
have expertise of drug
discovery, drug development
as well as regulatory and HTA
requirements.
Basic, translational, and
clinical researchers from the
fields of T1DM autoimmunity
and β-cell biology,
Drug discovery and medical
staff in Pharmaceutical
Industry and Small and
Medium size Enterprises
Uždarymo data
Stage 1
deadline for
submission: 12
November
2014 – 17:00
CET
Stage 2
deadline for
submission: 21
April 2015 –
17:00 CET
Hands-on data base specialists
and big data managers
Patient
organizations/representatives
Experts in regulatory science
and health technology
assessment preferably
representing European health
authorities.
Academia has expertise in
methods to assess visual
function and structural (bio-)
markers that may correlate
with visual impairment both
pre-clinically and clinically.
They have access to databases
on the natural history and the
course under treatment of the
diseases in-scope that would
allow a retrospective analysis
of potential correlations.
Imaging and medical device
companies have expertise in
development and application
of contemporary examination
methods.
Hospitals/practicing
physicians have access to dry
Stage 1
deadline for
submission: 12
November
2014 – 17:00
CET
Stage 2
deadline for
submission: 21
April 2015 –
17:00 CET
AMD and/or DR patients.
They have a good
understanding of
epidemiology,
pathophysiology, or other
evidence to predict clinical
benefit.
Patients, users and
caregivers can also play an
important role in the
establishing the value of new
endpoints.
Regulators, Health
Technology Assessment
(HTA) bodies and payers
could provide guidance on
prerequisites for acceptability
of endpoints.
Others such as technological
centres and Contract
Research Organisations may
be able to contribute to the
deliverables of the project.
Kvietimo identifikatorius
IMI2-2014-01-01
Numatomas biudžetas
The indicative contribution
from EFPIA companies and
Associated Partners is EUR
17 630 000.
The financial contribution
from IMI2 JU is a
maximum of EUR 17 630
000
IMI2-2014-01-02
The indicative EFPIA
contribution is EUR 7 000
000
The financial contribution
from IMI2 JU is a
maximum of EUR 7 000
000
Vertinimas
Research and Innovation
action
Two stage submission and
evaluation process
Only the applicant
consortium whose proposal
is ranked first at stage 1 is
invited for stage 2
Research and Innovation
action
Two stage submission and
evaluation process
Only the applicant
consortium whose proposal
is ranked first at stage 1 is
invited for stage 2