Informative Day ERA PerMed JTC 2021 - ISCIII
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Informative Day ERA PerMed JTC 2021
MULTIDISCIPLINARY RESEARCH PROJECTS ON PERSONALISED MEDICINE
DEVELOPMENT OF CLINICAL SUPPORT TOOLS FOR PM IMPLEMENTATION
Dr Maria Jose Ruiz Alvarez, Joint Call Secretariat 2021
Italian Ministry of Health
Virtual conference, 25 January 2021
Personalised medicine definition
• “Personalised Medicine refers to a medical model
using characterisation of individuals’ phenotypes
and genotypes (e.g. molecular profiling, medical
imaging, lifestyle data) for tailoring the right
therapeutic strategy for the right person at the right
time, and/or to determine the predisposition to
disease and/or to deliver timely and targeted
prevention”
“..as stated in the Strategic Research and Innovation Agenda (SRIA) of PerMed, adopted
from the H2020 advisory group!
Mentimeter code 72 00 426
Personalised Medicine is non-disease-specific
Proposals from any medical research area are encouraged in
ERA PerMed calls
Mentimeter code : 72 00 426
JTC 2018- 2019- 2020 ERA PerMed newsletter- information about all funded projects http://www.erapermed.eu/category/newsletter/ If you’d like to receive our Newsletter, please fill in the form http://www.erapermed.eu/newsletter/follow-us/
ERA PerMed – non EU co-funded JTC 2021
16 EU countries ( AU, BE, CR, DE, EST, FI
FR, GE, HU, IT, LAT, LU, PO, RO, SP, SW)
CSC*
23 Countries 3 H2020 associated countries: Turkey, Norway, Israel
30 Partners
4 third countries: Brazil, Chile, Egypt & Panama
5 regions (Saxony, Lombardy, Catalonia,
Navarra and Tuscany)
1 charity: AECC
Call Secretariat (JCS)
Italian Ministry of Health (IT-MoH)
ITALY with the support of FRRB
Countries´ ex ante Budget
healthresearch@sanita.it 24M € approx.
CSC*: Call Steering Commitee
Mentimeter code : 72 00 426
Finding suitable partners for your research Consortia while
participating in ERA PerMed calls
https://partnering.pt-dlr.de/ICPerMed
Mentimeter code : 72 00 426
Eligible Academia (research teams working in universities,
partners: other higher education institutions) or research
institutes
Clinical/public health sector (research teams working
in hospitals/public health and/or other healthcare
settings and health organisations)
Participation of clinicians (e.g. medical doctors,
nurses) in the research teams is encouraged
Private partners
For a definition of eligible partners, see “Guidelines for Applicants”, the
regional/national regulations, and contact your regional/national
funding organisation (see also Annex I)
Aim of the call • What? …..fosters research and innovation building linkage between clinical research, computer science /medical informatics and research on ELSA in PM. • How? …multidisciplinary activities brought together stakeholders from academia, clinical/public health research and private partners, policy makers, regulatory / health technology assessment (HTA) agencies and patients / patient organisations • Why? …to improve disease prevention and disease management (patient stratification, diagnostics and tailored treatment / prevention protocols for both patients and individuals at risk of disease)
Objectives • Support translational and transnational research projects • Encourage and enable interdisciplinary collaboration towards the implementation of PM, combining clinical research, bio-informatics components and ethical, legal and social aspects. Additionally, pre-clinical and health economic research • Encourage collaboration between academia, clinical/public health research , private partners as well as policy makers, regulatory/HTA agencies and patient representative organisations.
ERA PerMed Co-funded JTC 2018
“Research projects on personalised medicine – smart combination
of pre-clinical and clinical research with data and ICT solutions”
Joint Call
Secretariat (JCS)
National
Institute of
22 funded projects Health Carlos III
24.6M € requested funding (ISCIII) SPAIN.
31 Partners
from 23
CountriesERA PerMed JTC 2019
30 Partners
… MULTIDISCIPLINARY RESEARCH TOWARDS
IMPLEMENTATION
22 Countries
Call Secretariat (JCS)
French National Research Agency (ANR)
FRANCE
Each project proposal MUST address at least one module
of Research Area 3 and at least one module of Research
Area 1 or 2.
22 funded projects
24.6M € requested fundingERA PerMed JTC 2020
31 Partners
….PRE-/CLINICAL RESEARCH, BIG DATA AND ICT,
23 Countries IMPLEMENTATION AND USER’S PERSPECTIVE”
Call Secretariat (JCS)
German Aerospace Centre (DLR)
GERMANY
Each project proposal MUST address at least one module of Research Area 3
and at least one module of Research Area 1 or 2.
18 funded projects
23.3M € requested fundingERAPerMed –JTC 2021 “MULTIDISCIPLINARY RESEARCH PROJECTS ON PERSONALISED MEDICINE – DEVELOPMENT OF CLINICAL SUPPORT TOOLS FOR PERSONALISED MEDICINE IMPLEMENTATION”
✓ application and validation of known biomarkers
✓ On therapeutic targets
✓ How implementation of technology and research findings will
be transformed into clinical practice and address regulatory
questions-
Pre-clinical Clinical Research
---------ensure the robustness and reproducibility of results is
strongly encouraged✓ pre-clinical predictive models for (A) validation of data and hypotheses from human population, clinical, molecular and genomics studies and/or (B) prediction of clinical outcomes ✓ Classification of diseases at the molecular level ✓ Validation and characterisation of the role of biomarkers in predictive medicine
Mandatory Research module ✓ Improvement, validation and combination of analytical tools and methods for diagnostics and treatment, allowing the discovery and validation of molecular and environmental factors that can be used for patient stratification and treatment decisions. ✓ Pharmacokinetics & pharmacodynamics on preparation of clinical trials. ✓ Innovative clinical trial methodologies; novel strategies to accelerate the transition from clinical observation to diagnostic development.
Mandatory Research module ✓ New concepts and stratification strategies in exploratory clinical studies (pilot studies and Feasibility studies) ✓ Clinical, omics and environmental data integration, use of machine learning to provide the basis for more personalised treatment for patients. ✓ Implementation in the treatment of patients with comorbidities. ✓ Clinical support tools testing and validation in clinical practice. ✓ Innovative m/e-health or telemedicine applications testing and validation in a clinical setting.
✓ Re-use and sharing of data through public databases are encouraged and the re-use or combination of existing tools ✓ Data from experimental evidence (also present), various types of data generated in silico or directly by patients and Clinical data ✓ Robust analysis and interpretation of results with data security / protection. ✓ Development of common standards and working practices for storage, accessibility, interoperability and re-use of samples and data generated
Mandatory Research module ✓ Artificial intelligence approaches to Big data to find new subgroups of patients, to predict patient outcome to treatment and for biomarker validation. ✓ Development of good practices for the management of samples and data (FAIR and GDPR ). ✓ Development of approaches for the innovative and combined use of already validated and / or new eHealth and mHealth ✓ Development of innovative telemedicine applications for direct contact between healthcare personnel and patients.
✓ The studies conducted in 3A and 3B and the corresponding work package
should relate directly to the research question(s) addressed in A 1 and 2.
✓ Research on health economic aspects of newly innovative PM approaches
✓ Research investigating whether a patient-centred, new PM approach
requires refinement of – or even new – health economic and pharma-
economic models, for the treatment of diseases or for their prevention.Mandatory Research module
✓ Research on ethical, legal and social aspects, when using artificial intelligence
techniques & genetic engineering.
✓ Genetic testing in clinical practice, the clinical interpretation of test results
and the potential clinical, ethical and legal consequences
✓ potentially biased datasets lacking (sample) heterogeneity of information
✓ personal/individual component during the creation of decision support toolsMandatory Research module ✓ regulatory approval of clinical decision systems based on statistical learning, machine learning and artificial intelligence technologies ✓ decision support tools in the prevention and stratification of the healthy society/population and fair access ✓ equal access to PM approaches for all patients ✓ Right to know/not to know and sharing of research findings ✓ How to enable stakeholder exchange and collaboration from the beginning of a study
Evaluation: Pre-proposal phase
Changes from the
2-Steps procedure pre-proposal to the
full-proposal phase
Full–proposal phase
are limited
Peer Review Panel
Rules Ranking list Available funds
Take note ! All documents are available
on the website: Selection of Projects to be funded
…
Pre-eligibility document if required
Call text
Guidelines National/ Regional Funding process
Annex with national/ regional budget &
specific rules
Eligible annexes in the pre- and
full-proposal stage Follow up National/Regional &
…… InternationalPre-proposal
template
CALIBRI FONT SIZE 11……
In order to confirm your eligibility,
please contact your state/national
representatives of the participating
funding organisation prior to
submission.Timeline JTC2021
Final funding decision
Beginning of April: End September/ Beginning October 2021
Pre-proposals
sent to reviewers
Submission Submission Rebuttal
Pre-announcement
deadline CSC deadline Phase and PRP and CSC
Launch pre-proposals meeting full-proposals Quality evaluation meeting
October
14 December 4 March March May June August September
Evaluation 1st stage Evaluation 2nd stage
Formal and national/regional eligibility check
Central eligibility check: Joint Call Secretariat
Regional/national eligibility check by the respective funding
organisations
Take note!
Pre-eligibility
check form
Underrepresented countries can
join the proposals at this stage!Notes about evaluation process:
Coherent integration and combination of the different research areas and
modules in the proposals is part of the evaluation process
Remote evaluation (pre-proposal & full-proposal)
• Allocation of 3 Reviewers /Proposal
• 3 Evaluation criteria: Excellence, Impact and Implementation
Scoring system from 0 to 5 : maximum 15
Threshold 3 for each criterion (mean of 3 experts)
• Ranking list: The PRP establishes a list of proposals recommended for funding and
NOT recommended for funding
• 1st step evaluation (pre-proposal) General budget rules and rank list influence the
decision on the number of proposals invited to the second phase (of 150 50 )
2nd step evaluation (full-proposal) Negotiations following rank list to allow the
funding of as many projects as possible by optimizing the regional/national budget
(of 50 20 )Evaluation Criteria
1.- Excellence of the proposal:
a. Clarity and relevance
b. Scientific quality of approach and methodology
c. Soundness
d. Novelty
e. Feasibility of the project
f. Relevance for the advancement of PM
g. Quality of the consortium: international competitiveness,
previous work and expertise, added value of the transnational
collaboration.2.- Impact of the proposal: a. Added value of the transnational collaboration; sharing of resources, platforms/infrastructures, harmonisation of data and sharing of specific know-how b. Potential impact of the expected results c. Involvement of pertinent patient organisations/representatives (if available/applicable) d. Involvement of private partners if available/applicable e. Innovative potential f. Consideration of sex aspects and underrepresented populations in research teams. Inclusion of sex and/or gender analysis and underrepresented populations in the research, if applicable
3.- Quality and efficiency of the implementation
a. Quality of the project plan;
b. Adequateness of the work package structure and work plan;
c. Balanced participation of project partners and integration of workload in
the different work packages, quality and efficiency of the coordination and
scientific management;
d. Scientific justification and adequateness of the requested budget
e. Risk assessment, regulatory and ethics issues properly addressed (when
necessary);
f. Coherent integration and combination of Research Areas and Modules in
the proposal.ERA PerMed Experts Peer Review Panel (PRP)
• The selection is based on their experience on the different research
areas and in this very broad medical field , taking into account the
right Geographical and Gender Balance (also experts from outside
the consortium)
• Good skills in the evaluation process.
• Conflict of Interest and Confidentiality Declaration has to be signed
Are you interested in increasing your knowledge of the evaluation process
and strengthening your network and position internationally ?
Check your CI and contact usResearch consortium: • Each consortium must involve at least 3 partners eligible for funding from 3 different countries whose funders participate in the call. All 3 legal entities must be independent • Maximum number of partners /pre-proposal is 6 (no more than 2 partners from the same country) • At least 2 partners out of the minimum 3 eligible project partners of the consortium must be from two different EU Member States or Associated Countries.
Each project partner (research group) has to be represented by one principal
investigator .
The coordinator represent a research group/partner and must be eligible for funding
being responsible for the internal scientific management of project
For regional/national eligibility reasons, applicants shall avoid applying to different
calls for same research activities.
Double funding is not permitted
Strongly encouraged:
- the active involvement of members of the public in the proposed research
projects.
- Inclusion of sex, gender analysis and/or underrepresented populations
- Scientific Data Open Access Policy- DMPPatient involvement ERA PerMed strongly encourages the active involvement of members of the public in the proposed research projects. This includes patients, citizens/potential patients, healthcare providers, people who use health and social care services, as well as patient organisations. Goal: to raise awareness, share knowledge and improve dialogue between researchers, healthcare providers, policy-makers, industry and citizens. The involvement of patient representatives/organisations in research proposals submitted to this call is part of the evaluation: “2. Impact: c. “3. Quality and efficiency of the implementation: e.
JTC 2021- Take note
• Interdisciplinary (academia, clinical/public health sector and
private partners)
• Clear impact on PM and benefit for patient/public
1 • Discus your project with all stakeholder involved
• Areas & modules: Coherent integration and combination in the
WP. Module/WP/Partner
• Partners: Coherent integration /WP and complementarity
2 • Active participation of early-career researchers/scientists
• Active involvement of public
• Inclusion of sex, gender analysis and/or underrepresented
population
3 • Data : FAIR & DMP
PLEASE, READ CALL TEXT , ANNEX AND GUIDELINES CAREFULLYAfter the selection for funding:
• Consortium
members of projects
must establish the • No later than three
months after the • No later than six
start data of months after the
scientific project scientific project
start date scientific project
which will be the start date.
reference date for
the annual progress Data
reports and final management Consortium
reporting. Plan Agreement (CA)
Start dataWhy you should join this call
Enhance the networking : quality of their research teams,
international position, reduce health R&D cost by aligning
Funding expenses with other countries/regions
Organisation Socio-economic positive impacts: health service improvement, new
employment lines
Strengthening the network
Receiving funding and international position
Researcher Knowledge/technology transfer
Helping/ Encouraging researchers to become
entrepreneurs
Increasing Knowledge process of evaluation
Expert on Panel and Strengthening the network and improve
Evaluation your international positionThanks on behalf of Joint Call Secretariat
Italian Ministry of Health
Dr. G. Guglielmi, Dr. M. Paganelli, Dr. M. Jose Ruiz
& the support of Fondazione Regionale per la Ricerca
Biomedica (FRRB): P Bello, G. Caldieri & C. De Francesco.
healthresearch@sanita.it
This project has received funding from the European Union’s Horizon 2020
research and innovation programme under grant agreement No 779282”.Questions ? Mentimeter code : 72 00 42 6
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