Antragstellung in Horizon 2020 - Erste Aufrufe in den LifeSciences Morgensternstrasse 24 12207 Berlin www.consultech.de - Dechema
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
Antragstellung in Horizon 2020 Erste Aufrufe in den LifeSciences Webinar 25.02.2014 Morgensternstrasse 24 12207 Berlin www.consultech.de
ConsulTech+GmbH+ • Firmen+und+ Beantragung+von+ Forschungseinrichtungen+ Fördermi:eln+ • In+D+(Bund,+Länder)+EU,+USA+ • pharmazeu@sche,+ Spezialisierung+auf+ • Biotechnologische++ LifeSciences+ • medizintechnische+Projekte+ • Iden@fika@on+von+passenden+ Fördermöglichkeiten+ • Zusammenstellung+von+ Consul@ng+ Projektkonsor@en+ • Konzep@on,+Begleitung+der+Projekte+ +von+der+Planungsphase+bis+zum+ Abschlussbericht+ www.consultech.de
ConsulTech+GmbH+ Kleine und Großunternehmen Mittelständische Forschungseinrichtungen Unternehmen www.consultech.de
ConsulTech+GmbH+ Erfolgreiche EU Projekte seit Eingeworbene Beratung großer 1994 Fördersumme Forschungsverbünde Laufende Projekte (Cluster) Miracle Neuroallianz >250 Mio € EuroCalin CI3 SmartBees www.consultech.de
Übersicht+ Förderinstrumente in Beteiligungs- und Rechtliche Aspekte Horizon 2020 Förderregeln Administrative Aufrufe mit Relevanz Inhaltliche Aspekte Aspekte im für die Life Sciences der Antragstellung Antragsprozess www.consultech.de
Hintergrundinforma@onen+ zu+Horizon+2020+ Vereinfachungen Laufzeit Budget vs FP7 • 2014 - 2020 • 80 Mrd. € Budget'Horizon'2020'in'Mrd'€' I%Excellent%science% 2,8,%4%% 1,9,%2%% 1,6,%2%% II%Industrial%leadership% 31,7,%39%% 24,6,%31%% III%Societal%challenges% 17,9,%22%% IV%European%Ins@tute%of%Innova@on%and% Technology%(EIT)%% V%NonHnuclear%direct%ac@ons%of%the%Joint% Research%Centre%% VI%Euratom% www.consultech.de
Programmstruktur+von+Horizon+2020+ Wissenschaftliche Führende Rolle der Gesellschaftliche Exzellenz Industrie Herausforderungen Lösungsansätze industrie- wissenschafts- getriebene in 7 getriebene, Forschung Themenfeldern grundlagen- von orientierte Unterstützung übergeordneter Forschung und Vernetzung gesellschaftlicher von KMU Bedeutung Gemeinsame Forschungsstelle (JRC) Europäisches Innovations- und Technologieinstitut (EIT) EURATOM www.consultech.de
Programmstruktur+von+Horizon+2020+T+ Bereiche+mit+Relevanz(für(Life( Science(Unternehmen( Wissenschaftliche Führende Rolle der Gesellschaftliche Exzellenz Industrie Herausforderungen European Research Technologien Gesundheit, Counsel - ERC • ICT demographischer Wandel, Wohlergehen • Nanotechnologie Future Emerging • Werkstoffe Ernährungssicherheit Technologies - FET • Biotechnologie (KBBE) • Produktionstechnol. Energieversorgung Marie Skłodowska Curie • Raumfahrt Verkehr Stipends - MSC Risikofinanzierung Klimaschutz, Ressourceneffizienz, Rohstoffe Research Infrastructure - Allg. Gesellschaftsfragen RIS Innovationen in KMU (integrativ, sicher, frei etc.) www.consultech.de
Instruments+in+Horizon+2020+ 1. Research collaborations 2. SME Funding 3. Access to risk financing 4. Co-Financing-Instruments (EC + Member states, .... ) www.consultech.de
Instruments+Horizon+2020+–+FP7+(1)+ Horizon 2020 FP7 Integrated project (IP) Research and Innovation Action (RIA) Focused project (STREP) Integrated project (IP) Innovation Action (IA) Focused project (STIPs) www.consultech.de
Main+instruments+for+collabora@ve+ research+and+development+projects+ Research and Innovation Actions Innovation Actions (RIA) (IA) • Development of new knowledge • Plans, schemes, drafts for new, • Feasibility tests modified or optimised products, • Basic and applied research, processes or services technology development and • Prototypes, demonstration and integration pilot actions • Prototypes (lab scale) • Transfer to market actions • Small scale demonstration and • (large) product validation pilot actions actions 100 % funding 70% funding (100% funding for non profit organisations) One project – one funding rate www.consultech.de
Instruments+Horizon+2020+–+FP7+(2)+ Horizon 2020 FP7 Support Action (SA) Coordination and Support Actions (CSA) Co-ordination Action (CA) Network of Excellence (NoE) SME Instrument - www.consultech.de
SME+Instrument+ • Phase 1: Feasibility study 3 phases • Phase 2: Development phase • Phase 3: Marketing phase • Phase 1: 4 cut-off dates p.a. No deadlines • Phase 2: 1 cut-off date p.a. (“Health” more than one) „bottom-up“ Pillars • 2 (Industrial Leadership) and 3 (Societal Challenges) • Phase 1: lump sum Funding rates • Phase 2: 70% (exception: 100% topic “Biomarker”) • Phase 3: no funding • Phase 1: 50.000 Euro per project Funding • Phase 2: 1-2.5 mill. € (exception: 5 mill. € “Biomarker”) • Phase 3: no funding Coaching • Enterprise Europe Network (EEN) www.consultech.de
Instruments+Horizon+2020+–+FP7+(3)+ Horizon 2020 FP7 Programme co-funding ERA-NET, Art.185 activities actions (AAL, EuroStars), JTIs (IMI) Pre-Commercial Procurement (PCP) - Public Procurement of Innovative Solutions (PPI) - www.consultech.de
Instruments+Horizon+2020+–+FP7+(4)+ Horizon 2020 FP7 Fast Track to Innovation - Prizes - - Research for SME www.consultech.de
Fast+Track+to+Innova@on+ Accelerating Technology Transfer • Time to grant = 6 months Increasing participation of industry and SMEs • Open for all types of organisations Bottom-up calls from 2015 • 3 cut-off-dates p. a. • Pillar 2: Industrial leadership • Pillar 3: Societal challenges Funding instrument • Innovation action (70% funding rate, max. 5 partners, max. 3 mill. Euro funding) Based on structure of national funding programmes • „KMU-innovativ“ www.consultech.de
Instruments+Horizon+2020+–+FP7+(5)+ Horizon 2020 FP7 Risk financing (loans, equity) - Public Private Public Private Partnerships (PPP) Partnerships (PPP) Public Public Public Public Partnerships (P2P) Partnerships (P2P) www.consultech.de
Risk+financing+instruments+–+ New+in+Horizon+2020+ Loans Equities venture capital Loans for companies and for young, research- innovative projects development and Guarantees for creditors innovation intensive companies • Accompanying measures • Implementation by European Investment Bank (EIB) / European Investment Fund (EIF) www.consultech.de
Accompanying+measures+ Diffe rent rules ! Public Private Partnerships (PPPs) • Financed by Horizon 2020 + Industry i.e. IMI2 • Financed by member states and EC Public Public Partnerships (P2Ps) (partly) Source: KoWi www.consultech.de
PreTdefined+instrument+for+each+call+ Participant Portal Select a call Topic description Type of action www.consultech.de
Summary+ New+Instruments+in+Horizon+2020+ RIA • Research and Innovation Actions IA • Innovation Actions SME • SME Instrument FTI • Fast track to innovation Risk • Risk financing instruments www.consultech.de
Beteiligungs- und Förderregeln Dr. Daniel Schubart
Wer+kann+sich+beteiligen?+ Alle Personen und Rechtsformen • Natürliche Personen und Personengesellschaften • Juristische Personen • Keine Firmen in Insolvenzverfahren Prinzipiell Teilnehmer aus allen Ländern • Ausnahmen • ERA-NET, PPP, Bestimmungen im Call www.consultech.de
Wer+wird+gefördert?+ Projektpartner • EU Mitgliedsländern • Mit dem Rahmenprogramm assoziierte Staaten (Schweiz ?, Norwegen, Israel, Türkei, etc.) • Best. Länder der 2. und 3. Welt • Andere Teilnehmer eigene Finanzierung • i.A. außereuropäische Länder der 1. Welt • Ausnahme: spezielle Regelungen im Call • China (Ausschreibungen in Landwirtschaft) • USA (immer in „Gesundheit“) www.consultech.de
Wie+wird+gefördert?+ Voraussetzung • Projekt mit mind. 3 unabhängigen Partnern aus 3 Mitglieds- bzw. assoziierten Staaten • Ausnahmen • ERC, Mobilitätsprogramm, KMU Instrument, CSA, im Arbeitsprogramm explizit festgelegt • Erfolgreicher Evaluations- und Verhandlungsprozess • Nachweis der Kosten durch Buchführung • Führen von Time-Sheets • Ausnahme: 100% Tätigkeit im Projekt • s. part A general annexes, General Work Programme www.consultech.de
Wie+wird+gefördert?+ Indirekte Erstattungsfähige Nicht Kosten / Kosten erstattungsfähig Overhead Personalkosten Pauschale von 25% auf Sachkosten Zölle, direkte, erstattungsfähige Kosten Wechselkurzverluste, Reisekosten Schulden, Unteraufträge Kosten anderer Projekte, ! Keine Projektspezifische Kosten unverhältnismäßige Kosten Vollkostenabrechnung ! (eventuell für non-profit Forschungsorganisationen) MwSt. (Partnerabhängig) • Financial guide -> annotated model grant agreement www.consultech.de
Funding+rates+for+eligible+costs+ Funding rate* 100 % 70 % Research and Coordination Innovation innovation and Support Actions (IA)** actions (RIA) Actions (CSA) * direct and indirect costs ** except Universities, public institutions (100% funding) www.consultech.de
Zusammenfassung+ Transnationale Verbundforschung • Ausnahmen: MSC, SME-Instr., call spezifisch i.A. Industriebeteiligung wichtig, aber ausschreibungsabhängig Time to Grant • Maximal 8 Monate ab Call – Deadline Eine Förderquote pro Projekt • 100% oder 70% auf direkte Kosten + Overhead • Max. ein Certificate on Financial Statements pro Partner • Weniger Audits Partner aus den USA in Health-Pillar förderbar Klinische Studien förderbar (s. Ausschreibung) www.consultech.de
Rechtliche Aspekte Dr. Daniel Schubart
Important+Agreements+ www.consultech.de
Model+Grant+Agreement+(MGA)+ A single document with all provisions no more Core agreement + Annex II, specific Annex III or special clauses Electronic signature of Grant Agreement Accession Forms coordinator and European by all beneficiaries Commission (Annex 3) www.consultech.de
Model+Grant+Agreement:+Structure+ Chapter 1: General Annex I: Description of the action Chapter 2: Action Annex II: Estimated budget Chapter 3: Grant Annex III: Accession Form for Chapter 4: Rights and obligations Beneficiaries Annex IV: Model for Financial Chapter 5: Division of roles statements Chapter 6: Rejection, reduction, Annex V: Model of Certificate on penalties, termination, etc the financial statements Annex VI: Model of Certificate on Chapter 7: Final provisions the methodology www.consultech.de
Model+Grant+Agreement+ Chapter 1: General • Art 1: subject of the agreement Chapter 2: Action Chapter 3: Grant Chapter 4: Rights and obligations Chapter 5: Division of roles Chapter 6: Rejection, reduction, penalties, termination, etc Chapter 7: Final provisions www.consultech.de
Model+Grant+Agreement+ Chapter 1: General Chapter 2: Action • Art 2-4 Action, duration and budget Chapter 3: Grant Chapter 4: Rights and obligations Chapter 5: Division of roles Chapter 6: Rejection, reduction, penalties, termination, etc Chapter 7: Final provisions www.consultech.de
Model+Grant+Agreement+ Chapter 1: General Chapter 2: Action Chapter 3: Grant • Art 5-6 Amount, reimbursement rates, eligible costs Chapter 4: Rights and obligations Chapter 5: Division of roles Chapter 6: Rejection, reduction, penalties, termination, etc Chapter 7: Final provisions www.consultech.de
Model+Grant+Agreement+ Chapter 1: General Chapter 2: Action Chapter 3: Grant Chapter 4: Rights and obligations • Art 7–16: To implement the action: resources, in-kind contributions, subcontracts • Art 18-22: Grant administration: reporting, payments, audits • Art 23-31: Background and results: access rights, protection of results, exploitation, dissemination • Art 32-40: Others: gender equality, ethics, confidentiality Chapter 5: Division of roles Chapter 6: Rejection, reduction, penalties, termination, etc Chapter 7: Final provisions www.consultech.de
Model+Grant+Agreement+ Chapter 1: General Chapter 2: Action Chapter 3: Grant Chapter 4: Rights and obligations Chapter 5: Division of roles • Art 41: Roles and responsibilities, internal arrangements Chapter 6: Rejection, reduction, penalties, termination, etc Chapter 7: Final provisions www.consultech.de
Model+Grant+Agreement+ Chapter 1: General Chapter 2: Action Chapter 3: Grant Chapter 4: Rights and obligations Chapter 5: Division of roles Chapter 6: Rejection, reduction, penalties, termination, etc • Art 42-45: Rejection, reduction, recovery and penalties • Art 46-51: Liability, Suspension and termination of the action Chapter 7: Final provisions www.consultech.de
Model+Grant+Agreement+ Chapter 1: General Chapter 2: Action Chapter 3: Grant Chapter 4: Rights and obligations Chapter 5: Division of roles Chapter 6: Rejection, reduction, penalties, termination, etc Chapter 7: Final provisions • Art 52-58: Accession, entry into force, amendments, applicable law www.consultech.de
Annotated+Model+Grant+Agreement+ ! Detailed+explana@on+of+Art.+1+T+6++ ! Interpreta@on,+defini@ons,+examples+ ! Similar+to+financial+guide+in+FP7+ ! h:p://ec.europa.eu/research/par@cipants/data/ref/h2020/ grants_manual/amga/h2020Tamga_en.pdf+ + www.consultech.de
Consor7um(Agreement+ • Consortium Agreement (MGA Art. 41.3) • Is mandatory unless otherwise stated • There will be a template like the DESCA template www.consultech.de
Consor7um(Agreement+ • internal organisation • distribution of EU funding • additional matters regarding Foreground and Background CA • settlement of internal disputes, breaches, sanctions should deal • confidentiality with • liability and indemnification • receipts • grant reduction • etc. www.consultech.de
Electronic(communica7on(( + Electronic signature • Of the Grant Agreement coordinator and European Commission • Of the Accession Forms by all beneficiaries • Of the Amendments • Financial Statements and Technical reports • LEAR - important: assigns roles in IT system for GA signature and management Communication between the Commission and the beneficiaries • Through the Participant Portal • Electronic-only submission of reports www.consultech.de
Wie gestaltet sich der Antragsprozess? Dipl. Ing. Ursula Wirtz
Administra@ve+Aspects++ Documents & Definitions Application: process & levels Participant Portal Registration process – organisation related Registration process – project related www.consultech.de
Important+documents+T+overview+ Specific Programme Horizon 2020 Rules for participation work programme – call topics & general annexes Guide for evaluators Model Grant Agreement Annotated Model Grant Agreement www.consultech.de
Defini@ons+ Participant Portal • single-entry point for interactions between participants and EC Beneficiary • legal entity which benefit from the GA Coordinator • contact point of the consortium towards EC MGA / CA • Model Grant Agreement / Consortium Agreement • European Commission Authentification Service ECAS to create an account for the portal based on your email address • Participant Identification Code (PIC) , PIC unique identifier for every validated organisation • Rights a user can have in in projects and/or organisations Roles (e.g. Participant contact, LEAR, LSign, FSign) • Legal Entity Appointed Representative, correspondent on all legal LEAR status related issues www.consultech.de
Applica@on:+Process+&+Levels+ Administrative Part Scientific Part Organisation Level Proposal Level project idea ECAS Account register for a call Call text PIC - Registration download template Part B consortium Verification complete Form A project plan Partner /financials Financial & Legal Viability work packages Check upload Part B financials Lear-Appointment Submission Part B writing www.consultech.de
Administra@ve+Part:++ Registra@on+Process+–+Two+Levels+ 1. ECAS Account 6. Register for a call 2. PIC - Registration 7. Download template Part B 3. Verification 8. Complete Form A Partner /financials 4. Financial & Legal Viability Check 9. Upload Part B 5. LEAR-Appointment 10. Submission www.consultech.de
The+Par@cipant+Portal+ A(single(gateway(for(( " informa@on+++ (documents,+calls)+ " registra@on++ " proposal++applica@on++ " project+management+ ( https://ec.europa.eu/research/participants/portal/desktop/en/home.html www.consultech.de
Par@cipant+Portal+w/o+Login+ Funding How to My AREA Experts Support opportunities participate • ….. • FAQ for • FAQ • H2020 • Documents • ….. Experts • Calls • Beneficiary • ….. • Funded • FP7 Register • ….. Projects • Financial • Calls Viability Self-Check www.consultech.de
Par@cipant+Portal+with+Login+ Funding How to My AREA Experts Support opportunities participate • Organisation • H2020 • Documents related area • FAQ for • FAQ • Calls • Proposal(s) Experts • Funded • FP7 for funding Projects • Calls • Financial • Project(s) • Expert Viability Self- related service registration Check • Managing roles www.consultech.de
Example:+My+Proposals+ www.consultech.de
Example:+My+Projects+ www.consultech.de
Registra@on+Process+–+Two+Levels+ 1. ECAS Account 6. Register for a call 2. PIC - Registration 7. Download template Part B 3. Verification 8. Complete Form A Partner /financials 4. Financial & Legal Viability Check 9. Upload Part B 5. LEAR-Appointment 10. Submission www.consultech.de
1. Create+Your+Personal+ECAS+ Account+ The+unique(iden7fier(( for(a(physical(person++ is+the+eTmail+address+ choose “Register” create an ECAS account receive identification email finalize user registration Login www.consultech.de
2.++Get+Organisa@on’s+PIC+ choose PIC number Fill in the “Beneficiary Submit on screen forms Register” and by email www.consultech.de
3.+ +Verifica@on+of+Organisa@on’s+Legal+ Existence+and+Status+ Public Entities • Legal Entity Form (public status) • official document establishing your organisation • VAT registration document or document attesting VAT exemption Non profit research organisations • Legal Entity Form (public status) • document mentions • status of a non-profit organisation by national or international law • that your organisation carries out research or technological development as one of its main objectives Source: Rules of verification; not yet available for H2020 www.consultech.de
3.++Verifica@on+of+Organisa@on’s+Legal+ Existence+and+Status+ Private Entities • Legal Entity Form (private status) • extract of registration (Company Register, Official Journal) • registration number • VAT registration document (official document not older than 6 months ago) Small and Medium Sized Enterprises (additional) • SME check-list • Annual Balance sheet for the last approved accounting period • Profit and Loss account for the last approved accounting period • Appendix indicating the number of declared employees and possible ownership for the last approved accounting period. www.consultech.de
SMETDefini@on+ Recommendation 2003/361/EC relating to the definition of micro, small and medium-sized enterprises Enterprises (incl. linked organisations), which have an annual have an annual balance sheet employ less than turnover not total not 250 persons exceeding exceeding 50 million euro 43 million euro http://ec.europa.eu/enterprise/policies/sme/files/sme_definition/sme_user_guide_de.pdf www.consultech.de
+5.+Appoint+a+LEAR++ +++ Legal signatory (e.g. managing director / chancellor) • appoint the LEAR • sole formal process using blue ink signature European Commission • send password • send Link LEAR • use validation link • finalise process via password • Nominate+ • nominate+ • onlineT LSIGN FSIGN update+of+ organisa@on+ data www.consultech.de
Registra@on+Process+–+Two+Levels+ 1. ECAS Account 6. Register for a call 2. PIC - Registration 7. Download template Part B 3. Verification 8. Complete Form A Partner /financials 4. Financial & Legal Viability Check 9. Upload Part B 5. LEAR-Appointment 10. Submission www.consultech.de
6.1.+Call+Registra@on+ ! find+your+topic+ + ! use+sec@on++ “submission++ service”++ to+register++ for+a+proposal+ www.consultech.de
6.2.+Call+Registra@on+ ! PIC+is+required+ www.consultech.de
7.+Download+Part+B+(S&T)+ Download+Templates+to+drap+Part+B+ www.consultech.de
8.+Add+Partners+ www.consultech.de
8. Completion of Part A ! Details ! Name, address of organisation ! Dept. carrying out work ! Responsible scientist ! Budget (stage 1 vs. stage 2) ! Ethics issues ! Call specific questions
Inhaltliche Aspekte der Antragstellung Dr. Daniel Schubart
Birds+Eye+Perspec@ve+–+From+Idea+to+ Proposal+Submission+ • One or two • Research stage proposal organisations • Companies • others Find and interpret Assemble appropriate consortium Call Administrative Write proposal aspects • Scientific part • Coordinator • Financials • Partner • PIC, LEAR etc www.consultech.de
Find a call ! Participant portal / calls ! Search & filter function ! Pillar level ! In general, call texts broader than FP7 ! ConsulTech Homepage Horizon 2020 ! Headlines ! Link to PP page
Example:+Advancing+bioinforma@cs+to+ meet+biomedical+and+clinical+needs+ www.consultech.de
Participant Portal ! Important documents ! Call specific information ! Political background papers ! List of countries and applicable (framework programme, model rules for funding grant agreement) ! Eligibility and admissibility ! Work programme conditions ! General annexes ! Evaluation criteria and ! call topics procedure, scoring and threshold ! Rules for participation ! Guide to the submission and evaluation process ! Financial guide ! Proposal template
Topics+2014+–+Health+/+Examples+ Area Topic Instrument Budget Improving diagnosis PHC 10: Development of new diagnostic tools RIA (100%) 48 Mio. € and technologies: in vitro devices, assays and platforms (4-6 Mio. €) PHC 12: Clinical validation of biomarkers RIA (100%) ca. 60 Mio. € and/or diagnostic medical devices (50.000 € for Phase 1, 1-5 Mio. € in Phase 2) Innovative PHC 13: New therapies for chronic non- RIA (100%) 60 Mio. € treatments and communicable diseases (4-6 Mio. €) technologies PHC 15: Clinical research on regenerative RIA (100%) 72 Mio. € medicine (4-6 Mio. €) PHC 17: Comparing the effectiveness of RIA (100%) 48 Mio. € existing healthcare interventions in the elderly (4-6 Mio. €) To be found in work programme www.consultech.de
Basics+of+a+good+proposal+ • Scientific, technical excellence • Reference to political objectives • Reference to call and work programme good idea Excellent consortium perfect • Meet formal requirements formulated • Please reviewers proposal www.consultech.de
Proposal template & evaluation ! Review process ! Score of each chapter from 1 (worst) – 5 (best) ! Threshold: call specific ! Page limits ! Max. 7 / 10/ 15 pages for stage 1 (call specific) ! Max. 70 pages for stage 2 ! Financial planning / Budget
Proposal+Template+ ! 1.+Excellence+ ! Work+plan+ ! Objec@ves+ ! Management+structure+&+ ! Rela@on+to+work+programme+ procedures+ ! Concept+&+approach+ ! Consor@um+as+a+whole+ ! Ambi@on+ ! Resources+ ! 2.+Impact+ ! 4.+Members+of+consor@um+ ! Expected+impact+ ! 5.+Ethics+&+Security+ ! Measures+to+maximise+impact+ ! 3.+Implementa@on+ www.consultech.de
Important+aspects+for+proposal+ wri@ng+ Topic • Analyse conditions of application (formal, impact) Analyse the call • Is this an appropriate topic? • Is my idea fitting the topic text? • Does my idea meet the goals of the call? Understand evaluation criteria • Annex H, reviewer’s guide • Write comprehensible www.consultech.de
Consor@um+ + +Iden@fy+project+partners+++ • Minimum+of+partners+ • Type+of+beneficiary+ • SME+par@cipa@on+ • Field+of+ac@vi@es++ • Complementary+characteris@cs+ • Interdisciplinary+ www.consultech.de
Overview+ Applica@on+process+–+step+by+step+ + Submit++ just+in++ update++ @me+ 2 upload++ Part+B+to+ financials+in+ Part+A+ according+to+ write++ Par@cipant+ Part+B+ Part+B++ Portal+ Download+ template+for+ complete++ Part+B+ Form+A+ add+Partners+ (partner+and+ to+Form+A+ project+ register+for+ (Portal)+ specific)++ call+/+topic++ make+a+Lear+T+ (coordinator)+ appointment+ finish+Financial+ 1 Registra@on+of+ &+Legal+ Viability+Check++ register+your+ create+ECAS+ organisa@on+ Account+at+ (PIC)+ par@cipant+ portal+ www.consultech.de
Vorstellung aktueller relevanter Aufrufe Dr. Daniel Schubart
Important+calls+ Call identifier: H2020-PHC-2014-two-stage • Pillar or sub-theme: e.g. PHC, SFS, LEIT, NMP, SMEINST, ICT • Deadline: e.g. 2014 Work programme (budget: pro call PHC und topic PHC-12) Examples • New therapies for chronic non-communicable diseases • Development of new diagnostic tools and technologies: in vitro devices, assays and platforms • Vaccine development for poverty-related and neglected infectious diseases: tuberculosis • Advancing bioinformatics to meet biomedical and clinical needs www.consultech.de
Topics+2014+–+Health+/+Examples+ Area Topic Instrument Budget Understanding PHC 1: Understanding health, ageing and RIA (100%) 54 Mio. € health, ageing and disease: determinants, risk factors and disease pathways (4-6 Mio. €) Effective health PHC 5: Health promotion and disease RIA (100%) 24 Mio. € promotion, disease prevention: translating “-omics” into prevention, stratified approaches (4-6 Mio. €) preparedness and screening PHC 6: Evaluating existing screening and RIA (100%) 15 Mio. € prevention programmes (2-3 Mio. €) PHC 7: Improving the control of infectious RIA (100%) 20 Mio. € epidemics and foodborne outbreaks through rapid identification of pathogens (15-20 Mio. €) PHC 8: Vaccine development for poverty- RIA (100%) 25 Mio. € related and neglected infectious diseases: Tuberculosis (15-20 Mio. €) www.consultech.de
Topics+2014+–+Health+/+Examples+ Area Topic Instrument Budget Improving diagnosis PHC 10: Development of new diagnostic tools RIA (100%) 48 Mio. € and technologies: in vitro devices, assays and platforms (4-6 Mio. €) PHC 12: Clinical validation of biomarkers RIA (100%) ca. 60 Mio. € and/or diagnostic medical devices (50.000 € für Phase 1, 1-5 Mio. € in Phase 2) Innovative PHC 13: New therapies for chronic non- RIA (100%) 60 Mio. € treatments and communicable diseases (4-6 Mio. €) technologies PHC 15: Clinical research on regenerative RIA (100%) 72 Mio. € medicine (4-6 Mio. €) PHC 17: Comparing the effectiveness of RIA (100%) 48 Mio. € existing healthcare interventions in the elderly (4-6 Mio. €) To be found in Work programme www.consultech.de
Example+1:+New+therapies+for+chronic+ nonTcommunicable+diseases+ www.consultech.de
Example+1:+New+therapies+for+chronic+ nonTcommunicable+diseases+ ! Specific+challenge:+Chronic+nonTcommunicable+diseases+represent+a+significant+burden+on+individuals+and+healthcare+ systems.+Innova@ve,+cost+effec@ve+therapeu@c+approaches+are+required+to+provide+the+best+quality+of+care+when+ preven@on+fails.+While+a+considerable+amount+of+knowledge+has+been+generated+by+biomedical+research+in+recent+ years,+the+development+of+new+therapies+is+stagna@ng,+in+part+due+to+a+lack+of+clinical+valida@on.+ ! Scope:+Clinical+trial(s)+suppor@ng+proof+of+concept+in+humans+to+assess+the+poten@al+clinical+efficacy+of+the+novel+ therapeu@c+concept(s)+and+/+or+op@misa@on+of+available+therapies+(e.g.+drug+repurposing).+The+applica@on+may+build+ on+preTexis@ng+preTclinical+research+and+addi@onal+results+from+large+scale+databases.+A+concise+feasibility+assessment+ jus@fied+by+available+published+and+preliminary+results+and+suppor@ng+data+should+also+be+provided.+Considera@ons+of+ effec@veness+and+poten@al+clinical+benefit+(possibly+including+real+world+data)+should+be+integrated+in+the+applica@on+ if+relevant.+++++++++ The+Commission+considers+that+proposals+reques@ng+a+contribu@on+from+the+EU+of+between+EUR+4+and+6+million+ would+allow+this+specific+challenge+to+be+addressed+appropriately.+Nonetheless,+this+does+not+preclude+submission+and+ selec@on+of+proposals+reques@ng+other+amounts.+ ! Expected+impact:+New+therapeu@c+strategies,+adapted+where+relevant+to+the+differing+needs+of+men+and+women,+with+ the+highest+poten@al+to+generate+advances+in+clinical+prac@ce+for+chronic+diseases,+including+mul@T+or+comorbidity,+ ready+for+further+development.+ Early+exclusion+of+candidate+strategies+unlikely+to+succeed.+ Contribute+to+the+improvement+of+the+therapeu@c+outcome+of+major+chronic+health+issues+with+significant+impact+on+ burden+of+diseases+both+for+individual+pa@ents+and+for+health+care+systems.+ ! Type+of+ac@on:+Research+and+innova@on+ac@ons+ www.consultech.de
Example+2:+Clinical+valida@on+of+ biomarkers+and/or+diagnos@c+medical+ devices+(PHCT12T2014T1)+ ! SME+instruments+(100%+funding+!)+ ! Specific+challenge:++ ! Biomarkers+are+used+in+clinical+prac@ce+to+describe+both+normal+and+ pathological+condi@ons.+They+can+also+have+a+prognos@c+or+a+predic@ve+ power.+They+are+therefore+increasingly+used+in+medicine+and+many+ poten@al+biomarkers+are+proposed+every+year.+ ! Only+a+few+of+them+are+however+validated+for+use+in+a+clinical+research+ sevng.+Such+valida@on+implies+the+demonstra@on+of+a+link+to+a+per@nent+ clinical+endpoint+or+process,+as+well+as+a+robust+and+appropriate+analy@cal+ method.+ ! The+clinical+valida@on+of+biomarkers+will+be+increasingly+important+for+the+ development+of+new+diagnos@cs,+and+this+is+a+research+area+where+many+ small+European+companies+are+ac@ve.+ ! Improved+clinical+decisions+should+lead+to+be:er+health+outcomes+while+ contribu@ng+to+the+sustainability+of+the+health+care+system.+ www.consultech.de
Example+2:+Clinical+valida@on+of+ biomarkers+and/or+diagnos@c+medical+ devices+(PHCT12T2014T1)+ ! Scope:++ ! The+SME+instrument+consists+of+three+separate+phases+and+a+coaching+and+ mentoring+service+for+beneficiaries.+Par@cipants+may+apply+to+phase+1+with+a+ view+to+applying+to+phase+2+at+a+later+date,+or+directly+to+phase+2.+ ! Proposals+submi:ed+to+phase+1+shall+consist+of+a+drap+business+plan+and+ feasibility+study+verifying+the+technological/prac@cal+and+economic+viability+ of+the+clinical+valida@on+proposed.+These+may,+for+example,+comprise+risk+ assessment,+market+study,+user+involvement,+intellectual+property+(IP)+ management,+innova@on+strategy+development,+partner+search,+feasibility+ of+concept+etc.+Proposals+may+analyse+bo:lenecks+preven@ng+advance+of+ the+applicant+SME+in+this+area+and+iden@fy+how+a+phase+2+proposal+may+ contribute+to+a:aining+growth+or+sustainability.+ ! The+main+outcome+of+the+proposal+should+be+a+detailed+business+plan.+ Funding+for+phase+1+will+be+provided+in+the+form+of+a+lump+sum+of+EUR+ 50.000+and+proposals+should+have+a+dura@on+of+around+6+months.+ www.consultech.de
Example+2:+Clinical+valida@on+of+ biomarkers+and/or+diagnos@c+medical+ devices+(PHCT12T2014T1)+ ! In+phase+2+proposals+should+address+the+specific+challenge+described,+elaborated+in+the+scope+sec@on+ above,+and+demonstrate+high+poten@al+in+terms+of+applicant's+compe@@veness+and+growth+ underpinned+by+a+strategic+business+plan.+ ! Proposals+shall+be+based+on+a+business+plan+developed+either+through+phase+1+or+another+means.+ Par@cular+a:en@on+must+be+paid+to+IP+protec@on+and+ownership;+applicants+should+provide+evidence+ of+the+possibility+of+commercial+exploita@on+(‘freedom+to+operate’).+ ! The+clinical+valida@on+of+exis@ng+poten@al+biomarkers+(not+the+iden@fica@on+of+new+ones)+is+sought.+ This+valida@on+should+provide+evidence+for:+high+analy@cal+validity;+appropriate+sensi@vity+and+ specificity;+clinical+validity/+u@lity.+Preference+will+be+given+to+valida@on+of+biomarkers+with+high+ poten@al+for+short+term+uptake+into+clinical+prac@ce.+ ! In+addi@on,+valida@on+of+the+clinical+performance+of+new+diagnos@c+devices+can+be+supported,+either+in+ combina@on+with+the+biomarker+valida@on,+or+against+exis@ng+standards.+ ! Both+in+vivo+and+in+vitro+poten@al+biomarkers+are+eligible.+Preference+will+be+given+to+the+valida@on+of+ disease+related+biomarkers+(i.e.+diagnos@c,+suscep@bility/risk,+monitoring+and+prognos@c+biomarkers)+ ! Proposals+shall+contain+a+specifica@on+for+the+outcome+of+the+project,+including+a+first+ commercialisa@on+plan,+and+criteria+for+success.+ ! The+Commission+considers+that+phase+2+proposals+reques@ng+a+contribu@on+from+the+EU+of+between+ EUR+1+and+5+million+would+allow+this+specific+challenge+to+be+addressed+appropriately.+Nonetheless,+ this+does+not+preclude+submission+and+selec@on+of+proposals+reques@ng+other+amounts.+Phase+two+ projects+should+duly+jus@fy+their+dura@on+making+reference+to+obtaining+pa@ent+samples,+ensuring+ pa@ent+follow+up,+etc.+ www.consultech.de
Example+2:+Clinical+valida@on+of+ biomarkers+and/or+diagnos@c+medical+ devices+(PHCT12T2014T1)+ ! Expected+impact+ ! Increased+clinical+availability+and+exploita@on+of+biomarkers+for+the+benefit+of+ the+pa@ent.+ ! New+diagnos@c+devices.+ ! Facilita@on+of+entry+of+improved+diagnos@cs+in+the+clinic+and+the+market.+ ! Support+for+the+implementa@on+of+the+Commission+proposal+for+a+revised+in+ vitro+diagnos@c+devices+regula@on[1].+ ! Enhancing+profitability+and+growth+performance+of+SMEs+by+combining+and+ transferring+new+and+exis@ng+knowledge+into+innova@ve,+disrup@ve+and+ compe@@ve+solu@ons+seizing+European+and+global+business+opportuni@es.+ ! Contribu@on+to+the+sustainability+of+health+care+systems.+ ! Increased+likelihood+of+market+uptake+and+distribu@on+of+resul@ng+ innova@ons+tackling+the+abovemen@oned+specific+challenge(s)+in+a+sustainable+ way.+ ! Leveraging+of+private+investment+in+clinical+valida@on+as+described+above,+ notably+leverage+of+private+coTinvestor+and/or+followTup+investments.+ www.consultech.de
Summary+ ! Simplifica@on+?+ ! One+or+two+stage+proposals+ ! Rules+of+par@cipa@on+and+ ! Refer%to%topic%text%and% funding+(finances,+@meT evalua2on%criteria% recording,+single+indirect+cost+ ! Quality%of%consor2um%% rate,+only+2+funding+rates,+less+ ! Innova2on%of%idea%% CFS,+less+audits)+ ! Find+calls!?+ ! Legal+aspects+ ! Electronic+submission+(grants,+ ! GA,+CA,+IP+rules+ amendments)+ ! Amendments+ ! Quicker+@me+to+grant+ ! Budget+alloca@on+flexible+ ! Applica@on+process++ ! Consor@um+members+may+be+ ! Administra@ve,+financial+&+ exchanged+ technical+part+ www.consultech.de
Websites+ ! Research+par@cipant+portal:++ h:p://ec.europa.eu/research/par@cipants/portal/desktop/en/ opportuni@es/index.html+ ! NKS+Deutschland+&+BMBF:+Informa@on+&+Ansprechpartner:+ www.horizont2020.de+ ! h:p://www.consultechTct.de/H2020/+ www.consultech.de
Thank you very much for your attention! Dr. Daniel Schubart Dipl.-Ing. Heidrun Gürtler Dipl.-Ing. Ursula Wirtz Tel.: +49 30 7720 5920 Email: info@consultech.de www.consultech.de
You can also read