Biopeople: Danish Innovation Cluster for Life & Health Sciences

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1 Innovation across disciplines Biopeople: Danish Innovation Cluster for Life & Health Sciences GÅ-Hjemmøde Horizon januar 2014 Niels Westergaard, PhD, Dr pharm Science and Innovation Network Manager

2 Biopeople Innovation across disciplines We focus on setting up: cross disciplinary projects public private partnerships internationalisation. To reach these strategic goals, we use the following services: matchmaking events knowledge transfer, innovation projects strategy development. Cartoons: Jens Hage;

3 3 Innovation across disciplines Biopeople receives the European Cluster Excellence Initiative (ECEI) Gold Label of Cluster Management Excellence in June Based on expert assessment of 31 quality indicators Endorsed by the European Commission Biopeople is the first European Life Science Network to obtain that recognition

4 4 Horizon 2020 New framework programme for Research and Innovation ( ) Innovation across disciplines Biopeople to take an active role to stimulate the formation of strong consortiums within life sciences and be an active player in reference groups and advisory boards Reference group: Health, Demographic Change and Wellbeing Food Security and Biobased Economy Matchmaking Cartoons: Jens Hage;

5 Horizon 2020 Innovation across disciplines

6 Innovation across disciplines European Patients Academy on Therapeutic Innovation (EUPATI) The project is receiving support from the Innovative Medicines Initiative Joint Undertaking under grant agreement n , resources of which are composed of financial contribution from the European Union's Seventh Framework Programme (FP7/ ) and EFPIA companies.

7 Innovation across disciplines

8 IN2LifeSciences: Access to Market, Technology and Financing fore SMEs Shared among 8 bioregions, of which Denmark is one ~ 250 incentives: 500, 4000 or 7000 Regional Access Brokers Easy access to facilities and experts

9 (this is not a logo) Biopeople den 23. januar 2014 Anne-Mette Mikkelsen EuroCenter ammi@fi.dk Ministeriet for Forskning, Innovation og Videregående Uddannelser Styrelsen for Forskning og Innovation

10 EuroCenter National Contact Point (NCP) Vejledning til danske FP-7 og Horizon 2020 deltagere Vejledning og rådgivning fra projektidé til projekt- afslutning (via telefon, , individuelle møder) Vejledning ift. juridiske og økonomiske regler Tæt kontakt til Europa Kommissionen Ansøgningsvejledning Kurser om ansøgningsskrivning, rapportering, koordinatorrollen mm. Kontakt: Telefon: Ministeriet for Forskning, Innovation og Videregående Uddannelser Styrelsen for Forskning og Innovation

11 Hvorfor 70 mia. til forskning og innovation? Styrke Europas position indenfor videnskab på den globale scene Fremme Europas industrielle lederskab Adressere store samfundsmæssige udfordringer skabe vækst og beskæftigelse i Europa Ministeriet for Forskning, Innovation og Videregående Uddannelser Styrelsen for Forskning og Innovation

12 Budget: 77 milliarder euros EXCELLENT SCIENCE INDUSTRIAL LEADERSHIP SOCIETAL CHALLENGES European Research Council 17% 17,6% Future and Emerging Technologies 3,5% Marie Sklodowska-Curie actions 8% 3,69% 0,8% Leadership in enabling and industrial technologies Access to risk finance Innovation in SMEs Health, demographic change and well-being; Food security, sustainable agriculture and forestry, marine and maritime and inland water research and the bioeconomy Secure, clean and efficient energy; 9,7%7 % 5% 7,7% 3,23% Research Infrastructures Widening Participation: 1,06% Science with and for society: 0,6% EIT: 3,52% JRC: 2,47% Ministeriet for Forskning, Innovation og Videregående Uddannelser Styrelsen for Forskning og Innovation Smart, green and integrated transport; Climate action, resource efficiency and raw materials; Inclusive, innovative and reflective societies. Secure Societies 8,23% 4% 1,7% 2,2%

13 Én type tilskudsrate per projekt Projekttyper Tilskudsrate Research and Innovation Actions Innovation Actions 100 % + 25 % 70 % + 25 % (100 % til non-profit) Coordination & Support Actions 100 % + 25 % Dvs. at alle støtteberettigede udgifter i f.eks. et forskningsprojekt støttes med 100 % + 25 % overhead uanset aktivitets- og partnertype, 70 % + 25 % i et innovationsprojekt (demonstration/close to market a.) Ministeriet for Forskning, Innovation og Videregående Uddannelser Styrelsen for Forskning og Innovation

14 Muligheder for SMVer (I) Forsknings- og innovationsprojekter, som udbydes i arbejdsprogrammer (WP) under Leadership in enabling and industrial technologies (søjle 2) og Societal Challenges (søjle 3). Time to grant: 8 måneder (5+3) Konsortiekrav: Min. 3 partnere fra 3 forskellige EU-lande ell. ass. lande Varighed: Typisk 3-5 år Budgetstørrelse: Typisk 3-9mio euros Spg vedr. wp for bioteknologi og bioøkonomi Kontakt NCP Ulrik K. Olsen Telefon: uko@fi.dk Spg vedr. wp for sundhed Kontakt NCP Kim Kryger Telefon: klk@fi.dk Ministeriet for Forskning, Innovation og Videregående Uddannelser Styrelsen for Forskning og Innovation

15 Muligheder for SMVer (II) Fast track to innovation (projekttype fra 2015), som udbydes i arbejdsprogrammer (WP) under søjle 2 og 3 Bottom up indenfor rammerne af det givne arbejdsprogram Forventet tilskud ca. 3 millioner euros Time-to grant max 6 måneder Løbende ansøgningsfrist Små konsortier (3-5 partnere) Ministeriet for Forskning, Innovation og Videregående Uddannelser Styrelsen for Forskning og Innovation

16 Muligheder for SMVer (III) Marie Sklodowska Curie Actions (program under søjle 1) gratis forsker eller ph.d (udstationering til virksomheden) ITN- call et (støtte til uddannelse af ph.d.-er) - smv en bliver del af en ph.d-skole med vidensinstitutioner - smv en bliver tilknyttet netværket og tager imod en ph.d.-studerende i en periode RISE-callet (støtte til staff exchange) - smv en deltager i et forskningsprojekt med vidensinstitutioner og får tilskud fra EU til udveksling af personale Ministeriet for Forskning, Innovation og Videregående Uddannelser Styrelsen for Forskning og Innovation Spg vedr. wp for MSC Kontakt NCP Bodil Palmberg Telefon: bep@fi.dk

17 Muligheder for SMVer ud (IV) Eurostars (NB - særligt program med national medfinansiering). Primær målgruppe: innovations- og forskningsaktive SMV er (anvender mindst 10 % af deres omsætning eller af deres fuldtidsansatte på FoU aktiviteter). Medfinansiering af forsknings- udviklings- og demonstrationsaktiviteter. Tværnationale konsortier (min. 2 deltagere fra 2 lande). Varighed: maximalt 3 år og 2 år til markedsføring efter projektafslutningen. Biotek-projekter skal mindst være klar til klinisk fase ét to år efter projektafslutningen. Uafhængigt internationalt bedømmelsespanel. Svar på ansøgning inden for 4-5 måneder. SMV er kan få op til 50 % af projektomkostningerne dækket. Det maksimale tilskudsbeløb pr. projekt er til de danske deltagere. De danske tilskud dækker primært lønudgifter. Spg. vedr. EuroStars Kontakt: Lisbet Elming Ministeriet for Forskning, Innovation og Videregående Uddannelser Styrelsen for Forskning og Innovation Telefon: lel@fi.dk

18 Muligheder for SMVer (V) Budget: ca. 3 mia euros SMV-instrument (projekttype, som udbydes i arbejdsprogrammer (WP) under søjle 2 og 3) Ministeriet for Forskning, Innovation og Videregående Uddannelser Styrelsen for Forskning og Innovation

19 Fase 1 Konsortiekrav: Min. 1 smv Concept & Feasibility Assessment Ansøgningsfrist: Løbende ansøgning Time to grant: 3 måneder Projektvarighed: 6 måneder Budgetstørrelse: euros (70 %) Ansøgning: 10 sider Ministeriet for Forskning, Innovation og Videregående Uddannelser Styrelsen for Forskning og Innovation

20 Fase 2 Demonstration Market Replication Research Development Miniaturisation Testing Piloting Prototyping Scaling up Kan søges direkte uden forudgående deltagelse i fase 1 Konsortiekrav: Min. 1 smv Ansøgningsfrist: Løbende ansøgning Time to grant: 6 måneder Projektvarighed: måneder Budgetstørrelse: Typisk mio euros (70 %) Ansøgning: 30 sider Ministeriet for Forskning, Innovation og Videregående Uddannelser Styrelsen for Forskning og Innovation

21 Concept & Feasibility Assessment Demonstration Market Replication Research Development Miniaturisation Testing Piloting Prototyping Scaling up Support No direct funding IDEA business coaching throughout the project MARKET Ministeriet for Forskning, Innovation og Videregående Uddannelser Styrelsen for Forskning og Innovation

22 Ministeriet for Forskning, Innovation og Videregående Uddannelser Styrelsen for Forskning og Innovation

23 Nyttige links Deltagerportalen (participant portal) hvor al information om H2020 findes: Genvej til arbejdsprogrammer, regler for deltagelse, ansøgningsskabeloner mm: _docs.html Ansøgningsskabelon fase 1 SMV-instrumentet: call-pt-sme-1_en.pdf Ansøgningsskabelon fase 2 SMV-instrumentet: call-pt-sme-2_en.pdf Ministeriet for Forskning, Innovation og Videregående Uddannelser Styrelsen for Forskning og Innovation

24 EUopSTART EUopSTART yder tilskud til danske virksomheders og videninstitutioners forberedende arbejde med at deltage i udvalgte europæiske og internationale forskningsprogrammer. EUopSTART giver støtte til forberedelse af ansøgninger til Horizon 2020 Puljen åbner igen 1. juli 2014 Kontakt Helle Poulsen Ea Elisabeth Bauchy Telefon: Telefon: hepo@fi.dk eeb@fi.dk Ministeriet for Forskning, Innovation og Videregående Uddannelser Styrelsen for Forskning og Innovation

25 Ministeriet for Forskning, Innovation og Videregående Uddannelser Styrelsen for Forskning og Innovation

26 January, 2014 Copenhagen Bio Science Park Experience gained from working in EU framework programs Peter Mouritzen, MSc, PhD VP R&D

27 Agenda 2 Introduction to Exiqon today How did we get there A historic perspective on the role of EU FP projects Exiqon Roles in EU FP projects Workload of roles Internal guidelines

28 Exiqon at a glance Highlights Locations Based on proprietary LNA detection technology Established one-stop shop for mirna products Promising diagnostic pipeline based on mirna 214 patents and patent applications (114 issued) cover products, pipeline and mirna biomarkers Exiqon facilities Distributors Business divisions Life Sciences Exiqon Life Sciences combines leading-edge scientific expertise in gene expression with our proprietary LNA technology. Our products, services and scientific staff enable life science researchers to make groundbreaking discoveries Diagnostics Exiqon Diagnostics is the leader in providing technologies for mirna biomarker detection. Exiqon Diagnostics is dedicated in collaboration with partners to develop novel molecular diagnostic tests for early detection of diseases and knowledge based treatment selection.

29 Exiqon at a glance - We took innovation conducted at universities into commercial success 4 Exiqon develops, manufactures and sell products for genetic testing addressing a 12 billion USD market 98% of products sold are exported. 60% are exported out of EU >75 highly educated employees (40% has a Ph.D.) from >10 nationalities Knowhow: Molecular & cell biology, (bio)chemistry, bioinformatics, robotics and IT Raised 600 mdkk in risk capital mdkk Our proprietary technology was invented at U of CPH and Osaka University Exiqon in-licensed the technology First product launched Q1 Q

30 LNA technology overview LNA technology increases binding affinity LNA is a bicyclic high affinity RNA mimic with the sugar ring locked in the 3 -endo conformation Stable A-helix with good base-stacking Increased Tm (Tm increases by 2-8ºC per base) Improved mismatch discrimination High sensitivity and specificity in hybridization assays Obeys Watson-Crick base-pairing rules Easy to implement in standard oligo synthesis K. Bondensgaard et al., Chem. Eur. J. 2000, 6, 2687 M. Petersen et al., J. Am. Chem. Soc. 2002, 124, 5974

31 MicroRNA research: Broad product portfolio

32 Exiqon Diagnostic Pipeline Diagnostic Product Development Colorectal Cancer (Recurrence stage II test ) RUO kit in 2014 Colorectal Cancer (Early detection diagnostic test) Prostate Cancer (Diagnostic and prognostic test) NGS precision medicine

33 Synergies within business areas Life Sciences Molecular tools microrna profiling platforms Protocols Experience & Innovation Diagnostics microrna as biomarkers Biofluids serum, plasma, urine, CSF Protocols Exiqon Services Exiqon Core lab Centralized expertise In house experts with our own products Protocol validation

34 Important events in building one-stop shop for mirna products Papers Wienholds et al Science Development Start RIBOREG Development & of 1 Development of of first mirna st mirna LNA PCR mirna LNA LNA ISH probes microarray Development of 2 nd mirna LNA PCR mirna papers per year according to PubMed lin-4, critical for C.elegans developmental timing mirnas found in mouse & human mirnas implicated in cancer mirnas implicated in viral infection

35 Excellent timing for product development and perfect application for LNA 10 Exiqon in 2004 ~20 employees Large R&D organization LNA oligo business RIBOREG FP6 project 36 month project duration 250 T EUR Grant 9 partners Work package leader role RIBOREG Identification of putative precursors of si/mi RNAs WP2 Identification of new si/mirnas, their precursors and targets WP1 Identification of new large noncoding RNAs Transfer to WP3 or new non-coding mi/si RNAs for expression studies WP4 Dissection of molecular mechanisms involving non-coding RNAs Transfer to WP3 or new non-coding RNAs for expression study WP3 Determination of the expression patterns of non-coding RNA genes Selection of most interesting non-coding RNAs for WP4 WP5 Co-ordination and Management European Commission and the European Scientific and Industrial Communities

36 Experiences from >7 EU FP projects invites per year to join EU projects Roles Work Package leader Contributing partner Initiative taker Tasks Proposal writing coordination of reporting - Some workload own scientific reporting - Moderate workload Financial reporting

37 Innovation at Exiqon - Publicly funded projects is one pillar in our innovation strategy 12 Innovation at Exiqon: Internal Innovation Challenge In collaboration with customers Based on public funding with academic partners We use externally funded programs to: Access specific knowhow Access to key opinion leaders Get the products validated and tested Get access to relevant biological material

38 EU funded programs have been instrumental to Exiqon - Public funded projects work 13 Program Number of partners Total budget/exiqon budget Commercial outcome (Exiqon) Riboreg/FP6 9 Initiated 80% of our product portfolio Sirocco/FP ,0 / 0,6 meur Very limited Oncomirs/FP7 6 4,3 / 0,6 meur Development of the fastest growing product line Prosper/FP7 7 4,0 / 0,6 meur Launch March 2013 Colon cancer/htf 4 42 / 28 mdkk Best selling product Riboreg was the most successful EU program so far it was used by EU to showcase FP6: From concluding report: They note that the collaboration in the RIBOREG project has allowed speeding up the development of the LNA probe technology and Exiqon has been able to commercialize a number of products based on this technology

39 Learning from public funded programs 14 Learning: The fewer partners the better Project leadership is essential: Best when project leader is in company Commercial outcome: The innovation is often applied in products for other markets than originally intended Innovation from publicly funded programs only results in commercial success when it simultaneously is supported by risk capital e.g. Riboreg was launched in the financial heydays

40 Without money, innovation is worth nothing - Access to risk capital is essential. 15 Even within established organizations it is expensive to take new products to the global market The actual product development, manufacturing processes, marketing and selling process cost more in working capital than received in public funding Demand for risk capital In SME s (cash flow negative) that is funded by risk capital

41 Innovation creates value once the need for risk capital is addressed - We can do it much better 16 E.g. on financial audit manuals On public funded innovation programs: FP7: 107pages + 96 pages HTF: 15 pages + 15 pages Simplify management of public funded EU programs Increase focus on project management In FP7 programs, Exiqon has spend 5% of the budget on internal financial control Fund fewer programs with fewer participants but make programs more ambitious = better funded On commercialization of innovation: It is very costly to take public funded innovation into commercial products It takes time: In Life Sciences 5-10 years is common We can only harvest the commercial potential if DK (EU) improve the access to risk capital

42 Exiqon guidelines in considering participation 17 Hire a professional coordinator A lot of ressouces writing Interacting with the commision Don t get involved if you have to do a lot of stuff you did not intend to Only participate if this will take you the way you planned anyway Ultimately, initiate the project yourself Challenges beeing a partner supermarket for consumables

43 Summary EU projects may be a good way to Access specific knowhow Access KOLs Get the products validated and tested Get access to relevant biological material Consider alignment of project with overall company strategy Devote a partner role to project coordination

44 Thank you Contact information: VP R&D Peter Mouritzen

45 23. januar Horizon2020 Netværksmøde Hos BioPeople Christina Yoon Petersen EUhelp.dk - Tlf.:

46 Erfaring Revideret for EU via Moore Stephens Revideret FP6 via PwC Afrapporteret Form C FP6 og FP7 via GEUS, KU og virksomheder.

47 Horizon2020 Få hjælp fra en række aktører. Private Innovationsnetværk/BioPeople Offentlige Styrelser Universiteter/forskningsinstitutioner GTS Virksomheder Udlandet

48 Offentlige EuroCenter Agropark (partnerskab) EU DK support Innovationsnetværk/BioPeople Universiteter: KU, DTU, Århus Universitet GTS (halv offentligt) Andre forskningsinstitutioner

49 Private Innovayt 1stmile Wiborg Anders Bjerrum Udenlandske (hyperion, G & H Associates Limited) EUhelp Revision: Deloitte eller PwC

50 Regler og dokumentation Ansøgning: Højteknologifonden (Innovationsfonden) - erfaring Private/offentlige aktører Dokumentation/revisor: EUhelp Deloitte/PwC Bogholder med erfaring fra fx en forskningsinstitution. Eurocenter (inkl. Kurser)

51 Netværk BioPeople og Netmatch (Innovationsnetværk) Kurser og arrangementer hos Eurocenter Dansk Industri og Dansk Erhverv Arrangementer hos universiteterne (Erhvervssamarbejder, forskerparker etc.) Udenlandske universiteter/virksomheder. EUhelps netværksarrangementer

52 Netværksarrangement 23. maj Adgang til finansiering I samarbejde med Deloitte. Oplægsholdere. Idéen med at hjælpe hinanden. Fredagsbar. Tidligere arrangementer