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Division of work in the Workplan

Division of work in the Workplan. David Hulmes Institut de Biologie et Chimie des Protéines, CNRS UMR 5086, Lyon, France. European Commission. Three-dimensional reconstruction of human corneas by tissue engineering. Acronym : CORNEA ENGINEERING.

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Division of work in the Workplan

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  1. Division of work in the Workplan David Hulmes Institut de Biologie et Chimie des Protéines, CNRS UMR 5086, Lyon, France

  2. European Commission Three-dimensional reconstruction of human corneas by tissue engineering Acronym : CORNEA ENGINEERING Coordinator : D Hulmes, Institut de Biologie et Chimie des Protéines, CNRS UMR 5086, Lyon

  3. THE CORNEA epithelial cells Bowmans membrane extracellular matrix of collagen fibrils and proteoglycans stromal cells (keratocytes) endothelial cells Descemets membrane

  4. WP 2 : Recombinant Proteins WP 3 : Extracellular Enzymes WP 4 : Building the Cell Scaffold WP 5 : Stem Cells WP 6 : Cell-Matrix Interactions WP 1 : Coordination and Management WP 10 : Exploitation and Dissemination WP 7 : Tissue engineering WP 8 : Clinical Testing WP 9 : Functional Testing WORKPACKAGE ORGANISATION

  5. WORKPACKAGES Other partners involved Lead cont- ractor No Deliver- able No Person- months Start month End month WP No Workpackage title D1 Co-ordination and Project D7 WP1 1b 35 0 36 3 Management D20 One or several partners per workpackage ? D22 1b,1c,1d, 10,11,12,13 WP2 Recombinant Proteins 1d 180 0 18 D4 1b,1c,1d, 10,11,13 D5 WP3 Extracellular Enzymes 13 128 0 18 D6 1b,1d,5, 10,11,14 D8 WP4 Building the Cell Scaffold 11 158 6 30 D11 D3 3,6,7,8 WP5 Stem Cells 8 203 0 30 D12 D13 1c,1d, 6,11,13 Cell-Matrix Interactions and D14 WP6 1c 97 6 30 Basement Membranes D15 1a,5,6, 8,9 D9 WP7 Tissue Engineering 1a 149 0 36 D16 1a,2,3, 4,7,8 WP8 Clinical Testing 7 237 6 30 D10 D17 2,5,6, 7,8,9 WP9 Functional Testing 2 165 12 36 D18 D19 Exploitation and D2 WP10 1b 70 0 36 All partners Dissemination D21 TOTAL 1412

  6. Workpackages Month No. Title 0 3 6 9 12 15 18 21 24 27 30 33 36 1 Co-ordination and Management 2 Recombinant Proteins 3 Extracellular Enzymes 4 Building the Cell Scaffold 5 Stem Cells 6 Cell-Matrix Interactions and Basement Membranes 7 Tissue Engineering 8 Clinical Testing 9 Functional Testing 10 Exploitation and Dissemination CORNEA ENGINEERING - WORKPLAN

  7. DELIVERABLES Delivery Date (month) Other partners involved Lead cont- ractor No Dissemin- ation level Deliverable name WP No. Person- months Nature Del No. - D1 Project presentation 1 1a 1 R PU 3 One or several partners per deliverable ? Optimisation of culture of epithelial cells D2 5 8 20 R PU 6 - Initial plan for use and dissemmination of knowledge D3 10 1b 20 R CO 12 all Protocols for production of recombinant proteins 1b,1c,10,11,12,13 D4 2 1d 180 R PU 18 C-proteinases and associated proteins D5 3 13 84 R PU 18 1b D6 N-proteinases 3 44 R PU 18 10 - all D7 Mid-term report 1 1b 15 R PU 18 Collagen/proteoglycan fibril composites D8 4 11 1b,10 79 R PU 24 Production of a hemi-cornea 1b,6,8,14 D9 7 1a 75 P CO 24

  8. Hints on project writing David Hulmes Institut de Biologie et Chimie des Protéines, CNRS UMR 5086, Lyon, France

  9. Start early ! • (12 months before the deadline) • Attend a training course on how to write a proposal (e.g. www.hyperion.ie) • Choose a good project ! • Identify a need (consult EC documents and directives at www.europa.eu.int) • Become an expert evaluator (www.cordis.lu/experts) • Get in touch with national FP6 representatives and their delegations in Brussels • Arrange a meeting with a Commission officer in an area related to your project

  10. WHY RECONSTRUCTED CORNEAS ? • Corneal grafting (10,000 / year in Europe) • shortage of donors, unsuitability of tissue (HIV, Creutzfeld-Jacob, Hepatitis C, corrective surgery) • limitations of artificial keratoprostheses • 6 million world-wide blinded by infectious diseases of the cornea • Pharmacotoxicology • alternatives to animal testing (Draize test)

  11. Building the consortium • (at least 6 months before the deadline) • Define clear and measurable goals • Choose the best people for the job, not just your friends • Good mix of nationalities (do not exceed the 40 % rule for any one country) • Complementarity of basic research (different disciplines), applied research and socioeconomic partners • Arrange a first meeting of the consortium • Assign clearly defined roles for each partner

  12. OVERVIEW • GOAL : • to reconstruct an artificial cornea using recombinant human extracellular matrix proteins and adult stem-cell derived epithelial, stromal and endothelial cells • REQUIREMENTS : • biocompatibility and stability • optical transparency and refractive properties • mechanical strength

  13. THE CONSORTIUM - Countries • France • Institut de Biologie et Chimie des Protéines, CNRS UMR 5086 Lyon (3 groups) • Skin Substitutes Laboratory and Corneal Tissue Bank, E. Herriot Hospital, Lyon • Ophthalmology Department, Hôtel-Dieu, Paris • Banque Française des Yeux, Paris • IOLTECH LABORATORIES (SME), La Rochelle • COLETICA (SME), Lyon • Germany • Universitats-Augenklinik, Hamburg • Finland • FIBROGEN EUROPE / University of Oulu • Sweden • Department of Cell and Molecular Biology, University of Lund • Belgium • Lab. of Connective Tissue Biology, Université de Liège • Italy • Laboratory of Tissue Engineering, Fondazione Bana degli Occhi del Veneto, Mestre Venezia • Ophthalmology Department, San Raffaele Hospital, Milan • Israel • Goldschleger Eye Research Institute, Tel Aviv University • United Kingdom • Departments of Civil Engineering, Ophthalmology and Mathematics, University of Dundee • Turkey • Biotechnology Research Unit, Middle East Technical University, Ankara

  14. THE CONSORTIUM - Expertise • Applied Research/ Ophthalmology • Skin Substitutes Laboratory and Corneal Tissue Bank, E. Herriot Hospital, Lyon, France • Laboratory of Tissue Engineering, Fondazione Bana degli Occhi del Veneto, Mestre Venezia, Italy • Ophthalmology Department, San Raffaele Hospital, Milan, Italy • Ophthalmology Department, Hôtel-Dieu, Paris, France • Banque Française des Yeux, Paris, France Fundamental Research Institut de Biologie et Chimie des Protéines, CNRS UMR 5086 Lyon, France (3 groups) Universitats-Augenklinik, Hamburg, Germany Department of Cell and Molecular Biology, University of Lund, Sweden Lab. of Connective Tissue Biology, Université de Liège, Belgium Departments of Civil Engineering, Ophthalmology and Mathematics, University of Dundee, UK Goldschleger Eye Research Institute, Tel Aviv University, Israel Biotechnology Research Unit, Middle East Technical University, Ankara, Turkey • Industrial Partners • IOLTECH LABORATORIES (SME), La Rochelle, France • COLETICA (SME), Lyon, France • FIBROGEN EUROPE / University of Oulu, Finland

  15. COMPLEMENTARITY OF EXPERTISE Partner No. 1a 1b 1c 1d 2 3 4 5 6 8 9 10 11 12 13 14 Partner Short Name LBO ULg EBFV HSR UoD BFY FGE UKE TAU METU ULUND COLETICA IOLTECHH CNRS-DR07 CNRS-DR07 CNRS-DR07 CNRS-DR07 Partner Type (A = academic, C = A A A A C C I I A A A A A I A A C clinical, I = industrial) Management X X X X Recombinant Proteins X X X X Collagens X X X Proteoglycans X Matrix Enzymes X X X Matrix Assembly X Epithelial Stem Cells X Endothelial Stem Cells X Keratocytes X Cell Matrix Interactions X EXPERTISE Tissue Engineering (TE) X X X Scaffolds for TE X Mathematical Modelling X Biomechanics X Tissue Banking X X X Corneal Grafting X X Animal Models X Keratoprostheses X Pharmacotoxicology X

  16. Writing the proposal • (start at least 3 months before deadline) • Diagrams • Deliverables and milestones • Cost models and person months • Don’t just concentrate on the science and technology, other aspects are equally important : • Quality of the consortium • Relevance • Impact • Mobilisation of resources • Management (need for a project manager) • Gender issues • Ethical issues • Consortium agreement

  17. WP 2 : Recombinant Proteins WP 3 : Extracellular Enzymes WP 4 : Building the Cell Scaffold WP 5 : Stem Cells WP 6 : Cell-Matrix Interactions WP 1 : Coordination and Management WP 10 : Exploitation and Dissemination WP 7 : Tissue engineering WP 8 : Clinical Testing WP 9 : Functional Testing WORKPACKAGE ORGANISATION

  18. Workpackages Month No. Title 0 3 6 9 12 15 18 21 24 27 30 33 36 1 Co-ordination and Management 2 Recombinant Proteins 3 Extracellular Enzymes 4 Building the Cell Scaffold 5 Stem Cells 6 Cell-Matrix Interactions and Basement Membranes 7 Tissue Engineering 8 Clinical Testing 9 Functional Testing 10 Exploitation and Dissemination CORNEA ENGINEERING - WORKPLAN

  19. Delivery Date (month) Other partners involved Lead cont- ractor No Dissemin- ation level Del. Deliverable name WP No. Person- months no Nature - D1 Project presentation 1 1a 1 R PU 3 Optimisation of culture of epithelial cells D2 5 8 20 R PU 6 - Initial plan for use and dissemmination of knowledge D3 10 1b 20 R CO 12 all Protocols for production of recombinant proteins 1b,1c,10,11,12,13 D4 2 1d 180 R PU 18 C-proteinases and associated proteins D5 3 13 84 R PU 18 1b D6 N-proteinases 3 44 R PU 18 10 - all D7 Mid-term report 1 1b 15 R PU 18 Collagen/proteoglycan fibril composites D8 4 11 1b,10 79 R PU 24 Production of a hemi-cornea 1b,6,8,14 D9 7 1a 75 P CO 24 DELIVERABLES - for measuring progress 22 deliverables in total, not too many, not too few

  20. Milestone Month Objective 1 18 Availability of recombinant extracellular matrix proteins for use in building scaffolds (WP2) 2 18 Identification of key enzymes, variants and associated proteins for use in building scaffolds (WP3) 3 30 Identification of adult corneal epithelial and endothelial stem cell sources (WP5) 4 30 Protocols for scaffold construction meeting biological, biomechanical and optical criteria (WP4) 5 30 Identification of optimal conditions for epithelialisation, endothelialisation, stromal and basement membrane assembly (WP6) 6 30 Availability of reconstructed full depth or hemi-corneas (WP7) 7 30 Validation of protocols using limbal-derived corneal epithelial cells for the treatment of superficial corneal injury (WP8) 8 36 Validation of reconstructed full-depth or hemi-corneas in animal models for use in tissue grafting (WP9) 9 36 Validation of reconstructed full-depth or hemi-corneas for use as alternatives to animal testing for toxicity testing (WP9) MILESTONES - key decision points

  21. COST MODELS Maximum grant as percentage of Maximum grant as percentage full costs (participants applying the of additional costs FC or FCF model) (participants applying the ACF model) RTD activities 50% 100% Demonstration activities 35% 100% Innovation-related 50% 100% activities Consortium management 100% (up to a maximum 100% (up to a maximum activities percentage of 7% of the percentage of 7% of the Community contribution) Community contribution)

  22. STRP Project Effort Form 1. 2. 3. 4. 5. 6. 7. Participant CNRS-DR07 APHP-HTD BFY IOLTECH COLETICA UKE HSR Research/innovation activities WP2 Recomb. Proteins 27/61 0/0 0/0 0/0 0/0 0/0 0/0 WP3 Extracell. Enzymes 2/45 0/0 0/0 0/0 0/0 0/0 0/0 WP4 Cell Scaffold 28/48 0/0 0/0 0/0 1/1 0/0 0/0 WP5 Stem Cells 0/0 0/0 9/21 0/0 0/0 20/62 18/30 WP6 Cell-Matrix & BM 27/60 0/0 0/0 0/0 0/0 5/16 0/0 WP7 Tissue Engineering 30/66 0/0 0/0 0/0 10/20 5/15 0/0 WP9 Functional Testing 0/0 12/65 0/0 0/0 10/20 0/5 0/27 TotalResearch/innovation 114/280 12/65 9/21 0/0 21/41 30/98 18/57 Demonstration activities WP8 Clinical Testing 0/6 0/40 9/21 0/24 0/0 0/0 18/42 Total Demonstration 0/6 0/40 0/2 0/24 0/0 0/0 18/42 Management activities WP1 Co-ord. Management 12/19 0/1 4/4 0/1 0/1 0/1 0/1 WP10 Exploit. Dissemin. 6/14 0/2 2/2 0/12 0/12 0/2 0/2 Total Management 18/33 0/3 6/6 0/13 0/13 0/3 0/3 TOTAL ACTIVITIES 132/319 12/108 24/48 0/37 21/54 30/101 36/102 Note : For each partner, two figures are given for person-months (PMs): (1) PM’s for staff whose salaries are to be funded by the project, (2) PMs for all staff to be deployed (salaries funded or not by the project).

  23. General Assembly Intellectual Property Council Ethics and Standardisation Advisory Panel Executive Board WP 1 WP 2 WP 3 WP 4 WP 5 WP 6 WP 7 WP 8 WP 9 WP 10 MANAGEMENT STRUCTURE

  24. Evaluation Summary Report for a STREP Proposal No. : 504017-1 Acronym : CORNEA ENGINEERING 1. Relevance Mark: (Threshold 3/5; Weight 1) The project is innovative and ambitious and fits 3.4.4.2 as well as objectives of Priority 1. 4.2 Correct selection of standardization authorities. 2. Potential impact Mark: (Threshold 3/5; Weight 1) Major areas of potential impact that can be an alternative to animal experimentation. It can 4.2 lead to savings in health care costs and addresses cornea donor shortage. Detailed exploitation/dissemination plan should be provided. 3. S&T excellence Mark: (Threshold 4/5; Weight 1) Very clearly defined and focused objectives. Very ambitious project. There is a risk with the 4.5 scaffolds. A WP on scaffold evaluation (biomechanical, biocompatibility) should be added. A risk management plan should also be added with alternatives planned. 4. Quality of the consortium Mark: (Threshold 3/5; Weight 1) The consortium is high quality, interdisciplinary, well suited, and complementary with 4.2 experience in joint work among some partners. There are three SME’s involved. 5. Quality of the management Mark: (Threshold 3/5; Weight 1) The plan is adequate for management steering and decision making for the project 3.8 knowledge, IPR and innovation related issues. However, the consortium is very large and it can be problematic, especially with regard to IPR. 6. Mobilisation of the resources Mark: (Threshold 3/5; Weight 1) Well planned, coherent project with good mobilization of resources. Travel budgets have to 4.3 be discussed. Overall remarks Total score: (Threshold 21/30) Recommended budget cut of 20%. 25.2 Yes Has the proposal passed all evaluation thresholds? Yes Does this proposal have ethical issues that need further attention?

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