division of work in the workplan
DESCRIPTION
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. - PowerPoint PPT PresentationTRANSCRIPT
Division of work in the Workplan
David Hulmes
Institut de Biologie et Chimie des Protéines, CNRS UMR 5086, Lyon, France
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
European Commission
THE CORNEA
epithelial cells
endothelial cells
stromal cells(keratocytes)
Bowmansmembrane
Descemetsmembrane
extracellular matrix of
collagen fibrils and
proteoglycans
WP 4 : Building the Cell Scaffold
WP 2 : Recombinant
Proteins
WP 3 : Extracellular
Enzymes
WP 5 : Stem Cells
WP 6 : Cell-Matrix Interactions
WP 7 : Tissue
engineering
WP 9 : Functional
Testing
WP 1 : Coordination and Management
WP 10 : Exploitation and Dissemination
WP 8 : Clinical Testing
WORKPACKAGE ORGANISATION
WORKPACKAGES
WPNo Workpackage title L
ead
con
t-ra
ctor
No
WP1 Co-ordination and ProjectManagement 1b 35 0 36
D1D7D20D22
WP2 Recombinant Proteins 1d 180 0 18 D4
WP3 Extracellular Enzymes 13 128 0 18 D5D6
WP4 Building the Cell Scaffold 11 158 6 30 D8D11
WP5 Stem Cells 8 203 0 30D3D12D13
WP6 Cell-Matrix Interactions andBasement Membranes 1c 97 6 30 D14
D15
WP7 Tissue Engineering 1a 149 0 36 D9D16
WP8 Clinical Testing 7 237 6 30 D10
WP9 Functional Testing 2 165 12 36D17D18D19
WP10 Exploitation andDissemination 1b 70 0 36 D2
D21
TOTAL 1412
Per
son
-m
onth
s
Sta
rtm
onth
En
dm
onth
Del
iver
-ab
le N
o
Oth
erp
artn
ers
invo
lved
3
1b,1c,1d,10,11,13
1b,1c,1d,10,11,12,13
1b,1d,5,10,11,14
3,6,7,8
1c,1d,6,11,13
1a,5,6,8,91a,2,3,4,7,8
2,5,6,7,8,9
All partners
One or several partners per workpackage ?
CORNEA ENGINEERING - WORKPLAN
Workpackages MonthNo. Title 0 3 6 9 12 15 18 21 24 27 30 33 361 Co-ordination and
Management2 Recombinant
Proteins3 Extracellular
Enzymes4 Building the Cell
Scaffold5 Stem Cells6 Cell-Matrix
Interactions andBasementMembranes
7 Tissue Engineering8 Clinical Testing9 Functional Testing10 Exploitation and
Dissemination
DELIVERABLES
Deliverable name WP No. Nature
D1 Project presentation 1 1a 1 R PU 3
D4Protocols for production of recombinant proteins
2 1d 180 R PU 18
D5C-proteinases and associated proteins
3 13 84 R PU 18
D6 3 10 44 R PU 18
D7 Mid-term report 1 1b 15 R PU 18
D8Collagen/proteoglycan fibril composites
4 11 79 R PU 24
D9Production of a hemi-cornea
7 1a 75 P CO 24
D2Optimisation of culture ofepithelial cells
5 8 20 R PU 6
Per
son
-m
onth
s
Dis
sem
in-
atio
n le
vel
Del
iver
yD
ate
(mon
th)
Lea
d c
ont-
ract
or N
o
One or several partners per deliverable ?
Oth
erp
artn
ers
invo
lved
-
D3Initial plan for use anddissemmination of knowledge
10 1b 20 R CO 12all
N-proteinases
-
1b,1c,10,11,12,13
1b
all
-
1b,10
1b,6,8,14
Del
No.
David Hulmes
Institut de Biologie et Chimie des Protéines, CNRS UMR 5086, Lyon, France
Hints on project writing
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
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
WHY RECONSTRUCTED CORNEAS ?
Pharmacotoxicology
• alternatives to animal testing (Draize test)
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
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
OVERVIEW
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
Israel• Goldschleger Eye Research Institute, Tel Aviv
University
Sweden• Department of Cell and Molecular Biology, University
of Lund
Italy• Laboratory of Tissue Engineering, Fondazione Bana
degli Occhi del Veneto, Mestre Venezia
• Ophthalmology Department, San Raffaele Hospital, Milan
Belgium• Lab. of Connective Tissue Biology, Université de Liège
United Kingdom• Departments of Civil Engineering, Ophthalmology and
Mathematics, University of Dundee
Finland• FIBROGEN EUROPE / University of Oulu
Turkey• Biotechnology Research Unit, Middle East Technical
University, Ankara
THE CONSORTIUM - Expertise
Industrial Partners• IOLTECH LABORATORIES (SME), La
Rochelle, France
• COLETICA (SME), Lyon, France
• FIBROGEN EUROPE / University of Oulu, Finland
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
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
Partner No. 1a 1b 1c 1d 2 3 4 5 6 8 9 10 11 12 13 14
Partner Short Name
CN
RS-
DR
07
CN
RS-
DR
07
CN
RS-
DR
07
CN
RS-
DR
07
LB
O
BFY
IOL
TE
CH
H
CO
LE
TIC
A
UK
E
HSR
EB
FV
UoD
UL
g
UL
UN
D
FGE
TA
U
ME
TU
Partner Type (A = academic, C =clinical, I = industrial)
A A A A C C I I A A A A A I A A
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
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
EX
PER
TIS
E
Pharmacotoxicology X
COMPLEMENTARITY OF EXPERTISE
C
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
WP 4 : Building the Cell Scaffold
WP 2 : Recombinant
Proteins
WP 3 : Extracellular
Enzymes
WP 5 : Stem Cells
WP 6 : Cell-Matrix Interactions
WP 7 : Tissue
engineering
WP 9 : Functional
Testing
WP 1 : Coordination and Management
WP 10 : Exploitation and Dissemination
WP 8 : Clinical Testing
WORKPACKAGE ORGANISATION
CORNEA ENGINEERING - WORKPLAN
Workpackages MonthNo. Title 0 3 6 9 12 15 18 21 24 27 30 33 361 Co-ordination and
Management2 Recombinant
Proteins3 Extracellular
Enzymes4 Building the Cell
Scaffold5 Stem Cells6 Cell-Matrix
Interactions andBasementMembranes
7 Tissue Engineering8 Clinical Testing9 Functional Testing10 Exploitation and
Dissemination
DELIVERABLES - for measuring progress
22 deliverables in total, not too many, not too few
Del.no
Deliverable name WP No. Nature
D1 Project presentation 1 1a 1 R PU 3
D4Protocols for production of recombinant proteins
2 1d 180 R PU 18
D5C-proteinases and associated proteins
3 13 84 R PU 18
D6 3 10 44 R PU 18
D7 Mid-term report 1 1b 15 R PU 18
D8Collagen/proteoglycan fibril composites
4 11 79 R PU 24
D9Production of a hemi-cornea
7 1a 75 P CO 24
D2Optimisation of culture ofepithelial cells
5 8 20 R PU 6
Per
son
-m
onth
s
Dis
sem
in-
atio
n le
vel
Del
iver
yD
ate
(mon
th)
Lea
d c
ont-
ract
or N
o
Oth
erp
artn
ers
invo
lved
-
D3Initial plan for use anddissemmination of knowledge
10 1b 20 R CO 12all
N-proteinases
-
1b,1c,10,11,12,13
1b
all
-
1b,10
1b,6,8,14
MILESTONES - key decision points
Milestone Month Objective
1 18 Availability of recombinant extracellular matrix proteins for use inbuilding scaffolds (WP2)
2 18 Identification of key enzymes, variants and associated proteins foruse in building scaffolds (WP3)
3 30 Identification of adult corneal epithelial and endothelial stem cellsources (WP5)
4 30 Protocols for scaffold construction meeting biological, biomechanicaland 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 cellsfor the treatment of superficial corneal injury (WP8)
8 36 Validation of reconstructed full-depth or hemi-corneas in animalmodels for use in tissue grafting (WP9)
9 36 Validation of reconstructed full-depth or hemi-corneas for use asalternatives to animal testing for toxicity testing (WP9)
Maximum grant as percentage offull costs (participants applying the
FC or FCF model)
Maximum grant as percentageof additional costs(participants applying the ACFmodel)
RTD activities 50% 100%Demonstration activities 35% 100%Innovation-relatedactivities
50% 100%
Consortium managementactivities
100% (up to a maximumpercentage of 7% of the
Community contribution)
100% (up to a maximumpercentage of 7% of the
Community contribution)
COST MODELS
STRP Project Effort Form
Participant 1.CNRS-DR07
2.APHP-HTD
3.BFY
4.IOLTECH
5.COLETICA
6.UKE
7.HSR
Research/innovation activitiesWP2 Recomb. Proteins 27/61 0/0 0/0 0/0 0/0 0/0 0/0WP3 Extracell. Enzymes 2/45 0/0 0/0 0/0 0/0 0/0 0/0WP4 Cell Scaffold 28/48 0/0 0/0 0/0 1/1 0/0 0/0WP5 Stem Cells 0/0 0/0 9/21 0/0 0/0 20/62 18/30WP6 Cell-Matrix & BM 27/60 0/0 0/0 0/0 0/0 5/16 0/0WP7 Tissue Engineering 30/66 0/0 0/0 0/0 10/20 5/15 0/0WP9 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 18/42Total Demonstration 0/6 0/40 0/2 0/24 0/0 0/0 18/42
Management activitiesWP1 Co-ord. Management 12/19 0/1 4/4 0/1 0/1 0/1 0/1WP10 Exploit. Dissemin. 6/14 0/2 2/2 0/12 0/12 0/2 0/2Total 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).
Ethics and Standardisation Advisory Panel
Intellectual Property Council
General Assembly
Executive Board
WP 1 WP 2 WP 4WP 3
WP 6 WP 10WP 7 WP 8 WP 9
WP 5
MANAGEMENT STRUCTURE
Evaluation Summary Report for a STREP
Proposal No. : 504017-1 Acronym : CORNEA ENGINEERING
1. Relevance (Threshold 3/5; Weight 1)The project is innovative and ambitious and fits 3.4.4.2 as well as objectives of Priority 1.Correct selection of standardization authorities.
Mark: 4.2
2. Potential impact (Threshold 3/5; Weight 1)Major areas of potential impact that can be an alternative to animal experimentation. It canlead to savings in health care costs and addresses cornea donor shortage. Detailedexploitation/dissemination plan should be provided.
Mark: 4.2
3. S&T excellence (Threshold 4/5; Weight 1)Very clearly defined and focused objectives. Very ambitious project. There is a risk with thescaffolds. A WP on scaffold evaluation (biomechanical, biocompatibility) should be added. Arisk management plan should also be added with alternatives planned.
Mark: 4.5
4. Quality of the consortium (Threshold 3/5; Weight 1)The consortium is high quality, interdisciplinary, well suited, and complementary withexperience in joint work among some partners. There are three SME’s involved.
Mark: 4.2
5. Quality of the management (Threshold 3/5; Weight 1)The plan is adequate for management steering and decision making for the projectknowledge, IPR and innovation related issues. However, the consortium is very large and itcan be problematic, especially with regard to IPR.
Mark: 3.8
6. Mobilisation of the resources (Threshold 3/5; Weight 1)Well planned, coherent project with good mobilization of resources. Travel budgets have tobe discussed.
Mark: 4.3
Overall remarks (Threshold 21/30)Recommended budget cut of 20%.
Total score:
25.2
Has the proposal passed all evaluation thresholds? YesDoes this proposal have ethical issues that need further attention? Yes