Slide 1

From Expressions of Interest to a Workprogramme for 2003

PRIORITY 1

Life sciences, genomics and biotechnology for health

Slide 2

FP6 - Expressions of Interest - Response

Priority theme 1:

Life Sciences, Genomics & Biotechnology for Health

IPs NoEs Unspecified Total

Fundamental genomics 288 190 45 523

Applied genomics & biotech 240 125 36 401

Major diseases 459 219 24 702

Cancer 196 102 4 302

Poverty related diseases 41 28 - 69

Total 1224 664 109 1997

17% of EoIs for all 7 priority themes

Slide 3

FP6 - Expressions of Interest - Theme 1

Distribution of EOIs - by type of submitting institution

65%

25%

4%6%

HigherEducation

ResearchInstitute

Industry

Other

Slide 4

FP6 - Expressions of Interest - Theme 1

Industry, including SME, involvement (% submitters)4% overall8% Fundamental knowledge and basic tools10% Applications of knowledge and technologies...

N.B 15% of budget for SMEs

Gender balance (% submitters)16% female84% male

Slide 5

EoIs- countries of submitters - Theme 1

No. of EoIs per country of submitter (n)

0

50

100

150

200

250

300

350

ATBE

BG CH CY CZDE DK EE ES FI

FR GR HU IE IL IS IT LT MT NL

NO PL PTRO SE Sl

SK UKOth

er

No. of EoIs

10 % from candidate countries

Slide 6

FP6 - Expressions of Interest - Theme 1

Outcome of the panel meeting

Categories of scientific topics - all panels

1. Strategic importance for Europe & thematic priority; ready for implementation through an IP or NoE

2. Not-relevant to the thematic priority; less obvious strategic importance for Europe

Some panels

3. Strategic importance for Europe & thematic priority; BUT not yet mature for an IP or NoE (based on the EoIs received)

4. Strategic importance but not covered by any EoIs or the EoIs were not well argued

Slide 7

FP6 - Expressions of Interest - Theme 1

Analysis Methodology

At the panel meeting in Bussels

“Citation list” of EoIs to start the discussion

- cited EoIs- non-cited EoIs- expert rapporteur for every EoI

Some EoIs analysed by more than one panel (broad scope)

Definition of topics for IP and NoE- no pre-selection of particular EoI or consortium

Slide 8

Fundamental knowledge and basic tools for functional genomics in all organisms

• In total, 30 recommended topics

• 15 topics will be published in first call; 15 in second call

• The selected topics will be open only for the call

indicated

• It is envisaged that no more than 1 project utilising a

new instrument will be funded for each topic

• There will be competition between topics as well as

within topic areas

• This will result in some topic areas not being supported

Slide 9

Gene expression and Proteomics

Examples

Structural genomics

Examples

• Advanced array technologies

• High throughput proteomics for large data set of protein-protein interactions

• In situ gene expression analysis in mouse and human tissues

• Membrane proteins • Supramolecular analysis (NoE) • Hardware and software for

automated technologies at synchrotron sites (IP)

• Viral replication• Large protein complexes

Slide 10

Comparative genomics & Population genetics

Examples

Bioinformatics

Examples

• Non-mammalian vertebrate models (IP)

• In-vivo imaging for phenotyping and functional analysis

• RNA interference screening in Arabidopsis for processes relevant to health

• Phenotyping human populations • Bacterial diversity with relevance to

human health (NoE)• High throughput genotyping in

human populations (NoE)

• Annotation of human and other genomes (NoE)

• Genomics grid for European research (NoE)

• Software platform to tackle sequence-structure-function relationships

Slide 11

Basic biological processes

Examples:

• Cell cycle

• Non-human embryonic stem

cell differentiation

• Erythroid development (IP)

• Lymphangiogenesis

• Inflammation processes (NoE)

• Ubiquitin-proteasome (NoE)

• Epigenetics (NoE)

• Kidney disease

• Peroxisomes

• Inner ear or retina

development

• DNA damage and repair

• Disease of the immune

system or of the muscle

• X-linked syndromes

Slide 12

Traditional instruments

Examples:

• Transcription activation

• Signal transduction

• Intracellular communication

• Non-coding genomic information

• Integration of genes

• In silico prediction of gene function

• Simulation of complex regulatory networks

• New tools and approaches, standard protocols producing

knowledge in functional and structural genomics

Slide 13

Applications of knowledge and technologies in the field of genomics and biotechnology for health

Strategic Objective:

To foster the competitiveness of Europe’s biotechnology industry by exploiting the wealth of biological data produced by genomics and advances in biotechnology

Slide 14

Applications of knowledge and technologies in the field of genomics and biotechnology for health

Development of Technological Platforms

TECHNOLOGICAL PLATFORMS

IntegratedMultidisciplinaryResearch

EU project

- Health care progress- Increased quality of life- Cost reduction- Precise diagnostics- Individualised treatments- New drugs and therapies- Novel products from genomicsand biotechnology

Deliverables

• Industry• SME• Academics• Stakeholders

Civil society

Slide 15

Applications of knowledge and technologies in the field of genomics and biotechnology for health

Technology Platforms will focus their research activities on:

• New, safer and more effective drugs including pharmacogenomics approaches

• New diagnostics

• New in vitro tests to replace animal experimentation

• New preventive and therapeutic tools such as somatic gene and cell therapies (in particular stem cell therapies) and immunotherapies

• Innovative research in post-genomics (novel products from genomics and biotechnology)

Slide 16

STEM CELL Therapies

• Detailed implementing provisions concerning research

activities involving the use of human embryos and

human embryonic stem cells which may be funded

under the 6th Framework Programme shall be

established by 31 December 2003.

• During that period and pending establishment of the

detailed implementing provision, the Commission will

not propose to fund such research, with the exception

of the study of banked or isolated human embryonic

stem cells in culture.

Slide 17

New, safer and more effective drugs including pharmacogenomics approaches

Examples

Development of new diagnosticsExamples

Development of new in vitro testsExamples

• Drugs for aberrant molecular signalling in protein phosphorylation pathways (IP)

• Genome-based individualised medicine

• Drugs for psychiatric disorders (NoE)• Antiviral therapies (IP)

• Medicines for paediatrics

• Computer-assisted modelling for drugs

• Therapeutics for neurodegenerative diseases

• Genetic tests allowing for harmonisation, validation and standardisation

• In-vivo molecular imaging

• Non-invasive diagnostics: Development of markets for ante- and neonatal screening (NoE)

• Test batteries for human acute toxicity

• Combined in vitro cell and sensor technologies for animal toxicology (IP)

Slide 18

New preventive and therapeutic toolsExamples

Innovative research in Post-Genomics

Examples

• New cell lines for cell-based therapies (IP)

• Allogenic stem cell transplantation for haematological and neoplastic diseases (IP)

• Cell-based therapies for regeneration of connective tissue (IP)

• Gene delivery systems against severe acquired diseases

• Gene therapy of inherited diseases

• Safety, quality, standardisation of stem cells (European registry)

• Regeneration therapies for vital organs

• Vaccine delivery systems (bacterial, synthetic, aimed at dendritic cells, etc…)

• New chemokine modulators in autoimmune diseases

• Post-genomic approaches against asthma and autoimmune diseases (IP)

• Plant platforms for immunotherapeutic biomolecule production (IP)

• RNA as human therapeutic tool • Post-genomic approaches to study

human pathogens • Pre-clinical and clinical applications

Slide 19

New, safer and more effective drugs including pharmacogenomics approaches

Examples: Blood substitutes (e.g. oxygen carriers), G-Protein coupled receptors

Development of new diagnostics

Development of new in vitro tests

Examples: Non-invasive diagnostics using bioinformatics tools, Diagnostics for prion diseases

Examples: Competitive product screening & development process stages lead compounds by introduction of alternative testing

New preventive and therapeutic toolsExamples: Vaccine technologies targeted to dendritic cells

Databank on immuno therapies, comprising advances fromgenomics, proteomics and cell biologyStem cell products for myocardial repair

Innovative research in post-genomicsExamples: Combinatorial biosynthesis, Optically-active therapeutic

biomolecules by biocatalysis, Precision technology platforms from post-genomics

Slide 20

Combating major diseases

Fields of research:

• Combating cardiovascular diseases, diabetes and rare diseases

• Combating resistance to antibiotics and other drugs

• Studying the brain and combating diseases of the nervous system

• Studying human development and the ageing process

TOTAL

• Cancer

286

77

281

58

Number of EoIs:

702

58

Slide 21

Combating cardiovascular disease, diabetes and rare diseases

Examples:

• Molecular targets in obesity from diabetes

• Coronary Artery Disease• Genomics of heart muscle

development (NoE)• Genomics of vascular disease

(NoE)• Pancreatic ion channels in type II

diabetes (IP) • Rare disorders of mitochondria

• Hypertension• Genomics of type II

diabetes• Exercise and

metabolic syndrome• Eicosanoids and

nitric oxide as mediators of diseases

• Rare disorders of plasma membrane transporters

N° of EoIs: 286

Slide 22

Combating resistance to antibiotics and other drugs

Examples:

• Upper Respiratory Tract Infections (NoE)

• Anti-viral drug resistance

• Antibiotics producing organisms

• New targets for drugs - the ribosome

• Anti-fungal resistance• Microbial ecology -

epidemiology• Control of hospital acquired

infections

• Broadening the knowledge base on molecular mechanisms behind resistance

• Non antimicrobial therapies

Slide 23

Studying the brain and combating diseases of the nervous system

Examples:

• Protein aggregation

• Eating disorders (IP)• Bipolar disorders (IP)• Rare neurological diseases:

ataxias• Brain development,

degeneration and regeneration (NoE)

• Brain tissue research (NoE)

• Addiction• Cortical processing:

learning, memory, behavior

• Cortical development• Stem cells and

nervous system

• Rare monogenic neurological disorders, Genetics and neurobiology of pain, Schizophrenia

N° of EoIs: 281

Slide 24

Human Development and Ageing

Examples:

• Longevity

• Mesodermal organ system (NoE)

• Mitochondrial dysfunction

• Embryo implantation• Congenital anomalies

Markers• Aberrant Steroid

signalling

• Biochemistry of Reactive Oxygen Species• Molecular mechanisms of bone homeostasis

N° of EoIs: 58

Slide 25

Cancer

Selected 6 out of 14 topics for first call in order to ensure:

Potential co-ordination of complementary areas (e.g. molecular targets - molecular imaging)

Balanced coverage of the main WP areas:

A. Establishing facilities for exploitation of research• Registries and repositories

B. Clinical research • European networks for clinical trials• Molecular imaging for early detection • Radiation therapy

C. Translational research• Functional oncogenomics• Molecular targets

Slide 26

Overall Research Strategy of the 6th Framework Programme to confront HIV/AIDS, Malaria and Tuberculosis

EUROPEAN DEVELOPING COUNTRIES CLINICAL TRIALS PARTNERSHIP (EDCTP)

• Vaccines

• Microbicides

• Therapy Trials in Europe

• Vaccines

• Biology and

Pathology (NoE)

• Drugs

•Vaccines

•Drugs

HIV/AIDS Malaria TB

NEW INSTRUMENTS

H I G H R I S K P R O J E C T S ( S T R E P)

CROSS-CUTTING TOPICS: Mucosal vaccines for PRD

Neonatal vaccination strategies for PRD

Pre-clinical

Discovery

Genomics

Clinical Trials(Phase II/III)

Phase I trials

Slide 27

Confronting the major communicable diseases linked to poverty

Fields of research Number of EoIsTuberculosis 13Malaria 17HIV 22Horizontal topics coveringthe three diseases

11

Not relevant1 6TOTAL 69

High level of interest, excellent quality of the EoI: most EU leading researchers represented in one or more EoI

Slide 28

EoI’s Panel main recommendations

• Encourage participation of partners from DC

• Stimulate the training component both for the North

and the South

• Increase the professionalism of management

• Include in the projects pre-clinical testing in non-

human primates and GMP production of candidate

drugs or vaccines

Slide 29

From Expressions of Interest to a Workprogramme for 2003

PRIORITY 5

Food Quality & Safety

Slide 30

Response to invitation to submit Expressions of Interest for priority 5

Type of instrument Type of submitter

Gender of submitter

eoi

Not indicated

Integrated project

Network of excellence

24%

33%43%

EOI

industrial

public

educational

51%

41%8%

MALE

FEMALE

77%

23%

Slide 31

Expert comments on nonselected EoI

• Very many EOIs on similar subjects

• Many were technical skills looking for funds

• Many were on a very large scale with little indication of

management skills

• Need for a “Development Bank” business plan approach

• Lack of analysis on the importance of the problems to be

addressed and of any potential benefits

• No gender balance awareness

• IP management was weak

• No gender balance awareness and IP management was weak

Slide 32

From EoI to Workprogramme

• Budget: 149 M€ in 2003

• Focussing: from 53 topics through EoIs down to ...

• Consultation of AG and committee

• Maturity of the topic

• Readiness of the topics for new instruments or

traditional instruments

• Urgency of the issue: 2003 or 2004

Slide 33

Format of the Draft Workprogramme (1)

• Common format for all Thematic Priorities

• Follows the specific programme

• Introduction to each area: clear signals

• NI (NE/ IP) or TI (STREP/ CA)

Slide 34

Format of the Draft Workprogramme (2)

• 2003:- selected topics

- detailed description

(objectives/disciplines/expected outcome)

• 2004:- indicative areas

- outline description

• Objectives for Specific Support Measures

Slide 35

A likely (but non-binding) scenario

2003 2004Area NI TI NI TITotal food chain 2 1 1 0Epidemiology of food-related diseases andallergies

1 1 2 1

Impact of food on health 2 1 4 0Traceability processes along the food chain 1 0 0 0Methods of analysis, detection and control 2 1 2 1Safer and environmentally production methods 3 4 3 5Impact of animal feed on human health 1 1 0 0Environmental health risk 2 2 2 2Total 14 11 14 9

Slide 36

Total Food Chain

Examples:

Food from low input and organic production systems: Ensuring the safety and improving quality along the whole chain

Quality seafood for improved consumer health and well-being

Improving the quality and safety of beef for the consumer

Pathogen free production systems

Slide 37

Epidemiology of food-related diseases and allergies

Examples:

Validated food information database for Europe (NoE) Epidemiology of food allergy Influence of gene-nutrient interaction on the development of

chronic diseases

Influence of nutrition and lifestyle on healthy ageing aimed at preventing adult degenerative disease

Nutritional and lifestyle habits of adolescents throughout Europe, including production of functional foods with sensory properties attractive to adolescents

Slide 38

Impact of food on health

Examples:

Functional genomics in relation to food, nutrition and health (NoE)

Lipid metabolism and the metabolic syndrome Food safety, risk assessment and communication Programming effects of early nutrition on long-term health Microbes, the immune system and gut health Improving and enhancing the nutritional value and health

benefits of cereals

Health risks from heat-treated foods and food products

Slide 39

“Traceability” processes along the production chain

Development of reliable traceability methods and systems to establish the origin/mode of productin of food products

Slide 40

Methods of analysis, detection and control

Examples:

Zoonoses including food borne diseases (NoE) Prion diseases (NoE) Chemical contaminants in food products Emerging and future food borne pathogenic microorganisms

throughout the food chain

Quantitative risk assessment strategies based on probabilistic, genomic and profiling approaches including a risk-benefit analysis for novel foods

Cost-effective tools for risk management and traceability systems for zoonotic agents and phycotoxins in seafood

Slide 41

Safer and environmentally friendly production methods and healthier foodstuffs

High throughput analysis of plant composition and metabolism for optimising end-product quality

Animal welfare for improved food quality

Genomics of host-pathogen interactions in animals (NoE)

Soil microbial community management for safe production under stress conditions

Plant biodiversity to reduce pesticide application

Immunological basis for protection against animal disease

Antibiotic resistance Crop protection systems based on biological control agents and semiochemicals Modelling of improved crop establishment in low input systems Plant flavonoids Recycled organic wastes from the food chain Sustainable aquaculture GMO co-existence analysis Use of genetic resistance to control plant viruses Disease risk from alternative and enriched cage and free-range systems

Examples:

Slide 42

Impact of animal feed on human health

New strategies to improve grain legumes for food and feed

Alternatives to antimicrobials in feeds

Slide 43

Environmental health risks

Examples:

Allergy and asthma network Exposure to chemical residues in the environment Environmental factors and puberty onset Cancer risk from environment, diet and genetic

Human pathogens in drinking water Food and fertility Neurotoxic effects of environmental contamineants Exposure to complex chemical mixtures