Gender Aspects in Research on Major Diseases

1. Combating major diseases Gender aspects in research Gender aspects in research have a particular relevance to this theme as risk factors, biological mechanisms, clinical, manifestation, causes, consequences for disease and disorders may differ in men and women. ·       In the formulation of research hypotheses, protocols and methodologies ·     In biological, pre-clinical and epidemiological, behavioural research/studies on both human and animal subjects ·       In the use of cells, tissues and other specimens ·       In the choice for a particular study population Child Health Causes, clinical manifestation, consequences and treatment of disease and disorders often differ between adults and children. Focus on differences in research protocols, methodologies and analysis of results. Clinical research and clinical trials Early phase clinical trials (Phase I & II), for orphan drugs, paediatric medicines and new biotherapy developments Late phase clinical trials (phase III & IV) for poverty related diseases.

2. Combating major diseases • Application-orientated genomic approaches to medical knowledge and technologies • Combating Cancer • Confronting the major communicable diseases linked to poverty

3. a) Application-orientated genomic approaches to medical knowledge and technologies To develop improved strategies for the prevention and management – using advanced technologies for health - of human disease and for living and ageing healthily. Integration of genomic approach through all relevant organisms into established medical approaches for investigating disease and health determinants. The emphasis will be on translational research aimed at bringing basic knowledge through to clinical application.

4. a) Application-orientated genomic approaches to medical knowledge and technologies  Combating, cardiovascular disease, 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

5. ·Combating, cardiovascular disease, diabetes and rare diseases Topics for first call Molecular pathogenesis of Coronary Artery Disease (CAD) and diagnostic tools for prevention and treatment – (IP or NoE) Novel molecular targets for the treatment of obesity in the context of diabetes – (IP or NoE) The role of pancreatic ion channels in defective insulin secretion in type 2 diabetes – (IP or NoE) Rare disorders of mitochondria or of nuclear organisation with broader implications for biological processes – (IP or NoE) Genomics of heart muscle development and disease – (IP or NoE) (NoE preferred). Genomics of vascular disease and atherothrombosis – (IP or NoE) (NoE preferred). Rare disorders of plasma membrane transporters for amino-acids, lipids and sugars - STREP. Aetiology, pathology and prediction of type 1 diabetes in Europe - CA. Network for early clinical trials in rare diseases - CA. Overcoming the challenges of translational research in cardiovascular disease - SSA. Type II diabetes and obesity - SSA. Co-ordination of rare disease research in Europe, with various stakeholders from research, SMEs and patient organisations – SSA.

6. ·       Combating resistance to antibiotics and other drugs. Topics for first call Management of respiratory tract infections – (IP or NoE) (NoE preferred) Testing anti-viral drug resistance and understanding resistance development – (IP or NoE) Broadening the knowledge base on the molecular mechanisms behind resistance – STREP/CA Workshop: “The structuring of European research activities to more effectively combat drug resistant hospital infections” - SSA Workshop: “Strategies to address antimicrobial resistance through the exploitation of microbial genomics” - SSA

7. ·Studying the brain and combating diseases of the nervous system Topics for first call Genomics and neurobiology of bipolar disorders – (IP or NoE) Eating disorders, from genes to behaviour – (IP or NoE) Role and mechanisms of protein aggregation in neurodegenerative diseases – (IP or NoE) Rare hereditary neurological disorders: ataxias – (IP or NoE) Molecular and cellular basis of brain development – (IP or NoE) (NoE preferred). Human brain tissue research – (IP or NoE) (NoE preferred). Rare monogenic neurological disorders – STREP/CA. Genetics and neurobiology of pain – STREP/CA. Schizophrenia: from genotype to phenotype – STREP/CA. Specific brain research support actions – SSA.

8. ·Studying human development and the ageing process Topics for the first call Genetic factors of longevity and healthy ageing – (IP or NoE) Molecular and cellular processes underlying the development of mesodermal organ systems – (IP or NoE) (NoE preferred). Molecular mechanisms of bone homeostasis – STREP.

9. Combating Cancer • The objective is to combat cancer by developing improved patient-oriented strategies, from prevention to more effective and earlier diagnosis and better treatment with minimal side effects. • The research will concentrate on translating the knowledge being created by genomics and other fields of basic research into applications that improve clinical practice and public health.

10. b) Combating Cancer Establishing facilities and developing initiatives for the exploitation of research on cancer in Europe Supporting clinical research, particularly clinical trials, aimed at validating new and improved interventions. Supporting translational research aimed at bringing basic knowledge through to applications in clinical practice and public health. Other issues related to cancer, such as ageing and cancer, regional differences, psycho-social aspects, palliative care and guidance to support groups.

11. b) Combating Cancer Topics for first call: Translating basic knowledge of functional oncogenomics into cancer diagnosis and treatment – (IP or NoE) Multidisciplinary research to explore and validate molecular targets for innovative treatment – (IP or NoE) Networking for treatment and/or prevention clinical trials (phase I and II) aimed at improving clinical practice in the light of new molecular knowledge – (IP or NoE) (NoE preferred). Innovative research in radiation therapy – (IP or NoE) Molecular imaging for early detection of tumours and monitoring of treatment – (IP or NoE) Networking of quality controlled cancer registries and repositories for molecular epidemiology and quality assessment – (IP or NoE) (NoE preferred). Molecular mechanisms involved in organ-specific metastatic growth processes in breast cancer – STREP/CA. Translational research on promising predictive and prognostic markers – STREP/CA. Molecular mechanisms of cancer-related pain – STREP/CA. Workshop on correlative laboratory studies relevant to therapeutic clinical studies - SSA

12. c) Confronting the major communicable diseases linked to poverty HIV/AIDS, malaria and tuberculosis – development of effective disease interventions, particularly for use in developing countries From basic molecular research, taking advantage of microbial genomics, through to pre-clinical testing Establishing a clinical trials programme to unite and support Europe’s clinical trials activities specifically targeted at interventions for use in developing countries (EDCTP)

13. c) Confronting the major communicable diseases linked to poverty • Developing new promising candidate vaccines, therapies and microbicides •  Establishing a clinical trials programme

14. c) Confronting the major communicable diseases linked to poverty Topics for first call: ·Developing new promising candidate vaccines, therapies and microbicides Tuberculosis vaccine development – (IP or NoE) Biology and pathology of the malaria parasite – (IP or NoE) (NoE preferred). Development of an HIV vaccine – (IP or NoE) HIV microbicides – (IP or NoE) Development of mucosal vaccines for poverty-related diseases – (IP or NoE) ·Establishing a clinical trials programme European and Developing Countries Clinical Trials Partnership (EDCTP) to support phase II and phase III clinical trials of promising candidates in developing countries.