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EU firms targeted in calls for new biomarkers and drug development tools

This article was originally published in SRA

Personalised medicine, biomarkers and systems biology are among the collaborative projects aimed specifically at small and medium-sized companies in the latest call for proposals under the EU's funding programme, FP71-3.

Other opportunities for pharma and biotech firms, as well as academic and patient groups, feature in the 4th call for proposals by Europe's Innovative Medicines Initiative, covering areas such as targeting mechanisms for biological macromolecules, predictive tools for oral drug delivery, and methods for reducing the drug development attrition rate.

FP7

Through the FP7, the EU is making available some €546 million to fund proposals under the "Health 2012 innovation 1" call title. The largest single budget line, at €85 million, is for projects on detection, diagnosis and monitoring (including personalised medicine), followed by systems biology and rare diseases at €70 million each, and HIV/AIDS/TB/malaria at €54 million.

Under the biotech heading, the personalised medicine project involves the development of technologies with a view to patient group stratification. Companies are also asked to put forward proposals for innovative strategies for translation of stem-cell based therapies in regenerative medicine (EU-Australia co-operation), and targeted nucleic acid delivery as a therapeutic or prophylactic approach.

Under the data gathering and systems biology heading, projects are invited on support for international rare disease research, clinical utility of "-omics" for diagnosing rare diseases, validation of -omics based biomarkers for diseases affecting the elderly, SME-driven research on systems biology approaches to addressing medical and clinical needs, and preparing for future research and innovation in systems medicine.

Among research projects required in diabetes and obesity are innovative approaches to managing diabetes and investigator-driven trials for type I diabetes research, while rare diseases projects include development of substances with clear potential as orphan drugs, observational trials and rare disease databases and biobanks.

Other areas covered in this call include biomarkers and diagnostics for chronic inflammatory diseases of the joints or digestive system, co-morbidity between infectious and non-communicable diseases, prevention and treatment of HIV/AIDS, TB and malaria, and low-cost interventions for disease controls in resource-poor settings.

The deadline for proposals is 4 October 2011. The FP7 call can be found at the European Commission's innovation portal.

IMI projects

The final 4th IMI call for proposals involves seven topics in three clusters: EU medical information system; chemistry, manufacturing and control' and technology and molecular disease understanding.

Cluster one comprises a European medical information framework of patient-level data to support a wide range of medical research, including metabolic complications of obesity (particularly in children), the development of innovative diagnostic tests and novel therapeutics for high-risk obese individuals, and predictive biomarkers for the development of dementias such as Alzheimer's disease. The cluster also covers the sharing of knowledge between preclinical and clinical activities in translational research in drug discovery and development.

The CMC cluster covers delivery and targeting mechanisms for biological macromolecules such as proteins, peptides and oligonucleotides, which may have issues of therapeutic ratio that could be mitigated by improvements in selective delivery; new in vivo predictive biopharmaceutical tools for oral drug delivery; and the discovery of new sustainable synthetic methods for developing and manufacturing small molecule medicines.

Improving drug development

A major IMI project under the technology and molecular disease cluster is research into human induced pluripotent stem (iPS) cells for drug discovery and safety assessment, particularly in neurodegenerative diseases and diabetes. Human iPS cells can mimic patient responses and allow the development of personalised medicines by population-relevant efficacy and toxicity testing, says the IMI. This could help to optimise drug development by increasing the correlation between therapeutic mode of action, safety assessment and clinical trials, thereby leading to safer drug profiles and reducing the attrition rate.

The cluster includes a project on better understanding of the interactions of small molecules with protein targets, which could also significantly reduce attrition in drug development. The project focuses on the kinetics of binding, which the IMI says is increasingly important in drug discovery, with recent reports suggesting that compounds with slow off-rates, such as candesartan, maraviroc and montelukast, are more likely to succeed in development.

Consortium approach

Each IMI topic is associated with a group of companies that belong to the European R&D-based industry federation EFPIA. These companies will collaborate in consortia with public and private organisations such as SMEs, academia and patient bodies that are eligible for funding from the IMI Joint Undertaking (IMI JU).

The IMI JU is providing a maximum of €105 million to support these activities, which will be matched by in-kind contributions from EFPIA members. Expressions of interest should be filed between 19 September and 18 October 2011.

References

1. European Commission health research homepage, Call for proposals under the Health Theme, site accessed 29 July 2011, http://cordis.europa.eu/fp7/health/

2. IMI press release, 18 July 2011, www.imi.europa.eu/sites/default/files/uploads/documents/4th%20Call/IMILaunches4thCall.pdf

3. IMI 4th Call 2011 – Stage 1, 18 July 2011, www.imi.europa.eu/content/stage-1-2

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