European Foundation for the Study of Diabetes (EFSD)

and

Amylin Pharmaceuticals, Inc.

Paul Langerhans Grant on the Integrated Physiology of the Entero-Insular Axis and the Brain in Metabolic Homeostasis

Request for Applications

EFSD and Amylin
announce increased research funding
up to Euro 500,000 in 2008

New Deadline date: 10 April 2008

   Background

The European Association for the Study of Diabetes (EASD) was founded in Montecatini, Italy, in 1965. In 1999, the Association created the European Foundation for the Study of Diabetes (EFSD). The aims of EFSD are to encourage and support research in the field of diabetes, to rapidly diffuse acquired knowledge and to facilitate its application.

Amylin Pharmaceuticals, Inc. is a biopharmaceutical company committed to improving lives through the discovery, development and commercialisation of innovative medicines. The company was founded in 1987 on the discovery of a hormone, amylin, that is produced by the same beta cells of the pancreas that make insulin. Since then, Amylin has built a strong foundation on research and development. Amylin challenges conventional thinking to create innovative approaches to the discovery, development and commercialisation of novel therapies for metabolic diseases.

This grant honours the memory of Paul Langerhans, who discovered the islet cells of the pancreas.

   Programme

Growing evidence supports the notion that the gastrointestinal tract plays an important role in the pathogenesis of diabetes. While incretin-based therapies are proving to be an effective pharmacological intervention to diabetes and other dysglycaemic states, bariatric surgery - which alters the passage and/or absorption of nutrients - has been shown to be extraordinarily efficacious in diabetes associated with morbid obesity.

With this background, EFSD and Amylin Pharmaceuticals, Inc. have established a partnership for studies of integrated physiology of the entero-insular axis and the brain in metabolic homeostasis.

The Programme invites applications from non-profit organisations for research projects in this area. In particular, proposals dealing with the following are especially, but not exclusively, welcome:

1. Physiology of release and action of gut hormones including glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypetide (GIP); islet hormones including amylin and glucagon; localisation and expression of GLP-1, GIP, amylin and glucagon receptors and their regulation;
2. Impact of hyperglycaemia on expression, release and action of gastrointestinal and pancreatic hormones;
3. Cross-talk between gut, brain and islet signals;
4. Neural regulation of the gut and islet and the role of central neurohormonal signalling in diabetes and obesity;
5. Changes in entero-insular interaction induced by bariatric surgery;
6. Neurohormonal regulation of weight loss, including gut, pancreatic and adipocyte-derived hormones.

Both in vitro and in vivo studies - in animal models as well as humans - will be considered.

To achieve the goals and objectives of this Programme, EFSD and Amylin invite applications by issuing this "Request for Applications" (RFA), which indicates joint funding as well as areas of research emphasis.

   Funding

In 2008 up to 5 grants will be available, each of up to Euro 100,000 for basic research and up to Euro 300,000 for clinical research.

   Mechanism of Support and Review 

Basic research will be supported through the award of a fixed sum grant of up to Euro 100,000. The duration of each award may be one year or longer, depending upon the needs of the project and as justified in the application, so long as the total budget does not exceed the fixed sum of Euro 100,000.

Clinical research will be supported through the award of a grant of up to Euro 100,000 annually for a period of up to 3 years. The total award may not exceed Euro 300,000.

For both types of award, the Programme Board, at the suggestion of the Review Committee, may at its discretion recommend an award in a lesser or greater amount than requested and considered more appropriate for the proposed studies.

Applications for an EFSD/Amylin Paul Langerhans grant award are invited from single non-profit institutions or groups of such institutions from Europe and associated countries. The principal investigator and any co-investigators must be employed full-time at a non-profit institution and the study must be performed at such a place of work.

Applications will be subject to scientific review by a specialised ad hoc committee. Funding will require approval by a joint EFSD and Amylin Board convened for this purpose. It is anticipated that applications for the grant year 2008 will be received, reviewed and approved for funding by July 2008.

   Research Grant Applications

Applications for research grants may be subjected to pre-review (or triage) procedures. In this event, any application rejected at pre-review will not be subject to a complete scientific review. The deadline for receipt of research grant applications for funding this year is 10 April 2008.

Research grants for the purposes of this Programme may not exceed Euro 100,000 for basic research regardless of the duration of the study, or Euro 100,000 annually for up to 3 years for a total of Euro 300,000 for clinical research. All budgets are to be prepared in Euro. For countries in which the Euro is not yet the common currency, the exchange rate (between the Euro and the local currency in the country where the work is to be performed) used for calculating the Euro budget must be mentioned under "Budget Justification". EFSD and A mylin reserve the right to increase or decrease approved funding in Euro amounts to compensate for any significant change in the exchange rate.

Application forms may be requested from:
Foundation@easd.org

All applications must be prepared on the official forms and completed in strict accordance with the detailed instructions to be found on these forms. In particular, applicants are reminded that any pages in addition to the maximum of 10 allowed for the scientific section of the application will be deleted prior to review. Similarly, no applications using a font or line-spacing smaller than that defined in the instructions will be considered for review. Additional material (in the form of an appendix, attachment, reprints, etc.) is not receivable and will not be sent to reviewers.

Applications should be submitted by post no later than 10 April 2008 (date of receipt) to:

   Review Considerations

Completed applications will be evaluated in accordance with the criteria stated below for scientific/technical merit by an appropriate scientific committee convened by EFSD.

Review criteria are as follows:

• Significance: Does the study address an important problem in keeping with the goals and focus areas of this EFSD/Amylin Partnership Programme? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of the proposed studies on the concepts or methods that drive this field?
• Approach: Are the conceptual framework, design, methods and analyses adequately developed, well integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?
• Innovation: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies?
• Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers, if any?
• Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support?
• Budget: Is the requested budget appropriate for the proposed study?

   Reporting Requirements

All investigators funded by this Programme are required to submit a scientific report at the end of the funding period. For clinical research grants, funding for years 02 and 03 will be contingent upon satisfactory progress on the basis of annual reports, to be approved by the Programme Board or its designated experts. Investigators must provide EFSD with copies of papers accepted for publication, and must acknowledge the support of the Programme in all written material by use of the phrase: "Supported by an EFSD/Amylin research grant".

   Schedule