European Foundation for the Study of Diabetes (EFSD)
and
Merck Sharp & Dohme (MSD)

European Studies on Islet Cell Function and Survival:
Clinical Research Programme

Request for Applications

EFSD and MSD
announce funding of
Clinical Research Grants in 2008

Deadline for submission of applications: 05 December 2007

   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.

Merck & Co., Inc is a global research-driven pharmaceutical company. Merck discovers, develops, manufactures and markets a broad range of innovative products to improve humans and animal health, directly and through its join ventures. Merck Sharp & Dohme, or MSD, is the name Merck uses for conducting its business in all other countries outside the United States and Canada.

   Programme

EFSD and MSD have established a new Clinical Research Programme for European Studies on Islet Cell Function and Survivalto encourage new projects aimed at advancing current knowledge in this domain.

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

The Programme is intended to stimulate and accelerate European research into clinical aspects of islet cell function and survival: areas of particular interest include, but will not necesarily be limited to:

• alterations in islet cell mass/function in diabetes and obesity
• non-invasive imaging of islet cells
• mechanisms of beta cell dysfunction in type 2 diabetes, including beta cell gluco- and lipotoxicity
• preservation or prevention of further loss of beta cell functional mass in individuals with impaired glucose
tolerance, type 2 diabetes or early type 1 diabetes
• methods for improving survival of transplanted islets or beta cells
• genetic defects that elucidate beta cell dysfunction in type 2 diabetes

   Funding 

Clinical research will be supported through the award of fixed sum grants, each of up to Euro 100,000 per annum for a period of up to three years, for a total individual funding amount not exceeding Euro 300,000.

   Mechanisms of Support and Review

Research will be supported through the award of fixed sum grants, each of up to Euro 300,000. The Programme Board, at the suggestion of the Review Committee, may at its discretion recommend an award in a lesser or greater amount considered more appropriate for the proposed studies.

This EFSD/MSD Programme is intended only to support clinical research in the chosen area. The definition of clinical research for the present purposes is the study of living individuals or patients. Projects that focus exclusively on ex-vivo studies without associated integrative physiology will not be considered for funding.

Applications for an EFSD/MSD clinical research grant are invited from single non-profit institutions or groups of affiliated institutions from Europe and associated countries. The principal investigator and any co-investigators must be normally employed 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 MSD board convened for this purpose.It is anticipated that applications for this year will be received, reviewed and approved for funding by March 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 is 05 December 2007.

The budget of the research grants for the purpose of this Programme is limited to Euro 300,000. 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".

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 defined in the instructions will be considered for review. Additional material (in the form of an appendix,attachment, reprints, etc.) is not acceptable and will not be sent to reviewers.

Applications should be submitted by post no later than 05 December 2007 (date of receipt) to:

Dr. Viktor Jörgens
Executive Director
European Foundation for the Study of Diabetes
Rheindorfer Weg 3
40591 Düsseldorf
Germany

   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 and MSD.

Review criteria are as follows:

• Significance: Does the study address an important problem? 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?
• Relevance: A brief statement of the impact of the proposed study on islet cell function and survival and its clinical relevance.
  
  

   Reporting Requirements and Approval of Funding for Second and Third Year

All investigators funded by this Programme are required to submit a scientific progress report at the end of each year of funding, as well as a final report at the end of the funding period. Funding for years 02 and 03 will be contingent upon receipt of annual reports 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: "This work was supported by an EFSD/MSD clinical research grant".

   Schedule

Royalties and Intellectual Property
Patent applications and the execution of royalty agreements to use inventions protected by such patent applications relating to any invention made with the support, in whole or in part, of research grants must be reported in a timely fashion to the Partnership. The foregoing obligation shall survive for a period of three years after the expiration of the grant.

• Unless otherwise indicated or requested by the grantee institution, title to any invention shall reside with the grantee institution. If a grantee institution has no established patent policy or procedure for administering inventions, EFSD reserves the right to determine the disposition of invention rights, including the right to take title to an invention or patent and develop technologies/products resulting from Partnership-sponsored research in the event that the grantee and his/her institution elect not to patent and pursue these developments. In this event, it is EFSD's policy to request that the institution execute appropriate assignments in favor of EFSD (which assignments shall be prepared by EFSD at its own expense) for purposes of patenting the results of the Partnership-funded research.



• In acknowledgement of the Partnership's support, net royalties resulting from the commercialisation of discoveries made with Partnership support will be shared with EFSD. The portion of royalties to be shared with EFSD shall be determined on a case-by-case basis in accordance with the policies of the grantee institution and will be based on the relative contribution of Partnership funding to the overall project. Net royalties shall mean gross royalties and other licensing payments less administrative, licensing, legal and other reasonably related expenses. The grantee institution shall provide to EFSD, upon request, financial information adequate to establish and document the amount of net royalties received.



• No patent or patent application shall be abandoned without first notifying EFSD and giving EFSD the opportunity to take title to or continue the patent/patent application at the Partnership's own expense.



• In making decisions whether to continue ongoing grants or whether to award additional grants to a researcher or his/her institution, the Partnership will consider whether the institution has honoured the above policy.



• EFSD agrees that the grantee institution shall undertake, if Merck is interested in obtaining a license on the results of any Partnership funded research, to grant to Merck a worldwide exclusive license on such results, under such reasonable conditions as shall be negotiated between Merck and the grantee institution.



• EFSD further agrees that it shall undertake, if Merck is interested in obtaining a license on the results of any Partnership funded research for which EFSD obtains patent and invention rights under this section, to grant to Merck a worldwide exclusive license on such results or inventions, under reasonable conditions as shall be negotiated between Merck and EFSD.