Juvenile Diabetes Grants

American Society of Transplantation/Juvenile Diabetes Research Foundation Faculty Grant (For diabetes-related applications)

This is a two-year grant ($40,000/year) for Junior Faculty (basic or clinical science).

This grant is co-sponsored by AST and Juvenile Diabetes Research Foundation International (JDRF) to specifically support research targeted to the application of transplantation to the understanding and treatment of juvenile onset (i.e., type I) diabetes mellitus (e.g., the studies of islet transplantation, autoimmunity, etc.).

Appropriate applications in the general pool of the AST Faculty Grants will be considered for the AST/JDRF Grant if no Fellowship Grant applications of sufficiently high quality are reviewed.

To be considered for the AST/JDRF Grant, individuals applying for the AST Basic Science or Clinical science grants, whose proposal pertains to diabetes should check the appropriate box on the front page of the application. Checking this box will ensure that the application is considered for this additional grant which will increase chances for funding.

The highest scoring grant application in the general pool of Fellowship Grants that pertains to diabetes will be selected for this grant.

Funding of this grant will be dependent upon the budgetary constraints of the two co-sponsoring organizations. The application, review and funding process for the general pool of the AST Faculty Grants will apply to this specialty grant.

IMPORTANT DISCLAIMER: The AST will not assume responsibility for any clinical study funded by the AST Awards and Grants Program. Such proposals must be IRB-approved. Any responsibility will be assumed by the P.I. and the funded institution.

Application deadline: Midnight Eastern Time on Friday, November 21, 2008.

American Society of Transplantation
15000 Commerce Parkway
Suite C
Mt.Laurel, NJ,08054

Phone: 856.439.9986
Fax: 856.439.9982

Email: ast@ahint.com

The JDRF/ITN Partnership in Immune Tolerance Program will encourage and support early stage clinical development of tolerogenic protocols in Type 1 diabetes. The initiative aims to facilitate the development of novel tolerance agents in type 1 diabetes through targeted funding available through a fast-turnaround, streamlined application process administered by the ITN, with JDRF participation.

In particular, this initiative aims to foster the development of partnerships between academia and industry in order to bridge early clinical studies of therapies that have strong preclinical evidence for efficacy by supporting pre-clinical toxicology studies, phase 1 safety trials and small human efficacy trials that will provide proof-of-principle in well controlled, safe settings.

Examples of research that will be considered for support under this program:

* therapeutic strategies aimed at promoting immune tolerance in new/early onset type 1 diabetes
* therapeutic strategies aimed at promoting immune tolerance in established type 1 diabetes
* interventions aimed at restoring/reconstituting beta cell function without long term immunosuppression

Types of studies:

* drug development
* pre-clinical toxicology studies
* phase I safety studies in humans

Research outside the scope of this initiative:

* any animal studies not directly related to toxicology or pharmacodynamics in preparation of human clinical studies
* studies in Type 2 diabetes or gestational diabetes are not eligible for funding.
* type 1 diabetes prevention studies will not be considered – these should be submitted to the ITN or TrialNet as regular Concept Proposals

1. Mission
The JDRF/ITN Partnership in Immune Tolerance Program will encourage and support early stage clinical
development of tolerogenic protocols in Type 1 diabetes. The initiative aims to facilitate the development
of novel tolerance agents in type 1 diabetes through targeted funding available through a fast-turnaround,
streamlined application process administered by the ITN, with JDRF participation.
In particular, this initiative aims to foster the development of partnerships between academia and industry
in order to bridge early clinical studies of therapies that have strong preclinical evidence for efficacy by
supporting pre-clinical toxicology studies, phase 1 safety trials and small efficacy trials that will provide
proof-of-principle in well controlled, safe settings. It is the intent that successful projects emerging from
this initiative would then qualify for broader clinical support via the ITN’s existing support programs or
other funding sources.
Proposals for support from the JDRF/ITN Partnership in Immune Tolerance Program are considered via
one of two streams:
Stream 1: Investigator-initiated proposals are accepted via the ITN website utilizing ITN’s online
Concept Proposal submission system. There are no formal submission deadlines for the initiative
– proposals are accepted at all times throughout the year.
Stream 2: Clinical Concept Proposals and/or Full Applications in the area of type 1 diabetes
reviewed by the ITN that are deemed by the ITN review panel to be scientifically valid and
important, but without sufficient toxicology data to warrant full ITN clinical funding may be
considered as candidates for funding from the JDRF/ITN Partnership initiative. In such cases, the
ITN may provide a commitment in principle to funding phase II clinical studies should results from
the JDRF/ITN initiative be positive.

2. Scope
Total amount of funding available for this initiative is $3-5 million per year. The size and duration of
individual awards will vary depending upon the proposed research and total remaining funds available.
Individual project funds will be limited to 10% indirect cost recover rate and can be used for drug
development, pre-clinical/toxicology and Phase I safety. All projects funded by this initiative must receive
formal approval by appropriate regulatory and safety groups.
Basic Criteria
In general, proposals accepted for review under this initiative must meet the following general criteria:
- projects must exhibit the potential for direct clinical benefit in the treatment of type 1 diabetes.
- there must be appreciable scientific evidence from basic research and small/large animal studies
that the proposed intervention has the potential to induce tolerance to the autoimmune response
that causes type 1 diabetes.
- proposals aimed at promoting tolerance to islet transplants in type 1 diabetes will be considered
providing that the proposed interventions have conceptual underpinnings demonstrating benefits
specific to the islet transplantation setting where both auto and alloimmune responses must be
controlled.
- support is available to principal investigators or teams of investigators holding positions in
academia, industry, government or nonprofit research institutions.
Research that will be considered:
- therapeutic strategies aimed at promoting immune tolerance in new/early onset type 1 diabetes
- therapeutic strategies aimed at promoting immune tolerance in established type 1 diabetes
- interventions aimed at restoring/reconstituting beta cell function without long term
immunosuppression
- Therapeutics based on:
o monoclonal antibodies
o small molecule drugs
o cell-based therapies
o RNA/DNA-based therapies
o other
- Types of studies:
o drug development
o pre-clinical toxicology studies
o phase I safety studies in humans
Research outside the scope of this initiative:
- any animal studies not directly related to toxicology or pharmacodynamics in preparation of
human clinical studies
- studies in Type 2 diabetes or gestational diabetes are not eligible for funding.
- type 1 diabetes prevention studies will not be considered – these should be submitted to the ITN
or TrialNet as regular Concept Proposals.

Applications for support are accepted year-round, with no application deadlines.

If you would like to discuss your Concept Proposal or Full Application:

GENERAL CONCEPT & FULL PROPOSAL ENQUIRIES

Philip Bernstein, Ph.D. - Executive Director of Strategic Planning and Review
Phone: 240.235.6158
Facsimile: 240.235.6198
e-mail: pbernstein@immunetolerance.org