MDA Translational Research Program

Translational Research Corporate Grant (TR-CG)

Summary: The purpose of the TR-CG is to provide a mechanism to fund directly for-profit companies engaged in preclinical or clinical therapy development for any neuromuscular disease(s) covered in MDA's program. Proposed projects should be focused on translational aspects of therapy development (e.g., optimization, scale-up, manufacturing, toxicology testing, and phase I/II clinical trials), and grants will be awarded with the understanding that there is a reasonable expectation that a therapeutic product will be brought to market by the awardee, either during the tenure of the grant, or subsequent to the MDA grant. A collaborative effort with academic or institutional researchers in an appropriate field is required. The TR-CG may last for 1-3 years, with award amounts generally not to exceed $1 million per year. This award is highly competitive.

Deadlines / Frequently Asked Questions / Letter of Intent / Policy Manual / Contact /

Deadlines*

*Potential applicants are strongly encouraged to contact MDA staff before submitting a letter of intent for this grant.

For Review at the August 2006 TRAC Meeting:
Letter of Intent: May 1, 2006
Grant Application: June 1, 2006
Start Date: October 1, 2006

For Review at the February 2007 TRAC Meeting:
Letter of Intent: November 1, 2006
Grant Application: December 1, 2006
Start Date: April 1, 2007

Frequently Asked Questions:
Translational Research Corporate Grant

Who can apply?
Biotechnology, pharmaceutical, or other related for-profit businesses are eligible for this funding opportunity. The Principal Investigator must be primarily employed by the applicant company at the time of the award and during the conduct of the proposed project (at least 50% effort; precludes full-time employment at another institution). Companies do not need to be based in the U.S. to be eligible for this award.

What kind of projects are funded?
Projects should advance the development of a therapy for one or more neuromuscular disease in MDA’s program. Applicants should have solid “proof-of-principle” evidence on which to base preclinical development. Funds may be used to conduct regulatory testing required to support an Investigational New Drug Application and/or phase I or II clinical testing of the therapy. The grant is awarded with the understanding that a reasonable effort will be made to bring the candidate therapy to market, either by the applicant company or by a collaborative partner.

What are the review criteria?

1. RELEVANCE TO THERAPY DEVELOPMENT: Project should be directly relevant to developing a therapy to treat a disease or diseases specifically named in MDA’s program

2. QUALITY AND FEASIBILITY OF PROPOSED WORK: Proposed aims, methods and project design are well thought-out; time line is reasonable for goals described; milestones are appropriate

3. BUDGET AND JUSTIFICATION FOR MDA FUNDING: Appropriateness of proposed budget; justification for need for MDA funding

4. QUALITY OF APPLICANT: Productivity and viability of the company; commitment to the proposed project; relevance of the project to the company’s overall business strategy; availability of necessary infrastructure and support

5. QUALITY OF KEY STAFF: Capability in coordinating, managing project; relevant experience; relationship with appropriate collaborators

6. COLLABORATIONS: Appropriateness, experience and quality of proposed academic collaborators or contractors; cost-effectiveness of contractors

When are the deadlines and what is the turn-around time for grant review?
Letters of intent, which may be submitted online, will be reviewed at the Translational Research Advisory Committee meetings in early February and early August. If you are invited to apply for a grant, full applications will be due the first week of the following May or the first week of the following November, respectively. The start date for the grant will be approximately six months from the deadline for the letter of intent. See deadlines for an exact schedule of dates.

How is the application reviewed?
Grant applications to the Translational Research Program are reviewed by two or more expert ad hoc reviewers for scientific feasibility. Recommendations of ad hoc reviewers are passed on to the Translational Research Advisory Committee, which makes a final funding recommendation by taking into account the ad hoc reviews, business feasibility of the project and MDA priorities. All applicants, whether selected for funding or not, receive copies of the anonymized ad hoc reviews.

How is the grant administered?
Corporate grants are administered as milestone-driven quarterly payments that are defined by a contract. A five-member steering committee composed of one company member, one MDA staff member and three outside experts is chosen to monitor progress on milestones. An award may be cancelled if a majority of steering committee members agree that a milestone has not been met and an extension is not warranted.

Does MDA have a royalties-sharing agreement?
MDA will negotiate a royalties-sharing agreement.

What other requirements apply to this grant?
Recipients of an MDA Corporate Grant are required to contribute to the awarded project funds that match or exceed MDA’s contribution within one year of the start date of the contract. In most cases, the requirement for matching funds is a designated milestone. Companies are also expected to coordinate public announcements about MDA-funded projects with MDA, and to adhere to other reporting requirements.

More Information
For more information about the MDA Corporate Grant, please see the Corporate Grant Policy Manual. Applicants are strongly encouraged to review this manual and to speak with MDA staff before sending a letter of intent.

Letter of Intent
A letter of intent must be approved to receive a grant application. Letters of Intent are reviewed at the next scheduled TRAC meeting, but must be received at least by the date listed in the deadlines section. Letters of intent received after the deadline for submission will automatically be scheduled for consideration at the following TRAC meeting in six months time.

Applicants are strongly encouraged to contact MDA staff before submitting a letter of intent.

Contact
Sharon Hesterlee, Ph.D.
Director of Research Development
(520) 529-5433
shesterlee@mdausa.org