MDA Translational Research Program
Translational Research Pre-IND Grant (TR-INDG)
Summary: This one- to two-year grant is designed to aid academic investigators
in meeting the requirements for submitting an Investigational New Drug (IND)
application to the Food and Drug Administration for a drug or biologic intended
to treat neuromuscular disease(s) in MDA’s program. It is understood that the
applicant will have completed preclinical proof of principle studies, and
informal toxicology testing, and will have identified a manufacturer or
supplier for clinical-grade quantities of the final drug or biologic at the
time the TR-INDG is submitted. TR-INDG funding may be used for the following:
1) contracting of manufacturing and toxicology services needed to meet the
regulatory requirements of an IND; 2) limited use of contract research
organizations (CROs) or regulatory consultants; 3) salaries of staff as needed
with appropriate experience in meeting regulatory requirements; 4) completion
of training courses in regulatory compliance and human subject protection. The
applicant should be the Investigator or Co-Investigator on the resulting IND or
the Investigator/Sponsor or Co-Investigator/Sponsor.
Deadlines / Frequently Asked Questions
/ 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:
IND Planning Grant
Who can apply?
The applicant should be a professional or faculty member at an appropriate U.S.
educational, medical or research institution who is qualified to conduct and
supervise a program of original research. The applicant should hold a Doctor of
Medicine, Doctor of Philosophy, Doctor of Science or equivalent degree.
What kind of projects are funded?
The IND planning grant is designed to support the filing of an Investigational
New Drug Application (IND) for a potential neuromuscular disease therapy with
the U.S. Food and Drug Administration (FDA). For example, the applicant may use
the IND planning grant to fund toxicology and biodistribution studies required
by the FDA, regulatory consultations, and meetings between collaborators. This
grant is primarily intended for the academic investigator who does not have
substantial support from a for-profit partner.
What are the review criteria?
1. THERAPY DEVELOPMENT POTENTIAL: Rationale of treatment
modality; quality of preclinical data; results of informal toxicology studies;
adequate optimization; clinical study plan
2. ABILITY TO MEET IND REQUIREMENTS: Institutional facilities
and support; manufacturing plan; regulatory compliance plan
3. QUALITY OF PI AND CO-PIs: General excellence; experience in
clinical research or educational plan to obtain training (i.e., planned
training in statistics, human subject protection etc.)
4. COLLABORATIONS AND KEY STAFF: Appropriate expertise
represented in clinical research, basic research and regulatory compliance
5. PROPOSED CONTRACTS: Ability and experience of vendor;
cost-effectiveness
When are the deadlines?
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 and MDA priorities. All applicants, whether selected for funding or
not, receive copies of the anonymized ad hoc reviews.
How is the grant administered?
Funding is paid in quarterly installments and is contingent upon completion of
milestones and a satisfactory progress report at the end of year one.
Does MDA have a royalties-sharing agreement?
MDA will negotiate a royalties-sharing agreement.
What restrictions apply to this grant?
Recipients of a pre-IND grant are expected to work toward the submission of IND
to the Food and Drug Administration, with the ultimate goal of conducting a
phase I clinical trial. If the applicant is filing an IND for the first time,
he/she is required to participate in a pre-IND meeting with the FDA.
More Information
For detailed information about the pre-IND grant, applicants are strongly
encouraged to speak with MDA staff.
Contact
Sharon Hesterlee, Ph.D.
Director of Research Development
(520) 529-5433
shesterlee@mdausa.org
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