Pre-Solicitation Notice: SMA Project Funding Opportunity for Spinal Muscular Atrophy Research
From the SMA Project email service (June 8, 2007):
Technorati Tags: National Institute of Neurological Disorders and Stroke, request for proposals, research, sma, SMA Project, spinal muscular atrophyDear Colleague,
I am pleased to announce the following funding opportunity for researchers in the field of spinal muscular atrophy (SMA):
The SMA Project (http://www.smaproject.org) expects to release a Request for Proposals (RFP) within the next 14 days to identify and fund facilities capable of providing the necessary research and development support for an Investigational New Drug (IND) submission in a format acceptable to the U.S. Food and Drug Administration (FDA).
The intention is to award a subcontract to a facility capable of conducting safety, toxicology, pharmacokinetic/dynamic, and biodistribution studies with candidate small molecule compounds that act as therapeutic agents for SMA. These studies will be done in partial fulfillment of the requirements for submitting an IND application to the FDA. Science Applications International Corporation (SAIC), on behalf of the Government, shall supply the Offeror with a small amount of each candidate therapeutic compound.
The Offeror will be required to prepare and deliver, for each selected therapeutic compound provided by SAIC for testing, a specific Test Implementation Plan including a proposed budget for the specific testing activities. Activities within the facility shall be highly coordinated with efficacy testing activities outside the facility by SAIC. SAIC shall require from the Offeror preclinical development data that are required by the FDA for filing successful IND applications.
Offers will be due approximately 28 days from the release of the RFP. Relevant documents will be available through the Solicitations page of the SMA Project website at http://www.smaproject.org/solicitations.html.
The National Institute for Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov/) launched The SMA Project: A Collaborative Program to Accelerate Therapeutics Development for Spinal Muscular Atrophy in September 2003. This program funds milestone-driven research aimed at identifying and rapidly developing a treatment for SMA, a paralyzing neurodegenerative disease of childhood.
