NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE (NINDS)
The mission of NINDS is to reduce the burden of neurological disease—a burden borne by every age group, by every segment of society, by people all over the world. To this end, the Institute supports and conducts research on the healthy and diseased brain, spinal cord, and peripheral nerves. Hundreds of disorders afflict the nervous system. Common disorders such as stroke, epilepsy, Parkinson’s disease, and autism are well-known. Many other neurological disorders are rare and known mostly to the individuals and families affected, their doctors, and scientists.
The NINDS SBIR/STTR program funds small business concerns to conduct innovative neuroscience research and/or development (R/R&D) that has both the potential for commercialization and public benefit. NINDS is committed to helping small business concerns commercialize their technologies through its grant funding, technical assistance program participation, and outreach at meetings. NINDS is increasingly tracking the progress of its funded small business concerns and the products they develop. Funding priority will be given to those small business concerns that show not only their ability to develop products but their growth as a small business concern towards independence from the SBIR/STTR program.
PHASE IIB COMPETING RENEWAL AWARDS
In addition to the traditional Phase I and II applications, NINDS accepts Phase IIB SBIR/STTR Competing Renewal applications through specific opportunities that focus on the commercialization of SBIR and STTR developed technologies.
RESEARCH TOPICS OF INTEREST TO NINDS
GENERAL AREAS OF INTEREST
The NINDS accepts a broad range of small business applications that are significant, innovative, and relevant to its mission.
Examples of research topics within the mission of NINDS that may be of interest to small businesses are shown below. This
list is not all inclusive and some research areas fall into multiple categories.
1. Therapeutics and Diagnostics Development for Neurological Disorders, including biomarker and diagnostic assays, therapeutics (drugs, biologics, and/or devices) for treatment of neurological disorders, and technologies/methodologies to deliver therapeutics to the central nervous system.
2. Clinical and Rehabilitation Tools, including intraoperative technologies for neurosurgeons, rehabilitation devices and programs for neurological disorders, and brain monitoring systems
3. Technology and Tools, including imaging technologies to image the nervous system, neural interfaces technologies, and tools for neuroscience research and drug development.
In addition to the research topics listed, NINDS also encourages applications in specific program areas. For additional information about NINDS program announcements, please visit our small business home page. Information on eligibility and budget limits might also be of interest.
There is increasing awareness among neurological disease communities that to assess the predictive value of preclinical research, sufficient information must be available about study design, execution, analysis, and interpretation. Program Directors/Principal Investigators (PD(s)/PI(s)) should consider including blinding, randomization, power analysis for sample size, and independent replication in their application. Examples of the critical elements of a well-designed study are summarized here. NINDS urges applicants to the program to consider these elements when describing supporting data and designing the proposed studies.
The NINDS is committed to identifying effective treatments for neurological disorders by supporting well-executed clinical trials. NINDS accepts SBIR and STTR clinical trial applications through specific opportunities. NINDS will not accept unsolicited SBIR/STTR applications that include clinical trials under the Omnibus solicitation. A clinical trial is a prospective biomedical or behavioral research study of human subjects designed to answer specific questions about the safety, tolerability, efficacy and/or effectiveness of pharmacologic, behavioral, biologic, surgical, or device interventions. This policy does not apply to (1) exploratory IND studies as defined by the FDA, or (2) early feasibility studies of devices as defined by the FDA. Other human subjects research can also be submitted through the Omnibus solicitation. NINDS may decline funding of any application that includes human subjects for programmatic or administrative reasons. SBIR applicants considering projects involving human subjects research are strongly encouraged to contact Stephanie Fertig or Joanne Odenkirchen.
COUNTERMEASURES AGAINST CHEMICAL THREATS
NINDS manages the NIH Countermeasures Against Chemical Threats (CounterACT) program. CounterACT supports research and development
on new and improved therapeutics or diagnostic technologies to prevent or mitigate the toxic effects from exposure to chemical
threats, defined as toxic
chemical agents that could be used in a terrorist attack against civilians, or those that could be released at toxic levels by accident or natural disaster. This includes the development of new (or support of existing) partnerships between small business and not-for-profit laboratories engaged in this research. The scope of research supported includes early screening for compounds with the desired biological activity, advanced preclinical and efficacy testing, through clinical research with promising candidate therapeutics. More information on this program, including specific program announcements, can be found here. Applicants are strongly encouraged to consult with Dr. David Jett to determine the programmatic relevance of their proposed research.
David A. Jett, Ph.D.
Program Director, NIH CounterACT Research
Last updated February 10, 2014