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NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE (NINDS)

Description:

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 only to the individuals and families affected, their doctors, and scientists. The NINDS SBIR/STTR program funds small business concerns to conduct innovative neuroscience research or neuroscience research and 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 encourages all Phase II applicants to apply to the NIH Commercialization Assistance Program (CAP) to gain assistance in transferring their products to the marketplace. The CAP program is open to all Phase II grants that were active in the past six years. 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. LIMITED AMOUNT OF AWARD For budgetary, administrative, or programmatic reasons, NINDS may decrease the length of an award and/or the budget recommended by a review committee, or not fund an application. Generally, NINDS does not fund Phase I applications greater than $350,000 total cost per year for up to 2 years or Phase II applications greater than $1,000,000 total cost per year for up to 3 years. Applicants considering a requested budget greater than these limits are strongly encouraged to contact program staff before submitting an application. Phase IIB Competing Renewal Awards In addition to the traditional Phase I and II applications, NINDS will accept Phase IIB SBIR/STTR Competing Renewal grant applications to continue the process of developing products that require approval of a federal regulatory agency. Such products include, but are not limited to: medical implants, drugs, biologics, and new treatment or diagnostic tools that require FDA approval. NINDS will accept applications for up to three years that do not exceed $1,000,000 per year in total costs. The following examples would make appropriate topics for proposed SBIR or STTR Phase IIB Competing Renewal projects. This list is not meant to be all-inclusive, and applications for other appropriate activities will be accepted. 1. Studies for preclinical discovery and development of drugs to treat neurological disorders. Appropriate areas of effort may include the following (but are not limited to): medicinal chemistry structure-activity relationship (SAR) studies to develop drug candidates, pharmacology studies aimed at evaluating the potential therapeutic activity and side effect profile of drug candidates, medicinal chemistry and pharmacology studies aimed at synthesizing and evaluating compounds as potential drug leads and as preclinical drug candidates, and studies aimed at evaluating drug metabolism and pharmacokinetic behavior in rodents. These efforts should extend beyond those conducted under the initial SBIR Phase I and Phase II grants. The studies conducted under the previous grants should be sufficient to provide a sound rationale for continued development. 2. Completion of studies as required by the FDA for an IND application. 3. Safety and effectiveness studies of novel medical devices. 4. Human clinical trials/studies to determine the safety profile, metabolism, and/or efficacy of a drug. Please contact Ms. Stephanie Fertig (contact information provided below) before beginning the process of preparing an application. Prospective applicants are strongly encouraged to submit a letter of intent that includes the following information: • Descriptive title of the proposed research • Name, address, and telephone number of the Principal Investigator • Names of other key personnel • Participating institutions • Funding Opportunity Announcement Number (e.g., PA-10-XXX) Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIH staff to estimate the potential review workload and plan the review. It is expected that only a portion of NINDS SBIR/STTR Phase II awards will be eligible for a Competing Renewal grant. Any Phase IIB Competing Renewal applications that do not propose to develop products that require regulatory approval, or that exceed the total cost budget cap, will be withdrawn from consideration prior to peer review. For more information on Competing Renewal Awards of SBIR Phase II grants for Brain and Behavior Tools: http://grants.nih.gov/grants/guide/pa-files/PA-08-056.html. Ms. Stephanie Fertig, M.B.A. Project Manager, Small Business Programs 301-496-1447; Fax: 301-480-1080 Email: fertigs@ninds.nih.gov For general questions related to the small business program, email: nindssmallbusiness@mail.nih.gov. 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 solicits applications in specific program areas. For additional information about NINDS program announcements, please visit our small business home page at: http://www.ninds.nih.gov/funding/small-business/. Clinical Trials The NINDS is committed to identifying effective treatments for neurological disorders by supporting well-executed clinical trials. NINDS may decline funding of a clinical trial application for programmatic or administrative reasons. SBIR applicants are strongly encouraged to contact Joanne Odenkirchen (contact information provided below) within the NINDS Office of Clinical Research for advice about potential clinical trial applications prior to submission in order to determine the relevance of the proposed research to NINDS and its potential for translating discoveries to clinical interventions for neurological disorders. For more information about what is generally required before trials are funded, applicants are encouraged to review the NINDS Office of Clinical Research webpage (http://www.ninds.nih.gov/research/clinical_research/index.htm). Joanne Odenkirchen, M.P.H. Clinical Research Project Manager, Office of Clinical Research 301-496-3104 Email: jo21x@nih.gov NINDS Cooperative Program in Translational Research Although translational research is supported through the general SBIR/STTR program announcement, the NINDS also has a Cooperative Program in Translational research (PAR-08-235). The NINDS Cooperative Program encourages Phase II and Fast-Track applications that directly address the identification and pre-clinical testing of new therapeutics for neurological disorders. The program will facilitate solicitation, development, and review of therapy-directed projects to accelerate the translation of basic research discoveries into therapeutic candidates for clinical testing. This program is specifically directed at projects that include therapeutic leads with demonstrated activity against the intended disease target. The program supports pre-clinical optimization and testing of these leads and projects must be sufficiently advanced that an IND or IDE application to the FDA can be submitted by the end of the project period. The program does not support early-stage therapeutic discovery activities such as high throughput screening. The program also excludes clinical research, basic research, and studies of disease mechanism. This is a milestone-driven cooperative agreement program involving participation of NINDS staff in the development of the project plan and monitoring of research progress. For more information on the NINDS Cooperative Program in Translational Research-Small Business Awards (SBIR[U44]): http://grants.nih.gov/grants/guide/pa-files/PAR-08-235.html. Due to the unique requirements of the NINDS Cooperative Program in Translational Research, applicants are strongly encouraged to consult with Dr. Tom Miller at least three months prior to the next receipt date. Dr. Tom Miller, Ph.D., M.B.A. Program Director, Office of Translational Research 301-496-1447 Email: millert@ninds.nih.gov 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. For more information on this program, including specific program announcements, please see: www.ninds.nih.gov/counteract. 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 301-496-6035 Email: jettd@ninds.nih.gov For additional information on research topics, contact: Ms. Stephanie Fertig, M.B.A. Research Project Manager, Small Business Programs 301-496-1447, Fax: 301-480-1080 Email: fertigs@ninds.nih.gov or for general questions related to the small business program, email: nindssmallbusiness@mail.nih.gov For administrative and business management questions, contact: Ms. Tijuanna Decoster Chief, Grants Management Branch 301-496-9231, Fax: 301-402-4370 Email: decostert@mail.nih.gov
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