Small Business Areas of Interest

Small Business Areas of Interest


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 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.


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. 


HUMAN SUBJECT RESEARCH AND CLINICAL TRIALS

The NINDS is committed to identifying effective treatments for neurological disorders by supporting well-executed clinical trials. NINDS will not accept unsolicited SBIR/STTR applications that include clinical trials under the Omnibus solicitation. NIH defines a clinical trial as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. See NOT-OD-15-015. NINDS only accepts and supports SBIR and STTR clinical trial applications through specific opportunities. Please note, many of these funding annoucements have specific regulatory approvals required prior to submission. Please see NOT-NS-11-018. Other human subjects research, including the development of diagnostics or clinical research tools, can be submitted through the Omnibus solicitation. However, NINDS may decline funding of any application that includes human subjects for programmatic or administrative reasons. Additional information on human subject research can be found here.  SBIR applicants considering projects involving human subjects research are strongly encouraged to contact program staff in advance of submission.


BRAIN RESEARCH THROUGH ADVANCING INNOVATIVE NEUROTECHNOLOGIES (BRAIN) INITIATIVE 

The Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative is a Presidential project aimed at revolutionizing our understanding of the human brain. NIH is one of several federal agencies involved in the BRAIN Initiative. Planning for the NIH component of the BRAIN Initiative is guided by the long-term scientific plan, “BRAIN 2025: A Scientific Vision,” which details seven high-priority research areas. 

NIH has a number of specific funding opportunity announcements through the BRAIN Initiative that are targeted to small business concerns. Applicants are encouraged to consider if these funding opportunities may be appropriate to their research. Contact NINDS SBIR/STTR program staff for additional information.


COOPERATIVE TRANSLATIONAL RESEARCH 

The NINDS offers a variety of specific funding opportunities and programs to accelerate the preclinical discovery and development of new therapeutic interventions for neurological disorders. The programs have specific funding opportunities and allow for budgets over the hard cap. All three programs utilize the cooperative agreement (U44) mechanism, which is milestone-driven and involves NIH program staff’s participation in developing the project plan, monitoring research progress, and appropriate go/no-go decision-making. SBIR applicants considering projects involving translational research are strongly encouraged to contact program staff well in advance of submission. 

  • Cooperative Research to Enable and Advance Translational Enterprises for Biotechnology Products and Biologics (CREATE Bio) is dedicated to biotechnology product- and biologics-based therapies, which broadly include modalities such as peptides, proteins, oligonucleotides, gene therapies, and cell therapies.  The program supports lead optimization, IND-enabling studies for the candidate, and early-phase clinical trials. Contact: chris.boshoff@nih.gov

  • Translational Neural Devices Program provides support for projects that focus on pre-clinical and pilot clinical studies for therapeutic devices.  Activities supported in this program include implementation of clinical prototype devices, preclinical safety and efficacy testing, design verification and validation activities, pursuit of regulatory approval for the clinical study, and a clinical study. Contacts: Stephanie Fertig (fertigs@ninds.nih.gov) and Nick Langhals (nick.langhals@nih.gov)

  • Blueprint Neurotherapeutics Network (BPN) provides both funding and non-dilutive support for small molecule drug discovery and development, from hit-to-lead chemistry through phase I clinical testing. The program offers funding, access to NIH-funded contract research organizations (CROs), and access to consultants with expertise in various aspects of drug discovery and development. Contact: Charles Cywin (cywincl@mail.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. Applicants are strongly encouraged to consult with Dr. David Jett, Director, CounterACT Program (jettd@ninds.nih.gov) to determine the programmatic relevance of their proposed research.