Notice Number: NOT-NS-18-048

Key Dates
Release Date: March 5, 2018

Issued by
National Institute of Neurological Disorders and Stroke (NINDS)

Purpose

The purpose of this Notice is to inform potential applicants to the National Institute of Neurological Disorders and Stroke (NINDS) Innovation Grants to Nurture Initial Translational Efforts (IGNITE) and Cooperative Research to Enable and Advance Translational Enterprises for Biologics (CREATE Bio) program Funding Opportunity Announcements about an area of special interest. NINDS would like to accelerate the development of pain treatments with little or no potential for misuse or addiction.

The IGNITE program contains a suite of early-stage therapy development funding programs and is meant to serve as a feeder program to later-stage therapy development programs. The three IGNITE programs are in the following areas: Assay Development and Neurotherapeutic Agent Identification, Neurotherapeutic Agent Characterization and In vivo Efficacy Studies, and Development and Validation of Model Systems and/or Pharmacodynamic Markers to Facilitate Neurotherapeutic Discovery. All of the IGNITE programs would like in encourage applications related to non-addictive therapies for the treatment of pain.

The CREATE Bio program is interested in receiving applications in biotechnology products and biologics-based therapies, which broadly include modalities such as peptides, proteins, oligonucleotides, gene therapies, cell therapies, and novel emerging therapies directed at optimizing and developing non-addictive therapies for the treatment of pain. The CREATE Bio program includes the following two tracks: The Optimization Track supports optimization of agents to obtain a clinical candidate appropriate for entry to the Development Track. The Development Track supports IND-enabling studies of a clinical candidate and projects are expected to achieve filing of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA), at the end of the funding period. For more advanced projects, an optional small delayed-onset first in human Phase I clinical trial may also be proposed to follow the filing of the IND package.

Additionally, the IGNITE and CREATE Bio programs will hold an informational webinar for potential applicants. The webinar is recommended for investigators who meet the entry criteria for the programs of interest.

This webinar is optional and not required for submission of applications.

WEBINAR INFORMATION
Informational Webinar on the IGNITE and CREATE Bio Programs with a focus on Non-Addictive Pain Therapies
April 16, 2018 1:30 p.m.- 2:30 Eastern Time
Please visit the following link to register for the webinar:
Link to webinar
A registration button is available at the bottom of the page.

Inquiries

Please direct all inquiries to:

Chris Boshoff, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1779
Email: chris.boshoff@nih.gov

Rebecca Roof, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1779
Email: Rebecca.Roof@nih.gov

Michael Oshinsky, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9964
Email: michael.oshinsky@nih.gov