Notice Number: NOT-NS-15-035

Key Dates
Release Date: August 6, 2015

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

Purpose

This Notice is to inform potential applicants to PAR-13-208 "Countermeasures Against Chemical Threats (CounterACT) Cooperative Research Projects (U01)" that priority will be given to research applications that clearly describe a goal of developing one or more therapeutic candidates that is ready for advanced development by the end of the proposed project periods (up to 5 years). Projects proposed that will be given priority should culminate in the submission of a Pre-Investigational New Drug (Pre-IND) Application Package to the FDA, or should be very close to securing all the data and planning needed for submission of the Pre-IND package. As such, applicants are encouraged to address the regulatory strategy necessary to achieve this goal.

Research supported under this FOA is to prepare for advanced development after filing the Pre-IND package.  Most of the advanced development activities required for regulatory approval (to include GMP and GLP level efforts) are not usually covered under this FOA, but could potentially be supported by other federal agencies or industry once the NIH-supported research is completed. 

The HHS advanced development agency relevant to this FOA is the Biomedical Advanced Research and Development Authority (BARDA). Once research funded under this FOA is completed, you should have the following before exploring the possibility of additional funding through BARDA for advanced development.

• At least one lead compound. Lead compounds are biologically active compounds or hits where affinity, potency, and selectivity have been established.
• Efficacy in an appropriate animal model
• Initial pharmacology and toxicology studies
• Stable and scalable synthesis of the lead compound
• Preliminary regulatory strategy including a Target Product Profile and regulatory expertise
• Commercialization plan for other indications if applicable
• Intellectual Property Rights

Applications that focus specifically on the above goal will be deemed of high programmatic priority.

All applicants are strongly encouraged to discuss their applications with the Scientific/Research contact listed in the FOA early in the application development process.

Inquiries

Please direct all inquiries to:

David A. Jett, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-443-8189
Email: jettd@ninds.nih.gov