Notice Number: NOT-NS-16-005

Key Dates
Release Date: February 3, 2016
Response Date: February 29, 2016

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

Purpose

This is a time sensitive Request for Information (RFI) to solicit feedback from pharmaceutical and biotechnology companies regarding the potential convening of a meeting to facilitate partnerships between active NIH CounterACT investigators and entities from the commercial and industrial sectors.

Background

The mission of the NIH Countermeasures Against Chemical Threats (see CounterACT) program is to develop new and improved therapeutics to treat and/or prevent injuries resulting from exposure to chemical threats. Chemical threats are toxic chemicals that could be used in a terrorist attack or accidentally released from industrial production, storage or shipping. They include traditional chemical warfare agents and toxic industrial chemicals and materials. These chemical threats have a variety of effects. Classes of chemicals encompass cholinesterase and GABA-inhibitors that can induce prolonged and uncontrolled excitation of the nervous system, metabolic/cellular poisons that prevent cellular respiration, vesicating agents that cause moderate to debilitating ocular, dermal, and mucosal injuries, and pulmonary compounds that corrosively injure, irritate, or react with the lining of the respiratory tract.

Many NIH CounterACT projects are developing candidate therapeutics and are now poised for more advanced development activities, including pre-Investigational New Drug (pre-IND)-enabling and clinical studies that could be supported by other federal agencies that fund advanced development, FDA approval and licensure, as well as procurement activities under Project BioShield (see medical countermeasures.gov). The majority of projects supported by NIH are in academic labs that often do not possess the resources and expertise for these types of advanced studies. To address this need, it is critical that the NIH facilitate partnerships between academic laboratories and pharmaceutical or biotechnology companies that typically have more experience in drug development and regulatory approval.

Please see CounterACT Projects for a list of active projects. Note that not all of these projects are mature enough for engaging industry. If there is general interest in an Investigator-Industry Partnership meeting, more information about specific projects that are ready for engagement from industry will be provided by a method to be determined.

Information Requested

The NIH is especially interested in identifying and facilitating the establishment of partnerships between funded researchers and industrial entities. These partnerships would aid in the successful development of approved medical countermeasure products and the sustainability of the overall research enterprise. The NIH seeks input specifically from industry stakeholders on potential interest in attending a meeting with specific NIH CounterACT investigators ready for partnerships. To achieve the goal of this time-sensitive RFI, we invite comments on any or all of the following areas:

1. Interest in attending presentations from NIH CounterACT investigators regarding their lead candidate therapeutics
2. The most important characteristics of a project that would influence your interest in a product under development. For example, what is the type of product, the market beyond biodefense, available non-dilutive funding including federal, etc.?
3. Please provide any comments on specific features of the meeting that would be most useful.
4. Please provide any other comments on this proposed initiative that respondents feel are relevant.

The meeting would also include presentations from federal government officials on the various funding programs available to support the advanced development of medical products within this mission.

How to Submit a Response

Responses to this RFI must be submitted electronically to Dr. Shardell Spriggs [email protected] no later than February 29, 2016. Reference the Notice number (NOT-NS-16-005) in the subject line of the email.

Responses to this RFI are voluntary. This RFI is for planning purposes only and should not be construed as a solicitation or as an obligation on the part of the Federal Government, the National Institutes of Health, or individual NIH institutes or Centers. The NIH does not intend to make any type of award based on responses to this RFI or to pay for either the preparation of information submitted or the Government’s use of such information.

The NIH will use the information submitted in response to the RFI at its discretion. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information provided and will not provide feedback to respondents. The information submitted will be analyzed and may be shared internally and used by NIH CounterACT staff for planning future Investigator-Industry Partnership meetings, as appropriate and at the Government’s discretion. Proprietary, classified, confidential, or sensitive information should not be included in your response.

Inquiries

Please direct all inquiries to:

David A. Jett, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-6035
Email: [email protected]