Notice Number: NOT-NS-17-006

Key Dates
Release Date: October 27, 2016

Estimated Publication Date of Announcement: February 14, 2017
First Estimated Application Due Date: August 11, 2017
Earliest Estimated Award Date: February 2018
Earliest Estimated Start Date: March 2018

Issued by
National Institute of Neurological Disorders and Stroke (NINDS)
National Eye Institute (NEI)
National Institute on Aging (NIA)
National Institute on Dental and Craniofacial Research (NIDCR)
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)

Purpose

The NIH announces its intention to reissue PAR-14-292 for SBIR-eligible small businesses seeking support from the Blueprint Neurotherapeutics Network (BPN). Applicants are encouraged to utilize a customized set of contract resources, and consultants from the Blueprint Neurotherapeutics Network (BPN) to help advance their neuroscience-focused drug discovery and development projects into the clinic. This Notice is provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. This FOA will utilize the U44 activity code. Details of the planned FOA are provided below.

The FOA is expected to be published in February of 2017 with an expected application due date in August 2017.

Research Initiative Details

To facilitate drug discovery and development by the neuroscience community, the NIH Blueprint for Neuroscience Research (http://neuroscienceblueprint.nih.gov/) has established the Blueprint Neurotherapeutics Network (BPN), a collection of contract service providers and consultants with extensive industry experience in the areas of pharmacology, medicinal chemistry, pharmacokinetics, toxicology, GMP synthesis, formulation development, and Phase I clinical safety testing. A list of consultants and contract service providers can be viewed at http://neuroscienceblueprint.nih.gov/bpdrugs/bpn.htm.

The reissued Funding Opportunity Announcement (FOA) will encourage applications from SBIR-eligible small businesses seeking funding through a Fast-Track phased U44 cooperative agreement mechanism to help advance their drug discovery and development projects into the clinic. Applicants will be encouraged to build in customized utilization of BPN services into their applications.

To be eligible for the BPN, an applicant must have well-validated bioactive compound(s) in hand; the BPN does not support screening for hit compounds. Projects can enter the BPN during Discovery or Development and may seek support through phase I/first-in-human testing. Discovery involves iterative medicinal chemistry to improve the potency and ADMET properties of compounds, toward the goal of identifying a clinical candidate. During Development, a clinical candidate undergoes preclinical toxicology testing required for an IND and manufacturing, ultimately advancing into phase I/first-in-human testing. BPN Development activities include chemical manufacturing and controls (CMC), formulation development, toxicology studies, regulatory support, and phase I/first-in-human testing.

The NIH will assemble a customized Lead Development Team for each project accepted into the program. The Lead Development Team typically will be co-chaired by the Program Director/Principal Investigator (PD/PI) and a consultant with extensive industry expertise identified and supported by the NIH. The Lead Development Team may also include members of the PD/PI's team, NIH-hired consultants with additional expertise, and NIH staff. The Lead Development Team will plan and coordinate the work supported by the cooperative agreement award and conducted by BPN contractors.

All Discovery projects will begin with a U44 Phase I award of up to two years. The first 6-12 months will be used to complete any studies required to meet the Discovery or Development entry criteria and to engage the Lead Development Team in establishing a detailed research plan, with go/no-go milestones, for all subsequent work.

Applicants are strongly encouraged to consult with NIH program staff as plans for an application are being developed. Consultations will include conference calls with NIH program staff and webinars. Early contact provides an opportunity for NIH program staff to discuss the program scope, entry criteria, and goals, and to provide information and guidance on how to develop a competitive application. It's recommended that applicants contact the NIH staff at least 8 weeks before the receipt date.

For additional information on the BPN, please see http://neuroscienceblueprint.nih.gov/bpdrugs/index.htm

APPLICATIONS ARE NOT BEING SOLICITED AT THIS TIME.

Inquiries

Please direct all inquiries to:

Charles Cywin, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone:301-496-1779
Email: [email protected]