Notice of Intent to Publish a Funding Opportunity Announcement for Blueprint Neurotherapeutics Network (BPN): Small Molecule Drug Discovery and Development of Disorders of the Nervous System (UG3/UH3 Clinical Trial Optional)

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National Institute of Neurological Disorders and Stroke (NINDS)

The NIH announces its intention to reissue PAR-18-546 for investigators seeking support from the Blueprint Neurotherapeutics (BPN) Network. Applicants will be encouraged to utilize a customized set of contract resources, and consultants from the BPN Network 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 UG3/UH3 activity code. Details of the planned FOA are provided below.

The FOA is expected to be published in February of 2020 with an expected application due date in August 2020.

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 (BPN) Network, 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 planned reissue Funding Opportunity Announcement (FOA) will encourage applications from investigators seeking funding through a UG3/UH3 phased 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 projects that enter the BPN will begin with a preparatory phase (UG3) of up to one year, which can 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

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Regional Organization Applications are not being solicited at this time. Please direct all inquiries to:

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