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

Key Dates

• April 23, 2021 - Blueprint Neurotherapeutics Network (BPN): Biologic-based Drug Discovery and Development for Disorders of the Nervous System (U44 Clinical Trial Optional). See Notice PAR-21-233.
• March 11, 2021 - Blueprint Neurotherapeutics Network (BPN): Biologic-based Drug Discovery and Development for Disorders of the Nervous System (UG3/UH3 Clinical Trial Optional). See Notice PAR-21-163.
   

National Institute of Neurological Disorders and Stroke (NINDS)

National Eye Institute (NEI)

National Institute on Aging (NIA)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

National Institute of Dental and Craniofacial Research (NIDCR)

National Institute on Drug Abuse (NIDA)

National Institute of Environmental Health Sciences (NIEHS)

National Institute of Mental Health (NIMH)

National Center for Complementary and Integrative Health (NCCIH)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Office of Behavioral and Social Sciences Research (OBSSR)

The NIH announces its intention to reissue PAR-21-163 to solicit applications from researchers developing diverse biotherapeutic modalities — including but not limited to antibodies, peptides, proteins, oligonucleotides, gene therapies, cell therapies, and other emerging therapeutic modalities — for the treatment of nervous system and neuromuscular disorders.

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. 

The NOFO is expected to be published in Fall 2024 with an expected application due date in Winter 2025.

This NOFO will utilize the UG3/UH3 activity code. Details of the planned NOFO are provided below.

The Blueprint Neurotherapeutics Network for Biologics (BPN Biologics) was established by the NIH Blueprint for Neuroscience Research (http://neuroscienceblueprint.nih.gov) to accelerate the development of diverse biotherapeutic modalities, including antibodies, peptides, proteins, oligonucleotides, gene and cell therapies, and other emerging modalities (e.g., microbial or microbiome-based), for the treatment of nervous system and neuromuscular disorders.  

BPN Biologics provides funding, resources, and expertise for drug discovery and development activities, from lead optimization through first-in-human clinical trials. Awarded projects will receive: (1) grant funding for investigator-led research activities; (2) in-kind access to BPN Biologics contract resource organizations (CROs) that specialize in industry-standard manufacturing, nonclinical, and early phase clinical services; and (3) assistance from BPN Biologics-contracted consultants with industry expertise across drug development areas and therapeutic modalities. Applicants may propose the number and types of activities to be conducted through BPN Biologics CROs. The use of BPN Biologics CROs is optional, and the costs are covered by NIH.  

The planned NOFO reissue will use a milestone driven UG3/UH3 cooperative agreement that involves close collaboration and regular interactions with NIH program staff. All projects will begin with a UG3 phase of up to 2 years. To be eligible, applicants may enter the program with lead biologic agents that are supported by in vivo data and require further optimization or after a clinical candidate has been selected. The UG3 phase of this award supports lead optimization, candidate selection, and any remaining activities required to initiate Investigational New Drug (IND)-enabling studies. After successful completion of the UG3 milestones, a project may advance to the UH3 phase. The UH3 phase of this award supports completion of safety and pharmacology in compliance with Good Laboratory Practices (GLP), production of material under current Good Manufacturing Practices (cGMP) in support of IND filing, and a first-in-human clinical trial. The total duration of both the UG3 and UH3 phases cannot exceed 5 years.

For more information, please visit our website at: https://neuroscienceblueprint.nih.gov/neurotherapeutics/bpn-biologics.

Funding Information

Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
Independent school districts
Public housing authorities/Indian housing authorities
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)
Non-domestic (non-U.S.) Entity (Foreign Organization)
Regional Organization
Eligible Agencies of the Federal Government

Applications are not being solicited at this time. 

Inquiries

Please direct all inquiries to:

Lauren Friedman, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-827-5065
Email: [email protected]