NOT-NS-21-032 - Notice of Intent to Publish a Funding Opportunity Announcement for Blueprint Neurotherapeutics Network (BPN-Biologics): Biologics-based Drug Discovery and Development for Disorders of the Nervous System (U44 Clinical Trial Optional)
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 Biomedical Imaging and Bioengineering (NIBIB)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute on Drug Abuse (NIDA)
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 Blueprint for Neuroscience Research announces its intention to publish a Funding Opportunity Announcement (FOA) for investigators seeking support from the Blueprint Neurotherapeutics Network for Biologics (BPN-Biologics). Applicants will be encouraged to utilize a customized set of contract resources and consultants from the BPN-Biologics Network to help advance their neuroscience-focused biotherapeutic discovery and development projects into the clinic. This Notice is provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. Details of the planned FOA are provided below.
The FOA is expected to be published in Spring 2021 with an expected application due date in Summer 2021.
The NIH Blueprint for Neuroscience Research is a collaborative framework through which 14 NIH Institutes, Centers and Offices jointly support neuroscience-related research, with the aim of accelerating discoveries and reducing the burden of nervous system disorders (for further information, see http://neuroscienceblueprint.nih.gov/). To facilitate biotherapeutic discovery and development by the neuroscience community, the NIH Blueprint for Neuroscience Research has established the Blueprint Neurotherapeutics Network for Biologics (BPN-Biologics), a collection of contract service providers and consultants with extensive industry experience in the areas of pharmacokinetics, toxicology, manufacturing, and Phase I clinical safety testing.
A planned Funding Opportunity Announcement (FOA) will solicit applications from investigators seeking funding through a UG3/UH3 phased cooperative agreement mechanism to help advance their biologic drug discovery and development projects into the clinic. This FOA will support preclinical discovery and development of potential therapeutic biologics and biotechnology products including, but not limited to, large biologic macromolecules, (e.g., proteins, antibodies, and peptides), gene-based therapies (i.e., oligonucleotide- and viral-based), cell therapies, and novel emerging therapies (e.g., microbial and microbiome therapies). Applicants will collaborate with NIH-funded consultants and can augment their project with NIH contract research organizations (CROs) that specialize in manufacturing, pharmacokinetics, toxicology, and Phase I clinical testing. BPN-Biologics awardee institutions retain their assignment of IP rights and gain assignment of IP rights from the BPN-Biologics contractors (and thereby control the patent prosecution and licensing negotiations) for biotherapeutic candidates developed in this program.
To be eligible for the BPN-Biologics program, an applicant must have identified one or more lead biologic agent(s) with established preliminary in vivo efficacy and target engagement data using the agent(s) in relevant animal model(s).The agent(s) should show in vivo efficacy using clinically relevant outcome measures and in vivo target engagement at the clinically intended site of action. The applicants should have key in vitro and in vivo assays that may be needed for any characterization and/or optimization of the lead biologics.
Projects can enter the BPN-Biologics program during Discovery or Development stages and may seek support through phase I/first-in-human testing. Discovery involves lead characterization and optimization to improve the potency and/or suitability for clinical testing, 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-Biologics Development activities include cGMP manufacturing, toxicology studies, regulatory support, and phase I/first-in-human testing.
The NIH will assemble a customized Lead Development Team (LDT) for each project accepted into the program. The LDT 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 LDT may also include members of the PD/PI's team, NIH-hired consultants with additional expertise, and NIH staff. The LDT will plan and coordinate the work supported by the cooperative agreement award and conducted by BPN-Biologics contractors. All projects that enter the BPN-Biologics program will begin with a UG3 phase during which the LDT will establish 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 as well as webinars. Early contact provides an opportunity for NIH program staff to discuss the program’s scope, entry criteria, and goals and to provide information and guidance on how to develop a competitive application. For additional information on BPN, please see: neuroscienceblueprint.nih.gov.
If you would like to be notified of more details regarding this Notice and registration for future program webinars, make sure to subscribe to the Division of Translational Research Listserv.
Application budgets must reflect the actual needs of the proposed project but should not include the costs of NIH contract resources requested.
The total duration may not exceed 5 years.
Applications are not being solicited at this time.
Please direct all inquiries to:
Ann-Marie Broome, Ph.D., MBA
National Institute of Neurological Disorders and Stroke (NINDS)