Other NIH Programs for Translational Neuroscience that Support Biologics

Funding for Assay Development and Screening

  • PAR-21-124: Innovation Grants to Nurture Initial Translational Efforts (IGNITE): Assay Development and Neurotherapeutic Agent Identification (R61/R33 Clinical Trial Not Allowed).

​​This program supports 3-year R61/R33 for development of in vitro and/or ex vivo assays and conduct iterative screening efforts to identify and characterize potential neurotherapeutic agents.

Participating Institutes: NINDS, NCCIH.

  • RFA-NS-21-029: HEAL Initiative: Planning Studies for Initial Analgesic Development [Small Molecules and Biologics] (R61 Clinical Trial Not Allowed).

This 2-year program supports planning projects that are designed to build a strong research team and conduct studies to establish feasibility, validity, or other technically qualifying results that support, enable, and/or lay the groundwork for a subsequent U19 application to RFA-NS-22-052.

Participating Institutes: NINDS, NEI, NIA, NIAAA, NIAMS, NICHD, NIDCR, NIMH, NCCIH, NHLBI.

  • RFA-NS-22-052: HEAL Initiative: Team Research for Initial Translational Efforts in Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] (U19 Clinical Trial Not Allowed).

This program supports pain-related projects to develop assays, conduct screening and early optimization work followed by pharmacokinetic, pharmacodynamic, and in vivo efficacy studies to demonstrate that proposed therapeutic agent(s) have sufficient biological activity to warrant further development and, ideally, advance a hit or lead asset to the point where it can meet the entry criteria for RFA-NS-21-010.

Participating Institutes: NINDS, NEI, NHLBI, NIA, NIAMS, NICHD, NIDCR, NCCIH, NCI.

  • RFA-NS-20-009: HEAL Initiative: Development of Therapies and Technologies Directed at Enhanced Pain Management (R41/R42 Clinical Trial Not Allowed),
  • RFA-NS-20-011: HEAL Initiative: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 - Clinical Trial Not Allowed).

Participating Institutes: NINDS, NEI, NHLBI, NIA, NIAAA, NIAMS, NIBIB, NICHD, NIDCR, NIDDK, NIGMS, NIMH, NINR, NIMHD, NLM, NCCIH, NCATS, OPIP, NCI.

Funding for Preclinical Proof-of-Concept

  • PAR-21-122: Innovation Grants to Nurture Initial Translational Efforts (IGNITE):

Neurotherapeutic Agent Characterization and In vivo Efficacy Studies (R61/R33 Clinical Trial Not Allowed).

Support 3-year R61/R33 to conduct pharmacodynamic, pharmacokinetic, and in vivo efficacy studies to demonstrate that proposed therapeutic agent(s) have sufficient biological activity to warrant further development.

Participating Institute: NINDS.

  • Drug Discovery for Nervous System Disorders, Clinical Trials Not Allowed:

PAR-19-147 (R01),  PAR-19-146 (R21).

Participating Institutes: NIMH, NIA, NIAAA, NIDA.

Funding for Translational Model Development

PAR-21-123: Innovation Grants to Nurture Initial Translational Efforts (IGNITE): Development and Validation of Model Systems to Facilitate Neurotherapeutic Discovery (R61/R33 Clinical Trial Not Allowed).

Supports development and validation of animal models and ex vivo systems that recapitulate the phenotypic and physiologic characteristics of a defined neurological or neuromuscular disorder.

Participating Institute: NINDS.

Funding for Preclinical/Clinical Development

URGenT supports the development of gene-based therapies for ultra-rare neurological diseases (affecting 1 in 50,000 people, or fewer). The funding and resources would be provided to advance a lead gene therapy candidate from late-stage pre-clinical development into first-in-human clinical testing over a 3-year period from start-to-finish.

PAR-22-030: Translational Efforts to Advance Gene-based Therapies for Ultra-Rare Neurological and Neuromuscular Disorders (U01 - Clinical Trial Optional),

PAR-22-028: Ultra-Rare Gene-based Therapy (URGenT) Network Resource Access (X01, Clinical Trial Not Allowed).

Participating Institute: NINDS.

The PTDP is a part of the Helping to End Addiction Long-term® (HEAL) Initiative ®,a trans-NIH research effort focused on improving prevention and treatment for opioid misuse and addiction and enhancing pain management. The PTDP supports preclinical optimization and development of safe, effective, and non-addictive small molecule and biologic therapeutics to treat pain. This is a milestone-driven phased cooperative agreement grant involving participation of NIH program staff and consultants in the development of the project plan and monitoring of research progress.

RFA-NS-21-010: HEAL Initiative: Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Optional).

This program is to support preclinical optimization and development of safe, effective, and non-addictive small molecule and biologic therapeutics to treat pain. The scope of this program includes optimization and early development activities, Investigational New Drug (IND) - enabling studies, development of a pharmacodynamic/target engagement biomarker, assembly and filing of an IND application and Phase I clinical testing.

Participating Institutes: NINDS, NEI, NIAAA, NIAMS, NICHD, NIDCR, NIDDK, NIDA, NCCIH, NHLBI, and ORWH.

RFA-NS-20-008HEAL Initiative: Development of Therapies and Technologies Directed at Enhanced Pain Management (R41/R42 Clinical Trial Required),

RFA-NS-20-010: HEAL Initiative: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 Clinical Trial Required)

Participating Institutes: NINDS, NEI, NHLBI, NIA, NIAAA, NIBIB, NICHD, NIDDK, NIGMS, NIMH, NINR, NIMHD, NCCIH, NCI, NIAMS.

  • National Cooperative Drug/Device Discovery/Development Groups (NCDDG) for the Treatment of Mental Disorders or Alcohol Use Disorder.

The program supports up to 5 years of funding for multidisciplinary teams, Public Private Partnerships.

PAR-22-143 (U01 Clinical Trial Optional),

PAR-22-144 (U19 Clinical Trial Optional)

Participating Institutes: NIMH, NIAAA.

  • Investigational New Drug (IND)-enabling and Early-Stage Development of Medications to Treat Alcohol Use disorder and Alcohol-Associated Organ Damage).

The program supports up to 2 years for Phase I and up to 3 years for Phase II may be requested. Budgets up to $1.0M total costs per year for Phase I and up to $1.5 total costs per year for Phase II may be requested.

PAR-22-103 (UT1/UT2 Clinical Trial Optional, STTR),

PAR-22-102 (U43/U44 Clinical Trial Optional, SBIR).

Participating Institute: NIAAA.

  • Grand Opportunity in Medications Development for Substance-Use Disorders (U01 - Clinical Trial Optional)

PAR-19-327  is to accelerate the development of medications for the treatment of substance use disorders (SUDs) by encouraging research applications to support a diverse array of preclinical and/or clinical research projects. Up to 3 years of funding, milestone-driven, up to $5M per year.

Participating Institute: NIDA.

  • Alzheimer's Drug-Development Program (U01 Clinical Trial Optional)

PAR-22-047 is to provide funding support for the pre-clinical and early stage clinical (Phase I) development of novel small-molecule and biologic drug candidates that prevent Alzheimer's disease (AD), slow its progression, or treat its cognitive and behavioral symptoms. Up to 5 years of funding, milestone-driven, up to $1M per year.

Participating Institute: NIA.

Services:

  • Services for Pharmacology

Epilepsy Therapy Screening Program (ETSP)

Support: Screens compounds in animal seizure models

To apply: contact Brian Klein, Ph.D.

  • Addiction Treatment Discovery Program (ATDP)

Support: Screens compounds in animal models of addiction

To apply: contact David White, Ph.D., (301) 443-8889

Services for Toxicology

Support: Provides synthesis, formulation, pharmacokinetic and toxicology expertise and resources to its collaborators and is open to any disease.

To apply: contact National Center for Advancing Translational Sciences NCATS personnel for more information.

  • NIDA Toxicology Program

Support: Provides IND-directed toxicology services for substance abuse indications.

To apply: contact Nathan M. Appel, Ph.D., (301) 443-8475

  • Regulatory Affairs Assistance for Medications Development

Support: Provides consultation and advice on regulatory requirements

Participating Institute: NIDA

To apply: contact Robert Walsh, R.A.C.

BPN-Biologics Staff

Program Director
Dr. Chris Boshoff

Health Program Specialists
Ms. Shruthi Thomas

 

Project Managers

Ms. Elena Barnaeva
Ms. Sonia Gales

Operations Coordinator
Ms. Natasha Davis

CONTACT US