BPN-Biologics Participating Institutes and Contacts

Institute specific interests are briefly described below, whereas more detailed descriptions can be found within the BPN-Biologics notices of funding opportunities. Interested applicants are highly encouraged to contact NIH Scientific/Research staff for more information about this program before submitting an application.

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The National Center for Complementary and Integrative Health (NCCIH) 
Contact: Hye-Sook Kim, PhD
NCCIH is interested in projects focused on development of novel biologic therapies that involve natural product-derived components. These may include microbial-based interventions such as probiotics and live biotherapeutic products (LBP) and macromolecular natural products such as peptides and toxins from marine and terrestrial plants, animals, and microbes. The NCCIH interest in BPN Biologics is to modulate symptoms of nervous system disorders such as chronic pain, stress, sleep disorders, anxiety disorders, mild depression and to manage symptoms associated with nervous system disorders. Investigators are strongly encouraged to discuss their research plans with the NCCIH Scientific/Research contact prior to submitting their applications.

The National Eye Institute (NEI)
Contact: Paek Lee, PhD; Tony Gover, Ph.D.
NEI’s interest in BPN-Biologics is to develop novel therapies to treat diseases and disorders of the visual system, especially blinding eye diseases such as glaucoma, age-related macular degeneration, retinitis pigmentosa and other conditions of the visual nervous system.  Each project should have a well-defined endpoint, achievable within a five-year time frame, for developing a treatment for a specific disease or disorder of the visual system. The steps towards this goal should be clearly delineated in a series of milestones that support the development of a novel therapeutic.  If successful, a project funded under this program may lead to filing an IND application to the FDA. Investigators are encouraged to contact NEI program staff to discuss potential research projects prior to application submission to determine alignment of the planned studies with priorities of the Institute.

The National Institute on Aging (NIA)  
Contact: Shreaya Chakroborty, PhD 
NIA is interested in projects that will provide drug development expertise and infrastructure support to researchers interested in developing new biologics aimed at modifying the behavioral symptoms in Alzheimer's disease (AD), delaying the onset or slowing the progression of AD, mild cognitive impairment (MCI), other dementias of aging and age-related cognitive decline. Researchers who may have the necessary drug development expertise and access to infrastructure to advance small molecules to the clinic should consider submitting an application to the Alzheimer's Drug Development Program (PAR-22-047). Regarding therapeutic approaches, NIA is interested in traditional biotherapeutic modalities such as gene, peptide/protein-based, cell-based and immunotherapies and other modalities such as genome editing, gene silencing, and PROTAC. NIA and the AD scientific community recognize that one of the major challenges to the successful development of drugs for AD is the poor translation of preclinical efficacy from AD animal models to the clinic. Meta analyses of preclinical studies indicate that a key factor contributing to the poor predictive power of AD animal models is the lack of standards in the design, conduct, and data analyses. Studies using animal models presented to justify the choice of therapeutic target, drug candidate or to determine efficacy must be in compliance with NIH guidance on rigor and reproducibility. In particular, investigators proposing animal model studies are expected to follow the general ARRIVE guidelines for rigorous animal research and the best practices guidelines for AD preclinical efficacy studies. These studies should include a power analysis and associated assumptions for the determination of sample size, statistical handling of the data (such as criteria for data inclusion or exclusion), procedures used for blinding and randomization, and whether studies were balanced for sex and were replicated.

For investigators who plan to submit a grant application with direct costs greater than or equal to $500,000 in any one year, NIH requires that they seek prior approval from its relevant institute or center. Approval must be sought in the form of an Awaiting Receipt of Application (ARA) at least six weeks prior to submission. PIs requesting approval for an ARA should contact the NIA Scientific/Research Contact 10 weeks earlier than the ARA submission due date to obtain assistance in submitting an ARA.

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Contact: Qi-Ying Liu, MD, MSci
NIAAA is interested in research aimed to develop pharmaceuticals targeting new molecular sites to provide effective therapy for alcohol use disorder. Recent research has discovered specific genetic variants that may contribute to the risk for alcoholism and/or render individuals with alcohol use disorder responsive to specific therapeutic agent. NIAAA is interested in supporting research to develop pharmaceuticals targeting individuals with identified genotypic and phenotypic characteristics to improve efficacy and safety.

National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Contact: Guoying Liu, PhD

National Institute on Drug Abuse (NIDA)
Contact: Jason Sousa, PhD
NIDA aims to provide drug development expertise and infrastructure to support addiction researchers interested in developing new biotherapeutics for substance use disorders (SUD). Projects focused on cocaine, methamphetamine and marijuana use disorders are of high priority for NIDA because there are currently no FDA-approved treatments for these indications. NIDA will only support projects to develop innovative pharmacological approaches entering the BPN-Biologics at the Discovery stage.

National Institute of Dental and Craniofacial Research (NIDCR)
Contact: Melissa Ghim, PhD
NIDCR is interested in BPN Biologics development for craniofacial disorders and painful disorders of the orofacial region including temporomandibular joint disorders, trigeminal neuropathies, burning mouth syndrome, oral cancer pain, dental pain and other conditions.

National Institute of Environmental Health Sciences (NIEHS)
Contact: Jonathan Hollander, PhD

The National Institute of Mental Health (NIMH)
Contact: Enrique Michelotti, PhD
NIMH supports neuroscience research to discover the causes of mental illness and to develop more effective and safe treatments. NIMH has interest in applications proposing the development of biologics as an approach for the treatment of mental disorders, including treatment-resistant depression, bipolar disorder, schizophrenia, PTSD, and autism spectrum disorder.

Researchers with expertise and interest in advancing small molecules to the clinics should consider submitting an application to the BPN-small molecules Program (PAR-24-043) and PAR-24-063), small molecules projects at the early clinical trials phase should consider the NIMH SBIR/STTR Programs, and NIMH also Support for Clinical Trials. Investigators interested in the development of small molecule projects are also encouraged to review the following NIMH drug discovery FOAs: Drug Discovery for Nervous System Disorders PAR-22-031 (R01) and PAR-22-032 (R21), Assay development and screening for discovery of chemical probes or therapeutic agents PAR-23-168 (R01), Discovery of in vivo Chemical Probes for Novel Brain Targets PAR-24-088 (R01), National Cooperative Drug Discovery/Development Groups (NCDDG) for the Treatment of Mental Disorders, Drug or Alcohol Addiction PAR-22-143 (U01) and PAR-22-144 (U19). For this initiative, NIMH will only support projects entering the BPN-Biologics at the Discovery stage, specifically, programs in the lead optimization stage. Investigators are strongly encouraged to discuss their research plans with NIMH Scientific/Research contact prior to submission to determine alignment of the planned studies with NIMH priorities and to assess whether this or other NIMH funding opportunities are most appropriate.

Consistent with NIMH's Research Domain Criteria (RDoC) initiative, research projects directed towards ameliorating pathophysiology that is potentially more proximal to specific functional deficits (domains) than DSM diagnostic entities are encouraged. Additional information about the RDoC approach can be found at the RDoC website.

High-quality and reproducible studies that are reported to the scientific community in a transparent manner are an essential cornerstone of the research enterprise. Attention to principles of study design and transparency are essential to enable reviewers, the scientific community, and NIH to assess the quality of scientific findings. In support of this important goal, investigators must follow instructions to address Rigor and Reproducibility (http://grants.nih.gov/reproducibility/index.htm)

NIMH has published a Note with guidelines and priorities for potential applicants considering animal neurobehavioral approaches in research relevant to mental illnesses, investigators are strongly to follow the guidelines summarized at NOT-MH-19-053 if proposing to include behavioral measures.

Further information on NIMH research priorities can be found in the NIMH Strategic Research Plan and Interventions Workgroup Report. Applicants are strongly encouraged to discuss applications with NIMH staff listed in Section VII - Agency Contact(s)Scientific/Research Contacts.

National Institute of Neurological Disorders and Stroke (NINDS)   
Contact: Dr. Chris Boshoff
NINDS aims to support discovery and development of biologic drugs relevant to its mission. Examples of diseases relevant to the research mission of the NINDS.

National Institutes of Health Office of Behavioral and Social Sciences Research (OBSSR)
Contact: William Riley, PhD