Funding Opportunity PAR-22-169 from the NIH Guide for Grants and Contracts. The overall goal of this initiative is to identify neurophysiological measures potential assays for treatment development research. The funding opportunity announcement (FOA) will support efforts to optimize and evaluate measures of neurophysiological processes that are disrupted within or across mental disorders in both healthy humans and in another species relevant to the therapeutic development pipeline. The initiative will support initial proof of concept studies aimed at identifying measures for potential development as preclinical assays for evaluating potential new drug and device therapies and their targets. Data will also reveal assay measures where the performance between preclinical animal species and humans is dissimilar, thus establishing a firm basis for limiting speculative extrapolations of preclinical animal findings to humans. The ultimate practical goal of this FOA is to improve the efficiency of the therapeutic development process by identifying coherence of measures and inconsistencies between the preclinical screening pipeline and clinical evaluation of new treatment candidates and thereby hasten the development of more effective treatments for mental disorders.

Funding Opportunity PAR-22-170 from the NIH Guide for Grants and Contracts. The overall goal of this Funding Opportunity Announcement (FOA) is to identify, in animals, in vivo neurophysiological and behavioral measures for use as assays in the early screening phase of treatment development. The FOA will support efforts to optimize and evaluate measures of neurophysiological and behavioral processes that may serve as surrogate markers of neural processes of clinical interest based on available knowledge of the neurobiology of mental illnesses. The screening assays thus developed from this FOA are expected to build upon systems neurobiology and clinical neuroscience to enhance the scientific value of preclinical animal data contributing to a therapeutic development pipeline by assessing the impact of therapeutic targets and treatment candidates on neurobiological mechanisms of clinical relevance to mental illnesses.

Funding Opportunity RFA-HL-23-020 from the NIH Guide for Grants and Contracts. The National Institutes of Health (NIH) participating Institutes and Centers, in coordination with the U.S. Food and Drug Administration (FDA) support the Regenerative Medicine Innovation Project (RMIP), which aims to explore and enable the development of safe and effective regenerative medicine (RM) interventions using adult stem cells. Before a research team undertakes a clinical trial, it is critical to have clear delineation and documentation of the trials rationale, design, analytic techniques, protocols, and procedures in a Manual of Procedures (MOP). Additionally, there are other elements essential to the launching of a trial, such as obtaining regulatory authorizations or approvals and establishing agreements with requisite partners including cell manufacturing and production facilities, assay or cell analysis centers, and data coordinating centers. These activities are often costly and time-consuming, and they may involve collection of preliminary data to assess feasibility. Applicants may use the RMIP Clinical Trial Planning Grant to support the preparation of a clinical trial MOP and procedures necessary for implementing a clinical trial to evaluate interventions (or new treatments) that explore and enable the evaluation of the safety and/or efficacy of RM interventions using adult stem cells that are not of embryonic or fetal origin. Due to the complex nature of requirements in this FOA (e.g., 1:1 matching funds, resource sharing), applicants are strongly encouraged to communicate with the appropriate NIH Scientific/Research Contact and review online Frequently Asked Questions (FAQs) prior to submitting an application. Staff will be able to advise applicants in determining if their research meets the requirements and objectives of this FOA.

Funding Opportunity RFA-HL-23-019 from the NIH Guide for Grants and Contracts. The National Institutes of Health (NIH) participating Institutes and Centers, in coordination with the U.S. Food and Drug Administration, invite cooperative agreement (U01) applications to support investigator- initiated clinical research studies aimed at furthering the field of regenerative medicine (RM) using adult stem cells. This Funding Opportunity Announcement (FOA), issued as part of the Regenerative Medicine Innovation Project (RMIP), represents one step in fulfilling a statutory provision set forth in the 21st Century Cures Act. Applications are expected to focus on innovative projects that propose solutions to widely recognized issues in the development of safe and effective RM therapies. Emphasis will be given to projects that address critical issues in product development relevant for regulatory submissions. Areas of focus may include improved tools, methods, standards, or applied science that support a better understanding and improved evaluation of in-depth product characterization, manufacturing, potency, identity, quality, safety, in vivo function and integration, or effectiveness. Toward these ends, the NIH will consider applications for late-stage preclinical research studies involving adult stem cells in the context of generating or supplementing the necessary evidence for clinical development, including, but not limited to, the submission of an Investigational New Drug (IND) or Investigational New Device Exemption (IDE) package; or to support such research conducted under an authorized IND or IDE. Due to the complex nature of requirements in this FOA (e.g., 1:1 matching funds, resource sharing), applicants are strongly encouraged to communicate with the appropriate NIH Scientific/Research Contact and review online Frequently Asked Questions (FAQs) prior to submitting an application. Staff will be able to advise applicants in determining if their research meets the requirements and objectives of this FOA.

Funding Opportunity RFA-HL-23-017 from the NIH Guide for Grants and Contracts. The National Institutes of Health (NIH) participating Institutes and Centers, in coordination with the U.S. Food and Drug Administration (FDA), seek highly meritorious clinical trial applications proposing to explore and enable the development of safe and effective regenerative medicine (RM) interventions using adult stem cells. This Funding Opportunity Announcement (FOA), issued as part of the Regenerative Medicine Innovation Project (RMIP), represents one step in fulfilling a statutory provision set forth in the 21st Century Cures Act. Applications submitted in response to this bi-phasic, milestone-driven cooperative agreement FOA are expected to propose highly innovative projects with a focus on solutions to widely-recognized issues in the development of safe and effective RM therapies. Of particular interest are projects using RM products that have undergone appropriate product development and pre-clinical studies and have demonstrated readiness to advance into clinical trials. This FOA seeks Phase I and beyond clinical trial applications that present a strong scientific rationale for the proposed clinical trial and a comprehensive scientific and operational plan. Trials must be relevant to the research mission of one or more participating NIH Institutes and Centers and meet the NIH definition of a clinical trial (see NOT-OD-15-015). Applications will be required to include plans for project management, participant recruitment and retention, performance milestones, conduct of the trial, and dissemination of results. Before the time of award and if applicable, successful applicants must obtain an Investigational New Drug (IND) authorization or Investigational New Device Exemption (IDE) approval to administer the product to humans.

Notice NOT-CA-22-102 from the NIH Guide for Grants and Contracts

Funding Opportunity PAR-22-213 from the NIH Guide for Grants and Contracts. This FOA allows for applications that propose large-scale, complex research projects with multiple highly integrated components focused on a common research question relevant to aging. Such projects will likely involve an integrated multidisciplinary team of investigators within a single institution or a consortium of institutions.

Notice NOT-HL-22-027 from the NIH Guide for Grants and Contracts

Funding Opportunity RFA-HL-23-015 from the NIH Guide for Grants and Contracts. The purpose of the initiative is to utilize the cohort study design to address key population research gaps in the health of Asian Americans (AsA), Native Hawaiians, and Pacific Islanders (NHPI). This FOA is for clinical/community field centers (CCFCs), and a companion one will solicit for the coordinating center (CC).

Funding Opportunity RFA-HL-23-016 from the NIH Guide for Grants and Contracts. The purpose of the initiative is to utilize the cohort study design to address key population research gaps in the health of Asian Americans (AsA), Native Hawaiians, and Pacific Islanders (NHPI). This FOA is for the coordinating center (CC), and a companion one will solicit for clinical/community field centers (CCFCs).

Notice NOT-GM-22-036 from the NIH Guide for Grants and Contracts

Notice NOT-GM-22-040 from the NIH Guide for Grants and Contracts

Notice NOT-OD-22-157 from the NIH Guide for Grants and Contracts

Notice NOT-AG-22-025 from the NIH Guide for Grants and Contracts

Notice NOT-MH-22-235 from the NIH Guide for Grants and Contracts

Create and use scripting tools to perform a variety of bioinformatic/computational analyses. Perform data aggregation, integration and analysis.
From Arrowhead Pharmaceuticals - Wed, 06 Jul 2022 23:37:37 GMT - View all Madison, WI jobs

Skilled in the use of bioinformatics tools for antibody repertoire sequence and structure analyses. Present research findings to project teams and governance…
From Arrowhead Pharmaceuticals - Wed, 06 Jul 2022 23:37:36 GMT - View all Madison, WI jobs

Notice NOT-OD-22-171 from the NIH Guide for Grants and Contracts

Funding Opportunity PAR-22-209 from the NIH Guide for Grants and Contracts. This Funding Opportunity Announcement (FOA) solicits applications for the early-stage development of therapeutics to mitigate the adverse health effects resulting from toxic chemical exposure. Chemical threats are toxic compounds that could be used in a terrorist attack or accidentally released from industrial production, storage or shipping. They include specific chemical warfare agents, toxic industrial chemicals, pesticides, and pharmaceutical-based agents. The overall scope of this solicitation includes validation of therapeutic targets and preclinical characterization of lead compounds. The UG3 phase of this FOA supports target validation and characterization of initial lead compound(s); UH3 phase activities include candidate optimization and in vivo demonstration of activity and efficacy in relevant post-exposure models. At the conclusion of the overall UG3/UH3 funding period, projects are expected to deliver at least one well-characterized therapeutic candidate.

Notice NOT-OD-22-170 from the NIH Guide for Grants and Contracts