Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required)
Funding Opportunity RFA-NS-24-029 from the NIH Guide for Grants and Contracts. The National Institute of Neurological Disorders and Stroke (NINDS) and the Office of the Director, National Institutes of Health (OD), intend to promote a new initiative by publishing a Funding Opportunity Announcement (FOA) to solicit applications for the conduct of scientific research utilizing data from expanded access (EA) to investigational drugs or biological products. These applications will target intermediate size populations of patients living with amyotrophic lateral sclerosis (ALS) who are not otherwise eligible for clinical tria...
Source: NIH Funding Opportunities (Notices, PA, RFA) - November 21, 2023 Category: Research Source Type: funding
Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required)
Funding Opportunity RFA-NS-23-012 from the NIH Guide for Grants and Contracts. The National Institute of Neurological Disorders and Stroke (NINDS) and the Office of the Director, National Institutes of Health (OD), intend to promote a new initiative by publishing a Funding Opportunity Announcement (FOA) to solicit applications for the conduct of scientific research utilizing data from expanded access (EA) to investigational drugs or biological products. These applications will target intermediate size populations of patients living with amyotrophic lateral sclerosis (ALS) who are not otherwise eligible for clinical tria...
Source: NIH Funding Opportunities (Notices, PA, RFA) - January 9, 2023 Category: Research Source Type: funding
Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required)
Funding Opportunity RFA-NS-22-071 from the NIH Guide for Grants and Contracts. The National Institute of Neurological Disorders and Stroke (NINDS) and the Office of the Director, National Institutes of Health (OD), intend to promote a new initiative by publishing a Funding Opportunity Announcement (FOA) to solicit applications for the conduct of scientific research utilizing data from expanded access (EA) to investigational drugs or biological products. These applications will target intermediate size populations of patients living with amyotrophic lateral sclerosis (ALS) who are not otherwise eligible for clinical tria...
Source: NIH Funding Opportunities (Notices, PA, RFA) - May 12, 2022 Category: Research Source Type: funding
IND-enabling Studies of Somatic Genome Editing Therapeutic Leads (U19, Clinical Trial Not allowed)
Funding Opportunity RFA-RM-22-015 from the NIH Guide for Grants and Contracts. This funding opportunity announcement (FOA) is part of a suite of FOAs of the NIH Common Fund Somatic Cell Genome Editing (SCGE) Phase II Program. The goal of this U19 FOA is to support team-based research Projects to accelerate further optimization and development of genome editing-based therapeutic leads towards IND-enabling studies and an IND (Investigational New Drug) application submission to the U.S. Food and Drug Administration (FDA). The proposed leads should demonstrate strong biological rationale and in vitro and/or in vivo proof of...
Source: NIH Funding Opportunities (Notices, PA, RFA) - April 11, 2022 Category: Research Source Type: funding
NIH and FDA Seek Feedback on Clinical Trial Protocol Template
I’d like to call your attention to an opportunity to provide comments on a proposed clinical trial protocol template, developed by the FDA and NIH, and informed by the guidance set forth by the International Conference on Harmonisation (ICH) E6 Good Clinical Practice.
The template provides a standard format, and corresponding instructions and sample text, for NIH-funded investigators to use when preparing protocols for phase 2 or 3 clinical trials that require an Investigational New Drug application (IND) or Investigational Device Exemption (IDE) application. It not only aims to help researchers address key details that ...
Source: NIH Extramural Nexus - March 31, 2016 Category: Research Authors: Mike Lauer Tags: blog Open Mike Clinical Trials FDA General Request For Information (RFI) Source Type: funding
The Effect of Different Preparation Methods on the In Vitro and In Vivo Performance of Solid Dispersion Formulations (U01)
The objective of this study is to investigate the in vitro and in vivo performance for solid dispersion drug products made from different manufacturing processes or polymer carriers, as well as their performance consistency during storage and among batches. The investigation should identify critical process parameters and critical quality attributes for solid dispersion made from different preparation methods, and develop discriminating analytical methods.
Detailed Descriptions:
The following studies should be conducted for the purpose of this project:
(1) Identify model drugs, and prepare amorphous solid dispersion us...
Source: Grants.gov - April 18, 2014 Category: Research Tags: Health Science and Technology and other Research and Development Source Type: funding
Pharmacometric Modeling and Simulation for Generic Drugs Evaluation
The objectives of this project are to develop quantitative models for generic drugs evaluation in the following areas:
1. Population pharmacokinetic and pharmacodynamic, dose-efficacy, and dose-toxicity modeling and simulation for narrow therapeutic index (NTI) drugs. The goal is to develop models and modeling approaches that will help FDA classify drugs as having a narrow therapeutic index and identify those products that have a clinical use profile that requires tighter control of product quality and equivalence attributes.
2. Pharmacometric modeling and simulation for generic drug substitutability evaluation and pos...
Source: Grants.gov - March 28, 2014 Category: Research Tags: Health Science and Technology and other Research and Development Source Type: funding
ISCTR-American College of Cardiology Foundation Cardiovascular Translational Research Scholarship
sponsored by Dignity Health, St. John's Hospital The purpose of the program is to recognize and provide financial support for research efforts by outstanding cardiovascular scholars. This scholarship is to encourage junior faculty in the early phases of their careers in the field of cardiology. The program is intended for a physician with a strong interest in developing a career in cardiovascular translational research. One year of previous interventional cardiology training is required. The duration of the program is one year. The awardee will develop skills and expertise in translating basic biological a...
Source: ScanGrants feed - May 6, 2013 Category: Research Authors: International Society for Cardiovascular Translational Research/American College of Cardiology Foundation Source Type: funding
