Key Dates

Related Announcements

May 07, 2020 - NIH Small Research Grant Program (Parent R03 Clinical Trial Not Allowed). See NOFO PA-20-200

May 07, 2020 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed). See NOFO PA-20-195

May 07, 2020 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required). See NOFO PA-20-194

May 07, 2020 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Basic Experimental Studies with Humans Required). See NOFO PA-20-196

May 05, 2020 - NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed). See NOFO PA-20-185

May 05, 2020 - NIH Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required). See NOFO PA-20-184

May 05, 2020 - NIH Research Project Grant (Parent R01 Clinical Trial Required). See NOFO PA-20-183

Issued by

National Institute on Drug Abuse (NIDA)

Purpose

This notice intends to inform potential applicants about a special interest in supporting research on the application of Model-informed Drug Development (MIDD) approaches for developing medications to treat substance use disorders (SUDs).

Background

Due to the limited availability of approved medications, there is an urgent need for effective therapeutics for SUDs. Drug development often involves an expensive and time-consuming process. MIDD approaches have evolved as a promising strategy to streamline the drug development process. MIDD uses data-driven and model-based approaches to support informed decision-making in drug development. Therefore, MIDD approach has the potential to speed up the drug development process and reduce the failure rate in drug development pipeline. The industry, academia, and regulatory agencies have made a collective effort to develop and apply many MIDD concepts/tools including physiologically based biopharmaceutics models, population pharmacokinetics (popPK) models. The physiologically-based pharmacokinetic model typically uses both drug-specific information (drug model) and patient physiology information (physiology model) to predict drug PK and assist first-in-human clinical study design, predict drug-drug interactions, and predict drug exposure in patients with organ impairment. popPK can investigate the drug PK variability among different subgroups of a population to support drug development and guide the design of individualized treatment plans for specific patient subgroups. It is expected that MIDD will play an increasing role in drug development and regulatory decision-making processes. The MIDD approaches have been successfully used to facilitate the development and approval of medications for treating SUDs (e.g., 3 mg nalmefene intranasal spray, 10 mg naloxone autoinjector). For the nalmefene intranasal spray, popPK and PK/PD modeling supported the extrapolation of its adult PK to the pediatric population (age 12-18) and supported its use in the pediatric population. Therefore, the MIDD approach can facilitate the development of medications for SUDs throughout the lifecycle of drug development including drug discovery, preclinical study, and clinical trial. MIDD can streamline the drug development process, reduce uncertainty, and increase the success of regulatory approval and clinical use. Moreover, MIDD will also support the design of precision medicines or personalized treatment plans for special patient sub-populations and reduce health disparity.

Research Questions

This Notice of Special Interest (NOSI) encourages, but is not limited to, research applications in the following areas:

Use MIDD approaches to:

• Predict drug toxicology profile, pharmacokinetics, ADME, biopharmaceutical properties, and drug-drug interactions.
• Assist in pre-formulation studies, formulation design and optimization.
• Optimize clinical trial design through modeling and simulation to increase the success rate.
• Support efficacy extrapolation in a new patient population, the use of different routes of administration, a new dosage form, and a new dose regimen.
• Develop precision medicines or personalized treatment plans for special patient sub-populations. 

Application and Submission Information

This notice applies to due dates on or after June 5, 2025, and subsequent receipt dates through September 8, 2028. 

Submit applications for this initiative using one of the following notice of funding opportunity (NOFO) or any reissues of these announcements through the expiration date of this notice.

• PA-20-200 – NIH Small Research Grant Program (Parent R03 Clinical Trial Not Allowed)
• PA-20-194 – NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required) 
• PA-20-195 – NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed)
• PA-20-196 – NIH Exploratory/Developmental Research Grant Program (Parent R21 Basic Experimental Studies with Humans Required)
• PA-20-183 – NIH Research Project Grant (Parent R01 Clinical Trial Required)
• PA-20-184 – NIH Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required)
• PA-20-185 – NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed) 

All instructions in the How to Apply - Application Guide and the NOFO used for submission must be followed, with the following additions:

• For funding consideration, applicants must include “NOT-DA-26-002” (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.

Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.

Inquiries

Please direct all inquiries to the Scientific/Research, Peer Review, and Financial/Grants Management contacts in Section VII of the listed notice of funding opportunity.

Scientific/Research Contact(s)

Feng Li, Ph.D.
Division of Therapeutics and Medical Consequences (DTMC)
National Institute on Drug Abuse (NIDA)
Telephone: 301-480-1830
Email: lif10@nih.gov