Preclinical Screening Platform for Pain

Overview

The Research Need

The Federal Pain Research Strategy identified an urgent need to reduce reliance on prescription opioid medications through the development of new, non-opioid pharmacologic and non-pharmacologic treatments for pain. This critical need aligns with the Helping to End Addiction Long-termSM Initiative, or NIH HEAL InitiativeSM, goal to accelerate the discovery and preclinical development of non-addictive pain treatments for the more than 25 million Americans who live with daily chronic pain and rely on opioid medications for pain management.

About the Program

Within the NIH HEAL Initiative, the National Institute of Neurological Disorders and Stroke (NINDS) created the Preclinical Screening Platform for Pain (PSPP) to identify and profile non-addictive therapeutics for pain. 

The PSPP is an efficient, rigorous, one-stop screening resource to accelerate discovery of effective, non-addictive pain therapies. The program offers testing including an assessment of in vitro and pharmacokinetic profiles, side effect profiles, abuse liability, and efficacy in models relevant to human pain conditions.

An External Consultant Board provides independent input and guidance on scientific and strategic priorities and implementation, including input on selecting new models, developing and monitoring screening flows, prioritizing targets and mechanisms for interrogation, and establishing milestones for program progress.

Read a detailed introduction to the PSPP and its role in the NIH HEAL Initiative.

Program Details

To date, through the Helping to End Addiction Long-termSM Initiative, or NIH HEAL InitiativeSM, NIH has awarded approximately $44 million to support the PSPP.

The PSPP is accepting assets, including small molecules, biologics, devices, and natural products, for evaluation on an ongoing basis.

NIH staff assess the suitability of assets for acceptance into the PSPP and direct the preclinical testing of submitted assets, which contract facilities perform in a blinded manner at no cost to PSPP participants. All testing is done under a defined participant agreement that ensures confidentiality and intellectual property (IP) protection.

Testing Services

Evaluation of a submitted compound for suitability for testing in the PSPP begins with an assessment of the proposed scientific rationale. Accepted agents are evaluated in assays whose sequence is described in specific flow charts. NINDS PSPP staff consult with participants at each stage of evaluation. The PSPP provides participants with feedback on results and recommends next steps in the process.

How to Participate

The PSPP is accepting compounds for evaluation continuously. Researchers from academia and industry in the United States or abroad are eligible to submit compounds for screening. A signed confidentiality agreement between NINDS and each potential participant is required before the potential participant submits compounds for evaluation.

To start the process, those interested in participating should contact Smriti Iyengar, Ph.D., for more information and to discuss research goals, resources and timelines. For compounds approved for testing in the program, initial evaluation is normally performed using in vitro assays and rat pharmacokinetic studies. The amount of compound required for subsequent testing in pain models will vary depending on the expected dose range. The program will provide directions for packaging and compound submission before sample shipment.

Confidentiality

NINDS recognizes the importance of confidentiality to the success of the PSPP and its participants. Participation in the PSPP begins only after the appropriate representatives from both the participant's organization and NINDS sign the participant agreement. This document defines the legal parameters for the partnership. All screening and other communication activities are performed in strict confidence to allow participants to retain IP. Chemical structures are considered proprietary unless otherwise specified by the supplier. The only testing undertaken by the PSPP is that agreed upon by participants in collaboration with PSPP personnel. To further ensure confidentiality, the PSPP assigns each newly submitted compound a unique number code to be used in communications, tracking, and analysis. Screening personnel are blinded to both the structure and the source of submitted compounds, and the PSPP provides screening results exclusively to the participating supplier unless otherwise authorized.

Resources

  • NCATS has established a complementary in vitro screening platform for testing of therapeutic candidates for pain in non-animal models.