Preclinical Screening Platform for Pain (PSPP)

Overview

The Preclinical Screening Platform for Pain (PSPP) program facilitates the identification of potential non-opioid, non-addictive treatments (small molecules, biologics, natural products, or devices) for acute and chronic pain conditions. PSPP accepts assets for evaluation from academic researchers, industry, including small businesses, and government institutions worldwide. Under NINDS direction, preclinical evaluation of accepted assets is performed by contract facilities on a blinded and confidential basis and at no cost to the PSPP participants.

Rationale

More than 25 million Americans live with daily chronic pain and lack effective and safe non-opioid options for pain management. The 2017 Federal Pain Research Strategy strongly supported the development of safer new, non-opioid analgesics. Research offered by the PSPP will be a key step in transitioning NIH HEAL Initiative preclinical programs into clinical programs, directly aligned with the HEAL Initiative goal of “accelerating the discovery and pre-clinical development of non-addictive pain treatments.”    

Description of Evaluation

The PSPP program uses a tiered approach to evaluate assets. Tier 1 focuses on ruling out opioid activity, assessing potential abuse liability, and identifying undesirable off-target activity profiles using in vitro screens. Assets without opioid receptor activity continue into pharmacokinetic studies to inform dose range and assessment times for subsequent in vivo evaluation. Within Tier 2, assets are first evaluated in assays designed to determine neurological side effects. Assets then continue to evaluation in acute to sub-chronic and chronic / persistent pain models. Given efficacy in Tier 2, assets are further profiled in Tier 3 using disease specific models and are evaluated for in vivo abuse liability.

NINDS PSPP program staff work collaboratively with the asset owner at each step to plan evaluation, provide results, and discuss next steps.

How to Participate

PSPP accepts compounds for evaluation continuously on an ongoing basis. Researchers from academic institutions, industry, and government institutions worldwide are eligible to apply for considerations of assets for evaluation. Following an introductory call, where an interested asset owner discusses their interest in the program, and with mutual agreement to move ahead, a signed confidentiality agreement between the NINDS and each potential participant is required and executed before an in-depth confidential discussion and acceptance of assets for evaluation.

To apply for consideration, those interested in participating should contact Smriti Iyengar, Ph.D., Program Director, for more information and to discuss research goals, resources, and timelines. 

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 the 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 the participant to retain intellectual property. Chemical structures are considered proprietary unless otherwise specified by the supplier. To further assure confidentiality, each newly submitted asset is assigned a unique PSPP number code to be used in communications, tracking, and analysis. The contract facility is blinded to assets and asset owners, and results are provided exclusively to the asset owner unless otherwise authorized.

External Consultant Board

The individual members of the Preclinical Screening Platform for Pain (PSPP) External Consultant Board (ECB) will provide independent input and oversight on strategy 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. As a link to the pain research community, the ECB will help the program to be more proactive in making adjustments and maintaining relevance as a unique community resource. The membership of this group should allow for some consistency over time as well as for ad hoc participation of individuals with expertise appropriate for specific programmatic matters.  Learn More

PSPP is Complementary with Other HEAL Initiative Therapeutic Development Programs

This platform will be a resource to academic, industry, and government asset owners to profile promising non-opioid, non-addictive therapeutics for pain. Asset owners are encouraged to contact the PSPP program for consideration.

Therapeutics that successfully ‘graduate’ from the PSPP (i.e., are shown to be effective in preclinical models of pain and lack abuse liability) will be better-positioned to benefit from other funding opportunities and utilize other  resources provided by NINDS, including PTDP, SBIR, and EPPIC-Net

 

Resources and Tools

Contacts

Smriti Iyengar, PhD | Program Director
smriti.iyengar@nih.gov

Sarah Woller, PhD | Program Manager
sarah.woller@nih.gov

News & Events

 

 

The ETSP is an NINDS-funded screening program for identifying new treatments for epilepsy which provides the concept for the PSPP.