Non-addictive Analgesic Therapeutics Development

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Neurological Disorders and Stroke

Non-addictive Analgesic Therapeutics Development

March 11, 2021

Dr. Michael Oshinsky Dr. DP Mohapatra Dr. Becky Roof

#NIHhealInitiative

NIH HEAL Initiative and Helping to End Addiction Long-term are service marks of the U.S. Department of Health and Human Services.

NIH Helping to End Addiction Long-term (HEAL) Initiative: Pain Research Priorities

Enhance Pain Management

? Understand the biological underpinnings of chronic pain

? Accelerate the discovery and preclinical development of non-addictive pain treatments

? Advance new non-addictive pain treatments through the clinical pipeline

? Inform best practices for effective pain management while minimizing risk of addiction

Read about the research plan:

heal-initiative

Collins, Koroshetz, Volkow; JAMA, 2018

Federal Pain Research Strategy 2017

PREVENTION OF ACUTE & CHRONIC PAIN

ACUTE PAIN & ACUTE PAIN MANAGEMENT

TRANSITION FROM ACUTE TO CHRONIC PAIN

CHRONIC PAIN & CHRONIC PAIN MANAGEMENT

WHAT HAPPENS AND TO WHOM?

WHY AND HOW DOES IT HAPPEN?

HOW TO MANAGE?

BASIC SCIENCE

CLINICAL SCIENCE

UNDERSTAND MECHANISMS

TRANSLATE/ TREAT

DISPARITIES



Proposed HEAL Analgesic Development Program

Discovery

Preclinical Development

Clinical Trials

Implementation/ Dissemination

Planning

RFA-NS-21-016

Initial Therapeutics Development RFA-NS-21-015

Optimization Stage

RFA-NS-21-010

EPPIC Net

PSPP & NCATS

Analgesics Development: Focus on deliverables Focus on scientific challenges Reduce program complexity Incentivize industry to reinvest

Grants

Grants & Contracts

Grants, Contracts & Intramural Resources

HEAL Analgesic Development Program

Planning Grant

Initial Therapeutics Development

RFA-NS-21-01C6u rrent RFA-NS-21-015

programs Discovery & Target Validation

Biomarkers

Planning for Therapeutic

Devel.

Team building Mechanisms

Feasibility

Initial Therapeutic Devel.

Mechanisms Assays Models

Biomarkers Proof of efficacy/concept

Optimization Stage

RFA-NS-21-010

Optimization

Biomarkers

Optimization Stage

Optimization of leads & Target Engagement

Biomarkers IND

1st in human trials

E

P

P h

P a

I

s e

C N II

E

T

? Type of pain ? Pain Condition ? ID Patient specific

targets ? Molecular Pathway ? Cell type ? Etc.

Identified "HIT to Lead"

IND approved, PHASE I complete asset

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