Overview of HEAL Initiative and EPPIC-Net Infrastructure

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This presentation provides insights into the HEAL initiative and the purpose of the EPPIC-Net (Early Phase Pain Investigation Clinical Network). It highlights the goals of EPPIC-Net in accelerating early-phase clinical trials of non-addictive pain therapeutics to reduce opioid reliance. The structure of EPPIC-Net, its infrastructure, and participating institutions are also outlined, offering opportunities for academic and industry investigators.

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Daniel L. Riddle, PT, PhD Otto D. Payton Professor Departments of Physical Therapy, Orthopaedic Surgery and Rheumatology NIH HEAL EPPIC-NET (Early Phase Pain Investigation Clinical Network) Lorem ipsum dolor sit amet, consectetur adipiscing elit.

Purposes of Presentation Provide a brief overview of the HEAL initiative Describe specific purposes of EPPIC-Net and VCU s role Summarize opportunities for VCU investigators FIRST UP 2 CONSULTANTS

About the HEAL Initiative From prevention research, basic and translational research, clinical trials, to implementation science Over $945M awarded in FY2019 12 NIH Institute and Centers leading 26 HEAL research projects Multiple projects integrating research into new settings Released 40+ funding announcements for FY2019 FIRST UP 3 CONSULTANTS

HEAL Research Overview FIRST UP 4 CONSULTANTS

Goals of EPPIC-Net (Early Phase Pain Investigation Clinical Network) Provide academic and industry investigators with expert infrastructure and support for early-phase clinical testing of pain therapeutics across populations and the lifespan AND to reduce reliance on opioids by accelerating early- phase clinical trials of non-addictive pain therapeutics, including drugs and devices. EPPIC-Net will also accept studies of biomarkers and include phenotyping. FIRST UP 5 CONSULTANTS

EPPIC-Net Structure U24 Cooperative Agreements are used to fund EPPIC-Net Infrastructure Other Transaction Awards are used to fund EPPIC-Net Clinical Trials FIRST UP 6 CONSULTANTS

Infrastructure Defined FIRST UP 7 CONSULTANTS

NYU SOM EPPIC-Net Structure Duke University North Carolina Medical College of Wisconsin Wisconsin Medical University of South Carolina South Carolina New York University School of Medicine New York University of California, San Diego California University of Florida Florida University of Pennsylvania Pennsylvania University of Pittsburgh at Pittsburgh Pennsylvania University of Rochester New York University of Washington Washington MGH Icahn SOM, Mount Sinai MGH FIRST UP 8 CONSULTANTS

Funding Targets EPPIC-Net will target Test new pain treatments (e.g., small molecules, biologics, devices) with go/no-go criteria in early-stage trials to move toward efficacy trials for regulatory approval. Provide proof-of-concept clinical testing of potential biomarkers and new treatments to help identify specific pathways or mechanisms that hold promise for future therapeutic development. Validate biomarkers for utility in assessing target engagement or pain outcomes that could be used to accelerate development of new, non-addictive pain therapies. Develop and test innovative clinical trial paradigms to evaluate pain therapies. Establish well-characterized patient cohorts with specific pain conditions and clearly defined outcome measures for early-stage trials. Continuously learn from experience to engineer adaptive, ever- improving early-phase testing of new pain therapies. FIRST UP 9 CONSULTANTS

Funding Targets contd Clinical Trials to Focus on: Investigational drugs and biologics, investigational devices, natural products, and surgical procedures for the treatment of pain Deeply phenotyped patients with pain conditions of high unmet need. Drugs or devices with strong potential to move to industry-funded Phase 3 efficacy trials, should the early-phase study achieve the pre- specified endpoints FIRST UP 10 CONSULTANTS

What About You as an Investigator? One of two roles Can either submit application as a holder of an asset (a drug, a device or a biomarker) Can serve as a site PI to conduct a study within the VCU spoke FIRST UP 11 CONSULTANTS

3 Stage Application Process for Asset Holder FIRST UP 12 CONSULTANTS

Application Overview FIRST UP 13 CONSULTANTS

Application Update EPPIC-Net initial preliminary application review round took place on October 30th. ----11 applications were reviewed Summary report pending; NINDS/NIH will determine which move forward to dossier stage The next review round submission deadline will be early-mid November, with review to take place in December Then Review cycles expected to be every 4-8 weeks FIRST UP 14 CONSULTANTS

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Preliminary Application FIRST UP 16 CONSULTANTS

General Topics of Recent Round of Apps Source Industry Industry Academia Industry Academia Academia Industry Asset Type Drug Device Drug Drug Device/biomarker Drug Drug Pain Indication Migraine Total knee replacement Chronic low back pain Knee osteoarthritis (n = 2) Chronic low back pain Multiple pain types Chemotherapy induced neuropathic pain Subarachnoid hemorrhage Chronic LBP, hip, knee, migraine Post herpetic neuralgia, acute dental pain Industry Academia Drug/procedure Behavioral Industry Drug FIRST UP 17 CONSULTANTS