Executive Summary - Helping to End Addiction Long-term Initiative HEAL Partnership Committee Face-to-Face Meeting

On Tuesday, March 5, 2019, a HEAL Partnership Committee (HPC) meeting was convened to discuss the National Institutes of Health (NIH) Helping to End Addiction Long-term (HEAL) Initiative. The NIH HEAL Initiative was funded by the U.S. Congress to help combat the opioid crisis. One of HEAL’s major components will be the Early Phase Pain Investigation Clinical Network (EPPIC-Net): a network of clinical sites to test novel pain therapeutics (i.e., drugs, devices, and other treatments; known collectively as “assets”) in Phase 2 trials in order to accelerate their commercialization, thereby displacing opioids for treating a wide variety of pain conditions. The HPC will assist on defined tasks related to the development of new treatments for pain and addiction through HEAL research. The purpose of this meeting was to discuss the structure and governance of the HPC, and solicit preliminary recommendations on the design of a template application and evaluation dossier for biopharmaceutical and device-based treatments to be tested through new clinical trials networks as part of HEAL.

Participants reviewed an outline of EPPIC-Net’s proposed operations. EPPIC-Net’s core function will be to receive candidate asset submissions from private entities, assess and prioritize assets in two stages, and design and conduct Phase 2 clinical trials on assets deemed highly meritorious by an objective review panel. The two-stage review process will begin with an initial asset submission template designed to collect basic information that the objective review panel can use to prioritize assets for further consideration. Each applicant whose assets pass through stage one review will receive contractor services to help develop an in-depth dossier for their asset. Participants discussed what information should be collected on each asset during these two review stages, and what criteria should determine which assets enter EPPIC-Net Phase 2 trials.

The diversity of participating stakeholders also highlighted challenges to developing therapeutics for pain from a variety of perspectives. A panel of presentations conveyed the regulatory, pharmaceutical, medical device, and patient perspectives, spurring fruitful discussions about how these myriad challenges overlap and might be addressed by the NIH HEAL Initiative in general, and by EPPIC-Net in particular.

Among the many topics discussed by the HPC during the meeting were: coordinating regulatory and NIH research efforts, creating a well-balanced portfolio of candidate assets with different risk/reward profiles, balancing proprietary asset confidentiality with public data, evaluating claims that submitted assets will reduce opioid use, pairing larger and smaller private partners to fill gaps in asset information, considering reimbursement and pricing issues when evaluating commercialization potential of assets, including not just drugs but also devices and other treatment modalities, testing multimodal therapies, designing the template and dossier to optimize the review process, and strategizing about the logistics of launching EPPIC-Net.

The design of EPPIC-Net is nearly complete. The HPC will meet once more via teleconference to finalize materials. EPPIC-Net will open the asset submission template in 2019, with the goal of launching its first Phase 2 trials in 2020.