HEAL Initiative: Translational Development of Devices to Treat Pain (U18 Clinical Trial Not Allowed)
NIH - National Institutes of Health (RFA-EB-18-003)
- Proposal: 02/21/2020
- Amount: $500,000
- Duration: 3 years
This FOA is part of the NIH HEAL (Helping to End Addiction Long-term) Initiative—an aggressive, trans-agency effort to speed scientific solutions to stem the national opioid public health crisis. The NIH HEAL Initiative will bolster research across NIH to (1) improve treatment for opioid misuse and addiction and (2) enhance pain management. More information about the HEAL Initiative is available at: https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative.
As part of the mission of the HEAL Initiative, the participating NIH Institutes and Centers are encouraging the translation of early- and mid- stage technologies and approaches into new non-addictive pain treatments. This program announcement is intended to provide support for engineering activities to develop mature medical devices that are built upon a mechanistic understanding of the underlying biology. A secondary goal of this program announcement is to catalyze the development of partnerships between the academic and industrial sectors so that translational research in pain can flourish as a cooperative, iterative process leading to safe, effective, and non-addictive treatments for pain. This funding announcement is specifically focused on the preclinical translational development necessary to advance existing and emerging technologies and approaches to the point of clinical testing. The program supports bench and preclinical development of technologies and approaches leading to assembly of market approval applications for the FDA. The scope of this program excludes basic research, and studies of disease mechanism or mechanism of action studies of the intended device. Applications to this FOA should not be hypothesis-driven, but should propose design-directed development of a new technology or approach.
The intended use of candidate devices may be to diagnose, treat, or rehabilitate, and there are no restrictions on invasiveness (i.e., the devices may be non-invasive, minimally invasive, or invasive). The devices may be combination products involving use of drugs and biologic agents, however the drugs or biologics must already be approved by the FDA for use in pain treatment. Devices may utilize any viable modality to focally interact with the nervous system, such as optical, electrical, magnetic, acoustic, chemical/pharmaceutical, microfluidic, or combinations thereof. This FOA is not specific for any one or a group of pain conditions. Projects to treat novel targets for acute pain, chronic pain, migraine, other headache disorders, osteoarthritis, diabetic neuropathy, chemotherapy-induced neuropathy, sickle-cell pain, post stroke pain, etc. will be responsive. Projects to treat a combination of chronic overlapping pain conditions or for specific pathological conditions will be responsive. Projects that seek to treat novel targets in specific patient populations such as women and children will also be responsive to this FOA.
General Entry Criteria:
Projects must have a rigorous mechanistic biological rationale, and scientifically sound assays to test the device. Supporting data must be provided that the mechanism of therapy, rehabilitation, or diagnosis has been demonstrated in humans or bench top, ex vivo, in silico, in vitro, and/or in vivo models representative of the intended patient population and indication. Early stage technologies will be considered, as long as there is a sufficiently credible research plan and supporting data that clinical testing is likely to commence within five years.
It is expected that by the end of the project period, awardees will have validated the technology or approach in vivo and demonstrated a credible path towards transitioning an emerging technology to broad and routine clinical practice. Preclinical activities supported by this FOA are expected to generate preliminary safety and effectiveness evidence. If the target product is likely to be regulated by the FDA, this safety and effectiveness evidence should be provided to the FDA in a pre-submission meeting during the course of a supported project in order to determine the scope of research needed for a future pilot clinical study.
Eligibility & Submission Requirements
Applications will be considered non-responsive if:
- The project seeks to develop or validate animal models, diagnostic procedures, biomarkers, rehabilitation strategies, small molecules, or biologics. Applicants seeking to pursue these scopes of work are encouraged to consider other HEAL FOAs, available at https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative/funding-announcements-opportunities.
- The primary objective is to study scientific or clinical hypotheses, efficacy, or effectiveness.
- The project does not conclude with clear path to human use.
- The basis for the device’s functionality is rooted in phenomenology or purely empirically determined measurements, and no credible mechanism of action is provided.
Applicants are strongly encouraged to consult the Scientific/Research Contact listed below to discuss the alignment of their proposed work with the goals of this FOA, and the HEAL Initiative.
Michael B. Wolfson
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Nick Langhals, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Xincheng Zheng (Ted), M.D., Ph.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Merav Sabri, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Yolanda F. Vallejo, Ph.D.
National Institute of Dental and Craniofacial Research (NIDCR)
National Eye Institute (NEI)
Diane St. Germain
National Cancer Institute (NCI)
H. Joe Wang, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Theresa Hayes Cruz, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Danilo Tagle, Ph.D.
National Center for Advancing Translational Sciences (NCATS)