Program Overview
An estimated 10 million Americans are impacted by primary lymphatic diseases, and lymphatic dysfunction contributes to the pathophysiology of many widespread chronic illnesses. Despite the importance of the lymphatic system in disease, there are currently zero FDA-approved treatments, medical devices, or therapies specifically targeting lymphatic growth and function. To catalyze a future where lymphatic structure and function can be targeted and leveraged to treat both primary lymphatic disease and other chronic diseases, the Advanced Research Projects Agency for Health (ARPA-H) has released a solicitation for Groundbreaking Lymphatic Interventions and Drug Exploration (GLIDE).
Key Technical Aspects of the Solicitation
GLIDE aims to develop a variety of treatment options that target the underlying mechanisms of lymphatic dysfunction. To accomplish these goals, GLIDE will address two important issues in the treatment of lymphatic dysfunction: decompression of obstructed lymphatic vessels and restoration of normal lymphatic function. Proposers can address these issues through two technical areas (TAs), focusing on physical interventions and/or on pharmacologic, gene and cell therapeutic interventions. In addition to the two TAs, GLIDE is structured into three phases to support translation from idea to market:
- Phase I: Platform development, proof-of-concept research, and feasibility studies.
- Phase II: Clinical viability and risk assessment.
- Phase III: Clinical trial readiness, with Phase I clinical trial support for selected disease indications.
Furthermore, GLIDE offers two pathways to success with different timelines to support technologies at various technical readiness levels (TRLs):
- The Activator pathway focuses on transformative early-stage solutions. Proposals must demonstrate the revolutionary nature of their approach for lymphatic disease treatment. The phase breakdown for this path is as follows:
- Phase I: Discovery and development (up to 36 months)
- Phase II: Preclinical studies (18 months)
- Phase III: Clinical focused on safety and securing regulatory approvals (up to 6 months)
- The Accelerator pathway focuses on technologies with demonstrated proof of concept that require more feasibility investigation (technologies much still require 18 months of research, development, and optimization during Phase I). The phase breakdown for this path is as follows:
- Phase I: Later-stage research and development (up to 18 months)
- Phase II: Preclinical studies (18 months)
- Phase III: Clinical trials (up to 24 months)
Proposers must prepare a submission that addresses one TA, declare their intended path to success based on maturity of their technology, and identify at least two disease indications (including at least one rare disease and at least one chronic disease) for ARPA-H to select for clinical trials during Phase III of GLIDE.
Important Deadlines
- Proposer’s Day: October 1, 2024 (passed)
- Q&A Deadline: December 5, 2024, 2:00 PM ET
- Solution Summaries Due: December 12, 2024, 2:00 PM ET
Eligibility Information
GLIDE primarily seeks proposals from commercial entities, academic institutions, and non-profits. FFRDCs and government entities may contribute if they offer unique capabilities essential to a proposed solution. FFRDCs or government employees cannot serve as primary or subcontracted team members unless a potential prime performer demonstrates an FFRDC’s unique, indispensable role.
If your company has considered applying for ARPA-H funding, your federal funding journey starts here.
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