Groundbreaking Lymphatic Interventions and Drug Exploration (GLIDE)
ID: ARPA-H-SOL-24-111Type: Presolicitation
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFNATIONAL INSTITUTES OF HEALTHNIH ADVANCED RESEARCH PROJECTS AGENCY FOR HEALTH (ARPA-H)Bethesda, MD, 208920004, USA

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714)

PSC

HEALTH R&D SERVICES; HEALTH CARE SERVICES; EXPERIMENTAL DEVELOPMENT (AN13)

Original Source

https://sam.gov/opp/b16fc9c8d9164bfcbc804d8608644820/view
Timeline
    Description

    The Department of Health and Human Services, through the National Institutes of Health's Advanced Research Projects Agency for Health (ARPA-H), is seeking proposals for the Groundbreaking Lymphatic Interventions and Drug Exploration (GLIDE) program. This initiative aims to develop innovative therapeutic interventions targeting lymphatic dysfunction, which affects millions of individuals in the United States, by addressing both physical and pharmacologic aspects of these conditions. Proposals must demonstrate efficacy in treating one rare and one chronic disorder, with a focus on collaboration, diversity, and inclusion in clinical trials. Interested parties should submit their Solution Summaries by November 14, 2024, and can reach out to the GLIDE Team at GLIDE@arpa-h.gov for further information.

    Point(s) of Contact
    The GLIDE Team
    GLIDE@arpa-h.gov
    Files
    Title
    Posted
    DRAFT GLIDE ISO - August 16 2024 amendment.pdf
    The Advanced Research Projects Agency for Health (ARPA-H) is issuing the solicitation ARPA-H-SOL-24-111 for the Groundbreaking Lymphatic Interventions and Drug Exploration (GLIDE) program, aiming to innovate treatments for lymphatic dysfunction affecting millions in the U.S. Proposals are sought from various eligible entities to develop therapeutic interventions that address both physical and pharmacologic aspects of lymphatic conditions. The program will be structured into phases focused on platform development and clinical feasibility, with distinct pathways for earlier-stage concepts (Activator) versus those having demonstrated proof of concept (Accelerator). Phased milestones will guide progress from initial research design to market readiness, incorporating rigorous criteria for assessment at each step, including metrics for safety and efficacy. The program emphasizes collaboration across diverse teams, encouraging engagement with patient communities and prioritizing diversity, equity, and inclusion in clinical trials. Proposers must submit their solutions, outlining commercial viability and data sharing plans, while ensuring accessibility and aligning with ARPA-H's mission to enhance healthcare solutions through innovative research. The anticipated timeline includes a proposer’s day, deadlines for questions, and submission stages culminating in potential funding agreements.
    DRAFT GLIDE ISO - July 31 2024.pdf
    The Advanced Research Projects Agency for Health (ARPA-H) has released a solicitation, ARPA-H-SOL-24-111, for its Groundbreaking Lymphatic Interventions and Drug Exploration (GLIDE) program. ARPA-H seeks innovative solutions for lymphatic diseases and dysfunction, aiming to develop a range of treatments and interventions. The program has two technical areas: physical interventions (TA1) and pharmacologic, gene, and cell therapies (TA2). Proposals should address either decompression of lymphatic obstructions or normalization of lymphatic function. The GLIDE program offers two pathways: Activator, for early-stage solutions, and Accelerator, for technologies with some proof of concept. Proposals must include targets for both rare and chronic diseases impacted by lymphatic dysfunction. Key metrics and milestones are outlined for each technical area and phase, with specific deliverables and go/no-go decision criteria. Teams must include a lead PI, project manager, product development lead, and a Discovery Duo to ensure patient involvement and address accessibility. Monthly status reports and semi-annual meetings are required, with a 90% attendance policy. ARPA-H will provide support through Phase II, with the possibility of Phase III clinical trials depending on progress and funding.
    GLIDE FAQ 20240815.pdf
    The GLIDE Frequently Asked Questions (FAQ) document provides essential information regarding the GLIDE program, aimed at addressing lymphatic system disorders. It outlines participant recruitment processes, submission timelines, and eligibility criteria for proposals. Key information includes that the program does not exclusively target peripheral lymphedema and emphasizes collaborative proposals incorporating patients as ambassadors. Solution Summaries must be submitted by October 31, 2024, and all eligible entities may propose, though only one full proposal as the prime proposer is allowed. Reviewers are selected based on expertise in relevant research areas, and both FDA-approved clinical trials and new IND applications are supported. The document encourages collaboration among national and international entities and emphasizes clear identification of team roles and capabilities. Overall, the FAQ serves as a crucial resource for understanding the GLIDE program's structure, submission guidelines, and evaluation processes under the context of government RFPs and grants, aimed at enhancing healthcare research and treatment options for lymphatic disorders.
    GLIDE FAQ 20240904 (1).pdf
    The GLIDE program, associated with the Advanced Research Projects Agency for Health (ARPA-H), outlines its requirements, recruitment strategies, and proposal submission process for technology targeting lymphatic dysfunction. Individuals with primary lymphedema can participate in studies by connecting with research teams or non-profits involved in GLIDE's patient engagement initiatives. Proposals should demonstrate efficacy in addressing one rare and one chronic disorder, with a Solution Summary due by November 14, 2024. ARPA-H stresses collaboration, requiring teams to include key personnel, such as a patient ambassador, to enhance technology impact. All eligible entities, including international applicants willing to partner with U.S. organizations, can submit proposals under specified criteria. The document details the evaluation process for Solution Summaries and full proposals, emphasizing accountability and alignment with program metrics. Proposers must prepare submissions that support the goals of advancing therapeutic solutions while being flexible in determining applicable technical areas. Overall, the document serves as a comprehensive guide for interested parties navigating the GLIDE program and endeavoring to develop innovations for lymphatic health.
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    Groundbreaking Lymphatic Interventions and Drug Exploration (GLIDE)
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