ARPA-H SSO: “AGENTIC AI-ENABLED CARDIOVASCULAR CARE TRANSFORMATION” (ADVOCATE)

Below is a brief summary. Please check the full solicitation before applying (link in resources section).

Executive Summary:

ARPA-H is now accepting proposals for ADVOCATE: Agentic AI-Enabled Cardiovascular Care Transformation, a major new Innovative Solutions Opening (ISO) focused on deploying autonomous, FDA-regulated clinical AI agents for cardiovascular disease (CVD) care at national scale.

This program is designed to fund teams that can build, validate, and deploy patient-facing AI agents, paired with independent supervisory AI, and integrate them directly into real healthcare systems. Selected performers will work closely with FDA, large health systems, and ARPA-H leadership to establish a blueprint for scalable, reimbursable agentic AI in healthcare. A Solution Summary is mandatory and is due February 27, 2026, at 5:00 PM EST. Full proposals are by invitation only and are due April 1, 2026, at 5:00 PM EST.

How much funding would I receive?

• Total award size: Not specified in the solicitation

• Number of awards: Multiple awards anticipated

• Funding mechanism: Other Transaction (OT) Agreements

• Program length: Up to 39 months

  • Phase 1A: 12 months

  • Phase 1B: 12 months (option)

  • Phase 2: 15 months (option)

What could I use the funding for?

Funding must support development, validation, and deployment of agentic AI systems for cardiovascular care, aligned to one or more of the following Technical Areas (TAs):

TA1 — CVD Agent (Patient-Facing Clinical AI)

• Autonomous or semi-autonomous AI agents that:

  • Provide diagnostic and treatment assistance

  • Adjust prescriptions for CV conditions (FDA medical device)

  • Integrate real-time EHR and wearable data

  • Deliver 24/7 outpatient care management

• Clinical reasoning using multimodal inputs (text, voice, image, video)

• FDA regulatory engagement and authorization

• Deployment into real health systems for scalability studies

TA2 — Supervisory Agent (AI Oversight & Control)

• Disease-agnostic AI that:

  • Monitors safety, accuracy, uncertainty, and risk of clinical AI

  • Enables real-time control and auditability

  • Supports FDA Medical Device Development Tool (MDDT) qualification

• Continuous post-market monitoring functionality

• Strong preference for open-source solutions

TA3 — Scaled Implementation (Health Systems Only)

• Integration of TA1 and TA2 agents into live clinical workflows

• Access to EHR production and pre-production environments

• Execution of large-scale Scalability Studies

• Clinical outcome, cost, and reimbursement evidence generation

Are there any additional benefits I would receive?

Selected teams receive:

• Direct engagement with FDA throughout development

• Access to real EHR data, clinicians, and patients (via TA3 performers)

• Participation in large, ARPA-H-funded scalability studies

• Validation by an independent IV&V partner

• Visibility with payers and CMS-relevant evidence generation

• Potential facilitation of investor engagement by ARPA-H

What is the timeline to apply and when would I receive funding?

Key dates (firm):

• Posting date: January 13, 2026

• Proposers’ Day: January 23, 2026 (8:30 AM – 5:00 PM EST)

• Proposers’ Day registration deadline:

  • In-person: January 21, 2026, at 5:00 PM EST

  • Virtual: January 21, 2026, at 5:00 PM EST

• Solution Summary due: February 27, 2026, at 5:00 PM EST

• Full proposal due (if invited): April 1, 2026, at 5:00 PM EST

Funding timing after submission is not specified and is contingent on negotiations and down-selection decisions.

Where does this funding come from?

• Agency: Advanced Research Projects Agency for Health (ARPA-H)

• Office: Scalable Solutions Office (SSO)

• Authority: Other Transaction (OT)

Who is eligible to apply?

Eligible applicants include:

• U.S. startups and growth-stage companies

• Universities and academic teams

• Non-profit organizations

• Non-federal research organizations

Not eligible:

• Federally Funded Research and Development Centers (FFRDCs)

• Federal government entities or employees (as performers)

• Entities from covered foreign countries or foreign entities of concern

• Organizations with unmitigable ARPA-H conflicts of interest

TA3 applicants cannot apply to TA1 or TA2.

What companies and projects are likely to win?

ARPA-H is explicitly seeking teams that:

• Are building agentic (not rules-based) clinical AI

• Can meet FDA medical device or MDDT requirements

• Have real experience integrating with EHRs and health systems

• Can demonstrate a path to non-inferiority vs cardiologists

• Are prepared for open data sharing and multi-party collaboration

• Can scale beyond pilots into national deployment

Incremental clinical decision support tools are unlikely to be competitive.

Are there any restrictions I should know about?

Key restrictions include:

• Foundation models cannot be developed from scratch

• Solutions must be interoperable with other agents

• Clinical AI must pursue FDA authorization or qualification

• Extensive data-sharing and collaboration are mandatory

• Foreign talent, ownership, or funding risks are heavily scrutinized

• TA1 and TA2 proposals must remain technically independent

How long will it take me to prepare an application?

• Solution Summary: ~2–4 weeks for competitive teams

• Full Proposal: ~6–10 weeks if invited

Team formation, regulatory strategy, and data architecture must be addressed early.

How can BW&CO help?

BW&CO helps teams:

• Translate ADVOCATE requirements into a clear, fundable narrative

• Position technical capabilities against TA-specific metrics

• Shape FDA and commercialization strategy language

• Design compliant multi-party teaming structures

• Avoid common ARPA-H disqualifiers

How much would BW&CO Charge?

Fractional support is $300 per hour.

For startups, we offer a discounted rate of $250 per hour to make top-tier consulting more accessible while maintaining the same level of strategic guidance and proposal quality.

Additional Resources

Review the solicitation here.

ARPA-H - BIOGAMI: Biomolecular Grammar for Protein Aggregation Modulation and Intervention

Below is a brief summary. Please check the full solicitation before applying (link in resources section).

Executive Summary:

ARPA-H’s BIOGAMI program is funding teams to predict, detect, and control protein misfolding before disease begins. The program targets intrinsically disordered proteins (IDPs) and regions (IDRs), which are implicated in neurodegeneration, cancer, diabetes, and other chronic diseases and are largely considered “undruggable.”

Solution Summary Due: March 4, 2026 (12:00 PM ET)

Funding & Structure

1. Awards: Multiple OT awards anticipated

2. Program Length: Up to 48 months

3. Phases:

   • Phase 1 (0–24 months): Model IDR behavior and demonstrate early modulation and sensing

   • Phase 2 (25–48 months): Translate to preventative therapeutics and early detection tools

4. Down-selection occurs after Phase 1 based on quantitative technical metrics.

What ARPA-H Is Trying to Build

BIOGAMI aims to create a generalizable, reusable platform that can:

• Predict IDR structure, dynamics, aggregation, and interactions from sequence

• Modulate protein folding to prevent or reverse aggregation

• Identify early indicators of misfolding—before symptoms appear

• Enable new therapeutic classes for currently undruggable targets

The program emphasizes root-cause intervention, not symptomatic treatment.

Technical Scope (Both Required)

Technical Area 1 (TA1): Molecular Grammar of IDRs

TA1 teams must establish foundational models that explain how IDR sequences and environments drive protein behavior.

Key requirements include:

• Integrated AI/ML + experimental approaches

• High-throughput in vitro, cell-based, and in vivo systems

• Prediction of structure, aggregation, condensate formation, and interactomes

• Validation across diverse sequences, conditions, and post-translational modifications

• Open-source sharing of TA1 models and datasets

By Phase 2, models must predict and validate IDR properties within 60 days of receiving a sequence.

Technical Area 2 (TA2): Modulate IDPs to Detect and Control Folding

TA2 focuses on therapeutic and diagnostic translation.

Teams must:

• Prevent or reverse aggregation and restore protein function

• Develop early, clinically translatable indicators of misfolding

• Target two diseases:

  • One rare disease (<1 in 100,000)

  • One non-rare disease
    (across neurodegenerative and non-neurodegenerative categories)

By Phase 2, teams must:

• Demonstrate in vivo efficacy

• Preserve or restore >90% of critical protein function

• Validate ≥1 novel biomarker and prepare for FDA Biomarker Qualification engagement

Eligible Applicants

• Startups and large companies

• Universities and nonprofits

• Multi-party teams required (not prime/sub)

• Not eligible:

• FFRDCs and government entities as performers

• Entities from covered foreign countries or foreign entities of concern

• Work is prioritized to be performed in the United States.

Evaluation Criteria (In Order)

Scientific and technical merit

1. Team capability and experience

2. Relevance to ARPA-H mission and health impact

3. Cost realism and value

Commercialization Expectations

1. 5-year and 10-year commercialization plans required

2. Translation Advisory Board required

3. Active or planned commercial partnerships strongly encouraged

4. TA2 outputs expected to be positioned for pre-clinical development

How can BW&CO help?

BW&CO helps biotech and deep-tech teams quickly determine whether BIOGAMI is the right opportunity and, if so, how to pursue it with a credible, ARPA-H–ready strategy by translating dense solicitation language into clear founder-level guidance, pressure-testing technical and team fit against TA1/TA2 requirements and metrics, shaping a compelling program narrative that aligns AI, biology, and validation, designing compliant multi-party teaming structures, aligning commercialization and open-source expectations, and proactively flagging proposal risks—so teams can move confidently toward a competitive submission or make an informed decision to walk away.

How much would BW&CO Charge?

With a flat rate of $4000, you’d work with our grant writing team to put the solution summary together and submit before the March 4th deadline.

Additional Resources

Review the solicitation here.