SN-ARPA-H-26-157_FASTPASS.pdf

Special Notice (SN) ARPA-H-SN-26-157

Proposer Workshop Announcement for Advanced Research Projects Agency for Health (ARPA-H) / Scalable Solutions Office (SSO)

Opportunity: Fast Assessment of Solutions, Therapeutics, Pharmaceuticals, and SupplieS

(FASTPASS)

I. KEY INFORMATION

Table 1. Proposer Workshop Key Information

Proposer Workshop Fast Assessment of Solutions, Therapeutics, Pharmaceuticals, and SupplieS (FASTPASS)

Location Virtual

Website for Registration solutions.arpa-h.gov/events

Registration Opens July 28, 2026 at 11:00am Eastern Time (ET)

Registration Closes August 20, 2026 at 12:00pm ET Technical Point of Contact James Coburn Program Email FASTPASS@arpa-h.gov

II. INTRODUCTION

The Scalable Solutions Office (SSO) of the Advanced Research Projects Agency for Health (ARPA-H) is hosting a Proposer Workshop in support of an anticipated Innovative Solution Openings (ISO) for the Fast Assessment of Solutions, Therapeutics, Pharmaceuticals, And SupplieS (FASTPASS) program. The virtual Proposer Workshop will be held on Monday, August 24, 2026. Advance registration is required. Registrants will have the opportunity to provide teaming presentations that can be shared with the other participants. There are a limited number of timeslots for teaming presentation briefings; however, presentations will be shared with meeting participants. Teaming presentation briefings will be offered on a first-come, first-served basis.

Please Note: All times listed in this announcement and on the registration website are Eastern Time.

The goals of the Proposer Workshop are to:

• Enable open discussion about the goals and Technical Areas (TA)s of the FASTPASS program.

mailto:FASTPASS@arpa-h.gov

• Encourage and promote teaming arrangements among organizations with the expertise, research facilities, and capabilities needed to execute research and development responsive to program goals.

• Provide guidance that will promote efficiency of proposal refinement and preparation to support quality proposal development process.

ARPA-H anticipates releasing the FASTPASS ISO in August 2026. When released, the ISO will be available on https://sam.gov/. To maximize the pool of innovative proposal concepts, ARPA-H strongly encourages participation in the Proposer Workshop and related solicitation by non-traditional performers, including small and medium-sized businesses, as well as academic and research institutions, including first-time government contractors. While attendance at the Workshop is not mandatory for submitting a proposal or being selected for funding, it provides valuable insights and guidance. Information shared during the Proposer Workshop will be accessible on the ARPA-H website:

https://www.arpa-h.gov/explore-funding/programs/fastpass

III. FASTPASS – PROGRAM INFORMATION

While full details of the FASTPASS program will be provided in the forthcoming FASTPASS ISO, the following is a brief description of the program. Proposers should refer to the forthcoming FASTPASS ISO for complete requirements and guidance.

The FASTPASS program seeks to prevent contaminated or substandard medications from reaching patients by developing a system, comprised of multiple technologies, to perform rapid, non-contact drug quality and safety testing at points of entry and across the supply chain.

American patients deserve to know that the drugs they take meet the quality and efficacy standards that the FDA approved. FDA inspections are still the gold standard for quality assurance, ensuring that U.S. medical products are safe and effective. However, United States depends heavily and increasingly on global pharmaceutical supply chains for key starting materials, active pharmaceutical ingredients, and finished drug products. As this dependence has grown, the challenge of ensuring the quality and safety of imported pharmaceuticals has grown with it. Existing oversight tools—including facility inspections and laboratory-based testing remain essential— but are stretched thin supporting the magnitude and complexity of today’s international supply chains. Consequences of unsafe drugs range from treatment delays, to recalls, to patient death, all of which can be prevented or substantially reduced with increased capabilities for fast and robust testing at ports. New tools and techniques developed by FASTPASS aim to increase the capacity and capabilities to ensure that every dose is right and every dose is safe.

FASTPASS is expected to solicit proposals in two Technical Areas (TAs) - Sampling and Detection:

https://www.arpa-h.gov/explore-funding/programs/fastpass

TA1 SAMPLE: TA1 performers will develop advanced through-packaging sensing technologies to evaluate the chemical makeup of a product using spectrographic or other non-contact, non-destructive means. Work in TA1 will advance and integrate one or more non-destructive sensing modalities capable of interrogating pharmaceutical products. It will achieve greater signal clarity without opening packaging via technical improvements that may include but are not limited to leveraging emerging and tunable radiation/light sources, signal offset methods, high sensitivity detectors, adaptive control algorithms, and more. Ultimately, the techniques will be expected to collect usable data through some but not all commercial packaging materials including, but not limited to: paperboard, plastic sheeting, white plastic, blister packs, glass, and related shipping materials.

FASTPASS technologies may include, but are not limited to, development or integration of methods such as nuclear magnetic/quadrupole resonance, spatially offset Raman spectroscopy, time-domain terahertz spectroscopy, x-ray fluorescence, x-ray diffraction, hyperspectral approaches, or other orthogonal, penetrating, non-destructive sensing techniques. ARPA-H is not prescribing a single sensing method and is interested in

1. Novel through-package sensing technologies

2. Advancing the capabilities of known technologies to increase resolution, penetrative performance, or meeting the need for mobile field operations

3. Novel system-level approaches that combine modalities to overcome the limitations of any individual technique.

For example, X-ray techniques have little difficulty penetrating typical pharmaceutical packaging, and instead would focus on meeting chemical specificity, regulatory, size, weight, and power metrics. Raman techniques are often used in manufacturing process controls, but may need to increase operational through-packaging thickness and reduce matrix noise to obtain signals with usable limits of detection.

TA2 DETECT: TA2 performers will develop analytics and models that will transform existing spectroscopic techniques and also address four areas critical to implementing next generation techniques, fully realizing the technological developments in TA1.

1. Frameworks for reliable signal capture under real-world conditions, across all sample types.

2. Incorporating chemometric and physicochemical features into processing of spectra

3. Deep learning models to appropriately categorize samples and outputs to increase specificity, improve consistency, and reduce noise.

4. Multimodal data fusion to synthesize signals from all available TA1 sensing modalities, filling the gaps left by each sensor’s physical limitations.

TA2 performers will develop signal processing, classification, data fusion, and Artificial Intelligence (AI) and Machine Learning (ML) approaches that can operate on weak, noisy, and heterogeneous signals and compare them against a growing range of reference standards or equivalent quality signatures. Reference “signatures” will be created or cataloged for many products to enable matching specific incoming product formulations that can be used for future matching and categorization.

It is expected that due to physical limitations that few, if any, TA1 sensor modalities will be able to definitively analyze all potential packages and products. There may be multiple TA2 methods that are used to address each of the critical areas across different sensing modalities. Filling these gaps will require synthesis of multiple sampling modalities and advanced processing methods. As such, data from all sensors and models will have to be interoperable to allow full system compatibility. Proposers will have the opportunity to identify ambitious but achievable goals specific to their sensing modality or modeling and processing techniques.

IV. TEAMING NEEDS

Creating a quality proposal to meet all criteria often requires combining technologies, research expertise, product design experience, and modeling development. This will likely require teams of complementary performers who may not have previously worked together. It is recommended that proposers submit a teaming profile before the Proposer Workshop to engage with potential collaborators as soon as possible to form the strongest teams.

Teaming Profiles Interested parties are highly encouraged to submit a ‘teaming profile’ via the FASTPASS Teaming Profile Form: https://solutions.arpa-h.gov/teaming/fastpass.

The teaming profile will describe the technical competencies, team capabilities, team composition, research areas of interest, unique facilities and other capabilities, as they relate to the program, and desired technical/other competencies sought from other potential team partners. The profile will include, at a minimum:

• Contact information, including name, organization, email, telephone number, and website

• Brief description of the proposer’s technical competencies and relevant facilities

• Desired technical competencies and facilities from other potential team members, if applicable.

All teaming profiles must be submitted through the designated FASTPASS Teaming Profile Form.

The teaming profile will be updated regularly and made available on the program's teaming profile page. Specific content, communications, networking, and team formation are the sole responsibility of participants. ARPA-H does not endorse any participating organization or exercise any responsibility for improper dissemination of the team profiles.

V. FASTPASS – PROPOSER WORKSHOP INFORMATION

The Workshop will consist of presentations from the Program Manager describing the program, discussions with the Program Team and government partners about the Independent and Verification and Validation (IV&V) process. Lastly, the Program team will hold a live Question and Answer (Q&A) session.

Live Q&A Presentations and discussions will be followed by a Live Q&A given by the Program Manager.

Participants are encouraged to use this time to ask programmatic questions related to the forthcoming FASTPASS ISO.

ARPA-H will collect participant questions and may make responses of general applicability available in a publicly available Frequently Asked Questions (FAQ) resource on arpa-h.gov/explore-funding/programs/fastpass/faqs.

Registration Information Participants must register in advance through the registration website.

PLEASE NOTE: The registration cutoff date is August 20, 2026, at 12:00 PM ET. Note that there will be no same-day registration. There is no registration fee for the FASTPASS Proposer Workshop. The online registration form and various other meeting details can be found at the registration website (https://solutions.arpa-h.gov/events).

All inquiries should be sent through http://solutions.arpa-h.gov/ask-a-question. Prior to submitting an e-mail inquiry, please check the FAQs on arpa-h.gov/explore-funding/programs/fastpass/faqs to see if your question is answered there. Prior to submitting an e-mail inquiry, please check the FAQs on arpa-h.gov/explore-funding/programs/FASTPASS/faqs to see if your question is answered there.

VI. POINTS OF CONTACT

Technical Point of Contact CAPT James Coburn, Portfolio Lead, ARPA-H/SSO Email:

FASTPASS@arpa-h.gov

All inquiries should reference “FASTPASS Proposer Workshop (ARPA-H-SN-26-157)” in the subject line of the email.

VII. DISCLAIMER

This SN is issued solely for information and advance planning purposes and does not constitute a formal solicitation for proposals or solution summaries. Responses to this notice are not offers and cannot be accepted by the Government to form a binding award. Submission of any http://solutions.arpa-h.gov/ask-a-question information in response to this SN is voluntary and is not required to propose to subsequent ARPA-H ISOs or research solicitations on this or any other topic. ARPA-H will not provide reimbursement for costs incurred in responding to this SN or participating in the FASTPASS Proposer Workshop. Respondents are advised that ARPA-H is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted under this SN.