SURPASS_SN_26-164.pdf

Special Notice (SN) ARPA-H-SN-26-164

Webinar and Proposers’ Day Announcement for Simulation-augmented, Real-time Platform Adaptive Seamless Trials (SURPASS)

I. KEY INFORMATION

Table 1. Key Information Informational Webinar (Online)

October 15, 2026, from 12:00 PM to 1:00 PM ET

Proposers’ Day (Hybrid)

Day 1: November 6, 2026, from 9:00 AM to 5:00 PM ET Hybrid: in-person and virtual Day 2: November 9, 2026, from 9:00 AM to 12:00 PM ET Virtual

Proposer’s Day Location Day 1: Washington, DC and Virtual (Hybrid event) Day 2: Virtual only

Website for registration https://solutions.arpa-h.gov/events Registration for Webinar Closes: October 12, 2026 at 11:59 PM ET Registration for Proposers’ Day Closes: October 28, 2026 at 11:59 PM ET Questions Due Questions received up to 3 business days in advance of the

Webinar and Proposers’ Day may be addressed at the event.

Technical Point of Contact Daria Fedyukina Program Manager, ARPA-H

Program email SURPASS@arpa-h.gov Optional proposer deliverables, details below

1) Teaming Profile- Submit a teaming profile through the portal that includes contact information, technical competencies, team capabilities/composition, relevant research interests or facilities, and any desired partner expertise.

2) Lightning Talk – Present one (1) slide on the presenters’ expertise and capabilities, as it relates to SURPASS program goals

3) Poster Session - Posters must fit into a 3.75 x 3.75 foot space

II. INTRODUCTION

This Special Notice (SN) is intended to alert the scientific community to a new ARPA-H Program, Simulation-augmented, Real-time Platform Adaptive Seamless Trials (SURPASS), and notify potential proposers of an associated webinar and Proposers’ Day (PD). Potential proposers should monitor SAM.gov for updates under ARPA-H-SOL-26-164.

The Proactive Health Office (PHO) of the Advanced Research Projects Agency for Health (ARPA- H) is sponsoring an informational webinar and hybrid PD to provide potential proposers with information about the SURPASS program, promote discussion, and encourage team networking. During the PD sessions, the proposer community will have opportunities to mailto:SURPASS@arpa-h.gov participate in Lightning Talks and a poster session. Sign-up for these activities will be available through the PD registration site.

Potential proposers are encouraged to attend the optional SURPASS PD. Attendance at this event is not a requirement for submission of a Solution Summary, presentation, full proposal, or selection for funding. The purpose of the PD is to provide information about the SURPASS program, including its goals, scope, timeline, and scale, and to foster potential collaborations and teaming opportunities.

Materials formally presented during the webinar and PD will be posted to the SURPASS program page and SAM.gov.

Advance registration is required to attend the webinar and PD as well as to present during the Lightning Talks session or display a poster during the poster session. Registration requests will be accepted only from the potential proposer community. Participation is not intended for media or general-interest audiences.

ARPA-H will not reimburse potential proposers for participation at the PD (nor for time and effort related to the submission of solution summaries, presentations, or full proposals).

III. SURPASS PROGRAM INFORMATION

Full details of the SURPASS program are provided in the SURPASS Innovative Solutions Opening (ISO)(ARPA-H-SOL-26-164). The following is a brief program overview.

Overview SURPASS envisions a future in which clinical development operates as a continuous learning system rather than as a sequence of disconnected trials. In doing so, SURPASS directly advances the goals of HHS’s Operation TrialBlazer to modernize clinical research, reduce unnecessary delays in drug development, and accelerate the delivery of new therapies while preserving scientific rigor.

SURPASS seeks to shorten the clinical development of drugs and biologics from more than 10 years to fewer than four by establishing Simulation-augmented, real-time Platform Adaptive Seamless Trials. Each Core Platform Team will build a persistent, multi-arm platform designed to function as a disease-focused engine for faster, smarter therapeutic development. These platforms will combine in silico modeling, AI-powered operational infrastructure, shared control information, and advanced adaptive designs to support seamless progression from first-in-patient evaluation through preliminary efficacy or confirmatory assessment.

SURPASS will produce a reusable blueprint for establishing future adaptive seamless platform trials. Key areas of transferable, technical innovation include simulation-based design tools integrated with in silico methods; novel approaches for continuous inference and adaptation;

and AI-enabled operational systems embedded within the platform trial’s clinical operations framework. Core Platform Teams will demonstrate not only that these capabilities can shorten development timelines within SURPASS, but also that the resulting methods, tools, processes, and regulatory precedents can be widely shared to reduce the effort required to establish similar platforms in other disease areas or institutions.

IV. SURPASS – PROPOSERS’ DAY INFORMATION

Proposers’ Day Participation and Deliverables In addition to providing program information to potential proposers, the webinar and PD include opportunities to identify team members. Teaming opportunities will include optional teaming profiles, Lightning Talks, and a poster session. The PD will be hosted as a hybrid event with in-person and virtual options for attendance. Registration is required.

Webinar Information An informational one (1) hour webinar will be hosted virtually on the date specified in Section I.

Registration is required (https://solutions.arpa-h.gov/events). Virtual attendees will receive the link to the webinar once they are verified and registration is confirmed.

Teaming Profiles Interested attendees are invited to submit a ‘teaming profile’ via the link here (https://solutions.arpa-h.gov/teaming). The teaming profile should 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, to include name, organization, email, telephone number, mailing address, and website

• Brief description of the proposer’s technical competencies

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

All teaming profiles must be submitted via the SURPASS Teaming Profile Form Link:

https://solutions.arpa-h.gov/teaming. The teaming profiles will be made available on the program's teaming profile site: https://solutions.arpa-h.gov/teaming/surpass. Participants are solely responsible for specific content, communications, networking, and team formation.

ARPA-H does not endorse any participating organization or exercise any responsibility for improper dissemination of the team profiles.

Lightning Talks Interested attendees are invited to submit one (1) Microsoft PowerPoint or Adobe PDF slide summarizing their interests, capabilities, and relevant research. Slides should focus on how the presenter’s expertise aligns with SURPASS technical areas and will be presented to the full PD audience.

Each submission is limited to one (1) slide. Lightning Talk slots will be accepted on a first-come, first-served basis and require advance registration through the SURPASS Proposers’ Day registration site.

Poster Session In-person attendees are invited to bring a poster (space will be limited; an option to reserve space will be presented at event registration) for the afternoon poster session. The poster session is intended to help members of the proposer community find collaborations. Posters https://solutions.arpa-h.gov/teaming https://solutions.arpa-h.gov/teaming https://solutions.arpa-h.gov/teaming/surpass will not be evaluated by the government team and do not contribute towards the government’s future evaluation of any submitted solution summary or proposal. Posters must fit into a 3.75 x 3.75 foot space. Set-up time will be provided during the lunch break. Posters should illustrate an organization’s technical competencies and potential contributions to SURPASS.

Live Q&A A live Q&A session will be held on Day 1 of the SURPASS PD. Virtual and in-person PD participants are encouraged to use this time to discuss any SURPASS questions you have with our team, including contracting experts. Questions can be submitted to solutions.arpa-h.gov/ask-a-question. Answers will be posted to the SURPASS program webpage: arpa-h.gov/explore-funding/programs/surpass.

Registration Information Participants must register in advance through the registration website to attend the webinar and PD. Registration is also required for attendees wanting to present optional Lightning Talks and posters. The registration cutoff date for the webinar and PD are specified in Section I. Note that there will be no same-day registration. An online registration form and other meeting details can be found at the registration website

Upon entry to the physical meeting, all attendees will be required to present valid, Government issued photo identification. Individuals who are unable to register because the deadline has passed, or capacity has been reached for the PD or for the optional Lightning Talks will be added to a waitlist. If slots remain open after registration closes or become available due to cancellations, the slots will be filled on a first-come, first-served basis from the waitlist.

V. POINTS OF CONTACT

All inquiries should be addressed to SURPASS@arpa-h.gov. Please refer to the SURPASS PD (ARPA-H-SN-26-164) in all correspondence. Prior to submitting an e-mail inquiry, please check the General FAQs (https://arpa-h.gov/explore-funding/submission-resources-and- FAQs/submission-faqs) to see if your question is answered there.

VI. DISCLAIMER

This SN is issued solely for information and potential new program planning purposes; the SN 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 information in response to the 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. 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.

mailto:SURPASS@arpa-h.gov https://arpa-h.gov/explore-funding/submission-resources-and-FAQs/submission-faqs https://arpa-h.gov/explore-funding/submission-resources-and-FAQs/submission-faqs