Computational ADME Tox AnaLYsis for Safer Therapeutics (CATALYST) Innovative Solutions Opening

Closed Solicitation Posted Nov 1, 2024

Solicitation number: ARPA-H-SOL-24-114
Agency: National Institutes of Health Department of Health and Human Services
Responses due: Feb 14, 2025, 5:00 PM ET
Set-aside: No set-aside

Opportunity facts

NAICS code: 541714 Research and Development in Biotechnology (except Nanobiotechnology)
PSC: AN13 Health R&D Services; Health Care Services; Experimental Development
Place of performance: Washington, District of Columbia, United States
Points of contact: CATALYST Email catalyst@arpa-h.gov

Notice details come from SAM.gov. Updated Jan 16, 2025.

About this opportunity

Written by GovTribe AI · Jan 16, 2025

The Advanced Research Projects Agency for Health (ARPA-H) is seeking computational solutions to develop advanced AI/ML-enabled in silico human physiology modeling platforms for ADME-Tox (Absorption, Distribution, Metabolism, Excretion, and Toxicity) simulation, with the goal of replacing traditional preclinical animal studies in drug development. This solicitation is structured as an Innovative Solutions Opening (ISO) and anticipates multiple other transaction awards across three technical areas: TA1, TA2, and TA3. Solution summaries are due by November 25, 2024, at 5:00 PM ET, with full proposals due on January 31, 2025, and interested parties must submit through the designated ARPA-H solutions submission website. Proposals will be evaluated based on four key criteria outlined in the solicitation, with reviews conducted by ARPA-H program managers and qualified government personnel. Proposers can submit solutions for individual technical areas or combinations thereof, with flexibility to transition between areas during the project lifecycle.

The contract opportunity is not designated with a specific set-aside and will be administered by the Department of Health and Human Services National Institutes of Health, with the primary place of performance located in Washington, DC. The program is structured in two phases: Phase I focuses on accelerated technology development and method qualification, while Phase II will demonstrate the capability of in silico platforms for novel drug development. International entities are eligible to participate, with proposers allowed to be part of multiple submissions but limited to a lead role in one project. While specific award values are not explicitly stated, the program aims to create predictive modeling platforms for qualified drug safety applications, leveraging public, governmental, and newly generated data. The solicitation falls under the NAICS category 541714 for Research and Development in Biotechnology and PSC category AN13 for Health R&D Services, indicating a focus on innovative biotechnological research and development.

Notice text

6 versions

As posted on SAM.gov.

Update #6 · Latest · Jan 16, 2025

The purpose of the amendment is to extend the due date for proposals to February 14, 2025 at 5PM ET.

In addition, the amendment clarifies a discrepancy between the Cost Proposal Narrative and Cost Proposal Spreadsheet bundle attachments. Specifically, the amendment clarifies that any material and equipment item exceeding $5,000 requires back-up documentation (e.g., copy of catalog price lists, past purchase order or invoice, or vendor quotes prior to purchase).

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The purpose of the amendment is provide the website address for the program FAQ. Please see below:

https://arpa-h.gov/research-and-funding/programs/catalyst/faqs

Please visit the FAQ for updates as Questions & Answers may be added prior to the closing date for receipt of proposals.

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The purpose of the amendment is provide a correction to the Bundle of Attachments. Specifically:

1. ARPA-H ADMIN & NATIONAL POLICY (Other Transaction) is updated to add paragraph 11. Synthetic Nucleic Acids Or Benchtop Nucleic Acid Synthesis Equipment.

2. ARPA-H TECH & MANAGEMENT is updated to correct the page limit to thirty-five (35) pages. In addition, the language regarding team members, subawardees, subcontractors, vendors, etc. has been updated to better reflect the program structure.

No changes were made to the other Bundle of Attachment documents.

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The purpose of the amendment is provide the proposal Bundle of Attachments.

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The purpose of the amendment is provide an FAQ for the program. Please see the below attachment.

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The Advanced Research Projects Agency for Health (ARPA-H) posts this Innovative Solutions Opening (ISO) in support of its Computational ADME Tox AnaLYsis for Safer Therapeutics (CATALYST) Program. ARPA-H anticipates multiple other transaction awards.

Interested parties are invited to review the attached CATALYST ISO. Solution summaries are due November 25, 2024, 5:00 PM ET. A solution summary must be submitted to submit a proposal. Submissions must be made to:

Solution Summary Submission Site: https://solutions.arpa-h.gov/Submit-Solution/
Proposal Submission Site: https://solutions.arpa-h.gov/Submit-Proposal/
Proposal Submission Questions: https://solutions.arpa-h.gov/Ask-A-Question/

Please ensure to follow this opportunity for any updates.

For more information about CATALYST, please visit this website: https://arpa-h.gov/research-and-funding/programs/catalyst

Update #5 · Jan 13, 2025