CATALYST Frequently Asked Questions

The programs are primarily advertised via ARPA-H's website, Vitals newsletter, and ARPA-H's official LinkedIn profile. Please encourage your network to sign up for the Vitals newsletter to stay up-to-date on all of ARPA-H's programs and activities.

Please carefully read the latest ISO, which contains all the necessary information.

No, in accordance with 5.2.1, the cover page and Rough Order of Magnitude (ROM) or Basis of Estimate (BOE) are excluded fromthe 4-page limit, but should still follow the formatting guidelines in Appendix A.

The CATALYST ISO can be found here on SAM.gov. The final version was released on November 1st, 2024. The latest version of the ISO supersedes any information presented in other publications, and sets forth the requirements for Full Proposals, the criteria for the evaluation, and instructions for the submission.   

The bundle of attachments for the CATALYST program will contain proposal submission templates and a Model Agreement (Other Transaction) with basic terms and conditions. The bundles will be provided to proposers who are encouraged to submit a proposal.  For proposers who are not encouraged to submit a proposal, they may request the bundle of attachments upon receiving notice that they are not encouraged to submit a proposal.

ARPA-H cannot provide formal approval or feedback on a specific technology, concept or idea prior to the submission of a Solution Summary. Refer to the language in the ISO to determine fitness. Feedback on the fit of specific technology will be provided following Solution Summary submission.

The Solution Summary for CATALYST is due by November 25th, 2024, at 5:00 PM ET.

There is no limitation on a team being part of multiple submissions. However, a team can only take one lead role with a significant effort on a project. 

All eligible entities as defined in the CATALYST ISO Section 4.1 may submit Solution Summaries.

Preliminary data are not required for the Solution Summary submission. Outside of guidance within the ISO, including Appendices, ARPA-H cannot advise proposers in terms of Solution Summary and/or Full Proposal strategy and content. Solution Summaries will be reviewed, and Full Proposals will be evaluated as described in the ISO Section 6. Proposers should prepare submissions accordingly. 

Yes, a Solution Summary is required.

The Team Organization and Capabilities, R&D timeline, and Rough Order of Magnitude (ROM) are not included in the 4-page limit, but should adhere to the formatting and length guidelines in Appendix A

ARPA-H will review conforming Solution Summaries and provide written feedback. At a minimum, feedback will encourage or discourage submission of Full Proposal. Feedback will be sent to the administrative and technical points of contact noted on the Solution Summary cover page. Regardless of whether the proposer is encouraged to submit a proposal in response to the ISO, it is eligible to do so. Solution Summaries must be submitted in accordance with the requirements of Section 6.1 and Solution Summary feedback must be received prior to submission of a proposal.

Responses and decisions will be sent to the email recorded in the submission system once the review process is complete. Additional details and instructions will be shared at that time.

Full Proposals are evaluated against the four criteria in the ISO (see Section 6). In addition to the criteria, carefully read the ISO to meet requirements and recommendations such as ELSI, equity, and data sharing.

Full Proposals will be evaluated by Government Reviewers who may be ARPA-H PMs or qualified personnel from other Government Organizations and Agencies who are deemed proficient in the pertinent research areas of the solicitation.

Letters of Opportunity/Intent are not required, instead you will be required to submit a Solution Summary, which functions as an LOI.

ARPA-H will require the underlying raw data used to generate the technology to be shared by the end of the program, but the IP does not need to be disclosed.  The CATALYST program aims for the innovative platforms that are developed to achieve commercial success through widespread usage and, therefore, expects the IP to be protected.

Please use the HHS guidelines for salary rate limitations. Salaries must be proposed beneath that rate limitation.

The Solution Summary requires a rough overview of the cost, while the Full Proposal requires more detail and needs to include at minimum a planned budget for Product Sponsor involvement.

A typical teaming organization includes a lead member and an administrative core to facilitate management and execution of proposed work. Please refer to the Business Innovation Division talk during the CATALYST Proposers' Day Presentation, approximately at the 1:02:30 mark, for more details.

There is no advantage to covering all TAs, as long as the proposal adheres to one of the three proposal options that are described in the ISO (see Section 2.3.3)

Product Sponsor identification is not required for Solution Summary submission. We encourage Full Proposal submissions to have one identified. However, a selected performer team will have 12 months after their full proposal is under contract to confirm their Product Sponsor.

No, the product sponsor can be anyone, such as major pharma, small start-up, non-profit, or academia, who has a potential drug candidate that will go into the clinic. Regardless of the size and characteristics of the Product Sponsor, the emphasis should be on alignment of the developing tools to their needs to address unmet needs in therapeutics development.

Within the context of the program, there are 36 months to assess in silico on a candidate. The Product Sponsor should be within 2-3 years of going into clinical studies, or ready to go into clinical studies with funding.

Pre-award costs will not be reimbursed unless a pre-award agreement is negotiated prior to award.

Reviews are done after the submission deadline. There is no benefit to submitting early.

There is no preference.

Yes, they can be repurposed as long as they meet the solicitation requirements and are not currently funded by another government agency.

Yes, a few partners (Product Sponsors) with different context of use, different requirements, different timelines are acceptable and can be used as a risk mitigation strategy. 

There is no threshold, but you should budget realistically. The budget should reflect the most technical and reasonable estimate of how to complete the tasks. Furthermore, budget alone does not determine selectability.

Yes, that is acceptable.

Yes, that is acceptable.

CATALYST would support IND-enabling work in Phase II.

Legal documents are not required at the proposal submission stage.

No there are no restrictions except for the involvement of federal government entities and FFRDCs. Proposers can develop a team consisting of any of the eligible groups. Please review eligibility requirements in the ISO.

Yes, teaming can be flexible and can change throughout Phase I and Phase II.

Yes, commercial vendors and consultants are acceptable. However, any entity performing research in an investigator role is expected to be a team member.

Cosmetic products are not within the scope of the CATALYST program.

The most important characteristics of a successful Product Sponsor would be having a candidate that meets an unmet need in the population, supported by underlying preclinical data.

MTDC is federal financial assistance (i.e., grants and cooperative agreements) terminology. CATALYST awards will be made as Other Transactions (OT) and OTs are not subject to the specific laws, regulations, and policies applicable to federal financial assistance awards. However, the Government expects proposing teams to faithfully follow their standard financial procedures when proposing to the CATALYST program.

ARPA-H intends to sign an Other Transaction agreement (OT) with the administrative agent for the team.  The team is expected to have a team membership agreement which makes the entire team responsible for the OT. A sample ARPA-H OT is available here: Sample OT. However, proposers are cautioned that it is a sample, and any resultant OT will likely be unique in construction. More information about the ARPA-H OT Community is available online: Other Transaction Community | ARPA-H

We intend to allow submission of sanitized proposals via the lead and agent direct submission of un-sanitized proposals to the government. 

There is not. However, there are samples on ARPA-H’s Other Transaction Community webpage. In addition, DARPA has provided a sample on their website.

Please note that that the samples should not be seen as prescriptive or required by ARPA-H. Teams are fully empowered to craft their teaming agreement to their needs and not rely on either sample. It is the team’s responsibility to ensure that their teaming agreement is tailored to their needs and is streamlined to effectuate an ARPA-H program, with tight timelines and ambitious milestones. Teams are also reminded that the ISO includes minimum requirements for all teams in Section 4 of the ISO that must be reflected in the teaming agreement. Additionally, teams are not required to use the “consortium” nomenclature to describe their teaming agreement as is used in the samples. Lastly, please note that statutory and other references in the sample do not necessarily apply to ARPA-H, the teaming agreement, or the CATALYST program.

Please use this link to submit an update to the teaming profile. 

Unlike a prime/subperformer arrangement where the prime performer is the leader of the team throughout, the teaming structure of the CATALYST program allows different members of the team to take the lead role at different stages of the program life cycle based on expertise and experience.

There is no limitation on a team being part of multiple submissions. However, a team can only take one lead role with a significant effort on a project. 

There is no maximum number. Proposers are responsible for proposing a team capable of meeting the proposed Statement of Work, recognizing the Government is evaluating team capability as well as price reasonableness.

Yes, non-U.S. entities are allowed to submit proposals for consideration. Non-U.S. entities are encouraged to collaborate with domestic U.S. entities. 

Key members of the Proposer's team should be identified as early as possible (e.g., Solution Summary). Failure to identify key personnel (e.g., Project Manager) and/or partners may impact the Government's evaluation. Product Sponsors need to be identified by 12 months after the project start. Proposers are encouraged to provide as many specific details as are available at the time of submission, while considering page limitations at each submission stage.

Documentation should demonstrate that the FFRDC has a unique capability without which their solution is unachievable and that the proposer team has exhausted all other options. This will be reviewed by ARPA-H to determine if inclusion is necessary. See CATALYST ISO Section 4.2 for more details.

There is no preference of the characteristics of the proposer team. Please see CATALYST ISO Section 4. Note that a key objective of CATALYST is the development of a digital CRO capability that can survive in the wild, so academic institutions should come with a strategy for commercialization or sustainable access for the CATALYST tool. This will likely require maintaining certifications, getting GLP accreditation, providing infrastructure and access, etc., which may be challenging for purely academic groups. Therefore, providing detailed strategies for licensing or spin-out to transition the technologies to commercialization could make a strong proposal.

Please refer to Section 2.4 PROGRAM GOALS AND METRICS which describes the breadth of clinical indications requested by each potential performing team.

ARPA-H does not facilitate team matching. Lightning talk slides and teaming requests are available for proposers to utilize for teaming.

Solution Summaries and Full Proposals are proprietary information and will not be shared beyond the CATALYST team. However, CATALYST is exploring mechanisms to allow potential Product Sponsors who take a “wait and see” approach to follow along during Phase I to inform their teaming approach prior to the Phase I Product Sponsor deadline. It is encouraged for Product Sponsors to reach out and participate in teaming early on.

No, a proposer team does not require a formal agreement during the Solution Summary phase.

ARPA-H cannot advise as to strategy and/or content of Solution Summaries and Full Proposals. Proposers must use the guidance in the ISO as well as their professional expertise when preparing submissions.

Unless indicated otherwise in the ISO (i.e., written as suggested), the CATALYST program metrics in the ISO are requirements for proposers. Proposals that do not propose to meet the metrics will be evaluated accordingly.  Proposers are expected to define success metrics appropriate for respective proposal and technology meaning not all metrics need to be addressed in a proposal and proposers can offer their own metrics and explain how these metrics show a quantitative or qualitative improvement compared to current best practices. Once agreed upon negotiation and approval with the Program Manager, the proposers are accountable to the final metrics.

Proposals should not assume provision of any Government Furnished Information (GFI). The Government may provide GFI, but the specific GFI would be negotiated after a proposal is selected for award negotiations (i.e., a proposal must stand on its own without assumptions and conditions related to GFI).

As the questioner correctly recognizes, the metrics are guidelines for the program and for developing projects. The particular metrics is written to encourage the generation of “comprehensive sets of ontologies”. 

Yes, those activities are acceptable. Please keep in mind that the TAs should reflect the predictive platform the team is building, with the ultimate goal of using the platform for regulatory approval purposes.

There is no limitation on how a team is built. The proposal should clearly distinguish the roles of each TA, even if one organization is interested in covering all TAs as well as the Product Sponsor role.

We would like the training data to be shared as much as possible. However, if this impedes the commercialization of the technology developed by CATALYST, we are using an OT to allow for negotiation. This will occur during the contract negotiation, through which we can reach a mutually agreeable understanding on data sharing.

The products themselves do not need to be publicly shared. In Phase II, if the products are successful, we would like the results of the IND-enabling studies to be published, but candidates themselves do not need to be.

Yes, these experiments are acceptable for intermediate data generation and tool validation. Please also ensure that these experiments align with the objectives of your proposal.

TA1 utilizes AI/ML technologies, while TA3 employs mechanistic models. These two approaches can intermingle during platform development if Option C proposal submission option is employed, and the metrics will guide the proposal on how to integrate these approaches effectively.

The targeting of a special subpopulation approach is acceptable. The development should keep in mind that the requirements can depend on the drug candidate, and the final platform should be generalizable to meet the program goal.

No. Platform success is measured, not drug candidates.

Yes. CATALYST program can trigger the next phase early.

Both approaches are acceptable. Please keep in mind that the requirements can depend on the final product the team is pursuing and also on the generalizability of the tool for regulatory application purposes. For single tissue versus whole-body approaches, CATALYST seeks to replace existing animal models that are used for ADME-Tox, so if the proposer believes their approach can improve on a more specific use case for an animal model, this is within scope.

Yes, the metrics exist as guidance. Proposing teams can offer their own metrics and explain how these metrics demonstrate a quantitative improvement compared to current best practices.

No. Both biologics and small molecule approaches are acceptable. In terms of disease and drug candidates, the proposal should focus on disease areas or drug candidates with significant unmet needs and high potential impact on equity and accessibility. 

CATALYST focuses on simulating Phase I-typical healthy physiology for ADME-Tox. There are some potential uses for disease-relevant ADME-Tox such as doing clinical trials in a disease model, but that should be in addition to – and not in place of – simulation in healthy individuals.

CATALYST focuses more on safety and toxicity to minimize overlapping with other agencies' funding efforts.

As addressed elsewhere in the FAQ, the involvement of multiple Product Sponsors with multiple candidates can be a risk mitigation strategy. However, the CATALYST program neither encourages nor discourages this strategy. The proposal should consider reasonableness in funding requests. From a programmatic point of view, the CATALYST team aims to diversify the performers for the overall success of the program within the budget limitations.

The FDA is a formal partner of the program and part of CATALYST’s government advisory team. The program can facilitate conversations between the FDA and the Product Sponsors to identify specific programs within CDER and CBER that align with the needs of the Product Sponsors. The FDA is amenable to the CATALYST approach, and it aligns with the FDA’s goal for predictive alternative approaches. The Phase I activities for performer teams include identifying context of use and understanding qualifications for FDA-approved product development. Therefore, it is important for Product Sponsors to be a part of this discussion and to lead engagement with our FDA partners early and often in Phase I.

The CATALYST program expects the proposing team to focus on replacing an in vivo method that is less than perfect but required in pre-IND studies. If you can perform tissue-specific toxicity (e.g., nephrotoxicity, cardiotoxicity, hepatotoxicity, etc.) in silico such that it can replace an animal model used for that toxicity evaluation, it is within scope. You can, of course, pursue all three or more, provided it is sufficiently robust to replace all tissues being studied in vivo. The guideline of three tissues in the ISO metrics is aspirational, but a focus on one, done well, can potentially meet program requirements.

During Phase II, the TAs will refine the platform based on the data produced and the feedback from the Product Sponsors

Yes, those activities are acceptable.

The technology development beyond what is described in ISO Section 2.41, Table 1, will not be considered.

Improvements in clinical trial enrollment and recruitment are out of scope for CATALYST.  

The goal of CATALYST is to develop a fully in silico platform independent of in vitro experiments.