CATALYST FAQ.pdf

CATALYST Frequently Asked Questions (FAQs)

Table of Contents

General

Proposer’s Day

Proposal and Submission

Teaming & Eligibility

Technical & Science Questions

Note

General

1. How have you been advertising these programs to make sure you're reaching labs, researchers, and early-stage investigators?

The programs are primarily advertised via ARPA-H's 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.

2. What advice, if any, do you have for first-time proposers to ARPA-H?

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

Proposer’s Day

1. How do I register for CATALYST Proposer’s Day?

The registration for CATALYST Proposer’s Day has closed.

2. Is a recording of Proposer’s Day available?

The recording of CATALYST’s Proposers' Day will be posted to CATALYST’s webpage once processed. NOTE: the content in the CATALYST Innovation Solutions Opening (ISO) supersedes any information presented in the recording.

Proposal and Submission

1. Where can I find the solicitation for the CATALYST Program?

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.

2. Where can I find the proposal attachments?

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.

3. Can we receive feedback or guidance on a technology, concept, or idea prior to the submission of the Solution

Summary?

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.

4. When is the Solution Summary due?

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

5. Is there a limit to the number of Solution Summaries an organization can submit?

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.

6. Who is allowed to submit a Solution Summary or Full Proposal?

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

7. Do you require preliminary data for the application?

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.

8. Is a Solution Summary required for Full Proposal submission?

Yes, a Solution Summary is required.

9. Do the Cover Page and ROM section of the Solution Summaries counted as part of the 4 pages allocated for the proposed work?

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.

10. How is the Solution Summary reviewed?

https://sam.gov/opp/325e7a5a97124b6b9b4916818e88cb91/view

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.

11. When would proposers be notified if they are encouraged or discouraged from submitting 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.

12. How will full proposals be evaluated?

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.

13. How are reviewers selected, and who is reviewing the technical merit of the proposal?

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.

14. Are Letters of Opportunity/Intent required?

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

15. Will developed technology IP be shared?

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.

16. How do we budget for employees?

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

17. Are detailed budgets necessary for submission?

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.

18. How are larger teams usually managed?

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.

19. Is there an advantage to covering all TAs vs just TA1, or TA2+TA3?

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)

20. Do we need to identify a Product Sponsor prior to submitting a Solution Summary?

https://www.youtube.com/watch?v=x4zVNeSYcvk https://www.youtube.com/watch?v=x4zVNeSYcvk

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.

21. Does the product sponsor need to be a major pharmaceutical company?

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.

22. What stage of discovery does the Product Sponsor need to be?

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.

23. Do you authorize pre-award costs to facilitate with recruitment of employees?

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

24. If we submit early, will we be reviewed early?

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

25. Is there a preference for developed AI vs pre-existing AI?

There is no preference.

26. Can some aspects of the project (models/tools/products) be repurposed?

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

27. Are multiple partners (Product Sponsors) OK?

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.

28. What is the budget threshold and can you provide total budget for the program?

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.

29. Can you use public datasets?

Yes, that is acceptable.

30. Is it acceptable to transition through different TAs throughout the project?

Yes, that is acceptable.

31. What would you fund in Phase II?

CATALYST would support IND-enabling work in Phase II.

32. Do we have to have legal documents in the Full Proposal?

Legal documents are not required at the proposal submission stage.

33. Are there any restrictions on an academic, biotech, or biopharma company submitting a proposal?

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.

34. If we get past Phase I and we want to open up to additional partners, is that OK?

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

35. Can we outsource work to vendors to perform work who are not in the teaming structure, like a Contract

Research Organization (CRO)?

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

36. Does the opportunity consider cosmetic products in addition to pharmaceutics?

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

37. What would be considered a good product sponsor?

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.

Teaming & Eligibility

1. Is there a template for teaming compliance?

There is not. However, there are samples on ARPA-H’s Other Transaction Community website: https://arpa-h.gov/engage-and-transition/other-transaction-community/templates-and-samples. In addition, DARPA has provided a sample on their website: https://acquisitioninnovation.darpa.mil/docs/Samples/12%20- %20SAMPLE%20OT(R)%20-%20Expenditure%20Consortium%20-%202024.06.20.docx.

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.

2. How do I sign up to the Teaming Page to initiate collaboration with others who may be interested in the

CATALYST program?

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

3. Can there be two or more PIs on the proposal?

https://arpa-h.gov/engage-and-transition/other-transaction-community/templates-and-samples https://arpa-h.gov/engage-and-transition/other-transaction-community/templates-and-samples https://acquisitioninnovation.darpa.mil/docs/Samples/12%20-%20SAMPLE%20OT(R)%20-%20Expenditure%20Consortium%20-%202024.06.20.docx https://acquisitioninnovation.darpa.mil/docs/Samples/12%20-%20SAMPLE%20OT(R)%20-%20Expenditure%20Consortium%20-%202024.06.20.docx https://arpa-h.gov/research-and-funding/programs/catalyst/teaming

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.

4. Can proposers be part of multiple proposals?

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.

5. What is the maximum number of teams and/or people for each proposal?

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.

6. Are international performers eligible to submit proposals for consideration?

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.

7. Is a non-U.S. company eligible to apply for the CATALYST program?

Non-U.S. entities may participate to the extent that such participants comply with any necessary nondisclosure agreements, security regulations, export control laws, and other governing statutes applicable under the circumstances. However, non-U.S. entities are encouraged to collaborate with domestic U.S. entities.

8. When do members of the performing team need to be named/selected?

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.

9. What is needed to demonstrate the unique capability of my program for FFRDC or Government entity participation?

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.

10. Is it more beneficial to apply as a company or as an academic institution?

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.

11. What is the breadth of clinical indications in applying?

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

12. Will ARPA-H assist in team matching for application improvement?

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

13. How can Product Sponsors assess proposers to decide who might be of interest to partner with, between the

Solution Summary phase and the Product Sponsor requirement 12 months into Phase I?

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.

Technical & Science Questions

1. Which technical area should I apply to?

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.

2. Do you intend to hold us to the metrics in the R&D Solicitation?

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.

3. Will ARPA-H provide/facilitate access to relevant healthcare data?

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).

4. In TA1 metrics table, the Data standardization requirements for repository platforms includes "...creating sets of ontologies (at least 20 for each data type)". While I recognize that these are meant to be directional, what's the rationale for 20 ontologies for each data type?

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”.

5. Is the inclusion of real-time, real-world human data in the data generation or validation process both permissible and encouraged in the TA2 task?

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.

6. Could TA2 capabilities for wet lab experimentation be done in-house by the Product Sponsor for Option B proposal submission option (Page 9 of the ISO). Similarly, can the Product Sponsor and the tool developer be the same entity?

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.

7. For TA1, must datasets collected and harmonized across public sources be made publicly available and if we train models using proprietary data does this need to be published?

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.

8. For the Product Sponsor, does the product have to be publicly shared?

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.

9. Are animal studies or animal MPSs allowed for CATALYST?

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.

10. It appears the end objectives for TA1 and TA3 are similar. What are the differences between the two?

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.

11. Can our TA2 development focus on a specific target population?

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.

12. Is having a drug candidate in Phase I a success metric?

No. Platform success is measured, not drug candidates.

13. If the 36-month timeline is met early, could Phase II be triggered sooner?

Yes. CATALYST program can trigger the next phase early.

14. Is a specific living systems tool, such as lung tissue samples that reflect population diversity, an acceptable approach for TA2 or does TA2 require comprehensive multiorgan ADME-Tox?

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.

15. Can technologies, such as cell printing assays that are not described in the ISO, be used for TA2 metrics?

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.

16. Are there any preferences in modality?

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.

17. Our approach involves disease modeling or uses a disease model as a proof of concept. Is that in scope?

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.

18. Is there a preferred focus between safety/toxicity and efficacy?

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

19. Is it possible to secure funding for multiple Investigational New Drug (IND) enabling studies, or is the funding limited to only one? Additionally, if there are several Product Sponsors within the group, would this allow for more IND studies to receive funding, and would such a scenario fall within the scope of CATALYST?

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.

20. Will the FDA approve the in silico methodologies produced by CATALYST for use in regulatory review?

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.

Note

For further questions, please refer to the CATALYST ISO or contact CATALYST@arpa-h.gov. The FAQ may be updated within 14 days pending received inquiries.

The latest version of the CATALYST 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.

https://sam.gov/opp/325e7a5a97124b6b9b4916818e88cb91/view mailto:CATALYST@ARPA-H.gov https://sam.gov/opp/325e7a5a97124b6b9b4916818e88cb91/view