ADAPT Questions and Answers

There is no limit to the number of solution summaries an entity may submit to the ADAPT program, providing that each proposal submitted has a unique principal investigator and unique solution.

Solution summaries will not be reviewed until after the deadline. 

The scientific review panel will encompass federal employees with the requisite background and expertise to readily grasp the scientific concepts stated in ADAPT. The composition of the review team is confidential. Please address your proposal materials to a broad scientific audience. Specific review criteria may be found in Section 4 of the Master Announcement Instruction file posted at https://sam.gov/opp/28b6849d34ce4268b96c0fb6c1ac6773/view. 

Please access information regarding solution summary (due March 29, 2024) and proposal (due May 6, 2024) submissions from ARPA-H ADAPT Program page. Solution summaries should be submitted at https://solutions.arpa-h.gov/Submit-Solution/. 

It is recommended that the solutions summary be submitted according to how the proposal will be submitted. If proposing as a team, one solution summary should be submitted. Individual solution summaries that only address one portion of a solution (and not that of other team members) are not desired and will likely receive a discouragement for proposal submission. 

A Solution Summary template should be used. The template and information regarding Solution Summary can be found on: https://sam.gov/opp/f0e9b3adcbc147708e152e0bf12fc998/view

Solutions Summaries may be submitted by all interested people. 

Only the summary table provided in the Solution Summary template is requested for the BOE.

The ADAPT team values the time and efforts each potential performer put into submitting a Solution Summary. Please note, in accordance with the ADAPT Solution Summary Special Notice, the ADAPT team may not provide feedback beyond the encourage or discourage recommendation in submitting a full proposal to the ARPA-H ADAPT Module Announcement.

The optional, but highly recommended Solution Summary is due at 10 AM EDT, on March 29, 2024. Details can be found in the Special Notice Request for Solution Summaries.

Curriculum Vitae (CV) are not required for Solution Summary submissions.
 

A reference page is not required; however, proposers may submit references within their Solution Summary. Please note, the government may not review any content beyond the 3-page limit. 

No, it is not required to submit a proposal to the Open BAA/ISO in order to be eligible to submit a proposal to the ADAPT program. 

Commercial entities are welcome to apply to any of the TAs to which their capabilities align.

If you have an idea for a solution summary that is responsive to the ADAPT Module Announcement, you should submit a solution summary to the ADAPT program. 

Keep in mind ARPA-H reserves the right, at its discretion, to reject as non-conforming proposals that it determines are duplicative of previously submitted solution summaries and proposals under this or other ARPA-H solicitations.

Multiple teams from the same entity may submit proposals addressing any TA or combination of TAs to which their capabilities align, provided that each proposal has a unique principal investigator and unique solution.

Yes, it is possible to include foreign collaborators. While ARPA-H will prioritize awards to entities (organization or individuals) that will conduct funded work in the United States, it is not a requirement. 

ARPA-H strongly prefers that clinical trials be performed in the United States. However, trials in other countries will be considered on a case-by-case basis at ARPA-H's discretion.  

There are no preferences for proposer organizations. Academic and industry groups may propose alone or in combination as a team. 

Intramural investigators from NIH may be eligible to apply on a case-by-case basis. Investigators at other organizations who are funded by NIH awards may apply, so long as they can devote the sufficient level of effort to both their NIH and ARPA-H awards and as long as the work funded in both awards is clearly different, as the government cannot provide overlapping funding. 

Proposers may apply to any TA or combination of TAs, regardless of their TA selection during their proposers' day registration. 

No. If the proposer desires to structure their proposal with multiple PIs from the same institution, one must be designated as a primary PI and the remaining must be designated as co-PIs. However, if the proposing team is composed of a prime entity and subcontracting entities, each entity may have its own, separate PI.

The same investigator may be a co-investigator on multiple proposals from the same institution, provided that the investigator could support the level of effort required and there is no duplication of work being funded by the government if all awards were funded. 

The "prime" is the organization that is legally contracted to perform the work for stated in the award. 

A co-PI is a role that can be proposed at the prime or subcontractor level. 

A co-PI may be on two different teams; however, the co-PI's level of effort proposed should be realistic to be performed if both proposals are selected for potential award. 

Teams can form and together submit applications to a single sub-TA, TA, or combination of TAs. The teaming page is provided as a way for you to submit your best proposal. 

You can build your team for your proposal. You can also use the teaming page to find collaborators you would like to work with. 

It's up to the proposer how they want to position the personnel for their proposal. You can propose as a team if you have already identified collaborators, or you may identify a team through the teaming page. 

Teams should consist of relevant experts to accomplish the work that is proposed, though there is not a specific make-up (academic versus commercial) of these entities that is preferred. 

Information regarding Proposers' Day can be found on this special notice and you can find the recording of the Proposers' Day presentation on the ADAPT webpage at. However, we do not disclose participant information.

The costs of generating multi-modal data are covered by TA2. 

Any cloud compute related costs should be listed in the estimate so that ARPA-H may plan for estimated computing needs, however, these costs should not be summed into the budget totals.

The salary cap does not apply to fixed priced Other Transactions.

The locations of the annual meetings are yet to be determined. 

ARPA-H includes metrics in its programs in order to challenge the community to pursue aggressive goals and advance technologies that improve the affordability of today's technologies. Proposers should not submit multiple proposals that are separate but related. Rather proposers are encouraged to submit one novel solution. Additionally, budgets should reflect the estimated level of effort necessary to successfully perform. With that said, ARPA-H has an established budget for the ADAPT program and intends to fund multiple performers under multiple Technical Areas to ensure a diversity of thought. Proposers are discouraged from proposing budgets substantially larger than the MEGA Module level. 

Please download the Task Description Document template which has tables embedded which you can find on SAM.gov.  Please use the tables to fill out your task description information. There is not a margin limit but please use a reasonable margin that does not make it difficult for the reader.

Labor hours refers to the hours each participant will work on the proposed project each year. The average full-time U.S. employee works five days a week for eight hours a day, totaling 40 hours a week. There are 52 weeks in a calendar year. On average, there are 2,080 working hours a year.

The fully burdened labor rate is the workers pay rate with all the added overhead costs included, which effectively gives you your fully loaded employee cost. The labor burden components are just the overhead costs on a per hour basis.

Please use your institution's appropriate federally negotiated rate for your proposal.

Module category levels are inclusive of all costs. 

Budgets should reflect the estimated level of effort necessary to successfully perform. With that said, ARPA-H has an established budget for the ADAPT program and intends to fund multiple performers under multiple Technical Areas to ensure a diversity of thought. Proposers are discouraged from proposing budgets substantially larger than the MEGA Module level.

Per the ADAPT Module Announcement, any proposals that combined TAs (TA1-TA2, TA2-TA3, TA1-TA3, etc.) are anticipated at the MEGA level.

Page restrictions for the Technical & Management proposal are associated with the applicable Module category level. BIT Module is ≤ $2,000,000: Volume 1 shall be limited to 10 pages. BYTE Module is > $2,000,000 ≤ $4,999,999: Volume 1 shall be limited to 15 pages. KILO Module is > $5,000,000 ≤ $10,000,000: Volume 1 shall be limited to 20 pages. MEGA Module is > 10,000,000 ≤ $25,000,000; Volume 1 shall be limited to 25 pages. 

See Amendment 01 to the ADAPT module announcement; Stage 1 Volume 1 proposal should be for the entire program including both Phase I and II. 

Please note, the solicitations states a full cost proposal will be required only if the proposer simply aligned their basis of estimate to the Module Category ceiling value. Thus, basis of estimates should reflect the scale and complexity of the proposed approach. 

Strong proposals will select a cost point that is commensurate with the scale and complexity of the proposed approach; therefore, project costs below the aligned Module category is acceptable. 

Yes.

Per the ADAPT Module Announcement, the government estimates a MEGA Module level for all 6-years of performance. 

 

Proposers should provide a cost proposal that includes a three-year base period followed by another three-year option period. 

Proposers should estimate costs based on historical and present information to include industry trends. Further, rebudgetting in an R&D environment is normal.  

An increase is project costs may be submitted to the Government during contract performance; however, proposers should not assume the Government will agree to the increase in contract costs.   

Proposers should estimate costs based on historical and present information to include industry trends. Further, rebudgetting in an R&D environment is normal.  

An increase in project costs may be submitted to the Government during contract performance; however, proposers should not assume the Government will agree to the increase in contract costs.   

Site specific clinical study costs should be budgeted for by the proposing team, including but not limited to the site start up costs, tumor collection, blood collection, image collection.  

Proposers should provide Basis of Estimate for Stage 1, Volume 1 proposal which includes a three-year base period followed by another three-year option period.  The ADAPT program will continue funding in the option period based on progress.  If your proposal is selected for potential award, proposers will be given additional instructions in the Stage 2, Volume 2 bundle of attachments. 

Yes, the BOE should include costs for the tests proposed in TA2. 

No, such letters are not required.

The government will provide access to a full account/subscription within Azure/AWS/GCP for the performer to use and manage as they need with charges flowing directly back to the government. The performer would be responsible for managing their environment within that provided account/subscription and would be free to create and manage services as Infrastructure as a Service (IaaS), Platform as a Service (PaaS) or Software as a Service (SaaS) as needed including the ability to use the cloud platforms container management services based on Kubernetes, or to create VMs to run Kubernetes as IaaS.

No, a signed letter of intent is not necessary from subaward sites for the Volume 1 proposal.

As ADAPT will award Other Transactions, neither of those formats are applicable. For-Profit organizations, excluding Universities and state and local governments, may propose fixed fee costs. Fixed fee costs are subject to Government negotiation and approval.

Administrative POC is the contact person at your organization for administrative matters.

According to the Small Business Administration, any company that has fewer than 500 employees is a small business, while anything above that is a large business.

Please use October 1st as the project start date. 

Stage 2 Volume 2 proposal requests would happen after selection of a potential award. Proposers can anticipate 2-week turnaround time for submission of Stage 2 Volume 2 proposal; however, the Agreements Officer will speak to proposal extensions and the impact of potential award. 

Page limits apply to everything in the "Volume 1 - Tech & Management" document except the coversheet, table of contents, bibliography, and Task Description Document. 

Based on award requirements, the Government anticipates Other Transactions as the award type. 

You may submit a proposal in response to the ADAPT Module Announcement whether you received an encourage or discourage full proposal response to your Solution Summary. 

The Basis of Estimate may be updated. If you choose to submit a proposal, your basis of estimate should reflect the scope of work proposed. 

If you are a foreign submitter please provide province/country code details on the "Prime Entity Address-Street 2" line and enter any US state / 5 digit numerical zip code.

There is no requirement for institutional signature for Stage I Volume I proposals. 

Yes, multiple proposals can be submitted using the same user account. 

Yes, ADAPT focuses on metastatic breast, lung, and colon cancer due to the timeline of the program.

ADAPT is limited to breast, lung, and colon cancers. However, proposers interested in applying approaches outlined in the ADAPT module announcement to another cancer type may submit a solution summary to receive feedback on their concepts. Nonetheless, ARPA-H reserves the right to focus investments on the types of cancers identified in the ADAPT solicitation. 

Please note that while we highly recommend submission of a solution summary for any other cancer types, full proposals submitted through the ADAPT solicitation that address a different cancer type will be considered non-responsive. 

We are considering new approaches and technologies.  These can be based on past research. 

The intellectual property is owned by the one(s) who developed it.

Proposal submissions should provide novel solutions to address the ADAPT Program objectives.

TA1 performers will receive data from the clinical trial in TA2, and thus, need not provide data independent from the ADAPT program. As mentioned below, TA2 performers will establish the evolutionary clinical trial protocol and infrastructure during the first 6 months of the program in Phase I, Stage I. During this lead time, TA1 performers will be expected to establish a framework for their multi-modal data fusion (TA1.1), resistance trait modeling (TA1.2), and drug response biomarker development (TA1.3) capabilities using either their own, previously obtained data, publicly available data, or synthetic data. This framework will then be further refined when clinical data becomes available from TA2 performers.

PDOs, PDXs, and preclinical models are currently out of scope of the ADAPT program. 

The ADAPT program considers genetic, epigenetic, and phenotypic evolution. 

ADAPT is focused on therapeutic interventions.

Middle data fusion methods are within the scope of ADAPT TA1.

Biomarkers developed using only a single data type are not responsive to ADAPT. A multi-modal biomarker pipeline using diverse data types is required. Please see the ADAPT Module Announcement for more details on TA1.3 requirements. 

No, TA1 proposers need not team with a TA2 proposing team. However, they may do so if they so choose. Those looking to find a partnering team may submit a teaming profile form and view other teaming submissions on the ADAPT teaming page. 

Proposals may address a combination of TA1.2 and TA1.3 together. As stated in the ADAPT module announcement, all performers are expected to collaborate with each other. In the event that performers awarded for TA1.2 and TA1.3 come from independent teams, they will be expected to collaborate. Please read the ADAPT Module Announcement for further details. 

Yes, a preliminary statistical and power analysis is recommended to be included in proposals. You may include estimates.

Mouse models are outside the scope of ADAPT. Wet lab cell-based experiements to confirm resistance mechanisms post-treatment may be proposed.

Yes, you may propose a computational approach for biomarker development with data from the program using a software system. 

Proposers can detail methods and data to highlight the strength of their approach as they best see fit.  

Yes, approaches to model drug tolerance are within scope of ADAPT. 

TA1.1 performers can use historical data to build their methods in addition to the data from the ADAPT trial. 

We welcome diverse solutions and methods from proposers.  Proposers should submit their best ideas and solutions for evaluation.  Please see the ADAPT Module Announcement for requirements.  

TA1.2 proposals may incorporate wet lab assays using human cell lines and human iPSC-derived materials. These experiments may also include primary samples from human patients that have been collected independently of the ADAPT program. Tissue collected as part of the ADAPT program will not be available for TA1.2 experiments. 

No, but TA1.3 proposers should demonstrate past experience with biomarker development including validation using patient data. Proposals should provide a framework for biomarker development that applies across a diversity of cancer types and data types. Therefore, while proposals may include biomarkers that have been developed previously, they must also describe a pipeline that is broadly applicable. 

Performers may use already discovered or new resistance mechanisms identified by TA1.2 performers to inform biomarker development, and may propose to build and refine these biomarkers for standard of care and non standard of care therapies as the data is generated from that stage of the trial. 

We need the source code and algorithm, as well as any external datasets for verification, to independently validate the performance of biomarkers. Any black box algorithms/code are not in scope of the ADAPT program.

No. TA2 performers develop and execute the clinical trials. 

Wearable treatments are out of scope of the ADAPT program at this time. 

These expected enrollment numbers are for all TA2 awards combined. 

ADAPT performers and the ADAPT program team will work closely with officials from the FDA throughout the course of the program to ensure that biomarkers meet all regulatory requirements. 

Tumor measurements will include both tumor intrinsic and extrinsic changes during treatment.

TA2 performers may propose their best recommendations for data types. Data processing, generation and use will be centralized for the ADAPT program.

The ADAPT vision is that most patients are initially treated with standard of care therapies. ARPA-H can provide support to connect proposers with pharmaceutical companies to access later-line therapies, however no guarantees can be given that an agreement with a pharmaceutical company will be reached. Proposers may propose their best treatment plan idea and the ARPA-H team will work with them on next steps, if awarded. 

The ADAPT Program Manager team will select a Contract Research Organization (CRO) that is well suited to manage the regulatory affairs, data management, auditing, clinical trial planning, protocol management, site initiation, recruitment support, clinical monitoring, biomarker testing/integration, sample collection and distribution, among other centralized clinical trial components. TA2 proposals should not include CRO costs in their budgets, nor should they include data storage and analysis costs, as these will be covered by the ADAPT program. 

The centers for the multicenter trial shall be defined by the proposing team. Proposing entities may team with other proposing entities if they find their own capabilities may not be sufficient to meet the metrics regarding patient enrollment and diversity goals. 

While the full list of sites need not be described at the time of proposing, a description of the current sites and plan for identifying additional sites should be included. 

ARPA-H includes metrics in its programs in order to challenge the community to pursue aggressive goals and advance technologies that improve the affordability of today's technologies. Teams are invited to propose innovative solutions that aggressively move toward the metrics.

Teams are invited to propose innovative solutions that are accessible and affordable.

Proposed treatment regimens can include combination therapy strategies.

Proposals to TA2 must address all sub TAs of TA2, and therefore, a proposal to just TA2.1 is not responsive to the ADAPT module announcement. Please visit the ADAPT teaming page if you would like to team up to with groups with capabilities to address TA2.2 and TA2.3. 

TA2 performers propose and budget for tumor measurement technologies. The ADAPT program will select measurements from proposals and ensure appropriate funding for the final measurments selected.

TA2 peformers should address a critial need in metastatic cancer patient treatment that can enroll sufficient patients in the ADAPT timeline as detailed in the Module Announcement.

Initial treatments for biomarkers development are expected to include standard of care treatments. Subsequent lines can include novel therapy strategies that can be carried out in the timeline and metrics described in the Module Announcement.

Please see the Module Announcement ARPA-H-MAI-24-01-03 for program details.

Please see the amendment to the ADAPT Module Announcement at https://sam.gov/opp/28b6849d34ce4268b96c0fb6c1ac6773/view. Figure 2 has been updated. 

ADAPT is focused on therapeutic strategies. Hyperthermia therapies are outside the scope of ADAPT.

Proposers can submit trials for one, two, or all three cancer types.

Yes, the CRO can help with site selection. 

Yes, please do include future therapy adaptations in your solution summary and proposal.

The CRO will store samples.

If the proposal would fulfill the requirements outlined in the ADAPT Module Announcement, you can submit a summary solution for evaluation. Note, it is important to meet the time constraints and metrics of the ADAPT clinical trial.

Please see the ADAPT Module Announcement for budget details. The costs for the trial should be included in the proposal budget. 

No, the CRO will only manage clinical trial related duties such as protocol sharing, trial enrollment, trial site setup, etc. 

Yes.

There may be tissue available from diagnostic biopsies to use for spatial genomics assays, but blood based biomarkers are preferred, as they will be more feasible for sequential measurements. There will not always be tissue available for tissue based assays. 

Proposers may choose how to structure their proposals. 

Individual sites and/or cooperative groups may apply to TA2. 

It is at the proposer's discretion to measure PFS at a reasonable timepoint in the patient's course of therapy. Proposers may propose the measurements that best fit their patient population.  

Yes.

Please see the ADAPT Module Announcement Amendment 02 for an update to the Bundle of Attachment Admin and National Security Document. Clinical Trial Protocol documentation may be submitted in accordance with directions stated therein. 

Clinical trials may be incorporated into proposals if they are capable of fulfilling the requirements outlined in the ADAPT module announcement, including the flexibility to follow patients through multiple lines of therapy and allowing for adjustment based on evolution of the tumor. Further, the existing trial must allow data collected to be centralized under the ADAPT CRO and made available across all ADAPT teams.  

Performers should consider the timeline and metrics of the ADAPT program when considering the scope of their proposals. Should their historical enrollment data suggest they will only be able to enroll sufficient numbers of a particular cancer subtype, they may propose such. 

Clinical trials must span multiple lines of treatment. Trials must include drug therapies; however, radiation therapy can be included in combination. 

Please see the recently posted request for information, 75N992-24-RFI-101, at https://sam.gov/opp/fec9d0926ff5421bb06c9a0fbb81b5f6/view

Any software licensing, non-commercial or commercial, should align with open-source software regime best practices and practices which will meet the objectives of the ADAPT program. 

Harmonization of bulk DNA-seq data with ctDNA-seq and RNA-seq data.

We are looking for innovative solutions from performers. Where the platform is hosted can be discussed if funded. 

ADAPT TA3 performers will work with ADAPT TA1 and TA2 performers on their unique data, algorithms, and clinical trial data, which is focused on translational oncology. BDF TA5 is focused on developing an executable architecture for the myriad of BDF tools.

We welcome diverse solutions and methods from proposers. As stated in the proposer's day and the ADAPT Module Announcement, there will be multiple TA2 performers and trial sites.  

The TA3 platform will be populated with data generated by TA1 and TA2 performers. As proposals are not yet due, these performers have not been selected. 

Performers will be assessed using the metrics and criteria outlined in the ADAPT Module Announcement.