No. One-on-one discussions between potential proposers and the BIOGAMI team should be requested as sidebars during Proposers' Day.

Correct, BIOGAMI requires two indications. The indications may be one rare NDD and one non-rare, non-NDD, or one non-rare NDD and one rare non-NDD.

BIOGAMI is not prescriptive towards a breadth vs depth approach. Proposers should describe their methods and justify their choice towards achieving the end goal of a highly accurate computational tool that can be applied to any intrinsically disordered protein.

BIOGAMI is agnostic to both therapeutic modality as well as delivery technology.

BIOGAMI is not prescriptive with respect to specific IDR targets or clinical indications, so long as the requirements for neurodegenerative disease and non-neurodegenerative disease, and rare and non-rare disease are met as stipulated by the ISO. 

Although BIOGAMI does not have a clinical component within the program requirements, the ultimate goal of clinical translation is important. A clinician is not required, but could be part of a proposing team as a research member, consultant, or member of the Translation Advisory Board. 

No. The BIOGAMI ISO does not include an affordability/accessibility requirement.

Protein-protein interactions should be mapped with respect to the IDP of interest and identified in the context of misfolding/aggregation. Protein-protein interactions should inform both protein function and how key functions are lost through misfolding/aggregation. Conversely, new interactions formed could inform toxic gain of function based on conformational changes.

Per Section 2.5 of the ISO, BIOGAMI proposers must agree to openly share deidentified/sanitized data acquired through TA1 activities during the period of performance. This requirement, however, does not presuppose prior open-source data sharing.

No. BIOGAMI proposals must address two disease indications to be conforming. 

While solutions that modulate IDR folding to prevent aggregation are desired, BIOGAMI will consider solutions that modulate features of aggregated proteins to facilitate their dissolution or removal with emphasis on restoration of healthy protein function. Incremental improvements to existing therapies targeting downstream aggregates (passive immunotherapy, etc.) that do not build on novel BIOGAMI TA1 approaches to transform efficacy are out of scope. 

BIOGAMI is open to both intracellular and extracellular interventions. 

Per Table 3, BIOGAMI requires demonstration of efficacy in a pre-clinical animal model and preliminary safety studies to investigate off-target activity. 

Yes. BIOGAMI is considered protein targets within scope if they contain one or more disordered domains. Disorder across the entire length of the protein is not required. 

No. BIOGAMI requires proposers to diversify applications of their TA1 models of IDR molecular grammar towards developing modulators and indicators of two separate protein targets.

BIOGAMI is not prescriptive as to the types of entities performing the work. All entities must be supported by cost proposal documentation.

Yes. A key BIOGAMI deliverable is Task 5: a computational platform that predicts target IDR protein properties (IDR structure, dynamics, biomolecular condensate formation, aggregation, and interactome informing protein function). 

No.

No. BIOGAMI proposers must identify their two disease indications including suspected or targeted mechanism of action for their proposed solution, along with recent literature citation(s) and/or evidence supporting the presence of IDR misfolding and/or aggregation in their chosen disease indication.

Yes, foreign CROs are permitted as BIOGAMI team members.

BIOGAMI is seeking innovative technical solutions to control protein structure after it has been translated. Proposed solutions that alter the upstream DNA or mRNA sequences are not within scope. 

Each of the mandatory requirements must be addressed directly and in detail in the full proposal. A Solution Summary should mention the mandatory requirements, but need not be as specific. For example, TA1 requires providing information regarding model throughput, scaling and speed. At the Solution Summary stage, this information could be provided as a notional range or approximation.

BIOGAMI aims to restore disordered protein function and proper folding that results from a wide variety of mechanisms – mutations, aberrant post-translational modifications, mislocalization, etc. IDP dysfunction could manifest as overt aggregation as well as conformational changes that inactivate protein function. Efforts to predict and model IDP dysfunction that result in misfolding, aberrant phase separation, and aggregation (whether fibrils or smaller structures) are within scope.

No. BIOGAMI is agnostic towards therapeutic modality as well as mechanism of action. 

Yes, the interactome can and should include interactions with both proteins and other molecules. 

Yes, TA1 models should be broadly applicable to both.  

Both are in scope. TA1 modeling should be expansive. 

Preliminary targets should be proposed, however there is flexibility to change during negotiations or later in the program during the performance phase based on data collected.  

As the BIOGAMI program aims to restore function(s) of IDPs, pure protein degrader approaches are out of scope unless they modulate the IDP by degrading an interacting protein. 

Yes, proposers may either build new foundational models of IDPs from scratch, or improve existing models as long as the approach accomplishes all the goals of BIOGAMI and is well-described and justified.

No central data repository is required. Proposals should address data management for the proposing team. 

No, but partnerships or letters of support are welcome.

TA1 data and models must be made public within a year of generation and as part of resulting publications.

Yes, post-translational modification is within scope if the modification directly modulates protein misfolding or aggregation.

 The US currently defines a rare disease as a condition affecting fewer than 200,000 people, which roughly corresponds to a fewer than 60 out of 100,000 people. By this definition, the chosen indications satisfy the BIOGAMI requirements. 

Yes. Many diseases stem from dysfunction of the same protein. To be responsive, the proposal should describe unique features of the rare disease etiology, as well as how the modulator strategy would focus on those unique features.

No. Although some NDD and non-NDD conditions may stem from dysfunction of the same underlying protein, proposers must select two separate protein targets for the two disease indications.

The BIOGAMI ISO prefers the 1 in 100,000 individual delineation for rare disease; however, the US currently defines a rare disease as a condition affecting fewer than 200,000 people, which roughly corresponds to a fewer than 60 out of 100,000 people so disease indications under this threshold will be considered. Because Light Chain Amyloidosis has an estimated incidence of approximately 1 case per 100,000, the indication satisfies BIOGAMI requirements.

The BIOGAMI ISO prefers the 1 in 100,000 individual delineation for rare disease; however, the US currently defines a rare disease as a condition affecting fewer than 200,000 people, which roughly corresponds to a fewer than 60 out of 100,000 people so disease indications under this threshold will be considered.

Yes. Any aberrant behavior of intrinsically disordered proteins – whether misfolding, oligomerization, condensate formation, fibril formation, etc. - is within scope of BIOGAMI as long as the link to disease is supported in the proposal.

Both of these disease indications fall within the NDD domain, and thus a conforming proposal would need to include a non-NDD indication.

While organoids can be used as part of TA1 experimental platforms and TA2 therapeutic lead characterization, BIOGAMI requires efficacy testing in an animal model at the end of Phase 2. However, if no appropriate animal model exists, proposers must discuss limitations of existing in vivo approaches and why an organoid system is superior. 

In the context of the BIOGAMI ISO, the guidance for a rare disease is prevalence of fewer than one in 100,000 people currently living with the disease in the US. However, diseases meeting the more common definition of rare disease in the US (affecting fewer than 200,000 people or fewer than 60 in 100,000) will be accepted with justification. 

BIOGAMI solution summaries are due March 4.  If you are interested in being part of a submitting team, please consult the BIOGAMI Teaming Page to submit a Teaming Profile and identify potential collaborators. 

No, there is no maximum team size for BIOGAMI submissions. Teams should have the expertise and capacity to achieve the goals of the proposed work.

Yes, individuals may participate on more than one team and be listed on multiple submissions. There is no restriction on being part of multiple teams. 

The consortium agreement does not need to be signed prior to proposal submission, but it should be formalized by the time of award.

Section 2.8 of the BIOGAMI ISO describes the requirements for a multi-party teaming arrangement structure. The multi-party team generally chooses one member to act as the agent and/or lead member for administration and reporting purposes. There is no preference for the lead member to be a for-profit company or a research institution.

Section 2.8 of the BIOGAMI ISO describes the requirements for a multi-party teaming arrangement structure, which is distinct from the traditional NIH model. In this structure, leadership can change among team members based on expertise and project phase. The multi-party team generally chooses one member to act as the agent and/or lead member for administration and reporting purposes, but this agent does not need to be the lead performing organization. The ISO does not prescribe specific titles (such as Executive Director, Scientific Director, and Principal Investigator) for team leadership. Instead, proposals should clearly describe the anticipated leadership structure and changes throughout the program. The key is to demonstrate a flexible, dynamic team structure that meets the program’s requirements.

Teaming Profiles can be found at BIOGAMI Teaming | ARPA-H and will be updated on a regular basis. 

BIOGAMI is not prescriptive regarding team size and/or composition. Proposing teams should ensure that expertise across both Technical Areas is represented. 

Section 2.6 of the ISO describes commercialization requirements. Teams are strongly encouraged to demonstrate an active partnership with a designated commercial entity at the time of proposal, although this is not required. 

No, UARCs are not eligible to propose directly to BIOGAMI.

ARPA-H does not form teams or match partners directly. However, Proposers’ Days are designed to help interested organizations learn about the program and identify potential collaborators. We encourage you to use the event to meet others who may have complementary capabilities. You can also explore potential teams on the BIOGAMI teaming page.

No. BIOGAMI welcomes ideas from all proposers. 

ARPA-H can directly fund a foreign entity; however, ARPA-H will prioritize awards to entities that conduct funded work in the U.S., as per 42 USC § 290c(n)(1). Awards will not be made to entities organized under the laws of a covered foreign country, defined in the National Security Act of 1947 (50 U.S.C. § 3059) as Russia, Iran, North Korea, and China. Each solicitation defines eligibility and requirements so please review the solicitation for detailed instructions. For more information, see the International Affairs FAQs. 

There is no preference for an international entity performing as a prime contractor or subcontractor. It is dependent on the merits of the proposal and the qualifications of the proposer. However, the Agency does prioritize awards to entities that will conduct funded work in the United States as dictated per 42 U.S.C. 290c(n)(1), which could be achieved through collaboration with U.S. entities. Interested international partners may sign up on “teaming” pages on our website – linked from each program description page – which are provided to facilitate prospective performers forming teams with varied technical expertise to submit a proposal.   

No, however, military academies are considered government entities and are not eligible to propose to the ISO or participate as a member of a performer team. 

Per Table 4 of the BIOGAMI ISO, commercial partnerships are encouraged at the proposal stage, but not required. 

In accordance with ISO Section 3.2, SAM registration must be active at the time of proposal submission. Please allow ample time for processing, as ARPA-H cannot influence SAM.gov timelines.

Only the submitting team member needs to register within the ARPA-H Solutions Portal.

Yes. ARPA-H is not prescriptive as to the seniority of PIs. However, proposals must address team capabilities such as any prior experience managing interdisciplinary efforts and BIOGAMI management plans. 

Yes, Co-investigators are allowed. The proposal must describe the team management structure, as well as government reporting responsibilities. 

ARPA-H is open to a variety of teaming structures. The BIOGAMI proposal must describe how the administrative functions will be carried out, whether centered in one administrative lead or spread across the team members.

ARPA-H is a separate agency from the NIH for funding and policy purposes.  We recommend you contact NIH ESI staff to confirm whether serving as a project lead on an ARPA-H project would affect your ESI status.

The BIOGAMI team will not provide specific feedback regarding proposal ideas.

While the BIOGAMI webpage hosts a teaming website for interested proposers to form connections, ARPA-H does not direct teaming strategies.

No. BIOGAMI is open to teams comprised of all types of members. Project management and oversight are more important. 

Team structure is flexible. PI effort should be realistic and not exceed 100% across other awards. 

Letters of encouragement/discouragement are sent, and feedback calls are possible.

Interdisciplinary expertise is expected to meet all ISO requirements.

The current BIOGAMI solicitation is the only anticipated call for proposals at this time.

Proposers may join several proposing teams; inclusion in multiple Solution Summaries will not disadvantage either the proposing entity or the teams which it has joined. If an entity is included on multiple proposals selected for funding, however, the Government will negotiate to ensure that no duplicative work is performed.

• The “Team Organization and Capabilities” and “BOE” sections in the Solution Summary is part of the 5-page limit.  
• The Key Personnel table and citations are not part of the limit.

Interested parties can:

• Rely on SAM.gov alerts
• Regularly check the ARPA-H news page and open funding opportunities page
• Subscribe to the ARPA-H Vitals Newsletter, which delivers weekly information about new program launches, deadline reminders, and other agency news
   

• The Proposers’ Day will be held from 9:00 AM to 5:00 PM Eastern Time on February 20, 2026.  
• Doors open and webinar login begins for registered attendees at 8:30AM.  
• A final agenda, including order of Lightning Talks and Sidebars, will be emailed to registered attendees before the meeting.

A recording of the Proposers' Day event is posted to the BIOGAMI webpage.

No, additional sidebars will not be available, but we encourage you to send any questions to BIOGAMI@arpa-h.gov. 

Lightning Talk slides were distributed to all Proposer’s Day attendees via email, and a video has been posted to the BIOGAMI webpage. 

No. Lightning talks can be presented either in person or virtually, but Proposer’s Day does not offer an option to play prerecorded videos.

The BIOGAMI audience will include ARPA-H staff and contractors, other US Government employees, and the potential performer community – including individuals from academia and industry. 

BIOGAMI Proposers' Day is a hybrid event with both virtual and in-person attendance options. A recording of Proposers' Day will be posted to the BIOGAMI website a few days following Proposers' Day.

No. One-on-one discussions between potential proposers and the BIOGAMI team should be requested as sidebars during Proposers' Day.

No, all the required information for Proposers' Day is requested within the registration portal.

Yes. Virtual attendees may present their Lightning Talk through the webinar, or they may delegate to an in-person attendee from their team.

Yes. Sidebars for virtual attendees will be scheduled for the following Monday, February 23rd.

Yes, a template for the Lightning Talk can be found at SAM.gov as part of ARPA-H-SN-26-147.

BIOGAMI Proposer’s Day serves as a means for potential proposers to meet and determine if they would like to form a team. Participation at Proposers’ Day is not required, however; teams may include members who did not attend. 

If attendance on February 20th is not feasible either in person or virtually, an interested party can view a recording of Proposers’ Day that will be posted to the BIOGAMI webpage a few days afterwards.

Lightning Talks are useful to facilitate teaming, as potential proposers can share their capabilities and their gaps with other attendees. 

Attendees will be notified via email within 10 days of their registration.

For an ARPA-H Proposers’ Day, the sidebar is a short, one-on-one meeting between a potential proposer (or team) and ARPA-H program staff, usually the Program Manager (PM) and their team. In practice, a sidebar is used to: Clarify fit to the program vision; Ask focused technical questions; Get high-level feedback on ideas; Network and refine teaming strategies.  Sidebars are not: Formal proposal reviews; A venue for getting an “advance decision” on funding; A place to share proprietary or selection-sensitive details of a proposal. They’re meant to help you better understand the program and sharpen your approach before you decide whether and how to submit. 

The Lightning Talk template provides useful guidelines for the types of information to be conveyed, but the specific template is not required. As a reminder, Lightning Talks are limited to 1 slide and 3 minutes. 

Yes, the Agenda will be sent to all attendees by Thursday, February 19, 2026. 

Yes, if registered for virtual attendance, you can tune-in at your convenience. A recording of Proposer’s Day will be posted to the BIOGAMI webpage and ARPA-H YouTube a few days after the meeting.   

Yes, there is time set aside for Q&A at the meeting.  Alternatively, you can submit questions to https://solutions.arpa-h.gov/Ask-A-Question/. 

The BIOGAMI Solution Summary submission deadline is fixed. You may submit a Solution Summary even if your SAM.gov registration is not yet complete.

BIOGAMI anticipates multiple awards.

In accordance with ISO Section 5.3, CRITERIA 4: Assessment of Proposed Cost/Price, proposers are encouraged to submit a fully justified budget that is appropriate for the scope, complexity, and risk of their proposed technical approach. ARPA-H will evaluate the reasonableness and value of the proposed cost in the context of the work to be accomplished, rather than against a predetermined budget amount or range.

The multi-party team will be structured through a single teaming agreement signed by all team members. The OT award is issued to the entire multi-party team, with all members as parties to the agreement. One member may act as the agent for administration, but the award is not structured as a traditional prime/sub-performer contract.

Yes. The contribution of both labor and resources to this task are considered cost-sharing and should be noted in the Cost Volume.

No specific indirect cost cap is set program-wide for BIOGAMI OTs. Indirect costs are negotiated on a case-by-case basis as part of the overall cost structure of each OT.

For budgeting purposes, please assume that the annual meetings will be held in the Washington, DC area.

Only the total cost of all subcontractors needs to be included in the Solution Summary Basis of Estimate.

• Labor Hours = amount of time worked, measured in hours (no dollars attached).
• Direct Labor (fully burdened) = the cost of those hours, including wages plus all indirects (fringe benefits, overhead, G&A, etc.). 

Yes, the Solution Summary Basis of Estimate (BOE) is included within the 5-page limit for the Solution Summary.  The technical narrative and BOE together must not exceed 5 pages.

Indirect costs are acceptable as long as they are consistent with the solicitation and its attachments, reasonable and supportable (based on your institution’s accounting practices) and clearly documented in the Basis of Estimate (BOE) and cost proposal.  Indirect costs are subject to negotiation with ARPA-H prior to award.

If in-kind resources or cost-sharing are proposed, this can be addressed briefly in the ROM budget for the Solution Summary; more detail is required in the Full Proposal, including type of resource (labor, materials, equipment, etc.) and scope of the resource being contributed.

Cost sharing is voluntary and should be noted in the proposal.

“Profit” refers to fee (often called “fee or profit”) that a for-profit entity may include in its cost proposal.  It is generally not applicable to universities and other non-profit organizations.

Because this award would be made under an Other Transaction (OT) authority rather than a standard grant or contract, there are no automatically applicable, uniform indirect cost rates in the same way you might see under traditional U.S. federal assistance mechanisms. You may apply your national costing methodology (such as FEC) as long as it is your standard practice and is well documented/justified; ARPA-H reserves the right to review and negotiate specific rates during award negotiations.

As noted in a prior FAQ, BIOGAMI is not prescriptive towards a breadth vs depth approach. Proposers should describe their methods and justify their choice towards achieving the end goal of a highly accurate computational tool that can be applied to any intrinsically disordered protein. The experimental throughput applies to unique parameter conditions, i.e. sequence variant paired with environmental condition.

There are no budget requirements for the Translation Advisory Board; participation could be proposed as consultants (with associated costs) or volunteered time and expertise.

ISO Section 2.1 provides the total program timeline, which is 48 months. 

Performers should anticipate a start date of August 15, 2026.

BIOGAMI will not publish total funding levels for the program. Proposer budgets must be realistic for the work proposed. Multiple awards are anticipated.

Yes, only the lead institution provides a detailed BOE breakout of labor, labor hours, materials, etc. in the Solution Summary.  Any anticipated subcontractor costs should be included in the “Subcontractor/Consultants” line at a high level.

A separate F&A line may be included in the Basis of Estimate table in the Solution Summary. The table within Appendix A is just an example; please edit it as needed to reflect your proposed BOE.

Proposers may select a multisystem disorder for one of the disease indications, and must clearly describe whether their modulator approach will be targeted against the CNS or peripheral instances of the disorder. The same multisystem disorder, however, cannot be used to satisfy both of the disease indications.

Yes. Proposers should apply the current HHS Executive Level II salary cap to all labor cost estimates for individuals whose base salary exceeds that level. 

Subcontractors and consultants should be listed in the “Other Team Members” block of the cover sheets. Vendors are not required to be listed in this block. 

ARPA-H defines a vendor as an entity that provides standardized goods or routine services that are broadly available on the market (e.g., lab supplies, standard testing services).  Vendors do not carry out a distinct portion of the project’s statement of work.  Subcontractors (or subawardees/subperformers, including Contract Research Organizations (CROs)), carry out defined tasks from the statement of work, contribute to the project’s aims, may have their own milestones and deliverables, and are subject to flow-down award terms and compliance.  At the full proposal stage, ARPA-H does not require proposal workbooks from vendors; however, ARPA-H does require proposal workbooks from subcontractors.