AOI 14 QA.pdf

Pre-submitted Questions:

Submission instructions:

Are white papers required?

A: SARS-CoV-2 targets should submit a Full Proposal and request a market research call prior to submission. White papers are not required, but are recommended for non-SARS-CoV-2 targets as the white paper process is intended to give offerors feedback on the intended approach before investing in the time and effort required to develop a full proposal.

We are exploring two different drug candidates – should we submit two applications?

A: It is recommended to submit one application with a single viral target in the base and options to address additional viral targets. If the two drug candidates are different mechanism of action / different "platforms”, separate proposals should be submitted.

Will you be accepting proposals for SARS-CoV-2 therapeutics after June 15th?

A: The June 15th deadline for products and technologies targeting SARS-CoV-2 is based on the availability of funds to support SARS-CoV-2 medical countermeasures. After that deadline, SARS-CoV-2 targeted technologies may still be considered if additional funding becomes available. In that case, a BAA amendment would be issued. Proposals for other viral targets will continue to be accepted after June 15th.

Will you be accepting proposals for non-SARS-CoV-2 indications before June 15th?

A: Yes

Our company has a therapeutic platform, but we lack a delivery system. Can you help us identify drug developers for potential partnership?

A: Partnerships between offerors with compatible or complementary technologies should be managed by the offerors prior to submission.

What is the maximum indirect rate a company can propose if they do not have a negotiated rate?

A: Any indirect rate proposed by a vendor will be reviewed by a government auditor to determine its appropriateness.

Can we apply this funding if we have already applied another AOI?

A: Yes, however the Statements of Work must be discreet and non-overlapping.

Targets:

Does the development candidate need to address multiple infectious diseases?

A: We are not looking for broad-spectrum antivirals. However, the proposed platform should be able to pivot and generate therapeutics able to address emerging viral diseases. If there is potential to also address other types of infectious disease, that would be seen as a strength.

Is AOI#14 specifically for direct-acting antibodies vs. the COVID virus or will other virus agnostic therapeutics be considered?

A: This AOI is not focused on development of SARS-CoV-2 antibodies. We are seeking to develop and improve therapeutic platforms that can pivot to new viral targets as the needs arise. Traditional mAb products are better suited under other AOIs. Threat agnostic therapeutics, specifically host directed therapeutics, are out of scope for this AOI.

Is drug discovery an absolute requirement if applicant has existing leads against multiple target pathogens?

A: Drug discovery is not a requirement. However, as this AOI is focused on development of therapeutic platforms, that could rapidly pivot to a new target an end-to-end system should be described including the method of discovery.

Is there any preference for a product to treat acute infection over a prophylaxis approach?

A: There is no preference for products to treat acute infection or prophylaxis. However, please note that PrEP indications will only be considered for influenza and SARS-CoV-2.

If the product sponsor elects to have SARS-CoV-2 as the primary target for testing their technology, what latitude will there be for shifting to other targets in the AOI A: Offerors are encouraged to propose options to develop a therapeutic for a second target pathogen to demonstrate the flexibility of the platform to respond to other priority pathogens.

What if I have platform product for a target other than SARS-CoV-2, influenza, or filovirus disease that meet all other criteria?

A: Platform technologies proposed in response to the solicitation should be sufficiently flexible to respond to the defined threat areas. The pathogens (primary target) in the solicitation are identified based on feasibility of testing technologies or products in systems that are priorities for BARDA’s mission space. A secondary viral target of the developer’s choosing may be proposed in addition to the primary target so as to validate the flexibility of the platform.

For platforms targeting influenza, does BARDA have a preference between seasonal vs. pandemic influenza?

A: BARDA’s priority in sponsoring technologies has been focused on addressing the threat area of pandemic influenza; however, for this specific solicitation, an adequate definition of a test bed system is paramount for pathogen selection. It is incumbent on the offerors to demonstrate compatibility of their technology/product with their proposed pathogen test bed. The strongest proposals will have data demonstrating broad-spectrum antiviral activity against both seasonal and pandemic influenza (H1N1, H3N2, H5N1, and H7N9) or other viral pathogens like SARS-CoV-2.

What plans does FASTx have to expand beyond viral infections?

A: BARDA cannot speak to future plans for FASTx at this time, however a platform that could be used to address multiple types of infections would be seen as beneficial.

Are host directed therapeutics considered in scope for this AOI?

Host directed therapeutics are out of scope for AOI14. The aim of this AOI is to develop platforms for direct-acting antivirals. The BAA has been amended to clarify this point.

Our company is developing a product that has two active components: (1) anti-viral; and (2) immunomodulatory. Will our application be considered given that host-directed therapeutics are out of scope?

A: Having an immunomodulatory component will not automatically eliminate the product’s eligibility.

The strength of the in-scope component will be considered in response to the solicitation, while the second component will be considered out of scope. Other areas of interest (AOIs) may be more appropriate for this technology. Offerors are encouraged to look at other AOIs which may be more appropriate for host-directed therapeutics.

What is your interest in supporting Oral circular mRNA therapeutics for COVID-19 and other emerging infectious disease?

A: Our interest is in developing platform therapeutic technologies. If you believe this technology fits that description, we encourage you to request a TechWatch or set up a market research call with our team to discuss further.

Can I propose small molecules, large polysaccharides, peptides, cell therapies, product?

A: Small molecules, large polysaccharides, peptides, and cell therapies will likely be less competitive for this AOI than the platforms listed within AOI 14. The focus of this AOI is to develop platform technologies that can rapidly pivot to new threats. The intention being that the development and regulatory pathways for the next target may be easier using already proven platforms with well understood mechanisms of action as the underlying technology. We aim to support platforms that will have the ability to move from viral identification to IND submission in less than 6 months. These modalities are of interest, in general, at BARDA. We suggest you look to the BAA for other applicable AOIs.

What kinds of data are needed to apply? Is it essential to have in vivo efficacy data? Is earlier than TRL4 acceptable?

A: In vivo data are not required but may strengthen a submission; the priority of this AOI is in developing the platform and products may therefore be early in development. As stated in the BAA – Candidates for funding under this area should be at TRL-4 (candidate optimization and Non-GLP demonstration of in vivo efficacy) or higher. However, candidate earlier in development may be considered if it is anticipated they will significantly improve existing capabilities. As this is a competitive process and there are limited funds available, technologies at an earlier development stage are encouraged to look at the EZBAA AOI#25 that is soliciting submission for early technology development and may be more appropriate.

Does the FASTx Program support early-stage development activities, such as candidate optimization and IND-enabling CMC.

A: Activities from discovery through Phase 1 clinical trials can be supported under AOI#14.

What CMC capacity to you require?

A: Development plans through Phase 1 clinical studies should be proposed including the manufacturing to support those trials. It is acceptable for companies to support these manufacturing activities through subcontracts.

Is Phase 1 data required to apply?

A: Phase 1 data is not required to apply. AOI#14 will only support development through Phase 1. Phase 2 testing and beyond is not supported under this AOI.

Will product development be supported past Phase 1? Will Phase 2 product evaluations be considered in this proposal?

A: Awards under AOI#14 will only support activities through execution of a Phase 1. Successful programs may be considered for follow on funding through other AOIs that would support licensure. Additional support for SARS-CoV-2 targeted products will be dependent upon availability of SARS-CoV-2 funding beyond the current Project NextGen funding.

What if I already have a product that is ready for Phase 1 testing?

A: Such products are eligible for funding; however, funding under AOI#14 does not go past Phase 1. We recommend offerors propose a second target indication leveraging the same platform in options or in the base; As this AOI is intended to support platform development, submissions would be strengthened by proposing improvements to the technology in options, and submissions that do not propose platform improvements will not be competitive.

Will any vaccine technologies be supported under this AOI?

No. AOI#14 is focused on development of therapeutic platforms. There are other BARDA AOIs open for vaccine development. We encourage you to look at those in the BAA to determine if they are appropriate for your technology.

Does the agency have interest in the development of companion diagnostics for therapeutics A: AOI#14 is not focused on development of diagnostics. BARDA does have other AOIs open for diagnostic development. Please refer to the BAA to find the appropriate AOI for your technology.

Is BARDA interested in antitoxins to BoNT H?

A: There is an open AOI for development of BoNT antitoxins. Please refer to the BAA for more information on this specific topic.

Is the US government only interested in products that are going to be viable in a commercial setting versus those that are for US Government only?

A: No. BARDA has funded development of numerous medical countermeasures that specifically support USG requirements as well commercially viable products. A platform technology should be able to pivot and be adapted for both.

Platform:

What do you mean by “traditional CHO-based manufacture”?

A: Conventional methods of producing monoclonal antibodies in fed-batch systems with Chinese Hamster Ovary cells have significant limitations in terms of overall cost of goods and production timelines. Proposals offering CHO-based manufacturing for monoclonal antibodies should explicitly outline innovations in the manufacturing approach that improve yield, recovery, and/or downstream manufacturing processes resulting in a cost of goods <$250/g in order to be considered responsive.

Traditional CHO based mAb products are more appropriate for other AOIs in the BAA.

Will CHO-based expression platforms for other than mAb technologies (e.g. bispecific or multi-specific antibodies) be considered?

A: CHO-based manufacturing approaches for bi-or multi-specific antibodies will be considered, and proposals including innovations to reduce cost of goods will be prioritized.

Will manufacturing outside of the US be supported by this AOI?

A: Ex-US manufacture is acceptable for early-stage (through Phase 1) development of products under AOI#14; however, US-based manufacturing will be prioritized.

Is there assistance available to navigate FDA approval?

A: While the companies drive the interactions with the FDA, BARDA regulatory Subject Matter Experts (SMEs) can provide advice and guidance for development of any anticipated communication with the FDA. BARDA is also actively engaged with the FDA through the BARDA Nonclinical Division to develop acceptable animal models for approval of filovirus therapeutics through the Animal Rule.

Note that BARDA SMEs support all areas of development, including nonclinical, clinical, manufacturing, and regulatory, and they support all BARDA funded projects, regardless of the stage of development.

Does BARDA’s intramural core services include in vitro and in vivo testing against SARS-CoV-2 or influenza? Can we propose to use BARDA intramural core services for antiviral testing?

A: BARDA does have IDIQ awardee labs that are able to do in vitro and in vivo testing for SARS-CoV-2 and influenza. Please contact us separately to discuss use of this network. You also have the option to subcontract with these labs directly.

Funding:

When do you anticipate the $5B allocated for FASTx be deployable by BARDA for projects?

A: Funding is currently available for FASTx awards. As reported in the public domain, approximately $5B has been identified to support Project NextGen, but Project NextGen encompasses several programmatic efforts, and the FASTx program is only a portion of these efforts.

What is the timeline for approval/rejection of proposals? What is the time anticipated to award?

A: The time to review will depend on the number of proposals received. Timeline to award will depend on the negotiation process for selected proposals. Awards for SARS-CoV-2 therapeutics are anticipated to be made within the current fiscal year (FY2023). For other viral targets this BAA topic will remain open and proposals will be reviewed and awarded on a rolling basis.

How much total funding is available for SARS-CoV-2 related projects?

A: BARDA cannot comment on the total amount of funding available.

Is there a size limit for individual awards?

A: Proposals are reviewed and evaluated for cost reasonableness based on the work proposed. The number and size of awards is dependent on available funding.

How many proposals do you expect to recommend for funding?

A: BARDA cannot comment on the number of expected proposals. Proposals will be reviewed based on their merit as outlined in the BAA. The number of awards will be dependent on proposal quality and scope and availability of funds.

When will funds expire?

A: NextGen funds for SARS-CoV-2 awards will not have an expiration date. Funding for other targets may utilize other funding lines, depending on the proposal scope.

What are the constraints for funding infrastructure?

A: Multiple types of awards are possible under this AOI. The type of funding mechanism would be discussed during negotiations but can be proposed in your submission.

Are non-US companies eligible for funding?

A: Yes

What size organizations are you targeting for this funding?

A: No particular size of organization is being targeted. However, the proposal needs to include plans and estimated timelines from discovery through Phase 1.

Live Q&A:

Written Questions:

1. Is it acceptable to submit the Gantt Chart/IMS as an attachment?

A: The Gantt chart can be included as an attachment.

2. We understand that the proposals will be under rolling reviews, thus the deadline for the technical proposal is June 15, but for the cost proposal is two weeks later. Are we correct on this?

No, both the technical and business proposal submissions must be submitted by the deadline in the

BAA.

3. It seems that only Development Approach should be in the body of technical proposal and counted towards the 50-page limit. Where should Scientific Rationale and Preliminary Data go? Can they be in the attachments?

A. As per the BAA, the Development Approach is a detailed description of the experimental design, including the rationale for experimental approaches, acceptance criteria and measurable objectives, and a description of alternative approaches to be employed if these methods do not achieve the defined goals. Previous results and data should be included as necessary to justify the proposed development activities. The Technical Proposal Attachments should contain supplemental data that accompanies the technical proposal. Scientific Rationale and Preliminary data could be included in either the Development Approach or Technical Proposal Attachments as allowable within the page limits.

4. The instructions for the white paper says 10 pages, plus 2 pages for the addendum. Under the instructions for the addendum it says to include biographical sketches for the key personnel (2 pages).

The biosketch template itself is several pages. So how can this fit in the addendum limit?

A. As per the BAA, the total package for a white paper submission should not exceed 14 pages (2 pages of which are the addendum). Additional biosketches could be submitted with a full proposal if one is invited. Please note for SARS-COV-2 proposals submitted by June 15, a white paper is not required and we suggest that instead you reach out for a market research call to assess whether your proposal will be responsive and competitive.

5. If applying with a technology platform applicable to both SARS-CoV-2 and IAV, is the deadline still June 15th?

A. That would depend on the primary target proposed in the submission. It is recommended to submit one application with a single viral target in the base and options to address additional viral targets. If SARS-CoV-2 is proposed in the base then the application would be due June 15. However, if IAV is proposed in the base then there is no deadline outside of the overall BAA submission deadline

6. Should in vivo testing of the anti-SARS-CoV-2 antibodies in animal models be included in the proposal?

A. Please note the focus of AOI#14 is not SARS-CoV-2 antibodies, but such products will be considered if they meet the scope and requirements of the AOI. If the product is found to meet the requirements of this AOI, any work supporting efficacy of the products should be included in the submission. Offerors should determine whether animal model testing is appropriate.

7. Is there an advantage of the TechWatch over a market research call?

A: TechWatch is a broad presentation to BARDA regarding your technology and will be open to representatives from other government agencies. Market research calls are focused presentations with FASTx representatives to discuss interest in BAA AOI 14 or EZ-BAA AOI 25 and potential objectives of your proposal. FASTx representatives will also attend TechWatch to assist in answering questions regarding the program.

8. Are funding requests involving biomanufacturing equipment procurement and some facility improvement be considered in a proposal? Any cap on the budget if allowed?

A. In regard to budget, proposals are reviewed and evaluated for cost reasonableness based on the work proposed. Facility improvement is not allowed.

9. Please share BARDA's definition of "platform technology".

A. "Platform technology" is used to reflect technologies that utilize similar technical, manufacturing, and regulatory processes, which would enable a follow-on candidate developed on the same platform to advance more rapidly.

10. Are Locked Nucleosides as antivirals considered a platform?

A. LNAs will likely be considered responsive

11. Can a startup with bare minimum include cost of equipment, and salaries required to complete?

A. You can include the cost to run the project for all of these items, but they must be justified. Please note for Firm Fixed Price contracts, only a portion of the funds are provided in the beginning of the project, you are paid per successful deliverable.

12. Do we need to submit an abstract before the market research call request?

A. No you should not submit an abstract first, we cannot speak with you once you submit.

Questions Live Answered:

1. For AOI#14: In the guidance for PrEP indication, is the single dose / six month protection a must have? We believe our product could be conveniently re-dosed periodically without diminished effect.

A. Yes, as stated in the AOI for PrEP indication, a single dose for 6 months protection is a requirement.

2. What is the anticipated timeline from award to initiation of phase I trial?

A: That is up to you to propose. It will be highly dependent on where your product is in the development pipeline.

3. We are an early-stage start-up with a small team, do we need to have a large negotiator team?

Does having a large team a prerequisite?

A: No, a small team is acceptable. You just need to have the correct partners and subcontractors to ensure that you can complete the work from discovery through Phase 1.

4. Can you apply for both the BAA and EZBAA if there are platform candidates at different stages?

A: You can submit to more than one AOI at BARDA. The statements of work there need to be discreet.

31. Is the timeline of 6 months from viral ID to IND necessary for application to the AOI14 or can one propose a platform development plan that, if successful, would enable the 6m to IND?

A: Yes. If this desired timeline is not possible with your technology now, please do propose improvements to that platform that would allow you to achieve that goal.

5. The BAA says that the platforms are not limited to those listed. Would you consider other platform technologies within scope?

A: Yes, other technologies that are not specifically called out in the BAA may be in scope. But what we are looking for in a platform is the ability to quickly pivot and generate therapeutics to address emerging viral diseases with the idea that licensure of a platform for one target would enable an easier, or more understood the regulatory pathway for the next or new emerging target.

6. Our team was notified to be identified through market research call, will we still need to request a market research call separately or will there be another mode of communication from BARDA with all teams identified in their market research call?

A. If you would like to request a market research call with our team, you can do that through the BAA Inbox. You can also request a TechWatch through the TechWatch portal. Either of those methods. It is acceptable to get in touch with us and tell us about your technology and get our responses.

7. The efficacy of our candidate has been successfully tested in animal models for variants of concern of SARS-CoV-2 and strains of influenza (including oseltamivir resistant). Could we use AOI#14 to fund additional animal model testing with other emerging viruses of concern? Which viruses are of greatest interest to BARDA?

A. Yes, you could propose additional viral targets under this AOI. As stated in the BAA, our specific primary targets are SARS-CoV-2, influenza and filovirus. Other targets can be proposed with a preferential focus from us on hemorrhagic and respiratory viruses.

8. Are there USG march-in rights related to technology access and/or caps on costs to USG that are involved in technologies that are funded by BARDA A: The USG, depending on the on the FAR clauses in the contract does have rights to utilize the technology at any time, but it's important to remember that the IP always belongs to the company.

There are basic data rights clauses that are used in USG contracts, and these are all subject to negotiations.

9. What are the limitations on period of performance?

A. For AOI 14, the offer should propose the necessary performance period to complete the work. These are typically five-year contracts.

10. For AOI 14, could scheduling a TechWatch or market research call be done instead of the June 15 proposal submission? Or does both need to happen?

A. You are welcome to schedule a TechWatch for a market research call before the June 15th proposal submission, or at any time, but the proposal itself does need to be submitted by June 15th. A TechWatch or a market research call does not substitute for submission proposal. The June 15th deadline is only for SARS-CoV-2 targets. Other targets do not have a deadline or for a submission. But in either case, the market research call or TechWatch does not substitute for the submission of the proposal.

11. Can you submit a proposal for AOI #14 on June 15 without a call or Abstract?

A: Yes, that is acceptable, but we do advise that you request a call with us so that we can give you feedback on your ideas before you put the kind of effort necessary for developing a full proposal.

12. Should a SARS-CoV-2 target be a platform based?

A: For this AOI, we are interesting specifically in funding platform-based therapeutics regardless of the viral target.

13. How soon are market research calls typically responded to by BARDA?

A: If those are requested through the BAA email inbox, we are trying to respond within 24 hours.

Through the TechWatch portal, I can’t comment specifically on how long it takes to respond, but we are doing our best to respond as quickly as possible and get those calls scheduled.

14. Are early submissions encouraged for non-SARS CoV2 proposals too by June 15 or will they be reviewed afterwards?

A. For non-SARS-CoV-2 targets, the June 15th deadline does not apply. However, we are accepting and reviewing and awarding those awards on a rolling basis. So, while you don’t have to abide by the June 15th deadline for non-SARS-CoV-2 targets, I would recommend getting those proposals in as quickly as possible.