FAQs

How does the Patch Forward Prize define a “patch”?

For the purposes of the prize, a patch is a vaccine delivery system that is applied to the body like a small adhesive disc or bandage, and has microscopic projections that penetrate the surface of the skin. The proposed product must be a single patch intended for intradermal RNA vaccine administration.

Is the prize looking for a specific type of microneedle patch technology or RNA vaccine platform technology?

The prize is agnostic toward the type of microneedle patches or RNA vaccines. 

Can the vaccine be delivered via multiple doses? 

There are no requirements on the dosing schedule. However, a complete vaccine dose must be delivered on a single patch; a single dose cannot be spread across multiple patches. 

What infectious disease targets are in scope for this prize?

The vaccine must target at least one of the required indications: COVID-19, trivalent or quadrivalent seasonal influenza, and/or pandemic influenza A/H5N1. Entrants may target any other indications as long as one of the required indications is included. For seasonal influenza, the isolates should be from the 2023 season, or preferably from 2024 onwards.

What is the technology readiness level required for the Concept Stage? What technical specifications or assessment will be used to evaluate submissions?  

There is no prescribed technology readiness level for the Concept Stage. Entrants must ensure that their technical metrics, such as functional immune assays and target product profile, align with FDA guidelines for preclinical and Phase I clinical studies. The judging panel will evaluate submissions on the degree to which the submission provides a credible approach to combining an RNA vaccine and microneedle patch into a product capable of delivering consistent intradermal doses under acceptable storage conditions for clinical use.

Who is eligible to enter the Patch Forward Prize? 

A single legal entity must enter the prize as the entrant. The prize is not open to individuals. There is no requirement that entrants be a specific type of entity and prior clinical vaccine development is not  required. The prize is open to both domestic and international entrants. See the rules, terms, and conditions for detailed eligibility criteria. 

Do RNA vaccine and patch companies need to form partnerships before entering the Concept Stage? What types of partnerships are eligible to enter the prize?

The prize does not prescribe the type of commercial and legal relationships between companies and third parties. However, a single legal entity must enter the prize to represent any collaborations and partnerships.

Does an entrant need to have ownership of both RNA vaccine and microneedle patch technologies before entering the prize competition?

Entrants must demonstrate that they will have access to the required intellectual property for both the RNA vaccine and patch technology platforms or demonstrate a documented pathway to acquire that access.

Is entering or winning any certain stage of the Patch Forward Prize a prerequisite to enter other stages of the prize? 

Each stage of the Patch Forward Prize is independent. Prospective entrants can participate in any stage without competing in other stages. Winning an award in one stage does not affect eligibility for any other stage.

 

Can an entrant collaborate with more than one partner to submit multiple concept papers?

Entrants may submit multiple concept papers, but each paper must describe a unique combination product with distinct RNA vaccine technology and/or microneedle patch technology.

Do entrants need to register at any federal agency websites such as SAM.gov?

No. Entrants do not have to register their profiles or submissions beyond registering for Luminary Lightbox™ on the Patch Forward Prize website. 

What product attributes will the judging panel consider when evaluating Concept Stage submissions?

Judges will evaluate submissions based on the evaluation criteria published on the Patch Forward Prize website. Judges will score each submission based on the five equally weighted criteria to recommend up to four Concept Stage awards. Winner recommendations will be subject to final approval by the award-approving official.

Does preclinical or clinical data need to be submitted as part of the Concept Stage?

Submissions should include any supporting evidence from development and testing efforts to date. 

Which FDA approval pathway should the entrants pursue?

The Patch Forward Prize does not dictate which regulatory pathways entrants must follow. Entrants are responsible for ensuring their clinical plans comply with FDA standards, irrespective of the chosen pathway. Submissions should outline entrants’ plans for engaging with the FDA and note previous engagements with the agency.

Can Concept Stage submissions include clinical development plans that extend beyond a Phase I clinical study?

Provided submissions include a comprehensive strategy for advancing the proposed combination product through a Phase I clinical study, demonstrating safety, tolerability, and immunogenicity in humans, there are no restrictions on including plans for clinical development beyond Phase I studies.

Will Concept Stage submissions be evaluated on a rolling basis, or will the submissions all be received and reviewed before any feedback is given?

All Concept Stage submissions will be reviewed simultaneously during the evaluation period. All Concept Stage winners will be announced at the end of the Concept Stage. For more details, please refer to Patch Forward Prize timeline.

Are there specific awards allocated for different types of microneedle patch products?

No, the prize is agnostic to the type of microneedle patch technology. Winners will be determined based on judges evaluation and deliberation against the official evaluation criteria.

How and when will prizes be paid? 

Each prize award will be made in a single payment. The Patch Forward Prize expects to disburse Concept Stage awards in December 2024. 

Are there restrictions on the use of prize funding? Are there financial or technical reporting requirements for prizes awarded, like with grants?

The prize does not impose restrictions on how winners use their  funds and there are no reporting requirements. However, entrants should ensure compliance with all requirements and restrictions imposed by any other federal funding they may receive. If entrants are using federal funds from a grant or cooperative agreement, they should coordinate with the awarding official at the federal agency. Additionally, entrants must adhere to all relevant federal, state, and local laws, regulations, and policies. 

What details of the winning technologies will the Patch Forward Prize disclose publicly? I.e., to what extent will the winners remain confidential?

The entrant must clearly delineate any confidential commercial information included in their submission that the entrant wishes to protect as proprietary data. Confidential information will be kept confidential to the extent allowed under applicable federal law. Entrants are encouraged to consult with their legal counsel as to whether publication of a submitted abstract will jeopardize their ability to secure patent protection for any invention described in their submission. Neither BARDA nor Luminary Labs shall be liable for any loss of IP rights or protection that results from publication of any entrant’s abstract by the Patch Forward Prize. See the rules, terms, and conditions for detailed information on confidentiality. 

Will the Patch Forward Prize team connect individual RNA vaccine developers and patch makers?

The prize encourages collaboration between patch makers and vaccine developers but it will not facilitate direct matchmaking for individual companies. Prospective entrants are encouraged to review the prize resources, which include lists of known patch makers and RNA vaccine developers. Additionally, entrants are urged to sign up for the Patch Forward Prize newsletter to receive updates on potential teaming and partnership opportunities.