The expert judging panel, composed of federal employees, will assess technical paper submissions based on the official evaluation criteria. Judges will assign each submission one to five points for each of the evaluation criteria. Winner recommendations will be subject to final approval by the award-approving official.
Evaluation criteria for technical papers
Concept Stage
Product design
The degree to which the submission provides a credible approach to combining an RNA vaccine and microneedle patch into a product that delivers consistent intradermal doses under acceptable storage conditions for clinical use. The degree to which the submission demonstrates feasibility of the proposed combination product, including supporting evidence.
Clinical development
The degree to which the submission provides a realistic and sufficiently articulated plan toward completing Phase I clinical evaluation of a patch-based RNA vaccine combination product, including defining appropriate functional immune assays and associated success criteria, aligned with FDA requirements for an Investigational New Drug (IND) application.
Regulatory and risk-mitigation plan
The degree to which the submission provides an appropriate plan for effective engagement with the FDA, and to effectively compile evidence for a submission of an IND application. The degree to which the submission demonstrates an approach to assess and mitigate risks associated with product development.
Manufacturing
The extent to which the submission details plans for consistent manufacturing for clinical evaluation, including any preliminary manufacturing data that indicates Phase I clinical trial readiness.
Operational readiness
The extent to which the submission demonstrates the entrant has sufficient expertise and capabilities to usher the product through a Phase I clinical trial, including access to necessary intellectual property. The degree to which the submission identifies any additional capabilities that may be required and provides a clear approach to addressing those needs.
Preclinical Stage
Product design
The submission demonstrates the team has achieved an effective combination of the RNA vaccine and patch technologies into a product that delivers consistent intradermal doses under acceptable storage conditions for clinical use.
The submission shows credible evidence that the combination product is capable of reliable and consistent intradermal vaccine dosing through preclinical studies in animal models, and provides rationale if using alternative animal models that are not reflective of FDA guidelines.
The submission demonstrates human-centered design and strategies to engage users and assess the product’s applications in clinical settings.
Preclinical development
The submission demonstrates study results outlining a successful induction of an immune response after administering the product in one animal model. The protective levels induced by vaccination are sustained for at least four months, and ideally six months.
The submission describes the comparative immunogenicity of the investigational product to reference product(s) using entrant-defined functional immune assay(s), and meets the corresponding assay success criteria.
- To demonstrate success in functional immune assay(s), studies do not need to include the testing of comparator vaccine(s), but should demonstrate comparable titers in the functional immune assay(s). For example, an entrant may use hemagglutination inhibition (HAI) assay to demonstrate the vaccine formulation can generate a standard HAI titer at a threshold that indicates clinically beneficial level of protection.
The submission includes results of toxicology studies that provide a detailed assessment of reactogenicity, evaluating redness, skin thickness, edema, itching, and other potential skin reactions, accompanied by photographic evidence.
The submission details satisfactory outcomes of a preclinical evaluation program for the proposed product to enable an Investigational New Drug (IND) authorization application.
The submission includes a brief overview of the clinical study synopsis and an attached detailed Phase I clinical study plan, covering but not limited to background/rationale, study design/methodology, primary and secondary endpoints, inclusion/exclusion criteria, sample size, and a safety monitoring plan.
Regulatory and risk-mitigation plan
The submission demonstrates effective engagement with regulatory agencies and plans for continued engagement, including evidence of pre-IND meetings and responses from the FDA on the feasibility of:
- Toxicology study plans and protocols.
- Proposed manufacturing plans.
- Proposed clinical development plans.
The submission demonstrates evidence of risk assessment and management during preclinical development, and risk-mitigation planning for continued product development.
- The submission should identify the top five key risks and approaches to address each of the risks in the format of a risk matrix or register.
The submission addresses gaps, considerations and recommendations identified by the FDA.
The submission provides an overall clear regulatory framework, including processes and capabilities to incorporate evidence generated from IND-enabling studies.
Manufacturing
The submission provides a plan to manufacture the product using a GMP process based on FDA pre-IND feedback. This includes stability testing criteria and any existing data, as well as release testing criteria — and data — for preclinical testing.
The submission provides assessment of the potency and stability of microneedle patches using appropriate assays, along with a plan for retrieving materials for testing after they have been loaded on the patch.
The submission includes information pertaining to the proposed manufacturer, and the composition, stability, and controls used for manufacturing the proposed product, including approach to Chemistry, Manufacturing and Controls (CMC), aligned to requirements for an IND submission.
Operational readiness
The submission demonstrates the entrant’s access to intellectual property and sufficient expertise and capabilities to usher the product through clinical evaluation, manufacturing, and regulatory approval for a Phase I clinical trial.
The submission provides a sound business plan including details on personnel and engaged clinical research organizations (CROs) to conduct the Phase I clinical trial.
The submission identifies any additional capabilities that may be required operationally to pursue product development and provides a clear approach to addressing those needs.
Clinical Stage
Product design
The submission demonstrates the team has achieved an effective combination of the RNA vaccine and patch technologies into a thermostable product under acceptable storage conditions for clinical use.
The submission shows credible evidence that the combination product is capable of reliable and consistent intradermal vaccine dosing through Phase I clinical studies in accordance with FDA guidelines.
The submission demonstrates human-centered design and approaches to engage users and assess the product’s applications in clinical settings.
Clinical development
The submission provides credible analysis and evidence that the product has met the pre-specified endpoints in the clinical trial protocol, and clearly articulates any modifications to the pre-specified protocol with a sound justification, including:
- Applying appropriate sample size and other relevant study parameters.
- Safety monitoring and immunogenicity readouts for at least 6 months post-vaccination. The safety and reactogenicity readouts should include:
- Assessment of safety using grading scales provided by the FDA.
- Evaluation of redness, skin thickness, edema, itching, and other potential skin reactions at the site of patch administration, accompanied by photographic documentation.
- Immunogenicity readouts that demonstrate:
- Success metrics in functional immune assay(s) have been met.
- COVID-19 vaccines that meet the entrant proposed thresholds based on the assays and strain of the virus, as described in the entrant declaration of intent.
- Influenza vaccines that meet the entrant proposed HAI assay thresholds based on the assay and strain of the virus, as described in the entrant declaration of intent.
- The submission should compare the product’s response rates to historical studies using qualified assays.
Regulatory and risk-mitigation plan
The submission addresses any gaps, considerations and recommendations identified during regulatory engagement.
The submission demonstrates clear subsequent plans to establish effective regulatory frameworks for continued clinical development, including any processes and capabilities incorporating evidence generated from Phase I studies.
The submission demonstrates evidence of risk assessment and management during Phase I clinical development.
- The submission should identify the top five key risks and approaches to address each of the risks in the format of a risk matrix or register.
Manufacturing
The submission includes evidence of establishing consistent production or manufacturing processes in Phase I clinical studies.
The submission provides evidence assessing potency of microneedle patches using appropriate assays, along with a plan for retrieving materials for testing after they have been loaded on the patch.
- The evidence should also include information pertaining to the manufacturer, and the composition, stability, and controls used for manufacturing the combination product, including approach to Chemistry, Manufacturing and Controls (CMC) and Good Manufacturing Practice (GMP), aligned to requirements for a Phase I submission.
Operational readiness
The submission demonstrates the entrant’s access to intellectual property for the proposed product. The submission identifies any additional operational capabilities that may be required to pursue product development and provides an approach to addressing those needs.
Continued development
The submission includes a clinical development plan for continued development building on the Phase I study results.