Development of monoclonal antibodies to prevent and treat infections from Flaviviruses

Expected outcomes

• Projects should contribute to all of the expected outcomes.
• For each outcome (EO1 to EO2), name who will use or adopt your results (a specific group, not “industry” or “society”), how they get them, and the indicator that shows the change, with baseline, target and date.
• Use the topic's own words for each outcome, so the evaluator can tick it off.

What the scope asks for

Evaluators check the proposal against these sentences of the scope. Answer each one visibly, in the call's own words.

• “Applicants should explicitly state in their proposal which of the following Flaviviruses is targeted and the proposed work should address only this specific Flavivirus.”
• “The proposed work should aim to advance the development of existing prophylactic and therapeutic monoclonal antibody candidates targeting exclusively one of the following Flaviviriuses:.”
• “Proposals should focus on antibodies produced or derived from a single cell clone through recombinant expression, such as B-cell derived antibodies, hybridoma derived antibodies and nanobodies.”
• “Proposals should thus aim to diversify and accelerate the global prophylactic and therapeutic research and development portfolio for emerging and re-emerging viral infections, and to strengthen the leading role of the EU in prophylactic and therapeutic research and development.”
• “Proposals should address all the following research areas:.”
• “Attention should be paid to critical biological and social factors such as sex, age, ethnicity and disability.”
• “Participation of third countries where viruses addressed in the proposal are endemic or where outbreaks have occurred or are ongoing is encouraged.”
• “The participation of start-ups, micro, small and medium-sized enterprises (SMEs) is encouraged with the aim of strengthening their scientific and technological foundations, enhancing their innovation potential, and exploring possibilities for commercial exploitation.”
• “All projects funded under this topic are expected to engage with regulatory bodies in a timely manner to ensure adequacy of the actions from a regulatory point of view.”
• “Proposals should advance research by leveraging already existing and emerging state-of-the-art research infrastructures such as those having contributed to the services developed under the ISIDORe project.”
• “Applicants should provide details of their clinical studies in the dedicated annex using the template provided in the submission system.”
• “As proposals under this topic are expected to include clinical studies, the use of the template is strongly encouraged. https://health.ec.europa.eu/health-emergency-preparedness-and-response-hera/preparedness/medical-countermeasures-strategy_en. https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en. https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32003H0361.”

Conditions that shape the proposal

• Part B, sections 1–3: 40 pages (standard application form). Text beyond the limit is not read; tables and figures count.
• Other Eligibility Conditions: “In recognition of the opening of the US National Institutes of Health’s programmes to European researchers, any legal entity established in the United States of America is eligible to receive Union funding.”
• Evaluation and award: Award criteria, scoring and thresholds: “To ensure a balanced project portfolio covering the Flaviviruses targeted in this topic[[Flavivirus i to vi, as given in the scope of this topic.]], grants will be awarded (within available budget) to proposals not only in order of ranking but at least also to those proposals that are the highest ranked within…”
• Evaluation and award: Submission and evaluation processes: “The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 4 (Implementation). The cumulative threshold will be 12.”

Impact pathway and traps

• The scope expects pilots or demonstration. Name the sites, the partners who run them and what is measured there.
• International cooperation is part of the scope. Explain what the non-EU partners add and how the cooperation is organised.
• Policy or regulation is in scope. Name the policy owners you will reach and what you will give them.
• Keep outputs, outcomes and impacts apart: what you deliver, what changes when others use it, and the long-term effect.
• For each destination impact you claim, show which of your outcomes feeds it. Destination impacts are long-term effects, not project deliverables.
• Name the barriers outside the project (regulation, markets, user behaviour) that could block uptake, and what you will do if they do.
• Section 2.3 (the summary canvas) is optional on this call; the old split into scientific, economic and societal impact is no longer required.