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Frequently Asked Questions (FAQ) - Fast Track To Innovation

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Yes, subcontracting of clinical studies is possible.

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Clinical trials can be subcontracted.

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Out-licensing after Phase 2 can be considered as market uptake.

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There is no exclusion of medical devices.

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Clinical trials can be sponsored. But the rules of this instrument have to be considered.

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As far as all three participants are independent from each other this is fine. A subsidiary company and the correspondent owner company do not qualify as 2 independent participants.

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As part of the consortium one partner will co-ordinate the consortium and report to the EU. They will bring that particular expertise and would fulfil the financial check.
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In principle is possible, but since this is still a pilot action with only 5 partners per consortium and due to the high number of proposals, we cannot foresee how the reviewers will compare such an application with other applications in which the coordinator also performs other core activities.

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Fit for Health 2.0 has a large database with companies and organisations interested in the health area of Horizon 2020.

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As far as they comply with the FTI goals (delivery of a new educational concept in three years), then it is possible.

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They can, but since FTI is allocated in part II (role of industry) and part III (societal challenges) of horizon 2020, they are not entitled to receive funding from Horizon 2020. Please contact the Swiss SME-NCP for clearing this.

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Yes, there is no exclusion of small markets.

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Universities are also eligible and they are reimbursed at a 100% rate.

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In the case this new application addresses a challenge under horizon 2020 and is innovative enough yes.

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Then it is not research infrastructure, but deployment infrastructure that should be checked in your specific case by your health NCP and SME-NCP.

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Unfortunately not. Actions should focus on bringing a product or service to the market.

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It is surely a decision criterium with equal points among several applications.

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Yes, but the scientific expertise and design of prototype should be within the consortium. However, engaging a technical subcontractor for building the prototype is possible.

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Under FP7 a Commission decision of 21/01/2011, Article II.14.1 of Annex II of the ECGA was followed to allow SME owners who do not receive a salary and other natural persons who do not receive a salary, to charge as personnel costs a flat rate based on the allowances used in the People Specific Programme ("Marie Curie" flat-rates).

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Yes, as far as these processes are needed for an innovative service or product to be pushed to the previous steps before market uptake.

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Only development of most innovative products or services will be funded. If these are needed for scale up, then yes.

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There is no explicit limit for subcontracting.

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If communication and interaction activities with potential investors or customers, or dissemination of milestone achievements during the project (under a work-package 'communication and dissemination activities') are necessary to implement the project, then those costs are eligible. Activities or products purely intended to support commercial purposes do not qualify as eligible costs.

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You must already provide a rough strategy in your application. Design of tailored strategies can be funded.

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Yes, as well as the preparation and fill of a patent.

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If you mean analytical services, yes.

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Please note that the SME is a first time applicant and has mainly borne research costs (so the proceeds are of course very low). The company was incorporated 5 years ago.
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As coordinator you have to pass the financial viability check. If this raises problems, it might be better if another partner is the coordinator of the project.

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As in any other Horizon 2020 project: personal, consumables, subcontractors...

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Research should not be a main focus of an FTI action, so equipment for research is difficult to get funded.

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For all innovation activities, a flat rate for indirect costs applies.

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“on the market” can be sale of device after completion of clinical trials. But out-licensing after Phase 2 can be considered as market uptake.

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What would happen, if a Phase 2 is funded, but the company owning the drug candidate decides afterwards to develop the program further through Phase 3 to market (and thus does no longer comply with the 36-months-to-market dogma)?
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Not reaching this goal will most probably have negative effects for the evaluation of the FTI instrument, but there will be no penalty for the consortium.

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You should have the EU market in focus. If you can also deliver solutions for additional markets you can do so.

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There is no other limitation than the fact that the time to market-uptake has to be no later than 3 years after the beginning of the project. So the project must not exceed 3 years. Expected are projects of 1-2 years.

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Although there are no formal limits in the Work Programme, you should note that in terms of impact, the expectation is that initial market take-up of the innovation should happen no later than 36 months after the start of the action.

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A dissemination plan is highly dependent on your project! There is not such a template.

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For a proposal of an Active Pharmaceutical Ingredient (API) manufacturing method development the target is pharmaceutical industry market. Would it be applicable to FTI?
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There are no limitations for target markets.

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There is no penalty. You must convincingly explain this time to market, which risks you could face and how you could overcome them.

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You must sound convincing in your application and offer solutions for overcoming that risk

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You must convincingly explain in your application in which TRL step your product/service is.

FTI-Other (3)

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It depends on the country. In Germany SME-NCPs work together with the thematic NCPs.

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PIC number is related to your organisation. Your organisation should register for a PIC number.