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    What happens after I submit a proposal?

    Initial triage takes place at the European Lead Factory Programme Office at Lygature, which assesses the feasibility and novelty of proposals, followed by a review and selection process. If selected, your assay passes to the European Lead Factory’s screening facilities. See here for more information on the submission process. 

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    What happens during screening?

    All experimental work is performed by the European Lead Factory Consortium Partners, supported by IMI funding. Your input will include specific scientific knowledge around your proposal and might include assay materials (DNA plasmids, proteins etc). You will receive a Qualified Hit List (QHL) of up to 50 compounds and all related biological data that is generated.

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    What are the publication and exploitation rights for my programme?

    You are free to decide for your own screening programme whether results (in part or whole) will be advanced for the purpose of direct exploitation and/or purely for research use, except that publication of results will be withheld until the option rights granted to the EFPIA Participants for direct exploitation can be evaluated. See Rights and obligations for a full breakdown.

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    What are the criteria for successful proposals?

    Broadly speaking, a proposal must be novel (new target, new assay approach or new chemistry for existing targets) and of the highest scientific quality. Furthermore, a HTS/HCS-compatible assay must be available. See Requirements for a detailed list.

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    Can I make more than one submission?

    Yes. Strict confidentiality applies during the submission process. There is an undertaking from all members of all offices, boards and committees (including EFPIA participants) that they will not disclose any details to their own organization or to third parties. After your programme is selected and you sign the Contributing Third-Party Agreement, your rights and obligations apply – described in our plain English guide.

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    Who assesses programmes?

    The initial triage programme is conducted by the European Lead Factory Programme Office, at Lygature. Submissions that pass triage then go to the Review Committee and the Selection Committee.

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    Will I have a chance to challenge rejection?

    The final say rests with the Selection Committee, but the European Lead Factory has been designed to promote collaboration and we try to encourage and promote valuable ideas. Although rejections cannot be appealed, if a submission fails because of shortcomings in the assay, you may be given up to six months to suggest an upgrade at the Committee’s discretion.

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    What type of assays can be submitted?

    Biochemical and cell-based assays (using stable cell lines) can be submitted, for example alpha-screen, fluorescent polarization, HTRF, colorimetric, FRET, TR-FRET, IMAP, beta-lactamase, and luciferase. Phenotypic screens can be submitted as well (HTS and HCS).

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    How well developed does the assay need to be?

    The assay has to be an endpoint assay, homogenous (meaning NO wash steps), reproducibly working in a 384-well format with maximum volume of 30 µl. If you need advice on how to reach that quality, you can contact us.

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    Does the data need to be validated for the assays submitted to the programme? At what level?

    Detailed validation is not warranted. However, the assay needs to be robust (Z-prime>0.6) and reproducible. Reagents that are used need to be stable for at least 8 hours. Furthermore, the assay plate, after completion of the reaction, needs to have a stable readout for at least 1 hour.

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    Is there a list of assay formats that will not be considered?

    Formats using less than 384-wells will not be considered. Also, kinetic assays are not compatible with HTS. Most of the time kinetic assays can be adapted to endpoint assays by introducing a stop reaction.

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    What type of screening is available? Is HCS screening available?

    The European Lead Factory can accommodate both High Throughput (HTS) and High Content Screening (HCS) programmes.

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    Do you have a list of assay detection technologies that will be available?

    All technologies based on luminescence, absorbance or fluorescence are available.

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    Can a phenotypic screen be performed as a follow-up screen if the results from abiochemical screen are promising?

    During the follow-up phase, potential phenotypic screens might be included. However, in the pre- Qualified Hit List phase all experiments need to be performed within the European Lead Factory, meaning that there are restrictions on the types of screens as well as on the resources. For example, the amount of compound available for all additional experiments is limited. Details will be discussed during preparation of the programme plan.

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    How much communication is there during the screening programme between the screening scientists and the programme owner?

    There is regular communication (~monthly) between the programme owner /target provider and the screening scientists of the consortium. The precise frequency will depend on the status of the programme: during data analysis, communication will take place more often.

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