3. Costs we fund - MRC

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3.6 Costs relating to Biomedical Catalyst calls

For the Biomedical Catalyst: Developmental Pathway Funding Scheme (DPFS) scheme supporting clinical evaluation, certain costs in excess of £50,000 for sub-contracts with contract ROs (CROs) may be paid at 100%. This is limited to activities that meet all three of the criteria outlined below:

  • are required to be undertaken to regulatory standards by a competent authority to allow clinical evaluation
  • do not involve creativity/intellectual input to the development of the entity by the CRO
  • require access to skills and resources not available in academia, where this can be robustly justified

Examples of eligible activities:

  • pre-clinical toxicology package carried out under Good Laboratory Practice (GLP)
  • synthesis or manufacture of an entity carried out under Good Manufacturing Practice (GMP)

Examples of typically ineligible activities include:

  • testing an intervention for efficacy in animal models
  • iterative development of an intervention, for example medicinal chemistry
  • preparation of regulatory submission.

If an applicant is considering applying for 100% FEC for such activities they must discuss with the relevant programme manager before submitting. The programme manager will advise on suitability and the mechanism for inclusion of the exceptional costs.

Please note that the first £50,000 of aggregated eligible CRO costs should be included under the ‘Directly incurred’ heading. The remaining balance should be entered separately as ‘Directly incurred’ and then the ‘Exceptions’ box must be ticked.

Last updated: 17 August 2021

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