Preclinical In Vitro Cardiovascular Studies

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Description

The Authority has a requirement for a preclinical in vitro cardiovascular de-risking package of work. The Authority wishes to understand the cardiovascular risk and establish QT prolongation potential for a single and multi-drug combination and fulfil the ICH S7B regulatory guidance requirements. This will include hERG (human ether a go go related gene) assays; additionally either human induced pluripotent stem cell derived cardiomyocyte (hiPSC-CM) assays or Purkinje fibre assays are required, but alternative proposals will also be considered. A further requirement for integrated risk assessments will be included as an Option. These studies are not required to be conducted to GLP but must be in compliance with ICH S7B. Additionally, a Specialist Review of relevant in house and published cardiovascular safety data is required to provide a risk assessment and data interpretation to inform decisions on the requirement for any further cardiovascular assessments and prepare for regulatory submission to the UK MHRA. As a result of the Specialist Review, the delivery of any recommended cardiovascular assessments may be required as a further Option. In order to apply, Applicants will need to access www.contracts.mod.uk and create an account and apply by completing the Pre-Qualification Questionnaire.

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