Risk assessment
- Richard Norman (Unlicensed)
Early risk assessment (challenges)
>Likely biggest challenge is IP and what is feasible to share.
Mitigation: identify low to high sensitivity data and pressure test with Legal departments (internal legal sponsor).
>First hurdle may be willingness within organisations to share data and assay method details.
Mitigation: target appropriate management level (internal executive sponsor) early and pressure test using 'basecase/upscale' scenarios and survey questions.
>Related to the above; willingness to share assay data correlation with endpoint data.
Mitigation: select 1-3 assays for which data is being shared and establish their correlation with PK, viscosity, solubility etc. internally, i.e. build model which can be shared thus circumventing the requirement for sharing primary data.
>Too great a variability and reproducibility between same assays leading to inability to effectively compare data (establish correlations).
Mitigation: start with assays with least variability, for other assays 'standardisation' may be of value.
>Willingness to share sequence/structure information on molecules.
Mitigation: use information from molecules in the public domain and/or 'dead' internal projects. Define and use structure descriptors.
>Reaching agreement on how and where data is stored.
>Reaching agreement on model for ownership of data.