Aim(s):
In the first instance, to compile a 'gold standard' data set of PK, Immunogenicity and Phys Chem properties for Biologics (primarily antibodies) based on information in the public domain.
Beyond this, would like to model PK from primary sequence.
Contributors:
Vincent Dubois (MedImmune), Dave Fairman (GSK), Anna Gaulton (EMBL-EBI), Theresa Goletz (EMD Serono), Boris Grinshpun (EMD Serono), Anne Hersey (EMBL-EBI), Tushar Jain (Adimab), Andrew Leach (EMBL-EBI), Chris Lloyd (MedImmune), Yves Fomekong Nanfack (EMD Serono), Friedrich Rippmann (Merck)
Value proposition and use:
>Need well curated and evolving data on reference molecules (this is already available internally but to a lesser extent).
>Use the dataset to link early screening data to later (endpoint) data.
>Use the dataset to cross reference and pick outliers.
Scope:
>Initial focus is on mAbs
>Include information on ADCs (this needs to be contextualised in the database)
Approach:
>Collate PK on 10 priority marketed Ab drugs which are know to have high quality published data.
>Propose 'data quality' tiers into which data from published molecules can be placed.
>Collate PK and other data from additional Ab molecules and fit these into proposed 'quality tiers'
Further needs:
-Discussion on sources of data e.g. Jain et al., (2017) publication, FDA drug approval packages
-Discussion on technicalities of database build, setup, etc. bearing in mind future inclusion of data from other biologic drug modalities beyond standard mAbs