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Aim(s):In the first instance, to

1.  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, in the first instance. 'Gold standard' dataset defined as one which allows the direct comparison of different studies and contains a minimum set of required parameters.
2. 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)

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>Other IgG-like molecules to be included based on absence of technical limitations

Approach:>'Gold standard' dataset defined as one which allows the direct comparison of different studies and contains a minimum set of required parameters.

>Collate PK on 10 priority marketed Ab drugs which are know to have high quality published data and check whether this meets the above definition.

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>Collate PK and other data from additional Ab molecules and fit these into proposed 'quality tiers'

Link to PK quality tiers page

Further needs:

-Discussion on sources of data e.g. Jain et al., (2017) publication, FDA drug approval packages

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