Goals:

  • SEND IG does not have the IS domain so IS representation of ADA concepts require both clinical and non-clinical input to determine what the modeling strategy should be.
  • Discuss the possibility of adding variables to represent drug name and endogenous antigens.

 Issues:

  1. When you administer a drug in a subject, the drug may stimulate the production of anti-drug antibodies (ADA). It is important to know the presence/absence of the ADA as well as its quantification in titer. If the ISTEST is a generic value: ISTEST = Detection of Anti-drug Antibody, how do you represent the name of the drug to which the ADA is reacting to? Or should the drug name be pre-coordinated into the TEST?
  2. A subject produces a certain endogenous antigen (e.g. glucagon), when you administer an analogue drug (e.g. glucagon analogue) that is structurally similar to this self-produced antigen, the ADA evoked by the analogue drug will cross-react to the endogenous antigen in the subject. There are cases where the ADA may cross-react to multiple endogenous antigens, it is therefore important to know what these antigens are. There needs to be a variable or place to represent the specificity of the endogenous antigen the ADA is reacting to. The IS domain currently has no standard variables to represent this type of INFO.
  3. AZ, BMS, Merck, and Covance comments: for representing ADAs, these companies have currently pre-coordinated the name of the drug into the TEST, such as "anti-AZ007 antibody". However, the "AZ007" part will change from the company's internal compound number, to the drug's generic name then to the drug's trademark name, so there are at least 3 variations of names for a single drug in AZ, which means 3 "anti-xxxxxx antibody" TESTs have to be created for essentially the same drug. Results would be presence/absence of the ADA and also the titer. Pre-coordination of the drug name into the TEST is practiced now but not preferred.

 

Thomas Gade Bjerregard from Novo Nordisk proposed the following modeling strategy for the ADA concepts. The virology terminology team is mainly concerned with the idea of the SCAT variable being used and taken up by the drug name.

2016-08-26_Novo Nordisk proposal for modelling of ADA_Thomas Gade Bjerregard_JL.pptx

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