2017-Jul-14 BiWeekly PhUSE Nonclinical ADA Endpoint Modeling
<< Go back to the Investigating Endpoint Modeling - ADA Minutes Page When: 2017-07-14, 09:00-10:00 EDT
Next meeting: Aug 11, 2017 at 09:00 to 10:00 EDT
Meetings: 2 week schedule
3) Reviewed charter
4) Discussions: Mike shared feedback received from PhUSE Steering Committee was to make sure we are not introducing new/conflicting methodology as to what clinical is doing. Can we model using existing domains in SEND 3.0?
Bill Question: Is there someone from clinical team that could join?
Thomas shared Novo Nordisk approach: shared usage of LB domain which was rejected by CDISC as terminology to be used in the LB code list and recommended it be used in IS. IS domain is used in clinical – where they intend to use as measurement for immunogenicity. Problem is IS domain is not available in SEND 3.0. ADA is compound specific and generic terms need to work together. Concern about hijacking the subcat used in clinical.
ADA reporting: positive/negative result as well as titer or RLU (e.g., magnitude of response)
Company to company variability in how assay methodology is applied (screen vs titre), neutralizing and cross reactivity, so needs to be flexible. Some companies may do binding and neutralizing. Methods can also be developed for cross reactivity (e.g. against administered compound and endogenous target).
Remit: guidance on SEND and future implementations and address how we should approach under SEND3.0.
FDA won’t expect dataset in standardized format until standard is defined and pilots have been conducted.
Types of expertise on the team:
Scientific representation – Nonclinical. Can we add someone from Clinical?
CDISC Controlled terminology team (Virology) – Jordan Li
SDTM IS representation – Craig ?
FDA rep -for expectations in nonclinical
|Mike||Update Wiki||Next few days|
|Group||Each member to track down an example of data set used in submission for clinical (SDTM). Will likely need to reach out to clinical data management function within your organization (target 1 month)||By next meeting|
|Group||Future meeting – share example of anonymized/mock data (Leslie and Thomas – 8/11 & 25) Can be shared in excel format.||By next meeting|
Last revision by Mwasko79, 2017-08-11