GSK Investigator-sponsored studies programme





Title:

Belimumab 2019 ISS proposals

Summary:

Currently accepting belimumab ISS proposals up to January 31st, 2019, with next review committee meeting in Q1-2019

Details:

Belimumab ISS Proposals can be submitted any time during the year, however GSK belimumab ISS committee will review them once a year (not applicable for other GSK ISS). In order to have your proposal reviewed by the next belimumab ISS committee (to be held in February 2019), please make sure to submit your proposal by 31st Jan, 2019. GSK belimumab ISS committee will communicate to investigators proposals that fall within current areas of interest and will be provisionally approved by March 2019. The investigators will then be requested to submit full protocol and ICF in English by April 2019. GSK will review these documents and come back to you with a final decision as soon as possible.

Summary of key dates:
-Submission of Proposal by Investigator: January 31, 2019
-Committee Review / Selection by GSK: February 2019
-Communication to Investigators by GSK: March 2019
-Submission of full Protocol and ICF by investigators: April 2019

GSK belimumab ISS committee is committed to the above review timelines, however, the review process might take longer for certain proposals.

The following areas are of interest to the Belimumab ISS Committee:
- Use of belimumab in SLE in clinical practice
- Association of biomarkers with clinical outcomes in SLE
- Contribution to scientific knowledge of SLE disease state
- BLyS inhibition with focus on other systemic and non-systemic autoimmune diseases and consistent with the belimumab mechanism of action (MOA)
- Contribution to scientific knowledge of belimumab
- Critical unmet medical needs based on belimumab MOADetails and timelines described above are not applicable and cannot be used as reference for other GSK ISS areas of interest.

Details and timelines described above are not applicable and cannot be used as reference for other GSK ISS areas of interest.

If you have any questions, please contact your local GSK Medical contact (e.g. MSL, others)

Click on "Submit Application" below to begin the process.

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Posted: 01-22-2018
Created: 01-22-2018
Modified: 06-06-2018
 




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