Hello GCTP Community!
Here are the January meeting minutes from the GCTP Core Leadership. Stay tuned for a February update. If anything interests you or you would like to get more involved in the community, contact Yan @Yan Ni or any of the subcommittee leaders:
Biomarker and Bioanalytical: @Vibha Jawa
Clin Pharm/ADME: @Steven Louie
CMC: @Allison Radwick
GCTPs Core Leadership Team Monthly Meeting Minutes
Date: January 11th, 2024
Attended by: Yan Ni, Steven Louie, Allison Radwick, Dale, Hardik Mody, Vibha Jawa, Nagendra Chemuturi, Shaik Saleem and Yun Liu; Guest Speaker: Manuela Braun
Meeting Notes:
- Meeting secretary/note taker needed: Yan
· Ami volunteered to take and post meeting minutes on the community web page
· Membership engagement subteam takes care of the newsletter. Allison will follow up.
- ADAT and request for collaboration: Manuela and Vibha
· Introduction and Request from Manuel Brown:
1. Discussion regarding how to get engagement/response for the already existing questionnaire for assessing the landscape for assays and formats for patient selection, validation of assays, details of assays, number of samples, which reporter gene/construct do you use etc.
2. Best way to get responses is to host it "live" and get attendees to respond
3. Vibha will share the questionnaire on screen with the CGT bioanalytical/biomarker group
4. Also proposed doing a joint publication with ARDAT
- Goals and updates from sub-teams
- Biomarker and BA: Vibha, Stephanie
Future topic for discussion:
1. Biomarker activity (potency) assays vs expression assays (quantitative): Q1) Is there a preference of which assay to be developed and validated? Q2) How is the information used within the preclinical and clinical program to determine efficacy and patient outcomes/treatment Ask out to Spirovant Q3) If available, should you use a CLIA validation approach or an FDA/EMA PD validation approach and when should you use which approach
2. How do we as an industry evaluate biomarkers in clinical studies: types of platforms; use of data; validation approaches; etc. For example, gene expression assays vs cell surface biomarkers: pros and cons to each approach Ask out to Takeda
3. Platform for discussion:
a. Definitely want to do one OSD in the next 3-4 months; Can bring someone from clin pharm or CMC to collaborate if they do an OSD – Maybe Dale can work with Stephanie on the process to make the OSD happen.
b. For the July summer Scientific Forum – they have not sent out emails for proposal
- Clin Pharm/ADME: Steven, Prathap
1. One AAPS NBC proposal accepted
2. Organizing a GCT workshop with a clin pharm focus
1. One proposal accepted on comparability assessments
2. Working on planning a webinar or OSD (Topic: Raw materials)
3. Couple of white paper topics have been revived. Allison leading the effort.
4. Allison shared regulatory updates tracker.
1. No update
- AAPS programming: Saleem, Hardik
1. Keep a tracking sheet across the subgroups for PharmSci and NBC. Saleem working on the tracking sheet and will be emailed to all the sub-team leads
2. Use the tracking sheet to track the ideas for proposals and coordinate among groups
- AAPS J themed issue: Vittal
1. No update
1. Date and venue is set (March 21st), registration is open, LinkedIn post is there; Steven will share the link
2. Confirmed speakers are on the website: Bostonsociety.org/conference
3. Cosponsored by AAPS Steven will finalize the AAPS co-sponsorship part
1. Vibha comments: FDA highlighted risk with Cell Therapies. GCTP should have a comment about it
2. Collaborations with other communities and organizations (ASCPT)
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Allison Radwick Ph.D.
Sr Regulatory & Policy Comms Mgr
USP
East Fallowfield PA
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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