Please join us Tuesday July 9, 2024 from 12 noon – 1 pm EST for a virtual Open Scientific Discussion (OSD) hosted by the AAPS Gene and Cell Therapy Products (GCTPs), Excipients and Regulatory Sciences Communities on the following topic:

Raw and Ancillary Material Quality Standards in Gene and Cell Therapy Products

•   What are the USP initiatives to support quality and consistency of emerging modalities?

•   How can we enhance compliance, supplier management, good manufacturing practices, traceability, and viral safety?

•   What are best practices for raw and ancillary material control and evaluation? 

Discussion Leaders:

Ben Clarke (USP)

Lynn Csontos (STEMCELL Technologies)

Mo Heidaran (Cellx Inc Consulting)

Organized by:  

Allison Radwick (USP)

Ami Patel (Boyds Consultants)

We start at 12:00 EST sharp. To avoid interruptions, please dial in before noon and mute yourself until Q&A starts.

(Please remain on mute unless asking questions)

Where: https://meet.goto.com/505947717 

You can also dial in using your phone.
United States: +1 (646) 749-3122
Access Code: 505-947-717

Join from a video-conferencing room or system.
Dial in or type: 67.217.95.2 or inroomlink.goto.com
Meeting ID: 505-947-717
Or dial directly: [email protected] or 67.217.95.2##505947717

Please feel free to share with colleagues who may be interested in this topic. Thank you!

The AAPS GCTPs, Excipients and Regulatory Sciences Communities Leadership Teams

Please join us for an Open Scientific Discussion (OSD) hosted by the AAPS Gene and Cell Therapy Products (GCTPs) Community on April 25, 2024, 12 pm – 1 pm EDT on the following topic:

Secondary malignancies post-CART cell therapy: Clinical and Regulatory Perspectives

·       Are you aware of the recent FDA requirement of class wide boxed warning on all commercial CAR-T therapies?

·       What do we know and not know about second malignancies?

·       What’s your experience in secondary malignancies and CART cell therapy?

Panelists:

Bruce Levine (Professor, Univ. PENN)

Nicole Verdun (Super Office Director, FDA, CBER)

Organized by:  

Vibha Jawa (BMS) Yan Ni (Passage Bio)

We start at 12:00 PM EDT sharp. To avoid interruptions, please dial in before noon and mute yourself until Q&A starts.

(Please remain on mute unless asking questions)

When: Thursday April 25, 12:00 – 1:00 PM EDT

Where: Please join from your computer, tablet or smartphone.
https://meet.goto.com/505947717

You can also dial in using your phone.
United States:    +1 (646) 749-3122

Access Code:    505-947-717

Join from a video-conferencing room or system.
Dial in or type:    67.217.95.2 or inroomlink.goto.com

Meeting ID:        505-947-717

Or dial directly:  [email protected] or 67.217.95.2##505947717

New to GoToMeeting? Get the app now and be ready when your first meeting starts:
https://meet.goto.com/install

Please feel free to share with colleagues who may be interested in this topic.

 Thank you,

The AAPS GCTPs Communities Leadership Teams