Session Details

Regulatory Spotlight - Clinical Site Cell Supply for Commercial CAR-T Products - How to Integrate Regional Rules and Policies into Global Networks
Thursday, May 30, 2019 11:00 AM - 12:15 PM 
Room 212
All the commercial CAR-T programs either approved/seeking approval are dependent for supply from clinical apheresis and cryopreservation services. This has raised myriad issues, not the least of which is the diversity of regulatory oversight and control in the markets where these products are already approved- EU, US, Canada and Australia. In some markets this is considered to be an essentially clinical activity with limited regulatory interaction other than meeting starting material specifications, in others this is covered by existing tissue practice standards which are variably regulated, whilst in Australia this is seen as a manufacturing step that requires the manufacturer to demonstrate they can exert control on some minimum quality and testing requirements. We propose to engage with regulators and industry to discuss their strategy in their relevant markets to foster a discussion on what a uniform requirement should look like for industry and clinical centers.

Chair: Simon Harrison, (AU)

Francesco Cicirello (AU)
Bryan Silvey (US)
Peter Holman (US)

Simon Harrison MBBS|PhD
Assistant Professor
Peter MacCallum Cancer Center

Francesco Cicirello PharmD|MSc
GMP Inspector and Chair of PIC/S Annex 2 Revision and Deputy Chair of the SCH

Peter Holman Other (please enter below)
Sr Director, Head of Apheresis Integration
Novartis Pharmaceuticals Corp.

Bryan Silvey BSc
Senior Director, Global Quality Compliance
Kite, a Gilead Company