2016 GRP Workshop Presentations

Please note: Only those presentations where permission has been received for posting are available to meeting delegates. A large number of speakers are in the process of providing ISCT with revised slides and as a result, these presentations will be gradually uploaded to the website as they are received.

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Speakers for the following presentations have given authorization to post their materials.

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Regulatory Roundup Focused on Asia 
Presenter: Antonio Lee, MEDIPOST America – Korea and USA

Session I
National Considerations for Screening/Transferring Cells for Further Manufacturing
Moderator: Dominic Wall, Peter MacCallum Cancer Centre – Australia
Yoshiaki Maruyama, Pharmaceuticals and Medical Devices Agency (PMDA) – Japan
Azizah Ab Ghani, National Pharmaceutical Control Bureau, Ministry of Health Malaysia – Malaysia 
Miguel Forte, TxCell SA – France

Case Study I
National Considerations for Screening/Transferring Cell for Further Manufacturing

Session II
Combination Treatments
Moderator: Karen Nichols, NantKwest Inc. – USA
Nicolas Ferry, Agence nationale de sécurité du médicament et des produits de santé (ANSM) – France
Jaeseung Lim, ChaBiotech – Korea
Kurt Gunter, Cell Medica Inc. – USA 

Case Study II
Combination Treatments

Session III
Vectors, Gene Transfer, Modifications
Moderator: Christopher Bravery, Consulting on Advanced Biologicals – United Kingdom
Maria Cristina Galli, Istituto Superiore di Sanità (ISS), EMA – Italy
Helen Heslop, Baylor College of Medicine – USA 

Case Study III
Vectors, Gene Transfer, Modifications

Session IV
Safety, Toxicity Issues, Risk Profile 
Moderator: Scott Burger, Advanced Cell & Gene Therapy – USA 
Feng Qi, Health Sciences Authority (HSA) – Singapore 
Bao-Zhu Yuan, Cell Collection and Research Center, National Institutes for Food and Drug Control, China FDA – China 
Sarang Chitale, Novotech – Australia 

Case Study IV
Safety, Toxicity Issues, Risk Profile 


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