Session 3: Clinical / Non-Clinical (Case study) · Coordinator: Lila Feisee (BIO) · Chair: Jian Wang (Health Canada) · Co-Chair: David Hutto (Eisai) Non-clinical ICH S6 9:00 - 9:45 David Hutto (Eisai) (Non-clinical evaluation of biotechnology products) The Importance of Immunogenicity Assessment of 9:45 - 10:15 Shalini Gupta (Amgen) Therapeutic Proteins 10:15 - Coffee Break 10:30 10:30 - Clinical data requirements for registration of Freddy Faccin (AbbVie) 11:00 biotherapeutics Panellists: Session Chairs, 11:00 - Speakers, Q&A and Roundtable Discussion 11:35 Invited Participants Session 4: CMC Considerations: Manufacturing and Quality · Coordinator: Wassim Nashabeh (Genentech) · Chair: Chung Keel Lee (MFDS) · Co-Chair: Wassim Nashabeh (Genentech) 11:35 Kowid Ho – ICH guidelines for biologics (Roche) 12:15 12:15 – Luncheon 13:15 Mats Welin 13:15 Review of recent ICH Quality guideline focused on – (Medical Products 13:45 enhanced process/product understanding (ICH Q8-11) Agency) 13:45 Krummen Feasibility of application of ICH Q8-11 to Biotherapeutic – (Genentech) products 14:05 14:05 LifeCycle Management for Biotherapeutics: The – Richard Lit (Amgen) 14:25 Complex world of post-approval changes 14:25 - Chung Keel Lee (MFDS) GMP highlights in Biopharmaceuticals 14:45 Panellists: Session Chairs 14:45 - Speakers, Q&A and Roundtable Discussion 15:15 Invited Participants 15:15 - Coffee Break 15:30 Plenary Lecture: New Upcoming Biotherapeutics Technology 15:30 High-level overview of new innovative technologies in – James Merson (Pfizer) 16:15 biotherapeutics
Session 3: Clinical / Non-Clinical (Case study) · Coordinator: Lila Feisee (BIO) · Chair: Jian Wang (Health Canada) · Co-Chair: David Hutto (Eisai) 9:00 - 9:45 David Hutto (Eisai) Non-clinical ICH S6 (Non-clinical evaluation of biotechnology products) 9:45 - 10:15 Shalini Gupta (Amgen) The Importance of Immunogenicity Assessment of Therapeutic Proteins 10:15 - 10:30 Coffee Break 10:30 - 11:00 Freddy Faccin (AbbVie) Clinical data requirements for registration of biotherapeutics 11:00 - 11:35 Panellists: Session Chairs, Speakers, Invited Participants Q&A and Roundtable Discussion Session 4: CMC Considerations: Manufacturing and Quality · Coordinator: Wassim Nashabeh (Genentech) · Chair: Chung Keel Lee (MFDS) · Co-Chair: Wassim Nashabeh (Genentech) 11:35 – 12:15 Kowid Ho (Roche) ICH guidelines for biologics 12:15 – 13:15 Luncheon 13:15 – 13:45 Mats Welin (Medical Products Agency) Review of recent ICH Quality guideline focused on enhanced process/product understanding (ICH Q8-11) 13:45 – 14:05 Krummen (Genentech) Feasibility of application of ICH Q8-11 to Biotherapeutic products 14:05 – 14:25 Richard Lit (Amgen) LifeCycle Management for Biotherapeutics: The Complex world of post-approval changes 14:25 - 14:45 Chung Keel Lee (MFDS) GMP highlights in Biopharmaceuticals 14:45 - 15:15 Panellists: Session Chairs Speakers, Invited Participants Q&A and Roundtable Discussion 15:15 - 15:30 Coffee Break Plenary Lecture: New Upcoming Biotherapeutics Technology 15:30 – 16:15 James Merson (Pfizer) High-level overview of new innovative technologies in biotherapeutics
RHSC_Biotherapeutic%20Product%20Roadmap_Apr25_2014.docx