Conference Schedule

Wednesday, 10 April 2013

07.30 – 09.00	Continental Breakfast
09.00 – 09.05	Welcome and Introduction Chris Potter, CMC Pharmaceutical Consultant, PQLI Technical Project Manager, ISPE, UK
09.05 – 09.45	Plenary Presentation: “Carpe Opportunite-Regulatory Experience with Implementation of QbD: An Industry Perspective” Roger Nosal, Vice President of Global Chemistry, Manufacturing & Controls Pfizer, Inc., USA
09.45 – 10.25	Plenary Presentation: "US Regulatory Expectations" Steven Kozlowski, MD, Director, Office of Biotechnology Products, FDA/OBP
10. 25 – 10.45	Plenary Question and Answer Discussion
10. 45 – 11.15	Networking Break
11:15 – 12.00	Case Study Presentation: "A-Mab and Beyond for Monoclonals" Lynne Krummen, Vice President and Global Head for Biologics, Technical Regulatory and Global Lead for Quality by Design, Genentech Inc., USA
12.00 – 13.00	Lunch
13.00 – 13.30	Summary of Current State and Introduction to Workshops
13.30 – 15.00	Workshop 1: Scalability of Design Space Leaders: Nathan McKnight, Genetech, USA; Tim Watson, Pfizer, USA
15.00 – 15.30	Networking Break
15.30 – 17.00	Workshop 2: Developing and Implementing an Effective Control Strategy Leader: Beth Junker, Merck & Co., Inc., USA
17.00 – 18.30	Networking Reception

07.30 – 08.30	Continental Breakfast
08.30 – 10.00	Workshop 3: Communicating an Effective Scientific Story Leaders: Vassiliki Tegoulia, Genentech, USA; Duane Bonam, Amgen Inc., USA
10.00 – 10.30	Networking Break
10.30 – 12.00	Workshop 4: Demonstrating and Maintaining a State of Control Throughout the Lifecycle Leaders: Joseph Famulare, Vice President, Genentech Inc, USA; Tom Monica, Amgen, USA
12.00 – 13.00	Lunch
13.00 – 13.45	Case Study Presentations: "QbD for Biologicals, A-Vax Case Study" Ranjit Deshmukh, MedImmune, Inc., USA
13.45 – 14.30	Case Study: QbD and Process Understanding: Essential Components of Good Process Development Alain Bernard, Biopharma Process Sciences (BS), UCB SA
14.30 – 14.45	Summary Presentations-Workshop 1: Scalability of Design Space
14.45 – 15.00	Summary Presentations-Workshop 2: Effective Control Strategy
15.00 – 15.30	Networking Break
15.30 – 15.45	Summary Presentations-Workshop 3: Communicating an Effective Scientific Story
15.45 – 16.00	Summary Presentations-Workshop 4: State of Control Throughout the Lifecycle
16.00 – 16.50	Plenary Presentation: “A Path Forward to Reconcile Regulatory Perspective” Roger Nosal, Pfizer, Inc., USA
16.50 – 17.00	Next Steps and Closing Remarks