Tuesday, 26 September 2017
9:00
Welcome and Introduction
Falk Klar, PDA Europe
Ursula Busse, Co-Chair, Novartis
Steffen Gross, Co-Chair, Paul-Ehrlich-Institut
Keynote: 10th Anniversary of the PDA Europe Workshop on Monoclonal Antibodies
9:10
Accomplishments of a Decade of mAbs
Gabriele Dallmann, 1st Chairwoman, Biopharma-Excellence
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Session 1: Regulatory Trends & Updates
Moderator: Martijn van der Plas, CBG-MEB
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9:40
Biologics Working Party: Lessons Learned
Veronika Jekerle, EMA
10:10
EDQM on Monographs related to Monoclonals
Mihaela Buda, EDQM
10:40
Comparability 2.0
Martijn van der Plas, CBG-MEB
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11:15
Coffee Break, Poster Session & Exhibition
11:45
Advancements in ADC Manufacture and Control
Nathan Ihle, Seattle Genetics
12:15
Regulatory Requirements of Antibody-Drug Conjugates -A Chemical Perspective
Nynke Brouwer, CBG-MEB
12:45
Q&A, Panel Discussion
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13:15
Lunch Break, Poster Session & Exhibition
Session 2: High Concentration Monoclonal Antibody Products
Moderator: Michael De Felippis, Eli Lilly
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14:15
Physical Stability Considerations for High Concentration Formulations
Wolfgang Friess, University of Munich
14:45
Formulation and Dosage Form Design
Nagarajan Thyagarajapuram, Eli Lilly
15:15
Primary Packaging Interactions & Delivery Systems
Julian Jazayeri, Amgen
Jean-Christophe Veilleux, California Institute of Technology
15:45
Q&A, Discussion
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16:00
Coffee Break, Poster Session & Exhibition
16:30
Delivery System Design
Susanne Joerg, Lonza
17:00
SC Products and Enzyme Co-Formulation
Claudia Mueller, Roche / Genentech
17:30
Q & A, Panel Discussion
18:00
End of Day 1
19:00
Networking Dinner
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Wednesday, 27 September 2017
9:00
Welcome and Introduction
Falk Klar, PDA Europe
Ursula Busse, Co-Chair, Novartis
Steffen Gross, Co-Chair, Paul-Ehrlich-Institut
Session 3: Advancements in Manufacturing Technologies for Monoclonal Antibodies
Moderator: Lutz Mathe, GE Healthcare
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9:05
Overcoming the Challenges – A Decade's Journey in Cell Culture Process Innovation
Tongtong Wang, Eli Lilly
9:35
How to Manage Bioburden: A Case Study from a mAb Production Facility
Reinhard Braaz, Roche
10:05
Addressing the Risks of Bioburden in mAb Downstream Bioprocessing
Lutz Mathe, GE Healthcare
10:35
Q & A, Discussion
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11:00
Coffee Break, Poster Session & Exhibition
Session 4: Life Cycle Management
Moderator: : Ursula Busse, Novartis
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11:30
ICH Q12: Status of the Lifecycle Management Guideline
Nanna Kruse, Danish Medicines Agency (DKMA), Expert Working Group
12:00
Case Study: Managing Post-Approval Changes
Brian Mullan, Novartis
12:30
Continued Process Verification as a Tool to Support Changes
Aaron Goerke, Roche
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13:00
Lunch Break, Poster Session & Exhibition
Session 5 Specifications & QbD
Moderator: Steffen Gross, Paul-Ehrlich-Institut
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14:00
Leveraging Principles of QbD to Establish Clinically Relevant pecifications
Barbara Rellahan, Amgen
14:30
Comparison of Justification of Specifications
Gerald Gellermann, Novartis
15:00
Setting Specifications for Monoclonals – A Regulator's View
Mats Welin, Swedish Medicines Agency (MPA)
15:30
Closing Panel Discussion
Barbara Rellahan, Amgen
Gerald Gellermann, Novartis
Mats Welin, Swedish Medicines Agency (MPA
Nanna Aaby Kruse, Danish Medicines Agency (DKMA), Expert Working Group
16:15
Closing Remarks & Farewell Coffee
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