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WCBP 2018: Roundtable Information
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Roundtable Session 1: Tuesday, January 30, 15:45 - 16:45

 

Spotlight Topic: From PPQ Batches to Product Licensure - Continuous Process Improvement
FACILITATORS: John Eschelbach, Genentech, a Member of the Roche Group and Bryan SilveyKite Pharma, Inc 
SCRIBES: Bharat Dixit, Finch Therapeutics Group and Bob Kuhn, Amgen Inc.

To view the table abstract and discussion notes, click here.

 

Table 1: Evolution of CQAs Throughout a Program Lifecycle
FACILITATOR: Nomalie Jaya, Seattle Genetics, Inc.
SCRIBE: John Kim, Teva Pharmaceuticals

To view the table abstract and discussion notes, click here.

 

Table 2: New Mechanisms for DS Process Control
FACILITATOR: Carmilia Jimenez Ramirez, Gilead Sciences Inc.
SCRIBE: Mandy Xie, GlaxoSmithKline

To view the table abstract and discussion notes, click here.

 

Table 3:  Visible Particles: Just Another Critical Quality Attribute
FACILITATOR: Roman Drews, Daiichi Sankyo, Inc.
SCRIBE: Zahra Shahrokh, STC Biologics

To view the table abstract and discussion notes, click here.

 

Table 4: PAI Inspections (including Mutual Inspection Experiences)
FACILITATOR: Cynthia Ball, MedImmune, A member of AstraZeneca Group
SCRIBE: Namita Nayak, BioMarin Pharmaceutical Inc.

To view the table abstract and discussion notes, click here.

 

Table 5: Replacing in vivo with in vitro Potency Assays
FACILITATOR: Barbara Capecchi, GlaxoSmithKline
SCRIBE: Todd Ranheim, Takeda Pharmaceutical Company Limited

To view the table abstract and discussion notes, click here.

 

Table 6: Immunogenicity and Regulator's Current Expectations
FACILITATOR: Taro Fujimori, AbbVie Inc.
SCRIBE: Fadi Hakki, MedImmune, A member of the AstraZeneca Group

To view the table abstract and discussion notes, click here.

 

Table 7: QbD Implementation: Learning from the Past to Shape the Future
FACILITATOR: Christof Finkler, F. Hoffmann - La Roche Ltd.
SCRIBE: Min Du, Waters Corporation

To view the table abstract and discussion notes, click here.

 

Table 8: Biosimilarity Assessment
FACILITATOR: Emily Shacter, ThinkFDA LLC
SCRIBE: Chris Chumsae, Abbvie Inc.

To view the table abstract and discussion notes, click here.

 

Table 9: Lifecycle Considerations for Bridging Analytical Methods
FACILITATOR: Ken Miller, AstraZeneca
SCRIBE: Eric Pastor, Sanofi

To view the table abstract and discussion notes, click here.

 

Table 10: ADCs: mAb or DS for Characterization and Control 
FACILITATOR: Scott Henry, Seattle Genetics, Inc
SCRIBE: Jolie Ziemba, Pfizer, Inc.

To view the table abstract and discussion notes, click here.

 

Table 11: Frozen Stability: To Test or Not to Test, A New DS Stability Paradigm?
FACILITATOR: Cleo Salisbury, Genentech, a Member of the Roche Group
SCRIBE: Anders Dybdal Nielsen, Novo Nordisk A/S

To view the table abstract and discussion notes, click here.

 

Table 12: Design of Stability Studies for Biotechnology Product Development and Lifecycle Management – A New USP Chapter 
FACILITATOR: Joseph Kutza, MedImmune, A member of the AstraZeneca Group
SCRIBE: Camilla Santos, Amgen Inc.

To view the table abstract and discussion notes, click here.

 

Table 13: Early Specs for Tox and FIH
FACILITATOR: Cristiana Campa, GlaxoSmithKline
SCRIBE: Kris Antonsen, BioMarin Pharmaceutical Inc.

To view the table abstract and discussion notes, click here.

 

Table 14: In-country Manufacturing to Enable Lower Cost Medicines in Developing Countries
FACILITATOR: John Amery, Pfizer, Inc.
SCRIBE: Stephanie Ranck, Eli Lilly and Company

To view the table abstract and discussion notes, click here.

 

Table 15: Lifecycle Management: Risk Assessments
FACILITATOR: Tom Monica, Amgen Inc.
SCRIBE: Kate Schembri, Genentech, a Member of the Roche Group

To view the table abstract and discussion notes, click here.

 

Table 16: Control Strategies IPCs/PAT
FACILITATOR: Taylor Zhang, Genentech, a Member of the Roche Group
SCRIBE: Carol Krantz, Seattle Genetics, Inc.

To view the table abstract, click here.

 

Table 17: Shipping Qualification
FACILITATOR: Edwin Moore, BioPhia Consulting, Inc.
SCRIBE: Rob McCombie, Genentech, a Member of the Roche Group

To view the table abstract and discussion notes, click here.

 

Table 18: Characterization Assays for Early Product Development
FACILITATOR: Joe Siemiatkoski, J Siemiatkoski Consulting
SCRIBE: Kathy Lee, Eli Lilly and Company

To view the table abstract, click here.

 

Table 19: Quality or Regulatory Submission: New Items in  Regulatory Filings?
FACILITATOR: Jennifer Mercer, BioMarin Pharmaceutical Inc.
SCRIBE: Uma Balasubramanian, Daiichi Sankyo. Co., Ltd.

To view the table abstract and discussion notes, click here.

 

Table 20: Glycan Comparability Between Processes
FACILITATOR: Dietmar Reusch, F. Hoffmann - La Roche Ltd.
SCRIBE: Nicole Piros, Genentech, a Member of the Roche Group

To view the table abstract and discussion notes, click here.

 

Table 21: Phase Appropriate Control Strategy for Host Cell Protein
FACILITATOR: Markus Haindl, F. Hoffmann - La Roche Ltd.
SCRIBE: James Carroll, Pfizer, Inc.

To view the table abstract and discussion notes, click here.

 

Table 22: Forced Degradation
FACILITATOR: Tanya Shang, Pfizer, Inc
SCRIBE: Cari Sänger – van de Griend, Kantisto BV

To view the table abstract and discussion notes, click here.

 

Table 23: Surfactants: Control, Use , and Characterization
FACILITATOR: Kunal Bakshi, GlaxoSmithKline
SCRIBE: Huan Wang, Teva Pharmaceuticals

To view the table abstract and discussion notes, click here.

 

Table 24: Rare Disease-specific and Expedited Review Regulations in Emerging Markets
FACILITATOR: Nina Cauchon, Amgen Inc.
SCRIBE: Santosh Yadev, Merck & Co, Inc.

To view the table abstract and discussion notesclick here.

 

Table 25: Pool for Tox…Pool for Ph1 GMP?
FACILITATOR: Patsy Lewis, Seattle Genetics, Inc.
SCRIBE: JR Dobbins, Eli Lilly and Company

To view the table abstract and discussion notes, click here.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


Roundtable Session 2: Wednesday, January 31, 12:15 - 13:15




Spotlight Topic: Reference Standard: Common Practices and Challenges

FACILITATORS: Zahra Shahrohk, STC Biologics and Qiang Qin, MedImmune, A member of the AstraZeneca Group
SCRIBES: Tami Wu, Seattle Genetics, Inc. and John Kim, Teva Pharmaceuticals

To view the table abstract and discussion notes, click here.

    
Table 26: Evolution of CQAs Throughout a Program Lifecycle
FACILITATOR: Armando Cordoba, Genentech, a Member of the Roche Group
SCRIBE: Kirby Steger, Johnson & Johnson

To view the table abstract and discussion notes, click here.

 

Table 27: Patient Centric Drug Development
FACILITATOR: Trent Munro, Amgen Inc.
SCRIBE: Cari Sänger – van de Griend, Kantisto BV

To view the table abstract and discussion notes, click here.

 

Table 28: Visible Particles: Just Another Critical Quality Attribute
FACILITATOR: Jan Stracke, F. Hoffmann-La Roche Ltd.
SCRIBE: Linda Wilbur, BioMarin Pharmaceutical Inc.

To view the table abstract and discussion notes, click here.

 

Table 29: PAI Inspections (including Mutual Inspection Experiences)
FACILITATOR: Richard Keane, Biogen
SCRIBE: Sianna Castillo, BioMarin Pharmaceutical Inc.

To view the table abstract and discussion notes, click here. 

 

Table 30: ID Testing from Start to Finish, Technical Approaches and Regulatory Requirements
FACILITATOR: Allison Torgesen, Seattle Genetics, Inc.
SCRIBE: Anissa Irwin, Genentech, a Member of the Roche Group

To view the table abstract and discussion notes, click here.

 

Table 31: Immunogenicity and Regulator's Current Expectations
FACILITATOR: Victor Lundin, Genentech, a Member of the Roche Group
SCRIBE: Nicholas Manzo, GlaxoSmithKline

To view the table abstract and discussion notes, click here.

 

Table 32: Surfactants: Control, Use , and Characterization
FACILITATOR: Jason Starkey, Pfizer, Inc.
SCRIBE: Edwin Moore, BioPhia Consulting, Inc.

To view the table abstract and discussion notes, click here.

 

Table 33: In-country Manufacturing to Enable Lower Cost Medicines in Developing Countries
FACILITATOR: Darrin Cowley, Amgen Inc.
SCRIBE: Joseph Siemiatkoski, J Siemiatkoski Consulting

To view the table abstract, click here.

 

Table 34: Validation of Release Assay for Aggregates Measurement
FACILITATOR: Shelly Ji, Janssen R&D, LLC
SCRIBE: Chris Broomell, Takeda Pharmaceutical Company Limited

To view the table abstract and discussion notes, click here.

 

Table 35: ADCs: mAb or DS for Characterization and Control
FACILITATORS: Justin Sperry, Pfizer, Inc.
SCRIBES: Scott Berger, Waters Corporation

To view the table abstract and discussion notes, click here.

 

Table 36: Lean Control Systems for Biotech Products
FACILITATOR: Ruth Cordoba, MedImmune, A member of the AstraZeneca Group
SCRIBE: Xiao-Ping Dai, Celgene Corporation

To view the table abstract and discussion notes, click here.

 

Table 37: Design of Stability Studies for Biotechnology Product Development and Lifecycle Management – A New USP Chapter
FACILITATOR: Bharat Dixit, Finch Therapeutics
SCRIBE: Mimi Roy, BioMarin Pharmaceutical, Inc.

To view the table abstract and discussion notes, click here.

 

Table 38: Risk Assessments to Address Differing Global Requirements
FACILITATOR: Annie Sturgess, Bristol-Myers Squibb Company
SCRIBE: Patsy Lewis, Seattle Genetics, Inc.

To view the table abstract, click here.

 

Table 39: Data Integrity: Harmonizing Regulatory Requirements with Current and Emerging Technology
FACILITATOR: Christina Vessely, Biologics Consulting
SCRIBE: Carmilia Jimenez Ramirez, Gilead Sciences Inc.

To view the table abstract and discussion notes, click here.

 

Table 40: Clinical Support of Specifications for Vaccines
FACILITATOR: Mark Schenerman, CMC Biotech-MAS Consulting
SCRIBE: Bill Egan, GlaxoSmithKline

To view the table abstract and discussion notes, click here.

 

Table 41: Low Endotoxin Recovery
FACILITATOR: Ned Mozier, Pfizer, Inc
SCRIBE: Fadi Hakki, MedImmune, A member of the AstraZeneca Group

To view the table abstract, click here.

 

Table 42: Data Management in the 21st Century
FACILITATOR: Joe Shambaugh, Genedata Inc.
SCRIBE: Linda Narhi, Amgen Inc.

To view the table abstract and discussion notes, click here. 

 

Table 43: Use of Crystal Structure-modelling Approach for CQA Assessment, Bioassay Design and Troubleshooting
FACILITATOR: Margaret Ricci, Amgen Inc.
SCRIBE: Mellisa Ly, Pfizer, Inc.

To view the table abstract and discussion notes, click here.

 

Table 44: Quality or Regulatory Submission: New Items in  Regulatory Filings?
FACILITATOR: Roman Drews, Daiichi Sankyo. Co., Ltd
SCRIBE: Carol Krantz, Seattle Genetics, Inc.

To view the table abstract and discussion notes, click here.

 

Table 45: Opportunities and Roadblocks to Global Access to Biopharmaceuticals
FACILITATOR: Helena Madden, Biogen
SCRIBE: Lesley Redfern, AbbVie, Inc.

To view the table abstract and discussion notes, click here.

 

Table 46: Combination Products – A Risk-Based Approach to Implement Control Strategy
FACILITATOR: Vickie Frydenlund, Genentech, a Member of the Roche Group
SCRIBE: Melissa Thompson, Pfizer, Inc.

To view the table abstract and discussion notesclick here.

 

Table 47: How will Global Isolationism Affect the Biopharmaceutical Industry
FACILITATOR: Jason Wood, Bruker Corporation
SCRIBE: Julia O’Neill, Tunnell Consulting

To view the table abstract, click here.

 

Table 48: ICH Guidelines for UV Exposure during Photostability Studies
FACILITATOR: Gregory Gallegos, Genentech, a Member of the Roche Group
SCRIBE: James Carroll, Pfizer, Inc.

To view the table abstract and discussion notes, click here.

 

Table 49: Global Strategies for Implementing QC Automation Post Approval
FACILITATOR: Cindy Wu, Genentech, a Member of the Roche Group
SCRIBE: Heather Hughes, Sanofi

To view the table abstract, click here.

 

Table 50: Pool for Tox…Pool for Ph1 GMP?
FACILITATOR: Varnika Roy, GlaxoSmithKline
SCRIBE: Gerry DiDonato, Bristol-Myers Squibb Company

To view the table abstract and discussion notes, click here.

 

    

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


 

 

 

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