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WCBP 2017: Roundtable Information
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Roundtable Session 1: Tuesday, January 24, 14:45 - 15:45


 

               
 

   Table 1: Process Performance Qualification for Accelerated Products
    Room: Cabinet Room

    Facilitator: Josh Grieco, Genentech, a Member of the Roche Group

    Scribe: Julia O'Neill, Tunnel Consulting

    To view the scope and discussion notes, click here.

 

   Table 2: Combination Products / Therapies:Development of Control Strategies
    Room: Cabinet Room

    Facilitator: Pat Rancatore, Genentech, a Member of the Roche Group

    Scribe: Peter Johnson, 3M Drug Delivery Systems

      To view the scope and discussion notes, click here.

 

   Table 3: Innovating Purity/Impurity Testing during LCM (Analytical - LCM)
    Room: Cabinet Room

    Facilitator: Narasaiah Dontha, Celgene 

    Scribe: Anders Lund, Sanofi

    To view the scope and discussion notes, click here.

 

    Table 4: Surrogate Sterility Testing
     Room: Cabinet Room

     Facilitator: Brian K. Nunnally, Biogen 

     Scribe: Allison Lehtinen, Biogen

     To view the scope and discussion notes, click here.

 

   Table 5: Scope of Analytical Target Profiles (ATP) in Biotherapeutiv Drug Development
    RoomCabinet Room

    Facilitator: Amisha Kizhakkedathu, Pfizer, Inc

   Scribe: Sherry Guo, Genentech, a Member of the Roche Group

    To view the scope and discussion notes, click here.

 

   Table 6: QbD for Analytical Methods
    Room: Cabinet Room

    Facilitator: Ed Moore, University of Illinois 

    Scribe: Ken Miller, MedImmune

    To view the scope and discussion notes, click here.

 

   Table 7: Analysis of Non-protein Particles
    Room: Cabinet Room

    Facilitator: Santosh Yadav, Merck & Co., Inc.

    Scribe: Petra Cavallaro, Eli Lilly and Company

    To view the scope and discussion notes, click here.

 

   Table 8: Applying Biosimilar Development Approaches to Innovative Products
    Room: Cabinet Room

    FacilitatorCarol Krantz, Sierra Oncology

   Scribe : Jason Rouse, Pfizer, Inc. 

   To view the scope and discussion notes, click here.

 

   Table 9: Regulatory Requirements for Gene Editing
    Room: Cabinet Room

    Facilitator: Joann Parker, Pfizer, Inc.

    Scribe: Ilona Reischl, AGES

    To view the scope and discussion notes, click here.

 

   Table 10: Forced Degradation as Part of Comparability
    Room: Cabinet Room

    Facilitator: Tapan Das, Bristol-Myers Squibb Company

    Scribe: Holly Cargill, Pfizer, Inc. 

   To view the scope and discussion notes, click here.

 

   Table 11: Antibodies with Effector Function: Development and Comparability Strategies
    Room: District Ballroom

    Facilitator: Mike Lewis, Janssen R&D, LLC

    Scribe: Reed Harris, Genentech, a Member of the Roche Group

    To view the scope and discussion notes, click here.

 

   Table 12: The Quality Overall Summary: Making the Best of It
    Room: District Ballroom

    Facilitator: Allison Wolf, Eli Lilly and Company 

    Scribe: Melia Grim, MedImmune

    To view the scope and discussion notes, click here.

 

   Table 13: Introducing a New Biologic into Your Commercial Facility: Best Practices
    Room: District Ballroom

    Facilitator: Lou Antinori, Pfizer, Inc.

    Scribe: Gerald DiDonato, Bristol-Myers Squibb Company

    To view the scope and discussion notes, click here.

 

   Table 14: Advances in Gene Therapy Manufacturing and Associated CMC Challenges
    Room: District Ballroom

    Facilitator: Francis Poulin, Genzyme 

    Scribe: Mike Abernathy, Amgen Inc.

    To view the scope and discussion notes, click here.

 

   Table 15: Host Cell Protein: Implementing Risk Assessment Strategies
    Room: District Ballroom

    Facilitator: Bharat Dixit 

    Scribe: Marisa Jones, GlaxoSmithKline 

    To view the scope and discussion notes, click here.

 

   Table 16: In-use Stability: How to Develop a Plan for your Product
    Room: District Ballroom

    Facilitator: Tim Schofield, GlaxoSmithKline 

    Scribe: Justin Sperry, Pfizer, Inc.

    To view the scope and discussion notes, click here.

 

   Table 17: Novel Modalities and their Comparability Challenges during Late Stage Development
    Room: District Ballroom

    Facilitator: James Carroll, Pfizer, Inc. 

    Scribe: Nick Bond, MedImmune 

    To view the scope and discussion notes, click here.

 

   Table 18: Streamlining In-country Testing Requirements, Transfers, and Post-approval Changes for         Global Markets
    Room: District Ballroom

    Facilitator: Mary Beth Pelletier, Biogen 

    Scribe: Justin Aldridge, Biogen

    To view the scope and discussion notes, click here.

 

   Table 19: Method Transfers: Industry and Regulatory Perspectives
    Room: District Ballroom

    Facilitator: Tam Soden, Janssen R&D, LLC

    Scribe: John Kim, Teva Pharmaceutical Industries Ltd.

    To view the scope and discussion notes, click here.

 

   Table 20: Visible Particulates
    Room: District Ballroom

    Facilitator: Tami Wu, Seattle Genetics, Inc.  

    Scribe: Jackie Moxham, Pfizer, Inc.

    To view the scope and discussion notes, click here. 

 

   Table 21: The Mechanisms of Polysorbate Degradation: Implications of this Degradation and Ways of Minimizing It
    Room: Palm Court Ballroom

    Facilitator: Barthelemy Demeule, Genentech, a Member of the Roche Group 

    Scribe: Atanas Koulov, Lonza Biologics

    To view the scope and discussion questions, click here.

 

   Table 22: Viral Segregation Practices
    Room: Palm Court Ballroom

    Facilitator: Michelle Wang, Bristol-Myers Squibb Company

    Scribe: Roman Drews, LFB-USA 

    To view the scope and discussion questions, click here. 

 

   Table 23: Tech Transfer into Manufacturing: The Initial Risk Assessment
    RoomPalm Court Ballroom

    Facilitator: Weiwei Hu, Celgene Corporation

    Scribe: Patsy Lewis, Seattle Genetics, Inc. 

    To view the scope and discussion notes, click here.

 

   Table 24: Quality by Design: Value and Challenges
    Room: Palm Court Ballroom

    Facilitator: Lynn Gennaro, Genentech, a Member of the Roche Group

    Scribe: Michael Chang, Shire

    To view the scope and discussion notes, click here. 

 

   Table 25: Raw/Ancillary Materials: Risk Management and Control
    Room: Palm Court Ballroom

    Facilitator: Maura Kibbey, U.S. Pharmacopeia

    Scribe: Emily Shacter, ThinkFDA

    To view the scope and discussion notes, click here.

 

   Table 26: Preparing for PAI and HA inspections: Trends and General Guidelines
    Room: Palm Court Ballroom

    Facilitator: Nancy Kavanaugh, MedImmune

    Scribe: Cishan (Kevin) Li, CDER, FDA

    To view the scope and discussion notes, click here. 

 

   Table 27: Shipping and Cold Chain Management
    Room: Palm Court Ballroom

    Facilitator: Kathy Lee, Eli Lilly and Company

    Scribe: Kevin King, Pfizer, Inc.

    To view the scope and discussion notes, click here.

 

   Table 28: Linking Process Variability to Clinical Experience
    Room: Palm Court Ballroom

    Facilitator: Jr Dobbins, Eli Lilly and Company

    Scribe: Jackie Macaulay, Pfizer, Inc. 

    To view the scope and discussion questions, click here. 

 

   Table 29: Potency Testing for Vaccine Development
    Room: Palm Court Ballroom

    Facilitator: Arjen Scholten, Janssen Vaccines 

    Scribe: John Amery, Pfizer, Inc.

    To view the scope and discussion notes, click here.

 

   Table 30: Regulatory Expectations and Challenges in China
    Room: Palm Court Ballroom

    Facilitator: Chi-Ting Huang 

    Scribe: MingFang Hong, Merck

    To view the scope and discussion notes, click here. 

 

 


Roundtable Session 2: Wednesday, January 25, 16:30 - 17:30



    
    Table 31: Assays Used in Process Monitoring: Lifecycle Management

    Room: Cabinet Room

    Facilitator: Julia O'Neill, Tunnell Consulting 
    Scribe: Heidi Holovics, Pfizer, Inc. 

      To view notes from this discussion, see Table 35. 

 

   Table 32: Fingerprinting Approaches: Impact for Biosimilars and Innovative Products
    Room:Cabinet Room

    Facilitator: Brian DiPaolo, AbbVie, Inc. 
    Scribe: Valerie Tsang, Biogen

      To view the scope and discussion notes click here.

 

   Table 33: Post-approval Analytical Comparability: Global Convergence
    Room: Cabinet Room

    Facilitator: Rob McCombie, Genentech, a Member of the Roche Group
    Scribe: Mike Jankowski, Pfizer, Inc.

      To view the scope and discussion notes, click here.

 

   Table 34: Novel Modalities: Process and Analytical Challenges
    Room: Cabinet Room

    Facilitator: Jessika Feliciano, Janssen R&D, LLC
    Scribe: Kris Antonsen, BioMarin Pharmaceuticals 

      To view the scope and discussion notes, click here.

 

   Table 35: Method Changes in a Commercial Environment
    Room: Cabinet Room

    Facilitator: Justin Aldridge, Biogen
    Scribe: Mary Beth Pelletier,  
Biogen

     To view the scope and discussion notes, click here.

 

   Table 36: Biosimilars: Ways to Manage Challenges Post-approval
    Room: Cabinet Room

    Facilitator: Patsy Lewis, Seattle Genetics, Inc.
    Scribe: Carmilia Jimenez Ramirez, Gilead Sciences 

      To view the scope and discussion notes, click here.

 

   Table 37: QbD and Design Space: Post-approval Experiences
    Room: Cabinet Room

    Facilitator: Christof Finkler, F. Hoffman - La Roche
    Scribe: Jette Wypych, Amgen Inc.

     To view the scope and discussion questions, click here.

 

   Table 38: Between Shipping and Administration: What is the Product Quality of the
    Drug Patients Actually Receive?
 
    Room: Cabinet Room

    Facilitator: Arun Tholudur, Amgen Inc.
    Scribe: Bryan Silvey, Kite Pharma 

      To view the scope and discussion notes, click here.

 

   Table 39: ID Testing: Managing Satellite Samples 
    Room: Cabinet Room

    Facilitator: Dieter Schmalzing, Genentech, a Member of the Roche Group 
    Scribe: Zahra Shahrokh, STC Biologics

     To view the scope and discussion notes, click here. 

 

   Table 40: WHO: Changes to the Naming Conventions for mAbs
    Room: Cabinet Room

    Facilitator: Patrick Swann, Biogen
    Scribe: Shadia Zaman, CDER, FDA

     To view the scope and discussion notes, click here.

 

   Table 41: Patient Access: Bringing Biologics to Everyone
    Room: District Ballroom

    Facilitator: Scott Whitlock, Seattle Genetics, Inc. 
    Scribe: Stephen Hadley,
 Bill & Melinda Gates Foundation

      To view the scope and discussion notes, click here.

 

   Table 42: Validation of Research Test Kits for QC Lot Release
    Room: District Ballroom

    Facilitator: Ken Miller, MedImmune
    Scribe: Maura Kibbey, U.S. Pharmacopeia

      To view the scope and discussion notes, click here.

 

   Table 43: PAT: Aseptic Sampling from Stainless and Disposable Bioreactors
    Room: District Ballroom

    Facilitator: Doug Richardson, Merck
    Scribe:Jeffrey Weber, Pfizer, Inc. 

     To view the scope and discussion notes, click here.

 

   Table 44: Control Strategies for Surfactants in Biopharmaceuticals
    Room: District Ballroom

    Facilitator: Jamie Moore, Genentech, a Member of the Roche Group
    Scribe: Carsten Jahn, AbbVie, Inc.

     To view the scope and discussion notes, click here.

 

   Table 45: Multi-attribute Methods (MAM)
    Room: District Ballroom

    Facilitator: Richard Rogers, Just Biotherapeutics 
    Scribe: Mike Abernathy, Amgen Inc. 

    To view the scope and discussion notes, click here.

 

   Table 46: Reduced Stability Testing Approaches for Biologics/Biotech Products
    Room: District Ballroom

    Facilitator: Brian K. Nunnally, Biogen
    Scribe: Allison Torgesen, Seattle Genetics, Inc.

     To view the scope and discussion notes, click here.

 

   Table 47: Potency Tests for Vaccines: Hard to Develop or Change?
    Room: District Ballroom

    Facilitator: Sally Seaver, Seaver Associates LLC 
    Scribe: Carol Krantz, ProNAI Therapeutics 

     To view the scope and discussion notes, click here.

 

   Table 48: Process Performance Qualification for Accelerated Products
    Room: District Ballroom

    Facilitator: Trevor Swartz, Genentech, a Member of the Roche Group
    Scribe: Annie Sturgess, Bristol-Myers Squibb Company

     To view the scope and discussion notes, click here.

 

   Table 49: Combination Products / Therapies: Development of Control Strategies
    RoomDistrict Ballroom

    Facilitator: Sherri Biondi, Genentech, a Member of the Roche Group
    Scribe: Peter Johnson, 3M Drug Delivery Systems

     To view the scope and discussion notes, click here.

 

   Table 50: Antibodies with Effector Function: Development and Comparability Strategies
    Room: District Ballroom

    Facilitator: John Kim, Teva Pharmaceutical Industries Ltd.  
    Scribe: William Matousek, Regeneron Pharmaceuticals 

      To view the scope and discussion notes, click here.

 

   Table 51: The Quality Dossier Overall Summary: Making the Best of It
    Room: Palm Court Ballroom

    Facilitator: Michelle Frazier, Coherus Biosciences 
    Scribe: Reed Harris, Genentech, a Member of the Roche Group

     To view the scope and discussion notes, click here.

 

   Table 52: Preparing for PAI and HA Inspections:  Trends and General Guidelines
    Room: Palm Court Ballroom

    Facilitator: Jessica Snow, Bristol-Myers Squibb Company
    Scribe: Kristen Nickens, CDER, FDA

      To view the scope and discussion notes, click here.

 

   Table 53: Linking Process Variability to Clinical Experience
    Room: Palm Court Ballroom

    Facilitator: Juliana Kretsinger, Eli Lilly and Company
    Scribe: Kim Wolfram, Biogen

     To view the scope and discussion notes, click here.

 

   Table 54: Raw Materials: Risk Management and Control
    Room: Palm Court Ballroom

    Facilitator: Sarah Demmon, Eli Lilly and Company 
    Scribe: Charles Morgan, Genentech, a Member of the Roche Group

      To view the scope and discussion notes, click here.

 

   Table 55: Tech Transfer from R&D into Commercial Manufacturing: The Initial Risk
    Assessment

    Room: Palm Court Ballroom

    Facilitator: Sid Advant, Celgene Corporation
    Scribe: Chris Broomell, Takeda Pharmaceuticals North America, Inc.

     To view the scope and discussion questions, click here. 

 

   Table 56: Viral Segregation Practices
    Room: Palm Court Ballroom

    Facilitator: Roman Drews, LFB-USA
    Scribe: Nina Brahme, CDER, FDA

       To view notes from this discussion, see Table 22.

 

   Table 57: In-use Stability: How to Develop a Plan for your Product
    Room: Palm Court Ballroom

    Facilitator: Wei Liu, Genentech, a Member of the Roche Group 
    Scribe: Sharon (Xiao) Chen, MedImmune 

      To view the scope and discussion notes, click here.

 

   Table 58: Analytical Target Profiles
    Room: Palm Court Ballroom

    Facilitator: Juhong Liu, CDER, FDA
    Scribe: Ed Moore, University of Illinois

      To view the scope and discussion notes, click here.

 

   Table 59: Novel Modalities and their Comparability Challenges during Late Stage
    Development

    Room: Palm Court Ballroom

    Facilitator: Andy Weiskopf, Biogen 
    Scribe: Nick Bond, MedImmune

     To view the scope and discussion questions, click here.

 

   Table 60: Host Cell Protein: Implementing Risk Assessment Strategies
    Room: Palm Court Ballroom

    Facilitator: Markus Haindl, F. Hoffman - La Roche 
    Scribe: James Carroll, Pfizer, Inc.

      To view the scope and discussion notes, click here.

 

   Table 61: Regulation of Biologics in Africa: A Case Study in Ghana 
    Room: Palm Court Ballroom

    Facilitator: Eric Karikari-Boateng, Food and Drug Authority, Ghana
    Scribe: Fadi Hakki, MedImmune 

      To view the scope and discussion notes, click here.

 

    


 

 

 

more Calendar

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CMC Strategy Forum Japan 2017

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