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WCBP 2019: Roundtable Information
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MiniCase Roundtables

Roundtable MiniCases were a new format developed to address the needs of attendees looking to learn more about a subject but who don’t have an extensive background in that area. These sessions featured a brief introduction to the topic that included data, examples or a case study intended to stimulate both discussion and learning. The subsequent discussion was facilitated by experienced professionals and focused on knowledge sharing.

Due to the format and intent of the MiniCase Roundtables, notes were not taken during these sessions.

Method Validation Deliverables
Pennsylvania Room
Facilitators:
Nadine Ritter, Global Biotech Experts, LLC
Pinger Wang, Janssen R&D, LLC
Setting Specifications - Review of FIH and
Commercial Strategies

South Carolina Room
Facilitators:
Shawn Novick, Seattle Genetics, Inc.
Felix Kepert, F. Hoffmann - La Roche Ltd.


 
Comparability Concepts and Case Studies
Rhode Island Room
Facilitators:
Markus Blümel, Novartis Pharma AG
Reed Harris, Genentech, a Member of the Roche Group

Regulatory Dossier Preparation
Virginia Room

Facilitators:
Michelle Frazier, Independent Consultant
Kathy Lee, Eli Lilly and Company
 
 Roundtable Topics
The Roundtable Discussions have become a cornerstone of WCBP. These collegial discussions allow participants to pose questions, share insights and learn from one another. There were two 60-minute sessions. The first ten topics were repeated at both sessions and share a single abstract and notes.
 Locations Day 1
Tables 1 - 8: Palm Court Ballroom
Tables 9 - 14: Chinese Ballroom
Tables 15 - 20: Cabinet Room
Locations Day 2
Tables 1 - 8: Palm Court Ballroom
Tables 9, 10, 21 - 24: Chinese Ballroom
Tables 25 - 30: Cabinet Room
     


Session 1: Tuesday, January 29, 16:00 - 17:00

 

Table 1: Leveraging New Technologies to Get to Market Faster
Facilitator: Latonia Harris, Janssen Pharmaceutical R&D, LLC
Scribe: Jason Wood, Bruker Corporation
Abstract and Notes

Table 2: Best Practices for QbD Development of Analytical Methods
Facilitator: Claudia Magagnoli, GlaxoSmithKline
Scribe: Joe Glajch, JLG AP Consulting LLC
Abstract and Notes

Table 3: Practical Considerations: Mass Spec Based Multi-attribute Methods
Facilitator: Carly Daniels, Pfizer, Inc.
Scribe: John Kim, Teva Pharmaceuticals
Abstract and Notes

Table 4: Brexit
Facilitator: Joe Kutza, MedImmune, A member of the AstraZeneca Group
Scribe: Courtney Sawicki, Merck & Co., Inc.
Abstract and Notes

Table 5: Translating cGMPs Between Traditional Large-scale Modalities and Small-scale Personalized Medicines
Facilitator: Matt Kalo, Genentech, a Member of the Roche Group
Scribe: Rich Cornell, Pfizer, Inc.
Abstract and Notes

Table 6: EU Clinical Trial Regulation and Impact to Clinical Trial Materials
Facilitator: Patsy Lewis, Alpine Immune Services
Scribe: Matt Campagna, MedImmune, A member of the AstraZeneca Group
Abstract and Notes

Table 7: Continuous Manufacturing, RTRT, PAT
Facilitator: Markus Haindl, Roche Diagnostics GmbH
Scribe: Jason Starkey, Pfizer, Inc.
Abstract and Notes

Table 8: Contractors and In-licensing: Working Effectively Across Companies
Facilitator: Megan Ward, Bayer
Scribe: Ian Meemaduma, Biogen
Abstract and Notes

Table 9: ICH Q12 and Life Cycle Management (LCM)
Facilitator: Gerald Gellerman, Novartis Pharma AG
Scribe: Ruth Cordoba, AstraZeneca
Abstract and Notes

Table 10: Breakthrough Therapies
Facilitator: Bharat Dixit, Finch Therapeutics Group
Scribe: Bob Kozak, Bayer
Abstract and Notes

Table 11: BioACCESS: Technology Based Solutions for Global Health Needs for Non-communicable Diseases
Facilitator: John Frenz
Scribe: Daniel Peng, Merck & Co., Inc.
Abstract and Notes

Table 12: MCB and WCB Stability Testing
Facilitator: Fadi Hakki, Viela Bio
Scribe: Penelope Sharpe, Pfizer, Inc.
Abstract and Notes

Table 13: Raw Materials
Facilitator: Amy St. Charles, Pfizer, Inc.
Scribe: Gerald DiDonato, Bristol-Myers Squibb Company
Abstract and Notes

Table 14: Single Use and Extractables/Leachables
Facilitator: Katherine Hsia, Bayer
Scribe: Carsten Worsøe, Novo Nordisk A/S
Abstract and Notes

Table 15: Vaccines: Potency Assays
Facilitator: Julia O'Neill, Tunnell Consulting
Scribe: Emilia Byrne, Pfizer, Inc.
Abstract and Notes

Table 16: Knowledge Management - The Nuts and Bolts
Facilitator: Sofi Fexby, Biogen
Scribe: Catherine Eakin, Seattle Genetics, Inc.
Abstract and Notes

Table 17: Cell and Gene Therapy Critical Quality Attributes
Facilitator: Phoebe Baldus, Pfizer, Inc.
Scribe: Mary Denton, Pfizer, Inc.
Abstract and Notes

Table 18: Gene Therapy
Facilitator: Zahra Shahrokh, STC Biologics
Scribe: Ingrid Markovic, Genentech, a Member of the Roche Group
Abstract (Notes Not Available)

Table 19: BioPhorum Operations Group (BPOG): Rapid Methods for Adventitious Virus Detection and Sterility Assurance
Facilitator: Afahin Sohrabi, BioReliance Corporation
Scribe: Ken Miller, AstraZeneca
Abstract and Notes

Table 20: Compatibility and Globally Relevant In-use Stability Testing
Facilitator: Isabelle Lequeux, BioPhorum Operations Group
Scribe: Trevor Swartz, Genentech, a Member of the Roche Group
Abstract and Notes


Session 2: Wednesday, January 30, 11:30 - 12:30

Table 1: Leveraging New Technologies to Get to Market Faster
Facilitator: John Armando, Biogen
Scribe: Eileen Berkay, Janssen Biologics
Abstract and Notes

Table 2: Best Practices for QbD Development of Analytical Methods 
Facilitator: Jason Starkey, Pfizer, Inc. 
Scribe: Bharat Dixit, Finch Therapeutics Group
Abstract (Notes Not Available)

Table 3: Practical Considerations: Mass Spec Based Multi-attribute Methods 
Facilitator: Liqiang Zhou, AbbVie Inc. 
Scribe: Tyler Carlage, Biogen
Abstract and Notes

Table 4: Brexit 
Facilitator: Jennifer Eck, MedImmune, A member of the AstraZeneca Group 
Scribe: Carol Krantz, Seattle Genetics, Inc.
Abstract and Notes

Table 5: Translating cGMPs Between Traditional Large-scale Modalities and Small-scale Personalized Medicines 
Facilitator: Beth Anne Bort, Pfizer, Inc. 
Scribe: Elizabeth Schmidt, GlaxoSmithKline
Abstract and Notes

Table 6: EU Clinical Trial Regulation and Impact to Clinical Trial Materials 
Facilitator: Melia Grim, MedImmune, A member of the AstraZeneca Group 
Scribe: Joe Siemiatkoski, J Siemiatkoski Consulting
Abstract and Notes

Table 7: Continuous Manufacturing, RTRT, PAT 
Facilitator: Doug Richardson, Merck & Co., Inc.
Scribe: Lene Hørlyck, Novo Nordisk A/S
Abstract and Notes

Table 8: Contractors and In-licensing: Working Effectively Across Companies 
Facilitator: Houjun Yang, Johnson & Johnson
Scribe: Isabelle Lequeux, BioPhorum Operations Group
Abstract and Notes

Table 9: ICH Q12 and Life Cycle Management (LCM) 
Facilitator: Joe Glajch, JLG AP Consulting LLC
Scribe: Ruth Cordoba, AstraZeneca
Abstract and Notes

Table 10: Breakthrough Therapies 
Facilitator: Emily Shacter, ThinkFDA
Scribe: Kimberly Wolfram, Biogen 
Abstract and Notes

Table 21: Vaccines: Control Strategies 
Facilitator: Emilia Byrne, Pfizer, Inc.
Scribe: Rob Dufield, Pfizer, Inc. 
Abstract (Notes Not Available)

Table 22: Current Hot Topics in Biologics Formulation 
Facilitator: Kevin King, Pfizer, Inc. 
Scribe: Mary Beth Pelletier, Biogen
Abstract and Notes

Table 23: Particulate Testing 
Facilitator: Chris Broomell, Takeda Vaccines
Scribe: Penny Sharpe, Pfizer, Inc. 
Abstract and Notes

Table 24: Non-standard mAbs: ADCs & Bispecifics 
Facilitator: Jessika Feliciano, Janssen Pharmaceutical R&D, LLC
Scribe: Jeff Ryczek, Pfizer, Inc. 
Abstract and Notes

Table 25: Policy, Advocacy, and Industry Trends 
Facilitator: Joe Kutza, MedImmune, A member of the AstraZeneca Group
Scribe: Katherine Hsia, Bayer
Abstract and Notes

Table 26: Regenerative Medicine, Stem Cells, and Tissue Engineered Products 
Facilitator: Steve Bauer, CBER, FDA
Scribe: Roman Drews, Daiichi Sankyo, Inc.
Abstract (Notes Not Available)

Table 27: Immunogenicity: Impact on Therapeutic Proteins 
Facilitator: John Alvino, MedImmune, A member of the AstraZeneca Group
Scribe: Linda Narhi, Amgen Inc.
Abstract and Notes

Table 28: Multi-product Manufacturing and Chromatography Resins 
Facilitator: Ekta Mahajan, Genentech, a Member of the Roche Group
Scribe: Angela Pishioneri, MedImmune, A member of the AstraZeneca Group
Abstract and Notes

Table 29: Replacing in vivo with in vitro Safety Tests for Biological Products 
Facilitator: William (Bill) Egan, GlaxoSmithKline
Scribe: Lesbeth Rodriquezs, Bayer
Abstract and Notes

Table 30: Cell Therapy: Unique Challenges and Strategies to Meet Patient Needs 
Facilitator: Wallace Kaserer, Janssen Pharmaceutical R&D, LLC
Scribe: Bob Kozak, Bayer
Abstract and Notes

  


 

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