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WCBP 2018: Roundtable Information Session II
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Roundtable Session 2: Wednesday, January 31, 12:15 - 13:15




Spotlight Topic:Reference Standard: Common Practices and Challenges

FACILITATORS: Zahra Shahrohk,STC Biologicsand 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, 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, 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, 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, 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, click here.

Table 30:ID Testing from Start to Finish, Technical Approaches and Regulatory Requirements
FACILITATOR: Allison Torgesen,Seattle Genetics, Inc.
SCRIBE: Bita Badiei,Kite Pharma, Inc.

To view the table abstract, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, click 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, 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, click here.

 

    

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

To view the list of Roundable Session I tables click here.

 

 

 

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