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Mass Spec 2017: Roundtable Discussion Sessions
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The Roundtable sessions will be a truly interactive workshop to connect and discuss real issues with your peers. These sessions were designed to be informal (but structured) discussions on topics which are of interest to participants, but were not able to be incorporated into the other sessions within the program.  The Roundtable Sessions are scheduled for Wednesday, September 20, 16:15-17:15 and Thursday, September 21, 16:20-17:20. 

 

Table 1: Host Cell Proteins: Sample Preparation, Methods, Instruments, Software, Validation

To view the abstract and discussion questions, click here. 

SESSION I FACILITATOR: Ying Zhang, Pfizer, Inc.
SESSION I SCRIBE: Jacky Smith, Pfizer, Inc.

SESSION II FACILITATOR: Stephanie Wohlrab, Roche Diagnostics GmbH
SESSION II SCRIBE: Jacky Smith, Pfizer, Inc.

To view notes from both Session I and II, click here. 



Table 2: Instrumentation: What is Required Re. Resolution, Mass Accuracy, Sensitivity, System Suitability for Methods [MS, LC/MS, LC/MSn]

To view the abstract and discussion questions, click here.

SESSION I FACILITATOR: Jonathan Josephs, Thermo Fisher Scientific
SESSION I SCRIBE: David Ripley, Pfizer, Inc.

To view notes from Session I, click here. 

SESSION II FACILITATOR: Greg Staples, Agilent Technologies
SESSION II SCRIBE: Jonathan Knibbe, Janssen Infectious Diseases and Vaccines

To view notes from Session II, click here. 



Table 3: Product Characterization Strategies: Biosimilars, Viral Capsids, Gene Therapy, mAbs, ADCs

To view the abstract and discussion questions, click here.

SESSION I FACILITATOR: Ramsey Saleem, Amgen Inc.
SESSION I SCRIBE: Thomas Powers, Pfizer, Inc.

SESSION II FACILITATOR: Promod Mehndiratta, Janssen R&D LLC
SESSION II SCRIBE: Thomas Powers, Pfizer, Inc.

To view the notes from both Session I and II, click here. 



Table 4: Multi Attribute Methods: Early Development, Hot Spot Analysis, CQA Assessment, Process Development, Release, Stability

To view the abstract and discussion questions, click here. 

SESSION I FACILITATOR: Kristin Boggio, Pfizer, Inc.
SESSION I SCRIBE: Promod Mehndiratta, Janssen R&D LLC

SESSION II FACILITATOR: Yan Jiang, Sanofi
SESSION II SCRIBE: David Ripley, Pfizer, Inc.

To view notes from Session II, click here. 



Table 5: Multi Attribute Methods: Low Versus High Resolution MS, Relative Quantitation, Choice of Output, Explanations for Small Differences

To view the abstract and discussion questions, click here. 

SESSION I FACILITATOR: Haihong Zhou, Merck & Co., Inc.
SESSION I SCRIBE: Yelena Lyubarskaya, Sanofi

To view notes from Session I, click here. 

SESSION II FACILITATOR: Kristin Boggio, Pfizer, Inc.
SESSION II SCRIBE: 
Michael Boyne, BioTechLogic, Inc.

To view notes from Session II, click here.



Table 6: Biotransformation and Bioanalysis: Analytical Strategies, Experiences with Protein Therapeutics, Correlation with LBA Formats

To view the abstract and discussion questions, click here. 

FACILITATOR: Steve Cohen, SAC Analytical Consultants
SCRIBE: Jason Rouse, Pfizer, Inc.

To view notes from both Session I and II, click here. 



Table 7: Glycosylation/Released Glycan Analysis: New Enzymes, Labels, LC/MS Methods and Software

To view the abstract and discussion questions, click here. 

SESSION I FACILITATOR: Yihong Zhang, Bristol-Myers Squibb Company
SESSION I SCRIBE: Eef Dirksen, Synthon Biopharmaceuticals B.V.

To view note from Session I, click here.

SESSION II FACILITATOR: Yihong Zhang, Bristol-Myers Squibb Company
SESSION II SCRIBE: Yelena Lyubarkaya, Sanofi

To view notes from Session II, click here.



Table 8: Applications of Native MS: Can it be Used for Relative Quantitation?

To view the abstract and discussion questions, click here. 

SESSION I FACILITATOR: Aaron Bailey, Thermo Fisher Scientific
SESSION I SCRIBE: David Passmore
Tenaya Analytical Consulting

SESSION II FACILITATOR: Hao Zhang, Amgen Inc.
SESSION II SCRIBE: David Passmore
Tenaya Analytical Consulting

To view notes from both Session I and II, click here.



Table 9: Regulatory Submissions: Effective Ways to Include MS Methods/Results in INDs

To view the abstract and discussion questions, click here. 

SESSION I FACILITATOR: Scott Henry, Seattle Genetics, Inc.
SESSION I SCRIBE: Heather DeGruttola, Pfizer, Inc.

To view notes from Session I, click here. 

SESSION II FACILITATOR: Scott Henry, Seattle Genetics, Inc.
SESSION II SCRIBE: Chris Yu, Genentech, a Member of the Roche Group

To view notes from Session II, click here.



Table 10: Top-Down Sequencing: Is it Coming to Biotech Soon?

To view the abstract and discussion questions, click here. 

FACILITATOR: Guillaume Tremintin, Bruker Daltonics, Inc.
SCRIBE: Arjen Scholten, Janssen Infectious Diseases and Vaccines

To view notes from both Session I and II, click here.



Table 11: MS Deconvolution Software: Latest Software and Developments

To view the abstract and discussion questions, click here. 

SESSION I FACILITATOR: Rose Lawler, Protein Metrics, Inc.
SESSION I SCRIBE: Anders Lund, Sanofi

SESSION II FACILITATOR: Joe Shambaugh, Genedata Inc.
SESSION II SCRIBE: Anders Lund, Sanofi

To view notes from both Session I and II, click here. 



Table 12: Sequence Variant Analysis: New Developments, Strategies and Methods

To view the abstract and discussion questions, click here. 

SESSION I FACILITATOR: Sreekanth Suravajjala, Amgen Inc.
SESSION I SCRIBE: Jay Jones, Seattle Genetics, Inc.

To view notes from Session I, click here.

SESSION II FACILITATOR: Eric Carlson, Protein Metrics, Inc.
SESSION II SCRIBE: Heather DeGruttola, Pfizer, Inc.

To view notes from Session II, click here.



Table 13: De novo Sequencing: Applications in a Discovery Setting

To view the abstract and discussion questions, click here. 

FACILITATOR: St John Skilton, Protein Metrics, Inc.
SCRIBE: Richard Rogers, Just. Biotherapeutics

To view notes from both Session I and II, click here.



Table 14: Peptide Mapping for Sequence Determination Versus Confirmation: Should This be in an IND? Should This be Combined with Protein MS/MS?

To view the abstract and discussion questions, click here. 

SESSION I FACILITATOR: Bing Zhang, Genentech, a Member of the Roche Group
SESSION I SCRIBE: Shibu Philip, Pfizer, Inc.

To view notes from Session I, click here.

SESSION II FACILITATOR: Jessica Wang, Regeneron Pharmaceuticals, Inc.
SESSION II SCRIBE: Shibu Philip, Pfizer, Inc.

To view notes from Session II, click here.



 
Table 15: Higher Order Structure Analysis by MS: is this a Rare or Routine Biopharma Application?

To view the abstract and discussion questions, click here. 

SESSION I FACILITATOR: Sean McCarthy, SCIEX
SESSION I SCRIBE: John Valliere-Douglass, Seattle Genetics, Inc.

SESSION II FACILITATOR: Sarah Rogstad, CDER, FDA
SESSION II SCRIBE: John Valliere-Douglass, Seattle Genetics, Inc.

To view notes from both Session I and II, click here.


 

 

 

 

 

 

 

 


 





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