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CE Pharm 2019: Roundtable Discussions
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The roundtable sessions are truly interactive workshops to connect and discuss real issues with 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 CE Pharm 2019 roundtable sessions allowed attendees to interact and discuss the following topics. If you missed a topic that interested you and want to see what was discussed, please use the links below to see the notes.

 

Table 1: Advantages and Challenges for Implementing CE-MS (including chip-MS) and Other New Technologies
Session 1
Facilitator: Mei Han, Amgen Inc.
Scribe: Tim Blanc, Eli Lilly & Company
Session 2
Facilitator:Eleanor Le, Amgen Inc.
Scribe: Jun Dai, Bristol-Myers Squibb Company
Abstract and Notes

Table 2: CE in Forced Degradation
Session 1
Facilitator: Nomalie Jaya, Seattle Genetics, Inc.
Scribe: Claudia Michael, Solvias AG
Session 2
Facilitator: Deepti Ahluwalia, Bristol-Myers Squibb Company
Scribe: Jason Candreva, Bristol-Myers Squibb Company
Abstract and Notes

Table 3: CE Usage for Process and Product Characterization
Session 1
Facilitator: Kathir Muthusamy, Regeneron Pharmaceuticals, Inc.
Scribe: Sang Bong Lee, CDER, FDA
Session 2
Facilitator: Tara Enda, Bristol-Myers Squibb Company
Scribe: Kelci Schilly, University of Kansas
Abstract and Notes

Table 4: CE's Role in Real Time Release Testing/PAT
Session 1
Facilitator: C. Mark Lies, SCIEX
Scribe: , Edith Binder, Boehringer Ingelheim Pharma GmbH & Co. KG
Session 2
Facilitator: Nathan Lacher, Pfizer, Inc.
Scribe: C. Mark Lies, SCIEX
Abstract and Notes

Table 5: Future of CE with MAM Used in QC for Lot Release/Stability?
Session 1
Facilitator: Bazarragchaa Damdinsuren, CDER, FDA
Scribe: Tara Enda, Bristol-Myers Squibb Company
Session 2
Facilitator: SungAe Suhr Park, Korea Biotechnology Industry Organization
Scribe: Zoran Sosic, Biogen
Abstract and Notes

Table 6: Identifying New Attributes of Drugs Using CE Technology (AAVs, Bispecifics, ADCs)
Session 1
Facilitator: Eoin Cosgrave, Seattle Genetics, Inc
Scribe: Emmanuel Kizekai, Amgen Inc.
Session 2
Facilitator: Richard Rustandi, Merck & Co., Inc.
Scribe: Colleen Reed, Pfizer, Inc.
Abstract and Notes

Table 7: Peak Characterization of CE-based Size and Charge Heterogeneity Methods
Session 1
Facilitator: Merry Christie, CDER, FDA
Scribe: Göran Hübner, Boehringer Ingelheim Pharma GmbH & Co. KG
Session 2
Facilitator: David Michels, Genentech
Scribe: Handy Yowanto, SCIEX
Abstract and Notes

Table 8: Specification Setting for CE Methods
Session 1
Facilitator: Bernd Moritz, F. Hoffmann-La Roche Ltd
Scribe: Steffen Kiessig, F. Hoffmann-La Roche Ltd
Session 2
Facilitator: Bazarra Damdinsuren, CDER, FDA
Scribe: Nomalie Jaya, Seattle Genetics, Inc.
Abstract and Notes

Table 9: The Good, The Bad and The Ugly for Charge Heterogeneity: Which Electrophoretic Method to Pick and When?
Session 1
Facilitator: Tim Blanc, Eli Lilly & Company
Scribe: Gordon Freckleton, Celgene
Session 2
Facilitator: Joel Welch, CDER, FDA
Scribe: Jeffrey Tyner, Eli Lilly & Company
Abstract and Notes

Table 10: Troubleshooting Complex Separation
Session 1
Facilitator: Mohamed Dawod, Merck & Co., Inc.
Scribe: Sarah Wright, University of Notre Dame
Session 2
Facilitator: Hermann Wätzig, University of Braunschweig
Scribe: Colleen Reed, Pfizer, Inc.
Abstract and Notes

Table 11: What Attributes Have Not Been Explored Using CE Methodologies?
Session 1
Facilitator: Clare Ryan, Regeneron Pharmaceuticals, Inc.
Scribe: April Blodgett, PerkinElmer Inc.
Session 2
Facilitator: Joel Welch, CDER, FDA
Scribe: Nate Lacher, Pfizer, Inc.
Abstract and Notes



 

 

 

 

 

 

 


 

more Calendar

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