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HOS 2018: Roundtable Session Information
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HOS 2018 will include a Roundtable Discussion Session on Tuesday, April 10. Roundtable sessions allow participants to have conversations about industry issues, connect with their peers, and learn from one another. This format is designed to offer informal and truly interactive discussions on topics that are of interest to the community but might not otherwise be included in the meeting. Topics for the Roundtable session are listed below. 



Table 1: Biological Consequences – Function, Safety and Other Issues

Facilitator: Wim Jiskoot, Leiden University
Scribe: Yves Aubin, Health Canada

To view the notes for this table, click here.



Table 2: Comparability/Similarity: Past, Present, and Future

Facilitator: Asish Chakraborty, Waters Corporation
Scribe: Natalie Ciaccio, BioMarin Pharmaceutical Inc.

To view the notes for this table, click here.



Table 3: Characterization and Formulation of Novel Proteins 

Facilitator: Anthony Leone, Bristol-Myers Squibb Company
Scribe: Katherine Bowers, FUJIFILM Diosynth Biotechnologies U.S.A, Inc.

To view the notes for this table, click here.



Table 4: HOS Method Qualification Strategies

Facilitator: Lea Bonnington, F. Hoffman - La Roche Ltd.
Scribe: Alexander Bepperling, Novartis

To view the notes for this table, click here.



Table 5: New and High-resolution Methods for HOS Characterization

Facilitator: Jason S. Wood, Bruker Corporation
Scribe: Will Weiss, Eli Lilly and Company

To view the notes for this table, click here.



Table 6: HOS in Downstream Process Development

Facilitator: St John Skilton, Protein Metrics, Inc. 
Scribe: Galahad Deperalta, Genentech, a Member of the Roche Group

To view the abstract for this table, click here.



Table 7: Characterization Requirements for Phase Appropriate Filings

Facilitator: Yan Chen, Genentech, a Member of the Roche Group
Scribe: Shawn Cao, Amgen Inc.

To view the notes for this table, click here.



Table 8: HOS Analysis in Problem Solving

Facilitator: John Gabrielson, Elion Labs
Scribe: Tom Lerch, Pfizer, Inc. 

To view the notes for this table, click here.



Table 9: HOS in Candidate Selection – Developability and Technology Evaluation

Facilitator: Brad Jordan, Amgen Inc.
Scribe: Anders Nielsen, Novo Nordisk, A/S 

To view the notes for this table, click here.



Table 10: CTD/IND: Past, Present, and Future

Facilitator: Mark Schenerman, CMC Biotech-MAS Consulting
Scribe: John Schiel, NIST

To view the notes for this table, click here. 


more Calendar

7/15/2019 » 7/16/2019
CMC Strategy Forum North America Summer 2019

9/17/2019 » 9/20/2019
Mass Spec 2019

9/29/2019 » 10/2/2019
CE Pharm 2019

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