7 th International Symposium on Higher Order Structure of Protein Therapeutics (HOS 2018)

Transcription

1 7 th International Symposium on Higher Order Structure of Protein Therapeutics (HOS 2018) Symposium Co-Chairs: Guodong Chen, Bristol-Myers Squibb Company David Keire, CDER, FDA April 9-11, 2018 Omni Providence Hotel Providence, RI USA Organized by 1

2 Table of Contents Program Partners, Exhibitors, and Media Partners... Acknowledgements... Student Travel Grants... Scientific Final Program Summary... Plenary and Session Abstracts... Poster Abstracts... 2

3 The organizing committee gratefully acknowledges the program partners and exhibitors for their generous support of the 7 th International Symposium on Higher Order Structure of Protein Therapeutics Strategic Platinum Program Partner MedImmune, A member of the AstraZeneca Group Strategic Gold Program Partners Eli Lilly and Company Pfizer, Inc. Platinum Program Partner Amgen Inc. Bronze Program Partner FUJI Film Diosynth Biotechnologies 3

4 Exhibitor Partners Bruker Daltonics, Inc. Charles River Laboratories NanoImaging Services, Inc. Postnova Analytics Inc. Protein Metrics Inc. Waters Corporation 4

5 The organizing committee gratefully acknowledges the following media partners for their promotional consideration of HOS 2018 Media Partners American Laboratory/labcompare American Pharmaceutical Review BioProcessing Journal Genetic Engineering & Biotechnology News LCGC North America Pharmaceutical Outsourcing Technology Networks 5

6 Symposium Co-Chairs: Guodong Chen, Bristol-Myers Squibb Company David Keire, CDER, FDA Acknowledgements Scientific Program Committee: Wasfi Al-Azzam, GlaxoSmithKline Yves Aubin, Health Canada Alexander Bepperling, Sandoz GmbH Katherine Bowers, FUJIFILM Diosynth Biotechnologies Shawn Cao, Amgen Inc. Natalie Ciaccio, BioMarin Pharmaceuticals Inc. Steven Cohen, SAC Analytical Consultants Galahad Deperalta, Genentech, a Member of the Roche Group Tom Lerch, Pfizer, Inc. Krishna Mallela, University of Colorado Anschutz Medical Campus Anders Nielsen, Novo Nordisk A/S Gang (Gary) Ren, Lawrence Berkeley National Laboratory John Schiel, National Institute of Standards and Technology (NIST) William Weiss, Eli Lilly and Company Audio-Visual: Michael Johnstone, MJ Audio-Visual Productions CASSS Staff: Karen Bertani, Director of Meetings Amy Cano, Administrative Assistant Stephanie Flores, Executive Director Julie Fowle, Meeting Coordinator Anna Lingel, Meeting Coordinator Carisa Lubeck, Business Information Analyst Renee Olson, Senior Program Manager Catherine Stewart, Finance Manager 6

7 Student Travel Grants CASSS is pleased to provide a limited number of student travel grants for Ph.D. students and post-docs who present applicable posters at the 7th International Symposium on Higher Order Structure of Protein Therapeutics (HOS 2018)). Ph.D. students or post-doctoral fellows conducting research at academia throughout the world are eligible. This year s grant winners announced in January. 7

8 7th International Symposium on Higher Order Structure of Protein Therapeutics Scientific Program Summary Monday, April 9, :30 18:00 Registration in the Narragansett Ballroom Foyer 07:30 08:30 Continental Breakfast in Narragansett B&C Ballroom 08:30 08:45 Welcome and Introductory Comments in Narragansett A Ballroom David Keire, CDER, FDA, St. Louis, MO USA Keynote I Session in Narragansett A Ballroom Session Chair: William Weiss, Eli Lilly and Company, Indianapolis, IN USA 08:45 09:45 Manipulating Protein Structure for Therapeutic Utility (Engineering for Properties That Mother Nature Never Had to Consider) John Beals, Eli Lilly and Company, Indianapolis, IN USA 09:45 10:15 Networking Break Visit the Exhibits and Posters in Narragansett B&C Ballroom Discovery and Candidate Selection Session in Narragansett A Ballroom Session Chair: Wasfi Al-Azzam, GlaxoSmithKline, King of Prussia, PA USA 10:15 10:35 Determination of Interaction Parameters for Reversibly Self-Associating Antibodies: A Comparative Analysis David Bain, University of Colorado Anschutz Medical Campus, Aurora, CO USA 10:35 10:55 Sequence and Structure Inspire Predictive Tools for Developability Assessment of Antibody Molecules Stanley Krystek, Bristol-Myers Squibb Company, Princeton, NJ USA 10:55 11:15 TBD 11:15 11:40 Discussion Questions and Answers 11:40 13:10 Hosted Lunch in Narragansett B&C Ballroom 8

9 Monday, April 9, 2018, continued 13:10 14:10 Technical Seminar Sponsored by Waters Corporation Narragansett A Ballroom HOS in Development Session in Narragansett A Session Chairs: Natalie Ciaccio, BioMarin Pharmaceuticals Inc., Novato, CA USA and Anders Nielsen, Novo Nordisk A/S, Måløv, Denmark 14:10 14:30 Application of HDX-MS to Biopharmaceutical Development Requirements: Improved Sensitivity to Detection of Conformational Changes Lea Bonnington, F. Hoffmann - La Roche Ltd., Penzberg, Germany 14:30 14:50 What X-Ray Footprinting Can Tell You About Protein Interactions and Conformation Corie Ralston, Lawrence Berkeley National Laboratory, Berkeley, CA USA 14:50 15:10 Effects of Excipients of Filgrastim Products on the Structure and Dynamics of the Drug Substance Yves Aubin, Health Canada, Ottawa, ON Canada 15:10 15:35 Discussion Questions and Answers 15:35 16:35 Poster Session in Narragansett B&C Ballroom Biological Consequences of HOS Session in Narragansett A Ballroom Session Chairs: Galahad Deperalta, Genentech, a Member of the Roche Group, South San Francisco, CA USA and Krishna Mallela, University of Colorado Anschutz Medical Campus, Aurora, CO USA 16:35 16:55 Linking Structure to Function, Criticality Assessment of Thiol-Related Variants in Therapeutic mabs Yan Chen, Genentech, a Member of the Roche Group, South San Francisco, CA USA 16:55 17:15 Immunogenicity of Protein Aggregates: What s New? Wim Jiskoot, Leiden University, Leiden, Netherlands 17:15 17:35 TBD Haripada Maity, Eli Lilly and Company, Indianapolis, IL USA 17:35 18:00 Discussion Questions and Answers 9

10 Monday, April 9, 2018, continued 18:00 19:30 Exhibitor Reception in Narragansett B&C Ballroom 10

11 Tuesday, April 10, :30 08:30 Continental Breakfast in Narragansett B&C Ballroom 08:00 18:00 Registration in the Narragansett Ballroom Foyer Keynote II Session in Narragansett A Ballroom Session Chair: Krishna Mallela, University of Colorado Anschutz Medical Campus, Aurora, CO USA 08:30 09:30 Approaches and Challenges for Quantifying Multi-body Interactions as Higher-order Structure for Key Product Attributes Christopher J. Roberts, University of Delaware, Newark, DE USA 09:30 10:00 Networking Break Visit the Exhibits and Posters in Narragansett B&C Ballroom Established Methods and Fundamentals for HOS Session in Narragansett A Ballroom Session Chair: Yves Aubin, Health Canada, Ottawa, ON Canada and William Weiss, Eli Lilly and Company, Indianapolis, IN USA 10:00 10:20 TBD Tom Laue, University of New Hampshire, Durham, NH USA 10:20 10:40 TBD Allen Minton, National Institute of Health (NIH), Bethesda, MD USA 10:40 11:00 TBD Sergey Arzhantsev, CDER, FDA, St. Louis, MO USA 11:00 11:25 Discussion Questions and Answers 11:25 12:55 Hosted Lunch in Narragansett B&C Ballroom Emerging Technology for HOS Evaluation Session in Narragansett A Ballroom Session Chairs: Tom Lerch, Pfizer, Inc., Chesterfield, MO USA and Gang (Gary) Ren, Lawrence Berkeley National Laboratory, Berkeley, CA USA 12:55 13:15 Seeing Is Believing: How We Use Single-molecule 3D Image to Understand ph-dependent HOS Change in a IgG1 Homodimer Ming Lei, Genentech, a Member of the Roche Group, South San Francisco, CA USA 13:15 13:35 Identifying HOS Variation with Multivariate Analysis of 2D NMR John Marino, National Institute of Standards and Technology (NIST), Rockville, MD USA 11

12 Tuesday, April 10, 2018, continued 13:35 13:55 TBD 13:55 14:20 Discussion Questions and Answers 14:15 14:50 Networking Break Visit the Exhibits and Posters in Narragansett B&C Ballroom Young Scientist Session in Narragansett A Ballroom Session Chairs: Alexander Bepperling, Sandoz GmbH, Oberhaching, Germany and Steven Cohen, SAC Analytical Consultants, Hopkinton, MA USA 14:50 15:05 TBD 15:05 15:20 TBD 15:20 15:35 TBD HOS Biosimilarity and Comprability in Narragansett A Ballroom Session Chairs: Shawn Cao, Amgen Inc., Thousand Oaks, CA USA and John Schiel, National Institute of Standards and Technology (NIST), Rockville, MD USA 15:35 15:55 TBD Brad Jordan, Amgen Inc., Thousand Oaks, CA USA 15:55 16:15 Leveraging X-ray Crystallography for Biosimilarity Assessment Tom Lerch, Pfizer, Inc., Chesterfield, MO USA 16:15 16:35 TBD George Bou-Assaf, Biogen, Cambridge, MA USA 16:35 17:00 Discussion Questions and Answers 17:00 17:30 Networking Break 17:30 18:30 Roundtable Discussion Session in the Narragansett B&C Ballroom 12

13 Wednesday, April 11, :30 08:30 Continental Breakfast in Narragansett B&C Ballroom 08:00 12:00 Registration in the Narragansett Ballroom Foyer Computational Methods for HOS Session in Narragansett A Ballroom Session Chair: Katherine Bowers, FUJIFILM Diosynth Biotechnologies, Cary, NC USA 08:30 08:50 Computational Approaches for Assessing Developability and Optimization of Biotherapeutics Nels Thorsteinson, Chemical Computing Group (CCG), Montreal, QC Canada 08:50 09:10 TBD 09:10 09:30 Structure-Based Engineering to Improve Homogeneity of Bi-specifics and ADCs Eric Bennett, Pfizer, Inc., Cambridge, MA USA 09:30 09:55 Discussion Questions and Answers 09:55 10:25 Networking Break Visit the Exhibits and Posters in Narragansett B&C Ballroom Late Breaking Session in Narragansett A Ballroom Session Chairs: Guodong Chen, Bristol-Myers Squibb Company, Princeton, NJ USA and David Keire, CDER, FDA, St. Louis, MO USA 10:25 10:45 TBD 10:45 11:05 TBD 11:05 11:25 TBD 11:25 11:50 Discussion - Questions and Answers 11:50 12:00 Closing Remarks Guodong Chen, Bristol-Myers Squibb Company, Princeton, NJ USA 13