8 th International Symposium on Higher Order Structure of Protein Therapeutics (HOS 2019)

Transcription

1 8 th International Symposium on Higher Order Structure of Protein Therapeutics (HOS 2019) Symposium Co-Chairs: Katherine Bowers, FUJIFILM Diosynth Biotechnologies Guodong Chen, Bristol-Myers Squibb Company April 8-10, 2019 San Mateo Marriott San Francisco Airport San Mateo, CA USA Organized by 1

2 Table of Contents Program Partners, Exhibitors, and Media Partners... Acknowledgements... Student Travel Grants and Make the CASSS Connection... Scientific Final Program Summary... Roundtable Discussion Topics... Poster Summary... 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 Gold Program Partners Eli Lilly and Company Pfizer, Inc. Exhibitor Partners Applied Photophysics Ltd. Bruker BioSpin Charles River Laboratories GenNext Technologies NanoImaging Services Postnova Analytics RedShiftBio Wyatt Technologies 3

4 Acknowledgements Symposium Co-Chairs: Katherine Bowers, FUJIFILM Diosynth Biotechnologies Guodong Chen, Bristol-Myers Squibb Company Scientific Program Committee: Wasfi Al-Azzam, GlaxoSmithKline Sergey Arzhantsev, CDER, FDA Yves Aubin, Health Canada Alexander Bepperling, Novartis Natalie Ciaccio, BioMarin Pharmaceuticals Inc. 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 Gary Pielak, University of North Carolina, Chapel Hill John Schiel, National Institute of Standards and Technology (NIST) William Weiss, Eli Lilly and Company Mats Wikstrom, Amgen Inc. Audio-Visual: Michael Johnstone, MJ Audio-Visual Productions CASSS Staff: Noelle Atkins, Administrative Coordinator Karen Bertani, Director of Global Engagement and Knowledge Sharing Stephanie Flores, Executive Director Julie Fowle, Program Planning and Event Specialist Anna Lingel, Exhibitor Relations and Technology Specialist Renee Olson, Senior Program Manager Catherine Stewart, Finance Manager 4

5 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 8th International Symposium on Higher Order Structure of Protein Therapeutics (HOS 2019)). Ph.D. students or post-doctoral fellows conducting research at academia throughout the world are eligible. This year s grant winners will be announced soon. Make the CASSS Connection HOS 2019 is pleased to continue the CASSS Connection, a professional mentoring program designed to guide students, post-doctoral researchers, and entry-level professionals with interest in HOS of protein therapeutics towards career opportunities in industry. This program seeks to foster deeper engagement of researchers new to the study of HOS with experts in the field. The program offers guidance to the opportunities presented at the symposium, and career development discussions. Interested in participating? Please see the registration desk for more information. 5

6 8th International Symposium on Higher Order Structure of Protein Therapeutics Scientific Program Summary Monday, April 8, :30 17:30 Registration in the Convene Lobby 07:30 08:30 Continental Breakfast in Inspire 2&3 Ballroom 08:30 08:45 Welcome and Introductory Comments in Convene Ballroom Guodong Chen, Bristol-Myers Squibb Company, Princeton, NJ USA Keynote I Session in the Convene Ballroom Session Chair: 08:45 09:45 HOS: The Journey from Characterisation to QC Carl Jone, UCB Pharma SA, Braine l'alleud, Brussels 09:45 10:15 Networking Break Visit the Exhibits and Posters in Inspire 2&3 Ballroom Discovery and Candidate Selection Session in the Convene Ballroom Session Chair: Mats Wikstrom, Amgen Inc., Thousand Oaks, CA USA 10:15 10:35 A Rational Preformulation Approach for Biologics Aiding Candidate Selection at the Preclinical Stage Pradyot Nandi, Bristol-Myers Squibb Company, Princeton, NJ USA 10:35 10:55 Darren Bates, Amgen Inc., Thousand Oaks, CA USA 10:55 11:15 11:15 11:40 Discussion Questions and Answers 11:40 13:10 Hosted Lunch in Inspire 2&3 Ballroom 6

7 13:10 13:40 Technical Seminar Monday, April 8, 2019 continued Sponsored by Convene Ballroom 13:40 14:10 Technical Seminar Sponsored by Convene Ballroom HOS in Development Session in the Convene Ballroom Session Chairs: Tom Lerch, Pfizer, Inc., Chesterfield, MO and Anders Nielsen, Novo Nordisk A/S, Måløv, Denmark 14:10 14:30 Antibody Higher Order Structure Analysis using High Throughput Protein Conformational Array for Product and Process Understanding Dennis Yu, Bristol-Myers Squibb Company, Devens, MA USA 14:30 14:50 On the Diversity and Polymorphic Nature of Protein Aggregates Vito Foderà, University of Copenhagen, Copenhagen, Denmark 14:50 15:10 15:10 15:35 Discussion Questions and Answers 15:35 16:35 Poster Session in Inspire 2&3 Ballroom Biological Consequences of HOS Session in the Convene Ballroom Session Chair: Alexander Bepperling, Novartis Pharmaceuticals Corportation, Oberhaching, Germany 16:35 16:55 16:55 17:15 17:15 17:40 Discussion Questions and Answers 17:40 19:00 Exhibitor Reception in Inspire 2&3 Ballroom 7

8 Tuesday, April 9, :30 08:30 Continental Breakfast in Inspire 2&3 Ballroom 08:00 19:00 Registration in the Convene Lobby Keynote II Session in the Convene Ballroom Session Chair: 08:30 09:30 Analysis, Control and Engineering of Protein Dynamics, Stability and Aggregation Paul Dalby, University College London, London, United Kingdom 09:30 10:00 Networking Break Visit the Exhibits and Posters in Inspire 2&3 Ballroom Established Methods and Fundamentals for HOS Session in the Convene Ballroom Session Chair: Natalie Ciaccio, BioMarin Pharmaceuticals Inc., Novato, CA and William Weiss, Eli Lilly and Company, Indianapolis, IN USA 10:00 10:20 Kinetic Analysis of the Conformational Stability and Aggregation of mabs Using Calorimetry Ernesto Freire, Johns Hopkins University, Baltimore, MD USA 10:20 10:40 Characterization and Biological Relevance of Protein Aggregates and Other Particles nm in Size (Submicron and Subvisible) Linda Narhi, Amgen Inc., Thousand Oaks, CA USA 10:40 11:00 11:00 11:25 Discussion Questions and Answers 11:25 12:25 Hosted Lunch in Inspire 2&3 Ballroom Emerging Technology for HOS Evaluation Session in the Convene Ballroom Session Chairs: Yves Aubin, Health Canada, Ottawa, ON Canada and Krishna Mallela, University of Colorado Anschutz Medical Campus, Aurora, CO USA 12:25 12:45 Bioinformatics Methods for Comparison of NMR Spectra Bostjan Japelj, Lek, a Sandoz company, Ljubljana, Slovenia 12:45 13:05 8

9 Tuesday, April 9, 2019 continued 13:05 13:25 13:25 13:50 Discussion Questions and Answers 13:50 14:20 Networking Break Visit the Exhibits and Posters in Inspire 2&3 Ballroom Young Scientist Session in the Convene Ballroom Session Chair: Gary Pielak, University of North Carolina, Chapel Hill, Chapel Hill, NC USA 14:20 14:35 14:35 14:50 14:50 15:05 15:05 15:20 HOS Biosimilarity and Comparability Session in the Convene Ballroom Session Chairs: Sergey Arzhantsev, CDER, FDA, Silver Spring, MD USA Galahad Deperalta, Genentech, a Member of the Roche Group, South San Francisco, CA USA 15:20 15:40 Chemical Structure and Composition of Major Glycans Covalently Linked to Therapeutic Monoclonal Antibodies by Middle-Down Nuclear Magnetic Resonance David Keire, CDER, FDA, Silver Spring, MD USA 15:40 16:00 John Hickey, University of Kansas, Lawrence, KS USA 16:00 16:20 16:20 16:45 Discussion Questions and Answers 16:45 17:30 Networking Break Refreshments in Inspire 2&3 Ballroom 17:30 18:30 Roundtable Discussion Session 9

10 Wednesday, April 10, :30 08:30 Continental Breakfast in Inspire 2&3 Ballroom 08:00 12:00 Registration in the Convene Lobby Molecular Framework beyond mabs Session in the Convene Ballroom Session Chairs: Wasfi Al-Azzam, GlaxoSmithKline, King of Prussia, PA USA and John Schiel, National Institute of Standards and Technology (NIST), Rockville, MD USA 08:30 08:50 Structural and Functional Characterization of the Different Homodimer Variants of an IgG4 "knob-into-hole" Bispecific Antibody Hui-Min Zhang, Genentech, a Member of the Roche Group. South San Francisco, CA USA 08:50 09:10 09:10 09:30 09:30 09:55 Discussion Questions and Answers 09:55 10:25 Networking Break Visit the Exhibits and Posters in Inspire 2&3 Ballroom 10:25 10:45 10:45 11:05 11:05 11:25 Late Breaking Session in the Convene Ballroom Session Chair: 11:25 11:50 Discussion - Questions and Answers 11:50 12:00 Closing Remarks Katherine Bowers, FUJIFILM Diosynth Biotechnologies, Cary, NC USA 10