Open Innovation Resources for Biomanufacturing
Therapeutic proteins represent a number of the currently top 10 best-selling drugs and have combined sales of almost $64 billion per year. The enormous market potential for biosimilars or biobetters has created a crowded field of developers. As a result, there is a growing emphasis on emerging analytical techniques and their lifecycle appropriate application. Industrial, federal, and academic researchers will gather to discuss available open innovation resources and technological advancements for fueling biopharmaceutical development. On Thursday, June 23, 2016 at 8:30 AM join the thought leaders, policy makers, and developers of therapeutic proteins as we present current trends, ideas, and predictions on the use of open innovation biomanufacturing resources and emerging technologies.
MORNING SESSION: Open Innovation and State-of-the-Art Characterization Methodology, Chair: John Marino, NIST
AFTERNOON SESSION: Emerging Technologies for Higher Order Structure, Chair: William Bentley, UMD
EVENT CO-HOSTS:
Dr. Thomas Fuerst, Director, Institute for Bioscience Biotechnology Research
Dr. John Marino, Leader, Biomolecular Structure & Function Group, National Institute of Standards and Technology
Institute for Bioscience and Biotechnology Research
9600 Gudelsky Dr.
Rockville, MD 20850
(240) 314-6000
Morning Session: Open Innovation and State-of-the-Art Characterization Methodology
Chair: John Marino, NIST
8:30 Registration Opens
9:00 Welcome and introduction to IBBR, Thomas Fuerst, IBBR
9:15 Introduction to NIST, John Marino, NIST
9:30 Antibody Reference Standard Characterization, Richard Remmele, Medimmune
10:00 Getting to the future state in Biomanufacturing: Role of collaboration, Linda Narhi, Amgen
10:30 Coffee Break and Posters
11:00 Leveraging the MAM to Improve Biotherapeutic Characterization, Richard Rogers, Just Biotherapeutics
11:30 N-linked glycan product characterization without losing too many details, Justin Prien, Shire
12:00 Lunch and Poster Session
Afternoon Session: Emerging Technologies for Higher Order Structure
Chair: William Bentley, UMD
1:30 Characterization of pegylated protein therapeutics and antibodies by 2D NMR, Yves Aubin, Health Canada
2:00 Hydrogen exchange mass spectrometry: An enabling tool in therapeutic protein development, David Weis, University of Kansas
2:30 Coffee Break and Poster Session
3:00 Covalent labeling and mass spectrometry to map epitopes and establish biosimilarity for biologic drugs, Mark Chance, Case Western
3:30 Roundtable Introduction, Steven Kozlowski, FDA
4:00 Roundtable Discussion - Prospective next steps for biopharmaceutical open innovation and Reference Materials, Led by John Schiel, NIST
Participants:
Steven Kozlowski, FDA
Darryl Davis, JNJ
Oleg Borisov, Novavax
4:30 Closing Remarks and Awards, John Schiel, NIST