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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

REGISTRATION:
The Biomanufacturing Technology Summit registration fee for attendees is $99. Registration includes access to speaker presentations, panel sessions and content, plus breakfast, lunch, breaks, and the evening networking reception. Seating is limited so register today.  For driving directions and parking information to IBBR click here.

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

Thanks to our sponsors:

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