The Impact of Biosimilars and Biobetters on Biopharmaceutical Manufacturing

November 15, 2012 (8:00 AM – 6:30 PM)

Event Details:

Location: MIT Faculty Club – 50 Memorial Drive, 6th Floor, Cambridge, MA 02139 (map)
Time: 8:00 AM – 6:30 PM
Morning Session: 8:00 AM – 12:00 PM
Afternoon Session: 1:00 PM – 5:00 PM
Networking Reception: 5:00 PM – 6:30 PM

This all-day event, featuring panel discussions and presentations by MIT faculty and other academics, members of the biomanufacturing industry and the FDA will examine the impact of biosimilars and biobetters on biopharmaceutical manufacturing.

Agenda:

Thursday, November 15, 2012
Welcome and Introduction (8:00 AM – 8:15 AM)

Anthony J. Sinskey
Faculty Director, MIT Center for Biomedical Innovation; Professor of Microbiology and Engineering Systems, Professor of Health Sciences and Technology, Harvard-MIT Health Division of Health Sciences, MIT
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Invited Presentations (8:15 AM – 9:45 AM)
Managing Risks Associated with Biosimilars and Biobetters

Biosimilars and biobetters hold the promise of cost-effective treatments that have the potential benefit of dramatically impacting today’s global healthcare system. While this represents a tremendous opportunity, there are also many risks associated with this promise (regulatory, technical, business etc.). Through a series of short presentations and a panel discussion among experts this session aims to help identify the risks associated with biosimilars and biobetters and how they could be managed.

Patricia Seymour (8:15 AM – 8:45 AM)
Senior Consultant, BioProcess Technology Consultants
“State of the Biosimilar Industry and Implications for Technology
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Scott Stern (8:45 AM – 9:15 AM)
School of Management Distinguished Professor and Chair of the Technological Innovation, Entrepreneurship, and Strategic Management Group, MIT Sloan of School of Management
“The Industrial Organization of the Biologics Industry: Lessons So Far
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Richard H. Brudnick (9:15 AM – 9:45 AM)
Vice President and Co-Head, Business Development / M&A, Biogen Idec
“A Unique Biosimilar Partnership: Biogen & Samsung
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Break (9:45 AM – 10:00 AM)
Invited Presentations (10:00 AM – 10:30 AM)

Ajaz S. Hussain
Chief Scientific Officer and President of Biotechnology, Wockhardt, Ltd.
“Building an Organization for Successful Biosimilar Development”
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Keynote Presentation (10:30 AM – 11:00 AM)

Steven Kozlowski
Director, Office of Biotechnology Products, CDER, FDA
“Biosimilars: Regulatory Approaches”
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Panel Discussion (11:00 AM – 12:00 PM)

Ajaz S. Hussain
Chief Scientific Officer and President of Biotechnology, Wockhardt, Ltd.

Steven Kozlowski
Director, Office of Biotechnology Products, CDER, FDA

Rohin Mhatre
Vice President, Technical Development, Biogen Idec
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Ellen L. McCormick
Senior Director, Bio-manufacturing Sciences Group, Global Supply Division, Pfizer
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Scott Stern
School of Management Distinguished Professor and Chair of the Technological Innovation, Entrepreneurship, and Strategic Management Group at the MIT Sloan of School of Management

Moderated by GK Raju
CEO, Light Pharma, Inc.; Chairman, BioMAN Steering Committee; and Executive Director, Pharmaceutical Manufacturing Initiatives, CBI, MIT
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Lunch (12:00 PM – 1:00 PM)
Invited Presentations (1:00 PM – 3:00 PM)
Are New Technologies for Follow-on Biologics Needed?
Biosimilar development requires proving ‘similarity’ to a reference protein product, in part, through comparison of each product’s physicochemical and functional characteristics. Comparison may require examination of higher order structure, post-translational modifications, and degradation and impurity profiles among other attributes. This session aims to explore technologies for the development and manufacture of biosimilars. What is the current state-of-the art? Are the current tools for biosimilar development adequate, or do gaps exist where new technologies are needed? This session will be comprised of a series of invited talks and a panel discussion among experts.

Bernhardt L. Trout (1:00 PM – 1:30 PM)
Professor, Department of Chemical Engineering; Director, Novartis-MIT Center for Continuous Manufacturing, MIT
“Rational Approaches to Developability, Formulation, and Design of Biobetters
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William S. Hancock (1:30 PM – 2:00 PM)
Bradstreet Chair in Bioanalytical Chemistry, Barnett Institute of Chemical and Biological Analysis, Northeastern University

“Mass Spectrometric Analyses of Different Types of Biosimilar Drugs
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John R. Engen (2:00 PM – 2:30 PM)
Professor, Bioanalytical Chemistry, Barnett Institute of Chemical and Biological Analysis, Northeastern University

“Assessing Higher-order Structure and Conformational Similarity with Hydrogen Exchange Mass Spectrometry”

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John P. Marino (2:30 PM – 3:00 PM)
Leader, Macromolecular Structure & Function Group, National Institute of Standards and Technology (NIST)
“Application of High-resolution NMR in the Characterization of Protein Therapeutics”
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Break (3:00 PM – 3:15 PM)

Invited Presentations (3:15 PM – 3:45 PM)

Jongyoon Han
Associate Professor, Electrical Engineering and Computer Science and Biological Engineering, MIT
“Concentration-enhanced Immunoassay and Enzyme Activity Assay”
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Panel Discussion (3:45 PM – 4:45 PM)

Rohin Mhatre
Vice President, Technical Development, Biogen Idec


Michael J. Tarlov

Chief, 
Biomolecular Measurement Division, Material Measurement Laboratory, NIST
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Ganesh V. Kaundinya
Co-Founder, Chief Scientific Officer and Senior Vice President of Research, Momenta Pharmaceuticals

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Rajeev J. Ram

Professor, Electrical Engineering and Computer Science, MIT

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Moderated by William S. Hancock
Bradstreet Chair in Bioanalytical Chemistry, Barnett Institute of Chemical and Biological Analysis, Northeastern University

Closing Remarks (4:45 PM – 5:00 PM)
Networking Reception (5:00 PM – 6:30 PM)