CBI Hosts 5th Annual Biomanufacturing Summit
The Impact of Biosimilars and Biobetters on Biopharmaceutical Manufacturing
(November 15, 2012, 8:00am – 6:30pm)
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.
Steve Kozlowski, Director of the Office of Biotechnology Products at the FDA will be featured in a special key-note address.
The sessions for this year’s summit are:
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.
- What are the key risk factors that pertain specifically to biosimilars and biobetters?
- What is the role of regulator, industry, academia and government to help manage risk and enable potential benefits?
- Many are pursuing strategic partnerships. How will these partnerships help manage risk while simultaneously reaping the expected benefits?
- What approach should a pharma/biotechnology company that is responsible for both developing a “highly-similar” biologic and proving such similarity in an uncertain regulatory environment take to manage risk?
- With market acceptance of biosimilars in the U.S. unclear, are biobetters a “better” approach?
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.
- Richard H. Brudnick, Vice President and Co-Head, Business Development / Mergers & Acquisitions, Biogen Idec
- John R. Engen, Professor, Bioanalytical Chemistry, Chemistry and Chemical Biology Department; Barnett Institute of Chemical and Biological Analysis, Northeastern University
- Jongyoon Han, Associate Professor, Electrical Engineering and Computer Science; Associate Professor, Biological Engineering, MIT
- William S. Hancock, Bradstreet Chair in Bioanalytical Chemistry, Barnett Institute of Chemical and Biological Analysis, Northeastern University
- Ajaz S. Hussain, Chief Scientific Officer and President of Biotechnology, Wockhardt
- Ganesh V. Kaundinya, Co-founder, Chief Scientific Officer and Vice President of Research, Momenta Pharmaceuticals
- Steven Kozlowski, Director, Office of Biotechnology Products, CDER FDA
- James C. Leung, Advisor, BioMAN Program; Project Lead, CAACB, CBI, MIT; Academic Director, Professional Science Master Biotechnology Programs, Northeastern University
- John P. Marino, Leader, Macromolecular Structure and Function Group, National Institute of Standards and Technology
- Ellen L. McCormick, Senior Director, Bio-Manufacturing Sciences Group, Pfizer
- Rohin Mhatre, Vice President, Technical Development, Biogen Idec
- GK Raju, Chairman, BioMAN Steering Committee; Executive Director, Pharmaceutical Manufacturing Initiatives, CBI, MIT; and CEO, LightPharma, Inc.
- Rajeev J. Ram, Professor, Electrical Engineering and Computer Science, MIT
- Patricia Seymour, Senior Consultant, BioProcess Technology Consultants
- Anthony J. Sinskey, Faculty Director, MIT Center for Biomedical Innovation; Professor, Microbiology and Engineering Systems; Professor, Health Sciences and Technology, Harvard-MIT Division of Health Sciences & Technology, MIT
- Scott Stern, School of Management Distinguished Professor and Chair of Technological Innovation, Entrepreneurship, and Strategic Management Group, MIT Sloan School of Business
- Michael J. Tarlov, Chief, Biomolecular Measurement Division, Material Measurement Laboratory, National Institute of Standards and Technology
- Bernhardt L. Trout, Professor, Chemical Engineering; Director, Novartis-MIT Center for Continuous Manufacturing, MIT