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Event Information
Conference: September 20 - 24, 2010 · Exhibition: September 21-23, 2010 ·
Document Title
Keynote Presentations
Keynote Presentations
- Agenda overview: Go to the agenda overview to view the detailed agenda for each track or symposium.
- To view the complete agenda: Please download the PDF brochure.
Symposia: Monday | Main Conference: Tuesday | Wednesday | Thursday | Friday
Managing Manufacturing Networks Keynote Presentation
8:05
Optimizing Manufacturing Network Performance and Planning for the FutureBiologics manufacturing network performance can be measured across many dimensions including cost, compliance, cycle time etc. It has been useful to consider both plant and network parameters to optimize current state performance. These parameters in addition to considerations of likely business, technology and socioeconomic changes help shape our thoughts for future biologics manufacturing.
Alison Moore, Ph.D., Vice President, Corporate Manufacturing, Amgen
Keynote Presentations
Chairperson: Curran Simpson, Senior Vice President, Operations, Human Genome Sciences, Inc.
4:00
Regulatory Modernization - FDA's Desired State for Product QualityThe Pharmaceutical Initiative of 2002 introduced the concept of improving the regulation of product quality throughout the pharmaceutical community. As a result, CDER initiated "quality by design" as a tool to assist industry in meeting higher product quality standards. Many innovator and generic firms have moved forward in implementing quality by design. This presentation will focus on the opportunities and challenges of implementing quality by design for biotech products.
Helen N. Winkle, Director, Office of Pharmaceutical Science, CDER, US FDA
4:45
The Role of Biosimilars in Driving Innovation in the Biopharmaceutical IndustryOver the past few years, biosimilars have emerged as an important new sector of the biopharmaceutical industry. The competitive nature of this new sector is encouraging innovation among leading biosimilar companies to bring differentiated and lower cost biologic products to patients. The introduction of biosimilar products is also likely to spur innovation from originator companies facing a more competitive marketplace. This presentation will explore the growing role of the biosimilars sector in driving innovation across the biopharmaceutical industry.
Thomas J. Vanden Boom, Ph.D., Vice President, Global Biologics R&D, Hospira, Inc.
Symposia: Monday | Main Conference: Tuesday | Wednesday | Thursday | Friday
Rapid Vaccine Development and Production Keynote Presentation
8:30
Global Vaccine Production Challenges: Emerging Immunotherapeutics, Manufacturing Flexibility and Reducing COGSManufacturers have to face the challenges of being able to answer the many challenges of a growing and changing global vaccines business. The amplitude of the challenges ranges from a need to develop innovative and/or sophisticated approaches to properly address the complexity of immune system and the patient interaction, to strong economical pressures to make products affordable for broader population. To best serve patient interest, staying economically efficient, manufacturers need to re-invent themselves to be agile in a highly changing and regulated environment.
Pierre Fournier, Ph.D., Associate Vice President, Manufacturing Technology International, Sanofi Pasteur, France
Keynote Presentations
Chairperson: Wolfgang Noe, Ph.D., Vice President, Bioprocess Development, Biogen Idec
4:00
Sustainable Commercial Cell Culture OperationsDeveloping a cell culture process which delivers a product with defined and acceptable critical quality attributes is but the first, and in many respects the easiest, element in the product lifecycle. Maintaining performance, ensuring the currency of the technical foundation and improving productivity and efficiency become the key challenges in having a sustainable operation. Knowledge is perishable; establishing routine can maintain performance but inhibit improvement; and everything ages. Hear about the systems that can be put in place to deal with these concepts across People, Process and Infrastructure.
W. Blair Okita, Ph.D., Senior Vice President, Manufacturing Sciences and Technical Operations, Genzyme Corporation
4:45
Finding a Home for Process and Product DevelopmentIn order to compete in today's cost-conscious world, the biotechnology industry needs to reinvent itself. Recognition of Manufacturing Technology and Product Development as a critical strategic element in this reinvention process and putting in place organizational design which enables their contributions are key to ultimate success. Process and product development are effectively carried out within the biotechnology industry under a number of different organizational designs (OD). The presentation will address, through example and guiding principles, where OD can enable game-changing outcomes.
S. Robert Adamson, Ph.D., Advance Biotech Consultants; former Senior Vice President Product and Process Development, Wyeth Biopharma
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