Conference Luncheon Presentations

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Ticket Required: Open to Speakers, Conferees and Designated Exhibitors

*Please note that lunch service will begin promptly at 12:30pm with the presentation beginning shortly after

Tuesday, April 20, 2010

12:30 PM - 2:00 PM | Room: 1E18, 1E19, 1E20
Accelerating Process Development: New Approaches to Biopharmaceutical Design
Moderator: S. Anne Montgomery, Editor in Chief, BioProcess International
Bill Whitford, Sr. Marketing Manager, Thermo Scientific Cell Culture and BioProcessing; Peter Latham, Co-Founder & President, BioPharm Services US; James Blackwell, Senior Consultant, Bioprocess Technology Consultants & George Koch, Chief Scientific Officer and Senior Director, Diosynth

Today’s new mantra, “better, faster, safer (and cheaper)” lies at the core of the evolving drug development paradigm emerging from the FDA. Numerous cutting-edge innovations are being designed to reduce process inefficiency and cost while creating a new series of risk-based methodologies and analytical tools.

This is creating a scenario in which smaller capitalized drugs, vaccines, and personalized medicines are an attractive business model for biopharmaceutical companies.

So what effect do these changing paradigms have on today’s bio/pharmaceutical process design and development teams? How is increased process knowledge changing approaches to process development and manufacturing? Moderator S. Anne Montgomery (Editor in Chief, BioProcess International) will lead panel of industry experts in a discussion of modern process design activities, with an emphasis on case studies.

Topics covered include:

• The new tools at the disposal of design teams
• The effects of platform technologies on process design approaches
• What can and cannot be automated
• What design and development activities are done in parallel these days
• Does a company’s downstream capacity (or that of its eventual CMO) place practical constraints on increasing production titers?
• How far will single-use applications take us?

You can access this exclusive content by visiting www.bpiroundtables.com/process.html.

Wednesday, April 21, 2010

12:30 PM - 2:00 PM | Room: 1E18, 1E19, 1E20
Market Globally, Manufacture Locally: Geographic Trends and Strategies in Biomanufacturing
Moderator: Anne Montgomery, Editor in Chief, BioProcess International
Chair: Mike Ultee, Vice President of Process Sciences, Laureate Pharma
Mani Krishnan, Director Mobius Single-Use Processing Systems, from Millipore Corporation; James Wilkins Chief Technology Officer, Sensorin & Rahul Singhvi, CEO of Novavax, Tom Ransohoff, BioProcess Technology Consultants

As of 2008, the 10 largest multinational biomanufacturers controlled ~80% of world capacity, concentrated in North America and Europe. With the global recession, mergers, technological advances, and the entry of China and India, there may even be excess global capacity.

However, factors such as emerging countries’ growing demand; new technologies (e.g., single-use, automation); supply chain and biosecurity concerns, are driving interest in smaller, more geographically distributed production. A panel of global experts will forecast geographic trends and discuss strategies to turn geographic constraints into opportunities for safer, cheaper, faster and better biological products.

Topics covered include:

• A global bioeconomy: globalization vs. national interest, protectionism vs. free trade, the growth of outsourcing vs. current capacity concentrations, cost vs. control
• Legal and regulatory: IP and patents, the global regulatory framework, GMP and market approval, supply-chain risk, the threat/opportunity of biogenerics/biosimilars
• Technological change and comparative advantage: automation, disposables, infrastructure, disruptive technologies, labor supply, IP
• Biosecurity and safety: cost vs. safety, pandemic preparation, vaccines demand, supply-chain contamination risks bioterrorism, biodefense R&D funding opportunities