Cell Culture & Upstream Processing - IBC Life Sciences

THE Meeting Place for the
Bioprocessing Industry
September 23-26, 2008
Disneyland® Hotel • Anaheim, California
www.IBCLifeSciences.com/BPI/US
Keynote Presentations
Biosimilars – Follow-on Biologics
Subsequent Entry Biologics – Biogenerics?
Robert L. Garnick, Ph.D.
Senior Vice President
Regulatory, Quality and Compliance
Genentech, Inc.
Paths to Flexible Regulatory Notification of
Large Molecule Life-Cycle Changes
John K. Towns, Ph.D.
Director
Global CMC Regulatory Affairs
Eli Lilly and Co.
The Challenges and Successes of Creating
a Biologics Organization within Pfizer
Rick Rutter, Ph.D.
Vice President
Pharmaceutical Sciences Biologics
Pfizer Inc
Manufacturing Support – Lessons
Learned and Trends for the Future
Konstantin Konstantinov, Ph.D.
Vice President
Technology Development
Genzyme Corp.
Using Knowledge Management for Technical
Collaboration across Generations
Jeanne Holm, Ph.D.
Chief Knowledge Architect
NASA Jet Propulsion Laboratory
How to Motivate Staff to Implement Lean
Manufacturing to Raise the Bottom Line
Rob Bryant, MBA
Vice President, Quality, Lean/Six Sigma
Program Lead Master Blackbelt
Computer Sciences Corporation
Featured Presentations
What's Inside
FDA Manufacturing
Initiatives in
Biotechnology Products
Steven Kozlowski, Ph.D.
Director, Office of
Biotechnology Products
OPS, CDER, US FDA
Post-Registration Process
Changes: Considerations
for Comparability
Robert A. Baffi, Ph.D.
Senior Vice President
Technical Operations
BioMarin Pharmaceutical Inc.
Special Exhibit Hall Keynote Presentation
Biomanufacturing 2008:
Where We’ve Been, Where
We’re Going, and Why
Randy Maddux, Ph.D.,
Vice President, Manufacturing
Operations, Human Genome
Sciences, Inc.
The Treacherous Path to Success
in the Biotech Industry
Prof. Charles L. Cooney
Robert T. Haslam (1911) Professor, Department of
Chemical Engineering, and Faculty Director,
Deshpande Center of Technological Innovation, MIT
Conference-at-a-Glance. . . . . . . . . . . . . . 3
Track Descriptions . . . . . . . . . . . . . . . . . . . 4
Pre-Conference Workshops . . . . . . . . . . 5
Main Conference Sessions . . . . . . . . 6-17
Site Tour Information . . . . . . . . . . . . . . . 14
Formulation Conference Highlights . 18
Training Courses . . . . . . . . . . . . . . . . . . . . 19
Sponsorship Information. . . . . . . . . . . . 20
Exhibit Information . . . . . . . . . . . . . 20-21
Poster Guidelines . . . . . . . . . . . . . . . . . . . 22
Venue Information. . . . . . . . . . . . . . . . . . 22
Registration Form. . . . . . . . . . . . . . . . . . . 23
1 To Register, Call: (800) 390-4078 • Fax: (941) 365-0104 • E-mail: reg@ibcusa.com