Institute for International Research

Maximize your Savings by Registering Early Take advantage of early registration discounts by registering early. Still waiting on approval? You can register now to lock in the discounted rate and we will bill you directly. Keynote Presentations PDAC: A Cross-Functional Team Driving the Successful Transition of Biologics from Discovery Research to Pharmaceutical Development and Beyond Mark Cunningham, Lead Development Coordinator, Discovery Research, Centocor, Inc. Product Quality Ownership throughout Clinical Product Development Sharon Ma, Ph.D., Senior Scientist, Clinical Quality, Genentech, Inc. Quality by Design Initiative in the Biotechnology Industry Yelena Lyubarskaya, Ph.D., Principal Scientist, Bioprocess Development, Biogen Idec Scientific Advisory Board Daotian Fu, Ph.D. Senior Director Bioanalytical Development Genzyme Corporation Rajesh Krishnan, Ph.D. Senior Principal Scientist Schering Plough Jennifer F. Nemeth-Seay, Ph.D. Principal Research Scientist Centocor, Inc. Kenneth G. Payie, Ph.D. Senior Research Scientist Eli Lilly and Company T. Shantha Raju Research Fellow Centocor R&D, Inc.

IBC's 5th Annual Early to Late Stage Bioprocess Development Summit offers strategies for your analytical and process development programs that optimize the use of internal and external resources and accelerate the development timeline. The meeting is ideally suited for both early stage companies working toward clinical development and for members of cross-functional project teams in larger organizations aiming to streamline and platform development functions.

Program highlights for 2008 include:

• Centocor describes how a novel cross-functional team improved the selection of biologic candidates by understanding the impact of critical structural and biophysical properties on drug development
• Biogen Idec presents two examples of how QbD strategies were used to improve formulation robustness for early and late-stage therapeutic antibodies
• CSL offers an in-depth case study of a strategic partnership with a CMO used to create a large scale manufacturing program suitable for Phase III trials and commercial supply
• Human Genome Sciences outlines the application of a cell culture platform used to optimize a late-stage process that showed scalability, productivity improvements and conformance with product quality goals
• MedImmune demystifies the process of regulatory risk management by reviewing common CMC hurdles and new approaches for improving application quality

Plus, select from four small group problem-solving discussions to receive feedback from your peers on problems specific to your company size or stage of development:

• Timing and Strategies for Analytical Characterization (Moderated by Wyeth Biopharma)
• Process Development Strategies (Moderated by ImmunoGen Inc.)
• Program and Project Management for Bench Scientists (Moderated by Centocor, Inc.)
• Optimizing Inter-function, Inter-site and Company-CMO Transfers (Moderated by BioProcess Technology Consultants, Inc.)