Tuesday, October 13, 2009

4:00

Reinventing Biologics Pharmaceutical Development and Marketed Product Support
Today's development groups are tasked with moving diverse and complex pipelines forward in record time with undivided attention required for both product quality and safety as well as cost of manufacturing. These challenges don't require incremental change in the development operating model but revolutionary change in our model. In this talk, we will discuss activities ongoing at Centocor to meet these challenges. We will discuss the changes required for the processes, plants and people to ensure successful commercial products.
Paul F. McKenzie, Vice President, BIO Pharmaceutical Development and Marketed Product Support, Centocor R&D

5:00

Operational Excellence: The Opportunity in the Life Sciences Industry
In this presentation, the speaker will describe the operational excellence opportunity in the life science industry. A "science" perspective to:

• Highlight the Strategic Role of Operations
• Describe its Current State ("Here")
• Envision its Desired Future State ("There")
• Identify barriers in getting from "Here" to "There"
• Summarize Current Approaches to Overcome These Barriers

Initiatives such as PAT and QbD will be put into this context.
G.K. Raju, Ph.D., Executive Director, Manufacturing Initiatives, MIT Center for Biomedical Innovation

Wednesday, October 14, 2009

4:15

Future Trends in Biopharmaceutical Operations and Facilities
This presentation will analyze current and future biopharmaceutical products and review history and technology trends in process development and operations. Based on these analyses and trends, potential conclusions will be drawn for the future of biopharmaceutical operations, manufacturing capacity and manufacturing technology. Finally, the impact of these trends on design, cost and operation of biopharmaceutical facilities will be discussed.
Johannes R. Roebers, Ph.D., Senior Vice President, Biologic Strategy, Planning & Operations, Elan Pharma International Limited, Ireland

5:00

ObamaCare: Stimulus Spending, System Reform and Market Change
Could it happen this time? Decades of a hybrid private market and government health care system have resulted in one of the most costly and least efficient health care systems in the world. Combine this moment with a renewed belief that government may be able to fix what deregulated markets cannot, and serious, systemic health reform may be signed into federal law by the end of 2009. What will the plan look like? Will it work? What does it mean for the pharmaceutical industry and particularly biotech drugs? This keynote session examines probable new policies and outcomes for the pharmaceutical industry under ObamaCare.
J.D. Kleinke, Medical Economist and Author, Oxymorons: The Myth of a U.S. Health Care System

Thursday, October 15, 2009

4:15

Integrating New Technologies in Upstream and Downstream Processing -When to Innovate? What are the Barriers? What are the Challenges?
Genzyme has developed and implemented several large scale continuous processes for manufacturing of therapeutic proteins and synthetic molecules. While the corresponding technology platforms have evolved independently, there are multiple essential concepts and approaches that are compatible. We will review these similarities, and will explore the synergistic opportunities to bridge knowledge in these two areas, including process design concepts, new technologies, and logistics.
Konstantin Konstantinov, Ph.D., Vice President, Technology Development, Genzyme Corp.