Keynote Sessions

Michael Lewis, President, Eisai product Creation Systems, USA
Manufacturing Challenges During Pharmaceutical Development: Science Based Lessons from Halaven^®

Halaven^® is one of the most complex totally synthetic drugs ever approved. This presentation will provide examples of how the application of a rational scientific approach helped create the innovative solutions that effectively meet the specialized development needs of this unique product.The assessment of risk associated with new drug development often dominates discussions of pharmaceutical commercialization. Effective risk management through rational analysis can generate innovative solutions, novel opportunities, competitive advantage, while driving organizational performance.

Andy Skibo, Executive Vice President, MedImmune 
A Biotech Perspective on Cost Effective Operations

This session will examine the current environment of BioManufacturing and consider industry-wide pressures and external events that led to our current state. We will highlight the components of manufacturing cost that should not be reduced, given industry’s commitment to delivering quality products to patients, and explore potential solutions for meeting cost constraints impacting each of our organizations.

Chaz Calitri, Vice President, Global Engineering, Pfizer, USA
2020 Vision - the Next Generation of Manufacturing Facilities

This presentation will explore how the factory of the future for Pharmaceutical Manufacturing will look and operate. We will examine enablers of the factory of the future, including technological breakthroughs. We will also examine how the factory of the future will enhance efficiency, quality and compliance through operational excellence and advanced automation and control. Will future factories be designed for shorter life cycle? Large or small scale processing? What skills will be needed to operate these facilities? We will examine these questions and many more.

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