Speakers
Keynote speakers:
- Helen Winkle, Director of the Office of Pharmaceutical Science at the FDA's Center for Drug Evaluation and Research
- Roger Perlmutter, Executive VP of Research and Development, Amgen
- Tony Lubiniecki, Centocor R&D
Among others, session speakers include:
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Ray Arnold (Genentech) - Avastin Transfer to Multiple Sites
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Jon Coffman (Wyeth) - High Throughput Purification Development
- Peter DePhillips (Merck) - High throughput analytical development and lot release
- Bing He (Amgen) - Automating Formulation Development
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Michael Karmack (Wyeth) - History of manufacturing capacity management at Wyeth
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Drew Kelner (Amgen) - Application of Quality by Design principles to biopharmaceutical development
- Mark Leonard (Wyeth )- High-performing cell line development within a rapid and integrated platform process context.
- Hassan Madani (Amgen) - Embrel Transfer
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Thomas Porter (Wyeth) - Assignment and control of desired molecular forms
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Chris Roberts (University of Delaware) - Designing Stability studies for rapid formulation screening: guidance from fundamentals of physical protein stability
- Eugene Schaeffer (Bristol-Myers Squibb) - BMS decision-making about manufacturing capacity at Syracuse, Mass and Celltrion
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Pieter Schmalzing (Genentech) - Specification settings for biotechnology products
- Amy Shen (Genentech) - Stable antibody production cell line development with an improved selection process and accelerated timeline.
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Jim Swartz (Stanford University) - Cell-free Protein Synthesis