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Biopharmaceutical Manufacturing and Development Summit

Event Information

December 08 - 09, 2008 · Washington Duke Inn & Golf Club · Durham, NC

Document Title

Event Overview

Event Overview

Implement Disposables and Operational Excellence Strategies to Optimize Facility Use and Achieve Cost and Waste Reduction

"Great assembly of speakers." – Kim Titus, Business Development, Corning

"The case studies presented at this conference are helpful in sharing best practices and leading the way for others to follow." – James M. Robinson, P.E., Vice President, Technical and Quality Operations, Novavax Inc.

Keynote Presentations

An Integrated Approach to Global Operations: Making Biotech Manufacturing and Operations Strategically Relevant in Today's Global Biotechnology Environment
John Cox, Senior Vice President, Global Manufacturing, Biogen Idec
Translation of Operational Excellence Methodologies from Theory to Action, Results and Sustainability
Curran Simpson, Senior Vice President, Operations, Human Genome Sciences, Inc.

Cost pressures on the biopharmaceutical industry are mounting both from domestic consumer demand and the growth of biosimilars and emerging manufacturers around the globe. For organizations to remain competitive and gain sustainable cost reductions, they must drive innovation and accelerate their rate of implementation of novel technologies.

The BMD Summit is the one forum where you can gain in-depth knowledge in two complementary subject areas. Learn the newest uses for disposables, including their advantages and limitations, or learn how to apply the best principles for operational excellence to achieve lean manufacturing – or both! During the conference you will benefit from a clear understanding of how manufacturing can become a strategic tool for remaining competitive in the face of industry globalization in the keynote by John Cox of Biogen Idec. Hear how to achieve results and sustain an operational excellence program in the keynote by Curran Simpson of Human Genome Sciences, Inc.

Attendees of both tracks can profit from the shared session on regulatory updates, risk management and validation. Streamline validation with an approach to risk-based validation and inspection readiness from Genentech's Director of Corporate Quality and hear the inside story on risk-based commissioning and qualification experience from a former EMEA Inspections Administrator.

Create an agenda to meet your specific needs by choosing sessions from either track. All attendees receive speaker materials from both tracks. Plan now to attend this unique forum to help you advance your career by boosting your organization's competitiveness! Register today to ensure your place.

Two Intensive Tracks in a Unique Interdisciplinary Forum
Disposables and Facilities:
Improving Flexibility and Plant Utilization
Operational Excellence:
Enhancing Efficiency and Quality
  • Understand extractables and leachables through first release of industry data
  • Gain new data on evaluation of upstream technologies
  • Hear strategies for disposal of disposables
  • Analyze limitations of disposables
  • Enhance productivity, flexibility and economics of facilities with realistic process models, design simulation and perfusion technologies
  • Learn Genentech's approach to shipping bulk drug substance in disposables
  • Apply lean principles to achieve cost and waste reduction with strategies and case studies from Genentech, Biogen Idec, GlaxoSmithKline, and Amgen
  • Understand raw material re-use and shelf life extension opportunities
  • Significantly reduce process variability by uncovering the quantitative "sweet spot" during the validation process
  • Hear how Abbott used a 3-week diagnostic approach to achieve impressive cost savings through waste reduction
  • Utilize process analysis to support QbD and to quantify the impact of new technologies

Plus:

  • 14 Case Studies with Technniques You Can Use Right Away
  • Site Tours to Catalent Pharma Solutions and Golden LEAF BTEC Training Facility

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