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BMD Summit: Biopharmaceutical Manufacturing and Development

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tagline

Maximize Facility Output, Effectively Manage Capacity,
Minimize Errors and Assure Raw Material Quality

Event Information

December 14 - 15, 2009 · San Francisco Airport Marriott · San Francisco, CA

Document Title

Event Overview

Event Overview

Over 40 Presentations and Extensive Case Studies

Keynote Presentations

R. Andrew Ramelmeier, Ph.D. The Tale of Two Manufacturing Platforms: What will the Future Hold?
R. Andrew Ramelmeier, Ph.D.
Vice President, Manufacturing, Process Sciences and Facilities
BioMarin Pharmaceutical Inc.
 William Botha From Clatter to Chorus: Reconciling the Voice of the Business with the Voice of the Customer
William Botha
Director of Manufacturing and QLP
Baxter Bioscience

Plenary Presentations

Latest update on biosimilars to help you plan for future market conditions

How Genentech used campaign frequency adjustments to reduce inventory and maximize plant output

Flexible Facilities:
Enabling Efficiency with Process Improvements, Single Use and Other Technologies
Operational Excellence:
Enhancing Efficiencyand Quality
  • Quickly Achieve Manufacturing Agility
  • Disposables: Latest Case Studies and Regulatory Strategies
  • Extractables Testing: Harmonizing Industry Practices
  • Optimizing Capacity Utilization: Internal Programs and Contracting
  • Pfizer and Biogen Idec Strategies to Open the Downstream Bottleneck
  • Assuring Cell Substrate Quality and Safety
  • Avoid Supply Interruption through Risk Assessment for Raw Materials
  • Achieve the Reliability of a Naval Nuclear Submarine by Developing an Effective Learning Organization
  • Improve Quality Management, Performance and Process Control while Reducing Cost

Added Benefit: Site Tours to Amgen Fremont and BioMarin


According to a recent industry survey, the top three goals of most biopharmaceutical manufacturing companies are to improve in these areas:

  • Manufacturing agility
  • Capacity utilization
  • Internal quality management

Close on the heels of those top three are:

  • Improve alignment of internal goals with those of business partners
  • Improve on-time delivery
  • Reduce inventory*

* Thomas, P., Pharmaceutical Manufacturing, Volume 8, Issue 6, p.22 (2009)

The BMD Summit is the best forum to gain the data and consultation you need to enable you and your interdisciplinary team members to achieve these important goals.

At this event you can choose to attend any presentations you wish from the tracks: Flexible Facilities and Operational Excellence. You will receive all of the presentation materials provided by the presenters from both tracks and you will have the chance to learn even more by seeing first-hand how leaders in the field put it all together if you opt for a in-person visit to BioMarin or Amgen's Fremont facility.

From the keynote presenters, you will learn how disposables and continuous processing can redefine the manufacturing platform of the future, and hear the latest best practices in lean manufacturing from Baxter Bioscience.

The US Naval nuclear submarine program is the gold standard for operational excellence programs. Hear experiences from a former nuclear submarine captain, Dennis Murphy, who is now the site head at Amgen's Fremont manufacturing facility, on bringing effective programs in learning from mistakes to continuous improvement in GMP manufacturing operations.

Hear the latest from FDA on CMC microbiology review and inspections for therapeutic biological proteins.

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