According to a recent industry survey published in Pharmaceutical Manufacturing, the top three goals of most biopharmaceutical manufacturing companies are to improve in these areas: manufacturing agility, capacity use, and internal quality management. Close on the heels of those top three are improved alignment of internal goals with those of business partners, improved on-time delivery, and reduced inventory. 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 two tracks: Flexible Facilities and Operational Excellence. You will receive all presentation materials provided by the presenters from both tracks. Hear the latest from FDA on CMC microbiology review and inspections for therapeutic biological proteins. And you have the chance to learn even more by seeing firsthand how leaders in the field put it all together if you choose to join the in-person visit to BioMarin or Amgen’s Fremont facility. 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.

New this Year

• Site tours to Amgen Fremont and BioMarin

• 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

• Hear the latest best practices in lean manufacturing from the Baxter Bioscience keynote presenter

Advisory Board

Joshua Froimson (Abbott Bioresearch Center)

Rick Johnston (US Berkeley Center for Biopharmaceutical Operations)

Sourav K. Kundu (Amgen)

Frank Menkel (Genentech, Inc.)

Wolfgang Noe (Biogen Idec)

Curran Simpson (Human Genome Sciences, Inc.)

Todd Winge (ImClone Systems a wholly-owned subsidiary of Eli Lilly and Company)

BMD Tracks

Flexible Facilities: Enabling Efficiency with Process Improvements, Single Use and Other Technologies

• 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

Operational Excellence: Enhancing Efficiency and Quality

• 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

Keynotes

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 Tale of Two Manufacturing Platforms: What will the Future Hold?” by R. Andrew Ramelmeier, vice president of manufacturing and process development at BioMarin Pharmaceutical Inc.

• “From Clatter to Chorus: Reconciling the Voice of the Business with the Voice of the Customer” by William Botha, director of manufacturing and QLP at Baxter Bioscience

Colocated Training Course

Colocated with BMD will be the IBC Professional Training Course on “Supply Chain Management.” This two-day course overviews the management of moving biologics from starting point to destination. It uses examples from biologics manufacturing and related products. See www.IBCLifeSciences.com/C5354 for more information.