| Day OneJanuary 26, 2010 |
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07:30 |
Delegate registration & coffee
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08:30 |
Chairperson's opening remarks
Laura Bush, Editor in Chief, Biopharm International
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08:40 |
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Opening keynote presentation: Creating a sustainable Operational Excellence (OE) culture in Biomanufacturing organizations
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- To create a sustainable and lasting OE culture, leaders in the biomanufacturing world must pay attention to an important, yet often overlooked, part of Operational Excellence - change management. Hear what Bayer Healthcare did.
- Leaders must look beyond just deploying the appropriate "tools" and "methodologies" to streamline processes, eliminate waste and generate savings. They need to recognize that there is a mindset change that needs to happen within each individual in the organization and that can be challenging in a regulated and complex industry like biopharmaceuticals. Therefore, sustained success can be achieved only if the implementation is run as an organizational change management initiative
- Using examples from his own experience, Joerg Heidrich will discuss the critical role that leaders at every level in the organization play in driving the change necessary to create a sustainable Operational Excellence culture
Joerg Heidrich, Senior Vice President & Global Head, Product Supply-Biotech, Bayer HealthCare Pharmaceuticals
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09:20 |
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Commitment to total improvement: Operational excellence and beyond
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- Understanding how Amylin Pharmaceuticals began their journey to total improvement in their operations
- Evaluating how the system was set-up and how the change in culture was achieved
- Determining how an ISO 14001 environmental management system and LEED certification system was simultaneously deployed, and how the unexpected benefits of the improvement culture led to successes in sustainability, conservation, and waste reduction
Paul Marshall, Senior Vice President, Operations, Amylin Pharmaceuticals
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10:00 |
Pre-arranged one-to-one meetings
Accelerate the networking process by taking one-to-one meetings with fellow delegates and leading solution providers
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| 11:20 |
| Interactive workshop |
| Single-use is here: Are you ready? |
- Single-use trends and drivers
- Millipore and single-use innovations
- Responding to critical industry demands
Edward Graham-Brown, Vice President of Strategic Marketing, Bioprocess Division, Millipore Corporation
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| Interactive workshop |
| Implementing a Quality by Design (QbD) program that makes process validation a lifestyle rather than an event |
The FDA now defines process validation as "the collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products." On-going process validation is therefore the most important practical outcome of any QbD prorgam. In this presentation you will learn:
- The relationship between process validation and QbD and why QbD starts in process development and doesn't end in manufacturing
- The business benefits and practical user requirements for QbD
- How to make paper-based data available for data analysis and the importance of data contextualization and how to implement it
- How to provide a self-service data access and analytics environment for QbD
- The benefits of using on-line and off-line data together for process analysis
- The value of removing technology and geographic barriers to collaboration
Dr Justin Neway, Executive Vice President and Chief Science Officer, Aegis Analytical Corporation
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| 12:00 |
| Interactive workshop |
| Advances in single use capture chromatography |
- Assessing newly developed high performance membrane-based single us capture chromatography technology
- Evaluating applications of single use capture chromatography technology
Lisa Crossley, President & CEO, Natrix Separations USA
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| Interactive workshop |
| Understanding the latest automated online analytic as a QbD tool in fermentation process |
In association with
- Assessing the latest online sampling technologies
- "Close loop" concepts: Fom automated sampling through real time process adjustment
- Determining the constrains of analytical instruments and data management concepts
- Hear the developments encountered from a Roche Diagnostics Case Study
Dr Stefan Steigmiller, Senior Project Manager PAT, Bayer Technology Services GmbH
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12:40 |
Networking lunch sponsored by 
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14:00 |
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Optimizing and mitigating risk within manufacturing design and operations by creating a culture of operational excellence
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Uncover advanced strategies to improve operating efficiency and significantly reduce cost
- Implementing a lean OpEx program throughout the supply chain operations
- Managing global change without disruption of capabilities
Jeff Cisneros, Global Technical Operations, Operational Excellence Manager, Genentech, Inc.
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14:40 |
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The process oriented organization – an implementation case study
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- Understanding what a Process Oriented Organization is
- Determining the reason behind the change
- Preparation – outlining how you should manage the risks and the employee expectations
- Implementation – analyzing the experiences and lessons learned
- Ongoing operations – enhancing the maturing of the new organization
Robert Carter, Site Head, BPO Vacaville, Novartis
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15:20 |
Pre-arranged one-to-one meetings & networking coffee break
Accelerate the networking process by taking one-to-one meetings with fellow delegates and leading solution providers
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17:05 |
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Paradigm changes over the years: Technology drivers and a future perspective for Biotech manufacturing
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A changing market requires a changing strategy
- The productivity challenge: Why are ever increasing titers needed?
- Reviewing the latest upstream processes and approaches
- Understanding the impact on 'high titer' for downstream operations
- Evaluating the analytical methods and the improvements made
- Determining the life cycle management and DP devices
- Learn about 'FIP', considerations on '1-cycle' development
Dr Wolfgang Noe, Vice President, Strategic Development and Technical Alliance, Biogen Idec
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17:45 |
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Hear how biosimilars are fuelled by improved manufacturing technologies, cost constraints, and political and healthcare legislation
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- What is the current legislation and hear people’s perspectives on the impact to the biotech industry
- Hear how manufacturing strategies and costs may differ
- What has this meant for the biopharmaceutical manufacturing industry; data exclusivity, approvals of biosimilars, will they be marketable and prescribed using unique or (bio)generic- like names?
William Haddad, Chairman & CEO, Biogenerics Inc
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18:25 |
Close of day one and networking drinks reception
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