day one | day two

Day OneJune 14th 2010
8:00am
Delegate registration and morning refreshments
9:00am
Chairpersons' opening remarks

David Hanfland, Partner, A.T. Kearney, Inc.
David Powell, Partner , A.T. Kearney, Inc.
9:10am
Operational excellence - engaging the workforce throughout the change process
The effects of refocusing business processes, restructuring and lean programs on the workforce at Novo Nordisk
  • Engaging the workforce from top to bottom and across multiple worldwide sites
  • Delivering the right competencies to the workforce, aligning communication and establishing transparency to sustain improvements and ensure morale

Jonathan Walker, Head, cLEAN® Program and Master Black Belt, Novo Nordisk Pharmaceuticals,
9:45am
Supporting the sustainable implementation of operational excellence
Identifying critical factors that can support or hinder sustainable change
  • Overcoming internal inertia within operational excellence initiatives
  • Providing a framework for analyzing improvement potential at site level and knowledge exchange opportunities on the manufacturing network level
  • Launching corporate OpEx initiatives and making the best use of benchmarking from an organizational development perspective

Dr. Thomas Friedli, Managing Director, Chair of Production Management, Institute of Technology Management, University of St. Gallen
10:20am
One to one meetings and networking break
11:40am
Manufacturing intelligence workshop
Aegis
Workshop: Achieving the Goals of QbD and PAT – bridging the gap between process development and manufacturing
  • Utilising a simple, user-centric interface for direct, on-demand access to all relevant data from disparate sources
  • Capturing paper-based data and making it easily available in electronic form
  • Sharing data, analysis results and reports across disciplines, scales of operation, and geographically dispersed sites
  • Simplifying the preparation and distribution of analysis results
  • Automating the generation of periodic reviews and reports of batches and campaigns

Randy Tatlock, Senior Applications Specialist, Aegis Analytical Corporation
 
Extending your product lifecycle workshop
Workshop: How product stewardship can add value to help extend your product lifecycle while protecting your brand
  • Strategies to engage supply chain
  • Integrate reuse solutions for customers
  • Peaking consumer interest

Holly Gamage, Vice President, Heritage Environmental Services
 
12:15pm
Energy and water management workshop
Veolia
Workshop: Maximizing cost reduction while increasing environmental performance: Illustrations
  • Maximize cost reduction deploying synergies
  • Ensure social success when outsourcing services
  • Get the relevant technical expertise to mitigate your operational risks

Jean-Jacques Delobelle, Pharma Sales Director, Veolia Environnement
 
Clean air systems workshop
Workshop: Hear the latest advancements in clean air solutions for the pharmaceutical industry
Sean O'Reilly, Air Filtration Segment Specialist, Cleanroom and Bio-Pharma Applications, Camfil Farr
 
12:50pm
Networking lunch
2:00pm
Breaking operations’ paradigms to unlock value
  • Understand how leading companies are breaking typical operations’ paradigms to drive change beyond historical organizational and functional boundaries
  • Examples of specific initiatives showing how companies have taken on this challenge

David Powell, Partner , A.T. Kearney, Inc.
David Hanfland, Partner, A.T. Kearney, Inc.
2:45pm
Case study: Genentech's continued journey to operational excellence. A bio-manufacturing site's experience
  • Examining the multi-year methodical approach taken to achieve the goals set out at Genentech's bulk biopharmaceutical manufacturing facility in Vacaville, CA
  • Hear how the approach has achieved 180 production runs in a row without a loss due to contamination or other processing issues
  • Understanding the key initiatives, as well as the integrated partnership between quality, manufacturing, process sciences and facilities personnel
  • Analyzing the operational and system improvements made through continued analysis and learning, as well as the deployment of rapid micro techniques to mitigate media contaminations and respond to issues

Robert Lippe, Director, Manufacturing, Genentech
3:20pm
One to one meetings and networking break
5:05pm
Facilitating and achieving QbD for drug products
Implementation of QbD / PAT at Novartis and their uses in production
  • Incorporation of the QbD principles and PAT applications through the successful re-design of a commercial drug product
  • Details on the design space and control strategy for this drug
  • The use of MVDA models to ensure quality compliance in routine production

Olivia Darmuzey, QbD Expert Pharmaceutical Operations, Novartis Pharma AG
5:40pm
Panel discussion
With the number of new compounds falling over the past decade, there are growing concerns that federal policy and increasing patent challenges contribute to productivity decline. The panel will begin by exploring implications to the question: Do we need to incentivize industry innovation?

Dr. Bob Miller, Executive Director, The Shingo Prize for Operational Excellence
Dr. Thomas Friedli, Managing Director, Chair of Production Management, Institute of Technology Management, University of St. Gallen
6:20pm
Close of day one and networking drinks reception

day one | day two

Day TwoJune 15th 2010
8:30am
Delegate registration and morning refreshments
8:55am
Chairpersons' remarks

David Hanfland, Partner, A.T. Kearney, Inc.
David Powell, Partner , A.T. Kearney, Inc.
9:00am
Manufacturing capacity planning in a highly volatile environment; survival techniques, opportunities and risks
  • As a pre-commercial company, HGSI decided early to build out significant manufacturing infrastructure
  • As clinical outcomes were known, we developed a variety of strategies to compensate for both excess capacity and insufficient capacity situations
  • The resulting outcome was robust capacity utilization which enabled our systems to develop and attain commercial readiness
  • As our products enter the market, we must prepare for additional growth in a manner which avoids undue risk while maintaining cost awareness - the talk will describe the current industry capacity trends and how a producer might take advantage of changes in the market

Curran Simpson, Senior Vice President, Operations, Human Genome Sciences
9:35am
Adding value through ‘whole process understanding’
How creative collaborations in process design are enabling companies to get further ahead, faster!
  • Understanding your processes to better inform business decisions
  • Engaging in global collaborations to drive innovative process design
  • Using whole process understanding tools and methodologies to gain competitive advantage
  • Delivering tangible business value though whole process understanding

Sue Fleet, Chief Executive Officer, Britest Limited
10:10am
Operational excellence
Successfully implement OpEx into the organization
  • Understand the sustainability lessons of The Shingo Prize from 22 years of experience with the best Lean Implementers
  • Discuss the dangers of allowing your lean/operational excellence efforts to become too “tool” oriented
  • Learn the critical relationships between the principles, systems and tools related to Operational Excellence
  • Discover how to organize roles in your company to ensure a sustainable cultural transformation

Dr. Bob Miller, Executive Director, The Shingo Prize for Operational Excellence
 
Clearing the regulatory hurdles for continuous manufacturing
Setting up an API continuous manufacturing facility
  • Experiences of FDA and MHRA inspections - gaining approval for this next generation manufacturing process
  • Benefits and pitfalls of continuous manufacturing - lessons learned during the development process
  • Understanding the business case for continuous manufacturing

Peter McDonnell, Senior Technical Director, Genzyme
 
10:45am
Networking coffee break
11:45am
Supply chain management workshop
Workshop: Supply chain optimization - driving operational performance
  • Handle uncertainties and global supply chain complexities to reduce inflated inventories while maintaining reliable service levels
  • Accelerate value creation and improve collaborative decision-making capabilities with key trading partners
  • Drive operational performance through improved planning, risk management, and responsiveness to change

Ellen Reilly, Managing Director, Life Sciences Practice, PricewaterhouseCoopers
 
Containment workshop
Workshop: Understanding containment within your facilities dust collection systems. Take a behind-the-scene look at containment enhancements for your dust collector systems.
  • Gain insight into dust containment outside the production room
  • Learn how to minimize exposure with Clean Change Bag-in/Bag-out
  • Understand containment verification testing with ILC Dover Continuous Liner

RJ Twiford, Pharmaceutical Market Manager, Donaldson Torit
 
12:20pm
Using Quality Risk Management (QRM) to enable flexible multiproduct biotech manufacturing facilities
  • Using QRM to strategic advantage by enabling flexible and progressive facility designs
  • Gaining insight into proven methodologies for multiproduct facility risk assessments
  • Understanding the array of cross-contamination risks associated with multiproduct facilities
  • Strategies for engaging boards of health to facilitate understanding and concurrence with risk-based justification of contemporary facility designs

Kristin Murray, Senior Manager, GCMC Regulatory, Pfizer
Stephen Reich, Risk Management Principal, Global Quality, Pfizer
12:55pm
Themed luncheon discussions
Discussions include:
1:00pm
Optimizing the selection of air filters by use of life-cycle cost calculations
Led by:
 
Reuse solutions for manufacturing by-products
Led by:
 
The dynamics between quality and operations
Led by:
 
A discussion of custom metallic filter media as used by the Pharmaceutical industry
Led by:
 
Protect the integrity and legally defend the authenticity and ownership of your scientific intellectual property
Accelerate your products’ time-to-market and protect its long-term revenue stream
Led by:
 
1:00pm
Specialty or fully integrated CDMO: Which is right for you?
Led by:
 
Safe transportation packaging for your Pharma products through the supply chain – alternative pallet solutions
Led by:
 
Advanced aseptic blow-fill-seal technology
Led by:
 
Futureproofing the laboratory - QbD in the regulated analytical process from discovery to delivery
Led by:
 
Clean rooms for pharmaceutical manufacturing facility for cGMP compliance
Hear how your existing facility can be renovated to create the aseptic environment required
Led by:
 
2:05pm
Strategies for environmentally sustainable manufacturing - harnessing the opportunities for cost reduction
The profitability of sustainability
  • Tracking and trending energy consumption to lower operating expense and minimize exposure to fluctuating energy prices
  • Developing site specific strategies to reduce excess water use and land-fill waste
  • Using MES to drive green initiatives that provide quantifiable competitive advantage
  • Assessing the potential of PAT for strategic energy and quality monitoring

James Hagan, Vice President, Sustainability and Environment, GlaxoSmithKline
2:40pm
Bayer case study: Use of agile PLM for product development, registration and global launch
Led by Oracle and Bayer Healthcare
Review how product lifecycle management at Bayer Consumer Care helps:

  • Provide global visibility to all formulation, heirarchical bills of material including digital assets
  • Manage better portfolio decisions and stage gate processes for new product launches
  • Support compliance to a global regulatory framework and manage product registration
  • Manage CAPA processes for closed loop quality management

Todd Hein, Senior Director, Oracle Life Science industry Business Unit
3:20pm
Creating the pharmaceutical facility of the future
Panel discussion: Achieving agility in pharmaceutical manufacturing
  • Transforming laboratories and manufacturing facilities
  • Understanding and implementing transformative technologies into new and existing facilities
  • Setting new benchmarks for the future of pharmaceutical manufacturing

Robert Lippe, Director, Manufacturing, Genentech
Peter McDonnell, Senior Technical Director, Genzyme
Mitch Lower, Director, Global Engineering, Biogen Idec
Abigail Smith, Vice President, Manufacturing Operations, MannKind Corporation
3:55pm
Chairpersons' closing remarks

day one | day two

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