2008 Conference Program
By::
Jun 30, 2008, 08:52
Jun 30, 2008, 08:52
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DAY 1, SEPTEMBER 11, 2008
Registration: 8:00 am - 9:00 am
Conference: 9:00 am - 5:30 pm
Cocktail Reception: 5:30 - 6:30 pm
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9:00 am - 9:10 am
Welcome Address: Devendra Mishra and Tim Salaver, Conference Chairmen
9:10 am - 9:45 am
"Acute to Chronic Care - Necessitating a Paradigm Shift in Healthcare"
Speaker: Dr. Mahender Singh, Research Director, MIT Center for Transportation & Logistics
Description: The emerging evolution of acute to chronic disease care in the healthcare industry will require a fundamental restructuring of healthcare over the next two decades. The necessary reconfiguration of the supply chain will be driven by the convergence of products and services for patient-centric lifestyle management where lessons learned from certain mistakes of the pharma industry will be incorporated.
9:45 am - 10:30 am
“The Importance of Supply Chain Management in Achieving Global Business Vision”
Speaker: Dave Malenfant, Vice President, Global Supply Chain, Alcon Laboratories
Description: Using real-life example initiatives and strategies, you will learn techniques to align your supply chain organization with your overall company goals and objectives so you can achieve superior results.
10:30 am - 11:00 am
Networking Break
11:00 am -11:30 am
“Managing The Supply Chain Today and Tomorrow: The Challenge”
Speaker: Tim Moore, Senior Vice President, Global Supply Chain, Genentech
Description: Building world-class, responsive clinical and commercial manufacturing operations globally to deliver planned, predictable performance at the right cost requires operational strategies of effective supply chain management, capacity planning, quality and reliability management, risk assessment and optimization, leveraging of 3rd party suppliers and deployment of technology.
11:30 am - 12:30 pm
Operations & Supply Chain Executives Panel: “A Holistic Supply Chain Perspective Driving Operations”
Moderator:
Devendra Mishra, Professor, Decisions Sciences, Pepperdine University
Panelists:
Tim Moore, Senior Vice President, Global Supply Chain, Genentech
Thomas Panzer, Vice President Global Supply Chain PS - Biotech, Bayer Healthcare
Nabil Rageh, Director of the Doctor Business Admin Program at Golden Gate University
Manu Kapapa, Production Manager, Bio-Rad
Dr. Lee Schruben, Professor, University of California, Berkeley, Department of IE and OR
Description: Operations executives from major biotech companies will address issues of interface with R&D, manufacturing capacity planning, process control, yield management, lean manufacturing, product traceability and safety, outsourcing, customer service and overall supply chain considerations.
12:30 pm - 1:30 pm
Networking Lunch
1:30 pm - 2:15 pm
R&D and Clinical Supply Chain Management Panel: “Innovation, Regulation and Drug Pipeline: Management for Profitability and Risk Abatement”
Moderator: Satish Jha, President, JM Consulting
Panelists:
Tilmann Pruesse, Deputy Director, Operations Management, Bayer Healthcare
Susanne Somerville, Director, Clinical Supply Chain, Genentech
Brian Maiorella, Department of Chemical Engineering, University of California, Berkeley. Former VP, Process Development, Chiron
Nabil Rageh, Director of the Doctor Business Admin Program at Golden Gate University
Description: Executives from R&D, clinical testing, regulatory agency and academia will address the challenges of long and high investment R&D Cycle, meeting regulatory requirements, integrating clinical testing and drug portfolio management, and supply chain considerations of COGS reduction, partner selection during late stage development and technology transfer to enable a smooth global launch.
2:15 pm - 3:00 pm
“Strategic Global Sourcing and Raw Material Supplier Lifecycle Management”
Panelists:
Venkat Yepuri, Executive Director, Global Strategic Sourcing, Amgen
Miguel Miciano, Director, Global Strategic Sourcing, Amgen
John Gersmeyer, Sr. Category Manager, Global Strategic Sourcing, Amgen
A Round Table of executives from Amgen will address the critical success factors for global sourcing with considerations of vendor certification, supplier relations management, quality assurance, demand and capacity balancing, inventory and transportation optimization, while ensuring regulatory compliance over the life cycle of the raw materials. Lessons learned and business relationship established will be discussed in the context of China.
3:00 pm - 3:30 pm
“Biotech Production: Flexibility and Risk Optimization”
Speakers: Dr. Philip M. Kaminsky, Associate Professor, Industrial Engineering & Operations Research, University of California, Berkeley
Rick Johnston, Research Scholar, UC Berkeley, IE-OR
Darren Johnson, Senior Manager, Forecasting and Business Analysis, Genentech
Description: Regulatory issues, long and uncertain research lead times, capital-intensive capacity expansion, and extremely demanding customer service present unique challenges in the biopharmaceutical industry. At the same time, demand is also driven by the impact of specific high-impact events, different capacity expansion projects can have dramatically different uncertainties, durations, and costs, and different projects are very difficult to compare. Speaker will explore how current decisions can limit future options and discuss decision making tools developed at UC Berkeley.
3:30 pm - 4:00 pm
Networking Break
4:00 pm - 4:30 pm
“Challenges of Planning Systems and Processes in BioTech”
Speaker: Thomas Panzer, Vice President, Global Supply
Chain, Bayer Healthcare
Description: This industry leader provides his perspective on the challenges and opportunities involved in planning systems and processes in today's dynamic biotech industry.
4:30 pm - 5:30 pm
Manufacturing Process Panel: “Improving Healthcare Quality and Cost with Six Sigma and Lean Manufacturing”
Moderator: Tim Salaver, President, Cornerstone Systems Solutions
Panelists:
Fadel Hamed, Associate Director, Operational Excellence, Genentech
Chuck Mignosa, CSSMBB, President, Business Systems Architect, LLC
Jennifer Maynard, Black Belt Operational Excellence, Bayer Healthcare
Carolyn Pexton, Director, PR & Communications, GE Healthcare
Description: Diverse case studies demonstrating successful deployment of the principles and tools of Six Sigma Process Control and Lean Manufacturing in operations within the biotech industry will be presented. Discussion will include key aspects of design and implementation approaches, hurdles, systems, resources, benefits and time lines. Analogy with the semiconductor industry will be drawn. Attendees will also learn what it takes to effectively lead organizational change initiatives and sustain results over time.
5:30 pm - 6:30 pm
Cocktail Reception
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DAY 2, SEPTEMBER 12, 2008
Conference: 9:00 am - 3:30 pm
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9:00 am - 9:45 am
Speaker: Joe Shedlawski, CPIM, Principal, Commercial Operations, Wyeth Consumer Healthcare
Description: As an industry globalizes, in terms of sourcing, manufacturing, and distribution, the complexity of business operations, particularly of demand and supply chain management, increases dramatically. Today, Operations Management is a critical determinant of an enterprise's success; the best-in-class "value chains" are nearly twice as efficient as the average in terms of the agility that they provide and the costs that they require. The key to superiority in this arena is not necessarily technology. Companies become mired in strategy, in process, and in organization. This presentation will offer some perspective on how to align these foundational elements of tomorrow's market leaders.
9:45 am - 10:15 am
“Regulatory Implications to Global Supply Chain Operations”
Speaker: Vitaly Glozman, Partner, PRTM
Description: The topic will address the impact of evolving and disparate regulatory requirements to support global supply chain operations in India, China, Eastern Europe and Latin America. The specific areas of focus will be supply availability and delivery, product quality and safety, social responsibility and “green” supply chain requirements.
10:15 am - 10:45 am
Networking Break
10:45 am - 11:15 am
“Global Contract Manufacturing: Trials, Tribulations and Triumphs”
Speaker: Glenn Snyder, Principal, Life Sciences, Deloitte Consulting
Jayant Lakshmikanthan, Manager, Deloitte Consulting, LLP
Description: What you should expect when you engage in global contract manufacturing in the biotech industry. Contract manufacturing in the Biotech industry is going through a significant transition with increasing acceptance of contract manufacturers. This presentation will explore trends affecting such partnerships geographically and strategically, challenges associated and ways in which companies are overcoming these obstacles.
11:15 am - 11:45 am
“Innovative Operations Solutions for Clinical Trials in Medical Devices”
Speaker: Ruchir Sehra, MD, MBA, Vice President of Clinical Research – Kyphon/Medtronic
Description: Kyphon has one of the largest worldwide clinical study portfolios in the $4+ billion spine therapy industry. Dr. Sehra will be speaking on novel ways to manage global trials with a focus on enterprise-wide clinical trial management solutions to improve planning, execution and efficiencies to maximize operational return. A systems solution will be discussed that integrates the supply chain for clinical trials.
11:45 am - 12:45 pm
ePedigree Panel: “Meeting California’s Drug Pedigree Requirements and Securing The Global Supply Chain”
Moderator: Douglas B. Farry, Managing Director, McKenna Long & Aldridge, San Diego
Panelists: Mary-Lou Quinto, Director, Global Logistics, Genentech
Matt Humphreys, Senior Manager, Deloitte Consulting, LLP
Kim Loughead, Director, Solutions Marketing, Axway
Joe Dugan, VP, Consulting Services - West Coast, Life Sciences, Capgemini
Description: Even with the delay, California’s drug pedigree legislation presents a real challenge for the Biotech industry. Securing information and product flow and providing visibility are vital to today's IT-driven biotech supply chain of drug manufacturers distributors, hospitals, physicians and the patients. This panel discussion will bring participants from across the industry to discuss the many facets of this issue in the global marketplace. How are companies meeting the challenge; what about regulatory uncertainty at the state and federal level; how to get started?
12:45 pm - 1:45 pm
Lunch
1:45 pm - 2:45 pm
Distribution Executives Panel: “Ensuring Agility, Adaptability and Alignment for Customer Service”
Moderator: Peter Emery, Senior Manager, Capgemini
Panelists: Tim Warner, Principal, PRTM
Rodney Derifield, CEO, EnviroCooler
Kim Loughead, Director, Solutions Marketing, Axway
Sergio Retamal, President & CEO, Global4PL
Description: In order to maximize customer service, the critical role of distributors between biotech suppliers and pharmacies, doctors, hospitals and patients will be presented where collaboration drives collaborative planning, information technology connectivity, data base management, temperature-sensitive product management, RFID deployment, transportation management, reverse logistics and customer service.
2:45 pm
Wrap Up: Tim Salaver and Devendra Mishra, Conference Chairmen
DAY 1, SEPTEMBER 11, 2008
Registration: 8:00 am - 9:00 am
Conference: 9:00 am - 5:30 pm
Cocktail Reception: 5:30 - 6:30 pm
-----------------------------------------------------------------------------
9:00 am - 9:10 am
Welcome Address: Devendra Mishra and Tim Salaver, Conference Chairmen
9:10 am - 9:45 am
"Acute to Chronic Care - Necessitating a Paradigm Shift in Healthcare"
Speaker: Dr. Mahender Singh, Research Director, MIT Center for Transportation & Logistics
Description: The emerging evolution of acute to chronic disease care in the healthcare industry will require a fundamental restructuring of healthcare over the next two decades. The necessary reconfiguration of the supply chain will be driven by the convergence of products and services for patient-centric lifestyle management where lessons learned from certain mistakes of the pharma industry will be incorporated.
9:45 am - 10:30 am
“The Importance of Supply Chain Management in Achieving Global Business Vision”
Speaker: Dave Malenfant, Vice President, Global Supply Chain, Alcon Laboratories
Description: Using real-life example initiatives and strategies, you will learn techniques to align your supply chain organization with your overall company goals and objectives so you can achieve superior results.
10:30 am - 11:00 am
Networking Break
11:00 am -11:30 am
“Managing The Supply Chain Today and Tomorrow: The Challenge”
Speaker: Tim Moore, Senior Vice President, Global Supply Chain, Genentech
Description: Building world-class, responsive clinical and commercial manufacturing operations globally to deliver planned, predictable performance at the right cost requires operational strategies of effective supply chain management, capacity planning, quality and reliability management, risk assessment and optimization, leveraging of 3rd party suppliers and deployment of technology.
11:30 am - 12:30 pm
Operations & Supply Chain Executives Panel: “A Holistic Supply Chain Perspective Driving Operations”
Moderator:
Devendra Mishra, Professor, Decisions Sciences, Pepperdine University
Panelists:
Tim Moore, Senior Vice President, Global Supply Chain, Genentech
Thomas Panzer, Vice President Global Supply Chain PS - Biotech, Bayer Healthcare
Nabil Rageh, Director of the Doctor Business Admin Program at Golden Gate University
Manu Kapapa, Production Manager, Bio-Rad
Dr. Lee Schruben, Professor, University of California, Berkeley, Department of IE and OR
Description: Operations executives from major biotech companies will address issues of interface with R&D, manufacturing capacity planning, process control, yield management, lean manufacturing, product traceability and safety, outsourcing, customer service and overall supply chain considerations.
12:30 pm - 1:30 pm
Networking Lunch
1:30 pm - 2:15 pm
R&D and Clinical Supply Chain Management Panel: “Innovation, Regulation and Drug Pipeline: Management for Profitability and Risk Abatement”
Moderator: Satish Jha, President, JM Consulting
Panelists:
Tilmann Pruesse, Deputy Director, Operations Management, Bayer Healthcare
Susanne Somerville, Director, Clinical Supply Chain, Genentech
Brian Maiorella, Department of Chemical Engineering, University of California, Berkeley. Former VP, Process Development, Chiron
Nabil Rageh, Director of the Doctor Business Admin Program at Golden Gate University
Description: Executives from R&D, clinical testing, regulatory agency and academia will address the challenges of long and high investment R&D Cycle, meeting regulatory requirements, integrating clinical testing and drug portfolio management, and supply chain considerations of COGS reduction, partner selection during late stage development and technology transfer to enable a smooth global launch.
2:15 pm - 3:00 pm
“Strategic Global Sourcing and Raw Material Supplier Lifecycle Management”
Panelists:
Venkat Yepuri, Executive Director, Global Strategic Sourcing, Amgen
Miguel Miciano, Director, Global Strategic Sourcing, Amgen
John Gersmeyer, Sr. Category Manager, Global Strategic Sourcing, Amgen
A Round Table of executives from Amgen will address the critical success factors for global sourcing with considerations of vendor certification, supplier relations management, quality assurance, demand and capacity balancing, inventory and transportation optimization, while ensuring regulatory compliance over the life cycle of the raw materials. Lessons learned and business relationship established will be discussed in the context of China.
3:00 pm - 3:30 pm
“Biotech Production: Flexibility and Risk Optimization”
Speakers: Dr. Philip M. Kaminsky, Associate Professor, Industrial Engineering & Operations Research, University of California, Berkeley
Rick Johnston, Research Scholar, UC Berkeley, IE-OR
Darren Johnson, Senior Manager, Forecasting and Business Analysis, Genentech
Description: Regulatory issues, long and uncertain research lead times, capital-intensive capacity expansion, and extremely demanding customer service present unique challenges in the biopharmaceutical industry. At the same time, demand is also driven by the impact of specific high-impact events, different capacity expansion projects can have dramatically different uncertainties, durations, and costs, and different projects are very difficult to compare. Speaker will explore how current decisions can limit future options and discuss decision making tools developed at UC Berkeley.
3:30 pm - 4:00 pm
Networking Break
4:00 pm - 4:30 pm
“Challenges of Planning Systems and Processes in BioTech”
Speaker: Thomas Panzer, Vice President, Global Supply
Chain, Bayer Healthcare
Description: This industry leader provides his perspective on the challenges and opportunities involved in planning systems and processes in today's dynamic biotech industry.
4:30 pm - 5:30 pm
Manufacturing Process Panel: “Improving Healthcare Quality and Cost with Six Sigma and Lean Manufacturing”
Moderator: Tim Salaver, President, Cornerstone Systems Solutions
Panelists:
Fadel Hamed, Associate Director, Operational Excellence, Genentech
Chuck Mignosa, CSSMBB, President, Business Systems Architect, LLC
Jennifer Maynard, Black Belt Operational Excellence, Bayer Healthcare
Carolyn Pexton, Director, PR & Communications, GE Healthcare
Description: Diverse case studies demonstrating successful deployment of the principles and tools of Six Sigma Process Control and Lean Manufacturing in operations within the biotech industry will be presented. Discussion will include key aspects of design and implementation approaches, hurdles, systems, resources, benefits and time lines. Analogy with the semiconductor industry will be drawn. Attendees will also learn what it takes to effectively lead organizational change initiatives and sustain results over time.
5:30 pm - 6:30 pm
Cocktail Reception
------------------------------------------------------------------------------
DAY 2, SEPTEMBER 12, 2008
Conference: 9:00 am - 3:30 pm
------------------------------------------------------------------------------
9:00 am - 9:45 am
APICS Golden Gate Chapter presents:
“Aligning Strategies, Operations, Metrics, and Practices”Speaker: Joe Shedlawski, CPIM, Principal, Commercial Operations, Wyeth Consumer Healthcare
Description: As an industry globalizes, in terms of sourcing, manufacturing, and distribution, the complexity of business operations, particularly of demand and supply chain management, increases dramatically. Today, Operations Management is a critical determinant of an enterprise's success; the best-in-class "value chains" are nearly twice as efficient as the average in terms of the agility that they provide and the costs that they require. The key to superiority in this arena is not necessarily technology. Companies become mired in strategy, in process, and in organization. This presentation will offer some perspective on how to align these foundational elements of tomorrow's market leaders.
9:45 am - 10:15 am
“Regulatory Implications to Global Supply Chain Operations”
Speaker: Vitaly Glozman, Partner, PRTM
Description: The topic will address the impact of evolving and disparate regulatory requirements to support global supply chain operations in India, China, Eastern Europe and Latin America. The specific areas of focus will be supply availability and delivery, product quality and safety, social responsibility and “green” supply chain requirements.
10:15 am - 10:45 am
Networking Break
10:45 am - 11:15 am
“Global Contract Manufacturing: Trials, Tribulations and Triumphs”
Speaker: Glenn Snyder, Principal, Life Sciences, Deloitte Consulting
Jayant Lakshmikanthan, Manager, Deloitte Consulting, LLP
Description: What you should expect when you engage in global contract manufacturing in the biotech industry. Contract manufacturing in the Biotech industry is going through a significant transition with increasing acceptance of contract manufacturers. This presentation will explore trends affecting such partnerships geographically and strategically, challenges associated and ways in which companies are overcoming these obstacles.
11:15 am - 11:45 am
“Innovative Operations Solutions for Clinical Trials in Medical Devices”
Speaker: Ruchir Sehra, MD, MBA, Vice President of Clinical Research – Kyphon/Medtronic
Description: Kyphon has one of the largest worldwide clinical study portfolios in the $4+ billion spine therapy industry. Dr. Sehra will be speaking on novel ways to manage global trials with a focus on enterprise-wide clinical trial management solutions to improve planning, execution and efficiencies to maximize operational return. A systems solution will be discussed that integrates the supply chain for clinical trials.
11:45 am - 12:45 pm
ePedigree Panel: “Meeting California’s Drug Pedigree Requirements and Securing The Global Supply Chain”
Moderator: Douglas B. Farry, Managing Director, McKenna Long & Aldridge, San Diego
Panelists: Mary-Lou Quinto, Director, Global Logistics, Genentech
Matt Humphreys, Senior Manager, Deloitte Consulting, LLP
Kim Loughead, Director, Solutions Marketing, Axway
Joe Dugan, VP, Consulting Services - West Coast, Life Sciences, Capgemini
Jim Brown, Director, Third Party
Mfg & Logistics, Allergan
Description: Even with the delay, California’s drug pedigree legislation presents a real challenge for the Biotech industry. Securing information and product flow and providing visibility are vital to today's IT-driven biotech supply chain of drug manufacturers distributors, hospitals, physicians and the patients. This panel discussion will bring participants from across the industry to discuss the many facets of this issue in the global marketplace. How are companies meeting the challenge; what about regulatory uncertainty at the state and federal level; how to get started?
12:45 pm - 1:45 pm
Lunch
1:45 pm - 2:45 pm
Distribution Executives Panel: “Ensuring Agility, Adaptability and Alignment for Customer Service”
Moderator: Peter Emery, Senior Manager, Capgemini
Panelists: Tim Warner, Principal, PRTM
Rodney Derifield, CEO, EnviroCooler
Kim Loughead, Director, Solutions Marketing, Axway
Sergio Retamal, President & CEO, Global4PL
Description: In order to maximize customer service, the critical role of distributors between biotech suppliers and pharmacies, doctors, hospitals and patients will be presented where collaboration drives collaborative planning, information technology connectivity, data base management, temperature-sensitive product management, RFID deployment, transportation management, reverse logistics and customer service.
2:45 pm
Wrap Up: Tim Salaver and Devendra Mishra, Conference Chairmen
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