| September 24, 2008Contract Manufacturing Forum |
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| Analyzing and mitigating the risk associated with manufacturing in emerging markets |
| 08:20 |
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Delegate Registration + Coffee |
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| 09:00 |
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CHAIRMAN'S OPENING ADDRESS |
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| 09:10 |
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OUTSOURCING: UNCOVER THE REALITIES OF THE NEW PARADIGM SHIFT IN MANUFACTURING AND ASSESS THE BUSINESS CASE FOR OUTSOURCING YOUR MANUFACTURING OPERATIONS |
- Forecast the trends: which countries are we headed to next and what other compounds are likely to be outsourced?
- Assess the risks and determine the business implications of outsourcing vs. in house manufacturing
- Analyze the effect that this shift will have on the US manufacturing base
- Identify the challenges and opportunities for overseas manufacturing
- Determine the other reasons for contract manufacturing, is there more to this than just the cost?
Jim Rider,
VP Global External Manufacturing,
Johnson + Johnson, GPSG
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| 09:50 |
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DEVELOPING A SUCCESSFUL CRITERIA FOR CMO SELECTION: DETERMINING THE WHO AND WHERE |
- Understand the critical steps needed to be taken once the decision to outsource has been made
- Uncover the winning opportunities for selecting a strategic CMO
- Establish what needs to be considered when selecting a manufacturer and how this will impact your supply chain and time to market
- Learn how to judge if the CMO you select can successfully align goals and business expectations with operational requirements
- Determine the benefits of developing a comprehensive selection process, not just based on price
Maura Windlinger,
Sr Director Supplier Management, Global Pharmaceutical Operations,
Abbott
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| 10:30 |
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MORNING REFRESHMENTS + NETWORKING OPPORTUNITY |
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| 11:00 |
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MONITORING AND ENSURING THE QUALITY OF FDA REGULATED PRODUCTS BEING IMPORTED FROM EMERGING MARKETS |
Understand the role the FDA is playing and the initiatives being implemented to ensure product quality
- Discover how they are ensuring regulatory interoperability, information exchange, and cooperation, especially on product quality and enforcement matters
- Uncover how the Beyond Border's Initiative will help facilitate the building of stronger cooperative relationships with the FDA's counterpart agencies around the world and enhanced technical cooperation with foreign regulators
- Determine how much of a presence the FDA will have in these emerging markets now and in the future
Barry Rothman,
Compliance Officer, CDER Office of Compliance, DMPQ, Guidance and Policy Development Team,
FDA
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| 11:40 |
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IMPORTING PRODUCTS FROM EMERGING MARKETS: OVERCOME THE CHALLENGES AND EFFECTIVELY MANAGE THE LENGTHENING PHARMACEUTICAL SUPPLY CHAIN |
- Assess how the globalization of supply chains is creating new political, logistical, and scientific challenges for the pharmaceutical industry and what you can do maintain a agile and safe supply chain
- Identify strategies to develop the technologies and metrics required for a global supply chain to ensure product integrity and security
- Learn how to anticipate potential supply chain risks and the mechanisms you can implement to prevent them
- Uncover successful methods for meeting GMP standards when importing products back into the United States
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| 12:20 |
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| 13:20 |
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CMO PERSPECTIVE: WHAT THEY ARE DOING TO ENSURE SATISFACTION AND WHAT THEY NEED FROM YOU TO HELP |
- Understand how a CMOs manufacturing differs and what they need from you to ensure a successful tech transfer
- Identify and build an understanding of the CMO business model and what a successful relationship means to them
- Learn of successful partnerships within North America and India
Sean Diver,
Vice President, CPS Sales & Business Development,
Dr. Reddy's Laboratories, Inc.
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| 14:00 |
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INNOVATIVE STRATEGIES FOR EFFECTIVELY WORKING WITH A CMO WHEN COST IS NOT THE MOTIVATOR: A VIRTUAL COMPANY PERSPECTIVE |
- Identify the steps you need to take when selecting a CMO when cost is not a factor and how it is going to impact your business
- Learn how to build a successful relationship by leveraging effective interaction tactics
- Determine how to identify the CMO’s business model to ensure you can successfully integrate and align it with your own model
Steve Pondell ,
Director Manufacturing,
Encysive
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| 14:40 |
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PANEL DICUSSION: STRATEGIES FOR ENSURING EFFECTIVE VENDOR OVERSIGHT AND QUALITY COMPLIANCE |
How often should you look over their shoulder?
- Outlining the use of mixed sourcing models and how you can effectively integrate in house operations and contract operations
- Methods for effective risk management and governance
- Discussing the challenges associated with qualification and training of individuals overseas
- Develop strategies for deviation resolution and determine who is ultimately responsible if something goes wrong
- Evaluate whether concerns of product quality from India and China are valid and how this will affect your oversight strategy
Kurt Wieditz,
Director Contract Manufacturing,
Pfizer
Jim Rider,
VP Global External Manufacturing,
Johnson + Johnson, GPSG
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| 15:30 |
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UNDERSTANDING QUALITY AND INTELLECTUAL PROPERTY AGREEMENTS AND THE STEPS YOU NEED TO TAKE TO NEGOTIATE AN EFFECTIVE CONTRACT |
- What is a quality agreement and why you need one to maintain an effective 3rd party relationship
- Learn how to prevent the use of your intellectual property to ensure you maintain your competitive advantage
- Understand how to negotiate and write a contract. Determine the functional aspects required within an agreement to ensure a successful 3rd party transaction
- Understand how to end the outsourcing relationship efficiently and effectively
Kurt Wieditz,
Director Contract Manufacturing,
Pfizer
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| 16:10 |
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CHAIRMAN'S CLOSING REMARKS |
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