day one | day two | day three

September 22, 2008Day One 08:00 Delegate Registration + Coffee 08:40 CHAIRMAN'S WELCOME ADDRESS Emil W. Ciurczak, Chief Technical Officer , Cadrai Group 08:50 SUSTAINING OPERATIONAL EXCELLENCE AND REMAINING COMPETITIVE IN AN EVER CHANGING INDUSTRY Examining the increasing role of biopharmaceuticals as a means for innovation and maintaining competitive advantage Overcome the challenge of innovation and operational excellence to continuously improve leadership, operating efficiency and effectiveness Operational Excellence- what does it mean beyond the buzz word learn how to successfully foster a culture of operational excellence Innovation: where have we been and where will we be in 10 years? Formulate strategies to remain competitive: What must we do to continuously succeed? Back to the Basics: understand the vision and key focus areas required in order to achieve a world-class production operation. Evaluate Genentech's experiences and the lessons learned Understand the critical issues affecting biopharmaceutical manufacturers now and how this might impact your business in the future Dr. Pat Yang, EVP Product Operations, Genentech 09:40 ACHIEVING A TRULY LEAN ORGANIZATION: UNCOVER PROVEN STRATEGIES TO CHANGE MINDSETS AND BEHAVIORS TO ENSURE ORGANIZATIONAL BUY-IN OF YOUR LEAN INITIATIVE Ascertain how to define and communicate a consistent vision and value system throughout your entire organization while still maintaining a customer focus Weigh the benefits of self directed work-streams and functional teams and how they can help you increase overall efficiency Learn how to create a culture of empowered and multi-skilled employees to achieve higher first pass yields Identify how you can lean an entire organization vs. a specific process and the impact it can have on streamlining processes and reducing waste Evaluate current and future performance in order to shape effective operating and management systems William Botha, Director Pharmaceutical Manufacturing, Baxter Healthcare 10:10 Practical and Technical Implementations of QbD OUTLINING CRITICAL METHODS TO ACHIEVE A SUCCESSFUL QBD IMPLEMENTATION Case Study Uncover best practices and the business case for QbD Learn how QbD was used to create predictability and increase efficiency in real manufacturing scenarios Determine the role that CAPA and RFT programs had in helping to achieve successful QbD implementation Develop an understanding of PLM and how it helps with QbD Dr. Parimal Desai, VP New Products, Wyeth   Creating a Lean and Efficient Supply Chain CREATING A DEMAND DRIVEN MANUFACTURING STRATEGY: DISCOVER HOW TO DESIGN SUPPLY CHAINS, NOT INHERIT THEM Learn how to design your supply chain from an outside-in perspective to adaptively translate actual demand from the customer into tradeoffs that profitably fulfill perfect orders to meet demand Discover how to identify and then define supply chain as part of the demand-driven response in order to maximize value to trading partners and the end customer Assess the viability of demand driven production in the pharmaceutical industry and what needs to be achieved to move this forward Hussain Mooraj, Research Director, AMR Research   Lean Manufacturing Implementation Strategies TEVA CASE STUDY: LEARN HOW TO GET THE MOST OUT OF YOUR EXISTING CAPACITIES TO REDUCE CYCLE TIMES Uncover critical strategies that have allowed TEVA to increase commercial productivity while decreasing manufacturing incidents and deviations Identify methods used to integrate IT with manufacturing platforms and why it is essential to mining and interpreting data efficiently and quickly Hear best practices and gather information on lessons learned and determine the ROI of going lean and whether it is the right move for your organization Develop strategies to create tactical implementation plans and optimize layout Determine how your lean initiative will effect the layout of current and future facilities and the mechanisms you can use to adapt them Mike Randolph, Senior Director Manufacturing Operations, TEVA Pharmaceuticals Jonathan Young, Director Continuous Improvement, TEVA Pharmaceuticals   10:40 CASE STUDY: THE FDA-NOVARTIS QbD CRADA PILOT Optimizing QbD and applying the principle for Marketed Products Understand how this pilot is helping to uncover methods for increased product quality and advancing the scientific basis and efficiencies of process development, manufacturing, review assessment and inspection activities Identify the steps taken to design the project and how this going to help you apply QbD principles to the complete pharmaceutical manufacturing process Learn how this collaboration is allowing on-line process research related to the implementation and validation of PAT tools. James Cheney, Director Global PAT, Novartis   DETERMINE HOW TO INCREASE TRANSPARENCY AND VISIBILITY TO OPTIMIZE YOUR SUPPLY CHAIN ENABLING BEST IN CLASS PERFORMANCE Learn how to achieve agility to increase operational performance Uncover methods to reduce inventory and increase agility in order to achieve on time delivery Evaluate the cost and benefits of network rationalization as an effective cost cutting strategy Understand how transparency and supply chain optimization can help you handle recall scenarios Assess how you can leverage effective manufacturing execution systems (MES) to help you achieve an optimal supply Herminio Bosques, Director Sourcing, Merck Sharp & Dohme   LEAN MANUFACTURING CASE STUDY CON'T Conducting effective risk analysis and ensuring due diligence and compliance is maintained while running a lean process Understand the core principles of lean/six sigma and how to use them within specific manufacturing environments and operations Learn strategies to achieve a balance between achieving the needs of the regulatory bodies and the needs of your own processes Mike Randolph, Senior Director Manufacturing Operations, TEVA Pharmaceuticals Jonathan Young, Director Continuous Improvement, TEVA Pharmaceuticals   11:10 MORNING REFRESHMENTS 11:40 QbD: Fundamental Concepts for Implementation CLARIFYING THE CORE PRINCIPLES OF QBD TO ENSURE OPTIMAL QUALITY AND PERFORMANCE Answering the Question of Why are we doing this? Determine how globalization and international regulatory bodies are accepting the initiative and what this means for adoption of the initiative within your organization Building on the QbD Pilot Plant Project- learn what was successful and how you can turn it into a real time implementation Evaluate the principles to determine which processes are best suited and whether QbD is a viable option for the entire product life cycle Understand the true value of QbD as a mechanism for continuous improvement Dr. Patricia Tway, VP Analytical and Regulatory Sciences, Merck & Co   Effective Approaches for Cold Chain Management RE-ENGINEERING COLD CHAIN DISTRIBUTION: UNCOVER THE ‘MYTHS’ OF COLD CHAIN DISTRIBUTION AND DEFINE THE RIGHT AND WRONG APPROACHES TO ACHIEVE EFFECTIVE COLD CHAIN MANAGEMENT Learn methods to overcome the reoccurring issues of product loss, poor customer service and deterioration of product Determining how the traditional cold-chain management approach seems not to be able to provide effective and sustainable means for cold chain management and what you can do to change that Identifying the common misunderstandings, inappropriate assumptions, traditions and beliefs in cold chain distribution and understand how these ‘myths’ affect cold chain distribution performance Developing strategies to fundamentally re-think/ re-design and properly address the root causes to aim for more effective cold chain transportation approaches Sherman Cheung, Director Materials Management, Sanofi Pasteur   Implementing Lean: Interactive Workshop How to Leverage Lean Transformation to Achieve Operational Excellence Strategies to decrease the gap between commitment to Lean and implementing it as a tool to transform an organization Demystify the application of Lean while identifying the practical solutions and generating tangible improvements that can lead to operational excellence Learn important strategies and techniques that lead to improved flow, reduced cycle times, and increased productivity Influence the discussion and voice your opinions on topics including Quality Control, Tech Transfer, Manufacturing, Packaging, Sales, Planning, and Supply Chain. Barry Calogero, President, Tefen USA   12:10 Integrating QbD and PAT PAT IN A QBD WORLD: MAXIMIZING ITS USE TO INCREASE PRODUCT ASSET UTILIZATION RATES Case Study Understand the approaches Genentech has used to develop a Process Analtyical Technology (PAT) framework for both data management and variability reduction in a commerical manufacturing environment Uncover strategies and develop practical approahces for the application of QbD principles toward the continuous improvement of commercial biologics manufacturing processes Discover the role of PAT within a QbD and GMP framework and how you can use this knowledge to uncover the tangible benefits Dr. Eric Fallon , Associate Director Manufacturing Sciences and Technology, Genentech   The Supply Chain Quality Challenge CASE STUDY: USING STATISTICAL METHODS TO IMPROVE PRODUCT QUALITY FROM RAW MATERIALS TO FINAL CONSUMER Learn how Companies are using Technology and Real Time Statistical Methods to better manage and improve quality Learn how Pfizer is using statistical methodologies to improve quality in a diverse, highly complex and challenging manufacturing environment Discover how Pfizer automated data collection and alarming for both process- and product-specific data Understand how engineers, managers and Six Sigma project teams are benefiting through instantaneous access to critical quality information Hear Pfizer's positive results of improving supply chain quality Denny Walker, Senior Project Engineer, Pfizer Doug Fair , Vice President of Statistical Applications, Infinity QS   12:40 HOSTED LUNCHEON 13:40 INTERACTIVE WORKSHOP INCREASE YOUR MANUFACTURING PERFORMANCE: HOW TO ACHIEVE RESULTS IN WEEKS, NOT YEARS The business case for lean manufacturing Overcoming the challenges of implementing lean manufacturing in a regulated environment by learning how to select the right IT system to overcome these and other obstacles to traditional lean manufacturing principles Learn how to utilize the benefits of electronic batch records (EBR), not just the costs and discover how this can be done in weeks, not years Determine how to focus new projects on the premise of continuous improvement and learn how to use past experiences to improve existing production Understand how using electronic batch records and review by exceptions can greatly reduce quality control overhead Ascertain how the use of current IT systems can help you get a complete overview of the value stream focusing the attention on problematic areas Learn how using electronic kanbans can assist implementation of pull planning while keeping existing batch tracing mechanisms Lars Gabe, CEO, ICE A/S   INTERACTIVE WORKSHOP GAINING EFFICIENCY AND AGILITY THROUGH NORMALIZATION OF DISPARATE ISLANDS OF AUTOMATION Determine the historical paradigm that has resulted in high cost, low efficiency, disparate “Islands of Automation” in the manufacturing facility Understand the new paradigm shift toward unification of these “Islands of Automation” into a single, agile, enterprise control system Determine the business impact in terms of cost of migration of legacy systems vs. profits of unification of existing systems Identify the business case for migrating productivity and effectiveness data from multiple time-lagged historical systems into a single, central, real time data repository across the enterprise Dr. Peter Martin, Vice President of Strategic Ventures, Invensys   14:10 PANEL DISCUSSION: QbD/PAT, OVERCOMING THE BARRIERS AND CAPITALIZING ON OPPORTUNITIES Your Questions Answered! What are the opportunities and ROI of QbD/PAT? What are the barriers to acceptance within an organization? What strategies can you use to overcome this? Can QbD be used on legacy products? Discovering the inivative opportunities for PAT within pharmaceuticals Dr. Parimal Desai, VP New Products, Wyeth Dr. Patricia Tway, VP Analytical and Regulatory Sciences, Merck & Co Dr. Eric Fallon , Associate Director Manufacturing Sciences and Technology, Genentech 14:40 ONE TO ONE BUSINESS MEETINGS 17:05 GREEN MANUFACTURING: INNOVATIVE METHODS TO ACHIEVE A MORE SUSTAINABLE OPERATION TO REDUCE COST AND IMPROVE EFFICIENCY CASE STUDY Analyze the cost, benefits and the business case for going green Learn how to appropriately recycle and reuse the chemicals produced in drug manufacturing Determine how to successfully create a more sustainable process and the techniques you can use to reduce your environmental footprint Understand which aspects of your process you can make green James Hagan, VP Corporate Environment, Health and Safety, GlaxoSmithKline 17:35 CONTINUOUS MANUFACTURING: FORECAST THE LONG TERM IMPACT THIS INNOVATION WILL HAVE ON YOUR PROCESS AND THE PHARMACEUTICAL INDUSTRY Understand what the technology is and how it can help your manufacturing process and increase efficiency Learn how to build the technology in to your process and what specifications need to be adopted for this process Evaluate the business case for a move towards continuous manufacturing. How does it compare to batch processing? Understand how the technology is being validated and being used in large scale manufacturing Clarify how your QbD and PAT programs and the FDA’s Critical Path Initiative have helped clear the way for regulatory approval for this new process Prof. Bernhardt Trout, Director, Novartis-MIT Centre for Continuous Manufacturing, MIT 18:05 COUNTERFEITS: UNCOVER THE REALITIES OF THIS SILENT EPIDEMIC AND WHAT YOU CAN DO TO MINIMIZE THE IMPACT ON YOUR BUSINESS Understand where in the value chain counterfeits are most likely to enter and what you can do to prevent deviations, diversions and bioterrorism Uncover effective anti- counterfeiting strategies to ensure a positive consumer perception of your brand Understand the impact of counterfeits on your bottom line and what you can do to ensure you maintain maximum profitability Evaluate the role that the internet plays in bringing counterfeits to market Assess how the EUs policy of parallel trade affects the entry of counterfeits into the US market Mark R Seitz, Global Supply Chain Manager, Eli Lilly & Co. 18:35 NETWORKING DRINKS RECEPTION Sponsored by MG America

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September 23, 2008Day Two 07:45 Delegate Registration + Coffee 08:25 CHAIRMAN'S OPENING REMARKS Emil W. Ciurczak, Chief Technical Officer , Cadrai Group 08:30 EVALUATING THE ROLE OF GLOBALIZATION ON THE REGULATORY LANDSCAPE AND HOW THIS WILL IMPACT THE MANUFACTURING PROCESSES Clarify and analyze the role of ICH initiatives on regulation. Where have they taken us and what does the future hold? Understand how the policies of the EMEA and other agencies affect the state of manufacturing in the US Determine the role that globalization has on product launch and how to increase your success in achieving regulatory approval Dr. Michael Beatrice , Corporate Vice President Quality and Regulatory Compliance, Abbott 09:00 UNCOVER THE REALITIES OF LEAN MANUFACTURING: CONNECTING THE DOTS FOR A SUCCESSFUL IMPLEMENTATION IN PHARMACEUTICALS Understand how to get started on the path to lean manufacturing in a pharmaceutical environment Determine the dos and don’ts to achieve a successful lean implementation and develop a lean organization Clarify the key benefits lean can have for your process and organization and how it can help streamline processes and reduce waste Assess the impact lean can have on your organization and company culture Tom Van Laar, Head of Global Technical Operations, Novartis Pharma AG 09:30 ONE TO ONE BUSINESS MEETINGS + MORNING REFRESHMENTS 11:55 PERSPECTIVES FROM OUTSIDE PHARMA: UNCOVER THE METHODS USED BY OTHER INDUSTRIES TO ACHEIVE BEST IN CLASS OPERATIONAL PERFORMANCE AND HOW YOU CAN TRANSLATE THEM INTO YOUR OPERATIONS Understanding the Shingo Prize Model to help you effectively promote and achieve operational excellence within your organization Identify the criteria and principles of the Shingo Prize philosophy and how you can use the model as a benchmark for success Understand how operational excellence programs have been integrated throughout global organizations and the steps you can take to ensure the success of your lean manufacturing initiatives Discover winning strategies that have made companies like Toyota and Motorola leaders in the field of operational excellence Dave Rowlands, Member Board of Govenors , The Shingo Prize Paul Hesselschwerdt, , Shingo Prize 12:25 Winning Strategies to Achieve Operational Excellence SHINGO PRIZE CASE STUDY Discover winning strategies that have made companies like Toyota and Motorola leaders in the field of operational excellence Hear how top business leaders achieved success by implementing the Shingo Prize Model for operational excellence Dave Rowlands, Member Board of Govenors , The Shingo Prize Paul Hesselschwerdt, , Shingo Prize   Facility Management CLARIFYING GMP STANDARDS AND HOW YOU CAN KEEP YOUR FACILITY UP TO DATE Create non stifling, cutting edge GMPs that are also good for business! Understand where the most common GMP deviations occur to ensure your facility continues to operate with minimal interruption Learn how to minimize the impact of compliance related issues and the effect they have on floor operations Uncover strategies to meet contamination guidelines to decrease worker exposure to increasing amount of potent drugs being manufactured Understand the role that facility maintenance plays in maintaining GMP standards and compliance Assess the key opportunities involved in facility retrofit vs. new build to determine the business case of both and how this can effect compliance Michael Bruckheimer, Executive Director Group Quality Operations , Novartis   12:55 THEMED LUNCHEON 13:00 Data Management EBR 10 Years Later - What's been done to turn electronic batch reporting into a productivity tool? Hosted By: Informetric Systems, Inc.   Track and Trace Achieve best-in-class performance by implementing automated traceability systems   Scale-Up Uncover methods for a successful product scale-up into commercialization   13:00 Manufacturing Efficiency How to achieve faster batch release in existing production environments Hosted by: ICE A/S   Environmental Monitoring Successfully interpret data and understand regulatory inspections   Tech Transfer Determine how to ensure a successful transfer whether it is in house or to a third party   13:55 INTERACTIVE WORKSHOP AN ELECTRONIC, EFFECTIVE AND EFFICIENT QA SYSTEM? YES IT’S POSSIBLE! A Business Case on the Implementation of an electronic Quality Management System (eQMS) Learn, through a real life business case, how the burden of regulatory compliance can be transformed into a strategic advantage using available technology and regulations and how this brings tangible ($) benefits to your organization. Tips and guidance (Do’s and Don’ts) on how to implement a paperless Quality Management System Expose a new paradigm in quality/business process management, document/workflow optimization, cost reduction and compliance risk mitigation Richard Fecteau , CEO, Solabs   INTERACTIVE WORKSHOP INCREASE OPERATIONAL EFFICIENCY IN LIQUID BASED APPLICATIONS: HOW TO DETERMINE THE MOST COST-EFFECTIVE PATH FOR YOUR SCIENTIFIC REQUIREMENTS Determine the most attractive technological path for your liquid based applications involving sterilization requirements, prior to and/or after the filling operation Explore and investigate current lean production methodologies within traditional pharmaceutical production Uncover alternative sterilization technologies as well as software and hardware support for layouts and increasing production flow Joakim Sundberg, Managing Director + Business Development , Compliant Logistics   14:25 INTEGRATING BRAND PROTECTION INTO CORPORATE PROCESSES: OVERCOMING THE CHALLENGE OF IMPLEMENTING ANTI-COUNTERFEITING STRATEGIES INTO A HEAVILY REGULATED MANUFACTURING AND BUSINESS PROCESS Review the issues behind the design and adoption of a pharmaceutical anticounterfeiting progams and how you can create an effective strategy Evaluate and summarize recent benchmarking studies on the approaches different pharmaceutical companies have employed: from stand-alone systems to integrating brand protection across all relavent company functions Assess and review Amgen’s approach to integrating brand protection controls into is overall corporate processe Lew Kontnik, Director Global Brand Protection, Amgen 14:55 The “How” of product serialization with RFID THE PURDUE PHARMA CASE STUDY : HIGHLIGHTING THE ROLE OF RFID AS AN ESSENTIAL TOOL IN YOUR ANTI-COUNTERFEITING STRATEGY AND IDENTIFYING THE KEY STEPS TO SUCCESSFUL IMPLEMENTATION A Rare In depth look at the successful UHFGen2-based RFID program at Purdue Define the issues with implementation and understand what can lead to success and failure. Assess the challenges and uncover the successes Determine the ROI of RFID- Does it really cost more than 2D Evaluate the future viability of this technology – does it really work as advertised? Mike Celentano, Associate Director Supply Chain Systems, Purdue   PAT: Strategic Benefits and Advanced Implementation Methods GO FROM THEORY TO ACTION! SUCCESSFULLY TRANSFORM YOUR PAT IMPLEMENTATION CASE STUDY Determine how to successfully implement PAT into your process to increase efficiency Overcoming the data overload and how you can effectively put to work all the information you have generated to have a better understanding of your processes Understanding the technical components involved in a successful implementation Outlining the use of Quality Management Systems (QMS) to achieve maximum return on your PAT implementation Stephen Tyler, Director Strategic Quality and Technical Operations, Abbott   15:25 PURDUE PHARMA CASE STUDY CONTINUED Discover the use of UHFGen2 RFID as an effective tool for supporting the pedigree legislations. Determine how you will respond to the push from major wholesalers and retailers requiring vendors to implement this technology Identify the metrics, performance results and objective data that you need today in order to move forward with your implementation Mike Celentano, Associate Director Supply Chain Systems, Purdue   PAT CASE STUDY CONTINUED Uncover the advanced uses of PAT and how they can help you to reduce cycle time and inventory leading to a decrease in operating costs Discover the innovative opportunities of PAT within pharmaceuticals Overcoming the regulatory hurdles and uncover strategies that will allow for flexibility in process and submissions Stephen Tyler, Director Strategic Quality and Technical Operations, Abbott   15:55 THE GLOBAL STATE OF E-PEDIGREE LEGISLATION: WHAT YOU NEED TO DO TO ENSURE COMPLIANCE AT HOME AND ABROAD Compliance strategies for California 2011 and beyond Understanding the implications of California's precedent and how serialization legislation is going global Evaluating the current state of pedigree and serialization requirements and which technologies are needed for compliance Reviewing the supporting processes which must be integrated into your supply chain to ensure compliance Understanding the nuances of this massive undertaking and the effect that track & trace technologies are going to have on health care supply chains Ron Guido, VP Global Brand Protection + Supply Chain Integrity, Johnson + Johnson 16:25 E PEDIGREE AND SERIALIZATION: AN HONEST REVIEW OF THE STATE OF THE ART TECHNOLOGIES USED FOR ANTI COUNTERFEITING Panel Discussion The latest technologies that can help you protect your products and customers Assess the challenges involved in integration and how you can overcome these to successfully integrate new technologies into your supply chain Compare the ROI of technologies like point of dispense authentication, overt/covert technologies, 2D bar-coding, serialization, tamper evident packaging Lew Kontnik, Director Global Brand Protection, Amgen Mark R Seitz, Global Supply Chain Manager, Eli Lilly & Co. Ron Guido, VP Global Brand Protection + Supply Chain Integrity, Johnson + Johnson 16:55 CHAIRMAN'S CLOSING REMARKS Emil W. Ciurczak, Chief Technical Officer , Cadrai Group

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September 24, 2008Contract Manufacturing Forum 08:00 Delegate Registration + Coffee 08:40 CHAIRMAN'S OPENING ADDRESS Emil W. Ciurczak, Chief Technical Officer , Cadrai Group 08:50 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? Dr. Jim Rider, VP Global External Manufacturing, Johnson & Johnson, GPSG 09:30 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 10:10 MORNING REFRESHMENTS + NETWORKING OPPORTUNITY 10:40 MONITORING AND ENSURING THE QUALITY OF FDA REGULATED PRODUCTS BEING IMPORTED FROM EMERGING MARKETS Understand efforts being taken by FDA in the wake of health emergencies caused by the manufacture of drug products with contaminated ingredients. Discover how they are handeling incidents including those involving DEG contamination of glycerine and the contamination of heparin injection distributed in the US and in other parts of the world Uncover the initiatives the FDA is working on to promote the safety and security of the pharmaceutical supply chain, which include the development of new guidance and regulation, as well as new enforcement strategies. Barry Rothman, Compliance Officer, CDER Office of Compliance, DMPQ, Guidance and Policy Development Team, FDA 11:20 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 12:00 LUNCH 13:00 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. 13:40 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 Dr. Jim Rider, VP Global External Manufacturing, Johnson & Johnson, GPSG Steve Pondell , Director Manufacturing, Encysive 14:20 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 Develop strategies for deviation resolution and determine who is ultimately responsible if something goes wrong Understand how to end the outsourcing relationship efficiently and effectively Kurt Wieditz, Director Contract Manufacturing, Pfizer 15:00 CHAIRMAN'S CLOSING REMARKS