Day 2- October 4, 2011 - Supply Chain Hot Topics

7:45 Coffee & Registration Coffee & Registration

8:10 Chairs Opening Remarks Chairs Opening Remarks

8.20 BT PRESENTATION: Toward a Smarter Supply Chain Jim deMin, , Senior Consultant, , BT Jim deMin will offer BT’s point of view on today’s pharma supply chain in terms of communications based intelligence and process enablement, then discuss how technology is leading to a future when supply chains will be more intelligent, with packaging and transport equipment becoming “self aware.” With advanced analytics and new cloud-computing architectures, mountains of data will be sifted into the intelligence required to enable sense-and-respond business processes. Systems, processes and infrastructures will become more efficient, productive and responsive - in a word, smarter.Benefits and uses of this smarter supply chain include: Maintaining real-time, on-shelf store inventories Automatic recording and registration of warrantee (or return) data Alerting consumers to past-date products in the medicine cabinet Connecting to a wide range of web-based services Jim deMin, Senior Consultant, BT Jim deMin, Senior Consultant, , BT

8.50 Leveraging Interoperable Track & Trace Data To Improve The Efficiency & Effectiveness Of The Pharma Supply Chain Ron Guido, VP Brand Protection, , Johnson & Johnson Bullet Points TBC Ron Guido VP Brand Protection, , Johnson & Johnson Ron Guido has 34 years experience in the health care industry with Johnson & Johnson.  He has held executive positions in the areas of engineering, operations, sales, product marketing, international marketing, new business development, information technology and general management. His current role is Vice President, Global Brand Protection and Supply Chain Integrity for Johnson W [read more]

9.20 GS1 PILOT FRAMEWORK- CASE STUDY ON PHARMACEUTICAL INFORMATION FLOW: Outlining The GS1 Pilot Framework To Benchmark And Create Standards In Serialization Implementation Bob Celeste, Director- Healthcare, , GS1 US Producing a pilot framework to organize pilots and assemble pilots in a standardized manner Connecting the dots: linking policy, operations, info- systems decisions and more in a systemic matter Creating a methodology to understand the necessary steps that need to be implemented at what time Sharing best practices from pilot programs to determine what has been effective and what hasn’t Bob Celeste Director- Healthcare, , GS1 US Bob Celeste is a Director of GS1 Healthcare US. Mr. Celeste has more than 25 years of experience in business process and supply chain management in the healthcare, pharmaceutical and a variety of other industries. GS1 Healthcare US focuses on driving the adoption and implementation of GS1 standards in the healthcare industry to improve patient safety and supply chain efficiency. Previously, Mr. Ce [read more]

9.50 Morning Refreshments Morning Refreshments

10.20 PILOT CASE STUDY: Implementing Serialization From A Manufacturer Perspective: What Has Worked? What Hasn’t? How Can It Be Integrated With Existing Processes? Ron Guido, VP Brand Protection, , Johnson & Johnson David Buynak, Serialization Program Leader- North America,, Astrazeneca Kevin Webb, Senior Director Supply Chain Planning & Logistics, , BioMarin Pharmaceutical Gordon Glass, Global Manager Product Authentication, GE Healthcare Sharing the lessons learned from pilot programs to understand the practical implementation steps required and what they would do differently next time Discovering how to integrate serialization into existing processes including ERP systems Evaluating RFID v barcode technology to determine read rates and if RFID can be efficient enough to be used in production Discussing technological advances in pedigree/ serialization to determine how the implementation of serialization should be adjusted moving forward Ron Guido VP Brand Protection, , Johnson & Johnson Ron Guido has 34 years experience in the health care industry with Johnson & Johnson.  He has held executive positions in the areas of engineering, operations, sales, product marketing, international marketing, new business development, information technology and general management. His current role is Vice President, Global Brand Protection and Supply Chain Integrity for Johnson W [read more] David Buynak Serialization Program Leader- North America,, Astrazeneca David Buynak is the Program Leader for AstraZeneca’s Serialization Strategy Team within North America Operations. Mr. Buynak has over 25 years of experience in Operations including roles in Quality Assurance, Regulatory Affairs, Technical Services and Plant Management. Mr. Buynak has spent the past 5 years specializing in developing progressive strategies for AstraZeneca in product and supply chai [read more] Kevin Webb Senior Director Supply Chain Planning & Logistics, , BioMarin Pharmaceutical Kevin has led the Planning & Logistics team at BioMarin since joining at the end of 2006, responsible for commercial and clinical products. BioMarin is a multinational biopharmaceutical company that specializes in providing first-to-market therapeutics to patients with rare genetic diseases. Kevin has over 20 years of experience in supply chain management focusing on sales WBR_AMPE [read more] Gordon Glass Global Manager Product Authentication, GE Healthcare Subject matter expert for GE Healthcare’s Medical Diagnostics business regarding GS1 Global Standards, electronic coding, product serialization, and producttrack and trace (including electronic product pedigree). Coordinates intelligence gathering of global requirements, by market, for electronic coding, product serialization and traceability/authentication and then translates this information to [read more]

11:20 HOSPITAL PERSPECTIVE: Implementing Serialization From A Hospitals Perspective: What Progress Has Been Made? How Do They Plan On Collaborating With Manufacturers? Chris Tucker, Director- Bar Code Resource Office, , VHA Office of Health Information, VA Finding out the progress hospitals have made in preparing for serialized products Discussing how they will process pedigree when shipments arrive: What if there’s a problem in the container? At what point do they discover it? How do they correct it? Determining the tools, technologies and methodologies they are using to upgrade from manual to automatic systems Collaborating with wholesalers/ retailers/ hospitals to align goals, share best practices and realize what type of data each participant should capture to create a smoother transition of serialized products Chris Tucker Director- Bar Code Resource Office, , VHA Office of Health Information, VA Chris L. Tucker, RPh., is the Director of the Bar Code Resource Office (BCRO) within the Veterans Health Administration Office of Informatics and Analytics (VHA OIA). His office provides strategic direction for point of care bar code technology applications such as BCMA, Clinical Laboratory, Anatomic Pathology, and Transfusion Verification. He received his pharmacy degree from Kansas University in [read more]

12:05 Lunch Lunch

12:55 ROUNDTABLE DISCUSSIONS This is your opportunity to raise your questions and exchange ideas in a more intimate, casual environment. Each table is assigned a topic and a moderator. The moderator moves from one table to the next every 25 minutes so that all delegates will get a chance to discuss each topic. TABLE 1: COLD CHAIN Managing Rising Costs And Different Temperature Control Requirements Across Different Markets In Your Cold Chain Creating a risk management approach to manage excursions in the cold chain Establishing KPI’s to eliminate waste in key parts of the cold chain to create more efficiency Collaborating with key partners including 3pls and distributors to create proper distribution, product-handling requirements and discover cost- savings Getting to grips with varying temperature control requirements across multiple borders to understand best practices in getting products through the supply chain quicker Karen Oliver, Director Global Accounts, World Courier Inc., Les Sparrow, Manager Technical Support & Analytical Services, World Courier, Inc.  TABLE 2: GREEN SUPPLY CHAIN Realizing Financial Value From Sustainable Supply Chain Efforts   David Linich, Leader of Life Sciences Sustainable Supply Chain Services,Deloitte TABLE 3: MULTI- CHANNEL DISTRIBUTION MODEL Establishing How The Distribution Landscape Is Changing: What Value Will Wholesalers Provide? What New Channel Strategies Are Being Implemented? Examining the role of specialty distribution moving forward to realize what impact this will have on cost structure and the supply chain Assessing the role of wholesalers using cost benefit analysis: What value do they provide? What services will they offer moving forward? What are the alternative distribution channels? Evaluating pros and cons of the internet and Canadian pharmaceutical model to derive key learnings for the pharmaceutical industry  Volker Schulz, Senior Director, Customer Development – Healthcare, Exel  TABLE 4: Kinaxis Roundtable Discussion: The Role Of Simulation In Supply Chain Planning And Responding To Change Typical scenarios in planning and responding Tactical versus strategic use of simulations Simulation tools and limitations Users and Consumers Bill Dubois, Business Consultant, Kinaxis TABLE 5: Reusable Cold Chain Shipping Containers  Using Reusable Containers to Improve Product Quality and Lower Total Shipment Cost Pallet shipper model Small package model Total cost considerations for reusable containers Rent versus lease versus buy models for best value based on need Reusable unit versus consumable unit models Ecological impact of reusable containers  John Howe, COO/ CTO, Intelligent Thermal Solutions, LCC

3:05 Afternoon Refreshments & Networking Afternoon Refreshments & Networking

TRACK A: IMPACT OF THE SHIFT TOWARDS BIO-PHARMACEUTICAL ...TRACK B: IMPACT OF GLOBALIZATION AND OUTSOURCING ON THE ... 3.35 INTRO SESSION: Understanding The Complexities Of A Bio-Pharmaceutical Supply Chain To Manage Cost, Quality And Compliance TRACK A: IMPACT OF THE SHIFT TOWARDS BIO-PHARMACEUTICAL PRODUCTS ON THE SUPPLY CHAIN Bob DiVasto, VP Manufacturing & Supply Chain, , Cadence Pharmaceuticals Kevin Webb, Senior Director Supply Chain Planning & Logistics, , BioMarin Pharmaceutical Establishing the current regulatory requirements for implementing controlled room-temperature conditions for bio- pharmaceutical products Delivering the special handling and packaging requirements to manage more complex, shorter expiration products Investigating the shift in distribution channels of more specialized medicine and determining how to collaborate with pharmacies to provide services such as consignment Assessing contract manufacturing to determine the resources that exist that your company can tap into Bob DiVasto VP Manufacturing & Supply Chain, , Cadence Pharmaceuticals Bob is responsible for all manufacturing and supply chain operations at Cadence Pharmaceuticals including the development and execution of Cadence’s unique “owner driven” supply model. This outsourced model focuses on a secure and reliable supply chain across materials management, planning, procurement, manufacturing, logistics, inventory and distribution, while partnering with contractors on key [read more] Kevin Webb Senior Director Supply Chain Planning & Logistics, , BioMarin Pharmaceutical Kevin has led the Planning & Logistics team at BioMarin since joining at the end of 2006, responsible for commercial and clinical products. BioMarin is a multinational biopharmaceutical company that specializes in providing first-to-market therapeutics to patients with rare genetic diseases. Kevin has over 20 years of experience in supply chain management focusing on sales WBR_AMPE [read more] 3.35 IN- HOUSE VERSUS OUTSOURCING: Making Objective Decisions When Evaluating Whether To Produce In- House Or Subcontract Out TRACK B: IMPACT OF GLOBALIZATION AND OUTSOURCING ON THE SUPPLY CHAIN Craig Malzahn, Director Supply Chain,, Human Genome Sciences Inc. Jeff Simmons, Manager External Manufacturing, , Daiichi Sankyo Bill Connell, SVP Operations, , Iroko Cardio Outlining the decision- making process and guidelines to justify outsourcing vs. manufacturing in- house without bias Defining and prioritizing the key components in the analysis including cost, quality, flexibility and control to determine which is the best decision for your company Assessing when capacity is low if it is more beneficial to shed assets or to bring processes currently being outsourced back in house Determining the role of consultants and the value they add in the decision making processes Craig Malzahn Director Supply Chain,, Human Genome Sciences Inc. Craig Malzahn, the Senior Director of Supply Chain at Human Genome Sciences, is responsible for supply strategy, production planning, logistics, manufacturing outsourcing, and manufacturing technical services. He has over 15 years of manufacturing and supply chain experience in biopharmaceuticals. Since 2005, he has led HGS’ Raxibacumab Core Team and delivery of anthrax anti-toxin doses to the Str [read more] Jeff Simmons Manager External Manufacturing, , Daiichi Sankyo Jeff Simmons is currently Manager of Manufacturing Services at Daiichi Sankyo, Inc., Parsippany, NJ. He is responsible for managing the business relationship with several contract manufacturers to assure execution of the company’s marketing plan while maintaining regulatory compliance and compliance with contractual obligations. He is a licensed Professional Engineer and is APICS certified in Prod [read more] Bill Connell SVP Operations, , Iroko Cardio Mr. Connell has over 25 years of experience in Manufacturing, Supply Chain and Operations Management in various industries. Prior to Iroko, he served as a Principal and Practice Director of Tunnell Consulting Inc., located in King of Prussia, Pennsylvania, where he joined in 1998. At Tunnell, he was responsible for developing products and accounts, recruiting consultants, managing ... projects at [read more]

TRACK A: IMPACT OF THE SHIFT TOWARDS BIO-PHARMACEUTICAL ...TRACK B: IMPACT OF GLOBALIZATION AND OUTSOURCING ON THE ... 4.05 MANUFACTURING & WAREHOUSING: Working With Products That Require Certain Humidity Ranges For Which The Companies Manufacturing Did Not Have Those Controls In Place Previously TRACK A: IMPACT OF THE SHIFT TOWARDS BIO-PHARMACEUTICAL PRODUCTS ON THE SUPPLY CHAIN Kyle Kelley, Senior Director Supply Chain, , Vertex Pharmaceuticals   Kyle Kelley Senior Director Supply Chain, , Vertex Pharmaceuticals 4.05 DEVELOPING COUNTRIES: Best Practices When Outsourcing And Manufacturing In Developing Countries To Reduce Cost, Risk And Improve Timeliness TRACK B: IMPACT OF GLOBALIZATION AND OUTSOURCING ON THE SUPPLY CHAIN Tony Flammia, VP Global Manufacturing & Supply, , The Medicines Company Providing an update in key developing countries including China and India to determine the opportunities that exist there Assessing a wide variety of factors including manufacturing costs, quality, political stability of a country, where the demand is, regulations and more to determine total landing costs of outsourcing to developing countries Implementing best practices in compliance and quality control of raw materials coming from developing countries Delivering risk evaluation and risk mitigation strategies: Determining if it is manufacturing or supply chain who should set the strategy Identifying geographic regions and areas of the supply chain with high risk Finding out best practices to reduce risk in these areas Tony Flammia VP Global Manufacturing & Supply, , The Medicines Company Anthony Flammia strives to optimize supply chain performance, and has done so for over twenty years in the pharmaceutical, medical device and consumer products industries. Mr. Flammia has an MBA from Fairleigh Dickinson University and a BS degree from Florida Institute of Technology. His operating experience includes strategic planning & network design, manufacturing operations, st [read more]

TRACK A: IMPACT OF THE SHIFT TOWARDS BIO-PHARMACEUTICAL ...TRACK B: IMPACT OF GLOBALIZATION AND OUTSOURCING ON THE ... 4.35 TRANSPORTATION: Identifying Changes In Modes And Transportation Strategies To Optimize Logistical Efficiency TRACK A: IMPACT OF THE SHIFT TOWARDS BIO-PHARMACEUTICAL PRODUCTS ON THE SUPPLY CHAIN David Ulrich, QA Director, Distribution Global Pharmaceutical Operations (GPO), Strategic Quality Initiatives (SQI), , Abbott Laboratories Determining the key differences in transporting bio- pharmaceutical products: Cold chain shipping Cost structure Security Discovering best practices in using data loggers in the monitoring of temperature of product throughout transportation Establishing the routes, technologies and solutions to move products efficiently, but still meet tighter and varying temperature controls across borders Collaborating together as an industry to influence regulatory bodies to make more standardized and less stringent cold chain and temperature control requirements David Ulrich QA Director, Distribution Global Pharmaceutical Operations (GPO), Strategic Quality Initiatives (SQI), , Abbott Laboratories Dave is the QA Director for Distribution and Logistics for Abbott’s Global Pharmaceutical Operations (GPO) division. His responsibilities include standardization & optimization of quality systems (cGDPs), cold chain management, ePedigree/Track-n-Trace and import export compliance activities (FDA, USDA and EPA). He was a laboratory mgr at a Chicago hospital before coming to Abbott i [read more] 4.35 PRODUCT TRANSIT EFFICIENCY: Determining How To Comply, But Still Get Product Efficiently Across Borders In A Global Supply Chain TRACK B: IMPACT OF GLOBALIZATION AND OUTSOURCING ON THE SUPPLY CHAIN Carl Accettura,, Senior Director Production And Supply Chain Management, , Sunovion Pharmaceuticals Discovering as importing/ exporting gets more challenging and more ‘ship to points’ emerge, what the best approaches are to co-coordinating logistics Getting to grips with customs and border regulations across multiple borders to understand best practices in getting products through the supply chain quicker Establishing the routes, technologies and solutions to move products efficiently, but still meet tighter and varying regulations across borders Collaborating together as an industry to influence regulatory bodies to make more standardized and less stringent requirements Carl Accettura, Senior Director Production And Supply Chain Management, , Sunovion Pharmaceuticals Carl is a veteran of FDA regulated operations, with 27 years of diversified global experience in both large and small pharmaceutical firms. Carl has made contributions in the areas of global drug commercialization, development, project management & supply chain management in “Big Pharma” and “Small Biotech”. Over the past three years, Carl prepared for commercialization and launche [read more]

5.05 End of Day 2 End of Day 2