Program

Day One | Day Two

DAY ONE: WEDNESDAY OCTOBER 24TH 2007
08.30		Registration
09.00	Christi Gimber Director of Quality ALMAC	Opening remarks from the Chair
DEALING WITH GLOBAL CLINICAL TRIALS – BORDER REGULATIONS, DISTRIBUTION and LABELLING
09:15	Donna McDermott Associate Director Worldwide Regulatory Coordination and Clinical Supplies MERCK & CO INC	Improving the supply flow through emerging market borders The challenges we face moving CTM into emerging countries and how to address these challenges Current examples Helpful hints when designing your sourcing strategy Understanding the regulatory needs and wants of each country
09:45	Sandy Richwalski Vice President Operations CATALENT	Packaging for global clinical trials – the challenge of emerging markets Addressing the packaging challenges of global trials Understanding regulatory requirements and ensuring compliance Dealing with country specific aspects
10:15	Elizabeth Gallagher Director Clinical Supplies CENTOCOR	Managing cold chain distribution Interpreting FDA regulations vs. global regulations in temperature-controlled shipping Ensuring temperature stability through efficient validation systems Mitigating the problems of cold chain distribution to remote global locations
10:45		Morning refreshments
11:15	Terrence Walsh Director Clinical Trial Supply Chain GLAXOSMITHKLINE	Case study: GlaxoSmithKline – our approach to labeling for international trials Outlining the challenges of a global labeling system Dealing with individual country labeling regulations: two case studies how many lines of country requirements can you put on a 2ml vial? challenges with Peru and India Open label drug labeling – what is really required?
11:45	Bill Pezza Sales Manager, Clinical Trial Market SENSITECH and Mark Maurice Senior Project Manager, Sensitech Cold Chain Visibility Advisors~ SENSITECH	Applying electronic records and data analysis for good cold chain management practices Reviewing the historical and projected continued growth of temperature sensitive products Properly managing cold chain information to comply with regulatory expectations Maintaining quality, purity, and efficacy of clinical materials during storage, handling, and distribution Employing best practices for the collection, management, and evaluation of cold chain data
ENHANCING CTS MANAGEMENT AND ENSURING COMPLIANCE THROUGH TECHNOLOGY
12:15	Kelly Flood Sales Manager, Clinical Trial Market SENSITECH	A holistic technology view of the clinical supply chain What are the technologies available today to support the supply chain? How to use the existing technology as efficiently as possible Bringing it together – the use of standards and technology integration
12:45		Lunch
2:00	Lisa Ortega Manager Investigational Supply, Planning and Logistics ALLERGAN	Ensuring compliance with Interactive Voice Recognition Systems (IVRS) throughout the supply chain Highlighting advances in IVRS technology Practical examples of applying IVRS to increase supply efficiency Ensuring harmonization and compliance throughout the supply chain
2:30	Valarie Higgins Vice President Clinical Project Services ALMAC and Ellen Shea Associate Director, Clinical Project Services ALMAC	Implementing an integrated approach to the trial supply/IVRS interface Global study challenges Project start up - effective communication and information sharing Designing robust drug supply management strategies Managing supply distribution using effective metrics and procedures Data exchange and smooth operation of information flow Harnessing expertise with an integrated project management approach Samples of best practice from real life studies
3:00	Dave Engle Facilities Manager FISHER CLINICAL SERVICES and Patrisha Dimock Packaging Coordinator PFIZER	Electronic compliance for CTS An overview of electronic compliance developments Electronic devices that improve compliance Case study of compliance with blister cards The future of electronic devices in CTS
3:30		Afternoon refreshments
EVALUATING INVENTORY MANAGEMENT FOR CTS
4:00	Kevin Bardonner Team Leader CT Material Management ELI LILLY	The ABC of CTS inventory management Traditional use of ABC inventory classifications in other supply chain settings Challenges in CTS that are similar to and different from other industries Applications of ABC inventory classification to CTS management
DISCUSSING CLINICAL SUPPLY OUTSOURCING
4:30	Michael Wheeler Head Clinical Trial Supply Office US SCHWARZ BIOSCIENCES	How to effectively outsource your CTS needs Debating the pros and cons of outsourcing your CTS function Sourcing external companies and building relationships Effectively communicating the project definition and scope
5:00		Closing remarks from the Chair
5:10		End of day one

DAY TWO: THURSDAY 25 OCTOBER 2007
8:30		Registration
9:00	Terrence Walsh Director Clinical Trial Supply Chain GLAXOSMITHKLINE	Opening remarks from the Chair
9:10	Roundtable morning	Delegates will be able to attend three one-hour roundtable discussion groups from a selection of key topics. Each session will be chaired by an industry expert who will facilitate an exchange of opinions, essential experiences and learning related to an aspect of Clinical Trial Supply.
	Olga Crowther R&D QA Unit Manager ASTRAZENECA	1. Interface between Good Manufacturing Practice and Good Clinical Practice and its application in CTS
	Juergen Zeidler Senior Director, Global Drug Supply Management ABBOTT LABORATORIES	2. Packaging and labeling on-demand – a way to impact cycle times and costs?
	Andrea Janicki Project Team Manager ALMAC	3. Maximizing the effectiveness of IVRS and clinical trial supplies
	Donna McDermott Associate Director Worldwide Regulatory Coordination and Clinical Supplies MERCK & CO INC	4. Country focus – coordinating clinical trial supply in India
	Julia Castellanos Operations Group Manager CLINPHONE	5. Basic to advanced IVRS/IWRS trial supply management
	Gary Jones Director Clinical Supply Management TAP PHARMACEUTICAL PRODUCTS	6. Project management techniques to streamline global clinical trials
	Ed Tourtellotte, President & CEO, TOURTELLOTTE SOLUTIONS	7: Best Practice Forecasting Strategies for CTS Management
	Kevin Bardonner Team Leader, CT Material Management, ELI LILLY	8: Packaging and labeling strategies for typical study design
12:30		Lunch
FORECASTING STRATEGIES FOR CTS MANAGEMENT
1:45	Dave Riege Associate Research Fellow PFIZER	Strategies, processes and tools to manage clinical supplies Time horizons, events and players Forecasting API and drug product needs Forecasting comparator development Determining study-specific supply quantities – pre-study and during study
2:15	Ed Tourtellotte President & CEO TOURTELLOTTE SOLUTIONS	Simulation and continuous re-forecasting with actual trial data Pre-trial planning, simulation and optimization Monitoring trial data as it comes in and simulating steady state Detecting problems with steady state simulation Test driving study changes and modifying future state
RESOLVING THE DIFFICULTIES OF COMPARATOR CLINICAL SUPPLIES
2:45		Afternoon refreshments
3:15	Deirdre Ogorzalek Senior Director, Investigational Material Supply Chain CELGENE	Overcoming complications of blinded comparator products Understanding the additional challenges of a blinded comparator study Elements to consider in developing a blinded global comparator strategy Controlling the quality of comparators and overcoming the problem of stability
APPLYING SUPPLY CHAIN MANAGEMENT SYSTEMS TO MANAGE CTS
3:45	Bernie Cunningham Director Clinical Trial Supplies OSI PHARMACEUTICALS	Implementing a supply chain management system for clinical supplies Benefits of an integrated supply chain system commercial supply chain and clinical supplies in the same system Defining requirements and identifying a system Configuration, implementation and testing
IMPROVING COMMUNICATION TO REDUCE TIME AND COST
4:15		Closing remarks from the Chair and Champagne prize draw
4:30		End of Conference