Register by September 11th
                       Presents                                                                ...
A special thanks to our
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Pre-Conference Workshops
    Monday, December 7, 2009

          9:00am – 11:30am Registration 8:30am Morning Coffee Inclu...
Pre-Conference Clinical Data
    Management Master Class Day
    Monday, December 7, 2009

8:45     Registration and Coffe...
Main Conference Day One
    Tuesday, December 8, 2009
    7:30    Registration and Coffee                                 ...
Main Conference Day Two
    Wednesday, December 9, 2009

7:30    Registration and Coffee                                  ...
Registration Information

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Clinical Logistics Trial

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Clinical Logistics Trial

  1. 1. Register by September 11th Presents and SAVE UP TO $1,347 Clinical Trials Logistics TM December 7-9, 2009 Philadelphia, PA Maximizing Efficiency, Safety and Regulatory Compliance Within your Clinical Supply Chain Our Exceptional Speaker Faculty Includes Representatives From: • Sanofi-Aventis • Pfizer Discover and Learn Best Practices and Strategies Including: • AstraZeneca • Overcoming key inefficiencies within your • Building an effective risk management • Merck clinical supply chain strategy into your clinical trials logistics • Understanding how and why global clinical • Avoiding common mistakes and pitfalls • GlaxoSmithKline supplies effect enrolment for clinical trials logistics challenges in emerging countries • Genzyme • Developing and maintaining a successful and safe vendor relationship for your clinical • Addressing and overcoming challenges of • Takeda supplies storage and transportation of your clinical • Complying with US customs standards for supplies • Human Genome importing clinical supplies Sciences • Schering Plough Additionally, don’t miss the New Clinical Data Management Focus Master Class Day covering: • Celgene • Evaluating the risk of transitioning from • Using clinical trial data effectively to better • Gilead Sciences spreadsheet models to a sophisticated manage clinical trials supply clinical supply forecasting systems • Department of • Understanding strategies for predictive • Forecasting Clinical Trial Supply Demand Data patient recruitment and supply modeling Homeland Security accurately to reduce cost to ensure successful completion of clinical trials • Food & Drug Sponsor: Media Administration Partners: www.clinicaltrialslogistics.com
  2. 2. A special thanks to our Executive Advisory Board Clinical T ials r Mary Driver Vice President, Global Head, Clinical Supply Chain Pfizer Logistics Dear Colleagues, TM Karl Kussow Manager, Quality and Validation FedEx Custom Critical Rich Ellinger Director, Global Marketing and Business Development In today’s drug development clima Tegrant Corporation te, clinical supply professionals face These include adhering and complyin a unique set of challenges. Clifford W. Wyllie g with stringent regulations, cost- distribution, using specialized temp effective/ validated Vice President, Bio-Pharma Healthcare erature packaging and monitorin research labs/hospitals and many g devices, shipping to and from Services more. This timely conference will unique solutions to your organizat provide a series of novel and Cavalier Logistics ion’s clinical supply challenges. Mike Meakin At this year’s Clinical Trials Logistics conference, you will hear 17+ in-de Vice President, Quality Assurance & examples including: pth sessions and case study • Building a Regulatory Affairs, Life Science & supply chain project management Healthcare EMEA • Creating effic core competency iencies within your clinical supply DHL Supply Chain • Automating chain through product pooling clinical trials labeling in complian • Defining impo ce with FDA 21 CFR Part 11 Alex Guillen rt and export regulations, procedur studies es and strategies to run successfu Chief Executive Officer l global clinical • Due diligence in emerging markets Escort Cold Chain Solutions SA • Deciding on internal vs. external clinical manufac Lisa Ortega • Effectively turing for your organization managing domestic and global depo Manager, Clinical Supply Mgmt • Addressing ts for the efficient distribution of challenges of storage and transport clinical supplies Systems & Planning • Overcoming ation for your clinical supplies packaging challenges for the shipm Allergan ent of your clinical supplies Additionally, attend our Pre-Confe Eddie Montoya rence Workshops or Clinical Data Director, Clinical Supply Chain which include sessions and case-stud Management Master Class Day • The effective y examples on: Fisher Clinical Services use of IVRS in clinical trials managem • Transforming ent Donald L. Nolde your clinical supply chain to acco • Best practices mmodate adaptive trials for data management associated Vice President, Sales & Marketing clinical materials with the distribution of temperatu Cold Chain Technologies re-sensitive • Optimization of capacity planning, resource alloc Robert M. Zawacki trials ation and scheduling for portfolio of clinical Associate Director, Drug Supply Management Benefit from industry presentations from AstraZeneca, Merck, Pfizer, Wyeth Plough, Genzyme, Takeda, Human GlaxoSmithKline, Schering Genome Sciences, and many more CRO industry experts. This conferen pharmaceutical, biotech and Vladimir Shnaydman ce promises to be a networking and leaving you with new ideas and solut discussion-filled event President ions to help you maximize your clinic ORBee Consulting al supply chain. We look forward to seeing you in Karl Schlenker Philadelphia in December! Vice President, Sales and Marketing Best Regards, Minnesota Thermal Science Michael Colacino active and P Highly inter .S Director, Clinical Manufacturing e-confer ence Genzyme Drug & Biomedical R&D Simon Curtis informative pr e pages 3-4 Vladimir Anisimov Conference Director PharmaIQ workshops! Se Director, Research Statistics Unit GlaxoSmithKline for details Gerhard Fortwengel, MPH Director, Head of Quality Systems Actelion Pharmaceuticals Vildan Kortan Who Will You Meet At The Conference? Worldwide Director, Clinical Supplies Logistics CSO’s, Vice Presidents, Directors, Heads & Managers from Pharmaceutical, Biotech and CRO’s specializing in: Bristol Myers Squibb • Clinical Supply Operations • Regulatory Affairs Arminda Montero • Clinical Trials Logistics • Quality Assurance/Quality Control Distribution QA Program Manager, Global Pharmaceutical Operations • Clinical/Investigational Supplies • Import-Export Trade Compliance Abbott • Shipping and Distribution • Project Management Matty Toomb • Clinical Labeling/Packaging • Clinical Research/Planning Vice President, Sales & Marketing American Thermal Instruments • Clinical Trials Material Management • Drug Supply Management Mike Lewis • Clinical Supplies Manufacturing • Formulation Development Scientists Manager, Business Development • Clinical Data Management involved in CTM product development Sentry BioPharma Services, Inc. • Clinical Quality Assurance/Quality Control 2 Register Online at www.clinicaltrialslogistics.com or Call 1-800-882-8684
  3. 3. Pre-Conference Workshops Monday, December 7, 2009 9:00am – 11:30am Registration 8:30am Morning Coffee Included A Optimization of Capacity Planning, Resource Allocation and Scheduling for Portfolio of Clinical Trials Efficient capacity planning and resource allocation is becoming a hot • How to identify resource bottleneck topic for biopharmaceutical companies and Clinical Research • How to reallocate resources due to prioritization or cancellation of Organizations (CRO) due to increasing pressure to reduce cost of drug clinical trials development. It is critical for many clinical organizations to find a better • How to calculate understaffing risk approach to increase effectiveness in resource capacity planning in clinical process, especially for multiple clinical trials. Developing and using How you will benefit: powerful tools which allows to optimize resource capacity planning, • How to schedule new clinical trials to maximize manpower and budget allocate resources (both manpower and budget) optimally between capacity in biopharmaceutical company? planned and ongoing clinical trials. This technique can save up to 30% • How to “pack” maximum number of clinical trials in different by uncovering better resource allocation solutions. therapeutic areas to maximize capacity utilization (for CROs) across employee roles What you will learn: • How to optimize capacity planning across portfolio of clinical trials using • How to apply optimization technology to capacity planning in ORBee proprietary tool biopharma • How to derive workload demand and supply (overview) on a role level Your Workshop Leader: • How to optimize capacity planning and resource allocation across Vladimir Shnaydman, PhD, President, ORBee Consulting portfolio of clinical trials for both biopharma companies and CROs 12:00m – 2:30pm Registration 11:30am Lunch Included B Quality and Efficiency for Cost & Temperature Controlled Transportation The workshop will facilitate a discussion of considerations for choosing a How you will benefit: transportation method, including international regulations, shipping Through case studies of real-life examples and interactive exercises, you environments, and the strengths and weaknesses of available will understand how transport systems can be designed to significantly temperature control options for air and ground transport. reduce or eliminate common problems in domestic US and international The group will discuss solution options and criteria for designing best air transport. You will gain an appreciation for the relative costs and practice transportation systems and procedures that appropriately blend benefits of achieving your transportation objectives within the framework the needs of your product, your business, and available services. We will of your GDP requirements and discuss how to minimize those costs while also explore the effectiveness of various choices by considering case maintaining safe transport requirements. studies for both ground and air transport. • Improve your ability to implement high quality, secure, and cost- effective transportation What you will learn: • Enhance your ability to apply industry and governmental guidance on Gain insight into carrier quality systems for both standard transportation Good Distribution Practices in your transportation plans and temperature control including: • Increase your understanding of how to effectively work with your • Strategies for implementing best practices for achieving high quality carrier to maximize the quality, consistency, and economy of your and safety in both air and ground transport shipping lane • Effective procedures to address transport risk issues • Decision making factors for evaluating cost-effective transportation Your Workshop Leader: strategies for cold chain Speaker to be confirmed shortly. Please check www.clinicaltrialslogistics.com for additional information 3:00pm – 5:30pm Registration 2:30pm C Integrating Technology within Your Clinical Supply Chain Like all industries, clinical supplies must deal with the constant need for How you will benefit: improvement in terms of more efficient and innovative processes. Within • Discover factors affecting global distribution that sponsor companies this context, many pharma and biotech companies now expect “joined should take into account of when up thinking” - experts and systems in different disciplines working in • Examine the structure of software applications for forecasting and how tandem to deliver clinical supplies as efficiently as possible. This workshop they can be used effectively within a trial examines the key factors in today’s market for successful supply delivery, • Evaluate the benefits of drug pooling strategies using detailed case powered by effective supporting technologies studies • Understand how clinical supply and IVR staff can work together in an What you will learn: integrated fashion to enhance the delivery of supplies • Managing an expanding global clinical supply network • Explore the pitfalls of a fragmented supply chain • Improving the supply chain for existing technology • Integrating project management Your Workshop Leader: Speaker and sponsorship opportunities available: Please contact Simon.Curtis@iqpc.com for more information 3 Register Online at www.clinicaltrialslogistics.com or Call 1-800-882-8684
  4. 4. Pre-Conference Clinical Data Management Master Class Day Monday, December 7, 2009 8:45 Registration and Coffee 12:10 Transforming Your Clinical Supply Chain to Accommodate Adaptive Trials 9:30 Welcome Address and Chairperson’s Opening • Understanding how adaptive trials will impact on CTS Remarks • Adjusting current procedures to facilitate adaptive trials • Ensuring flexibility in the supply chain to support adaptive trial design 9:40 Benefits of Using a Sophisticated Clinical Supply Eddie Montoya Forecasting System: Case Studies Director, Clinical Supply Chain • Exploring realized benefits of using a clinical supply forecasting Fisher Clinical Services solution (Subject to final confirmation) • Discussing a cost benefit analysis to your organization • Discussing past experience with spreadsheets and identifying 12:50 Networking Luncheon potential limitations • Uncovering potential transition problems: E.g. missing doses in 1:50 Best Practices for Data Management Associated with patients leading to reducing time to market on drug products Distribution of Temperature-Sensitive Clinical Trial Materials • Understanding the benefits of enabling technology and how • Understanding regulatory and standards-based guidance for temperature forecasting models can bridge the gaps inherent to a spreadsheet sensitive clinical trial material presents many unique challenges model • Examining complex and remote distribution channels to collect, store and Buz Hillman retrieve critical time and temperature data Manager, Clinical Supplies Forecasting & Infrastructure, Centocor • Overview of the global regulatory environment and reviews proven practices Johnson & Johnson for collecting, managing and retrieving time and temperature data • Identifying opportunities for improving current practices with new 10:20 Panel Discussion: Accurately Forecasting Clinical Trial applications for existing technologies Supply Demand Data to Reduce Cost * Speaker and sponsorship opportunities available: Please contact • Understanding why demand forecasting is critical for your Simon.Curtis@iqpc.com for more information organization • Discussing novel and effective forecasting tools and techniques 2:30 Effective Use of Clinical Trial Data to Better Manage • Identifying best practices in forecasting clinical trials supply Clinical Trial Supply requirements • Discussing Gilead case study: Successfully using up-to-date IVR data Panelists: • Forecasting the Clinical Trial supply • Utilizing existing and past data for predicative modeling Lawrence Florin • Managing drug supply by real time data from forecast models Director, Clinical Outsourcing • Patient enrolment used as a key performance indicator for Clinical Trial AstraZeneca forecasting Mike Dallman Adrian Hsing Associate Director, Clinical Supplies Director of Clinical Data Management Cerexa Gilead Sciences, Inc. 11:00 Morning Networking Break 3:10 Predictive Patient Recruitment and Supply Modeling to 11:30 The Effective Use of IVRS in Clinical Trial Ensure Successful Completion of Clinical Trials • Uncovering the main sources of uncertainty and appropriate metrics for Management measuring success • Understanding the general aspect of using IVRS • Modeling and predicting recruitment at the initial and interim stages • Weighing up the pros and cons of using IVRS for your clinical • Examining adaptive adjustment of recruitment and number of clinical supplies • Discussing effective ways of how IVRS can be managed centers at any interim time • Evaluating study performance and site productivity • Examining case study simulation/modeling examples of clinical trial • Predictive modeling for drug supply supplies Valerii Fedorov Nirav Shah Head of Research Statistics Unit Senior Manager, IMSC GlaxoSmithKline Celgene Corp. 3:50 Chairpersons Closing Remarks and End of Master Class About our Sponsors FedEx Custom Critical offers a complete array of surface and air • Global distribution of temperature controlled trial medication, vaccines & CTM solutions to safely and securely ship temperature-sensitive products. • Temperature control monitoring for ambient, 2-8C and frozen products to maintain You can choose from exclusive-use vehicles with integrity of supplies temperaturecontrolled cargo boxes to airfreight solutions utilizing temperature-controlled • Advice on packaging materials and provision of containers for global transportation air containers. With our Temp-Assure Validated services, you also receive hard-copy • Refrigerated trucking services documentation of the temperature inside the vehicle or container throughout transport. • Customs brokerage accelerating clearance This assists our pharmaceutical customers with their compliance needs through a Website: www.marken.com documented audit trail of their productsÅf temperature throughout the shipping process. FedEx Custom Critical services are available 24/7/365 with surface solutions throughout World Courier has set the benchmark for worldwide time & the U.S. and Canada and air solutions across the globe. Website: temperature sensitive transportation. We remain the only specialist www.customcritical.fedex.com courier company with its own global company network .Each office ISO 9001 certified with the same operating standards dedicated to treating every shipment on an individual, Marken is one of the leading suppliers of cold-chain logistics for priority basis. World Courier is utilized in approximately 80% of the world’s clinical trials clinical supplies worldwide. Temperature-control during the handling, requiring the use of a specialty courier. With experience in managing the logistics of over storage and distribution of cold-chain products is a critical element of the clinical trial 7,500 clinical trials worldwide, we are the acknowledged experts in handling process. Our expertise is of critical importance to ensuring the safe arrival of high value temperature-sensitive specimen and drug shipments. 24 x 7 x 365. Website: shipments to sites. We provide: www.worldcourier.com 4 Register Online at www.clinicaltrialslogistics.com or Call 1-800-882-8684
  5. 5. Main Conference Day One Tuesday, December 8, 2009 7:30 Registration and Coffee • Evaluating your proposed clinical supply vendor’s necessary facility, equipment and personnel infrastructure 8:15 Welcome Address and Chairperson’s Opening Remarks • Understanding the Importance of quality agreements • Discussing best practice solutions approaches for a mutually beneficial working Optimizing Your Clinical Supply Chain relationships and strategic alliances between client and clinical provider Panelists: 8:30 Opening Keynote: Overcoming Key Inefficiencies Within Robert E. Holman your Clinical Supply Chain Global Account Manager, Technology • Pinpointing issues which are delaying your supply chain AstraZeneca • Discussing the ideology of implementing lean principals within your clinical supply chain, without increasing cost or damaging quality 2:00 Developing and Maintaining a Successful and Safe Vendor • Learning from examples: An overview of a successfully modified clinical Relationship for Your Clinical Supplies supply chain while displaying overcoming successful inadequacies within • Understanding strategic risk-management approach tools for vendor selection the original processes and management • Examining the options of working with a partner to speed up supply chain • Identifying and negotiating clear agreements to avoid pitfalls • Establishing a personal relationship with your vendor for a unified approach optimization • Aligning a mutually-agreeable approach for both parties Dick Winokur • Discussing techniques for successful contract re-negotiation Vice President, Clinical Supply Chain Sanofi-Aventis Spencer Comtois Manager, Vendor Relations, Clinical Supply Chain 9:15 Product Pooling: Creating Efficiencies Within your Clinical Schering Plough Supply Chain • Uncovering actual benefits of drug pooling and the most 2:45 Afternoon Networking Break effective strategies • Displaying technologies that support this approach to maximize clinical Investigating the Global Clinical Trials Regulatory Landscape trial supply efficiency • Examining novel supply labeling options to ensure efficient distribution 3:30 Complying with US Standards Regarding Customs Issues for • Addressing difficulties in implementation – Case study example Importing Clinical Supplies Linda Nichols • An overview of US importing and exporting shipping requirements Global Demand Logistics, Pharmaceutical Development, R&D • Considering key pointers to ensure smooth logistic and distribution processes • Understanding how to avoid detention of investigational material when GlaxoSmithKline importing to the USA 10:00 Morning Networking Break • Examining successful and unsuccessful case study examples of biopharma company compliance 10:45 Understanding How and Why Global Clinical Supplies Aileen Suliveras Effect Enrolment Director, Cargo Verification, Customs and Border Protection • Examining the impact of deploying lean initiatives to decrease clinical Department of Homeland Security supply overage • Weighing up the importance of lean implementation with the bigger Domenic Veneziano Director, Import Operations & Policy picture (enrolment and overage issues) • Discussing solutions and strategies for overcoming unforeseen clinical trial FDA delays (FDA inspections etc) • Risk assessment to operational efficiency to enrolment impact 4:15 Automated Clinical Trial Labeling Systems and Compliance • Addressing overage issues and implementing IVRS with FDA 21 CFR Part 11 • Examining automated clinical trial supply labeling techniques used to improve Dawn Furey efficiency and data integrity for randomized clinical trials Associate Director, Research Operations • Evaluating the use of computers in the clinical trial supply labeling, inventory Merck & Co. management, and disposition • Understanding the FDA requirements for compliance and scope of application 11:30 Optimal Planning for Clinical Supply of 21 CFR Part 11 as applied to your current systems • Presenting techniques based on optimization approaches to align Denise I. Webber production and delivery schedule • Optimizing warehouse and site storage inventory level, shipment size, and President & Founder, Clinical and Regulatory Operations D.I.Webber Consulting, LLC minimize wastage of clinical materials • Addressing the challenges of clinical trials supply chain planning • Understanding factors affecting complexity of supply chain planning 5:00 Defining Import and Export Regulations, Procedures and • Analysis of current approaches – simulation and optimization) Strategies to Run Successful Global Clinical Studies • Technique for optimal clinical trial supply chain planning • Outlining different global import and export requirements to prevent the oversight of key necessities Vladimir Shnaydman • Complying with import and export rules to ensure the smooth running of President global clinical trials and on-time distribution ORBee Consulting • Emphasizing the need of standardized global import and export requirements to facilitate compliance 12:15 Networking Luncheon • Forecasting lead times to ensure accurate planning and to guarantee the smooth operation of global trials 1:15 Panel Discussion: Analyzing Clinical Supplies Vendor • Outlining European shipping requirements to ensure efficient logistic and Market: Choosing A Preferred Vendor Organization distribution processes • Examining effective approaches for vendor selection and management as • Considering shipping times and delays for efficient forecasting of delivers and well as achieving senior management buy-ins for vendor suggestions clinical trial running times • Understanding and reviewing the scientific background and capabilities of Jessica Sonevytsky tentative vendor organizations - Compiling a data set in order to rank and Senior Regulatory Coordinator risk assess potential vendor organizations Merck & Co. • Assessing the potential of a vendor organization’s global reach with regards to clinical manufacture, supply channels, quality/regulatory requirements 5:45 Chairpersons Closing Remarks and End of Day One 5 Register Online at www.clinicaltrialslogistics.com or Call 1-800-882-8684
  6. 6. Main Conference Day Two Wednesday, December 9, 2009 7:30 Registration and Coffee 12:15 Networking Luncheon 8:15 Welcome Address and Chairperson’s Opening Remarks Novel Storage, Packaging and Transport Solutions for Accelerating Your Clinical Logistics Effective Clinical Trial Logistics Risk Mitigation Strategies 1:15 Efficient and On-Time Shipment of Global Clinical 8:30 Building Risk Management into your Clinical Trial Logistics Supplies – Case Study • Developing best practice risk management and joined up solutions-based • Creating an optimized clinical distribution model for maximum on time thinking delivery performance • Identifying and then measuring/assessing risks and developing strategies to • Establishing large volume shipping containers for clinical materials manage them • Overcoming customs controls within both the US and Australia • Displaying a tried and tested risk management framework • Displaying a successful joint strategic alliance between drug manufacturer • Delivering beginning to end clinical logistics management lowering costs and and freight forwarder improving compliance and efficiency in all aspects of clinical trial supplies Jason C. Mattis • Managing import/export requirements, coordination of drug supplies from Principal Scientist, Sterile Product Manufacturing manufacturers, distribution, drug return and destruction, and inventory GlaxoSmithKline management Gary Jones Jeff Sitzlar, Manager Director, Clinical Supplies Business Development Takeda FedEx Custom Critical (Subject to final confirmation) 9:15 Due Diligence in Emerging Markets (EM) • Examining emerging outsourced clinical trial markets 2:00 Interactive Global Distribution and Storage Strategies • Understanding effective contract negotiations with EM partners Roundtable Discussions: • Discovering how to structure and implement quality agreements with After a jam-packed day of big picture keynotes, panel discussions, case partners in EM studies, and presentations, the Clinical Trial Logistics gives you the chance to • Displaying structure of the partnership for a positive outcome for both meet and brainstorm with small groups of your peers during our interactive parties roundtable discussions. This is a great opportunity to make valuable • Addressing challenges in communication, time zones, and culture • Evaluating options for CMO options in EM contacts from your area of interest, and to deep-dive into the tricky details • Displaying specific details on a current project in EM that you may have missed in the course of the day’s sessions. ** Delegates are encouraged to bring their own data or study results for Mark Walls discussion or submit them earlier to simon.curtis@iqpc.com Director, Clinical Pharmacy Round Table Discussions include: Human Genome Sciences • Setting up a distribution process – focusing on overcoming cold chain challenges 10:00 Morning Networking Break • Complying efficiently with global regulatory bodies • Discussing depot selection and management in emerging markets 10:45 How to Avoid Common Mistakes and Pitfalls for Clinical • Managing supply volumes and overage for individual sites Trial Logistics Challenges in Emerging Countries • Reducing costs and maximizing ROI • Identifying potential consequences of poor risk mitigation frameworks when considering an overseas project and contingency planning to ameliorate 2:45 Afternoon Networking Break them • Balancing clinical product integrity, quality and cost • Understanding the cultural challenges of your new marketplace and how to 3:30 Panel Discussion: Effectively Addressing Challenges of Storage and Transportation of Clinical Supplies ensure on time delivery • Becoming aware of regulatory requirements both domestically and • Appreciating the High value of quality agreements and why it is essential to internationally collaboratively put them in place with your partner organizations • Understanding successful handling of clinical supplies • Examining techniques to retain and replace talented team members at home • Overcoming import/export shipping challenges and abroad • Developing and streamlining packaging, pre-qualification and • Showcasing successful and unsuccessful overseas deployment of Clinical transportation strategies Supplies Logistics • Managing and working successfully with your partnering organizations – Steve Jacobs Aligning an approach together President, Global BioPharm Solutions and former CEO Panelists: Bilcare Global Clinical Supplies Laurent Dhervilly Senior Director, Pharm. Sciences Supply Chain Management Research 11:30 Factors to Consider When Deciding on Internal vs. External Pfizer Clinical Manufacturing • Self Evaluation of Internal capabilities: Capacity, equipment, systems, 4:15 Cold Chain Distribution and Logistics of Clinical Supplies – technical expertise/core competencies and timing Case Study • Project Development Cycle: Phase of project, probability of commercialization • Stocking distribution depots with frozen medicinal supplies at -5° to -40 ° and probability of future formulation/process changes • Understanding when dry ice is too cold • Optimization of entire clinical supply chain • Examining engineered solution and gap • KPI’s vs. Critical Success Factors (Long term vs. Short term views) • Modified solution and operational testing • Using external Clinical Manufacturing as beginning of commercial Secondary • Evaluating performance during actual shipment from US to Brazil Sourcing Process Alfred Mottram • Managing organizational expectations/Involving the whole team • Legal and Regulatory Implications: Time required for CDA’s/MSA’s, time Associate Director, Drug Supply and Materials Management Medarex required for QA Audits, role of QP, quality agreements, filings and import/exports 5:00 Chairpersons Closing Remarks and Close of Conference Michael Colacino Director, Clinical Manufacturing Genzyme Drug & Biomedical R&D 6 Register Online at www.clinicaltrialslogistics.com or Call 1-800-882-8684
  7. 7. Registration Information Pricing Qualified Pharmaceutical Register by Register by Register by Register by Standard Organizations 9/11/09 9/25/09 10/9/09 11/6/09 Price Conference Only (Save $400) (Save $300) (Save $200) (Save $100) $1,199 $1,299 $1,399 $1,499 $1,599 All-Access: Main Conference + 3 workshops - OR - Main (save up to $1,347) (save up to $1,247) (save up to $1,147) (save up to $1,047) (save up to $947) Conference + Master Class $1,899 $1,999 $2,099 $2,199 $2,299 Master Class $799 $799 $799 $799 $799 Workshop Only $549 each $549 each $549 each $549 each $549 each Academic Standard Others Register by Register by Standard Price 10/9/09 11/6/09 Price Conference Only $999 Conference Only (Save $600) (Save $300) All-Access: Main Conference $1,999 $2,299 $2,599 + 3 workshops - OR - Main (Save up to $1,047) All-Access: Main Conference Conference + Master Class $1,599 + 3 workshops - OR - Main (save up to $1,447) (save up to $1,247) (save up to $947) Master Class $799 Conference + Master Class $2,799 $2,999 $3,299 Workshop Only $549 each Master Class $799 $799 $799 Workshop Only $549 each $549 each $549 each Sponsorship and Exhibition opportunities Sponsorships and exhibits are excellent opportunities for your company to showcase its products and services to high-level, targeted decision- makers attending the Clinical Trials Logistics. PharmaIQ helps companies like yours achieve important sales, marketing and branding objectives by setting aside a limited number of event sponsorships and exhibit spaces, all of which are tailored to assist your organization in creating a platform to maximize its exposure at the event and to its attendees. For more information on sponsoring or exhibiting at the Clinical Trials Logistics, please call Mario Matulich at (212) 885-2719 or sponsorship@iqpc.com Please visit www.clinicaltrialslogistics for an explanation of Details for making payment via EFT or wire transfer: Qualified Pharmaceutical Organizations, Academia and All JPMorgan Chase - Penton Learning Systems LLC dba IQPC: 957-097239 Others ABA/Routing #: 021000021 Reference: Please include the name of the attendee(s) and the event number: Please note multiple discounts cannot be combined. 18219.001 A $99 processing charge will be assessed to all registrations not Payment Policy: Payment is due in full at the time of registration and includes lunches and accompanied by credit card payment at the time of registration. refreshments.Your registration will not be confirmed until payment is received and may be MAKE CHECKS PAYABLE IN U.S. DOLLARS TO: IQPC subject to cancellation. * CT residents or people employed in the state of CT must add Venue Information: Venue is to be announced. Please check www.clinicaltrialslogistics.com for 6% sales tax. updates and announcements. Team Discounts: For information on team discounts, please For IQPC’s Cancellation, Postponement and Substitution Policy, please visit contact IQPC Customer Service at 1-800-882-8684. Only one www.iqpc.com/cancellation discount may be applied per registrant. Special Dietary Needs: If you have a dietary restriction, please contact Customer Service Special Discounts Available: A limited number of discounts at 1-800-882-8684 to discuss your specific needs. are available for the non-profit sector, government ©2009 IQPC. All Rights Reserved. The format, design, content and arrangement of this organizations and academia. For more information, please brochure constitute a trademark of IQPC. Unauthorized reproduction will be actionable contact customer service at 1-800-882-8684. under the Lanham Act and common law principles. Media Partners: 7 Register Online at www.clinicaltrialslogistics.com or Call 1-800-882-8684
  8. 8. International Quality & Productivity Center REGISTRATION CARD 535 5th Avenue, 8th Floor YES! Please register me for: Clinical Trials New York, NY 10017 Logistics TM ❑ Conference Only ❑ All Access* ❑ Conference + 1 workshop ❑ Master Class ❑ Conference + 2 workshops ❑ Workshop(s) ❑A ❑B ❑C See Page 7 for pricing details. Your customer registration code is: When registering, please provide the code above. Name__________________________________ Job Title ________________________ Organization____________________________________________________________ Approving Manager______________________________________________________ Address________________________________________________________________ City__________________________________State______________Zip____________ Phone________________________________Fax_______________________________ E-mail__________________________________________________________________ 5 EASY WAYS TO REGISTER: ❑ Please keep me informed via email about this and other related events. 1 Web: www.clinicaltrialslogistics.com ❑ Check enclosed for $_________ (Payable to IQPC) 2 Call: 1-800-882-8684 ❑ Charge my __Amex __Visa __Mastercard __Diners Club 3 Email: info@iqpc.com Card #__________________________________Exp. Date___/___ CVM code ______ 4 Fax: 1-646-378-6025 Details for making payment via EFT or wire transfer can be found on preceding page. 5 Mail: IQPC 535 5th Avenue, 8th Floor, ❑ I cannot attend, but please keep me informed of all future events. 18219.001/D/AL New York, NY 10017 Register by September 11th and SAVE UP TO $1,347 Presents Clinical Trials Logistics TM December 7-9, 2009 Philadelphia, PA Maximizing Efficiency, Safety and Regulatory Compliance Within your Clinical Supply Chain

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