Proudly Presents:                                                             Register by January 28, 2011 to             ...
Dear Colleague,                                                                Who	Should	Attend?ExL Pharma is proud to in...
Pre-Conference Workshop                                          Day One – Tuesday, March 8, 20118:00    Registration and ...
Main Conference                            Day Two – Wednesday, March 9, 20118:00     Continental breakfast for Conference...
Media Partners:Five Ways to Register                                            group discount Program:                   ...
Register       by January 28, 2011 to                                                                                     ...
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5th Forecasting and Optimizing the Clinical Supply Chain, March 2011, Philadelphia

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Effectively Managing the Global Clinical Supply Chain to Maximize Efficiency, Meet Time Lines, reduce Costs, and Streamline Logistics

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5th Forecasting and Optimizing the Clinical Supply Chain, March 2011, Philadelphia

  1. 1. Proudly Presents: Register by January 28, 2011 to Receive our discounted Rate!5 Forecasting and Optimizing th the Clinical Supply Chain Effectively Managing the Global Clinical Supply Chain to Maximize Efficiency, Meet Time Lines, Reduce Costs, and Streamline Logistics March 8-9, 2011 • Hyatt at the Bellevue • Philadelphia, PA Featured Sessions Include: dEFiNiNg aN OPtimal CliNiCal tRial matERial PROduCtiON PlaN industry Formulating a Comprehensive Clinical Supplies Production PlanParticipants include: and distribution Strategy for Planning and ForecastingaStRaZENECa Lee Miller, Senior Global Clinical Supply Planning Manager, mERCKallERgaN dEliVERiNg adEQuatE CliNiCal SuPPliES FOR adaPtiVE tRialSbiOmaRiN utilizing Strategies to Predict and Supply the Correct amount ofEiSai Clinical Supply Kits in adaptive Clinical trialsF. HOFFmaN-la ROCHE ag Buz Hillman, Clinical Supply Manager, JaNSSEN PHaRmaCEutiCal COmPaNiES of JOHNSON & JOHNSONglaxOSmitHKliNEglObal biOPHaRm CliNiCal SuPPliES OutSOuRCiNg bESt PRaCtiCESSOlutiONS implementing an Effective Clinical Supply Chain Outsourcing StrategyJaNSSEN PHaRmaCEutiCal Kevin Webb, Director of Supply Chain, biOmaRiNmERCKSuNOViON HOFFmaN-la ROCHE CaSE Study- RaNdOmiZatiON aNd CliNiCal SuPPly Optimizing Clinical Supply demands for global Studies usingSuPPly CHaiN iNStitutE monte Carlo Simulation Gabriele Janner, Simulation Expert, F. HOFFmaN-la ROCHE ag SPONSOR PRE-CONFERENCE Establishing and implementing a Clinical Supply Chain in Emerging markets WORKSHOP To Register Call 866-207-6528 or Visit Us At www.exlpharma.com/Forecasting
  2. 2. Dear Colleague, Who Should Attend?ExL Pharma is proud to introduce the new 5th This conference is designed for representatives from Forecasting and Optimizing the Clinical Supply Chain pharmaceutical, biotechnology, and medical device companies with responsibilities in the following areas:event on March 8-9, 2011. This conference providesparticipants with the tools and knowledge to effec- Departmentstively communicate and increase transparency to better • Clinical Trials Supply/ Clinical Suppliesforecast clinical supply demand, manage clinical supply • Clinical Trials Logistics, Planning and Distributionin emerging markets, understand the regulatory guide- • Trial Materials Management/Planning • Investigational Supplieslines and expectations, increase operational efficiencies, • Clinical Labeling and Packagingand learn new emerging forecasting technologies for global • Clinical Manufacturingclinical supply chain excellence. This is a must attend event • Clinical Pharmacyfor everyone involved in the clinical supply chain looking • Shipping and Distributionto advance their knowledge and learn new strategies, while • Import-Export Trade Complianceinteracting with other pharmaceuticals, medical device, and • Clinical Operations/Development • Drug Supply Managementbiotechnology professionals. • Supply Chain Management • IVRS/IWRSWe look forward to greeting you in March! • QA/QC • Data Management & StatisticsSincerely, • Regulatory Affairs This conference is also of interest to: • linical Services/ Clinical Process C Improvement ProvidersMary Ruggiero Kristen Hunter • Clinical Technologies CompaniesConference Director Team Leader, Production • Forecasting and Simulation Technologiesmruggiero@exlpharma.com ExL Pharma • Clinical Packaging and Logistics Companies • Contract Research Organizations • Manufacturing Solution Providers Hyatt at the Bellevue 200 South Broad Street, Philadelphia, Pennsylvania 19102 Tel: 215-982-4900 | Fax: 215.982.4922 | Email: conciergephlph@hyatt.com D iscover true grandeur, unrivaled style and service at our iconic downtown Philadelphia hotel. Situated on the famous Avenue of the Arts, Hyatt at The Bellevue (formerly Park Hyatt Philadelphia at the Bellevue) blends old-world architecture with modern amenities. Unwind in our luxuriously oversized guestrooms with posh amenities. Allow our European-style, Concierge to personally recommend and make arrangements at top restaurants, shows and events. Dine at XIX (NINETEEN) atop our Philadelphia luxury hotel, with sweep- ing city views. Peruse world-class shops within our landmark building. Work out in our remarkable 93,000 square foot health club. See why this elite Center City Philadelphia hotel has earned the Hyatt distinction.. ROOM RESERVATIONS: If you require overnight accommodations, please contact the hotel and state that you are with ExL Pharma’s Forecasting & Optimizing conference by Sunday, February 6, 2011. We encourage conference participants to make reservations with our designated venue to take advantage of ExL Pharma’s discounted room rate. To Register Call 866-207-6528 or visit www.exlpharma.com/Forecasting
  3. 3. Pre-Conference Workshop Day One – Tuesday, March 8, 20118:00 Registration and Continental breakfast for Workshop Participants PRE-CONFERENCE WORKSHOP:9:00 EStabliSHiNg a RObuSt CliNiCal SuPPly CHaiN iN EmERgiNg maRKEtS implementing a Clinical Supply Chain in Emerging markets Barriers for getting clinical supplies into emerging markets is incredibly complex and requires a depth of knowledge and understanding that has become critical with the expansion of global clinical trials. In this workshop attendees will: • earn the regulatory and global clinical supply requirements and how to overcome hurdles for shipping into emerging clinical supply markets L • lan for and be ready to handle the challenges of importing and exporting clinical supplies P • earn how to leverage shipping lanes to reduce the cost and time associated with the clinical supply chain L • aintain clinical supply on time delivery by understanding and adapting to the demands and limitations at locations M Steve A. Jacobs, MBA, PRh, President, glObal biOPHaRm SOlutiONS10:30 30-minute Networking & Refreshment break12:00 Workshop Concludes; luncheon for Workshop ParticipantsMain Conference Begins Day One1:00 CHaiRPERSON’S WElCOmE aNd OPENiNg REmaRKS the temperature of supplies during transport, monitoring the Rick Mann, Associate Director, Clinical Trial Material Management, delivery status to meet on time metrics, and ensuring products SuNOViON PHaRmaCEutiCalS are safe and meet environmental requirements1:15 imPROViNg tHE CliNiCal SuPPliES ExECutiON tHROugH Javad Seyed, PhD, Adjunct Professor, Operations Management, Performance COllabORatiON aNd COmmuNiCatiON and Risk Analysis, Principal Founder, SuPPly CHaiN iNStitutE building and Optimizing inter-departmental Communications 3:30 Networking and Refreshment break and Collaborations to better Forecast Clinical Supply demand • ncreasing transparency by developing communication and knowl- I 4:00 PaNEl diSCuSSiON- CONtROl COSt aNd maximiZE tHE EFFiCiENCy OF edge transfer with QA, regulatory, supply and clinical team members tHE CliNiCal SuPPly CHaiN tHROugH tHE uSE OF NEW tECHNOlOgy • roactive and early engagement techniques that increase com- P Enhancing the Clinical Supply Chain through the use and munication and best practices for exchanging information and application of New technology Programs to Reduce Costs and adjusting clinical supply projections meet time lines • apping the clinical supply process to best identify where to M • hy it is important to show the base line before implementing W implement better supply and demand management the new technology to clearly show the return on investment of • nderstanding the leader’s corporate responsibility to effectively U the new systems communicate up and down the chain • ow you can ensure consistent on time delivery with the highest H Kathie Sweeney, Investigational Products, aStRaZENECa quality by partnering with your stakeholders2:00 dEFiNiNg aN OPtimal CliNiCal tRial matERial PROduCtiON PlaN • he future of forecasting services and applications of the clinical supply chain T Formulating a Comprehensive Clinical Supplies Production Plan Gabriele Janner, Simulation Expert, F. HOFFmaN-la ROCHE ag and distribution Strategy for Planning and Forecasting Rick Mann, Associate Director, Clinical Trial Material Management, • egin with the end in mind to comprehensively manage the clinical B SuNOViON PHaRmaCEutiCalS supply chain and establish an efficient distribution strategy Are you interested in speaking on this session? If so please call • ssessing key areas of improvement, reducing waste, and control- A Mary Ruggiero at (212) 400-6242 mruggiero@exlpharma.com ling costs in clinical supply chain management 4:45 ROuNdtablE diSCuSSiONS • ffectively managing change in the clinical supply chain to adapt to E new clinical trial demands Choose from one of the following roundtable sessions: Lee Miller, Senior Global Clinical Supply Planning Manager, mERCK 1) RElatiONSHiP buildiNg: Identifying and selecting clinical supply third party logistics (3PL) and CROs, and building the relationship to2:45 uNdERStaNdiNg aNd imPROViNg tHE lOgiStiCS imPaCtiNg tHE optimize delivery CliNiCal SuPPly CHaiN 2) mid-Study mOdiFiCatiONS: Challenges and considerations when Enhancing demand and Supply Forecasts by aligning Supply modifying the clinical supply chain mid study Operations to Ensure a Robust delivery 3) gREEN CliNiCal SuPPly CHaiN: The application and value of a • nderstanding the newest concepts in packaging to include an U “green” clinical supply chain solution overview of new packing systems and their mobile environment, best packaging methods to guarantee stability and study execution, 4) PREdiCtiVE mOdEliNg tOOlS: Risk-based predictive modeling and ensuring temperature control across the entire supply chain tools to best assist with clinical demand planning scenarios • ays to get the most out of labeling operations through: language W 5) imPORt/ExPORt REgulatiONS: Understanding US import/export libraries, investigator-specific labeling for kits, just-in-time labeling regulations and hurdles • ow to improve shipping control and transparency by tracking H 5:30 Close of day One To Register Call 866-207-6528 or visit www.exlpharma.com/Forecasting
  4. 4. Main Conference Day Two – Wednesday, March 9, 20118:00 Continental breakfast for Conference Participants 12:45 luncheon9:00 CHaiRPERSON’S RECaP OF day ONE aNd KEy POiNtS FROm 1:45 CliNiCal SuPPliES OutSOuRCiNg bESt PRaCtiCES ROuNdtablE diSCuSSiONS implementing an Effective Clinical Supply Chain Outsourcing Rick Mann, Associate Director, Clinical Trial Material Management, Strategy SuNOViON PHaRmaCEutiCalS • dentifying what aspects of clinical supply should be outsourced, I and finding the best outsourcing partners9:15 maximiZiNg tHE ValuE OF iNtERaCtiVE RESPONSE tECHNOlOgy • he pros and cons of working with local or foreign clinical supply T using Either interactive Voice Response (iVR) or interactive vendors Web Response (iWR) Systems to Control Cost and Optimize Production of Clinical Supplies • anaging expectations, deliverables, and the long term relationship M • nderstanding when to employ IVR and IWR Independently or in com- U between sponsor companies and vendors bination, how to clearly show the cost benefit of using these systems • echniques for managing escalating clinical supplies work load and T • earning how IVR/IWR can streamline clinical supply operations L how outsourcing can be a solution and reduce overage Kevin Webb, Director of Supply Chain, biOmaRiN • electing an Interactive Response Technology (IRT) system, estab- S lishing what IRT functions will improve the efficiency of the clinical 2:30 CliNiCal labEliNg SyStEmS supply chain Optimizing the Clinical Supply Chain through the use of New • valuating the benefits of managing use-by dates using IRT technology E labeling technology • ew labelling technology that enhances global clinical studies N10:00 HOFFmaN-la ROCHE CaSE Study- RaNdOmiZatiON aNd CliNiCal through the use of a language library that can be used for rapid SuPPly design Optimizing Clinical Supply demands for global Studies using • earn the methods of new electronic routing of labels for rapid L monte Carlo Simulation approvals • ow to understand and deal with the unequal allocation to treat- H ment and optimization of site’s supply strategy • nderstanding new labeling technology that enhances accountabil- U ity of clinical supplies through bar code scanning • Know how to indentify key blinding considerations when setting up IVRS • ow to better understand the impact of randomization balancing H Steve A. Jacobs, MBA, R.Ph, President, glObal biOPHaRm SOlutiONS on a clinical trial’s supply 3:15 REgulatiON VS iNtERPREtatiON Gabriele Janner, Simulation Expert, F. HOFFmaN-la ROCHE ag identifying unclear international Regulations and the Potential10:45 Networking and Refreshment break impact of Varying interpretations on global Clinical Supplies • here to find clinical supply regulations and understanding how W11:15 dEliVERiNg adEQuatE CliNiCal SuPPliES FOR adaPtiVE tRialS interpretation can vary utilizing Strategies to Predict and Supply the Correct amount • ow to obtain an interpretation of the regulation with the right H of Clinical Supply Kits in adaptive Clinical trials regulatory contact • sing various tools and technologies to best forecast clinical supply U • hat country regulation take precedent over other country regu- W needs for adaptive trials lations for clinical supplies • reating accurate forecasts and estimates relating to adaptive C • ow to perform regulatory risk management in the clinical supply H adjustments world where nothing is black or white • xamining the likely level of necessary overage and solutions to E increase efficiency Antonia Daniel, Director, Global Head & Clinical Research Support, EiSai • eveloping a strategy to minimize the waste sometimes inherent D Mark Kothapalli, Ph.D., Global Demand and Logistics, with adaptive trial designs Investigational Material Supply, glaxOSmitHKliNE Buz Hillman, Clinical Supply Manager, 4:00 Close of Conference JaNSSEN PHaRmaCEutiCal COmPaNiES OF JOHNSON & JOHNSON12:00 ENHaNCiNg CliNiCal SuPPly mEtRiCS methods for identifying and developing appropriate metrics to improve Clinical Supply Performance • etermining the right metrics and data to collect in order to D increase efficiency in supply forecasting • esign and development of clinical supply chain metrics to mea- D sure and improve performance • Leveraging metrics to forecast future clinical supply needs Mark E. Apgar, Project Leader, Clinical Informatics, allERgaN Sponsorship and Exhibiting OpportunitiesDo you want to spread the word about your organization’s solutions and services to Lucas Carrascopotential clients who will be attending this event? Take advantage of the opportunity to Business Development Managerexhibit, present an educational session, host a networking event, or distribute promotional (212) 400-6231items to attendees. ExL Pharma will work closely with you to customize a package thatwill suit all of your needs. To learn more about these opportunities, please contact: lcarrasco@exlpharma.com To Register Call 866-207-6528 or visit www.exlpharma.com/Forecasting
  5. 5. Media Partners:Five Ways to Register group discount Program: Save 25% Per Person when Registering FourMail: ExL Events, Inc. For every three simultaneous registrations from your company, you will receive 555 8th Ave, Ste 310 a fourth complimentary registration to the program (must register 4 at one New York, NY 10018 time). This is a savings of 25% per person. Phone: 866-207-6528 Save 15% Per Person when Registering ThreeFax: 888-221-6750 Can only send three? You can still save 15% off of every registration. To find Email: register@exlpharma.com out more on how you can take advantage of these group discounts, please call 866-207-6528. Online: www.exlpharma.com/Forecasting IMPORTANT! Offers may not be combined. Discount only applies to standard rate. Make checks payable to ExL Events, Inc. and write code P1705 on your check. You may also use Visa, MasterCard, Discover or American Express. Pay- Registration Fees for Attending ExL Pharma’s 5th ments must be received in full prior to the commencement of the conference. Forecasting and Optimizing of the Clinical Supply Chain: Conference registrations may be transferred to other colleagues in the event you are unable to attend. Please notify ExL Pharma, info@exlpharma.com, prior EaRly biRd PRiCiNg to the event with the name and contact information of the replacement at- Register by Friday, January 28, 2011 : tendee. There will be an administrative charge of $300 to substitute, exchange, CORPORATE RATE: and/or replace attendance badge with a colleague occurring within five business days of the conference. Conference + Workshop $1995 Conference Only $1695 Cancellations: If you need to cancel your registration for an upcoming ExL conference, please StaNdaRd PRiCiNg note the following policies derived from the Start Date of the event: Register After Friday, January 28, 2011: Four weeks or more: A full refund (minus a $95 processing fee), or a voucher CORPORATE RATE: to another ExL event valid for two years from the voucher issue date. Conference + Workshop $2195 Four weeks or Less: A voucher to another ExL event valid for two years from Conference Only $1895 the voucher issue date. To receive a refund or voucher, please fax your request to 888-221-6750. ONSitE PRiCiNg Please Note: CORPORATE RATE: Speakers and agenda are subject to change without notice. In the event of a Conference + Workshop $2295 speaker cancellation, every effort to find a suitable replacement will be made. Conference Only $1995 *The opinions of this faculty do not necessarily reflect those of the companies they represent or ExL Events, Inc.* To Register Call 866-207-6528 or visit www.exlpharma.com/Forecasting
  6. 6. Register by January 28, 2011 to Receive our discounted Rate! q MasterCard q Visa q Discover q Amex Proudly Presents: 5th Forecasting and Optimizing Exp. Date: Make checks payable to ExL Events, Inc. PLEASE MENTION PRIORITY CODE: P1705 q Credit Card the Clinical Supply Chain 555 8th Avenue, Suite 310 New York, NY 10018 Effectively Managing the Global Clinical Supply Chain to Maximize q Check Efficiency, Meet Time Lines, Reduce Costs, and Streamline Logistics METHOD OF PAYMENT: March 8-9, 2011 • Hyatt at the Bellevue • Philadelphia, PA Name on Card: Card Number: CARD TYPE: Signature: Featured Sessions Include: industry dEFiNiNg aN OPtimal CliNiCal tRial matERial PROduCtiON PlaN Participants include: Formulating a Comprehensive Clinical Supplies Production Plan and distribution Strategy for Planning and Forecasting aStRaZENECa Lee Miller, Senior Global Clinical Supply Planning Manager, mERCK Zip: 866-207-6528 888-221-6750 allERgaN q I wish to receive email updates on Exl Pharma’s upcoming events biOmaRiN dEliVERiNg adEQuatE CliNiCal SuPPliES FOR adaPtiVE tRialS Register Me for the Conference and Workshop EiSai utilizing Strategies to Predict and Supply the Correct amount of Clinical Supply Kits in adaptive Clinical trials q I’m interested in marketing opportunities at this event F. HOFFmaN- Buz Hillman, Clinical Supply Manager, la ROCHE ag JaNSSEN PHaRmaCEutiCal COmPaNiES of JOHNSON & JOHNSON State: www.exlpharma.com/Forecasting glaxOSmitHKliNE Fax: glObal biOPHaRm CliNiCal SuPPliES OutSOuRCiNg bESt PRaCtiCES SOlutiONS implementing an Effective Clinical Supply Chain Outsourcing Strategy q Register me for the Conference Only Kevin Webb, Director of Supply Chain, biOmaRiN 555 8th Avenue, Suite 310 JaNSSEN PHaRmaCEutiCal New York, NY 10018 HOFFmaN-la ROCHE CaSE Study- RaNdOmiZatiON aNd CliNiCal SuPPly mERCK Optimizing Clinical Supply demands for global Studies using ExL Events, Inc. SuNOViON monte Carlo Simulation SuPPly CHaiN iNStitutE Gabriele Janner, Simulation Expert, F. HOFFmaN-la ROCHE agTo Register: Please contact me: PRE-CONFERENCE Establishing and implementing a Clinical Supply Chain in Emerging markets WORKSHOP Telephone: SPONSOR Company: Yes! Address: Name: Email: Dept.: To Register Call 866-207-6528 or Visit Us At City: Title: www.exlpharma.com/Forecasting q

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