dEFiNiNg aN OPtimal CliNiCal tRial matERial PROduCtiON PlaNFormulating a Comprehensive Clinical Supplies Production Plan and distribution Strategy for Planning and Forecasting Lee Miller, Senior Global Clinical Supply Planning Manager, mERCK

dEliVERiNg adEQuatE CliNiCal SuPPliES FOR adaPtiVE tRialSutilizing Strategies to Predict and Supply the Correct amount of Clinical Supply Kits in adaptive Clinical trialsBuz Hillman, Clinical Supply Manager, JaNSSEN PHaRmaCEutiCal COmPaNiES of JOHNSON & JOHNSON

CliNiCal SuPPliES OutSOuRCiNg bESt PRaCtiCESimplementing an Effective Clinical Supply Chain Outsourcing StrategyKevin Webb, Director of Supply Chain, biOmaRiN

HOFFmaN-la ROCHE CaSE Study- RaNdOmiZatiON aNd CliNiCal SuPPly Optimizing Clinical Supply demands for global Studies using monte Carlo SimulationGabriele Janner, Simulation Expert, F. HOFFmaN-la ROCHE ag

industry Participants include:aStRaZENECa

allERgaN

biOmaRiN

EiSai

F. HOFFmaN-la ROCHE ag

glaxOSmitHKliNE

glObal biOPHaRm SOlutiONS

JaNSSEN PHaRmaCEutiCal

mERCK

SuNOViON

SuPPly CHaiN iNStitutE

Proudly Presents:

Featured Sessions Include:

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

5th Forecasting and Optimizing the Clinical Supply Chain

March 8-9, 2011 • Hyatt at the Bellevue • Philadelphia, PA

Register by January 28, 2011 to Receive our discounted Rate!

To Register Call 866-207-6528 or Visit Us At www.exlpharma.com/Forecasting

SPONSORPRE-CONFERENCE WORKSHOP

Establishing and implementing a Clinical Supply Chain in Emerging markets

To Register Call 866-207-6528 or visit www.exlpharma.com/Forecasting

Dear Colleague,ExL Pharma is proud to introduce the new 5th Forecasting and Optimizing the Clinical Supply Chain event on March 8-9, 2011. This conference provides participants with the tools and knowledge to effec-tively communicate and increase transparency to better forecast clinical supply demand, manage clinical supply in emerging markets, understand the regulatory guide-lines and expectations, increase operational efficiencies, and learn new emerging forecasting technologies for global clinical supply chain excellence. This is a must attend event for everyone involved in the clinical supply chain looking to advance their knowledge and learn new strategies, while interacting with other pharmaceuticals, medical device, and biotechnology professionals.

We look forward to greeting you in March!

Sincerely,

Mary Ruggiero Kristen HunterConference Director Team Leader, Productionmruggiero@exlpharma.com ExL Pharma

Departments• ClinicalTrialsSupply/ClinicalSupplies• ClinicalTrialsLogistics,PlanningandDistribution• TrialMaterialsManagement/Planning• InvestigationalSupplies• ClinicalLabelingandPackaging• ClinicalManufacturing• ClinicalPharmacy• ShippingandDistribution• Import-ExportTradeCompliance• ClinicalOperations/Development• DrugSupplyManagement• SupplyChainManagement• IVRS/IWRS• QA/QC• DataManagement&Statistics• RegulatoryAffairs

Thisconferenceisalsoofinterestto:• ClinicalServices/ClinicalProcess

ImprovementProviders• ClinicalTechnologiesCompanies• ForecastingandSimulationTechnologies• ClinicalPackagingandLogisticsCompanies• ContractResearchOrganizations• ManufacturingSolutionProviders

Discover 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.

200 South Broad Street, Philadelphia, Pennsylvania 19102 Tel: 215-982-4900 | Fax: 215.982.4922 | Email: conciergephlph@hyatt.com

Hyatt at the Bellevue

WhoShouldAttend?Thisconferenceisdesignedforrepresentativesfrompharmaceutical,biotechnology,andmedicaldevicecompanieswithresponsibilitiesinthefollowingareas:

To Register Call 866-207-6528 or visit www.exlpharma.com/Forecasting

PRE-CONFERENCE WORKSHOP: 9:00 EStabliSHiNg a RObuSt CliNiCal SuPPly CHaiN iN EmERgiNg maRKEtS

implementing a Clinical Supply Chain in Emerging marketsBarriers 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:• Learntheregulatoryandglobalclinicalsupplyrequirementsandhowtoovercomehurdlesforshippingintoemergingclinicalsupplymarkets• Planforandbereadytohandlethechallengesofimportingandexportingclinicalsupplies• Learnhowtoleverageshippinglanestoreducethecostandtimeassociatedwiththeclinicalsupplychain• Maintainclinicalsupplyontimedeliverybyunderstandingandadaptingtothedemandsandlimitationsatlocations

Steve A. Jacobs, MBA, PRh, President, glObal biOPHaRm SOlutiONS

Pre-Conference Workshop Day One – Tuesday, March 8, 2011

1:00 CHaiRPERSON’S WElCOmE aNd OPENiNg REmaRKSRick Mann, Associate Director, Clinical Trial Material Management, SuNOViON PHaRmaCEutiCalS

1:15 imPROViNg tHE CliNiCal SuPPliES ExECutiON tHROugH COllabORatiON aNd COmmuNiCatiONbuilding and Optimizing inter-departmental Communications and Collaborations to better Forecast Clinical Supply demand• Increasingtransparencybydevelopingcommunicationandknowl-

edge transfer with QA, regulatory, supply and clinical team members• Proactiveandearlyengagementtechniquesthatincreasecom-

munication and best practices for exchanging information and adjusting clinical supply projections

• Mappingtheclinicalsupplyprocesstobestidentifywheretoimplement better supply and demand management

• Understandingtheleader’scorporateresponsibilitytoeffectivelycommunicate up and down the chain

Kathie Sweeney, Investigational Products, aStRaZENECa

2:00 dEFiNiNg aN OPtimal CliNiCal tRial matERial PROduCtiON PlaNFormulating a Comprehensive Clinical Supplies Production Plan and distribution Strategy for Planning and Forecasting • Beginwiththeendinmindtocomprehensivelymanagetheclinical

supply chain and establish an efficient distribution strategy• Assessingkeyareasofimprovement,reducingwaste,andcontrol-

ling costs in clinical supply chain management• Effectivelymanagingchangeintheclinicalsupplychaintoadaptto

new clinical trial demands

Lee Miller, Senior Global Clinical Supply Planning Manager, mERCK

2:45 uNdERStaNdiNg aNd imPROViNg tHE lOgiStiCS imPaCtiNg tHE CliNiCal SuPPly CHaiNEnhancing demand and Supply Forecasts by aligning Supply Operations to Ensure a Robust delivery• Understandingthenewestconceptsinpackagingtoincludean

overview of new packing systems and their mobile environment, best packaging methods to guarantee stability and study execution, and ensuring temperature control across the entire supply chain

• Waystogetthemostoutoflabelingoperationsthrough:languagelibraries, investigator-specific labeling for kits, just-in-time labeling

• Howtoimproveshippingcontrolandtransparencybytracking

the temperature of supplies during transport, monitoring the delivery status to meet on time metrics, and ensuring products are safe and meet environmental requirements

Javad Seyed, PhD, Adjunct Professor, Operations Management, Performance and Risk Analysis, Principal Founder, SuPPly CHaiN iNStitutE

3:30 Networking and Refreshment break

4:00 PaNEl diSCuSSiON- CONtROl COSt aNd maximiZE tHE EFFiCiENCy OF tHE CliNiCal SuPPly CHaiN tHROugH tHE uSE OF NEW tECHNOlOgy Enhancing the Clinical Supply Chain through the use and application of New technology Programs to Reduce Costs and meet time lines • Whyitisimportanttoshowthebaselinebeforeimplementing

the new technology to clearly show the return on investment of the new systems

• Howyoucanensureconsistentontimedeliverywiththehighestquality by partnering with your stakeholders

• The future of forecasting services and applications of the clinical supply chain Gabriele Janner, Simulation Expert, F. HOFFmaN-la ROCHE agRick Mann, Associate Director, Clinical Trial Material Management, SuNOViON PHaRmaCEutiCalSAre you interested in speaking on this session? If so please call Mary Ruggiero at (212) 400-6242 mruggiero@exlpharma.com

4:45 ROuNdtablE diSCuSSiONSChoose from one of the following roundtable sessions: 1) RElatiONSHiP buildiNg: Identifying and selecting clinical supply

third party logistics (3PL) and CROs, and building the relationship to optimize delivery

2) mid-Study mOdiFiCatiONS: Challenges and considerations when modifying the clinical supply chain mid study

3) gREEN CliNiCal SuPPly CHaiN: The application and value of a “green” clinical supply chain solution

4) PREdiCtiVE mOdEliNg tOOlS: Risk-based predictive modeling tools to best assist with clinical demand planning scenarios

5) imPORt/ExPORt REgulatiONS: Understanding US import/export regulations and hurdles

5:30 Close of day One

10:30 30-minute Networking & Refreshment break

12:00 Workshop Concludes; luncheon for Workshop Participants

8:00 Registration and Continental breakfast for Workshop Participants

Main Conference Begins Day One

To Register Call 866-207-6528 or visit www.exlpharma.com/Forecasting

Main Conference Day Two – Wednesday, March 9, 20118:00 Continental breakfast for Conference Participants

9:00 CHaiRPERSON’S RECaP OF day ONE aNd KEy POiNtS FROm ROuNdtablE diSCuSSiONS

Rick Mann, Associate Director, Clinical Trial Material Management, SuNOViON PHaRmaCEutiCalS

9:15 maximiZiNg tHE ValuE OF iNtERaCtiVE RESPONSE tECHNOlOgy using Either interactive Voice Response (iVR) or interactive Web Response (iWR) Systems to Control Cost and Optimize Production of Clinical Supplies• UnderstandingwhentoemployIVRandIWRIndependentlyorincom-

bination, how to clearly show the cost benefit of using these systems• LearninghowIVR/IWRcanstreamlineclinicalsupplyoperations

and reduce overage• SelectinganInteractiveResponseTechnology(IRT)system,estab-

lishing what IRT functions will improve the efficiency of the clinical supply chain

• Evaluatingthebenefitsofmanaginguse-bydatesusingIRTtechnology

10:00 HOFFmaN-la ROCHE CaSE Study- RaNdOmiZatiON aNd CliNiCal SuPPly Optimizing Clinical Supply demands for global Studies using monte Carlo Simulation• Howtounderstandanddealwiththeunequalallocationtotreat-

mentandoptimizationofsite’ssupplystrategy• KnowhowtoindentifykeyblindingconsiderationswhensettingupIVRS

• Howtobetterunderstandtheimpactofrandomizationbalancingonaclinicaltrial’ssupply

Gabriele Janner, Simulation Expert, F. HOFFmaN-la ROCHE ag

10:45 Networking and Refreshment break

11:15 dEliVERiNg adEQuatE CliNiCal SuPPliES FOR adaPtiVE tRialSutilizing Strategies to Predict and Supply the Correct amount of Clinical Supply Kits in adaptive Clinical trials• Usingvarioustoolsandtechnologiestobestforecastclinicalsupply

needs for adaptive trials• Creatingaccurateforecastsandestimatesrelatingtoadaptive

adjustments• Examiningthelikelylevelofnecessaryoverageandsolutionsto

increase efficiency• Developingastrategytominimizethewastesometimesinherent

with adaptive trial designs

Buz Hillman, Clinical Supply Manager, JaNSSEN PHaRmaCEutiCal COmPaNiES OF JOHNSON & JOHNSON

12:00 ENHaNCiNg CliNiCal SuPPly mEtRiCS methods for identifying and developing appropriate metrics to improve Clinical Supply Performance• Determiningtherightmetricsanddatatocollectinorderto

increase efficiency in supply forecasting• Designanddevelopmentofclinicalsupplychainmetricstomea-

sure and improve performance• Leveragingmetricstoforecastfutureclinicalsupplyneeds

Mark E. Apgar, Project Leader, Clinical Informatics, allERgaN

12:45 luncheon

1:45 CliNiCal SuPPliES OutSOuRCiNg bESt PRaCtiCESimplementing an Effective Clinical Supply Chain Outsourcing Strategy• Identifyingwhataspectsofclinicalsupplyshouldbeoutsourced,

and finding the best outsourcing partners

• Theprosandconsofworkingwithlocalorforeignclinicalsupplyvendors

• Managingexpectations,deliverables,andthelongtermrelationshipbetween sponsor companies and vendors

• Techniquesformanagingescalatingclinicalsuppliesworkloadandhow outsourcing can be a solution

Kevin Webb, Director of Supply Chain, biOmaRiN

2:30 CliNiCal labEliNg SyStEmSOptimizing the Clinical Supply Chain through the use of New labeling technology • Newlabellingtechnologythatenhancesglobalclinicalstudies

through the use of a language library that can be used for rapid design

• Learnthemethodsofnewelectronicroutingoflabelsforrapidapprovals

• Understandingnewlabelingtechnologythatenhancesaccountabil-ity of clinical supplies through bar code scanning

Steve A. Jacobs, MBA, R.Ph, President, glObal biOPHaRm SOlutiONS

3:15 REgulatiON VS iNtERPREtatiONidentifying unclear international Regulations and the Potential impact of Varying interpretations on global Clinical Supplies • Wheretofindclinicalsupplyregulationsandunderstandinghow

interpretation can vary

• Howtoobtainaninterpretationoftheregulationwiththerightregulatory contact

• Whatcountryregulationtakeprecedentoverothercountryregu-lations for clinical supplies

• Howtoperformregulatoryriskmanagementintheclinicalsupplyworld where nothing is black or white

Antonia Daniel, Director, Global Head & Clinical Research Support, EiSaiMark Kothapalli, Ph.D., Global Demand and Logistics, Investigational Material Supply, glaxOSmitHKliNE

4:00 Close of Conference

Do you want to spread the word about your organization’s solutions and services to potential clients who will be attending this event? Take advantage of the opportunity to exhibit, present an educational session, host a networking event, or distribute promotional items to attendees. ExL Pharma will work closely with you to customize a package that will suit all of your needs. To learn more about these opportunities, please contact:

Sponsorship and Exhibiting OpportunitiesLucas CarrascoBusiness Development Manager

(212) 400-6231lcarrasco@exlpharma.com

To Register Call 866-207-6528 or visit www.exlpharma.com/Forecasting

group discount Program:

Save 25% Per Person when Registering Four

For every three simultaneous registrations from your company, you will receive afourthcomplimentaryregistrationtotheprogram(mustregister4atonetime).Thisisasavingsof25%perperson.

Save 15% Per Person when Registering Three

Canonlysendthree?Youcanstillsave15%offofeveryregistration.Tofindout more on how you can take advantage of these group discounts, please call 866-207-6528.

IMPORTANT!Offersmaynotbecombined.Discountonlyappliestostandardrate.MakecheckspayabletoExLEvents,Inc.andwritecode P1705 on your check.YoumayalsouseVisa,MasterCard,DiscoverorAmericanExpress.Pay-ments must be received in full prior to the commencement of the conference.

Conference registrations may be transferred to other colleagues in the event youareunabletoattend.PleasenotifyExLPharma,info@exlpharma.com,priorto the event with the name and contact information of the replacement at-tendee.Therewillbeanadministrativechargeof$300tosubstitute,exchange,and/orreplaceattendancebadgewithacolleagueoccurringwithinfivebusinessdays of the conference.

Cancellations:

IfyouneedtocancelyourregistrationforanupcomingExLconference,pleasenotethefollowingpoliciesderivedfromtheStartDateoftheevent:

Fourweeksormore:Afullrefund(minusa$95processingfee),oravouchertoanotherExLeventvalidfortwoyearsfromthevoucherissuedate.

FourweeksorLess:AvouchertoanotherExLeventvalidfortwoyearsfromthe voucher issue date.

Toreceivearefundorvoucher,pleasefaxyourrequestto888-221-6750.

Please Note: Speakers and agenda are subject to change without notice. In the event of a speaker cancellation, every effort to find a suitable replacement will be made.

*The opinions of this faculty do not necessarily reflect those of the companies they represent or ExL Events, Inc.*

Media Partners:

Mail: ExL Events, Inc. 555 8th Ave, Ste 310 New York, NY 10018

Phone: 866-207-6528

Fax: 888-221-6750

Email: register@exlpharma.com

Online: www.exlpharma.com/Forecasting

Registration Fees for Attending ExL Pharma’s 5th Forecasting and Optimizing of the Clinical Supply Chain:

EaRly biRd PRiCiNgRegister by Friday, January 28, 2011 :

CORPORATE RATE:Conference + Workshop $1995Conference Only $1695

StaNdaRd PRiCiNgRegister After Friday, January 28, 2011:

CORPORATE RATE:Conference + Workshop $2195Conference Only $1895

ONSitE PRiCiNgCORPORATE RATE:Conference + Workshop $2295Conference Only $1995

Five Ways to Register

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Formulating a Com

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industry Participants include:

aStRaZENECa

allERgaN

biOmaRiN

EiSai

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la ROCHE ag

glaxOSmitHKliNE

glObal biOPHaRm

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To Register Call 866-207-6528 or Visit Us At www.exlpharma.com/Forecasting

Proudly Presents:

Featured Sessions Include:

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

5th Forecasting and Optim

izing the Clinical Supply Chain

March 8-9, 2011 • Hyatt at the Bellevue • Philadelphia, PA

Register

by January 28, 2011 to Receive our d

iscounted Rate!

SPONSO

RPRE-CONFERENCE W

ORKSHOPEstablishing and im

plementing a Clinical

Supply Chain in Emerging m

arkets

To Register:ExL Events, Inc. 555 8th Avenue, Suite 310 New York, NY 10018

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