cmo quality oversight & risk management, april 2011, boston

Featured Presentations:

April 28th – 29th, 2011, Omni Parker House Hotel, Boston MA

CMo Quality oversight & risk ManageMent

Managing CMOs to Deliver Your Product to Your Quality & Time Requirements

dhan amaria, Director, Quality Assurance, NEKTAR THERAPEUTICS

rhonda Fendelet, Director, External Supply Integration Quality – PDMS, JANSSEN SUPPLY CHAIN

rolf hartmann, Procurement Director, GLAXOSMITHKLINE

Juanita hawkins, Vice President, Global Quality Assurance and Compliance, CELGENE

Jeff huth, Ph.d., Leader, Quality & Compliance, JANSSEN ALZHEIMER IMMUNOTHERAPY RESEARCH & DEVELOPMENT

denise Mcdade, Senior Director, Quality Assurance, AMYLIN PHARMACEUTICALS

robert o’hagan, Director Quality Operations,ABBOTT BIORESEARCH CENTER

Caroline o’Brien, Associate Director QA Sourcing, Pharmaceutical Development, ASTRAZENECA

sandra roque, Director, Manufacturing QA, NOVEN PHARMACEUTICALS

Prashant savle, Ph.d., Director, Sourcing, Global Procurement, MERCK SHARPE & DOHME

Michael semo, Global Sourcing Manager, Virtual CMC Team, ELI LILLY & COMPANY

g. sean Williams C.P.M., sCor-P,Associate Dir, Global Facilities Procurement, BRISTOL-MYERS SQUIBB

Janice B Wilson, Phd, Vice President Corporate Quality Assurance, ELAN PHARMACEUTICALS

REGISTER BY FeBruary 25

AND SAVE $400!

regulatory Perspective on Quality assurance within the evolving Contract Manufacturing relationship sandra roque, Director, Manufacturing QA, NOVEN PHARMACEUTICALS

applying a risk Management system to the Contracting Process to sustain the highest level of Quality from a CMo/sponsor relationshipCaroline o’Brien, Associate Director QA Sourcing, PharmaceuticalDevelopment, ASTRAZENECA

how overall Product lifecycle and Product Phases including Commercialization Can Factor into the Contract Manufacturing relationship Jeff huth, Ph.d., Leader, Quality & Compliance, JANSSEN ALZHEIMER IMMUNOTHERAPY RESEARCH & DEVELOPMENT

Featured Panel disCussion:

global Considerations and Business differences when Contracting an off-shore CMo Partner: how Close are We to a harmonized standard of gMP?Panelists:

Prashant savle, Ph.d., Director, Sourcing, Global Procurement, MERCK SHARPE & DOHME

Michael semo, Global Sourcing Manager, Virtual CMC Team, ELI LILLY & COMPANY

dhan amaria, Director, Quality Assurance, NEKTAR THERAPEUTICS

sPeaking FaCulty

To Regis ter Cal l 866-207-6528 or v is i t www.exlpharma.com/cmo

Dear Colleague,There is industry agreement that a substantial investment must be made to

support the life-cycle of a pharmaceutical product from the developmental stage

to commercial production. There is also definitive data that shows in addition to

the FDA, regulatory bodies worldwide are becoming more and more conservative

with the candidates they approve for commercial access.

Within the contract manufacturing relationship, pharmaceutical companies are

taking the necessary steps to adjust to this changing industry trend, providing

increased resources to ensure control and consistency in the manufacturing of

their products to avoid unnecessary delays including regulatory action.

Join us April 28th - 29th where presentations dedicated to the successful CMO

partnership dynamic will be shared, including best practices in management such

as quality oversight, risk management, and ensuring time requirements are met.

The FDA has made it clear that if your name is on the label, you are responsible

for what’s inside the package.

Look forward to seeing you in Boston!

Sincerely,

Matthew MillmanSenior Conference [email protected]

OmNI PARkER HOuSE HOTEl

60 School StreetBoston, MA 02108

P:617-227-8600

As you pass through the sculpted bronze doors of this luxury Boston hotel, you will be enveloped by the timeless beauty that has made the Omni Parker House a landmark since 1855. Experience the perfect blend of modern amenities and historic charm at America’s oldest continuously-operating hotel. Walk to Beacon Hill, Faneuil Hall Marketplace, Quincy Market, the Financial District, shopping and more. Just 2.5 miles (10-15 minutes) from Logan International Airport.

room reservations: If you require overnight accommodations, please contact the hotel and state that you are with ExL’s CMO Quality Oversight & Risk Management Conference for information on our discounted room rates. We encourage conference participants to make reservations by Wednesday, April 6th with our designated venue as our discounted room rates are limited.

Sponsorship and Exhibit Opportunities

Do you want to spread the word about your organization’s solutions and services to potential clients who attend this event? Take advantage of the opportunity to exhibit, present an educational session, host a networking event, or distribute promotional items to attendees. ExL works closely with you to customize a package that suits all of your needs.

To learn more about these opportunities, contact Eric Morrin, Business Development Manager by calling 212-400-6228 or by emailing

[email protected].

This Summit is specifically designed for C-Levels, Department Heads, Vice Presidents, Directors and Managers at pharmaceutical, biotechnology and medical device companies from the following

departments:

Contract manufacturing

manufacturing Operations

Regulatory Affairs

Regulatory Compliance

Validation

Compliance

Quality Assurance

Quality Operations

Quality Development

Outsourcing

Sourcing

Supply Chain

Operational Excellence


Pre-ConFerenCe WorkshoP


day one – aPril 28th, 2011

8:00 Registration Opens and Continental Breakfast is Served for Workshop Attendees

9:00 selecting a CMo Partner

HowIncludingQualityEarlyintheSelectionProcesscanEnsurea StrongerOverallPartnership Led By: JaniceBWilson,PhD,Vice President Corporate Quality Assurance, ELAN PHARMACEUTICALS

• Includingqualityintheselectionprocess -Transparencyandaccessibilityofapotentialpartners’qualityhistory -Whatqualityfactorstolookforfromapartner -Whatissuescankillthedeal?

• Designingqualityagreementswithclearcriteriathatdefinetheresponsibilitiesofanoutsourcedpartner-IdentifyingtheimportantdeliverablesthatneedtobeincludedintheQualityAgreement-CustomizingaQualityAgreementthatfitsaspecificprojectaspect-Determiningwhichtypesofagreementstouse–technicalversusquality?Whatisthedifference?-ModifyingaQualityAgreementtoreflectexistingregulationsandindustrystandards

*There will be a 30-minute coffee and networking break during the workshop

12:00 Lunch for Workshop Attendees / Registration Opens for Main Conference

Main ConFerenCe

1:15 Chairperson’s Welcome and Opening Remarks

1:30 keynote talk: CMo ManageMent strategy

AligningYourCorporatePhilosophyandYourCMOOutsourcing StrategytoAchieveBusinessObjectives JuanitaHawkins, Vice President, Global Quality Assurance and Compliance, CELGENE

• Gaininginternalbuy-inandunderstandingtheriskrelatedtostrategy• Criticaldecisionmakingforinternal,externalorhybridmanufacturingallocation• Clarityforexpectations,delegatingworkversusresponsibility,andcontrol

2:15 regulatory Perspective

RegulatoryPerspectiveonQualityAssurancewithinthe EvolvingContractManufacturingRelationship SandraRoque, Director, Manufacturing QA, NOVEN PHARMACEUTICALS

• Agencyconcernsoverbusinessprocedures• ExpectationsforbothsponsorsandcontractsitesduringinspectionsandGMP

assessments• Bestpracticestoensurethatsponsors,contractmanufacturersandregulatory

agenciesareallonthesamepage• Upcominganticipatedguidanceforselectionofacontractfacilityand

conductingaudits

3:00 networking & refreshment Break

3:30 Case study: integrated Facilities Management outsourcing

ThinkingwiththeEndinMind:DrivingaStreamlinedGlobal IntegratedFacilitiesManagementOutsourcingDealfromConcept toImplementation G.SeanWilliamsC.P.M.,SCOR-PAssociateDir,GlobalFacilities Procurement,BRISTOL-MYERSSQUIBB

• EvaluatingtheprosandconstounderstandwhetheranIFMprogramfitsintoyourcompany’sstrategicplanning

• Buildingtheappropriatequalityandperformancemeasurementsinthenegotiationtopreventpostimplementationmarginerosion

• KeydriversofServiceProviderdownselectingoutsideofcost

4:15 Communication TheRoadmapforSuccessfulCommunicationwithinaPartnershipthat DrivesQualityOversightSuccess RhondaFendelet, Director, External Supply Integration Quality – PDMS, JANSSEN SUPPLY CHAIN

• ThegovernancemodelanddeploymentofCommunicationPlan• Clarifyingroles&responsibilitieswithintherelationshiptoavoiddysfunction• Usingmetricsandfeedbackasthekeyperformanceindicatorsforsuccess

5:00 Close of day one

Main ConFerenCe


day tWo – aPril 29th, 2011

9:00 Chairperson’s Day Two Welcome and Opening Remarks

9:05 lifecycle Considerations

HowOverallProductLifecycleandProductPhasesIncluding CommercializationCanFactorintotheContractManufacturing Relationship JeffHuth,Ph.D., Leader, Quality & Compliance, JANSSEN ALZHEIMER IMMUNOTHERAPY RESEARCH & DEVELOPMENT

Contract Manufacturing Organizations face an evolutionary dilemma in trying to establish their business plan strategy and technical capabilities every day. While clearly there is a capital investment consideration in this regard, there are also key technical, operational, and regulatory considerations. ThisSessionwillExamine:• Elementsassociatedwithpharmaceuticalproductlife-cycleastheyrelatetothe

technical,operational,andregulatoryissues• Discussiononthesignificanceofthepartnershipsrequiredtosuccessfullymanage

theevolutionarypharmaceuticalproductlife-cycle• HowICHguidanceconcepts(inparticular,ICHQ10)canprovideaplatformtonot

onlymanagetherelationship,buttoenhanceit.

9:45 risk Management ApplyingaRiskManagementSystemtoVendorAssuranceandSupplier ManagementinDevelopment CarolineO’Brien, Associate Director QA Sourcing, Pharmaceutical Development, ASTRAZENECA

• Clearlyandthoroughlytranslatingriskfactorsformaterials,processesandsuppliers• UnderstandingofSupplyChainandapplicationofriskmanagedsupplierauditing• DevelopmentandmaintenanceoftheholisticapproachtoSupplierManagement

10:30 networking & refreshment Break

11:00 spotlight session: outsourcing and Quality in latin america ConsiderationswhenContractingaCMOPartnerinLatinAmerica: RegionalBenefits&Constraints RolfHartmann,Procurement Director, GLAXOSMITHKLINE

• ExaminingcostdifferencesbetweenCMOsinLatinAmericaandotherRegions• Ensuringqualitystandardsandregulatoryrequirementsaremetandkeptwhen

workingwithaninternationalCMO• LatinAmericaregionalsnap-shot:contractingintraditionalversus

non-traditionalcountries

11:45 international Considerations PANELDISCUSSION:GlobalConsiderationsandBusinessDifferences whenContractinganOff-ShoreCMOPartner:HowCloseareWeto aHarmonizedStandardofGMP? Panelists Include: DhanAmaria,Director, Quality Assurance, NEKTAR THERAPEUTICS PrashantSSavle,Ph.D.,Director, Sourcing, Global Procurement, MERCK SHARPE & DOHME MichaelSemo,Global Sourcing Manager, Virtual CMC Team, ELI LILLY & COMPANY

• Whatarethedifferencesbetweenadomesticpartnerandaninternationalone,ifany?

• Whatculturalconsiderationsshouldbemadepriortocommencementofthepartnershipandhowdotheseaffectthelevelofcommunicationandexpectations?

• Howdoesriskacceptabilityvarybetweenasponsorandacontractpartner?

12:30 lunch

1:30 Metrics UsingKPIsandOperationalExcellencetoEnsureQualityinan OutsourcedSupplyChain DeniseMcDade, Senior Director, Quality Assurance, AMYLIN PHARMACEUTICALS

• Settingqualityoversightstandardsthatdrivethelevelofperformancemeasurementanddatacollection

• Buildingacorporateculturethatcancreateastrategytomeetthestandardsnecessaryforqualityexcellence

• Adoptingrisk-sharedprinciplesthatextendaccountabilitytoaproject-widescope

2:15 aPi development KeysforSuccessfulContractManufacturingofBiologicalAPI’sto SupportClinicalandCommercialMaterial RobertO’Hagan, Director Quality Operations, ABBOTT BIORESEARCH CENTER

• CMOSelectionConsiderations• SuccessfulBusinessModelforCMOthroughproductlifecycle• QualityAgreementsandRegulatoryConsiderations

3:00 Closing Panel disCussion: Decommissions,FacingProblems,andAcceptingthatthePartnership isFaulty–WhatShouldbeDonetoMinimizetheFailure FeaturingConferencePresenters

• Whataretheinitialstepstobetakenonceapartnershipisdisconnected?• Howtocalculatethefinancialimplicationsfromthemisstepsthathaveoccurred?• Determinewhattheconsequencesareandiftheycanbefixed?• Whatarethepublicandreputationaldamagethathasbeendone?

3:45 Close of Conference

RegistRation Fees FoR attending

exl’s CMo Quality oversight &

risk ManageMent ConFeRenCe:

Best valueREgISTER By FRIDAy, FEBRuARy 25TH AnD SAvE $400!

COnFEREnCE + WORkSHOP | $1795

COnFEREnCE OnLy | $1495

early-Bird PriCingREgISTER By FRIDAy, MARCH 25TH

TO TAkE ADvAnTAgE OF EARLy-BIRD PRICIng:



standard PriCingREgISTER AFTER MARCH 25TH:



visit WWW.exlPharMa.CoM/CMo

TO VIEw OuR VAluE JuSTIfICATION DOCumENT!

Group Discount proGram:

save 25% Per Person When registering Four For every three simultaneous registrations from your company, you will receive a fourth complimentary registration to the program (must register 4 at one time). this is a savings of 25% per person.

save 15% Per Person When registering three Can only send three? You can still save 15% off of every registration. to find out more on how you can take advantage of these group discounts, please call 866-207-6528.

Make checks payable to exl events, inc. and write code P742 on your check. You may also use Visa, MasterCard, discover or american express. Payments must be received in full 2 weeks prior to the conference.

Cancellations: if you need to cancel your registration for an upcoming exL conference, please note the following policies derived from the start date of the event:

• Four weeks or more: a full refund (minus a $95 processing fee), or a voucher to another exL event valid for two years from the voucher issue date Four weeks or less: a voucher to another exL event valid for two years from the voucher issue date.

• to receive a refund or voucher, please fax your request to 888-221-6750.

• there will be an administrative charge of $300 to substitute, exchange and/or replace attendance badges with a colleague occurring within five business days of the conference.

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. ExL Pharma’s liability is limited to the conference registration fee in the event of a cancellation*The opinions of this faculty do not necessarily reflect those of the companies they represent or ExL Events, Inc.*

Five Ways to register

PHOnE: 866-207-6528

EMAIL: [email protected]

OnLInE: www.exlpharma.com

FAx: 888-221-6750

MAIL: ExL Events, Inc.

555 8th Ave, Ste 310

new york, ny 10018

mEDIA PARTNERS

QuESTIONS? COmmENTS?do you have a question or comments that you would like to be addressed at this event? Would you like to get involved as a speaker or discussion leader?

Please email Conference director, Matt Millman at [email protected]

Regulatory Perspective on Quality Assurance within the Evolving Contract manufacturing Relationship

Applying a Risk management System to the Contracting Process to Sustain the Highest level of Quality from a CmO/Sponsor Relationship

How Overall Product lifecycle and Product Phases Including Commercialization Can factor into the Contract manufacturing Relationship

Global Considerations and Business Differences when Contracting an Off-Shore CmO Partner: How Close are we to a Harmonized Standard of GmP?

CMo Quality oversight & risk ManageMent

Managing CMOs to Deliver Your Product to Your Quality & Time Requirements

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

Featured Presentations:

ExLEvents,Inc.5558thAvenue,Suite310NewYork,NY10018

866-207-6528

888-221-6750

[email protected]

www.exlpharma.com/cmo

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sPeaking FaCultyFroM these CoMPanies

NEKTAR THERAPEUTICS

MERCK

GLAXOSMITHKLINE

CELGENE

ASTRAZENECA

NOVEN PHARMACEUTICALS

ELI LILLY & COMPANY

BRISTOL-MYERS SQUIBB

ELAN PHARMACEUTICALS

REGISTER BY FeBruary 25

AND SAVE $400!

April 28th – 29th, 2011, Omni Parker House Hotel, Boston MA

cmo quality oversight & risk management, april 2011, boston

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