5th lean sigma & kaizen for pharma r&d...

3rd Patient Engagement Summit3rd Annual Clinical Site Feasibility, Selection and Start-Up6th Forecasting & Optimization of the Clinical Supply Chain8th Latin America Clinical Trials Conference

Part of ExL Pharma’s

Register Now 866-207-6528 | www.crownclinical.com/lean

Seeing Problems in R&D, Solving Them, and Doing It Over Again and Again

Lean Sigma & Kaizen for Pharma R&D Conference

5th

Featured Sessions Include:Utilization of Lean Six Sigma To Speed Innovation

Building and Managing Through A3s

March 19–21, 2012 | Loews Hotel | Philadelphia, PA

Bringing Smaller Projects Under a Common Initiative by Aligning Interest from the Company President to the Individual Contributor

Ian See, Senior Director of Operational Excellence, MEDIMMUNE

Reducing Development Time in Order to Reach the Patients Faster – The Patients are Waiting!Joergen Ahm Petersen, Senior LEAN Project Manager, Financial Development & Strategic Planning, LEO PHARMA

Martin Hynes III, PhD, Senior Director, Product Research & Development, and Six Sigma Champion, ELI LILLY

Trafford Clarke, Executive Director, Six Sigma, ELI LILLY

The Purple Path to Operational Excellence

Patricia Hayes, Continuous Improvement Leader, R&D, ASTRAZENECA

Terence Barnhart, Senior Director, Strategy and Continuous Improvement, PFIZER

Bella Englebach, Senior Director, Strategic Business Improvement, CENTOCOR R&D

Applying Lean to the Regulatory Submissions Process

Patrick McCann, Associate Director of R&D Operations, BRISTOL-MYERS SQUIBB

Don’t Miss: 15+ 10+ 2 Two Separate Tracks Tailored to Clinical and Research Improvement

Yellow Belt Certification Pre-Conference Workshop

Unique Process Improvement Sessions

Different Pharma Companies Sharing Best Practices

Register Now | 866-207-6528 | www.crownclinical.com/lean

Loews Philadelphia Hotel1200 Market Street, Philadelphia, PA 19107Phone: (215) 627-1200 | Reservations: (888) 575-6397

Directly across from the Penn Convention Center, the Loews Philadelphia Hotel is 15 minutes from the Philadelphia International Airport, five minutes from the Amtrak 30th Street Station, and steps away from the his-toric district, shopping, restaurants, and sports arenas.

To make reservations, please call Loews Reservations at 1-888-575-6397 and request the negotiated rate for ExL’s CROWN. You may also use the following Web link to make reservations online:

http://www.loewshotels.com/en/Philadelphia-Hotel/GroupPages/253EXL.

The group rate is guaranteed until February 27, 2012.

Who should attend?R&D executives from Pharma, Biotech, and Medical Device companies who are responsible for:

• ProcessImprovement

• ContinuousImprovement

• Lean,SixSigma,Kaizen

• ClinicalOperations

• OperationalExcellence

• ClinicalResearch

• QualityAssurance/QualityControl

• Training

• ChangeManagement

• MetricsandBenchmarkingDevelopment

• PerformanceManagement

• GlobalStrategy

• DataManagement

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

9:00 Lean Kaizen Certification: Lean Six Sigma Yellow Belt ClassThis workshop course is designed to offer participants a broad understanding of Six Sigma and Lean methodologies. Participants will develop the capability to understand and use basic tools for process improvement while gaining the ability to contribute to Lean Six Sigma projects and deliver meaningful results.Over half of your time in the course will be working through interactive practice exercises and online self-assessments. Choose the examples you’d like to see in the training. Get prepared to play an important role as part of a process improvement team, as you become prof icient in using basic problem-solving tools.

Learning Objectives• CommunicateusingLeanSixSigmaconcepts• RelateLeanSixSigmaconceptstooverallbusinessobjectives• Usethefive-stepDMAICmodeltoimproveprocesses• Buildandunderstandprocessmaps• Identifytherootcauseofaproblem• Useafailuremodeandeffectsanalysistosetprioritiesforimprovement• Documentprocesschangesanduseacontrolplantopreventbacksliding

Who Should AttendAttendeesshouldbethoseseekingtoexpandtheirprocessimprovementskillsand/or companies that have embarked upon a Lean Six Sigma deployment.Donotmissthiscourseif:• YouareplanningtoparticipateonaLeanSixSigmaTeam• Yourorganizationisstartingacontinuousprocessimprovementprogram• Youareafunctional-levelmanagerwhowantstohavevisualtoolsto

enable quick wins in your areas of responsibility • Youarealeaderwhowishestobetterunderstandtheapplicationof

Lean Six Sigma tools (visual)

Certification Workshop Leader: David Asher, President and CEO, ASHER ASSOCIATES

3:00 Certification Concludes

Pre-Conference Workshop Day: Monday, March 19, 2012

Lean Six Sigma Yellow Belt Class

Lunch will be served for Certification attendees.

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Conference Day One: Tuesday, March 20, 2012

8:00 Registration and Continental Breakfast Opens

9:00 Chairman’s Welcome and Opening Remarks


9:15 LEAN IMMERSION MINI-WORKSHOP: Building and Managing Through A3sTrulyleanorganizationsaremorecompetitivebecausetheyknowhowto:• Makeproblemsvisible• Solveproblemseffectively• BuildtheirknowledgecapitalThePDCAcycle(Plan,Do,Check,Act)isthefoundationalbuildingblockofLean.TheA3processprovidesstructureanddirectionforef-fectivePDCAproblem-solving.Duringthissession,youwilllearnaboutPDCAandhowtouseA3stoensure effective problem-solving and knowledge-sharing, with hands-on practiceaddressingrealbusinessandscientificproblems.ParticipantswillhavetheopportunitytoshareideasabouthowPDCAisandshould be used in the drug development process.

Workshop Leaders:


Bella Englebach, Senior Director, Strategic Business Improvement, CENTOCOR R&D

12:15 Lunch

HOW LEAN IN PHARMA R&D IS WORKING ACROSS DIFFERENT ORGANIZATIONS

1:15 ORGANIZATIONAL SPOTLIGHT: MEDIMMuNEBringing Smaller Projects under a Common Initiative by Aligning Interest from the Company President to the Individual ContributorMedImmunehascreatedalargescaleinitiativetoremove2+yearsofproduct development, resulting in a new dynamic where employees now nominate projects for the operational excellence team, instead of the department having to seek them out.HearsomeofthecompellingprojectsMedImmunehastoshare.

Ian See, Senior Director of Operational Excellence, MEDIMMuNE

2:00 ORGANIZATIONAL SPOTLIGHT: ELI LILLY & CO.utilization of Lean Six Sigma to Speed InnovationThis presentation will provide tangible examples of how Lean Six Sigmamethodologycan:• Increasetheprobabilityoftechnicalsuccessinadiscoveryenvironment• Decreasecostandcycletimeofnewdrugdevelopmentduringthe

development phase• Improveregulatorycomplianceintheregulatedareas/functions

engaged in bringing innovative new pharmaceutical agents to patients in need


Trafford Clarke, PhD, Executive Director, Six Sigma, ELI LILLY

2:45 Networking and Refreshment Break

3:15 ORGANIZATIONAL SPOTLIGHT: ASTRAZENECAThe Purple Path to Operational Excellence• Introducingaprocessownertoensureprocessexcellence• Breakingdownsiloswithacross-functionalversusfunctional

perspective• Examplesofinnovativeprocessimprovementmethodologies

to reduce cycle time

Patricia Hayes, Continuous Improvement Leader, R&D, ASTRAZENECA

4:00 ORGANIZATIONAL SPOTLIGHT: LEO PHARMACEuTICALSBecoming Patient Centric: Reducing Development Time in Order to Reach the Patients Faster – The Patients are Waiting!LeoPharmaGroupManagementhasselectedoneimportantR&Dproject to act as a platform for a series of improvement activities that will be implemented to speed up the project. The improvement activities are led by a skilled Lean Six Sigma Task Force selected from differentfunctionalareasacrosstheorganization.• Runningseveralprojectsinaprogramframeworksupportingonly

oneR&Dproject• Projectacceleratorconcept–A3stepapproach: o Support the daily project execution o Optimizetheprocessesaheadoftheproject o DocumentandsharebestpracticeswithupcomingR&D

projects

Joergen Ahm Petersen, Senior Lean Project Manager, Financial Development & Strategic Planning, LEO PHARMA

4:45 PANEL DISCuSSION:

Not Only Changing Culture, But Sustaining Improvement and Optimizing Workforces

• Definingcommunicationandhowtocommunicateproperly• Processimprovementanditsroleininnovation• Therootcauseofresistanceandsustainingprogressoverthe

long term

Moderator:


Panelists:

Alister Thomson, Director, Strategic Process Optimization, BRISTOL-MYERS SQuIBB COMPANYHeike Roeder, Global SOP & Training Management, uCB

Patricia Hayes, Continuous Improvement Leader, R&D, ASTRAZENECAMartin Hynes III, PhD, Senior Director, Product Research & Development, and Six Sigma Champion, ELI LILLY

5:30 Close of Day One

There will be a 30-minute coffee & refreshment break during this workshop.


Conference Day Two: Wednesday, March 21, 2012

8:00 Continental Breakfast Opens

Track A: CLINICAL IMPROVEMENT Track B: RESEARCH IMPROVEMENT

9:00 CHAIRMAN’S WELCOME: CLINICAL IMPROVEMENT


9:00 CHAIRMAN’S WELCOME: RESEARCH IMPROVEMENT


9:15 BuILDING QuALITY INTO CLINICAL TRIALS uSING LEAN SIX SIGMA PRINCIPLES: An Integrated Quality Management Plan (IQMP)The traditional approach to ensure quality in clinical trials has been heavilyreliantonsitemonitoringandsourcedataverification,seekingtoretrospectivelyconfirmthatclinicaltrialquality/integritystandardsweremet.TheIntegratedQualityManagementPlan(IQMP)utilizesLean Six Sigma methodology to prospectively determine the factors critical to quality in the clinical trials and introduces metrics to track these factors during the conduct of the trial. This approach is risk-based and endeavors to prospectively design qual-ity into trials from the beginning, rather than to only monitor and audit.

• Qualityshouldbeprospectivelybuiltintoclinicaltrials• Themanywaystoproactivelyassessrisksinclinicaltrialsandthe

effectiveness of the Lean Six Sigma tools• Continuousimprovementasanessentialcomponenttoqualityand

the use of quality metrics to monitor performance

KenSprenger, MD, MBBCh, Medicine Team Leader, Primary Care BU, PFIZER

9:15 FOLLOW-uP ON 2011 PRESENTATION: Workload Leveling in a Biologics Research Discovery LabAttendeesofthe2011LeanSigma&KaizenforPharmaR&DSummitheard preliminary insights from a case study on the effect of workflow vari-abilityinanR&DDiscoveryLaboratoryonproductivityandre-design,usinglevel loading for increased productivity and decreased overburdening.Thisyearthepresenterreturnstosharetheresultsofthestudy:• IncorporatingLeanprinciplesandpracticesintotheoperationsof

thelaboratoryroutineactivities: o Reducednumberofpeoplerequiredforroutineactivities o Increasedproductivity o Enabledbetterresourcingofnon-routine,heuristicactivities,

which are high value-added• IncorporatingLeanprinciplesandpracticesintothecultureofthe

laboratory: o Increasedflexibility o Increasedproblemandsolutionidentification o Increasedspaceandresourcesharing

Jill Carton, Director, Biologics Research, CENTOCOR R&D

10:00 THE ROLE OF THE PROCESS OWNER: Comparing the Theory of the Process Owner to Real Life ExperiencesAProcessOwneroverseesaprocess,notaprojectoritspeople.Processownersrefine,codify,andtranslatebestpracticesforprojectmanagers. They may or may not be members of the project teams. This role can be essential in ensuring that process innovations remain intact over time and when there are personnel changes. This session shares the speaker’s experience of being a process owner before, dur-ing,andaftertheKaizenevent.

Mariana Sacchi, Site Monitor, Clinical Data Quality Manager, BRISTOL-MYERS SQuIBB

10:00 VARIATION REDuCTION IN THE LAB: using Statistical Tools to Discover and Eliminate Variation in R&DVariationistheresearcher’senemyinthelab–reducingoreliminatingit drastically increases effectiveness and decreases time to discovery. Learnhowto:• Identifydifferenttypesofvariation• Usedataanalysistofindfactorscontributingtothatvariation• Reduceoreliminateit• HelpresearchersembraceLeanSixSigma

Joel Smith, Statistician, MINITAB

10:45 Networking and Refreshment Break 10:45 Networking and Refreshment Break

11:15 EMEA-CLINICAL OPERATIONS CASE STuDY: Improving the Site Opening Process During the Start-up of a Clinical TrialReducingthestart-uptimeofanewinternationalclinicalstudybyoneweekoronemonthcanhaveasignificantpositiveimpactontheoverallproject timelines. • Usingadditionalexternalresourcestohighlighttheissuesata

clinicalorganization• TrainingacoreteamonprinciplesofLeanSigma,appliedtoan

officeenvironment• UsingVoiceofCustomertoselectthebiggestissuestoworkon• UsingDMIACon‘thebiggestissue’inordertoreducetimeandcost• Whataretheoutcomes?• What’snext?Control,Control,Control...overandoveragain

Tim Verfaillie, International Clinical Project Manager, ABBOTT VASCuLAR

11:15 QuALITY CONTROL FOR AN R&D LAB CASE STuDY: HPLC Cleaning and MaintenanceThissessionwillreviewalaboratory-ledKaizenthatdramaticallychanged the way analysts use their mainstay equipment, HPLC. The KaizeninvolvedbothQualityControlandResearch&Developmentlabs, as well as a lot of change management, procedure updates, and managerial agreement on process change.KeyLeanTakeaways:• Reducingthenumberofextraneouspeak/abnormalchromatography

investigations (reduction of wasted time writing investigations, and reduction in investigations) produce better metrics

• Alignedpracticesbetweenlaboratoriesincreasecompliance• ClearlydefinedprocessesoutlinedinSOPsleaadtostandardizedwork• Increasedconfidenceinequipmentanddata

Sally McGouran, Scientific Services Analyst, MCNEIL CONSuMER HEALTHCARE

Choose Between Two Tracks!

Conference Day Two: Wednesday, March 21, 2012PA

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Media PartnersSponsorship and Exhibiting Opportunities:


12:00 IMPLEMENTING AND SuSTAINING CONTINuOuS IMPROVEMENTS IN REGuLATORY SuBMISSIONSWithitsRegulatorySubmissionOptimization(RSO)initiative,BMSisimplementing new technologies and executing a variety of process improvement projects to reduce, re-work and improve cycle times.ThissessionwillfocusontheactionsBMSistakingtoensurethatthese improvements are sustained and that the submissions process is continuouslyimprovedafterRSOisover,suchas.• Sustainingthegainsresultingfromaprocessoptimizationinitiative• Definingaprocesshierarchy• Theroleofprocessownership,processgovernance,metrics,

and continuous improvement

Patrick McCann, Associate Director of R&D Operations, BRISTOL-MYERS SQuIBB

12:00 VIRTuAL PHARMACEuTICAL FACTORY CASE STuDY: How to Handle “Added Failure” in Pharmacological Drug DevelopmentDuringthispresentation,youwilllearnabout:• Viewing“addedfailure”asanon-valueaddedstepcausedbylong

development time and segmented supply chain• Handlingthesupplychainwithintheframeofoneorganizationto

reduce development time• DevelopingliposomesbyconcentratingR&Dprojectmanagement

and production within a virtual factory, and outsourcing all other functions

Gyorgy Bathori, Head of the Applied Liposome Research Laboratory, NANOMEDICINE RESEARCH AND EDuCATION CENTER

12:45 Lunch

1:45 EFFECTIVELY uSING STATISTICS: Visualizing and Communicating Results with Non-StatisticiansApictureisworthathousandwords.Datavisualizationisameansofcommunicatingstatisticalresultsinnon-technicalterms.Resultscanbecommunicatedvisuallywhiletheassociatedstatisticssubstantiatethem.Wheneveryoneunderstandstheresults,theycanmakebetterdecisions.Inparticular,thissessioncovers:• Whatisdatavisualization?• HowcanIusedatavisualizationinmyLeanSixSigmaprojects?• WhatothertypesofanalysescanIvisualize?

Christina Gilchrist, Director of Research, WELLSPAN HEALTH

2:30 LEAN SIGMA PROJECT SELECTION IN R&DProjectselectioncanmakeorbreakacontinuousimprovementprogram.ManyR&DorganizationsarediscoveringtherearemoreLeanSigmaprojectsthanthere are resources, while there is no process for selecting projects. Projects must address areas of the business which warrant the greatest concern, and where the most opportunities exist. ThissessionwillprovidetipstohelpdevelopaprocessforprojectselectionintheR&Denvironment.• OpportunitiesversuswasteinR&D• Aligningprojectswiththeorganizationsstrategyandpotentialbenefits• Communicatingandengagingeveryoneintheprojectselectionprocess

Jacqueline Jones, Associate Project Engineer II, NESTLE

3:15 CLOSING PANEL DISCuSSION: Defining the Direction of Lean Sigma Across Different IndustriesLean Sigma can be applied in a variety of different ways. This multi-industry panel of Lean professionals will address the use of Lean Sigma in their various roles. Attendeeswillevaluatethedifferencesandsimilaritiesacrossorganizationsanddepartments.• Doesindividualprojectimplementationorbroaderintegrationworkbetter?• WhichLeantoolshaveshownthemostsuccess?• Whatisthenextstepforimprovementevolution?

Moderator:

Christina Gilchrist, Director of Research, WELLSPAN HEALTH

Panelists:Bella Englebach, Senior Director Strategic Business Improvement, CENTOCOR R&DJacqueline Jones, Associate Project Engineer II, NESTLETom Forrestal, MPS Leader, MERCK

4:00 Close of Conference

Doyouwanttospreadthewordaboutyourorganization’ssolutionsandservices to potential clients who will be attending this event? Take advantage of the opportunity to sponsor, underwrite an educational session, host a networking event, or distribute promotional items to attendees. ExL Pharma will workcloselywithyoutocustomizeapackagethatsuitsallyourneeds.

To learn more about these opportunities, please contact Steve Decker at (212) 400-6243 or [email protected].

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Questions? Comments?Wouldyouliketogetinvolvedasaspeakerordis-cussionleaderatour6thLeanSigma&KaizenforPharmaR&D?PleaseemailConferenceDirector,[email protected]

3rd Patient Engagement Summit3rd Annual Clinical Site Feasibility, Selection and Start-Up6th Forecasting & Optimization of the Clinical Supply Chain8th Latin America Clinical Trials Conference

Part of ExL Pharma’s

“ Great opportunity to learn how to apply LEAN to Clinical Trials...Making real change with business results.”

- Ivan Walrath, Trial Master File Process Owner, Pfizer

5th lean sigma & kaizen for pharma r&d...

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