5th annual contract manufacturing (2011) pp
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Email [email protected] for early bird discountTRANSCRIPT
7th - 8th December 2011, Visiongain Conference Centre, London, UK
Organised By
Examining the best outsourcing practices, new technological developments and the latest regulatory issues
To Book Call: +44 (0) 20 7336 6100 | www.visiongain.com/contractmanufacturing
Dr. Dieter Roethlisberger, Outsourcing Manager & Senior Scientist, F. Hoffmann La-Roche
Peter Murray, Quality Director, External Supply Strategy, GlaxoSmithKline
Martin P Grosvenor, Drug Delivery Manager, AstraZeneca
Andrea Calenne, Sr. Manager, Contract Manufacturing, Biogen Idec
Gaelle Gibbs, QA Manager, MAX Products and Strategic Vendors, UCB Pharma
Sohail Chohan, Manufacturing Outsourcing Manager, Era Consulting
Dr. Nigel Allison, Process Development Specialist, Health Protection Agency
Philip Pratten, VP Manufacturing Services, Elan Pharmaceuticals
Professor Nigel Titchener-Hooker, Head of Department and Director Biochemical Engineering, University College London
Paul Ranson, Partner, Fasken Martineau LLP
Jo Pisani, Consultant, PricewaterhouseCoopers
Jan-Gunnar Gustafsson, Consultant, Bio-consulting
Alan Harris, Partner, Alacrity Pharma Associates
Dr. Steve Musgrave, Founding Partner, Unicorn Biologics
Key Speakers
BOOK NOW!
5th Annual Contract Manufacturing
Driving the Industry Forward | www.futurepharmaus.com
Media Partners
Conference Introduction5th Annual Contract Manufacturing
7th - 8th December 2011, London, UK
Dear Colleague, Theimportanceandroleofcontractmanufacturinghaschangedovertheyearsfrom
solelyprovidingefficienciesincost,capacityandtime-to-market,oraspecificexpertisenot available in-house to unique, innovative, and state-of-the-art processes andproductiontechnologytothepharmaceuticalindustry.
Asmoreandmorepharmaceuticalcompaniesarewillingtooutsource, thecontractmanufacturingmarketcontinuestogrowandisexpectedtoreach$61.51bnin2015and$94.70bnby20251
Visiongain’sContractManufacturingconferencehasgrownfromstrengthtostrengthin the last couple of years and now in its 5th year, the conference will addressevery aspect of the outsourcing process from selecting an outsourcing partner totech-transfer through to regulatory frameworks, latest FDA contract manufacturinglegislation,andrecentpatentandsafetyissues.
Atthis2dayeventtheattendeeswilllearn,debate,discussandnetworkwithleadersandkeyprofessionalsfromtheindustry.
Whether you are a service provider or a pharmaceutical company by attending this conference you will: •AssessfutureoutsourcingtrendsandmanufacturingstrategieswithchangingCMO
industrystructure •Hearaboutemergingbusinessmodels •Determine the essential criteria for CMO selection and effective relationship
management •LearnkeysuccessfactorsforestablishingsuccessfulCMOpartnershipswithanalysis
ofthemulti-stepsourcingprocessforCMOs •Gaininsightonfuturegrowthpotential,regulatoryframeworks,recentpatentand
safetyissues •IdentifythelatestFDAcontractmanufacturinglegislation •Evaluate the major risks and challenges of contract manufacturing projects by
gaininginsightsintothepotentialdownsides •Investigateaboutcosts:importanceoftech-transfer/scale-up •DiscovertheoutsourcingpotentialofIndiaandChina •MaximiseopportunitiesasaconsequenceofPATandQbDinitiatives •Deliversuccessfulexternalmanufacturingsupplychainandplanning •Build new relationships with other key players in pharmaceutical and contract
manufacturingindustry Ilookforwardtomeetingyouattheconference Bestregards
Sumita Sengupta Conference Producer
Who will be there?VPs Directors, Heads, and Managers in:
Directors, Heads of Department, Team Leaders and Scientists of:
• Research and Development
• PAT
• QbD
• CMC
• Process Development & Optimisation
• Process Science/ Analytics
• Manufacturing
• Contracts & Outsourcing
• Formulation
• Quality Assurance/ Quality Control
• Operations
• Strategic Alliances
• Compliance
• Regulatory Affairs
• Legal/ Patents
Pharmaceutical and Biotechnological Companies
Contract Manufacturing Organisations (CMOs)
Drug Regulators, Intellectual Property/Law Firms
Academia, Government Bodies, Regulatory Affairs
Media Partners:
PharmiWeb.comistheleadingindustry-sponsoredportalforthepharmaceuticalsector.Supportedbymostoftheleading
pharmaceuticalcorporations,PharmiWeb.comprovidesdynamicreal-timenews,features,eventslistingsandinternationaljobstoindustryprofessionalsacrossEuropeandtheUS.For further information please email: [email protected]
BIOTECHNOLOGYEUROPEisownedbyBIOTECHNOLOGYWORLD.ItisbasedandlocatedinWarsaw,Poland.BiotechnologyWorld
wasfoundedin2007toprovidetheworld’sbiotechandpharmainformationandmarkettomakeituniversallyaccessibleandusefulforscientificandbusinessprocesses.ItsfirststeptofulfillingthatmissionwasbuildingtheBIOTECHNOLOGYEUROPEplatformthatwillallowaquickspreadofinformationindifferentchannels.BIOTECHNOLOGYEUROPEofferscompaniescompletedinternetpublicrelations,publicationandmarketingsolutions.OneofthemainsgoalsofBIOTECHNOLOGYEUROPEistointegratetheBiotechandPharmaSectorinEuropetoglobalbiotechnology,pharmaceuticalandlifescienceactivities.For further information please visit: www.biotechnology-europe.com
FuturePharmaceuticalshasforgedpowerfulrelationshipswithkeyindustryleaderstoprovideaplatformforsuccessfulbrandrecognition,
andforseniordecision-makerstohavethemeanstoprocureandplanimplementationstrategiesbasedonthetopicscovered.Positionedtobeanauthoritativeresourcewithintoppharmacompaniesaswellassmall,specialty,andbiotech,FuturePharmaceuticalsmagazineisgearedtocreateadeeppenetrationintoahighlytargetedandresponsiveaudience,bridgingthegapbetweentheindustries’topissuesandthesolutionstop-tiervendorscanprovide.For further information please visit: www.futurepharmaus.com
InPharmistheonlineplatformforexclusivepharmaceuticalnews,comment,contracts,services,jobsandeventsandishometoInPharmjobs.com,PharmafileandPharmafocus.
For further information please visit: www.inpharm.com
“SupportingtheIndustrythroughCommunication”IPIwasestablishedtofillinthevoidforeffectivemarketingandcommunicationbetweenallstakeholdersinthelifesciencessector
globally.ClientsuseusduetotheextensiveknowledgeandreachwehavebuiltupovertheyearswithourEditor,EditorialAdvisoryboardandmarketresearch.WegiveyoulinksintoallareasofBiopharm,Medical,PharmaceuticalandHealthcare.InadditiontoourextensivereachintheAmericas&Europe,wehaveestablishedastrongpresenceintheMiddleEast,LatinAmerica,EasternEurope,AsiaandAfricawhicharebecomingincreasinglyimportanttothewaytheindustryismovingforwardsinareasofResearchandDevelopment,Trials,manufacturingandTechnologyTransfer.For further information please visit: www.ipimedia.com
Pharmatching.comisanefficient,targetedandeasy-to-use-“Web2.0”-toolforfindingtherightpartnersinthepharmaceuticalindustryworldwide.Itsavestimeandcostsinall(out)sourcingand
businessdevelopmentprocesses,asitfascilitatesandacceleratesthesearchingprocessforappropriatebusinesspartnerssignificantly.Pharmatching.comisparticularlyadvantageousforprojectswhereaspecialserviceis(immediately)requiredortooffercapacitieswhicharecurrentlyavailable.Itisusefulforservicesinallcategoriesandstagesofdrugdevelopmentincludingcontractmanufacturing,contractresearch,laboratoryinvestigations,contractualtesting,non-clinicalandclinicalresearch,activepharmaceuticalingredients,consulting,marketing,registration,in-andoutlicensingetc.For further information please visit: www.pharmatching.com
Driving the Industry Forward | www.futurepharmaus.com
Sponsorship and exhibition opportunities
Thiseventoffersauniqueopportunitytomeetanddobusinesswithsomeofthekey
playersinthepharmaceuticalandbiotechindustries.Ifyouhaveaserviceorproductto
promote,youcandosoatthiseventby:
•Hostinganetworkingdrinksreception
•Takinganexhibitionspaceattheconference
•Advertisinginthedelegatedocumentationpack
•Providingbrandedbags,pens,gifts,etc.
Ifyouwouldlikemoreinformationontherangeofsponsorshiporexhibitionpossibilities
forvisiongain's5thAnnualContractManufacturingConference,pleasecontactus:
Damian Gorman, +44 (0)20 7549 9934
1Visiongain’sreport:Pharmaceuticalcontractmanufacturing:industryandmarketprospects2010-2025
09:00 Registration and refreshments
09:30 Opening address from the Chair
09:40 To outsource or not - is it a solution for you? •Definingthestrategicdirectionofthepharmacompany
•Risksandbenefitsofoutsourcing
•Impactofoutsourcingonmarketplaceandpharmacompany
•Manufactureofcommodityproducts
•Manufactureofproductsusingproprietarytechnologies
•Assessingvaluebenefitsincost,timeandquality
Martin P. Grosvenor DrugDeliveryManagerAstrazeneca
10:20 Optimal information flow and communication structure when outsourcing clinical manufacturing of biotechnological drug products
•Maincommunicationstructuresandtheirdilemma
•Informationflowandhowtoavoidcommunicationgaps
•Howtoavoiddatagraveyardsbyusingsharedworkspaces
•Integrationofnoncompatibledatainoverviewtools
•Milestoneandpaymenttracking
Dr. Dieter Roethlisberger OutsourcingManager&SeniorScientistF. Hoffmann La-Roche
11:00 Morning refreshments
11:20 Experience, expertise and enthusiasm - key success factors in winning and keeping the deal.
•ThistalkwilloutlinewhythesethreekeyelementsaremostimportantinnotonlywinningthedealbutalsomaintainingyourCMOsuppliercontracts
•Experience–criticalforacompanyhandingovertheirdrugcommercialmanufacture.Withoutatrack-recordinmanufacturingproduct,itisnearonimpossibletogainacompany’strust.(citeexampleofEDT’sexperienceinsolidoralmanufacture,thisexperiencewhichismoreevidentinestablishedmarketsofEuropeandUSisalsoanimportantfactor)
•Expertise–aswellasexperience,havingtherightexpertisetosolvetheproblemathand,techtransferskillsparamountforseamlessmovementintofullscaleproduction,alsoregulatoryexpertiseveryimportant,particularlyforsmallerpharmaclients
•Enthusiasm–essentialforgettingthroughwhenproblemsdoinevitablyarise,alwayslookingatwaystoimprovetheservicetotheclient(OEinitiatives),essentialinbuildingrelationshipwithclients
•Manyotherfactorsthatareagivensuchasgoodqualityrecord,GMPfacilities,competitivepricing,healthandsafetyrecordetc,butthe3E’saremostimportant
Philip Pratten VPManufacturingServicesElan Pharmaceuticals
12:00 Using the principles of QbD for outsourced late phase process validation
Sohail Chohan ManufacturingOutsourcingManagerEra Consulting
12:40 Networking lunch
13:40 Methods for rapid process characterisation in the successful translation of process technologies
•Casestudiesofmethodsdevelopedtoallowfastprocesscharacterisation
•Toolsforeffectivescaleup
•Examplesdrawnfromindustrycollaborations
Professor Nigel Titchener-Hooker HeadofDepartmentandDirector,BiochemicalEngineeringUniversity College London
14:20 Timing API process route changes for optimum value
•TheimportanceofchoosingthebestrouteandprocesstoanAPI
•Dividingwhen,ifatall,tochange–chemistryinvolved,regulatoryaspects,costsandspeedofmanufacture
•Differencesinapproachbetweensmallandlargepharmawhenitcomestoroutechange
•TheroleofCROs
•Whychangingearlydevelopmentmakessoundscientificandeconomicsense
Alan Harris PartnerAlacrity Pharma Associates
15:00 Afternoon refreshments
15:20 Sponsor Spotlight Session
Takethisuniqueopportunitytobeapartoftheconferencetheme,network,shareideasandprovideanoverviewofyourproduct/servicestotheaudience.Formoreinformationpleasecontactdamian.gorman@visiongainglobal.com
16:00 Challenges of outsourcing biopharmaceutical manufacturing
•Uniquefeaturesofbiopharmaceuticals
•Keyconsiderationsinoutsourcingbiologicalmedicinesmanufacture
Dr Steve Musgrave FoundingPartnerUnicorn Biologics
16:40 Closing remarks from the chair
16:50 Networking drinks
Take your discussions further and build new relationships in a relaxed and informal setting
Day 15th Annual Contract Manufacturing
Wednesday 7th December 2011
Due to unforeseen circumstances the programme may change and visiongain reserves the right to alter the venue and/or speakers c Copyright visiongain Ltd, 2011
09:00 Registration and refreshments
09:30 Opening address from the Chair
09:40 To outsource or not - is it a solution for you?
•Definingthestrategicdirectionofthepharmacompany
•Risksandbenefitsofoutsourcing
•Impactofoutsourcingonmarketplaceandpharmacompany
•Manufactureofcommodityproducts
•Manufactureofproductsusingproprietarytechnologies
•Assessingvaluebenefitsincost,timeandquality
Martin P. Grosvenor DrugDeliveryManagerAstrazeneca
10:20 Optimal information flow and communication structure when outsourcing clinical manufacturing of biotechnological drug products
•Maincommunicationstructuresandtheirdilemma
•Informationflowandhowtoavoidcommunicationgaps
•Howtoavoiddatagraveyardsbyusingsharedworkspaces
•Integrationofnoncompatibledatainoverviewtools
•Milestoneandpaymenttracking
Dr. Dieter RoethlisbergerOutsourcing Manager & Senior Scientist
Day 25th Annual Contract Manufacturing
Thursday 8th December 2011
09:00 Registration and refreshments
09:30 Opening address from the Chair
09:40 Identifying and managing risks of contract manufacturing
•Understandingtheconceptof‘risk’
•Keyrisksapplicabletocontractmanufacturing
•Managingandmodellingrisks
Peter Murray QualityDirector,ExternalSupplyStrategyGlaxoSmithKline
10:20 Contract manufacturing: sharing the risk
•Settinguptheassignmentcovering:
-Deliverables
-Economical
-Regulatory
•Smallbiotechvs.bigCMO
•Howtocreateawin-windeal
Jan-Gunnar Gustafsson ConsultantBio-consulting
11:00 Morning refreshments
11:20 Evolution in contract manufacturing organisation management and risk management
•Changesincontractmanufacturingorganisationmanagementandregulatoryrequirements
•Complexityinproductsupplychains
•Contractmanufacturingorganisationandriskmanagement
•Proactiveriskmanagementofnewbusinessdevelopmentopportunities
•Adaptationoftheindustrytothenewriskswithfocusonpatientsafetyandregulatoryrequirements
Gaelle Gibbs QAManagerMAXProductsandStrategicVendorsUCB
12:00 Auditing regulatory compliance within a contract manufacturing business scenario
•Introduction:whatisregulatorycompliance,Module3,typicaldiscrepanciesandtheirorigin
•Background:contractualscenario,regulatoryrequirements,settingofboundaries
•Preliminarysteps:defininganagendaforregulatorycomplianceaudits
•Auditexecution:strategyandprioritisationofschedules
•Follow-up:reviewofaCAPA/Remediationplanrelatedtoregulatorygaps
•Conclusion
Andrea Calenne Sr.Manager,ContractManufacturingBiogen Idec
12:40 Networking lunch
13:40 Contractual arrangements
•Technologytransfer
•IPrights
•Liabilityissues
Paul Ranson PartnerFasken Martineau LLP
14:20 Sponsor Spotlight Session
Takethisuniqueopportunitytobeapartoftheconferencetheme,network,shareideasandprovideanoverviewofyourproduct/servicestotheaudience.Formoreinformationpleasecontactdamian.gorman@visiongainglobal.com
15:00 Afternoon refreshments
15:20 Process technology transfer between the US and the UK – a case history
•TechnologytransferattheHPA
•TransferofavaccinemanufacturingprocessfromtheUStotheUKforlatestageprocessdevelopment
•Processverificationatsmall-scale
•Scale-upandprocessimprovement
•Post-developmenttransferofa“GMP-ready”processtoaUSCMO
Dr Nigel Allison ProcessDevelopmentSpecialistHealth Protection Agency
16:00 Supplying the future: how to develop effective contract manufacturing relationships
•Anupdateonthetrendsimpactingthepharmaandlifesciencesindustries
•Areviewofcurrentoutsourcingtrends
•Anoutlineofnewbusinessmodelsforsuccess
Jo Pisani ConsultantPWC
16:40 Closing remarks from the chair
16:50 End of Conference
CA
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Registration Form5th Annual Contract Manufacturing
7th - 8th December 2011, London, UK
www.visiongain.com/contractmanufacturing
5th Annual Contract Manufacturing7th - 8th December 2011Location:VisiongainConferenceCentre
Address:230CityRoadLondonEC1V2TTUK
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