3rd – 4th November 2011, Visiongain Conference Centre, London, UK

Organised By

Bringing together the multiple facets of stability testing for improved efficacy and end product quality

To Book Call: +44 (0) 20 7336 6100 | www.visiongain.com/stabilitytesting

Dr Garry Scrivens, Senior Principal Scientist, Pfizer

Dr Glen Hodge, Senior Principal Scientist, Pfizer

Dr Simon Hicks, Senior Scientific Investigator, GlaxoSmithKline

Dr Bernhard Helk, Section Head, Technology department, Novartis

Dr Abigaill Moran, Deputy Manager and Pharmaceutical Asessor, Licencing Division, MHRA

Dr Leonardo Allain, Research Fellow, Merck

Dr Brett Cooper, Research Fellow, Merck

Dr Alexander Pontius, Laboratory Head, Bayer Schering Pharma

Sarah Hayter, Analytical Scientist, AstraZeneca

Professor Pauline Rudd, Principal Investigator, National Institute for Bioprocessing Research and Training

Dr Paul Matejtschuk, Principal Scientist, National Institute of Biological Standards and Control

Dr Simon Gaisford, Senior Lecturer in Pharmaceutics, The School of Pharmacy, University of London

Dr Paul Royall, Lecturer in Pharmaceutics, Kings College London

Key Speakers

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5th Annual Stability Testing

Driving the Industry Forward | www.futurepharmaus.com

Media Partners

Associate Sponsor

Conference Introduction5th Annual Stability Testing

3rd - 4th November 2011, London, UK

Dear Colleague, Pharmaceutical companies are under intense pressure to provide safe, effective

medicines for patient consumptionwhile alsomaintainingadherence to stringentregulatory and quality requirements. Stability testing is a highly integral part ofpharmaceuticalproductdevelopmentwhichconstitutesoneofthefastestgrowingmarketsinthepharmaceuticalandbiotechnologysectors.

In a state of affairs where the outcome of stability testing can have substantialmedicalandfinancialimplicationsitisimportanttoconsiderthemostcomprehensiveandcost-effectiveapproachtosuccessfulstabilitytesting.

Visiongain’s5thAnnualStabilityTestingConferencewilllookatthestabilityoftheingredients and overall product during different phases of the product lifecycle.By attending this event you will gain insight into the various aspects of stabilitytesting ranging from updates on current guidelines, effective planning, methodsandregulatoryrequirementstoevaluationofresults,thecaseofbiologicsandtheindustry-hospital interface. Our conference will provide you with current essentialinformationonthekeyissuessurroundingstabilitytestingviaourexpertspeakers.

Reasons to register today: •ReceiveanupdateontheWHOandICHstabilityguidelines •Learn strategies for effective planned stability testing at different stages of the

productlifecycle •Adaptyourforceddegradationstudies:predictingstabilityratedata •ExamineQualitybyDesigninthecontextofstabilitytesting •Considercomplianceofpharmaceuticalproductwithregulatoryrequirements •Assesschallengesinthestabilitytestingofbiologics:aggregation,denaturation,

oxidationandde-amination •Exploreanalyticaltestingmethodsandspecifications:focusonHPLC •Discusshowtoeffectivelyevaluatestabilityresults •Gainfurtherinsightsintooutsourcing:theprosandcons •Investigatethepharmaindustry-hospitalinterface:whatarethestabilityissues? •Utilisenetworkingopportunitieswithdiverseleaders Ilookforwardtomeetingyouattheconference Bestregards

Nima Farah Conference Producer

Who should attend this conference?Presidents, Vice Presidents, Directors, Chief Executive Officers, Chief Scientific Officers, Heads, Managers, Team Leaders, Researchers and Consultants of:

• Stability Testing• Quality Assurance• Quality Control• Regulatory affairs• Research and Development• Analytical Chemistry• Analytical Development• Analytical Laboratory• Contract Laboratory• Forced Degradation Studies• Formulation Studies• Formulation Development• Product Submission• Validation• Documentation and Technical writing• Business Development• Project Management• Product Development• Pharmaceutical & Biopharmaceutical Production• Product Lifecycle Management• Biologics• Biosimilars• Technical Operations

Branded and Generic Pharmaceutical Companies,Contract Research Organisations/ Contract Manufacturing Organisations Drug Regulators, Academics & Government Bodies

Associate Sponsor: EpichemoffersarangeofimpurityanddegradantstandardsforAPIsandexcipients,particularlyforOTCandgenericdrugs.ManyofthesestandardsarehardtofindorexclusivetoEpichemandcanbesuppliedinmulti-gramquantitiestoenableyoutorapidlyandcost

effectivelyundertakestabilitytestingforproductdevelopment.Epichem’slaboratoryandsystemshavepassedauditsbyfouroftheworld’stoppharmaceuticalcompaniesandallstandardsaresuppliedwithCoAandMSDS.Epichemalsohasconsiderableexperienceintheidentificationandsynthesisofnewimpuritiesanddegradants,andcanadviseonmethodstominimisetheirformation.

For further information please visit: www.epichem.com.au

Media Partners:PharmiWeb.comistheleadingindustry-sponsoredportalforthepharmaceuticalsector.Supportedbymostoftheleading

pharmaceuticalcorporations,PharmiWeb.comprovidesdynamicreal-timenews,features,eventslistingsandinternationaljobstoindustryprofessionalsacrossEuropeandtheUS.For further information please email: corporate@pharmiweb.com

BIOTECHNOLOGYEUROPEisownedbyBIOTECHNOLOGYWORLD.ItisbasedandlocatedinWarsaw,Poland.

BiotechnologyWorldwasfoundedin2007toprovidetheworld’sbiotechandpharmainformationandmarkettomakeituniversallyaccessibleandusefulforscientificandbusinessprocesses.ItsfirststeptofulfillingthatmissionwasbuildingtheBIOTECHNOLOGYEUROPEplatformthatwillallowaquickspreadofinformationindifferentchannels.BIOTECHNOLOGYEUROPEofferscompaniescompletedinternetpublicrelations,publicationandmarketingsolutions.OneofthemainsgoalsofBIOTECHNOLOGYEUROPEistointegratetheBiotechandPharmaSectorinEuropetoglobalbiotechnology,pharmaceuticalandlifescienceactivities.For further information please visit: www.biotechnology-europe.com

FuturePharmaceuticalshasforgedpowerfulrelationshipswithkeyindustryleaderstoprovideaplatformforsuccessful

brandrecognition,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

Driving the Industry Forward | www.futurepharmaus.com

Sponsorship and exhibition opportunities

Thiseventoffersauniqueopportunitytomeetanddobusinesswithsome

ofthekeyplayersinthepharmaceuticalandbiotechindustries.Ifyouhave

aserviceorproducttopromote,youcandosoatthiseventby:

•Hostinganetworkingdrinksreception

•Takinganexhibitionspaceattheconference

•Advertisinginthedelegatedocumentationpack

•Providingbrandedbags,pens,gifts,etc.

Ifyouwouldlikemoreinformationontherangeofsponsorshipor

exhibitionpossibilitiesforvisiongain's5thAnnualStabilityTesting

Conference,pleasecontactus:

Damian Gorman, +44 (0)20 7549 9934

damian.gorman@visiongainglobal.com

09:00 Registration and refreshments

09:30 Opening address from the chair Dr Garry Scrivens

SeniorPrincipalScientistPfizer

09:40 Forced degradation to develop stability indicating methods

•Overviewofregulatoryguidance •Whataretheappropriateconditions •Pitfallsofusingexcessiveconditions •Makingthelinkbetweenforceddegradationstudiesandstabilitydata

Dr Simon Hicks SeniorScientificInvestigatorGlaxoSmithKline

10:20 Increasing the reliability of shelf-life predictions from accelerated stability studies

•Short(e.g.2week)acceleratedstabilitystudiescanbeusedtopredictshelflifemuchmorethanconventionalapproaches

•Focusesonsolid-statedegradation–e.g.API,tabletsandcapsules(etc.) •Providesquantitativeinformationonthetemperatureandhumidity

dependenceofchemicaldegradationreactions •Canpredictdegradationratesinpackagingsuchasblistersandbottles

withandwithoutdessicantaswellasunpackagedproducts •Thisapproachhasprovenusefulinanumberofapplications,e.g.setting

shelf-life,selectingpackaging,assessingnewformulations,excipientcompatibilitystudies,assessingstabilityimpactofchangestoAPIsyntheticroute,demonstratingequivalencebetweenbatchesofAPIanddrugproduct,understandingimpactofprocessingchangesaspartofQbDstudies,inclusioninregistrationdocumentationassupportivedatatominimalizestabilitycommitmentandasapost-approvalchangestabilityprotocol

•Thisapproachisconvenient,inexpensiveandrapidlycarriedout

Dr Garry Scrivens SeniorPrincipalScientistPfizer

11:00 Morning refreshments

11:20 Novel thermal methods for stability testing of amorphous drugs and drug products

•Relaxationratesofamorphousglasses •Crystallisationkineticsofglasses •Stabilitytestingofamorphousdrugproducts(soliddispersionsandoralfilms) •Amorphouscontentquantification •Eachsectionwithafocusoninstrumentselectionandexperimentalbestpractice

Dr Simon Gaisford SeniorLecturerinPharmaceuticsThe School of Pharmacy, University of London

12:00 Stability studies: physical stability and extreme storage temperatures

•Overviewofphysicalstability: -Physicalprocess -Factorsaffectingstabilityacrosstheproductlifecycle •Extremestoragetemperature-impactonstabilitytesting •Summary

Dr Paul Royalll LecturerinPharmaceuticsKings College London

12:40 Networking lunch

13:40 Quality by design applied to a stability sensitive compound

•Qualitybydesignwithinpharmaceuticalsciences

•Targetproductprofiles

•Riskanalysisatvariousstagesofdevelopment

•Formulationvariablesandeffectonqualityattributes

•Casestudydemonstrationonastabilitysensitivecompound

Dr Brett Cooper ResearchFellow,PharmaceuticalSciencesMerck

14:20 Prediction of aggregation propensities of therapeutic proteins

•Reviewofmethodsforinsilicopredictionofaggregationpropensities

•IntroductiontotheSAP(spatialaggregationpropensity)technology,anewtechnologydevelopedatNovartisandMIT

•Identificationhot-spotsforaggregationbasedonthedynamicexposureofspatially-adjacenthydrophobicaminoacids

•RankingofmonoclonalantibodiesbySAPscoringandcomparisonoftheresultswithcharacterisationandlong-termstabilitydata

•DemonstrationoftheutilityoftheSAPtechnologyinproteinengineeringandinthedesignofantibodydrugconjugates

Dr Bernhard Helk SectionHead,TechnologyDepartmentNovartis

15:00 Afternoon refreshments

15:20 Sponsor Spotlight Session Takethisuniqueopportunitytobeapartoftheconference

theme,network,shareideasandprovideanoverviewofyourproduct/servicestotheaudience.Formoreinformationpleasecontactdamian.gorman@visiongainglobal.com

16:00 Stability testing in early phase clinical studies •Considerationswhenassessingpre-clinicalsolutionstabilitydata

•Assessingstabilityforsimple,earlyphaseclinicalformulations

•Areasforfutureimprovement:predictivescienceand/orhighthroughputtesting

Sarah Hayter SeniorScientistAstrazeneca

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 Stability Testing

Thursday 3rd November 2011

Duetounforeseencircumstancestheprogrammemaychangeandvisiongainreservestherighttoalterthevenueand/orspeakerscCopyrightvisiongainLtd,2011

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Day 25th Annual Stability Testing

Friday 4th November 2011

09:00 Registration and refreshments

09:30 Opening address from the chair

Dr Paul Matejtschuk PrincipalScientist,StandardisationScienceNational Institute of Biological Standards and Control

09:40 Impact of contaminants on the stability of pharmaceutical products

•Leachables:definition

•Overviewofmajorleachables

•QualityProblems

•Toxicologicalrisk

Dr Leonardo Allain ResearchFellowMerck

10:20 Potentially Genotoxic degradation products-strategies for control in clinical drug products

•Keyconsiderationsfordevelopingstabilityindicatingmethodsforpotentiallygenotoxicdegradationproducts

•Shelflifepredictionsindrugsubstancesanddrugproductsusingacceleratedstabilityassessments

•Specificationstrategiesformaximizingdrugproductshelflives

•Relevantcasestudyexamples

Dr Glen Hodge SeniorPrincipalScientistPfizer

11:00 Morning refreshments

11:20 A systematic approach to protein glycosylation analysis: a path through the maze

•Basicsofglycobiology

•Rolesforglycosylationindeterminingtheefficacy,pharmacokinetics,stabilityandsafetyofbiologicaldrugs

•Factorsthatcontrolglycosylationprocessingpathways

•Rapid,detailed,quantitativeglycananalysisatallstagesofbioprocessing

•Approachestoglycananalysisincludemassspectrometry,capillaryelectrophoresisandvariousHPLCtechniques.Theappropriatestrategydependsontheinformationthatisrequired

•AgenericroboticsHPLCplatformhasbeendesignedtoberuggedintermsofcost,reliability,datainterpretationandoperatortraining.Datacanbecoupledwithsoftwareanddatabasesforcomputerassisteddatainterpretation

•Thesystemcanbeusedasafrontendtomanyseparationstechnologiestodeterminethefactorsthatcontrolglycosylationandglycoproteinintegrity

Professor Pauline Rudd PrincipalInvestigatorNational Institute for Bioprocessing, Research and Training

12:00 Assessing and assuring stability of biological reference materials

•Roleofbiologicalreferencematerials

•Freezedryingreferencestandards

•Impactofformulation&manufactureonstability

•Accelerateddegradationtesting&stability

Dr Paul Matejtschuk PrincipalScientist,StandardisationScienceNational Institute of Biological Standards and Control

12:40 Networking lunch

13:40 Relevance of in vitro dissolution testing for evaluating stability effects on new formulations

•Prerequisitesfordissolutiontesting

•Selectionofdissolutionmethodparameters

•Automateddissolutiontesting

•Evaluatingmanufacturingprocess

•Evaluatingeffectsduringstabilitystudies

•Monitoringmodificationchangesduringstorage

Alexander Pontius LaboratoryHeadBayer Schering Pharma

14:20 A Regulator’s Perspective on Stability •ClarifyingICHandCHMPguidelinesforstability

•Identifyingcommonreasonsforfailureandforquestionsfromcompetentauthorities

•Outlininghowtoavoidproblemswithregulatorysubmissions

Dr Abigail Moran DeputyManagerandPharmaceuticalAssessor,LicensingDivisionMHRA

15:00 Afternoon refreshments

15:40 Sponsor Spotlight Session Takethisuniqueopportunitytobeapartoftheconference

theme,network,shareideasandprovideanoverviewofyourproduct/servicestotheaudience.Formoreinformationpleasecontactdamian.gorman@visiongainglobal.com

16:00 The pharma industry-hospital interface: what are the stability issues?

•Overviewofchallenges

•Prominentissues

•Clinicansperspective

•Future:problemsolvingforpatientbenefit

16:40 Closing remarks from the chair

16:50 End of conference

How to bookEmail:piyush.patel@visiongain.comWeb:http://www.visiongain.com/stabilitytesting

UK Office:Tel: +44(0)207549 9961Fax:+44(0)2075499932 VisiongainLtd230CityRoadLondonEC1V2QYUK

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Registration Form5th Annual Stability Testing

3rd - 4th November 2011, London, UK

www.visiongain.com/stabilitytesting

5th Annual Stability Testing3rd - 4th November 2011 Location:VisiongainConferenceCentre

Address:230CityRoadLondonEC1V2TTUK

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