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Course5.2Biomoleculanalysis:From methoddevelopmenttoclinic30January–3February2012BioMolecularAnalysisGroup,FacultyofSciencesVUUniversity,Amsterdam,theNetherlandsHomeAssignment(CaseStudiesandCoursequestions)th Tobecompletedbythe16March2012
BiomolecularAnalysis:FromMethodDevelopmenttoClinic:
Bioanalyticsforsmallmolecules9FromsamplingtodatahandlingBioanalyticsforbiopharmaceuticals9Differencestosmallmolecules9PK,PD9Immunogenicity9IntegratedbioanalyticalapproachWorkinginaregulatedenvironmentNoveldevelopmentsinbioanalytics
Introduction ThistrainingmoduleonintegratedbioanalyticsispartoftheEuropeanModular EducationSafeSciMETprogramme.Theprogrammeaimstoencompassthesafety,ethical,regulatoryandsocietalaspectsinallphasesofdrugdevelopment,with emphasisonintegrative,translationaland3Rs[replacement,reductionand refinement]aspectsofdrugsafetyassessment.Awell‐designedbioanalyticalstrategyisanimportantpillarforthedevelopmentofsafedrugs.Thiscourseaimsatthetranslationalaspectsoftransformingbasicbioanalyticalapproachestoreal‐lifeclinical/industrialapplications.WhyjointhecourseinBiomolecularanalysis:Frommethoddevelopmenttoclinic?Thiscoursedealswithbiomolecularanalysis,andaimsatprovidinginsightand knowledgeonmostaspectsofmethoddevelopment,validation,andapplication.A uniquefeatureofthiscourseisinthefactthatthebioanalysisofbothsmall‐moleculedrugsandbiopharmaceuticalsisdiscussed.Expertsfromthefieldwithhands‐onexperiencewillbetheretoguideyouthroughthedifferentstepsandstrategieso methoddevelopment,optimization,validationandapplication.Methoddevelopmentis discussedfrombothanalytepropertyandapplicationperspective.CourseObjectivesThecourseconsistsof•fivedaytraininginattheVUUniversityAmsterdam,theNetherlands.Therewillbelectureswhichcanbefreelyinterruptedforquestionsanddiscussion,andsessions dealingwithactualcasestudies.•aweekofhomeassignments.Keyareascoveredbythiscourse¾Physico‐chemicalparametersatthebasisofmethoddevelopment¾Bioanalyticalstrategiesforsmallmolecules:sampling,samplepretreatment,separation,detection,validationanddatahandling.¾Generalconsiderationinbioanalyticalstrategiesforbiopharmaceuticals¾PK,PD,andbiomarkerassayformats¾Developmentofimmunogenicassaystrategies:background,assaystrategies,redictiveimmuno enicit
TargetGroup SafeSciMETstudents,academicsandworkersinthepharmaceuticalindustryandregulatoryauthoritieswhoneedabroadcomprehensiveunderstandingofthedrugdevelopmentprocesswithparticularemphasisonsafety.
LearningoutcomesThecoursewillenableattendees:•Toevaluatestudiesinthebioanalyticalfield•Tocommunicatewithexpertsinthefield.
Morespecifically,participantswillbeableto:¾Understandhowthephysico‐chemicalpropertiesoftheanalytesshouldbeusedinthemethoddevelopmentofbioanalyticalstrategiesforsmallmoleculedrugs.¾Haveabasicunderstandingofwidelyappliedtoolsforsamplepretreatment,separation,anddetectioninsmall‐moleculebioanalysis.¾Definethebasicneedsforthedevelopmentofintegratedbioanalyticalmethodsforbiopharmaceuticals,involvingbothrecombinantproteinproductsand(monoclonal)antibodies.¾Haveabasicunderstandingofvalidationanddata‐handlingissues.¾Criticallyassessanumberofrecentdevelopmentsinthefieldofbiomolecularanalysis.
CourseProgrammeTheSyllabusAsyllabuscontaininganintroductorychapter,lecturehandouts,listofabbreviations, definitionsandreadingmaterialswillbeavailableviaBlackboard14dayspriortothe courseandpaperhand‐outswillbeprovidedbythecourseleaderonthefirstdayofthe course.Thematerialforthehomeassignmentwillbeprovidedduringthefirstweekofthe course.AssessmentTheassessmentisbasedona2‐hourwrittenexaminationonthelastdayofthecourseandontheevaluationofthehomeassessment
Type
Assessors(s)
ExamaidsCourseadministrator:
Thepurposeoftheexaminationistotestthattheexamineehasabroadknowledgeandcomprehensionofthedrugdevelopmentprocessasawhole.Thepercentageofitemsonthetestdevotedtoaparticulartopicwillroughlycorrespondtotheemphasisgiventhetopicinteachingofthecourse:ExperimentalDesign:30%Pre‐clinical:30%Clinical:30%Translational:10%Prof.dr.WilfriedNiessen(public)Dr.ChristianHerling(EFPIA)Allwrittenexamaidsareallowed.Prof.dr.W.M.A.Niessen VUUniversityAmsterdamDivisionofBioMolecularAnalysisDeBoelelaan10831081HVAmsterdamE‐mail:w.m.a.niessen@vu.nlPhone:Iamapart‐timer:usee‐mail!Phone:+31‐20‐5987544(Secr.)
PracticalInformation3ECTScrediCourseCredits:ts Level:Master’slevel(secondcyclehighereducation)CourseDates:30January–3February2012Location:BioMolecularAnalysisGroupFacultyofSciences,VUUniversityDeBoelelaan10831081HVAmsterdam,theNetherlands Teachingmethods:Lectures,caseworkgroupdiscussions,presentationsanddiscussions.Inordertoemphasizetheflowoftheprocess,thecourseistoalargeextentbasedontheuseofcasesinbothlecturesandassignments.StudentWorkload:Preparation:12hoursCourse:38hoursAssignment:38Examination:2hoursTotal:90CourseFee:2,500Euro—750Euro(dependantoncategoryofstudent)(pleasevisitwww.SafeSciMET.eu.Howtoapplyformoreinformation)Applicationdeadline:30December2011CourseCapacity:30Language:TheofficiallanguageofthecourseisEnglish.NosimultaneoustranslationswillbeprovidedCoursenotes:Notes(literature)usedinthecourseCourseaccreditation:ThecoursemeetsthecriteriaforcontinuousprofessionalDevelopment(CPD)diplomas,anditwillbepartofa(forthcomingEuropean)MastersofadvancedSafetySciencesdegree.Moreinformationcanbeobtainedthroughourwebsite:http://www.SafeSciMET.eu
CourseLeaders Prof.Dr.WilfriedNiessen,VUUniversityAmsterdam,FacultyofSciences,DivisionofBioMolecularAnalysis,DeBoelelaan1083,1081HVAmsterdam,theNetherlandsDr.ChristianHerling,NovoNordisk,Copenhagen,Denmark
Lecturers WilfriedNiessenChristianHerlingSteenHonoréHanssenAnnetteZaarPeterLloydSebastianSpindeldreherHenkLingemanPascalEspie
VUUniversity,Amsterdam,NL NovoNordisk,Copenhagen,DKUniversityofCopenhagen,DKNovartis,Basle,CHNovartis,Basle,CHNovartis,Basle,CHVUUniversity,Amsterdam,NLNovartis,Basle,CH
REGISTRATIONPleasevisitwww.safescimet.eutoregister.Onthehomepage,pleasegotoHowtopplyandsignup:ForMScofAdvancedSafetyCourses ForContinuingProfessionalDevelopment(CPD) ForSinglecourses
Youwillbenotifiedthatyourregistrationhasbeenreceived
Theclosingdatetoregisterforthiscourseis30December 2011
Pleasenotethatthenumberof participantsislimitedto30. Itishighlyadvisabletosendinyourregistrationformassoonaspossible.Registrationwillbemadeonafirstcomefirstservedbasis
TRANSPORTThecoursetakesplaceattheVUUniversityinAmsterdam.TheUniversityisonly10minbytrainfromSchipholAirporttothe"AmsterdamZuid/WTC"station,followedbya5minwalk.InformationofhowthereachtheVUUniversitycanbefoundon:www.vu.nl/en/about‐vu‐amsterdam/contact‐info‐cmd‐route.index.sp
ACCOMMODATIONAmsterdamhasanexcellentbus,metro,trainandtramsystem,whichmeansthattheVUUniversityeasilycanbereachedfromthevarioushotelsinthecity.Hotelinformationcanbefoundonthefollowingwebsite:www.hotels.nl/amsterdam.
CANCELLATION3January2012.BeforethatdatetheCoursefeewillberefundedexceptforanadministrativefeeofEUR75,‐Afterthatdate,norefundscanbemadeforcancellations
