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CITY AND REGIONAL PLANNING Cornell University · 106 West Sibley Hall · Ithaca, New York 14853 Tel: (607) 255-4331 · Fax: (607) 255-1971 · Working Paper Series A COMPREHENSIVE ECONOMIC IMPACT ANALYSIS OF NATURAL GAS EXTRACTION IN THE MARCELLUS SHALE May 2011 This is one in a series of policy working papers, prepared by a group of researchers centered at Cornell University with support from the Park Foundation and the Heinz Endowments, to inform policy makers and citizens about key economic issues related to shale gas drilling and production.

longer period of time differs from the amount
boom
analysis of the geographic pattern of drilling
shale gas drilling
environmental protection
drilling
economic development
economic impact
production

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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

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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

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