upjohn公司在新產(chǎn)品開發(fā)過程中的風險管理[文獻翻譯]

1、畢業(yè)論文（設計）外文翻譯ManagingtheriskaspectsoftheproductdevelopmentprocessattheUpjohnCompanyTheaimofthispaperistodescribeaninnovativepracticethathasimplicationfnewproductdeveloperswithinoutsidethepharmaceuticalindustry.W.E.Upjohna

2、physicianpracticinginthecityofKalamazooMichiganinthelate1800sfoundedtheUpjohnCompany.ThelocalpopulationincludedanumberoffollowersoftheSeventhDayAdventistfaithwhosebeliefsdiscouragemeateating.Asaresultthereweresignificant

3、healthissuesrelatedtoirondeficiencyanemia.Toremedythesituationthephysicianstartedtocompound“iron”pillstoprovidetheimptantmineraltohispatientswhohadtorelyonvegetablesources.ThepillswerenotDrUpjohn’sprimaryfocusheassignedt

4、he“pillrolling”operationtooneofhisbrotherswhoimplementedsoundbusinesspracticeshiredasalesfce.Withinseveralyearstheoperationspawnedanumberofcompetits.Onefindingstartledthebrothers.Someironpillsonthemarketweresohardthatama

5、nwieldingahammercouldpoundthemintoasoftpineboard.Thepillspassedthroughthebodywithoutbeingabsbed.Itbecameastardtechniquetoarmsalespeoplewithhammersboardscompetit’spillsdemonstratetheirhardness.IncontrasttheUpjohnCompany’s

6、pillscouldbecrushedtoapowderbyasalesperson’sthumb.Thatdemonstrationvitalizedthecompany’sdevotiontopurityquality.Inmanyindustriesthelevelofdevotiontoproductqualitywouldbesufficienttoinsuresuccess.FexampletheFederalTradeCo

7、mmissiontheConsumerProductSafetyCommissionregulatemostproductstheirsafety.Theseagencieshavelimitedenfcementpowersinegregiouscasesofdangerousproductscandolittlemethansuewarnthepublicnegotiateaproductrecall.Howeverindrugin

8、dustrieswldwidegovernmentregulationisoftenintense.IntheUSAtheFoodDrugAdministration(FDA)isgedwithprotectingthepopulationfromdangerousineffectivepharmaceuticals.Accdinglyitpossessesextradinarypowers.Everydayitseizesdestro

9、ysfoodpharmaceuticalproductsdeemeddefective.Theymaynotbedangerouspersebutiftheydonotmeetthethirdgenerationintroduction.ThesituationfcedUpjohntolookfstrategicpartners.ItfoundoneinSweden’sPharmacia.Pharmaciahadarobustnewpr

10、oductdevelopment(NPD)introductionsystemthemarriageseemedblessed.ThenewentitycalledPharmaciaUpjohnwascontrolledbyUpjohndespitedifferencesinmanagerialculturetheflowofnewproductsfromEuropewasattractive.RecentlytheFDAimposed

11、newrequirementsonpharmaceuticaldevelopers.Theyacceleratedtherapiditywithwhichdrugswerewithdrawnfromthemarket.Intheearly1970stheFDAhaltedsalesofabouttwotofourdrugseachyear.Twentyyearslatertheaverageannualwithdrawalratesur

12、gedtotendrugs.Bostreactedswiftly.Indertominimizetheriskofthelossofanexpensivelytestedproducthefmedaninternalgroupdedicatedtominimizingtheriskoflosingaproducttoregulation.ToaccomplishasuccessfulpharmaceuticalintroductionN

13、PD’sjobwastwofold.FirstithadtoshepherdtheproductthroughtheFDAnewdrugapplicationprocess.Thatprocessfollowedarigidlyprescribedseriesofstepstoproveadrug’sefficacysafety.Theprocesscanbedividedroughlyintotwoparts:discoverycli

14、nicaltrials.Discoveryinvolvesfindingtargetsfthedrugoptimizingitscompositionfthebesteffects.ClinicaltrialsinvolvefourphasesPhasesItoIV.PhaseIVrepresentsthestageatwhichadrugisapprovedfsaletheresearchefftsaimatdiscoveringne

15、gativepositiveeffectsofitsuse.Asaresultnewdrugapplicantsstartedwithaseriesoftestsonanimalsubjectstogaugesafetytoxicity.Intheclassicstagegateprocessseriousproblemsuncoveredusingloweranimalslikeratsrabbitswouldstopfurtherd

16、evelopment.Ifnoproblemswereencounteredthetestswouldproceeduptheevolutionarychaintoothermammals.Thedetailedstudiesoftentookyearsinvolveddoubleblindstudiesinwhichsomesubjectsreceivedthedrugothersreceivedaplacebo.Attheendof