Key events in the development of PsA-TT, a new ......MVP product development plan MVP Funding,...
Transcript of Key events in the development of PsA-TT, a new ......MVP product development plan MVP Funding,...
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KeyeventsinthedevelopmentofPsA-TT,anewmeningococcal
conjugatevaccine
Meningi'sVaccineProjectClosureConferenceAddisAbeba,Ethiopia,February22,2016
FMarcLaForce,MDSerumInsCtuteofIndiaPvt.Ltd.
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Threepivotalevents
• TheMeningi)sVaccineProjectbecomesavirtualvaccinecompanyinMarch2002
• Anewconjuga)onmethodistransferredfromFDA/NIHtoSerumIns)tuteinDecember2003
• SerumIns)tutesuccessfullyacceptstechtransfersandscalesupproduc)onfromlaboratorytocommercialscale(04-07)andlicensesanewPsA-TTvaccine,MenAfriVac(2009)
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AvailabilityofGroupAMeningococcalVaccinesforSub-SaharanAfricain2001
• OnlypolysaccharideAvaccineswereavailableandtheywereusedinreac)vecampaigns
• Over100milliondosesofA/CPSvaccinewerepurchasedbymeningi)sbeltcountriesfrom1999-2003.
• Thereac)vecampaignswereexpensive,largelyineffec)ve,butpoli)callynecessary.
• TherewerenoplanstodevelopmeningococcalAconjugate
vaccinesforAfrica.
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CreaConoftheMeningiCsVaccineProject
• Theterriblemeningi)sepidemicin1996leadAfricanpublichealthofficialstoaskWHOtohelpthemaddressthisproblem.
• Interna)onalmee)ngsorganizedbyWHOin2000and2001recommendthatconjugatemeningococcalvaccinesbedevelopedforAfrica.
• Aninformalcollabora)onbetweenPATH,WHOandCDC/Atlantafurtherassesstheproblem.
• InJune2001theMeningi)sVaccineProject(MVP)iscreatedwithGatesFounda)onsupportasa10yearpartnershipbetweenWHOandPATH.
Goal:toeliminateepidemicmeningi'sinAfricaasapublichealthproblemthroughthedevelopment,tes'ng,licensure,andwidespreaduseof
conjugatemeningococcalvaccines
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InformingAfricanpartnerswhilebeLerunderstandingtheproblem–Fall2001
• MVPdiscussionswithAfricanpublichealthofficialsandWHO/AFRO(Harare,Niger,BurkinaFaso,Nigeria)yieldedconsistentinforma)on
– Costofvaccinewasthemostimportantlimi)ngfactortotheintroduc)onofnewvaccinesinAfrica
– Meningi)sbeltcountriesareamongthepoorestintheworld
– SuccessofMVP(widespreaduseofaconjugatemeningococcalvaccineinmasscampaigns)wouldnotbepossibleunlessvaccineswerepricedlessthan$US0.50perdose
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Earlypressuresin2001
• DiscussionswithPharmahadalreadybegunwithWHOin2000andWHO/PATHinearly2001.
• Generalexpecta)onthatMVPwouldnego)ateacontractwithamul)na)onalforthedevelopmentofanA/Cconjugatevaccine
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Product development with established vaccine manufacturers
MVP Provides funds and monitors
Vaccine company Development, production, regulatory, clinical, fill/finish
Finished Product
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MVPnegoCaConswithPharma(01-02)
• Mee)ngswithChiron,BaxterandGSK(September2001–March2002)
• Keyissuesinthenego)a)onsincluded:– Vaccineprice– Guaranteedpurchase(effectofvolumeonprice)– Investmentstoincreasemanufacturingcapacity– Crea)nga“norisk”model
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MVPbecomesavirtualvaccinecompanyMarch2002
• MVPcouldnotreachanagreementwithmajorvaccinemanufacturersandnego)a)onsendinMarch02
• Acerconsulta)onswithMVPTechnicalandManagementCommideesandtheGatesFounda)on,MVPelectstobecomeavirtualvaccinecompanywiththegoalofdevelopingaGroupAconjugatevaccine.
• Crucialelementsinmakingthisdecisionincluded– InputsfromAfricanpublichealthofficialsontheimportanceofvaccineprice
– AvailabilityofabusinessplancommissionedbyTeresaAguadoandLuisJodar
atWHOindica)ngthat“costofgoods”formaking25-50milliondosesofaMenAconjugatevaccinecouldbeaslowas$US0.18perdose.
– Inputfromfourconsultants,CostanteCeccarini,JeanPetre,ArtElliotandDanGranoffwhoseopinionswerehighlyvalued.
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MVP product development plan
MVP Funding, technology
development
Developing country manufacturer Scale up, fill finish
Licensed vaccine
Contract manufacturer PsA and TT
Tech transfer Clinical and regulatory Tech transfer
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Challenges and opportunities with new development model
Challenges • Greater risk • More complex technical and
managerial issues • Identifying technology • Technology transfer • Clinical trials
• Changes in Nm epidemiology • Non A meningitis • Bivalent product
Opportunities • Low vaccine cost • IPR issues straightforward • Opportunity cost issue
resolved • Tailor-made vaccine for
Africa • Strengthens developing
country capacity • Model for other vaccines
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ConjugaConofPSAtocarrierprotein
• SynCoBioPartners,acontractmanufacturerfromAmsterdam,chosenasaPSAmanufacturer
• TTselectedasthepreferredcarrierprotein
• Iden)fyingaconjuga)onmethodtoprepareaPsA-TTconjugatevaccine– Pharmauninterestedinsharing/sublicensingIP– InJune2002MVPbeganworkingwithEuropeanbiotechcompanywithextensiveexperiencedevelopingPSconjugatevaccines
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“Emerging” vaccine manufacturers expressing interest and visited
• BioFarma(Indonesia)• BioManguinhos(Brasil)• BirMex(Mexico)• Finlay(Cuba)• SerumIns)tuteofIndia(India)
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TroubleswithconjugaConIP(June2003)
• Novelconjuga)onmethoddevelopedbyBiotech;testlotsofPsA-TT(laboratoryscale)madeandsuccessfullytestedinmice
• AtaUKmee)nginMarch2003theMVPTechnicalAdvisoryGroupapprovedtechtransferofmethodtoSerumIns)tuteinJune
• ThedevelopmentBiotechpartnerwithdrewfromtheprojectinJune2003.
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Falloutfromfaileddevelopmentpartnership(Summer2003)
• Majorblowtotheproject• Severalvaccineexpertsopined“Wetoldyouso…theseareonlyamateurs…”
• Opencri)cismoftheprojectatJuly2003WHOSAGEMee)ng
• Significantmoraleproblemsintheproject• InternalreviewatMVPinlateJuneconcludedthatthedevelopmentstrategywassoundbutthatapoorpartnerchoicehadbeenmade
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Productdevelopmentworkrestarted
• InJuly2003MVPrequestedproposalsfrom2publiclaboratoriesand4vaccinemanufacturers
• MVPreceived4proposalsthatwereevaluatedbytheMVPExpertPanelinOctober2003– Nofinalrecommenda)onmadebuttwoavenueswerechosenforfurtherevalua)on
• Transferaconjuga)onmethodfromCBER(FDA)toSerumIns)tuteofIndia
• AskBaxter,aUS-basedPharmacompany,tomakebulkMenAconjugateforfill/finishatSerumIns)tute.
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FDAandtheNIHstepup• CarlFraschhadindicatedinMay2003thatarobust
conjuga)onmethodforNmAhadbeendevelopedbyRobertLeeatCBER/FDAandwasavailable
• DiscussionswithFDAbegininlateJune• Muchofthebackgroundworkhadalreadybeendoneby
Drs.LeeandFrasch• Confirmatorytes)ngoftheCBER/FDAvaccinewasdoneby
DanGranoffinOctober2003.Heconcluded“…thisisthemostpotentMenAconjugateJhadevertested.”
• Transferformali)eswererapidlynego)atedattheNIHOfficeofTechnologyTransfer(PSoukasandCOdoson)
• TechnologytransfertoaSerumIns)tuteteambeganinBethesda,MDduringthe2003Christmasholiday.
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SerumInsCtutesuccessfullyacceptstransferofFDAconjugaContechnology
• PreclinicallotsofPsA-TTpreparedinMarch2004• FormalagreementbetweenPATHandSerumIns)tutesignedinJuneof2004
• GMPproduc)onisgraduallyscaledup• Analy)ctechniquesdeveloped• AdedicatedfacilityisbuiltinPunewithcostssharedbetweenMVPandSerumIns)tute
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Productdevelopmentdecisions2004-2009
• PsA-TTfromSerumIns)tuteusingtheFDAconjuga)onmethodweretestedatNIBSC(PodersBar,UK)inNovember2004
• ResultswerereviewedandapprovedbyMVPExpertPanelandWHOSAGEmembersinNovember04–Godecisionrendered
• ClinicaltrialsofthePsA-TTvaccinebeginin2005.• MenAfriVacislicensedbytheDrugsControllerGeneralofIndiainDecember2009
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Lessonslearned• PDPvaccinepartnershipscansolveimportantpublichealth
problemsbutthescien)ficbasemustbesolid• Expectcri)cismifyouaredoingsomethingnew• Recognizeandaccommodatetoculturalreali)es• Chooseconsultantswhoaresmartandcandidbutalsohave
soundinterpersonalskills• Thebusinessmodelmustbeacceptabletoallpartners• Facetoface)mewithpartnersisessen)al;whenindoubt–go
visit• Iden)fyandpayaden)ontothekeyplayers,worktounderstand
whattheywant• Betransparentandcommunicate,communicate,communicate…
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The Meningitis Vaccine Project
The2001MVPvaluesstatement• Theprojectisaboutpublichealthimpactandnotsimplymakingvaccinesavailable• Decisionsaboutcandidatevaccineslinkedtointroduc)onstrategiesandlikelyfinancial
constraints• AfricanpublichealthofficialstobecloselyinvolvedwithMVP