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DrugDiscoveryandIndia
Aforcetoreckonwith
Thepharmaceuticalindustryisgoingthroughatoughtimeduetodrying R&Dpipeline,poorproductivity,spirallingcostofresearchandcash crunch.However,Indiaisemergingasafavourablecountryforresearch collaborationtoprovidesolutionsthroughcostcompetitivenessand innovativedrugdiscoverycapabilities.
JBGupta
SeniorVicePresident CollaborativeResearch GVKBiosciencesPvt.Ltd. India

GlobalPharmaceuticalIndustryisatthecrossroads.Ontheonesidemarketdemandfornovelandbettermedicinesisgetting redefinedandgrowingduetodemographic,economicandepidemiologicaltrends.Butatthesametime,pharmaceutical companiesarefindingitdifficulttosurvivesincetheyareunabletoinnovateanddiscovernewmolecules.Thepipelineofthe newdrugmoleculesisdryingfastduetopoorR&Dproductivity,highfailurerateandgenericcompetition.Traditionally pharmaceuticalcompaniesreliedonspendingbigdollarsondiscoveringpossibleblockbustermoleculesforlargepatient populationthroughinternalresearch.However,newmoleculeinnovationfrominhouseresearchisdecliningandcompanies areforcedtoincreasetheirR&Dspendingaswellastoscoutin licensingopportunitiesfornewmolecules. Theimportanceofbiotechcompaniesasanalternativesourceofinnovativepotentialtherapiesandtofillthevoidhasbeen widelynotedinrecentyears.AccordingtoasurveypublishedinNatureReview/DrugDiscovery,basedonthenewapprovals betweenJanuary2006andDecember2007,65percentoftheUSFDAfilingwascontributedbybiotechindustriesand mainstreampharmacompanieswereresponsibleonlyfor35percentofthedrugs.However,thedisappointingpartisthat duringthisperiod91productsfailedinPhaseIIIand95percentofthesefailedproductsoriginatedfrombiotechcompanies. Alsowhenitcomestonewchemicalentitybasednovelmedicines,themainstreampharmacompaniesweretwo foldmore successfulthanbiotechcompanies.HighfailurerateandlessinnovativepipelineraiseconcernsontherobustnessofR&D processbeingfollowedbybiotechindustryandiscertainlynothelpingthedrugindustrytoreduceitscostofdiscovery.The recenteconomiccrisishasfurtherhitthebiotechindustryveryhard.RecentlyStevenBurrillofBurrill&Companyobservedthat mostofthebiotechcompanieshavelimitedcashandarepruningdowntheiroperationbyreducingworkforcesand eliminating/limitingresearchanddrugdevelopmentprojectsinadesperateefforttoextendtheirrunway.Thiswillfurther erodetheglobalpipelineoftheinnovativeproductsincomingyears. Thesefactorshaveforcedpharmaceuticalcompaniestothinkoutoftheboxandlookeastwardforinnovativesolutions. StrongCRObasetosupportR&D InrecentyearsIndiaandChinahaveestablishedthemselvesasstrongplayersinoutsourcingofresearchandmanufacturing. TodayIndiahasthelargestnumberofFDAapprovedmanufacturingplantsoutsidetheUnitedStatesandisaforcetoreckon incustomsynthesisandcontractmanufacturing.TheCROactivitiesindiscoveryandclinicaldevelopmentspacearealso growingfast.Forthelastfiveyearsorso,severalcompanieslikeGVKBiosciences,Aurigene,Syngene,Advinus,Jubilant, Suvenlifesciences,SaiLab,Accunova,iGateetc.havecomeintoprominencebothfordiscoveryanddevelopment.Asaresult, severallandmarkdealsweresignedbetweenIndianCROsandglobalpharmaceuticalgiants.Inearly2006,Wyeth Pharmaceuticalsstruckamulti yearoutsourcingdealwithGVKBiosciencesinvolving150chemistsworkingexclusivelyon Wyethprojectsandprovidingarangeofservicesinsyntheticchemistryresearch.Forthispurpose,adedicatedresearch centreequippedwiththelatesthigh endscientificequipmentandinstrumentation GVKBIOWyethHyderabadChemistry ResearchCenter wasbuiltinHyderabad.Lastyearonthesameline,BristolMyersSquibb(BMS)andSyngeneannounced amulti yearcollaborationtodevelopintegratedcapabilitiesinIndiainmedicinalchemistry,biology,drugmetabolism,and pharmaceuticaldevelopment.ThiscollaborationisintendedtoadvancethediscoveryandearlydevelopmentprojectsofBMS. Syngeneisonitswaytorecruit400scientistsandbuildingdedicatedlaboratoriesforthispurpose.

amulti yearcollaborationtodevelopintegratedcapabilitiesinIndiainmedicinalchemistry,biology,drugmetabolism,and pharmaceuticaldevelopment.ThiscollaborationisintendedtoadvancethediscoveryandearlydevelopmentprojectsofBMS. Syngeneisonitswaytorecruit400scientistsandbuildingdedicatedlaboratoriesforthispurpose.

Indiaoffersseveraladvantagesforclinicalresearchlikelargepatientpopulationnotexposedtotreatment(treatmentna ve population),worldclasshealthservicesalongwithwelltraineddoctorsandhasemergedasastrongbaseforclinicaltrials. TheclinicaltrialsmarketisexpectedtogrowataCAGRofnearly36percenttill2011toregisterrevenuesmorethanUS$600 million.Todaythereishardlyanymajortomid sizeglobalpharmaceuticalcompanythatdoesnotengageitselfinR&D activitiesinIndia.PharmaceuticalcompanieshavestartedrelyingonIndianCROsfortheirchemistry,clinicaldevelopmentand manufacturingrequirement. Vasttalentpooltosupportdiscovery Researchoutsourcingisamatteroftrustandsincethistrusthasalreadybeenbuiltthroughchemistryandclinicalservices, CROsinthecountryareconfidentthatpharmaceuticalcompanieswouldbewillingtooutsourcemorevalueaddedservices. Asaresult,IndianCROsarefastmovingupthevaluechainfromordertakerstoproblemsolversandvalueco creators.The initialconcernslikeintellectualpropertiesandregulatoryissuesaregraduallybeingaddressedthroughreformsinlawaswell asthroughsensitivitiesshownbyCROstoaddressthemupfront.Companiesareexpandingintootherdisciplineslike pharmacology,cellbiologyandpharmacokinetics.ThoughIndiaisconsideredweakinbiologyresearch,thecountryhasan impressivenumberofbiologicalscientists.AccordingtoIMAIndia sestimations,everyyearIndiaproduceshalfamillion graduatesinbiologicalsciences,biotechnologyandbioinformaticsandawardsmorethanaquartermillionpostgraduatesand 1,500PhDsinthebiosciences.Indiahasathrivinggeneric,formulationandbulkdrugindustrybutlaggedbehindin developingskillstosupportdiscoveryorientedinnovativeresearch.Asaresult,thediscovery focussedbiologyresearch remainedatanascentstage.However,afterupholdingtheIntellectualpropertiesagreement(TRIPS)andcommitmentto recogniseproductpatents,forlastdecadeorsoIndiancompanieshaveinvestedininnovation leddrugdiscoveryand producedareasonabletalentpoolinbiologicalsciences.Astheopportunitiesareincreasing,thenumberofUStrainedIndian scientistsincludingbiologistsarereturningtoIndiaandbeingrecruitedbyIndianCROs.

Initialsuccessstory

recogniseproductpatents,forlastdecadeorsoIndiancompanieshaveinvestedininnovation leddrugdiscoveryand producedareasonabletalentpoolinbiologicalsciences.Astheopportunitiesareincreasing,thenumberofUStrainedIndian scientistsincludingbiologistsarereturningtoIndiaandbeingrecruitedbyIndianCROs.

Initialsuccessstory BasedonthesestrengthsIndiahasstakeditsclaimtobecomeafrontrunnerininnovation ledcollaborationleadingto intellectualpropertygenerationthroughdiscoveryresearchandareaheadoftheirChinesecounterpartsasreportedinthe recentlypublishedreportsponsoredbyKauffmanFoundation.OnthegroundIndianCROshaveclosercollaborationwith establishedpharmaceuticalcompaniesfordiscoveringdrugsratherthanlimitingthemselvestoprovideservicesandare hopingtogetabiggerpieinintellectualproperties. ThepaceatwhichthesediscoverycollaborationsarebeingestablishedindicatethatWesternPharmaceuticalIndustryis relyingmoreonIndiafortheirbrainpowerandsourceofinnovativeresearchratherthanforcostcuttingmeasures.Timewill tellifIndianCROsandpharmaceuticalcompaniescanprovethemselves.However,initialmilestonesawardedtosomeof thesecollaborationsindicatethatIndianscientistshavenotdisappointedtheirwesterncounterparts. ChallengesofInnovationBasedCollaboration Inordertoleveragetheopportunitiesfordrugdiscovery,IndianCROsarefacingseveralchallengesaswell.InvestorsinIndia havenocultureofinvestinginriskyresearchleadingtodrugdiscovery.Thefirstwaveofinvestmentindrugdiscoverycame fromlargeIndianpharmaceuticalcompanieslikeRanbaxy,Dr.Reddys,NicholasPiramal,Zydus,Wockhardtetc.whenthey themselvesenteredinthisarena.Theeffortsyieldedresultsbutlimitedfundingandlackofexperienceclearlyreflectedinthe outcomesandwereshortonimpactingtheglobalscene.Thisnextwaveoffocussedeffortstocollaborateondrugdiscovery projectswithglobalpharmaceuticalcompanieshascomefromCROshavingarevenuegeneratingstreamthroughtheir contractservices.ManyCROslikeGVKBiosciences,Jubilant,Advinus,Aurigeneetc.spearheadsuchefforts.However,these companieshavelimitedfinancialsurplusandhencearerestrictedintakingrisks.Aninnovativefinancialmodelthatcanattract fundingfromlocalandglobalinvestorsforsuchactivitiesisyettoemerge. TheIndianGovernmenthasinitiatedseveralmeasurestoencouragepublicprivatepartnershipordirectinvestmentstowards discoveryrelatedactivitiesinprivatesectors.DepartmentofBiotechnologyhasformulatedacomprehensiveNationalBiotech DevelopmentStrategytoincentivisepublicprivatepartnership,hascontributedtothedevelopmentofregionalbiotechnology clustersandprovidedgreaterfinancialsupporttoindustry orientedearlystageresearchetc.TheTechnologyDevelopment BoardofDepartmentofScienceandTechnologyhasinvestedhundredsofmillionsofdollarsinsmallmolecules, biopharmaceuticalsandherbaldrugdiscoveryrelatedprojects.NewMillenniumIndianTechnologyLeadershipInitiativeof CouncilofScientificandIndustrialResearchhasmadesignificantinvestmentindiscoveryprogrammestobringtogether industries,nationalresearchlaboratoriesandacademia.However,theoutcomeofalltheseinitiativesindicatesthatthese initiativeshavenotbeenabletowintheconfidenceoftheindustriessofarandtheoverallimpactandeffectivenessofsuch measuresmayrequireclosemonitoring. Anothermajorchallengeisthetrainedmanpowerparticularlyintheareascriticalforthesuccessofdiscoveryprogrammes. Indiaisstrongininformaticsandchemistrybutstillneedspersonnelinmedicinalchemistry,invitrobiologyandefficacy relatedanimalmodels.Traditionaleducationsystemproducesbrilliantchemistsandbiologistsbuttheyarenotemployable forindustrialresearchandthereislimitedleadershipavailableinthesedisciplineswithinindustries.Morerecentlyindustry andgovernmenthavetakenconcretestepstobolstertheR&Dcapabilities.Industriesareprovidingmoreonthejobtraining andrecruitingaggressivelythekeypersonnelfromUSandEuropetofillthegaps.DuetoincreasedopportunitiesinIndia, increasingnumberofIndianscientistsworkinginAmericanandEuropeanpharmaceuticallaboratoriesareattractedtotakeup acareerinIndia. InrecentyearsIndiahasstrengthenedthepatentlawswhicharemoreincompliancewiththeglobalpractices.Thishas changedtheIPscenarioinfavourofinnovativeresearchandglobalcompanieshaveslowlystartedrespondingpositivelyby outsourcingtheirIP sensitiveresearchtoIndia.However,thereisaneedtobuildastrongproactivelawenforcingsystemso thattheconfidencebuildingandglobalperceptiononIPprotectionarechangedfavourablytocreateapositiveenvironmentfor discoverybasedcollaboration. Efficacyandsafetyofnewchemicalentitiesarebasedontheirevaluationindifferentanimalmodels.Accesstothequality animalsiscentraltoanydrugdiscoveryendeavour.Moreflexiblesystemhastobeputinplacetoprocuresmallandlarge animalsthroughqualityanimalbreedersbasedoutofIndiaorabroadthroughimportationwithminimaladministrativeand regulatoryhurdles.

changedtheIPscenarioinfavourofinnovativeresearchandglobalcompanieshaveslowlystartedrespondingpositivelyby outsourcingtheirIP sensitiveresearchtoIndia.However,thereisaneedtobuildastrongproactivelawenforcingsystemso thattheconfidencebuildingandglobalperceptiononIPprotectionarechangedfavourablytocreateapositiveenvironmentfor discoverybasedcollaboration. Efficacyandsafetyofnewchemicalentitiesarebasedontheirevaluationindifferentanimalmodels.Accesstothequality animalsiscentraltoanydrugdiscoveryendeavour.Moreflexiblesystemhastobeputinplacetoprocuresmallandlarge animalsthroughqualityanimalbreedersbasedoutofIndiaorabroadthroughimportationwithminimaladministrativeand regulatoryhurdles.

AuthorBio
JBGuptaistheSeniorVicePresident CollaborativeResearch,inGVKBiosciences,AsiasleadingContractResearch OrganisationdeliveringintegratedresearchservicestoPharma,BiotechandLifeSciencescompaniesglobally.Hehasover15 yearsofdrugdiscoveryexperiencehavingworkedwithBayerHealthCare,GermanyBayerYakuhin,JapanandRanbaxy,India.
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