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In Association With Organised ByMedia Partners

10-12AUgUST2011HolidaInnMumbaiInternationalAirportMumbai,India

NDDSINDIA 2011

Forulaion Dsign Rgulaion Scalabili Corcialisaion

Sbas C Manda,SeniorDrugInspector DIReCtORAte OF DRUG CONtROLWeSt BeNGAL

Smed Gaikwad,DirectorMedicalServicesRICHteR tHemIS meDICARe

Ra Gpa,SeniorGeneralManagerCorporateRegulatorAffairsPIRAmAL HeALtHCARe

Venkaa Ramana, Chief Scientic Ofcer ReLIANCe LIFe SCIeNCeS

Koma Sa Bkanwaa, DirectorINNOVARIP CONSULtING GROUP

Dange Veerapaneni, ManagingDirectorSPARSHA PHARmA INteRNAtIONAL

Devaraj Ramba,AdvisorNDDSNAtCO ReSeARCH CeNtRe

SP Vyas,Professor, DepartmentofPharmaceuticalSciencesSAGAR UNIVeRSIty, INDIA

Diraj Kaar,DirectorFormulationsFReSeNIUS KABI ONCOLOGy

Kapieswar Swain,VicePresidentProductDevelopmentmACLeODS PHARmA

Sogaa PramanickDirectorResearchandDevelopment(Formulation)EMCuRE PhARMACEutICAlS

Skjee Sing, SeniorVicePresidentResearchandDevelopmentPANACeA BIOteC

Rini Banerjee, Professor,DepartmentofBiosciencesandBioengineeringCentreforResearchinNanotechnologandScienceINDIAN INStItUte OF teCHNOLOGymUmBAI, INDIA

Priam D Kanagae,ManagerProductDevelopmentJOHNSON & JOHNSON

Garav Sarma, SeniorManagerBusinessDevelopmentandClinicalResearch WOCKHARDt

NeW

For2011PRe-CONFeReNCe SemINAR

INteRNAtIONAL

NDDS SHOWCASe

10AUgUST2011

outStanDIngpreSentatIonSfroM:

gaIn

SolutIon-orIenteDguIDanceon:

reulatoyClaications:Learnthemost efcient clinical trial procedures anddocumentationtoachievesmoothandswiftapprovalforNDDSproducts

InnovativeDuDeliveyUpdates:ExplorethenewtrendsinNDDSproductdemandandalignyourbusinessstrategywiththeseopportunities

ScienticAdvances:Leveragethelatestdevelopmentsinexistingdeliveryplatformstoimprove their efcacy in the most cost-effectiveway

CommecialisationStateies:Gaintechniquestotapnewmarketsandunlockthelatentpotentialtoensuremaximumreturnonyourproductinvestment

PacticalIntenationalShowcase:Heartheverylatestthinking,trendsandinnovationssurroundingNDDSdevelopmenttakingplaceacrosstheglobe

hearexeMplarypreSentatIonSfroMour

InternatIonalexpertS:

Benet from the

viewsofDamonSmithonthefuturedirectionofinnovativedrugdeliverysystemsandtheirgrowthpotentialgiventhemultifoldincreaseinthedemandofNDDS

CapitaliseonthegrowthpotentialofnanotechnologyinthecomingyearswithMahesh

ChaubalandunderstandqualityrequirementsofanNDDSproductdevelopedfortheinternationalmarket

Leverageonthe

variousadvancesmadeinnanotechnologyandevaluatetheoptionstomeetformulationsandscalabilitychallengesinacasestudydiscussionpresentedbyShelleyADurazo

EnsureeffectivelifecyclemanagementofatransdermalpatchandunderstanditstechnicalcomplexitiesintheinteractivediscussionwithGautamRanadeGautam RanadeResearch Fellow

PharmaceuticalDevelopment

Worldwide Researchand Development

PfizerUSA

Mahesh V ChaubalDirector Product

DevelopmentBaxter

HealthcareUSA

Shelley A DurazoResearch FellowDepartment ofPharmaceutical

SciencesUniversity of

Colorado Denver

Damon SmithSenior Vice President

Research andDevelopmentLabopharm

USA

For more detailsplease refer to

page 5

earlyBIrDDIScountS!

FRIDAy15JULy2011INR6,300/US$150

Toregister-Tel:+91(022)40461466Fax:+91(022)40461477Email:[email protected]

.dds-idi.m



Clarify everdoubtregardingclinicaltrials,documentationrequirementsandapprovalofNDDSproducts

LvragIPRtoprotectandcapitaliseonourinnovativeNDDSproduct

GaintechnicalinsightsintoeverdeliverplatformfrombenchmarkglobalpharmaceuticalcompaniesinvolvedinthedevelopmentofNDDS

ProplourgrowthtomatchtheglobalmarketthroughkelearningssharedinourexclusiveinteractiveseminarledbinternationalNDDSexperts

BenetfromintensivediscussionbetweenseniorscientistsonfuturetrendsandthedirectionofgrowthforNDDS

Idnify andaccessnewmarketsthroughinnovativemarketingstrategies

esablishnewpartnershipsandnetworkwithkedecision-makersfromleadingnationalandinternationalpharmaceuticalcompanies

7geatreasonsToAttend:

Nowinits2ndear,NDDSIndia2011bringsouarefreshed,industr-focused,in-depthagendaconcentratingonimplementablesolutionstothechallengesoufacearoundNDDS.Focusingonallthekebusinesscriticalissuesincludingregulatorapprovals,productdevelopmentchallenges,andinnovativecommercialisationstrategies,thisreallisaneventnottobemissed.Gainthelatestfactsandupdatesfromnationalandinternationalspeakersthroughlivecasestudies,stimulatingdiscussionsandinteractivesessionswiththeaudience.Withgenericpipelinesdringup,thisconferencewillequipoutocapitaliseuponthevastcommercialopportunitiesavailablethroughNDDS.

Organised by:

CPhIConferencesisaspecialistproviderofcontent-ledconferencesandseminarsaimedatthefastgrowthsegmentsoftheIndianpharmaceuticalindustr.Wemonitormarkets,identifthemostcriticaltrendsandprovidetimelconferencestohelpouassessandtargetnewbusinessopportunitiesinIndia.Eachofour

eventsisextensivelresearchedwithrepresentativesofboththelocalandinternationalmarkets,anddesigned specically to bring these audiences together to discuss, debate, network and create protablenewpartnerships!Backedbanextensivenetworkoflocalandinternationalexhibitions,onlineportalsandmagazines,ouraccesstoseniorleveldecisionmakersacrossthePharmaceutical,BiopharmaandOutsourcingindustriesremainsunrivalled!

SponsoringorexhibitingatNDDSIndia2011 isanexcellentwatopromoteourbusinesstoahighltargetedgroupofkedecision-makerswith a specic interest in product development,

processdevelopmentandmarketingofNDDSproducts.Wehavearangeofbusinessdevelopment,marketingandsalessolutionsthat will be tailored to specically deliver on your business objectives. To nd out more about howoucanmakethemostofourparticipationatthisevent,contactVenkatrajan,SalesManae,atTel+91(022)66122689,[email protected]

Proo your Businss

ExHIBITIONFLOORPLAN

Coffee& Lunch

point

Toregister-Tel:+91(022)40461466Fax:+91(022)40461477

WhatdeleateshadtosayatNDDSIndia2010:

Who Should And?

“ThetwodasoftheconferencewerevereffectiveandhelpedmegetallthecurrentinformationonNDDS

” ATMMasud,SeniorManager,SquarePharma,Bangladesh

“Good,informativeconference,coveringalmostallissuesandtechnologiesofNDDS

”

NareshHarisinghani,DeputGeneralManager,WanburLimited,India

“Excellentlhandledandverinformative”Nilesh Jaiswal, Senior Manager, Sano Aventis, India

NDDSINDIA 2011

JUSt SOme OF tHe AtteNDeeS OFNDDSINDIA2010:

AartiDrugs ActavisPharmaManufacturing AdvancedEnzmeTechnologies AkumsDrugsandPharmaceuticals AspireLifeSciences AstronResearchBioplusLifeSciencesCelonLabsCiplaConceptPharmaceuticalsDrRedd’sLaboratories

EmcurePharmaceuticalsEvonikDegussaIndiaGlenmarkPharmaceuticalsIndocoRemediesLailaPharmaceuticalsLincolnPharmaceuticalsLupinPharmaceuticalsMascotEngineeringMicrolabsMillipore(India)MonitorGroupMSDTechnologSingaporeNovartisHealthcareNovoNordiskOmniActiveHealthTechnologiesPanaceaBiotecParrLifeSciencesPiramalHealthcarePlethicoPharmaceuticalsRoquetteIndiaSano Aventis

SimpexPharmaSquarePharmaceuticalsStridesArcolabSunPharmaAdvancedResearchCompanSwatiSpentoseRichterThemisMedicareTirupatiMedicareTorrentPharmaceuticalsandResearchCentreUnichemLaboratoriesWanburZimLaboratories

This conference has been designed specically for VPs, Directors, GMs and Heads of R&D, NDDS,Formulations,AnalsisandTesting,ProductDevelopment,ProcessDevelopment,RegulationsandBusinessDevelopmentfrom:

InnovatorPharmaManufacturersBiopharmaManufacturersGenericPharmaManufacturersDrugDeliverPlatformProviders

MedicalEquipmentProvidersIngredientsandMaterialSuppliers AnalticalLaboratoriesCRAMS

Forulaion Dsign Rgulaion Scalabili Corcialisaion



CONFeReNCe DAy ONe – thurSDay11auguSt2011

Email:[email protected]

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08:30 Rgisraion and rfrshns

09:00 Opning rarks fro h Chair

mark Ovrviw

09:10 esablishing h currn picur for NDDS and forcasing dosic andglobal arks o idnif h fuur dircion of growh and ncouraginvsn

• ExaminingthesizeoftheglobalNDDSmarketandthelatestdevelopmentstodeterminethelearningsandexpertisethatcanbeappliedtotheIndianmarket

• ProjectingsupplanddemandtoensurethatIndiacanmeetthetechnologicalinvestmentandexpertiserequirements

• Understandingthecompetitiveadvantagesandchallengesassociatedwiththedevelopmentofinnovativetechnologplatformsanddelivermethods

• EvaluatingthevariousproductandmarketingstrategiesofkeIndianandglobalplaers

• Adopting a robust R&D process to speed-up regulatory approval and reduceproducttimetomarket

• DeterminingthequalitrequirementsofinternationalpharmaceuticalmarketsandaligningproductdevelopmenttomeettheseguidelinesandenableentrintonewmarketsSubhash C Mandal,SeniorDrugInspectorDircora of Drug Conrol, Ws Bngal

Rgulaory Landscap

09.40 Updaing on h las govrnn policis and plans currnl in placand in dvlopn o incras h growh of NDDS in India

• RecappingonNDDSguidelinesforgenericandnewproductapprovals• Identifying the nancial incentives and different initiatives designed to supportNDDSdevelopmentinIndia

• Understandingtheclinicaltrialsandrelateddocumentscriticaltothesuccessfulapprovalofproductsandtechnologies

• Clarifying guidelines and identifying the various ofces and auditing boardsfor specic NDDS platforms and coordinating with them accordingly to ensurecompliance

• Evaluatingtheparametersofbioequivalencestudiestoensurethatclinicaltrialsarefocusedintherightareas

Sumedh Gaikwad,DirectorMedicalServices,Richr this mdicar

10.20 exaining global rgulaor procsss and rquirns o nsur hsooh and spd approval of NDDS producs and nabl nr inoinrnaional arks

• ComparingregulatorbodiesandguidelinesaroundNDDSinwesterncountries,emergingmarketsandIndia

• Understanding the specic processes involved in the approval of NDDS productstoensurecomplianceandsuccessfulexportationfromIndia

• AnalsingtheparticularlchallengingregulatorrequirementsoftheUKandJapanesemarketsanddevelopingstrategiestoovercometheseandgainapproval

• Evaluatinginternationalregulatorrequirements,trendsandlikelfuturedevelopmentstoidentifnewmarketopportunities

Rahul Gupta,SeniorGeneralManager,CorporateRegulatorAffairsPiraalHalhcar

10:50 morning rfrshns and nworking

11.30Navigaing h coplxiis of h IPR ss in India o proo innovaionin NDDS dvlopn

• MappingoutthecurrentIPRscenarioinIndiatoestablishtheimportanceofIPRand identify the difculties involved

• UnderstandingthecurrentIndianIPRframeworkandleveragingthistoensurequalitwithinNDDSdevelopmentsandsupportfutureprogress

• Maximisingthepotentialoftechnologpatentsinavoidinginfringementandprotectingcompetitiveadvantage

• Overcoming the roadblocks to IPR protection specic to the various NDDSplatforms

• Identifingandapplingglobalcopwritingandtrademarkpoliciestoprotectandmaintainbrandequit

Komal Shah Bhukhanwala,Director,InnovarIP

Innovaiv Drug Dlivry Plafors

12:00 Dvloping ffciv dlivr sss for siRNA basd drugs o incrastheefcacyofthefomulationwhilemaintaininahealthyetunoninvsn

• ProjectingthecurrentmarketforsiRNAbaseddrugsandforecastingitsfuturegrowth potential to guarantee positive prot margins

• UnderstandingtheformulationrationaleanddesignchallengesofsiRNAbased

drugstoreduceresourcesinvolvedintheclinicaltrails • ClarifingtheregulatorguidelinesforthesiRNAbaseddrugdeliverplatformto

speed-uptheapprovalprocedure • IdentifingwastoincreasescalabilitinthesiRNAbaseddrugdeliverplatform

tosustaincommercialviabilit • FormulatingrobustmarketingandcommercialisationstrategiesforsiRNAbased

drugdeliverplatformstoenternewgeographicalareas Venkata Ramana, Chief Scientic Ofcer, Rlianc Lif Scincs

12.30 exploring parnral disprsd sss o idnif and ovrco hir dvlopn challngs and axiis hir corcial ponial

• Recognisingthemostappropriatetechnologiestoeffectivelmanagethedevelopmentallifeccleofparenteraldispersedsstems

• Understandingthecharacterisationforvariousformulationsinparenteralsuspensionsandemulsionstominimiseresourcesinvolvedinclinicaltrialsandtimeforapproval

• Comparingasepticandterminalsterlisationtechniquesemploedinparenteraldisperseddrugdeliversstemstounderstandtheirlimitationsandidentifthemost suitable methods to improve efcacy and commercial viability

• Maximisingthroughputandovercomingscalabilitissuestocost-effectivelproduceparenteraldisperseddrugdeliversstems

Sougata Pramanick,DirectorResearchandDevelopment(Formulation) ecur Pharacuicals

13:00 Lunch and nworking

Oral Conrolld Drug Dlivry Syss

14.10 evaluaing and lvraging advancs in osoic oral conrollddudeliveysystemstoimpoveefcacyandeducecosts

• Establishing the class of drugs and plasma prole suitable for oral controlleddrugdeliver

• Identifying and developing the specic technologies required to achieve thefollowingreleasemechanismsandensurecommercialsuccess:

- Pulsatile - Gastroretentive - Gastro in testinal therapeut icsstems - Otherimplantsusingmatrixmechanisms • Streamliningtheprocessesinvolvedinthemanufacturingoforalcontrolleddrug

delivery systems to lower investment costs and increase efciency • MaximisingthepotentialandovercomingthetechnicalchallengesofSMEDDsto

increasesolubilitandpermeabilitofclassIVdrugs • Developingnewdistributionchannelsfororalcontrolleddrugdeliversstemsto

drivecommercialisationandenternewmarkets Pritam D Kanagale,ManagerProductDevelopment

Johnson & Johnson

14.30 Dsigning pharacokinic sudis for nw oral conrolld drug dlivrsss o nsur spd approvals and rduc h challngs of larg-scal producion

• Understandingtheeffectofsingledose,multipledose,specialdosageandfoodstudies to increase the efcacy of a drug while reducing toxicity

• Settingtheacceptancecriteriainpharmacokineticstudiestodecreaseprojectresourcesrequiredandmeettheregulatorguidelines

• Reducingthetoxiceffectscausedbdosedumpingincontrolledreleasedeliversystems to increase systemic efcacy

• Identifingthecorrectprocedureforsubmissionanddocumentationofclinicaltrialresultstoaddresstheregulatorrequirementsandavoidduplicationofefforts

Sukhjeet Singh, SeniorVicePresident,ResearchandDevelopmentPanaca Bioc

transdral Drug Dlivry Sys

14.50 Slcing h os appropria and innovaiv arials in h dsign andforulaion procss of ransdral dlivr pachs o incras safandefcacy

• Evaluatingpolmersusedfortransdermaldeliversstemstomaximiseoverallpatchperformanceandensureexternalandinternalcompatibilit

• Examiningthechallengesregardingadhesivesusedintransdermalplasterstoovercomeproblemsrelatedtopliabilit,climate-sensitivitandpatientconvenience

• Adoptingaproactiveapproachfortransdermalpatchmaterialselectiontoensurequalitandregulatoracceptabilit

Gautam Ranade, ResearchFellow,PharmaceuticalSciences,WorldwideResearchandDevelopment,Pzer,USA

15:10 Afrnoon rfrshns and nworking

15.20 Ovrcoing h scalabili challngs around various rlaschaniss in ransdral dlivr sss o nsur corcialsuccss and incras bioavailabili

• Establishingthebusinesscasefortransdermalpatchesinsteadoforalcontrolled

drugdeliversstemsforthesustainedreleaseofdrugs • Comparingthedifferenttpesofreleasemechanismavailable–matrix,osmotic,andgeomatrix

• Determininghowdifferentreleasemechanismscanbeeffectivelusedintransdermalpatchesandifthearecommerciallviable

• Effectivelmanagingthecostsinvolvedinscaling-upthetransdermaldeliversstemwhenusingdifferentreleasemechanisms

Dange Veerapaneni,ManagingDirector,Sparsha Phara Inrnaional

16.10 exploring nw hrapuic applicaions for ransdral dlivr ssso driv dvlopn in his ara

• Understandingthecurrentdomesticmarketfortransdermalsandforecastingthetherapeuticareasinwhichdemandislikeltoincreaseinthefuture

• Tacklingthevarioustechnologicalscalabilitissuesinmakingtransdermalscommerciallviablefortherapeuticapplication

• Evaluatingcosmeceuticalapplicationoftransdermaltherapeuticstomeetevolvingconsumerandmarketdemands

• DeterminingtheuseoftransdermalsstemsinchronicailmentslikediabetesandtoovercomeBBBandMDRchallengestoincreasedrugdeliverthroughnon-invasivetechniques

• Balancing the expense of transdermal systems with the overall medical benet –ensuringnewtherapeuticapplicationsarecommerciallviable Damon Smith,SeniorVicePresidentResearchandDevelopment

Labophar, USA

16.40 roundtableDiscussions: Anopportunittojoininwithfacilitatedgroupdiscussionsaroundthekeissuesraisedduringthecourseoftheda.Comearmedwithourlivechallengesandtakeawapracticalimplementablesolutions.

17.30Clos of Confrnc Da On

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CONFeReNCe DAy tWO – frIDay12auguSt2011

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NDDSINDIA 2011

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Q &A Session at NDDS 2010

08:30 Rgisraion and rfrshns

09:00 Opning rarks fro h Chair

Nanochnology

09.10 evaluaing h las dvlopns in nanochnolog andovecominthespecicfomulationchallenestoinceaseefcacy,educetoxicityandminimisecost

• Determiningthepresentmarketdemandfornanotechnologandestimatingthefuturesizeoftheindustrandtheinvestmentrequired

• Achievingpharmacodnamicandpharmacokineticcorrelationfortargeteddrugdelivertechnolog

• Identifingthemostappropriatedosageandmethodofadministrationfordifferent therapeutic uses to increase efcacy and reduce surrounding celltoxicit

• Ascertainingtherequirementsforclinicaltrialsofnanotechnologiestodemonstratebioequivalenceandachievesmoothregulatorapproval

• Ensuringreproducibilitandminimisedcostswhenscaling-upeverspecialisationoftargeteddrugdelivertoachievecommercialsuccess

• Understandingthecharacterisationforvariousformulationsforfasterclinicaltrialresults

Mahesh V Chaubal,DirectorProductDevelopmentBaxr Halhcar, USA

09.40 exaining h various nanocarrirs availabl o nsur h oscost-effectiveandefcientmeansofdudelivey

• Establishingthenanocarriersavailablefororalandparenteraldrugdeliver

• Analsingdifferentpolmericnanocarrierstoenhancetheperformanceofdrugdeliversstems

• Achievingimprovedpenetrationofthedrugthroughmembranesusingnanocrstalsandamorphousnanoparticles• Determining how solid lipid nanoparticles contribute to better efcacy andreducedtoxicitoftumoursurroundingcells

• Identifinghowliposomeshelptomaximisedrugconcentrationinthetargetedareathroughnanotechnolog

• Developingbestpracticemethodsofencapsulationandentrapmentofdrug molecules into nanocarriers to ensure efcacy at the targeted site

• Clarifingregulatorguidelinesonclinicaltrialrequirementsforliposomesandnanoparticlesasdrugdeliverplatformstoachieveregulatorclearance

Devaraj Rambhau,AdvisorNDDS, Naco Rsarch Cnr

10:10 morning rfrshns and nworking

10.40 Naviatinthevaioussteilisationandltationchallenesncounrd whn dsigning a nanochnolog o safrquirns

• Achievingeffectivesterilisationofnanoparticlesthroughinsitupolmerisation

• Leveragingpartialpolmerisationofnanoparticlestoensuretargeteddrugdelivermeetssafetguidelines

• Maximisingtheuseofgammaradiationinachievingsterilisationinnanotechnolog

• EvaluatingtheeffectivenessofAPIsterilisationanditsadministrationtosepticareasinmaintainingsafetlevels

• Examiningalternativemethodsofsterilisationofnanoparticleswhichminimisecostandincreasesafet

SP Vyas, Professor,DepartmentofPharmaceuticalSciencesSagar Univrsiy, India

11.10 exploring and axiising h ponial of nanochnolog drugdlivr plafors in nw hrapuic and diagnosic aras

• Understanding the potential use and efcacy of nanotechnology inimplanteddeliversstems

• Summarisingtheadvancesmadeingenetherapthroughnanotechnologtoprovidetherapeuticoptionsforunmetmedicalneeds

• Establishinghownanotechnologcanbestbeappliedtooncologdrugsto increase their efcacy • UtilisingnanotechnologtoovercomeMDRandreducesurroundingcell

toxicit • Applingnanotechnologthroughoralandpatchdelivertochronic

therapeuticareassuchasdiabetesandhpertension • Leveragingnanotechnologfordiagnosticpurposesinscans,MRIsand

biomarkers Dhiraj Khattar,DirectorFormulations,Frsnius Kabi Oncology

11.40 Discussing h criical succss facors of corcialllaunchd Abraxant of Clgn Corporaion and uilising albuinnanopaticlestoinceaseefcacyintaeteddudeliveyplafors

• Evaluatingthevariousmethodsforpreparationofalbuminnanoparticalsto identify the most suitable procedure to increase efcacy and reducecosts

• Establishingthequalitstandardsofalbuminnanoparticlesessentialforreceivingregulatorapprovals

• Comparingthedeliveradvantagesofalbuminnanoparticleswithothercarriers and how they can increase the efcacy of the targeted drug

• Understandingtheroleofimmunogenicitinthedrugtoincreasetheeffectivenessofloadedformulation

• Assessingthepatentlandscapeforalbuminnanoparticlestooutlinethefuturedirectionandscopefordevelopment

Shelley A Durazo,ResearchFellow,DepartmentofPharmaceuticalSciences,Univrsiy of Colorado, Dnvr

12.20 Lunch and nworking

Liposos and microsphrs

13.30 Undrsanding h las advancs in lipid basd drug dlivrsss o iprov absorpion and rduc oxici and nsurhir corcial viabili

• Identifingthecurrentmarketandfuturerequirementsoflipidbaseddrugdeliversstemsinspecialtherapeuticareas

• MeetingtheexpertiseandinvestmentrequirementsnecessartocommercialisinglipidbaseddrugdeliversstemsasformsofNDDS

• Overcomingthetechnicaldrugloadingchallengesencounteredwhenusingliposomesasacarrierintargeteddrugdeliver

• Examining the efcacy of liposomes and microspheres in anti-cancer injectibles

• Developingprocessesandtechniquestotackletheinstabilitofliposomesasacarrierinnanotechnolog

Rinti Banerjee, Professor,DepartmentofBiosciencesandBioengineering,CentreforResearchinNanotechnologandScienceIndian Insiu of tchnology, mubai, India

Inhalaion Drug Dlivry Syss

14.10 Addrssing h roadblocks o dvlopn in inhalaion drugdlivr o driv progrss and growing dand for hisplatfomfomspecictheapeuticaeas

• Clarifingtheregulatorguidelinesandclinicaltrialrequirementsfornasalspras

• Identifingprocessestomeetparticlesizerequirementsandincreasedepositionratio

• Achievingpolmorphismtosupportsolubilitandpermeabilitinnasal

sprasandpromoteabsorption • Evaluatingvariousexcipientscreeningprocessesincludinghighthroughput to ensure the best match to the API and increase the efcacyofthedeliverdevice

• Examiningthelatestequipmentandtechnologtotackleinstabilitandimpuritandreducetoxicit

• Determiningthenextstepsforinhalationdrugdelivertoensureprogressandcommercialsuccess

Kapileshwar Swain, VicePresidentProductDevelopmentmaclods Phara

14:50 Afrnoon rfrshns and nworking

Corcialisaion in Pracic

15.20 Dvloping ffciv corcialisaion sragis o incrasspd o ark, axiis rurn on invsn and driv hgrowh of h Indian NDDS indusr

• Utilisingthe“ultralean”manufacturingprocesstoincreasethespeedofdevelopmentfromlabtomarketandensurethedeliverofqualitatallstages

• Adoptingthemostappropriateclinicaltrialsprocedureandusingonlineanalticsandcontrolstoreduceinvestmentcostsandspeedupregulatorapproval

• LeveragingadvanceddrugdeliverapproachestoensurereturnoninvestmentofNDDSindevelopment

• Mappingoutthepotentialofnewmarketsincludinginternationalandruraltoincreasemarketshare

• IdentifingandmeetingtheneedfordevelopingnewdistributionchannelstosupporttheacceptanceofNDDSproductsinnewandexistingmarkets

• ApplingnewmarketingtechniquesandstrategiestoenhancevisibilitandacceptanceoftheNDDSproductandbrand

Gaurav Sharma,SeniorManagerBusinessDevelopmentandClinicalResearch,Wockhard

16.00 LeveainpackainasatooltoimpovetheefcacyoftheNDDSproduc and o counica and proo h brand idni

• IdentifingandadoptingthemostsuitablepackagingmaterialsfordifferentNDDSproductsdependingontheiradministrationcharacteristics • Sourcingpackagingmaterialswhichsupporttheshelf-liferequirementsof

specic products and ensure safety and efcacy • UtilisingaestheticsinaugmentingacceptanceofNDDSproducts • Establishingbrandingstrategieswhicharecommunicatedthroughthe

packagingtoprotectandincreasethebrandequit Sponsor ld sssion

16:40 Closing rarks fro h Chair and clos of confrnc

S o l u i o s

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a d v e s

©2011. UBM India Pvt. Ltd. This programme may change due to unforeseen circumstances.UBM India Pvt. Ltd. reserves the right to alter the venue and/or speakers.



DearColleague,

RecentreportsandforecastssuggestalargeopportunitintheIndianNDDSmarketduetoawidegapbetweenglobaldemandandtherateoflocaldevelopment.WithgenericpipelinesdringupandsupportfromthelocalpharmaceuticalindustrandgovernmentencouragingfurtherdevelopmentinNDDS,areougeared-upforthischallengeandreadtoseizethisinvaluableopportunit?

The2ndAnnualNDDSIndia2011bringsoutheuniquechancetoclarifoureverdoubtonregulatorproceduresand capitalise on your innovative NDDS products. Evaluate the formulation and design solutions, nd answers toscalabilitchallenges,protectourinnovationsthroughIPR,andexplorenewmarketavenuestopursueandtakeadvantageofthegrowingdemandforNDDS.TheonlconferenceinIndiatofocusonthenicheNDDSmarket,thisessentiallearningforumisbasedonintensiveindustrresearchandwillprovideouwithanin-depthsolution-packed

agenda designed to meet your India-specic business needs.

AttendNDDSIndia2011to:

•Learnfrom Baxr Halhcar, USA aboutnewadvancesinNDDSonaglobalplatform

•ExaminethesuccessfulldevelopedandcommercialllaunchedNDDSproductswithFrsnius KabiOncolog

•ExplorenewopportunitiesforcommercialsuccessofNDDSproductswithLabophar USA

•HearSparsha Phara Inrnaionalsharekelearningsonhowtoovercomethescalabilitchallengesof NDDS

• Benet from practical guidance provided by Piraal HalhcarontheregulatorrequirementsforNDDS productswhenenteringnewmarkets

•AddresstheroadblockstodevelopmentforNDDSproductsthroughkeinsightsfrommaclods Phara

•EvaluatethefuturetrendsofNDDSwithJohnson & Johnsonandlearnhowbesttocapitaliseonthese opportunities

AdditionalspeakersfromPanaca Bioch, Richr this mdicar, Naco Rsarch Cnr and RliancLif Scincswillalsobesharingtheirexemplarexpertiseandpracticalinsights.Witheachdaofferingahostofexclusivenetworkingopportunities,thisisreallaneventnottobemissed.

Plus–Newfo2011!Anentirepre-conferenceseminardedicatedtoshowcasingtheverlatestthinkingandtrendsaroundNDDSfromtheinternationalpharmacommunit.LetourpanelofglobalNDDSexpertstakeouthroughallthecriticaldevelopmentsandinnovationstoensureouareup-to-dateandfullequippedtomakeourmarkintheindustranddriverealprogressintheIndianpharmaceuticalmarket.

Bookourplacenowforthisunparalleledsolution-drivenconferenceandseminartopropelourbusinesstonewheights.Justcall+91(022)40461466,[email protected].

WelookforwardtomeetingouatNDDSIndia2011,10-12Auust,Mumbai.

yourssincerel,

RituThomasProgrammeManager

CPhIConferences

P.S.Theenclosedbrochurecontainsthefulllistofin-depthtopicsandoutstandingspeakerline-up.Tosecureourplaceatadiscountedprice,pleasevisitwww.ndds-india.com,[email protected],calluson+91(022)40461466,orcompleteandreturntousthebookingformintheconferencebrochure.

10-12AUgUST2011HolidaInnMumbaiInternationalAirportMumbai,India

NDDSINDIA 2011



12.30 Rgisraion and rfrshns

12.50 Opning rarks fro h Faciliaor

13.00 Lvraging h las advancs in nanohrap for back of h disass in ocular hrapuics

• Examiningthecurrentmarketsizeofnanotechnologandunderstandingitsfuturedirection

• Identifingthevariousnanomaterialsbeingusedinocularnanotherapy to increase the efcacy of targeted drug

• Overcomingthekeformulationchallengesforocularnanotherapeutics

• Developingnanotherapasthemostsuitablemodeofadministrationinbackoftheeediseases

• DiscussingacommerciallsuccessfulNDDSproductutilisingnanotherapandanalsingthereasonsforsuccess

Shelley A Durazo,ResearchFellowDepartmentofPharmaceuticalSciencesUnivrsiy of Colorado, Dnvr

14.10 Focusing on innovaiv drug dlivr plafors o propl hgrowh of h Indian NDDS indusr

• Evaluatingdifferentstrategiestocost-effectivelmanagethedevelopmentlifeccleofadeliverplatform

• DiscussingthekefactorscriticaltoensuringagreaternumberofpipelinehitsandthecommercialsuccessofanNDDSproduct

• Mappingoutthefuturedirectionofgeno-medicinetoleverageonitscommercialpotentialincomingears

Damon Smith,SeniorVicePresidentResearchandDevelopmentLabophar, USA

15.20 Rfrshns and nworking

15.50 Updaing on h las dvlopns in nanochnolog ocapialis on h fuur growh ponial

• Identifingthehotareasofdevelopmentinnanotechnologtoensurepositivereturnoninvestmentinthenext4-5ears

• Understandingthequalitrequirementsofnanotechnologdrugdeliverplatformsdevelopedforinternationalmarkets

• Overcomingthescalabilitchallengesofnanotechnologinpracticetodeliveracommerciallsuccessfulproduct

Mahesh V Chaubal, DirectorProductDevelopmentBaxr Halhcar, USA

17.10 Undrsanding and navigaing h chnical challngs of a ransdral dlivr ss o axiis h rurn oninvsns in h coing ars wih

• Understandingthetechnicalcomplexitiesinvolvedinthedevelopmentofatransdermalpatchtominimiseinvestmentcostsandincreasetheefcacy of the delivery system

• Overcomingbioequivalencechallengesingenerictransdermalproductstoensurespeedregulatorapprovals

• Ensuringeffectivelifecclemanagementofatransdermalpatchthroughacasestudexampleofacommercialllaunchedproduct

• Determiningtherequirementsforqualitstandardsoftransdermalproductsforsuccessfullaunchinwesterncountries

Gautam Ranade,ResearchFellow,PharmaceuticalSciences,WorldwideResearchandDevelopment

Pzer,USA

18.20Closing rarks fro h Faciliaor and clos of sinar

InternatIonalnDDSShowcaSe

PRe-CONFeReNCe SemINAR – weDneSDay10auguSt2011

ExpandourknowledgeonthecurrentglobalNDDSscenariothroughthisdedicatedinteractiveseminarledbtop-levelexpertsfrom BaxteHealthcae,PzeandLabophar USA.Gear-uptotakeadvantageofthepotentialmarketopportunitiesandtackletheexpected

challenges by gaining key insights into the future trends and direction of the NDDS industry. This is a unique opportunity to benet from the sharedlearningsofinternationalindustrprofessionalsandacademicsteaminguponasingleplatform.Don’tmissourchancetohear

theverlatestthinking,drill-downintothenewestinnovationsanddiscussthemostup-to-datesolutionstoallourNDDSdevelopmentand scalabilitchallenges.

Benetfom:• The latest facts and gures and growth opportunities in the international NDDS industry• Key insights into the specics of quality requirements for NDDS products in international markets

•PracticalstrategiestolaunchandcommercialiseNDDSproducts •Thetechnicaldevelopmentsbeinguncoveredinresearchworkcurrentlinprogessonvariousdeliverplatforms •StrategicinformationonthefuturecourseofNDDSproductsandtheircommercialviabil it •EssentialupdatesoninnovativeNDDSproductsindevelopmentandthehostofmarketopportunitiesthesewillunearth

ShelleyADuazo is pursuingher doctoral degree at theUniversity of ColoradoDenver, in the field of ocularnanopharmaceutics. Herundergraduate research wasfocused on liposomal drugdelivery and gold nanoparticleactuated release mechanisms.Shelley Durazo also had theunique opportunity of conductingresearch at the AustralianInstitute of Biotechnology andNanotechnology (AIBN) at the

University of Queensland, Australiain Dr Max Lu’s laboratory. Thebasis of this research was focusedon fabricating and characterisingnovel layered double hydroxidespherical particles for the deliveryof siRNA.

Mahesh VChaubal

Director ProductDevelopment

BaxterHealthcare

USA

Shelley ADurazo ResearchFellow

Department ofPharmaceutical

SciencesUniversity

of ColoradoDenver

mahsh V Chaubal isthe Director of ProductDevelopment in Global Researchand Development at BaxterHealthcare. He has worked in thefield of formulations and drugdelivery for more than sixteenyears and has published overfifty peer-reviewed articles andindustry reports in this field.He was a member of theteam that brought Gliadel-the first sustained releasechemotherapeutic formulation

to market. His experienceincludes novel drug deliveryresearch, development of water-insoluble drugs, proteins andgene-based drugs, scale-up andvalidation of processes for drugdelivery formulation processes.

Daon Sih is a SeniorVice President for Researchand Development atLabopharm, a Montreal basedbiopharmaceutical companyspecialising in pain and CNSproducts. He has more than 20years experience in the industryand has presented at variousinternational conferences. Priorto joining Labopharm, DamonSmith was Senior Director ofResearch at ConjuChem Inc, apeptide development and delivery

company. He was also ExecutiveDirector of Development atProtherics Limited (formerlyTherapeutic Antibodies Inc) basedin the United Kingdom. DamonSmith holds a PhD in biologicalchemistry and pharmacology.

Damon SmithSenior VicePresident

Research andDevelopment,Labopharm

USA

Gautam RanadeResearch FellowPharmaceuticalDevelopmentWorldwide

Research andDevelopment PfizerUSA

MeetyourexpertS:Gaua Ranad is a ResearchFellow in PharmaceuticalSciences, Worldwide Researchand Developments, Pfizer, USA.He has 26 years of scientificproduct development andmanagerial experience inpharmaceutical research anddevelopment. He has 19 USpatents in the areas of novel drugdelivery, formulation developmentand polymeric materials. Hehas 20 publications in variousscientific journals in the areas of

dosage form development, drugdelivery systems and membranetransport. He was also on theplanning committee for the jointFDA-DIA-AAPS workshop ontransdermal patch developmentin 2011.

.dds-idi.m



10-12 August 2011Holiday Inn Mumbai International AirportMumbai, India

NDDSINDIA 2011

Ways to RegisterOnline: www.ndds-india.comTel +91 (022) 4046 1466Fax +91 (022) 4046 1477Email [email protected] Conerence Department,

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