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Pharmaceutical R&D is about the process of discovering, PHARMACEUTICAL R&D developing, and bringing to market new ethical drug products. Manufacturers in the pharmaceuticals industry turn out goods in five distinct areas; ethical products NCE Generics Biotechnology products Generic products p Diagnostics products medical products Megha Thakkar, PMP(r) W a N d N? Unmet medical need Why ARE new DRUGS NEEDED?
Pharmaceutical R&D is about the process of discovering, PHARMACEUTICAL R&D developing, and bringing to market new ethical drug products. Manufacturers in the pharmaceuticals industry turn out goods in five distinct areas; ethical products NCE Generics Biotechnology products Generic products p Diagnostics products medical products Megha Thakkar, PMP(r) W a N d N? Unmet medical need Why ARE new DRUGS NEEDED?
Pharmaceutical R&D is about the process of discovering, PHARMACEUTICAL R&D developing, and bringing to market new ethical drug products. Manufacturers in the pharmaceuticals industry turn out goods in five distinct areas; ethical products NCE Generics Biotechnology products Generic products p Diagnostics products medical products Megha Thakkar, PMP(r) W a N d N? Unmet medical need Why ARE new DRUGS NEEDED?
ProjectManager MeghaThakkar,PMP A AGENDA PharmaceuticalR&D The R&D Business Processes TheR&DBusinessProcesses WhyPharmaceuticalProjectManagement? P j t M t B i ProjectManagementBasics ProjectManagementIsAbout6C NeedsFromaProjectmanager ProjectManagementinPharma Research&Development MeghaThakkar,PMP P R&D PharmaceuticalR&Disabouttheprocessofdiscovering, PHARMACEUTICAL R&D developing,andbringingtomarketnewethicaldrug products. Manufacturersinthepharmaceuticalsindustryturnout goodsinfivedistinctareas; Ethicalproducts NCE Generics Biotechnologyproducts Genericproducts p Diagnosticsproducts Medicalproducts MeghaThakkar,PMP W A N D N ? Unmetmedicalneed WHY ARE NEW DRUGS NEEDED? Newdiseases(BSE;AIDS,Alzheimers;obesity) Lowefficacy(Dementia,Cancer) Sideeffects(Antidepressants,Antipsychotics) Downstreamhealthcosts;(Alzheimers;Spinalinjury) Costoftherapy;(Viagra,Interleukins) Coststoindividual/country;(Depression) S t i i d t i l ti it Sustainindustrialactivity Patentexpiry Comprehensive addressable to the disease like diabetes Comprehensiveaddressabletothedisease likediabetes ordiseasemodification MeghaThakkar,PMP S O D SOURCES OF DRUGS Biotech G i i i Mi bi l i l Geneticreconstitution Stemcell Microbiological Insulin (pig cow) Insulin(pig,cow) Growthhormone(man)(CreutzfeldtJakob) Animal Digitalis(digitalispurpurea foxglove) Morphine(papaver somniferum) Plant Arsenicmercury Lithium Inorganic Chemical(propranolol) Biological (penicillin) Synthetic MeghaThakkar,PMP Biological(penicillin) Biotechnology(humaninsulin) Synthetic D D /D P DRUG DISCOVERY/DEVELOPMENT PROCESS Discovery / R fi t Refinement Safety & toxicity in animals; Lessons & formulation development development Volunteer studies; patient studies Post registration monitoring MeghaThakkar,PMP Regulatory process Marketing THE R&D BUSINESS PROCESSES IN THE R&DBUSINESS PROCESSES IN THE PHARMA INDUSTRY NCE Research Development Production Administration Drug Discovery Pre Formulation Pharmaco kinetics T i l Pharma/ Chemical Development Clinical Trials Phase 1-3 Regulatory approval Regulated Production Clinical Toxicology Trials Phase 4 Go Documentation Go to Market MeghaThakkar,PMP Documentation THE R&D BUSINESS PROCESSES IN THE R&DBUSINESS PROCESSES IN THE PHARMA INDUSTRY GENERICS Research Development Production Administration Drug Selection Pre Formulation Development Development Optimization PilotBIO Technology Transfer Exhibit/Regist rationbatch Stability PivotalBIO Regulatory Enterin Market MeghaThakkar,PMP Market F B T B A medicine progresses from bench to bedside over FROM BENCH TO BEDSIDE Amedicineprogresses frombenchtobedside over aperiodofmanyyearsfrominitialdevelopmentin the laboratory, through clinical testing, licensing, thelaboratory,throughclinicaltesting,licensing, promotiontodoctorandpatient,andfinal prescription. prescription. MeghaThakkar,PMP THE R&D BUSINESS PROCESSES IN Identifyingactiveingredients THE R&DBUSINESS PROCESSES IN THE PHARMA INDUSTRY NCE Medicalchemistry Here,naturalsubstancesorknownchemicalsubstancesare systematicallymodifiedtoincreasetheireffectiveness, reducetheirsideeffects,orincreasetheirtherapeuticvaluein treatingdiseases.Themedicalchemistryandpharmacologyareas workcloselytogether. Screening Alargenumberofsubstancesareinvestigatedinoneormoretests i d t id tif ti l l inordertoidentifyanewactivemolecule Rationaldrugdesign h d b h d h h d l k l l h ll Theideabehindthismethodistotailormakeamoleculethatwill interactwithknownandwellresearchedbiologicalsystemsinthe desiredway. MeghaThakkar,PMP THE R&D BUSINESS PROCESSES IN Development THE R&DBUSINESS PROCESSES IN THE PHARMA INDUSTRY NCE Development Whenaresearchsubstancedemonstratesadesired pharmacological effect and a decision is made to pharmacologicaleffect,andadecisionismadeto passitontodevelopment. Preformulation Thefirststepistodeterminethesubstanceschemicaland p physicalproperties.Proceduresmustbefoundtoproduce sufficientquantitiesofthesubstancewiththerequiredpurity for the s bseq ent de elopment steps forthesubsequentdevelopmentsteps. MeghaThakkar,PMP THE R&D BUSINESS PROCESSES IN Pharmacokinetics THE R&DBUSINESS PROCESSES IN THE PHARMA INDUSTRY NCE Theeffectsofthesubstanceonlivingorganismsare investigatedwiththehelpofanimalexperiments.Thesemake bl ff l l l d d b itpossibletoeffectivelyassesstoxicologicaldataandtoobtain informationabouttheeffectsofthesubstanceonthehuman body. y Toxicology Bothanimalandnonanimaltestsareusedtoassesswhether asubstanceissafeforusebyhumans.Theseincludestudies on ac te to icit chronic to icit m tagenicit fertilit and onacutetoxicity,chronictoxicity,mutagenicity,fertility,and carcinogenicity. MeghaThakkar,PMP THE R&D BUSINESS PROCESSES IN Pharmaceutical and chemical development THE R&DBUSINESS PROCESSES IN THE PHARMA INDUSTRY NCE Pharmaceuticalandchemicaldevelopment Pharmaceuticalandchemicaldevelopment Theactiveingredientsynthesisdevelopedinthelaboratoryis g y p y thenscaledupforproduction,andthefinalformulationofthe newproductisdeveloped.Ifthescaleupistoolargeto accomplish straight away an interim step is included This accomplishstraightaway,aninterimstepisincluded.This interimstepcanbeusedtoproduceclinicalsamplesbefore thefinalscaleuppriortomarketlaunch. MeghaThakkar,PMP THE R&D BUSINESS PROCESSES IN Clinical trials THE R&DBUSINESS PROCESSES IN THE PHARMA INDUSTRY NCE Clinicaltrials Oncethepharmacokineticandtoxicological investigations have provided the necessary investigationshaveprovidedthenecessary informationaboutwhetherasubstanceiseffective and safe for use by humans a risk/benefit analysis is andsafeforusebyhumans,arisk/benefitanalysisis carriedoutandadecisionisthenmadeabout whether to use the substance on humans whethertousethesubstanceonhumans. The central objective is to achieve an improvement Thecentralobjectiveistoachieveanimprovement inthetreatmentofdisease. MeghaThakkar,PMP THE R&D BUSINESS PROCESSES IN PhaseI THE R&DBUSINESS PROCESSES IN THE PHARMA INDUSTRY NCE Thenewsubstanceisadministeredtohealthy,volunteertest subjectsortoselectedpatientswithparticularindications, h d h f l l d d suchascancerorAids.Thisfirstclinicalstudyprovides informationaboutthesubstancespharmacologicaleffects, sideeffects,pharmacokinetics,bioavailability,anddrug , p , y, g interaction.Basedontheseresults,whichtakeabout8 18 monthstogather,theinitialdosageanddosageintervalfor ti t d t i d At th d f Ph I d i i i patientsaredetermined.AttheendofPhaseI,adecisionis madeaboutwhethertocontinueorterminatetheclinical trialsforthesubstance. MeghaThakkar,PMP THE R&D BUSINESS PROCESSES IN PhaseII THE R&DBUSINESS PROCESSES IN THE PHARMA INDUSTRY NCE Thisphaseinvolvespatientswithtargetindications,andaims togatherdataonpharmacologicaleffects,therapeuticeffects, d d h k d f b correctdosage,andpharmacokinetics,andinformationabout chronicapplication.Inthisphasetoo,adecisionismadeabout whethertocontinueorterminatethestudy.Thissecondphase y p usuallylastsbetween18and36months. MeghaThakkar,PMP THE R&D BUSINESS PROCESSES IN PhaseIII THE R&DBUSINESS PROCESSES IN THE PHARMA INDUSTRY NCE Patientswiththetargetindicationreceivethepreparation undernormalmedicalconditions.Thenumberofpatients l d f d h b d involvedrangesfrom200to4,000.Basedonthisbroadscope ofapplication,thecompoundistestedforitsefficacyandside effectsonpeopleofdifferentages,sex,lifestyle,andethnic p p g , , y , origin(variouscountries).Thenatureandfrequencyofside effectsarerecorded,interactionwithothermedicamentsis b d d i i d ith t d d th observed,andacomparisonismadewithstandardtherapy. Thisphase,lastingbetween20and46months,leadstoa decisionaboutwhethertoapplyforregulatoryapprovalor pp y g y pp whethertoterminatetheproject. MeghaThakkar,PMP THE R&D BUSINESS PROCESSES IN PhaseIV THE R&DBUSINESS PROCESSES IN THE PHARMA INDUSTRY NCE PhaseIVbeginswhenthecompoundhasbeenapproved.It involvesclarifyingthesideeffectsnotedinrelativelylarge b f h h numbersofpatients,investigatinginteractionswithother drugs,andexaminingthelongtermeffects.Newareasof applicationmayalsobeidentifiedforacompoundduringthis pp y p g phase. MeghaThakkar,PMP THE R&D BUSINESS PROCESSES IN Regulatoryapproval THE R&DBUSINESS PROCESSES IN THE PHARMA INDUSTRY NCE g y pp Application: OncePhases1to3oftheclinicaltrialforanewsubstancehavebeen completed successfully the company can apply for regulatory completedsuccessfully,thecompanycanapplyforregulatory approval. Documentation: Th d t i d f th li ti d Thedocumentsrequiredfortheapplicationarepreparedonan ongoingbasisthroughoutthedevelopmentprocess,whichmeans thatonlytheresultsofPhase3needtobeaddedatthisstage. S b i i Submission: Whentheapplicationdocumentsarecomplete,theyaresenttothe responsibleauthority.Theapplicationprocesscantakeanything f h d d h h d d h from9to26months,dependingontheauthorityconcernedandthe qualityoftheapplicationdocuments. MeghaThakkar,PMP THE R&D BUSINESS PROCESSES IN Marketlaunch THE R&DBUSINESS PROCESSES IN THE PHARMA INDUSTRY NCE IntroductiontoMarket: Onceregulatoryapprovalhasbeenissued,thenextgoalistobring thenewcompoundtomarketasquicklyaspossible.Withthisgoalin mind,companiesbeginmanufacturingthecompoundandpreparing theirmarketingactivitiesbeforetheyactuallyreceiveapproval,so thatmarketlaunchcanbegintheinstantapprovalarrives. Postlaunch AnalysisofNewdrugformations: y g Oncethenewcompoundisonthemarket,anotherseriesofsteps begins.TheseincludePhaseIVofclinicaltesting,developingnew formsinwhichtoadministerthedrug,andmarketing.And,ifthis h t l d h d th d i l d f hasnotalreadyhappened,thecompoundisnowscaledupfor productioninanormalmanufacturingenvironment. MeghaThakkar,PMP A Project management embraces the entire project ADMINISTRATION Projectmanagementembracestheentireproject procedure,fromactiveingredientdiscoveryto compound development. It plans the entire R&D compounddevelopment.Itplans theentireR&D process,monitors execution,andevaluates the results. At the same time, it plans dates, defines results.Atthesametime,itplansdates,defines milestonesandresources,andsetsthebudget. MeghaThakkar,PMP W P P M Thecourseofdrugdevelopmentisunpredictableand WHY PHARMACEUTICAL PROJECT MANAGEMENT g p p thereforeitiscriticaltohaverealisticexpectationsfor anygivenproject. Thereareinherentdifficultiesinrunningadrug development successfully and the larger the project the developmentsuccessfullyandthelargertheprojectthe morenumerouspotentialproblemscanbe. Accountingforthefactorsthatcanstandinthewayofa projectssuccessandbeingabletotakeanobjective viewofthestrategiesrequiredisademanding,but necessarytask. MeghaThakkar,PMP P M B PROJECT MANAGEMENT BASICS MeghaThakkar,PMP P M Projectmanagementisacomplexundertaking,with PROJECT MANAGEMENT manystagesandprocesses.Itshouldfollowthefull businesslifecycle,fromdefinitionandjustificationofthe project, through to delivering demonstrable benefits for project,throughtodeliveringdemonstrablebenefitsfor thebusiness. P j i h b di f l i Projectmanagementistheobedienceofplanning, organizing,andmanagingresourcestobringaboutthe successfulcompletionofspecificprojectgoalsand p p p j g objectives. Project management is bringing cross functional team Projectmanagementisbringingcrossfunctionalteam memberstogethertoachieveacommongoal. MeghaThakkar,PMP W ? Costeffectiveplanning,executionandmonitoringof WHAT COMPANIES WANT FROM PROJECT MANAGEMENT? p g, g projects Optimizedbusinessprocessesandresources;fewer routineactivities; Fasterprojectprocedures Alsotheywanttobeabletocomparevarious differentprojectsinordertoidentifyataglance whichonestopressaheadwith. MeghaThakkar,PMP P M I A 6 C Concept PROJECT MANAGEMENT IS ABOUT 6C Concept Clarity Consensus Consensus Commitment C t l Control Confirmation MeghaThakkar,PMP 6 C P M Concept Highlevelideasabouttheproject 6COF PROJECT MANAGEMENT p g p j Projectproposal Abriefaboutscopeofproject Clarity Requirementselicitation,andanalysis.Defining therequirementsandthendocumentingthemor q g implementingthemintoasystemthatcantrackchanges andactasacontrolpoint. l ProjectExecutionplan SystemtodrawaroadmapoftheProjectexecution Projectstatusupdate j p Systemtotrackandcommunicateprojectstatuswhichincludes variancesystemandassignableroutecausessystems MeghaThakkar,PMP 6 C P M Consensus Socialization and approvals. 6COF PROJECT MANAGEMENT Consensus Socializationandapprovals. Projectkickoffmeeting+Projectstatusupdatemeeting Oneononediscussiononeachchallengesphasedtoavaila g p quickandreliablesolution Commitment Addressingrequirementsinthe solutiondesignandallocatingresourcestobuildthe solution. Preformulation/Formulationdevelopment Guidedbyexpertstoavailanoninfringementdevelopment MeghaThakkar,PMP 6 C P M Control Control process applied to requirements; 6COF PROJECT MANAGEMENT Control Controlprocessappliedtorequirements; understandingtheimpactofchanges(andpossibly making sure the developers stay focused on the makingsurethedevelopersstayfocusedonthe requirementswhilebuildingthesolution.) Analytical development Analyticaldevelopment Confirmation Confirming designs in testing and Confirmation Confirmingdesignsintestingand implementation. Tech transfer Techtransfer MeghaThakkar,PMP O S Project definition : to describe project goals in general OPERATIVE STRUCTURES Projectdefinition:todescribeprojectgoalsingeneral terms. Workbreakdownstructure:TheWBSisthehierarchical modelofthetaskstobeperformedintheproject.It p p j providesaclearoverviewoftheprojectby: Formingthebasisfororganizingandcoordinatingtheproject Showingthework,timeandcostsinvolvedintheproject. TheWBSalsoformsthebasisforsubsequentplanningsteps, such as planning dates and costs and allocating the budget suchasplanningdatesandcosts,andallocatingthebudget. MeghaThakkar,PMP O S Network:Themaincomponentsofanetworkare OPERATIVE STRUCTURES p activitiesandrelationships.Throughtheactivitiesin anetwork,youcanrepresentthepeople,capacities, dates,materials,productionresources/tools,and servicesthatyouneedforthevarioustasksinyour j t D di th t k d project.Dependingonthetaskconcerned,youcan createdifferenttypesofactivity: Internallyprocessedactivities Externallyprocessedactivities y p Generalcostsactivities MeghaThakkar,PMP O S Milestones : Milestones are events of particular OPERATIVE STRUCTURES Milestones:Milestonesareeventsofparticular significanceinaprojectorthattriggerpredefined functions. You can assign milestones to both functions.Youcanassignmilestonestoboth activitiesandWBSelements.IntheProjectSystem, milestones are used: milestonesareused: Totriggerpredefinedmilestonefunctions,suchas gg p , workflows Tocarryoutprogressanalyses Todeterminedatesinthebillingplanforsalesorders MeghaThakkar,PMP NEEDS FROM A PROJECT MANAGER NEEDS FROM A PROJECT MANAGER HARD SKILL SOFT SKILL Science DrugDevelopment Understanding Leadership MatrixManagement E Understanding LineFunctionComprehension Tools Energy Drive Passion Planning Risk Financial Influencing Negotiation C i i Financial Communication Facilitation Proactive StrategicThinking MeghaThakkar,PMP PROJECT MANAGEMENT IN PHARMA Bring3EstoProject: