Project Management Pharma Industry

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  • PROJECT MANAGEMENT INPHARMACEUTICAL INDUSTRYPHARMACEUTICAL INDUSTRY

    ProjectManagerMeghaThakkar,PMP

  • AAGENDA

    PharmaceuticalR&D The R&D Business Processes TheR&DBusinessProcesses WhyPharmaceuticalProjectManagement?P j t M t B i ProjectManagementBasics

    ProjectManagementIsAbout6C NeedsFromaProjectmanager ProjectManagementinPharmaResearch&Development

    MeghaThakkar,PMP

  • P R&D PharmaceuticalR&Disabouttheprocessofdiscovering,

    PHARMACEUTICAL R&D

    developing,andbringingtomarketnewethicaldrugproducts.

    Manufacturersinthepharmaceuticalsindustryturnoutgoodsinfivedistinctareas;

    9Ethicalproducts NCE Generics

    9Biotechnologyproducts9Genericproductsp9Diagnosticsproducts9Medicalproducts

    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 likediabetesordiseasemodification

    MeghaThakkar,PMP

  • S O DSOURCES OF DRUGSBiotechG i i iMi bi l i l Geneticreconstitution

    StemcellMicrobiological

    Insulin (pig cow)Insulin(pig,cow)Growthhormone(man)(CreutzfeldtJakob)Animal

    Digitalis(digitalispurpurea foxglove)Morphine(papaver somniferum)Plant

    ArsenicmercuryLithiumInorganic

    Chemical(propranolol)Biological (penicillin)Synthetic

    MeghaThakkar,PMP

    Biological(penicillin)Biotechnology(humaninsulin)

    Synthetic

  • D D /D PDRUG DISCOVERY/DEVELOPMENT PROCESSDiscovery / R fi tRefinement

    Safety & toxicity in animals; Lessons &

    formulation development

    development

    Volunteer studies; patient studies

    Post registration monitoring

    MeghaThakkar,PMP

    Regulatory processMarketing

  • THE R&D BUSINESS PROCESSES INTHE R&DBUSINESS PROCESSES INTHE PHARMA INDUSTRY NCE

    Research Development Production

    Administration

    Drug

    Discovery

    Pre

    Formulation

    Pharmacokinetics

    T i l

    Pharma/ Chemical

    Development

    ClinicalTrials

    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 INTHE R&DBUSINESS PROCESSES INTHE PHARMA INDUSTRY GENERICS

    Research Development Production

    Administration

    DrugSelection

    PreFormulation Development

    DevelopmentOptimization PilotBIO

    TechnologyTransfer

    Exhibit/RegistrationbatchStabilityPivotalBIORegulatory

    EnterinMarket

    MeghaThakkar,PMP

    Market

  • F B T B

    A medicine progresses from bench to bedside over

    FROM BENCH TO BEDSIDE

    Amedicineprogresses frombenchtobedside overaperiodofmanyyearsfrominitialdevelopmentinthe laboratory, through clinical testing, licensing,thelaboratory,throughclinicaltesting,licensing,promotiontodoctorandpatient,andfinalprescription.prescription.

    MeghaThakkar,PMP

  • THE R&D BUSINESS PROCESSES IN

    Identifyingactiveingredients

    THE R&DBUSINESS PROCESSES INTHE PHARMA INDUSTRY NCE

    9Medicalchemistry Here,naturalsubstancesorknownchemicalsubstancesaresystematicallymodifiedtoincreasetheireffectiveness, reducetheirsideeffects,orincreasetheirtherapeuticvalueintreatingdiseases.Themedicalchemistryandpharmacologyareasworkcloselytogether.

    9Screening Alargenumberofsubstancesareinvestigatedinoneormoretestsi d t id tif ti l linordertoidentifyanewactivemolecule

    9Rationaldrugdesignh d b h d h h d l k l l h ll Theideabehindthismethodistotailormakeamoleculethatwillinteractwithknownandwellresearchedbiologicalsystemsinthedesiredway.

    MeghaThakkar,PMP

  • THE R&D BUSINESS PROCESSES IN

    Development

    THE R&DBUSINESS PROCESSES INTHE PHARMA INDUSTRY NCE

    DevelopmentWhenaresearchsubstancedemonstratesadesiredpharmacological effect and a decision is made topharmacologicaleffect,andadecisionismadetopassitontodevelopment.

    9Preformulation Thefirststepistodeterminethesubstanceschemicalandpphysicalproperties.Proceduresmustbefoundtoproducesufficientquantitiesofthesubstancewiththerequiredpurityfor the s bseq ent de elopment stepsforthesubsequentdevelopmentsteps.

    MeghaThakkar,PMP

  • THE R&D BUSINESS PROCESSES IN

    9Pharmacokinetics

    THE R&DBUSINESS PROCESSES INTHE PHARMA INDUSTRY NCE

    Theeffectsofthesubstanceonlivingorganismsareinvestigatedwiththehelpofanimalexperiments.Thesemake

    bl ff l l l d d bitpossibletoeffectivelyassesstoxicologicaldataandtoobtaininformationabouttheeffectsofthesubstanceonthehumanbody.y

    9Toxicology Bothanimalandnonanimaltestsareusedtoassesswhetherasubstanceissafeforusebyhumans.Theseincludestudieson ac te to icit chronic to icit m tagenicit fertilit andonacutetoxicity,chronictoxicity,mutagenicity,fertility,andcarcinogenicity.

    MeghaThakkar,PMP

  • THE R&D BUSINESS PROCESSES IN

    Pharmaceutical and chemical development

    THE R&DBUSINESS PROCESSES INTHE PHARMA INDUSTRY NCE

    Pharmaceuticalandchemicaldevelopment9Pharmaceuticalandchemicaldevelopment Theactiveingredientsynthesisdevelopedinthelaboratoryisg y p ythenscaledupforproduction,andthefinalformulationofthenewproductisdeveloped.Ifthescaleupistoolargetoaccomplish straight away an interim step is included Thisaccomplishstraightaway,aninterimstepisincluded.Thisinterimstepcanbeusedtoproduceclinicalsamplesbeforethefinalscaleuppriortomarketlaunch.

    MeghaThakkar,PMP

  • THE R&D BUSINESS PROCESSES IN

    Clinical trials

    THE R&DBUSINESS PROCESSES INTHE PHARMA INDUSTRY NCE

    ClinicaltrialsOncethepharmacokineticandtoxicologicalinvestigations have provided the necessaryinvestigationshaveprovidedthenecessaryinformationaboutwhetherasubstanceiseffectiveand safe for use by humans a risk/benefit analysis isandsafeforusebyhumans,arisk/benefitanalysisiscarriedoutandadecisionisthenmadeaboutwhether to use the substance on humanswhethertousethesubstanceonhumans.

    The central objective is to achieve an improvementThecentralobjectiveistoachieveanimprovementinthetreatmentofdisease.

    MeghaThakkar,PMP

  • THE R&D BUSINESS PROCESSES IN

    9PhaseI

    THE R&DBUSINESS PROCESSES INTHE PHARMA INDUSTRY NCE

    Thenewsubstanceisadministeredtohealthy,volunteertestsubjectsortoselectedpatientswithparticularindications,

    h d h f l l d dsuchascancerorAids.Thisfirstclinicalstudyprovidesinformationaboutthesubstancespharmacologicaleffects,sideeffects,pharmacokinetics,bioavailability,anddrug, p , y, ginteraction.Basedontheseresults,whichtakeabout8 18monthstogather,theinitialdosageanddosageintervalforti t d t i d At th d f Ph I d i i ipatientsaredetermined.AttheendofPhaseI,adecisionis

    madeaboutwhethertocontinueorterminatetheclinicaltrialsforthesubstance.

    MeghaThakkar,PMP

  • THE R&D BUSINESS PROCESSES IN

    9PhaseII

    THE R&DBUSINESS PROCESSES INTHE PHARMA INDUSTRY NCE

    Thisphaseinvolvespatientswithtargetindications,andaimstogatherdataonpharmacologicaleffects,therapeuticeffects,

    d d h k d f bcorrectdosage,andpharmacokinetics,andinformationaboutchronicapplication.Inthisphasetoo,adecisionismadeaboutwhethertocontinueorterminatethestudy.Thissecondphasey pusuallylastsbetween18and36months.

    MeghaThakkar,PMP

  • THE R&D BUSINESS PROCESSES IN

    9PhaseIII

    THE R&DBUSINESS PROCESSES INTHE PHARMA INDUSTRY NCE

    Patientswiththetargetindicationreceivethepreparationundernormalmedicalconditions.Thenumberofpatients

    l d f d h b dinvolvedrangesfrom200to4,000.Basedonthisbroadscopeofapplication,thecompoundistestedforitsefficacyandsideeffectsonpeopleofdifferentages,sex,lifestyle,andethnicp p g , , y ,origin(variouscountries).Thenatureandfrequencyofsideeffectsarerecorded,interactionwithothermedicamentsisb d d i i d ith t d d thobserved,andacomparisonismadewithstandardtherapy.

    Thisphase,lastingbetween20and46months,leadstoadecisionaboutwhethertoapplyforregulatoryapprovalorpp y g y ppwhethertoterminatetheproject.

    MeghaThakkar,PMP

  • THE R&D BUSINESS PROCESSES IN

    9PhaseIV

    THE R&DBUSINESS PROCESSES INTHE PHARMA INDUSTRY NCE

    PhaseIVbeginswhenthecompoundhasbeenapproved.Itinvolvesclarifyingthesideeffectsnotedinrelativelylarge

    b f h hnumbersofpatients,investigatinginteractionswithotherdrugs,andexaminingthelongtermeffects.Newareasofapplicationmayalsobeidentifiedforacompoundduringthispp y p gphase.

    MeghaThakkar,PMP

  • THE R&D BUSINESS PROCESSES IN

    Regulatoryapproval

    THE R&DBUSINESS PROCESSES INTHE PHARMA INDUSTRY NCE

    g y pp9Application: OncePhases1to3oftheclinicaltrialforanewsubstancehavebeencompleted successfully the company can apply for regulatorycompletedsuccessfully,thecompanycanapplyforregulatoryapproval.

    9Documentation:Th d t i d f th li ti d Thedocumentsrequiredfortheapplicationarepreparedonanongoingbasisthroughoutthedevelopmentprocess,whichmeansthatonlytheresultsofPhase3needtobeaddedatthisstage.

    9S b i i9Submission: Whentheapplicationdocumentsarecomplete,theyaresenttotheresponsibleauthority.Theapplicationprocesscantakeanythingf h d d h h d d hfrom9to26months,dependingontheauthorityconcernedandthequalityoftheapplicationdocuments.

    MeghaThakkar,PMP

  • THE R&D BUSINESS PROCESSES IN

    Marketlaunch

    THE R&DBUSINESS PROCESSES INTHE PHARMA INDUSTRY NCE

    9 IntroductiontoMarket: Onceregulatoryapprovalhasbeenissued,thenextgoalistobringthenewcompoundtomarketasquicklyaspossible.Withthisgoalinmind,companiesbeginmanufacturingthecompoundandpreparingtheirmarketingactivitiesbeforetheyactuallyreceiveapproval,sothatmarketlaunchcanbegintheinstantapprovalarrives.

    Postlaunch9AnalysisofNewdrugformations:y g Oncethenewcompoundisonthemarket,anotherseriesofstepsbegins.TheseincludePhaseIVofclinicaltesting,developingnewformsinwhichtoadministerthedrug,andmarketing.And,ifthish t l d h d th d i l d fhasnotalreadyhappened,thecompoundisnowscaledupforproductioninanormalmanufacturingenvironment.

    MeghaThakkar,PMP

  • A Project management embraces the entire project

    ADMINISTRATION

    Projectmanagementembracestheentireprojectprocedure,fromactiveingredientdiscoverytocompound development. It plans the entire R&Dcompounddevelopment.Itplans theentireR&Dprocess,monitors execution,andevaluates theresults. At the same time, it plans dates, definesresults.Atthesametime,itplansdates,definesmilestonesandresources,andsetsthebudget.

    MeghaThakkar,PMP

  • W P P M

    Thecourseofdrugdevelopmentisunpredictableand

    WHY PHARMACEUTICAL PROJECT MANAGEMENT

    g p pthereforeitiscriticaltohaverealisticexpectationsforanygivenproject.

    Thereareinherentdifficultiesinrunningadrugdevelopment successfully and the larger the project thedevelopmentsuccessfullyandthelargertheprojectthemorenumerouspotentialproblemscanbe.

    Accountingforthefactorsthatcanstandinthewayofaprojectssuccessandbeingabletotakeanobjectiveviewofthestrategiesrequiredisademanding,butnecessarytask.

    MeghaThakkar,PMP

  • P M BPROJECT MANAGEMENT BASICS

    MeghaThakkar,PMP

  • P M Projectmanagementisacomplexundertaking,with

    PROJECT MANAGEMENT

    manystagesandprocesses.Itshouldfollowthefullbusinesslifecycle,fromdefinitionandjustificationoftheproject, through to delivering demonstrable benefits forproject,throughtodeliveringdemonstrablebenefitsforthebusiness.

    P j i h b di f l i Projectmanagementistheobedienceofplanning,organizing,andmanagingresourcestobringaboutthesuccessfulcompletionofspecificprojectgoalsandp p p j gobjectives.

    Project management is bringing cross functional team Projectmanagementisbringingcrossfunctionalteammemberstogethertoachieveacommongoal.

    MeghaThakkar,PMP

  • W ?

    Costeffectiveplanning,executionandmonitoringof

    WHAT COMPANIES WANT FROM PROJECT MANAGEMENT?

    p g, gprojects

    Optimizedbusinessprocessesandresources;fewerroutineactivities;

    Fasterprojectprocedures

    Alsotheywanttobeabletocomparevariousdifferentprojectsinordertoidentifyataglancewhichonestopressaheadwith.

    MeghaThakkar,PMP

  • P M I A 6 C

    Concept

    PROJECT MANAGEMENT IS ABOUT 6C

    Concept Clarity Consensus Consensus CommitmentC t l Control

    Confirmation

    MeghaThakkar,PMP

  • 6 C P M

    Concept Highlevelideasabouttheproject

    6COF PROJECT MANAGEMENT

    p g p j9Projectproposal Abriefaboutscopeofproject

    Clarity Requirementselicitation,andanalysis.Definingtherequirementsandthendocumentingthemorq gimplementingthemintoasystemthatcantrackchangesandactasacontrolpoint.9 l9ProjectExecutionplan SystemtodrawaroadmapoftheProjectexecution

    9Projectstatusupdatej p Systemtotrackandcommunicateprojectstatuswhichincludesvariancesystemandassignableroutecausessystems

    MeghaThakkar,PMP

  • 6 C P M

    Consensus Socialization and approvals.

    6COF PROJECT MANAGEMENT

    Consensus Socializationandapprovals.9Projectkickoffmeeting+Projectstatusupdatemeeting Oneononediscussiononeachchallengesphasedtoavailag pquickandreliablesolution

    Commitment Addressingrequirementsinthesolutiondesignandallocatingresourcestobuildthesolution.9Preformulation/Formulationdevelopment Guidedbyexpertstoavailanoninfringementdevelopment

    MeghaThakkar,PMP

  • 6 C P M

    Control Control process applied to requirements;

    6COF PROJECT MANAGEMENT

    Control Controlprocessappliedtorequirements;understandingtheimpactofchanges(andpossiblymaking sure the developers stay focused on themakingsurethedevelopersstayfocusedontherequirementswhilebuildingthesolution.)9Analytical developmentAnalyticaldevelopment

    Confirmation Confirming designs in testing andConfirmation Confirmingdesignsintestingandimplementation.9 Tech transferTechtransfer

    MeghaThakkar,PMP

  • O S

    Project definition : to describe project goals in general

    OPERATIVE STRUCTURES

    Projectdefinition:todescribeprojectgoalsingeneralterms.

    Workbreakdownstructure:TheWBSisthehierarchicalmodelofthetaskstobeperformedintheproject.Itp p jprovidesaclearoverviewoftheprojectby:9Formingthebasisfororganizingandcoordinatingtheproject9Showingthework,timeandcostsinvolvedintheproject.9TheWBSalsoformsthebasisforsubsequentplanningsteps,such as planning dates and costs and allocating the budgetsuchasplanningdatesandcosts,andallocatingthebudget.

    MeghaThakkar,PMP

  • O S

    Network:Themaincomponentsofanetworkare

    OPERATIVE STRUCTURES

    pactivitiesandrelationships.Throughtheactivitiesinanetwork,youcanrepresentthepeople,capacities,dates,materials,productionresources/tools,andservicesthatyouneedforthevarioustasksinyour

    j t D di th t k dproject.Dependingonthetaskconcerned,youcancreatedifferenttypesofactivity:

    9Internallyprocessedactivities9Externallyprocessedactivitiesy p9Generalcostsactivities

    MeghaThakkar,PMP

  • O S

    Milestones : Milestones are events of particular

    OPERATIVE STRUCTURES

    Milestones:Milestonesareeventsofparticularsignificanceinaprojectorthattriggerpredefinedfunctions. You can assign milestones to bothfunctions.YoucanassignmilestonestobothactivitiesandWBSelements.IntheProjectSystem,milestones are used:milestonesareused:

    9Totriggerpredefinedmilestonefunctions,suchasgg p ,workflows9Tocarryoutprogressanalyses9Todeterminedatesinthebillingplanforsalesorders

    MeghaThakkar,PMP

  • NEEDS FROM A PROJECT MANAGERNEEDS FROM A PROJECT MANAGERHARD SKILL SOFT SKILL

    Science DrugDevelopmentUnderstanding

    Leadership MatrixManagementEUnderstanding

    LineFunctionComprehension Tools

    Energy Drive Passion

    9 Planning9 Risk9 Financial

    Influencing NegotiationC i i9 Financial Communication

    Facilitation Proactive StrategicThinking

    MeghaThakkar,PMP

  • PROJECT MANAGEMENT IN PHARMA

    Bring3EstoProject:9

    PROJECT MANAGEMENT IN PHARMARESEARCH &DEVELOPMENT

    9 Efficient,Economic,Elite

    Oneofthemainfactorstoinfluencethesuccessofapharmaceuticalscompanyisitsefficiencyinbringingnewproductstomarket.

    Thefastermarketmaturityisgainedforaproduct,thegreaterthemarketlead.

    Thesuccessratefordevelopingnewcompoundsisabout1:6,000.Inotherwords,of6,000newlysynthesizedsubstances,onlyonewillmeettherequirementsforanewproductintermsofitseffectivenessandsafetyforuseindrugs.

    MeghaThakkar,PMP