PROJECT MANAGEMENT IN

PHARMACEUTICAL INDUSTRY PHARMACEUTICAL INDUSTRY

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:

PROJECT MANAGEMENT IN PHARMA

RESEARCH &DEVELOPMENT
Efficient,Economic,Elite
Oneofthemainfactorstoinfluencethesuccessofa
pharmaceuticalscompanyisitsefficiencyinbringingnewproducts
tomarket.
Thefastermarketmaturityisgainedforaproduct,thegreaterthe
marketlead.
Thesuccessratefordevelopingnewcompoundsisabout1:6,000.
Inotherwords,of6,000newlysynthesizedsubstances,onlyone
willmeettherequirementsforanewproductintermsofits
effectivenessandsafetyforuseindrugs.
MeghaThakkar,PMP