PROJECT MANAGEMENT IN

PHARMACEUTICAL INDUSTRY
ProjectManager
MeghaThakkar,PMP

AGENDA

PharmaceuticalR&D
The R&D Business Processes
TheR&DBusinessProcesses
WhyPharmaceuticalProjectManagement?
P j tM
ProjectManagementBasics
tB i
ProjectManagementIsAbout6C
NeedsFromaProjectmanager
ProjectManagementinPharma
Research&Development

MeghaThakkar,PMP

PHARMACEUTICAL R&D
PharmaceuticalR&Disabouttheprocessofdiscovering,
developing,andbringingtomarketnewethicaldrug
products.
Manufacturersinthepharmaceuticalsindustryturnout
goodsinfivedistinctareas;
9Ethicalproducts
NCE
Generics

9Biotechnologyproducts
p
9Genericproducts
9Diagnosticsproducts
9Medicalproducts

MeghaThakkar,PMP

WHY ARE NEW DRUGS NEEDED?

Unmetmedicalneed
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 likediabetes
Comprehensiveaddressabletothedisease
like diabetes
ordiseasemodification

MeghaThakkar,PMP

SOURCES OF DRUGS
Mi bi l i l
Microbiological

Animal

Plant

Inorganic

Synthetic
Synthetic
MeghaThakkar,PMP

Biotech
Geneticreconstitution
G
i
i i
Stemcell
Insulin(pig,cow)
Insulin (pig cow)
Growthhormone(man)(CreutzfeldtJakob)

Digitalis(digitalispurpurea foxglove)
Morphine(papaver somniferum)

Arsenicmercury
Lithium

Chemical(propranolol)
Biological(penicillin)
Biological (penicillin)
Biotechnology(humaninsulin)

DRUG DISCOVERY/DEVELOPMENT PROCESS

Discovery /
R fi
Refinement
t

Lessons &
development

Post registration
monitoring

Volunteer studies;
patient studies

Marketing
MeghaThakkar,PMP

Safety & toxicity in

animals;
formulation
development

Regulatory process

THE R&DB
R&D BUSINESS PROCESSES IN
THE PHARMA INDUSTRY NCE
Research

Development

Production

Administration

Drug

Pre

Discovery

Formulation

Pharmaco
kinetics

Pharma/
Chemical
Development

Clinical
Trials
Phase 1-3

Regulatory

Regulated

approval

Production
Clinical
Trials
Phase 4

T i l
Toxicology

Go
to
Market

Documentation

MeghaThakkar,PMP

THE R&DB
R&D BUSINESS PROCESSES IN
THE PHARMA INDUSTRY GENERICS
Research

Development

Production

Administration

Drug
Selection

Pre
Formulation

Development

Development
Optimization

PilotBIO

Regulatory

PivotalBIO

Stability

Exhibit/Regist
rationbatch

Technology
Transfer

Enterin
Market

MeghaThakkar,PMP

FROM BENCH TO BEDSIDE

A
Amedicineprogresses
medicine progresses from
frombenchtobedside
bench to bedsideover
over
aperiodofmanyyearsfrominitialdevelopmentin
the laboratory, through clinical testing, licensing,
thelaboratory,throughclinicaltesting,licensing,
promotiontodoctorandpatient,andfinal
prescription.

MeghaThakkar,PMP

THE R&DB
R&D BUSINESS PROCESSES IN
THE PHARMA INDUSTRY NCE
Identifyingactiveingredients
9Medicalchemistry

Here,naturalsubstancesorknownchemicalsubstancesare
systematicallymodifiedtoincreasetheireffectiveness,
reducetheirsideeffects,orincreasetheirtherapeuticvaluein
treatingdiseases.Themedicalchemistryandpharmacologyareas
workcloselytogether.

9Screening
Alargenumberofsubstancesareinvestigatedinoneormoretests
i
inordertoidentifyanewactivemolecule
d t id tif
ti
l l

9Rationaldrugdesign
Theideabehindthismethodistotailormakeamoleculethatwill
h d b h d h
h d
l
k
l l h
ll
interactwithknownandwellresearchedbiologicalsystemsinthe
desiredway.

MeghaThakkar,PMP

THE R&DB
R&D BUSINESS PROCESSES IN
THE PHARMA INDUSTRY NCE

Development
Development
Whenaresearchsubstancedemonstratesadesired
pharmacological effect and a decision is made to
pharmacologicaleffect,andadecisionismadeto
passitontodevelopment.
9Preformulation
Thefirststepistodeterminethesubstanceschemicaland
p
physicalproperties.Proceduresmustbefoundtoproduce
sufficientquantitiesofthesubstancewiththerequiredpurity
for the s bseq ent de elopment steps
forthesubsequentdevelopmentsteps.

MeghaThakkar,PMP

THE R&DB
R&D BUSINESS PROCESSES IN
THE PHARMA INDUSTRY NCE
9Pharmacokinetics
Theeffectsofthesubstanceonlivingorganismsare
investigatedwiththehelpofanimalexperiments.Thesemake
itpossibletoeffectivelyassesstoxicologicaldataandtoobtain
bl
ff
l
l
ld
d
b
informationabouttheeffectsofthesubstanceonthehuman
body.
y

9Toxicology
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&DB
R&D BUSINESS PROCESSES IN
THE PHARMA INDUSTRY NCE

Pharmaceuticalandchemicaldevelopment
Pharmaceutical and chemical development
9Pharmaceuticalandchemicaldevelopment
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&DB
R&D BUSINESS PROCESSES IN
THE PHARMA INDUSTRY NCE

Clinical
Clinicaltrials
trials
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.
Thecentralobjectiveistoachieveanimprovement
The
central objective is to achieve an improvement
inthetreatmentofdisease.
MeghaThakkar,PMP

THE R&DB
R&D BUSINESS PROCESSES IN
THE PHARMA INDUSTRY NCE
9PhaseI
Thenewsubstanceisadministeredtohealthy,volunteertest
subjectsortoselectedpatientswithparticularindications,
suchascancerorAids.Thisfirstclinicalstudyprovides
h
d h f
l
l d
d
informationaboutthesubstancespharmacologicaleffects,
sideeffects,pharmacokinetics,bioavailability,anddrug
,p
,
y,
g
interaction.Basedontheseresults,whichtakeabout8 18
monthstogather,theinitialdosageanddosageintervalfor
patientsaredetermined.AttheendofPhaseI,adecisionis
ti t
d t
i d At th
d f Ph
I d ii i
madeaboutwhethertocontinueorterminatetheclinical
trialsforthesubstance.

MeghaThakkar,PMP

THE R&DB
R&D BUSINESS PROCESSES IN
THE PHARMA INDUSTRY NCE
9PhaseII
Thisphaseinvolvespatientswithtargetindications,andaims
togatherdataonpharmacologicaleffects,therapeuticeffects,
correctdosage,andpharmacokinetics,andinformationabout
d
d h
k
d f
b
chronicapplication.Inthisphasetoo,adecisionismadeabout
whethertocontinueorterminatethestudy.Thissecondphase
y
p
usuallylastsbetween18and36months.

MeghaThakkar,PMP

THE R&DB
R&D BUSINESS PROCESSES IN
THE PHARMA INDUSTRY NCE
9PhaseIII
Patientswiththetargetindicationreceivethepreparation
undernormalmedicalconditions.Thenumberofpatients
involvedrangesfrom200to4,000.Basedonthisbroadscope
l d
f
d
h b d
ofapplication,thecompoundistestedforitsefficacyandside
effectsonpeopleofdifferentages,sex,lifestyle,andethnic
p p
g ,
,
y ,
origin(variouscountries).Thenatureandfrequencyofside
effectsarerecorded,interactionwithothermedicamentsis
observed,andacomparisonismadewithstandardtherapy.
b
d d
i
i
d ith t d d th
Thisphase,lastingbetween20and46months,leadstoa
decisionaboutwhethertoapplyforregulatoryapprovalor
pp y
g
y pp
whethertoterminatetheproject.

MeghaThakkar,PMP

THE R&DB
R&D BUSINESS PROCESSES IN
THE PHARMA INDUSTRY NCE
9PhaseIV
PhaseIVbeginswhenthecompoundhasbeenapproved.It
involvesclarifyingthesideeffectsnotedinrelativelylarge
numbersofpatients,investigatinginteractionswithother
b
f
h h
drugs,andexaminingthelongtermeffects.Newareasof
applicationmayalsobeidentifiedforacompoundduringthis
pp
y
p
g
phase.

MeghaThakkar,PMP

THE R&DB
R&D BUSINESS PROCESSES IN
THE PHARMA INDUSTRY NCE
Regulatoryapproval
g
y pp
9Application:
OncePhases1to3oftheclinicaltrialforanewsubstancehavebeen
completed successfully the company can apply for regulatory
completedsuccessfully,thecompanycanapplyforregulatory
approval.

9Documentation:
Th
Thedocumentsrequiredfortheapplicationarepreparedonan
d
t
i d f th
li ti
d
ongoingbasisthroughoutthedevelopmentprocess,whichmeans
thatonlytheresultsofPhase3needtobeaddedatthisstage.

9S b i i
9Submission:
Whentheapplicationdocumentsarecomplete,theyaresenttothe
responsibleauthority.Theapplicationprocesscantakeanything
f
from9to26months,dependingontheauthorityconcernedandthe
h d
d
h
h
d d h
qualityoftheapplicationdocuments.

MeghaThakkar,PMP

THE R&DB
R&D BUSINESS PROCESSES IN
THE PHARMA INDUSTRY NCE
Marketlaunch
9IntroductiontoMarket:

Onceregulatoryapprovalhasbeenissued,thenextgoalistobring
thenewcompoundtomarketasquicklyaspossible.Withthisgoalin
mind,companiesbeginmanufacturingthecompoundandpreparing
theirmarketingactivitiesbeforetheyactuallyreceiveapproval,so
thatmarketlaunchcanbegintheinstantapprovalarrives.

Postlaunch

9AnalysisofNewdrugformations:
y
g

Oncethenewcompoundisonthemarket,anotherseriesofsteps
begins.TheseincludePhaseIVofclinicaltesting,developingnew
formsinwhichtoadministerthedrug,andmarketing.And,ifthis
h
hasnotalreadyhappened,thecompoundisnowscaledupfor
t l d h
d th
di
l d
f
productioninanormalmanufacturingenvironment.

MeghaThakkar,PMP

ADMINISTRATION
Project
Projectmanagementembracestheentireproject
management embraces the entire project
procedure,fromactiveingredientdiscoveryto
compound development. It plans theentireR&D
compounddevelopment.Itplans
the entire R&D
process,monitors execution,andevaluates the
results. At the same time, it plans dates, defines
results.Atthesametime,itplansdates,defines
milestonesandresources,andsetsthebudget.

MeghaThakkar,PMP

WHY PHARMACEUTICAL PROJECT MANAGEMENT

Thecourseofdrugdevelopmentisunpredictableand
g
p
p
thereforeitiscriticaltohaverealisticexpectationsfor
anygivenproject.
Thereareinherentdifficultiesinrunningadrug
development successfully and the larger the project the
developmentsuccessfullyandthelargertheprojectthe
morenumerouspotentialproblemscanbe.
Accountingforthefactorsthatcanstandinthewayofa
projectssuccessandbeingabletotakeanobjective
viewofthestrategiesrequiredisademanding,but
necessarytask.
MeghaThakkar,PMP

PROJECT MANAGEMENT BASICS

MeghaThakkar,PMP

PROJECT MANAGEMENT
Projectmanagementisacomplexundertaking,with
manystagesandprocesses.Itshouldfollowthefull
businesslifecycle,fromdefinitionandjustificationofthe
project, through to delivering demonstrable benefits for
project,throughtodeliveringdemonstrablebenefitsfor
thebusiness.
P
Projectmanagementistheobedienceofplanning,
j
i h b di
f l
i
organizing,andmanagingresourcestobringaboutthe
successfulcompletionofspecificprojectgoalsand
p
p
p j g
objectives.
Project
Projectmanagementisbringingcrossfunctionalteam
management is bringing cross functional team
memberstogethertoachieveacommongoal.

MeghaThakkar,PMP

WHAT COMPANIES WANT FROM PROJECT MANAGEMENT?

Costeffectiveplanning,executionandmonitoringof
p
g,
g
projects
Optimizedbusinessprocessesandresources;fewer
routineactivities;
Fasterprojectprocedures
Alsotheywanttobeabletocomparevarious
differentprojectsinordertoidentifyataglance
whichonestopressaheadwith.
MeghaThakkar,PMP

PROJECT MANAGEMENT IS ABOUT 6C

6 C

Concept
Clarity
Consensus
Commitment
C t l
Control
Confirmation

MeghaThakkar,PMP

6C
6 C OF PROJECT MANAGEMENT
Concept
p Highlevelideasabouttheproject
g
p j
9Projectproposal
Abriefaboutscopeofproject

Clarity Requirementselicitation,andanalysis.Defining
therequirementsandthendocumentingthemor
q
g
implementingthemintoasystemthatcantrackchanges
andactasacontrolpoint.
9
9ProjectExecutionplan
l
SystemtodrawaroadmapoftheProjectexecution

9Projectstatusupdate
j
p
Systemtotrackandcommunicateprojectstatuswhichincludes
variancesystemandassignableroutecausessystems

MeghaThakkar,PMP

6C
6 C OF PROJECT MANAGEMENT
Consensus
Consensus Socializationandapprovals.
Socialization and approvals.
9Projectkickoffmeeting+Projectstatusupdatemeeting
Oneononediscussiononeachchallengesphasedtoavaila
g p
quickandreliablesolution

Commitment Addressingrequirementsinthe
solutiondesignandallocatingresourcestobuildthe
solution.
9Preformulation/Formulationdevelopment
Guidedbyexpertstoavailanoninfringementdevelopment

MeghaThakkar,PMP

6C
6 C OF PROJECT MANAGEMENT
Control
Control Controlprocessappliedtorequirements;
Control process applied to requirements;
understandingtheimpactofchanges(andpossibly
making sure the developers stay focused on the
makingsurethedevelopersstayfocusedonthe
requirementswhilebuildingthesolution.)
9Analytical
Analyticaldevelopment
development

Confirmation
Confirmation Confirmingdesignsintestingand
Confirming designs in testing and
implementation.
9 Techtransfer
Tech transfer

MeghaThakkar,PMP

OPERATIVE STRUCTURES
Project
Projectdefinition:todescribeprojectgoalsingeneral
definition : to describe project goals in general
terms.
Workbreakdownstructure:TheWBSisthehierarchical
modelofthetaskstobeperformedintheproject.It
p
p j
providesaclearoverviewoftheprojectby:
9Formingthebasisfororganizingandcoordinatingtheproject
9Showingthework,timeandcostsinvolvedintheproject.
9TheWBSalsoformsthebasisforsubsequentplanningsteps,
such as planning dates and costs and allocating the budget
suchasplanningdatesandcosts,andallocatingthebudget.

MeghaThakkar,PMP

OPERATIVE STRUCTURES
Network:Themaincomponentsofanetworkare
p
activitiesandrelationships.Throughtheactivitiesin
anetwork,youcanrepresentthepeople,capacities,
dates,materials,productionresources/tools,and
servicesthatyouneedforthevarioustasksinyour
project.Dependingonthetaskconcerned,youcan
j t D
di
th t k
d
createdifferenttypesofactivity:
9Internallyprocessedactivities
9Externallyprocessedactivities
yp
9Generalcostsactivities

MeghaThakkar,PMP

OPERATIVE STRUCTURES
Milestones
Milestones:Milestonesareeventsofparticular
: Milestones are events of particular
significanceinaprojectorthattriggerpredefined
functions. You can assign milestones to both
functions.Youcanassignmilestonestoboth
activitiesandWBSelements.IntheProjectSystem,
milestones are used:
milestonesareused:
9Totriggerpredefinedmilestonefunctions,suchas
gg p
,
workflows
9Tocarryoutprogressanalyses
9Todeterminedatesinthebillingplanforsalesorders

MeghaThakkar,PMP

NEEDS FROM A PROJECT MANAGER

HARD SKILL

SOFT SKILL

Science
DrugDevelopment
Understanding
LineFunctionComprehension
Tools
9 Planning
9 Risk
9 Financial

MeghaThakkar,PMP

Leadership
MatrixManagement
Energy
E
Drive
Passion
Influencing
Negotiation
C
Communication
i i
Facilitation
Proactive
StrategicThinking

PROJECT MANAGEMENT IN PHARMA

RESEARCH &DEVELOPMENT
Bring3EstoProject:

9 Efficient,Economic,Elite

Oneofthemainfactorstoinfluencethesuccessofa
pharmaceuticalscompanyisitsefficiencyinbringingnewproducts
tomarket.
Thefastermarketmaturityisgainedforaproduct,thegreaterthe
marketlead.
Thesuccessratefordevelopingnewcompoundsisabout1:6,000.
Inotherwords,of6,000newlysynthesizedsubstances,onlyone
willmeettherequirementsforanewproductintermsofits
effectivenessandsafetyforuseindrugs.

MeghaThakkar,PMP