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DOI: 10.1177/1745790412445292

19 April 20122012 12: 150 originally published onrnal of Medical Marketing: Device, Diagnostic and Pharmaceutical Marketing

Vandana Prajapati and Harish DurejaProduct lifecycle management in pharmaceuticals

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Original article

Product lifecycle managementin pharmaceuticals

Vandana Prajapati and Harish Dureja

Abstract

A product lifecycle is the succession of stages from the products birth until its final withdrawal from themarket. While each stage brings significant changes, a succession of strategies for the management ofproduct lifecycle is required. The product lifecycle management creates and manages a companys pro-duct-related intellectual capital starting from an idea to its final retreat. In pharmaceutical industry, it bene-fits through enhancing the lifespan of patent and pricing strategies. Improved patient compliance, revenuegrowth, expanded clinical benefits, cost advantages life extension exclusivity and quicker market launch are

amongst the main applications of product lifecycle management. To fabricate an effective and fruitful productlifecycle management program many attributes are considered. The chief ones are: early start; strategicplanning clear leadership; supporting knowledge and skills, preparedness for changing rules of governmentand organizations.The present manuscript focuses on product lifecycle management, its applications and thekey considerations for a successful product lifecycle management.

Keywords

Pharmaceuticals, product lifecycle, return of investment, product lifecycle management, strategy

Introduction

During the last years, the period of true marketing

exclusivity for pharmaceuticals has shrunk dramatic-

ally. Todays pharmaceutical industry is facing tremen-

dous pressure when a blockbuster drug patent expires

owing to short drug lifecycles, strong competition,

heightened health authority scrutiny, rising develop-

ment costs coupled with lower drug prices and the

need for the latest technologies.1,2

As a concept, product lifecycle management (PLM)

has existed for many years originating in electronics

and automotive sectors. It allows a company to actively

manage the way in which a product is being sourced,

manufactured and planned throughout its lifecycle.

PLM is a strategic approach for creating and managing

a companys product-related intellectual capital start-

ing from its initial conception to retirement. PLM

improves a companys product development processes

and its ability to use product-related information to

make better business decisions and deliver greater

value to customers.3,4

Many manufacturers pursue lifecycle management

tactics in reactive manner. Franchise can be sustained

if brand equity (and prescriptions) can be transferred

to a follow-on or derivative product, even a reformu-

lation or new delivery system. This is generally done

through secondary patents or second generationpatent. These patents seek to protect a drug after the

original patent on that drug expires. Thus, patent life-

cycle management is a part of PLM. Switching a pre-

scription drug to an over-the counter drug is also

another tactic to have an edge over generics. But

these tactics, despite great efforts, at some point give

way to generics although they enhance the return of

investment.5,6

The PLM program should be based on the devel-

opment and implementation of intellectual property

(IP). Rapid changes in markets, technologies, regula-

tions and laws and new competitor products and offer-

ings make lifecycle management programs highly

dynamic. Thus, PLM strategies should be constantly

reassessed for new opportunities. The PLM program

has become an increasingly more challenging due to

recent developments in the U.S. courts and potential

Department of Pharmaceutical Sciences, MD University, Rohtak,India

Corresponding author:

Harish Dureja Department of Pharmaceutical Sciences, MDUniversity, Rohtak 124001, India

Email: [email protected]

Journal of Medical Marketing

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legislative changes Hence, companies should not only

constantly reassess their strategies but overall

approaches towards PLM.7

Pharmaceutical companies are now determined to

extend the life of their drug beyond patent expiration,

devising strategies to manage the lifecycle of their most

important medicines that begin in the clinical phases.PLM has become a necessity to the continued success

of pharmaceutical companies. Companies that have

instituted a comprehensive lifecycle management

strategy and a detailed plan to guide their progress

toward their goal are reaping financial and clinical

rewards. Successful PLM involves the continued

development of scientific, technical, regulatory and

marketing strategies that enhance the value and

extend the life of medicines.8

It is of critical importance that IP protection per-

mits the innovators of successful products to recoup

their investment. With rising development costs, the

pressure to utilize IP protection to the fullest extent

permitted has become even greater. Thus, the most

successful innovator companies have developed

sophisticated IP strategies. For the purpose of pharma-

ceuticals, PLM does not mean a way to protect their

innovation through different patents or obtaining

patent term extensions to take the benefit of all avail-

able protection. It also means to co-ordinate world-

wide IP litigation strategies to achieve the desired

result at a global level. Successful PLM enforcement

strategy involves three distinct but interrelated laws:

patent law, regulatory law and competition law. An

integrated approach of all three aspects is necessary.An understanding of the regulatory process by which

drug products obtain their marketing authorizations

and prices is fundamental; however, patent litigation

is the key ingredient. To make a rather crude analogy,

if PLM strategy is considered a road vehicle, regula-

tory information is the steering, patent litigation the

engine and competition law both the seat belt and the

brakes. PLM requires firm grip over these three laws

and technical expertise necessary to make the most

informed decisions in litigation. This is more import-

ant for secondary patents, for example, patents pro-

tecting a route of chemical synthesis or a particulartablet composition. If the patent protects the new

chemical entity, a technical analysis for the purpose

of elucidating infringement need only to determine

whether the active substance is present or not. For a

secondary patent, the analysis could be required to

assess whether a competing synthetic process or

tablet composition is the same or equivalent to that

protected by the patent.

The interplay, between the laws and the technical

foundations, is of critical importance to strategy. For

example, an understanding of the regulatory drug

approval process for generic medicines enables accurate

assessment of the progress of generic competition. This

includes an understanding of the intensity of any given

generic threat. Understanding the regulatory approvals

process not only enables accurate assessment of threats

but also the identification of the most suitable trigger

point for entering into pre-action correspondence orcommencing litigation proceedings. Trigger points for

litigation can be evaluated by comparing the timeline of

the drug approvals process, from filing the application

to launching on the market, with the timeline for

obtaining injunctive relief in the country concerned.

It has to be always borne in mind the need to prove

the infringing activity, or threat of infringing activity

to the level required by local law.9

PLM was evolved in the 1990s and has played an

important role for manufacturing companies. During

the last two decades, changes have taken place due to

modified regulations, technological advancements and

globalization.10

In the last decade, PLM was viewed by

industry as a tool to extend lifecycle of products while

regulators found it a kind of antitrust activity to create

monopoly. However, the previous decade has wit-

nessed the transformation in their views. In the present

scenario, the industry considers PLM as a core process

to integrate its other business activities, whereas the

regulators support the industry to adopt PLM in a

proactive way to improve the innovation and quality

of product.11

In the present manuscript, an attempt has been

made to study PLM, its applications and key consid-

erations for a successful PLM.

Lifecycle of a pharmaceutical product

All products and services have a certain lifecycle. The

lifecycle is the period from the products first launch

into the market until its final withdrawal. In general,

product lifecycle is split up in five different phases;

however, the lifecycle of a pharmaceutical product is

longer and more complex due to loads of data, grow-

ing product complexity, regulatory oversight and val-

idation, time to market pressures, increasing quality

requirements and increased branded and generic com-petition.4 Therefore, the pharmaceutical product life-

cycle can be divided into six phases (product approval

phase is the additional one in comparison to other

products lifecycle):

. Product development

. Product approval

. Product introduction

. Product growth

. Product maturity

. Product decline

Prajapati and Dureja 151



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Significant changes occur during each phase reflect-

ing the products behavior into the market, i.e. the sales

which introduce the product into the market.4,1214

A Product lifecycle of a fictitious product in terms

of sales cost and profit is given in Figure 1.13

Product development phase

As and when a company finds and develops a new

product idea, the product development phase

begins.12,14

Those products that survive the rigorous

preclinical and clinical trials are then subjected to

approval from regulatory authority before their place-

ment into the marketplace.2

Product approval phase

All preclinical and clinical data are collected and sub-

sequently submitted in appropriate form(s) to the

regulatory authorities along with the quality data and

the description of the manufacturing process for

review. A continuum of communication with the regu-

latory personnel is required during this phase. Drug

approval is granted only if the regulators found that the

data prove the quality, efficacy and safety of the drug.

It is the most crucial phase because without the

approval from the corresponding regulatory body, no

drug can undergo commercialisation.2

Introduction phase

It includes the product launch with its requirements sothat it will have maximum impact at the moment of

sale. In this phase, distribution arrangements are intro-

duced. Commonly large expenditure on promotion

and advertising (in case of pharmaceuticals only

when permitted) is made and quick but costly service

requirements are introduced. A company spends a lot

of money. However, only a small proportion of that is

received back.

Growth phase

This phase provides the satisfaction of witnessing the

products take-off in the marketplace. This is the

appropriate timing to focus on increasing the market

share. When a product has been introduced first into

the market, it is able to gain market share relatively

easily. Promotion and advertising continues up to

some extent in this phase. In this period efficiencies,

product availability and services are developed and

improved. The major factors in gaining customer con-

fidence include cost efficiency, time to market, pricing

and discount policy.

Maturity phase

When the variations of the main product saturate the

market, the product enters the maturity phase. This

period can provide the highest returns from the

product. New brands are introduced during this

phase even when they compete with the companys

existing product. This is the actual time to extend

the products life. Changes in the pricing and dis-

count policies are frequent. Scope of promotion andadvertising relocates from getting new customers to

Figure 1. A product lifecycle of a fictitious product in terms of sales, cost and profit.12

152 Journal of Medical Marketing 12(3)



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product differentiation in terms of quality and

reliability.

Decline phase

The decision for withdrawing a product appears to be

a complex task and there are a lot of issues to be

resolved before deciding to move it out of the

market. Companies often retain a high price policy

for the declining products to increase the profit

margin and gradually discourage the few loyal remain-

ing customers from buying it. It is the time to start

withdrawing variations of the product from the

market that are weak in their market position. The

prices must be kept competitive and promotion

should be withdrawn at a level that will make the

product presence visible and at the same time retain

the loyal customer. The basic channel should be kept

efficient abandoning the alternative channels.1214

Various conditions and steps to be taken in differ-

ent phases of a products lifecycle are illustratedin Table 1.

Product lifecycle management

There is a continuous rise in need for PLM due to

following reasons:

. Decline in research and development productivity

. Escalation in average development costs

. Narrowing of return of investment

. Competition is soaring high

Table 1. Various conditions and steps to be taken in different phases of a products lifecycle.12,13

Developmentphase Approval phase

Introductionphase Growth phase Maturity phase Decline phase

Sales Zero Zero Low sales Rapidly risingsales

Peak sales Declining sales

Costs(per customer)

Very high High High Average Low Low

Profit Negative profits Negative Negative profits Rising profits High profits Declining profits

Customers Zero Zero Few Growing number Stable numberbeginning todecline

Decliningnumber

Competitors Almost not there Almost not there Early entry ofcompetitors intothe market

Price and distri-bution channelpressure

Establishment ofcompetitiveenvironment

Some competi-tors are alreadyWithdrawing

Strategic Goal Make the prod-uct known andestablish a testPeriod

Make theproductapproved atthe earliest

Acquire a strongmarket position

Maintain yourmarket positionand build on it

Defend marketposition fromcompetitors andimprove yourproduct

Milkall remainingprofits fromproduct

Product Limited numberof variations Product underapproval Introductionof productvariationsand models

Improvement upgrade ofproduct

Price decrease Variations andmodels that arenot profitableare withdrawn

Price goal High sales tomiddle men

Depend uponregulatorybodies

Aggressive pricepolicy (decrease)for salesincrease

Re-estimation ofprice policy

Defensive pricepolicy

Maintain pricelevel for smallprofit

Promotion goal Creation ofpublic marketproductawareness

Depend uponregulatorybodies

Reinforcementof productawarenessand preference

Reinforcementof middle men

Maintain loyal tomiddle men

Gradualdecrease

Distribution Goal Exclusive &selective distri-bution through

certain distribu-tion channelsand creation ofhigh profitmargins

Not applicable General & rein-forced distribu-tion through all

distributionchannelsavailable

general & rein-forced distribu-tion with good

supply to themiddle menwith lowmargins of profitfor them

General & rein-forced distribu-tion with good

supply to themiddle menwith low mar-gins of profit forthem

Withdrawal frommost channelsof distribution

except thoseused in thedevelopmentphase




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. Competition from generics

. Dispersing markets

Decline in research and developmentproductivity

The research and development pipelines are drying

up quickly. This can be estimated by the fact that

the number of new medicines approved by the US

Food and Drug Administration (FDA) in 2010 is

about half of those approved in 1996. This implies

that the industry is running out of new blockbusterdrugs in the near future. There are a number of

blockbuster drugs produced by many big and small

companies in the last few decades, but now the

blockbusters are, one by one, coming to the end of

their patent protected lives.15 A decline in research

and development productivity in new medicines

from 1996 to 2010 is illustrated in Figure 2.16

One of the reasons for this could be the high failure

rates due to more stringent regulatory environment

requiring new and more demanding hurdles to be

cleared by the new drug candidate to enter the

market.

Escalation in average development costs

The average sum of money required to develop a drug

is very high. At the same time, sufficient funds are

required to get it approved.15,17 The average drug

development costs may vary in accordance with drug

group, choice of strategy and type of therapy from

US$500m to US$2000m. For example, drugs

designed to treat respiratory disorders such as

asthma have an expected capitalized cost per approved

drug of US$1.3 billion while for drugs treating geni-

tourinary disorders, it is US$635 m.18,19 A recent

Tufts CSDD study has shown that the average capita-

lized cost to bring one new bio-pharmaceutical prod-

uct to market (including the cost of failures) is $1.24

billion, in 2005, while for conventional pharmaceutical

products, the same is $1.32 billion.20 With such devel-

opment costs, it is expected that only the leading

and well-heeled players can afford to take a drug

all the way from initial discovery through to

commercialization.15

Narrowing of return of investment

Modern patent protection was designed to safeguard

IP and allow companies to recoup costs incurred

during the research and development. The period of

time, however, for pharmaceutical companies to maxi-

mize the return on investment (ROI) has narrowed.17

Tufts CSDD has shown that the average time required

to take a product from the start of clinical testing to

regulatory approval is 7.2 years. For example, clinical

development times range from as short as 5.2 years for

AIDS antiviral agents to a long period of 7.9 years for

anti-neoplastic agents. If the average time to obtainregulatory approval for neuro-pharmacologic and

cancer drugs is 1.7 and 0.8 years, respectively, the

total time to take a candidate drug from the start of

human testing to market is about 9 years (excluding

the preclinical, animal testing phase, as well as discov-

ery and research).20 Thus, 1215 years for drug devel-

opment (including testing and regulatory approval)

leaves only about 58 years from the patent exclusivity

period of 20 years, for commercialization. The major-

ity of revenues are usually achieved during this period

of exclusivity.17

Figure 2. Decline in R&D productivity in new medicines.16




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Competition is soaring high

There is always a cutthroat competition for launching

newer products into the market. The companies are

running eagerly for success and approval processes

have become streamlined.13 Thus, the period of exclu-

sivity, which is the period to harvest ROI, has been

shortened from years to only a few months, as incase of Vioxx.

1

Competition from generics

Today, generic companies are stronger and more

sophisticated compared to earlier times, and generic

products are entering the market in early stages of

the lifecycle, in some cases, earlier than patent

expiry. Since generics are cheaper than their branded

competitors, their market share, in prescription terms,

is much higher, the research and development-based

industries face competition in a dual mode, i.e. com-

petition from the same field players as well as generic

companies.15

Dispersing markets

In earlier times, the physician was the main customer

in the prescription-drug pharmaceutical industry.

Thus, pharmaceutical companies had a relatively

simple approach to promoting and marketing prescrip-

tion drugs. However, presently pharmaceutical com-

panies increasingly need to address a networked

audience comprising: payer organizations and influen-

tial advisory functions, increasingly knowledgeableconsumers and other stakeholders such as nurses as

well as the traditional physician base.15

Declining research and development productivity,

rising costs of development and shorter exclusivity per-

iods have increased the average cost of launching a

successful new drug.21 Taking these points into con-

sideration, it can be easily sought out that extending

the lifespan of proven drugs by branded companies is a

rising need and can be fulfilled to a greater extent by

PLM.

Applications of PLM

PLM not only benefits through enhancing the lifespan

of patent but also pricing strategies. Thus, PLM pro-

vides benefits to both large and small industries. The

financial health of large, brand-name pharmaceutical

companies relies heavily on portfolios of drugs gross-

ing in excess of one billion dollars annually. Research

and development of these blockbuster drugs require a

tremendous investment of resources. According to the

Pharmaceutical Research and Manufacturers of

America (PhRMA), only one of every 10,000 potential

medicines investigated by Americas research-based

pharmaceutical companies makes it through the

research and development pipeline and is approved

for patient use by the US. In general, FDA approval

takes an average of 10 to 15 years of research and

development and may cost over $1.3 billion. Thus, it

is very important for these industries to incorporatePLM.

19,22

Applications of PLM include:

. In improving patient compliance

. For providing revenue growth

. To gain clinical benefits

. For quick to market launch

. For obtaining cost advantages

. For life extension exclusivity23

PLM benefits through:

. Revenue acceleration

. Unit profit enhancement

. Improved innovation and quality

. Lower costs and improved productivity

Revenue acceleration opportunities provide:

. Enhanced market penetration for a new indication

. Ways to meet the threat posed by generic drugs by

tracking them.

. Greater market penetration through product line

extension driven by prescriber/patient feedback

. Delivery changes to bulk drug or dosage form man-ufacturing processes that possess a novel patent,

thereby conferring additional patent protection

once generic competition occurs.

. Marketers to differentiate the product, reducing the

effect of generic erosion after patent expiration.

. Significant improvements to the manufacturing or

supply process that reduces the cost of goods,

thereby preserving unit margins or enabling more

competitive product pricing.

. Market variants through technology transfer to

regional manufacturing sites, enhancing local

market acceptance and deeper penetration whilereducing stock complexity that would otherwise

drive up costs at high-volume facilities.

Unit profit enhancement opportunities provide:

. Technology transfer to sites that give economies of

scale or enable cost reduction in some way, such as

lower inventory, lower stock expiry, better capacity

use; or relocating bulk active or dosage form manu-

facture to a low-tax or low-fixed-variable-product

costs environment




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. Optimization of manufacturing processes in situ

that drives down cost of goods, such as yield or

process robustness or reduction in raw material

costs.1

Key considerations for successful PLM

There are a number of factors that have been selected

in a benchmarking study for the purpose of successful

PLM.17

These factors are

. Early start

. Strategic planning

. Establish clear leadership

. Knowledge and skills to support the process

. Preparation for the changing rules of government

and organizations

. Focus on profitability throughout the lifecycle

. Monitoring and gauging of the success of the

processes implemented.

Early start

PLM approach needs to be proactive and not as a late-

stage attempt to fend off generic competition. In prac-

tice, product lifecycle activities are rarely considered

early enough for companies to execute them to the

best effect, but in principle companies should develop

a roadmap in a molecules early life to track the rise

and falls of a molecule through various stages of devel-opment. Such a molecular mapping optimises its mar-

keting potential. For example, Humira (Adalimumab)

was approved by US FDA in December 2002 for

rheumatoid arthritis. In the development phase of

the first indication, work to develop follow-up indica-

tions was started. Abbott Laboratories also initiated to

understand the effect of Humira in other autoimmune

diseases. As a result, Humira was approved for treating

psoriatic arthritis in 2005 and Crohns disease in 2006.

Similarly, Eli Lilly and Company had instigated map-

ping lifecycle management from discovery and devel-

oped antipsychotic Zyprexa for multiple indications.Zyprexa was approved in 1996 for manifestation of

psychotic disorder, in 2003 for treatment of depressive

episodes associated with bipolar disorder and in 2004

for long-term treatment of bipolar disorder.8

Strategic planning

The main purpose of PLM is to maximise the profit-

ability of a product over its lifecycle. Since the PLM is

becoming more crucial to the industrys future,

pharmaceutical companies need to move from viewing

lifecycle management as a collection of reactive strate-

gies to viewing it as a key organizational capability an

integrated set of governance mechanisms, rigorous

processes, people skills and knowledge, supported by

transparent product and portfolio information and

performance indicators. By concentrating their efforts

in the following areas, pharmaceutical firms candevelop a more integrated approach to lifecycle man-

agement and take advantage of every opportunity to

increase product profitability.15

The companies have established dedicated multi-

functional PLM teams to drive early planning, moni-

tor progress and benchmark efforts. They have also

planned for PLM in the context of their broad business

goals and product portfolios, evaluating the ROI of

PLM opportunities with alternative investments in

new research and development, strategic acquisitions

and the like.22

For example, Abbott Laboratories has redecorated

its lifecycle management teams organisation by

including a central data repository for all teams to

access the same information for all molecules develop-

ment and clinical testing.8

Establish clear leadership

A company should thrive to establish its leadership in

the market as well. Thus, establishment of clear own-

ership for lifecycle management and accountability for

key actions in the lifecycle plan is the main necessity

for a company. A small team should carry out strategic

programmes based on rational analysis of problemsand an innovative approach to solve them. In addition,

the lifecycle strategy should be supported by individ-

uals with the right combination of influence and nego-

tiation to challenge internal barriers and drive

performance against hard targets.15,24

A successful example for this is of Pfizers Lipitor

which generated global revenues of $13.6 billion, leav-

ing a benchmark in pharmaceutical history. Lipitor

was launched in 1997 (US, EU) and in 2000

(Japan). Pfizer extended its lifecycle by introducing

(Lipitor plus Norvasc). In November 2011, it lost its

patent protection but is still going well with strategieslike price reductions (up to 80%).2527

Knowledge and skills to support the process

A successful PLM program is fabricated around a firm

vision of the underlying product and its fit within the

product line, franchise or company, as well as an

exhaustive understanding of the overall competitive

landscape in which the product is marketed.7

Thus, the collection of PLM options must be

thoroughly scrutinized and assisted by a complete




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understanding of the complex dynamics that affect a

product during its market life. No PLM option can be

successful without sufficient knowledge and skills to

support the process. For example, without thorough

knowledge of a drugs pharmacokinetics, its safety and

toxicity profile, the indications for which it is being

targeted and the first generation products formatand treatment regimen, it is impossible to determine

the potential of product for PLM through reformula-

tion, expanded indications, over-the counter (OTC)

switch and/or fixed dose combination.24

Preparation for the changing rules ofgovernment and organizations

The governance and organizations have crucial influ-

ence on PLM. In general, the political winds are at the

back of the generics sector. There is a huge pressure to

keep low prescription prices. As the FDA is becoming

more concerned with safety and patient outcomes, it

has imposed more difficult hurdles regarding new

product approvals. The new product manufacturers

are always closely watched by third party payers. For

the purpose of reimbursement, the cost-effectiveness

and patient benefits should be closely proven.17,24

Thus, the PLM plan should be flexible enough to

take on such challenges. For instance, when bilingual

labeling (i.e., the label should contain all the necessary

details in both English & Hindi) was made mandatory

in India, it created ambiguity in the market. There

were doubts regarding readability of content (espe-

cially on ampoules) and opposition from southernstates. Though a relaxation period of 6 months was

provided, it was still a difficult task as excess of

expenditure on reprinting of labels was required.

Some companies put only the name of medicine in

Hindi while some others carried out all details in both

languages, but only on the medicine box and kept only

the drugs name in Hindi on the immediate

pack. However, later due to efforts from some pharma-

ceutical industry associations, Indian Pharmaceutical

Alliance (IPA) and Confederation of Indian

Pharmaceutical Industry (CIPI), the decision of bilin-

gual labeling was retracted from mandatory to onlyvoluntary.2831

Focus on profitability throughout thelifecycle

PLM strategies decisions are based on top-line growth

certainly a key driver of profitability, but by no

means the only one. Simultaneously, focus on profit-

ability does not, in any means, indicate that the qual-

ity, safety or efficacy of a drug will be compromised.

Lifecycle management activities focused on managing

cost are now rarely considered. Obviously, the cost

base of the product becomes particularly important

late in its lifecycle when generic is prevalent. When

cost pressures do not seem to be an issue, the decisions

concerned with the cost of the product need to be

taken well in advance. There should be other second-

ary objectives which will eventually lead to profitabilitysuch as the enrichment of number and type of cus-

tomers (through target population expansion or indi-

cation expansion), which will directly increase the sales

and fetch higher revenues to that firm.15

Monitoring and gauging of the successof the processes implemented

Since PLM is a dynamic process, the plan must be

constantly reassessed against the contemporary

market and aggressive milieu and be evolved in accord-

ance.7 In order to analyze whether a PLM option is

successful upon implementation and to see the current

position of the firm, a simultaneous monitoring of the

process and measurement of its success is a very

important aspect as it provides the plot for doing

much better. Comparative pharmaco-economic ana-

lysis plays an increasingly important role in positioning

the product with institutional, governmental and com-

mercial payer organizations on its launch. Keeping a

track record of the progress will always provide guid-

ance about what to do next.17,24

ConclusionPLM, a strategic approach for managing a companys

product-related intellectual capital that existed for

many years in electronics and automotive sectors,

can now be applied in pharmaceutical sector as well

to sustain the franchise of an innovator pharmaceutical

company and increase its return of investment. PLM

benefits both large and small industries and can be

applied for improving patient compliance, providing

revenue growth, gaining clinical benefits obtaining

cost advantages, life extension exclusivity and quick

to market launch. For a successful PLM, an early

start, a strategic planning, a clear leadership and sup-porting knowledge and skills are required. Preparation

for the changing rules of the Government and related

organizations, the focus on profitability throughout the

lifecycle, the monitoring and gauging of the success of

the process are must for taking this approach to higher

levels of success.

Funding

This research received no specific grant from any funding

agency in the public, commercial or not-for-profit sectors.




10/10

Conflict of interest

The authors declare that they do not have any conflicts of

interest.

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Authors Biographies

Vandana Prajapati is M. Pharm. research scholar at M.

D. University, Rohtak and has drug regulatory affairs

as the area of specialization. She possesses a Bachelors

degree in Pharmacy.

Harish Dureja is Associate Professor in Pharmaceutics

at Department of Pharmaceutical Sciences, M. D.

University, Rohtak. He possesses a Doctorate degree

in Pharmaceutical Sciences.


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