CHAPTER : 2 The pharmaceutical product

6hrs

a. Market consideration in product development,

marketing mix, product life cycle (PLC), effects of
different elements of marketing mix at different stages of
PLC, product classification, product planning, product
differentiation, me-too products, modification of existing
product.
b. New product development-All stages from the new
product idea to the stage of marketing the developed
product
(bulk
drug
&
formulations).
c. Branding-concept of brand, different types of brand,
importance and reasons for branding, packaging.
1

Product Life cycle

JSK NAGARAJAN
2

What is a product?
Product is anything which is of
value & is offered thro voluntary
exchange
A change in feature creates a
new product
Service : Set of activities,
benefits or satisfaction offered
for sale
Intangible
May not result in ownership

Goods and/or Services Are the

Product

Demand for products

What is the demand for these products in

2013 compared to 1990?

???

Fixed phone, land-line

Cell phones
Umbrella
Video cassette player
Diabetes Insulin injections

Why would demand change?

New products meet needs better
Maruti 800 v/s Premier Padmini
Technology changes
Video conference v/s air travel
Substitutes replace a product
Telegrams v/s SMS, SMS v/s Mobile Chat
Population moves to the next level in
Maslows NH
Basic variant of a car to full loaded model

PLC Concept Based on 4 Premises

Products have a
limited life.

Profits from a
product vary at
different stages
in the life cycle.

Product sales pass thru

distinct stages, each
With Different
marketing Implications

Products require
Different strategies
at different
life cycle stages.

PLC Duration

Product Lifecycle
Stages that a product goes through during its
life: Introduction, Growth, Maturity & Decline.

Concept apply to a brand or category

of a product.
Duration maybe as short as a few
months/years, depending on the
Asproduct.
a product progresses through the
stages, changes are made to how the

Product Life-Cycle
Strategies
PLC Stages
Product
development
Introduction
Growth
Maturity
Decline

Begins when the company

develops a new-product idea

Investment costs are

high
Sales are zero
Profits are negative

Product Life-Cycle
Strategies
Slow sales growth

PLC Stages

Intensive promotions,
communications
Price uncertainty
Demand is created

Customers made to try the

Product development
product
Little competition
Introduction
Uncertain competition
Growth
reactions
Uncertain consumer
Maturity
responses
Decline
Non-existent profits
Negative cash flow

Introduction Stage of PLC

Sales
Sales

Low
Low sales
sales

Costs
Costs

High
High cost
cost per
per customer
customer

Profits
Profits

Negative
Negative

Marketing
Marketing Objectives
Objectives

Create
Create product
product awareness
awareness
and
and trial
trial

Product
Product

Offer
Offer aa basic
basic product
product

Price
Price

Use
Use cost-plus
cost-plus

Distribution
Distribution
Advertising
Advertising

Build
Build selective
selective distribution
distribution
Build
Build product
product awareness
awareness among
among early
early
adopters
and
dealers
adopters and dealers

Introduction
Stage
Most products
fail at this stage? -Why?
Stage in which the product is initially promoted.
Public awareness -very important - success of product.
If people don't know -the product -won't go out & buy it.
2 different strategies -use to introduce -product to consumers:
Penetration
-Skimming
product price very high Set
prices
very
low
&
gradually
initially & then gradually beginning
increase them.
lowers it over time.
Good strategy to use- few Good strategy to use-lot of
competitors
for
your competitors who control a
large portion of the market.
product.
Profits are high -but great Profit
is
not
concern.
risk. If people don't want Important is to get product
&
worry-making
to pay high prices may lose known
money later time.
out.

Product Life-Cycle Strategies

Market acceptance

PLC Stages

Product development
Introduction
Growth
Maturity
Decline

Rapid sales growth

Price stabilization
Features stabilization
Profits start coming in
Brand building starts
Competition starts building

Growth
Product starts to grow.
Very large amount of money is spent on advertising.
Concentrate on telling advantage of product
than competitors' products.
What are the ways in which you could prompt
a product?
Successful with-advertising strategy then
increase in sales.
Once sales begin to increase - share of the
market will stabilise.
15

Growth Stage of the PLC

Sales
Sales

Rapidly
Rapidly rising
rising sales
sales

Costs
Costs

Average
Average cost
cost per
per customer
customer

Profits
Profits

Rising
Rising profits
profits

Marketing
Marketing Objectives
Objectives

Maximize
Maximize market
market share
share

Product
Product

Offer
Offer product
product extensions,
extensions, service,
service,
warranty
warranty
Price
Price to
to penetrate
penetrate market
market

Price
Price
Distribution
Distribution
Advertising
Advertising

Build
Build intensive
intensive distribution
distribution
Build
Build awareness
awareness and
and interest
interest in
in the
the
mass
mass market
market

Maturity
Third stage of PLC
If product completes FIRST TWO stages
then it will then spend great deal of time in
Maturity stage.
During this stage sales grow at very fast
rate & then gradually begin to stabilise.
17

Product Life-Cycle Strategies

PLC Stages

Product development
Introduction
Growth
Maturity
Decline

Slow sales growth Land lines,

100cc motorbikes, fountain
pens
Price reductions, promotions
Features changes /
reductions / new
Profits go down
Competitors introduce new
products
Brand sustainability is
imperative in communication

Maturity Stage of PLC

Sales
Sales

Peak
Peak sales
sales

Costs
Costs

Low
Low cost
cost per
per customer
customer

Profits
Profits

High
High profits
profits
Maximize
Maximize profit
profit while
while defending
defending
market
market share
share

Marketing
Marketing Objectives
Objectives

Product
Product

Diversify
Diversify brand
brand and
and models
models

Price
Price

Price
Price to
to match
match or
or best
best competitors
competitors

Distribution
Distribution
Advertising
Advertising

Build
Build more
more intensive
intensive distribution
distribution
Stress
Stress brand
brand differences
differences and
and benefits
benefits

Decline
Sales of your product begin to fall.

Either everyone that wants to has

bought your product or new, more
innovative products have been
created that replace yours.
Many companies decide to withdrawal
their products from the market due to
the downturn.
The only way to increase sales during
this period is to cut your costs reduce
your spending.
20

Product Life-Cycle Strategies

PLC Stages

Product development
Introduction
Growth
Maturity
Decline

Decline in sales audio &

video cassette players,
pagers
New products meet
satisfaction
Profits erode
Communication expenses
are stopped

Decline Stage of the PLC

Sales
Sales
Costs
Costs
Profits
Profits
Marketing
Marketing Objectives
Objectives

Product
Product
Price
Price
Distribution
Distribution
Advertising
Advertising

Declining
Declining sales
sales
Low
Low cost
cost per
per customer
customer
Declining
Declining profits
profits
Reduce
Reduce expenditure
expenditure and
and milk
milk the
the brand
brand
Phase
Phase out
out weak
weak items
items
Cut
Cut price
price
Go
Go selective:
selective: phase
phase out
out unprofitable
unprofitable
outlets
outlets
Reduce
Reduce to
to level
level needed
needed to
to retain
retain
hard-core
loyal
customers
hard-core loyal customers

PLC OF ASPIRIN
Aspirin market is about a century old.
Early it was used as anti pyretic-analgesic
but lost its market to PCM and due to
certain side effects of aspirin.
It was repositioned in the market with
safer dosage forms such as Enteric coated
tablets, Buffered coated , dispersible
tablets.
Brands like Disprin , Microfine Aspro
succeeded while lesser known brands
vanished from the markets.

Marketing Strategies in the PLC

Product Life Cycle

Examples of products in various stages of the product life cycle
Product

Introduction

Growth

Maturity

Decline

commnunication

E-conferencing

email

faxes

Handwritten
letters

Machines

Third
generation
mobile phones

Banking

Iris-based
personal
identity cards

Portable CD
Personal
players
Computers
Smart
cards

Credit
cards

Typewriter

Check
books

PLC &Customer adoption

process

Innovators
first on the block buyers
Typically younger in age
They enjoy taking risks with
new products
They are mostly well informed
Very small in numbers
Tolerate failures
They trigger the next level Adopters
Early adopters
These wait for initial
purchases to happen, product
reviews
They enjoy novelty, higher
incomes youth, educated,
socially forward
Opinion leaders
They help spread the world

PLC &Customer adoption

process

Majority Skepticism, senior in age,

mixed levels of education
They build the sales
volumes
Dont like to take too
much risk
Competitors enter the
market when these come in
Careful buyers &
choosers
Laggards They avoid change
Rely on existing products
until it outgrows completely
Form the last small
section
They dont need to much
ad & communication

PLC of different
products

Other Considerations
Very few products follow the same cycle.
Many products don't even make it thru all 4 stages.
Some stages even bypass stages

Problem with the PLC.

There is no set way for a product to go.
Therefore, every product requires a great deal of
research & close supervision throughout its life.
Without proper research & supervision your
product will probably never get out of 1st stage.

29

PLC Length & Shape

Style
Sales

Fashion
Sales

Time

Fad
Sales

Time

Time

Common Product Life Curves

Sale
s

Time
(a) Growth-Decline
plateau

Sales

Time
(b) Cycle-Recycle Pattern

Sales

Time
(c) Innovative Maturity or
Scalloped Pattern

Implications & Limitations of Product Life Cycle Concept

PLC concept shows a framework to spot
the occurrence of opportunities & threats
in a product market & the industry.
This can help firms to reassess their
objectives, strategies, & different elements
of marketing programme.

PLC shows the stages that products go

through from Introduction to withdrawal from the
market.

INTRO

GROWTH

MATURITY

DECLINE

IntroductionHindustan Unilever Limited (HUL) is India's largest FMCG

HUL
company, touching the lives of two out of three Indians with over
20 distinct categories in home & personal care products and food
& beverages.

1916
LUX launched
in USA as
Laundry soap

1925
LUX launched in
USA as Toilet
soap

1929
LUX
launched in
India

1960
LUX went
colored

INTRO
1929 -1950
Actions

GROWTH
1950 - 1990
Actions

MATURITY
1990 TILL DATE
Actions

Low

Rising Sales

Peak sales

Cost of mfg

High

Profits

Negative

Marketing
Objective

Create product
awareness in
major cities

Average cost
reduction
Positively
increasing
Maximise market
share

Product
strategy
Price strategy

Offer a basic
product

Offer variants

Higher than
Lifebuoy

Distribution

Created
network
in major cities

Advertising
strategy

Awareness
among
early adopters.

To penetrate the
market
Intensive network
in the entire
country
Awareness an
interest in mass
market

Company
Objectives
Sales

Low
High
Maximize profit
while defending
market share
Diversify brand
To match the nearest
competitor
More intensive
focusing on rural
area
Multiple brand
ambassadors for
different variants.

COLGATE PRESENTATION

His company sold the first toothpaste in a tube, Colgate Ribbon

Dental Cream, in 1896.
In 1928, Palmolive-Peet bought the Colgate Company to create
the Colgate-Palmolive-Peet Company.
In 1953 "Peet" was dropped from the title, leaving only
"Colgate-Palmolive Company", the current name.
Today Colgate has numerous subsidiary organizations spanning
200 countries, but it is publicly listed in only two, the USA &
India.

PRODUCTS
COLGATE

ORAL CARE

PROFESSIONAL
ORALCARE

HOME CARE

Product Life Cycle of Colgate

Sales

Introduction

Growth

Maturity

Decline

Time

SWOT Analysis for Colgate

Strengt
Stronghs
financial performance
Focus on innovation & new
product launches
Colgate business planning
initiative

Weakness
es
Product research
Highly leveraged

Opportunities
Emerging markets growth
Deploying advance technologies
Growing Hispanic population in the US

Promotional
Increasingtools
circumference of toothpaste tube.

Free Dental Check-up in mobile vans

Promotional
Free Dental
toolsCheck-up by sending a SMS

Scholarship offers like Learn & earn offer

ADVERTISEMENT
In 1940, Colgate Company used Slogan was "It
cleans your breath while it cleans your teeth " .
1960s onwards -slogan was "The Colgate ring
of confidence" .
Late 1950's & early 1960's, Colgate stressed
the
fact
their
"Dental
Cream"
contained Gardol, a formula that helped
protect teeth from cavities & tooth decay.
"Gardol" trademark
lauroyl sarcosinate .

for

ingredient Sodium

Slogan for different different products like For

MAX FRESH is A Whole new Dimension of
Freshness & For WHITE TOOTHPASTE is All
Around Decay Protection.

Various Surveys like

1. Colgate's Bright Smiles, Bright Futures
This Educational Program worldwide was developed to
teach children positive oral health habits of basic hygiene,
diet and physical activity.
2. Colgate Professional Program
Program works towards improving oral
health awareness &oral care on mass scale.
Oral care awareness is created & spread
thru appropriate mechanisms such as
exhibitions, use of audio-visuals, lectures,
demonstrations, teacher training Programs.

Attractive offers:
Super Saver Offer for 'All Around Decay Protection'. Buy
200g plus a 100g tube with a Colgate Extra Clean
Toothbrush in a Family Value Pack for Rs. 82/-. Save Rs.
18/-.
Colgate Maxfresh Gel is the first toothpaste infused with
cooling crystals giving you a whole new dimension of
freshness. Get a 150g plus a 80g tube with a Colgate
Extra Clean Toothbrush in a Freshness Value Pack for Rs.
79/-. Save Rs. 20/-

08/07/16

NOKIA 1011

08/07/16

08/07/16

08/07/16

08/07/16

08/07/16

08/07/16

08/07/16

08/07/16

Sales
or
Profit
s

Maturity
Nokia Symbian
& N- Series

Growth
Nokia E- series

Introducti
on
The Concept Phones

Decline

Nokia Windows
& Symbian
Sales curve
phones

Time

How to Effectively
Launch
a New Product

MARKET RESEARCH:
To determine:
Target Market
Market needs
Positioning and strategy
New product strengths and weaknesses
Company strengths and weaknesses
Packaging/ pricing

Focus Group Meetings

To distill product concept
Key promotional messages
Anticipate product resistances
Know strong points of competition
Unfulfilled needs of MDs

PRELAUNCH:

Marketing Plan
Anticipated date of registration approval
Update of SWOT analysis
Preparation of training materials
Clinical trials or seeding trials
Organization of scientific meetings
Participation at regional congresses
Final marketing plan

Field Force Training:

Materials to be sent one month before launch
With self-tests to check learning
Selection of Key Accounts
Hospital mapping
MD targeting & profiling
Press Conference

PRELAUNCH:

Final Launch Plan

Emphasis on skill building

Provide time for role play
All information should be given prior to launch date
Involve the field force in launch planning to get BuyIn and generate enthusiasm

Incentive plan, quota per Rep

Distribution plan: initial stocking and terms
Pre-announcement letters to MDs (teasers)
Skills models
Video models for use at launch role plays

LAUNCH:

Launch letters to MDs,

pharmacists, et al.
Press relations
Symposia
Video news releases
Press kit

Formulary kit
Product monograph
Collection of key
clinical studies
Seeding trials
expanded
Profiling target MDs
Action plans per
territory

DURING THE LAUNCH

PROGRAM:
Focus on Selling Skills
MD selection
Pre-call planning
Probing for needs
Features and benefits
Clinical studies
The effective use of the monograph

FOCUS ON SELLING SKILLS TO

SELL NEW PRODUCT:

Cost effectiveness
Handling objections
Handling competition
Ensuring that first trials are successful
Group presentations

How to put the new product into the hospital formulary

Doing a Hospital Action Plan
Presentations to nurses, pharmacists
Sampling allocation and plan

LAUNCH:
Medical Education Program
Patient Education Program
Gimmicks, posters, etc.

POST LAUNCH:

Analyze effectiveness of tactics & message

Analyze competitive response
Market and prescription survey
Handling MD queries

Handling MD resistance
Post launch bulletin
Producing the Audio Cassette Training Program, Post
Launch Feedback
Revising plans

Celebrating successes
Selling tips
New ideas to reinforce messages
Interviewing happy users of new product
How to respond to Reps questions

NEW PRODUCT LAUNCH

(Tactics)
The success of a new product launch
depends largely on the planning and
preparation you invest in the launch of
your new product.
Proper planning, preparation and
practice
prevent poor performance.
- Perri

Marketing Mix - Four Ps

Product
Place
Price
Promotion

Marketing Mix
Concept is simple - Cake mix.
Cakes contain eggs, milk, flour & sugar.
Can alter the final cake by altering the amounts
of mix elements contained in it.
Sweet cake add more sugar!
It is the same with the marketing mix.
The offer you make to your customer can be
altered by varying the mix elements.
So for a high profile brand, increase the focus on
promotion and desensitize the weight given to
price.

Target Market is the key

Competition

Designing the right marketing

mix
The most creative & challenging step
in marketing is designing the right
marketing mix
The marketing mix is the specific
collection of actions & associated
instruments employed by an
organisation to stimulate acceptance
of its ideas, products & services

Total Offer to the Customer

First, the firm chooses the product to
meet the identified need of the target
segment
Second, the right distribution channel is
used to make the product available
Third, the firm undertakes eye catching
promotion
Fourth, the price platform is acceptable to
the customer & firm

E. Jerome McCarthy
A prominent marketer, E. Jerome
McCarthy, proposed a 4 P
classification in 1960, which has seen
wide use.

4Ps &
4Cs
Product- Customer /Consumer

Price- Customer cost

Place- Convenience
Promotion- Communication

Four Cs
The Four Ps is also being replaced by
the Four Cs model, consisting of
consumer, cost, convenience, and
communication.

ProductConsumer
The product part of the
Four Ps model is replaced
by consumer or consumer
models, shifting the focus
to satisfying the
consumer.

PlaceConvenience
Placement is

replaced by the
convenience
function.
With the rise of
internet and hybrid

PriceCost
Pricing is replaced
by cost, reflecting
the reality of the
total cost of
ownership.

PromotionCommunicati
on

Finally, the
promotions feature
is replaced by
communication.

Extended Marketing Mix

There have been attempts to develop
an 'extended marketing mix' to
better accommodate specific aspects
of marketing.
For example, in the 1970s, Nickels
and Jolson suggested the inclusion
of packaging.
In the 1980s Kotler proposed public
opinion and political power

Booms & Bithner

Booms and Bitner included three additional 'Ps' to
accommodate trends towards a service or knowledge based
economy:
People all people who directly or indirectly influence the
perceived value of the product or service, including knowledge
workers, employees, management and consumers.
Process procedures, mechanisms and flow of activities which
lead to an exchange of value.
Physical evidence the direct sensory experience of a product
or service that allows a customer to measure whether he or she
has received value. Examples might include the way a customer
is treated by a staff member, or the length of time a customer
has to wait, or a cover letter from an insurance company, or the
environment in which a product or service is delivered

Extended- Marketing Mix

Extended Marketing
Booms andMix
Bitner included three additional

'Ps' to accommodate trends towards a

service or knowledge based economy:
People
Process
Physical Evidence

People
People all people who directly
or indirectly influence the
perceived value of the product or
service, including knowledge
workers, employees,
management & consumers.

Process
Process procedures,
mechanisms and flow of
activities which lead to an
exchange of value.

Physical
TheEvidence
direct sensory experience of a product or

service that allows a customer to measure

he has received value.
whether
Furnishings.
Examples might include the way a customer is
treated
Signage
(such as those on aircraft
by a staff member, or the length of time
vehicles).
aand
customer
has to wait, or a cover
letter from
There
are many
insurance company, or the environment
in inclu
an
Uniforms.
evidence,
which a product or service is delivered.

following:
Business cards.
asPackaging.
The
building
itself
(such
Physical evidence is the material

prestigious
offices
or
scenic
Internet/web pa
part of a service.
headquarters).
Paperwork
(suc
Strictly speaking there are
no
and despatch
n
physical attributes to a service,
so a

7Ps & 7Cs

The 7 Ps

The 7 Cs

Organisation Facing

Customer Facing

Product =

Customer/ Consumer

Price =

Cost

Place =

Convenience

Promotion =
People =

Communication
Caring

Processes =

Co-ordinated

Physical Evidence =

Confirmation

Fundamental Actions
The term 'marketing mix' however,
does not imply that the 4P elements
represent options.
They are not trade-offs but are
fundamental marketing issues that
always need to be addressed.
They are the fundamental actions
that marketing requires whether
determined explicitly or by default.

Optimizing the marketing mix-1 Strategic

& Tactical Changes

Broadly defined, optimizing the marketing mix is the primary

responsibility of marketing.
By offering the product with the right combination of the four Ps
marketers can improve their results and marketing effectiveness.
Strategic & Tactical Changes

Optimizing the marketing mix-2

Making large changes in any of the four Ps can be considered

strategic.
Making small changes in the marketing mix is typically considered
to be a tactical change.

Optimizing the marketing mix-3

For example, a large change in the price, say from Rs19.00 to

Rs39.00 would be considered a strategic change in the position of
the product.
However a small change of Rs130 to Rs129.99 would be
considered a tactical change, potentially related to a promotional

Product

A product, service or idea is that which satisfies the needs

& wants of the customers

A tangible object or an intangible service that is mass

produced or manufactured on a large scale with a specific
volume of units.
Intangible products are often service based like the tourism
industry & the hotel industry or codes-based products like
cell phone load and credits.

Variety
Quality
Design
Features
Typical
examples of a mass produced tangible object are
the motor car and the disposable razor. A less obvious but
Brand mass produced service is a computer
ever-present
operating system.
Name
Packaging
Service

Product
Even Variety
today, manufacturers of products which are built to

customer order, for example, cars, aeroplanes and medical

equipment, offer such a large range of combinations of
product features that millions of variants of a single product
are possible.
Commercially available software systems support the
automation of many aspects of the engineering process;
product databases enable the description of single products
and engineering applications can use these product
descriptions to carry out their tasks.

Product Quality

A product or process that is reliable, and that

performs its intended function is said to be a
quality product.
Quality in business, has an interpretation as
the non-inferiority or superiority of something.
Quality is a perceptual, conditional and

Product design
Product design can be defined as the idea
generation, concept development, testing
and manufacturing or implementation of a
physical object or service

Brand Name

The brand name is often used interchangeably

within "brand", although it is more correctly
used to specifically denote written or spoken
linguistic elements of any product.
In this context a "brand name" constitutes a
type of trademark, if the brand name
exclusively identifies the brand owner as the
commercial source of products or services

Product
Instruments that aim at satisfaction of the
prospective exchange partys needs
Examples: Product characteristics, options,
assortments, packaging, guarantees,
quality, features, style, brand name, size &
packaging, services, warranties/guarantees,
returns & replacements

Titan introduces quartz watches

24 Hour banking & ATMs by banks
Tetra pack cartons for milk, juices
Indoor coolers

Product &
Packaging
FMCG
Produ
ct
Consumer
durable
products
Increase in mobile services in India

Service
s
Courier Aviation

Place
Place represents the location where a product can be purchased.
Often referred to as the distribution channel. Includes physical/
virtual stores on the Internet.
Physical distribution are activities involved in transporting products
from the producer to the consumer:
Mode of transport
Warehousing & Storage
Order processing
Inventory control

Channels of distribution are the routes through which the ownership

of goods flow on its way from the producer to the customer
Distributor
Super-stockist
Instruments that determine the intensity
Wholesalers
or services will be made available
Retailers
Types of channels, density of distribution,
merchandising advise

Duty Free
Stores Airports

Hypermart-Store
Signage's

AvailabilityPlace
Large Format
stores

Lifestyle,
Westside
Shoppers Stop
Pantaloons
Big Bazaar

Retail
brands
Stores

Place
Global Players
in India

Market
s

Stores

Modern Grocery
Store

Local kirana
stores

List
Price
In retail, price regularly quoted to customers
before applying discounts. List prices are usually
the prices printed on dealer lists, invoices, price
tags, catalogs, or dealer purchase orders.

Price Lists

Discounts & Allowances

Discounting is a financial
mechanism in which a debtor obtains
the right to delay payments to a
creditor, for a defined period of time,
in exchange for a charge or fee
Discounts and allowances are
reductions to a basic price of goods
or services.

Payment Period & Credit

Terms
The stipulation by a business as to
when it should be paid for goods or
services supplied, for example, cash
with order, payment on delivery, or
within a particular number of days of
the invoice date

Price
Bills

Price
Price is the amount a consumer pays
in exchange for the product or
service.
Marketers must consider the
following in setting prices:

Price
Target segment- How much the target
segment is willing to pay at different
price levels- price elasticity of demand
Cost- How much it costs the firm to
produce & market the product
Competition- Prices of competitors
Society & Law- Within legal framework

Price elasticity of demand-1

Elasticity is a measure of responsiveness.
Two words are important here.
The word "measure" means that elasticity
results are reported as numbers, or elasticity
coefficients.
The word "responsiveness" means that there is
a stimulus-reaction involved.
Some change or stimulus causes people to
react by changing their behavior, and elasticity
measures the extent to which people react.

Price elasticity of demand-2

The most common elasticity measurement
is that of price elasticity of demand.
It measures how much consumers respond
in their buying decisions to a change in
price.
The basic formula used to determine price
elasticity is
e= (percentage change in quantity) /
(percentage change in price).
(Read that as elasticity is the percentage
change in quantity divided by the
percentage change in price.)

Price
Marketers have to determine prices
to consumers & channel partners
Prices across models & geographic
regions have to be established
Policies on discounts have to be
framed
These decisions are vital to enhance
sales volumes

Innovative Discounts

Discount sales in shopping malls

Off season sales
Closing down sales
Festival sales
Credit points
Exchange offers mobiles, cookers,
cars

Festive Sales
Christmas & Diwali Sales

Innovative discounts
Discounts

End of season sale

Special Sales
Sales

Gold Sale- Impact

Festive season revives gold demand,
premiums steady

Report- Gold Sales

Wednesday August 12, 01:40 PM Festive
season revives gold demand, premiums
steady
SINGAPORE/MUMBAI (Reuters) - Gold trading
picked up in India, the world's largest
consumer, as jewellers took advantage of a
price drop to replenish stocks during the
festive season, while premiums for kilobars
were mostly steady in Asia in the past week.

Discount Rush

Promotio
n activities are meant to
Promotion
communicate & persuade the target
Advertising
market
to buy the companys products
Personal
This
is doneselling
by: Sales promotion- POS
Public Relations
Word of mouth Viral advertising

Promotion
Promotion represents all of the communications that
a marketer may use in the marketplace.
Promotion has five distinct elements advertising,
personal selling, public relations, word of mouth and
point of sale.
A certain amount of crossover occurs when
promotion uses the five principal elements together
Advertising covers any communication that is paid
for, from and cinema commercials, radio and
Internet adverts through print media and billboards.

ATL & BTL

Above the line (ATL) is an advertising technique
using mass media to promote brands.
Major above-the-line techniques include TV and
radio advertising, print advertising and internet
banner ads.
This type of communication is conventional in
nature and is considered impersonal to customers.
The ATL strategy makes use of current traditional
media: television, newspapers, magazines, radio,
outdoor, and internet.
It differs from BTL (Below the line), that believes in
unconventional brand-building strategies, such as
direct mail.

BTL- Below the line

The terms "below the line" promotion
or communications, refers to forms of
non-media communication, even nonmedia advertising.
Below the line promotions are
becoming increasingly important
within the communications mix of
many companies, not only those
involved in FMCG products, but also
for industrial products.

ATL & BTL

Whats the difference between Above the line and
below the line advertising?
Below the line (BTL) is an advertising technique.
It uses less conventional methods than the usual
specific channels of advertising to promote
products, services, etc. than ATL (Above the line)
strategy.
These may include activities such as direct mail,
public relations and sales promotion for which a fee
is agreed upon and charged up front.

Below the Line

Below the line advertising typically focuses on direct
means of communication, most commonly direct
mail and e-mail, often using highly targeted lists of
names to maximize response rates
The term "Below the Line" is rapidly going out of
fashion in advertising circles as agencies and clients
switch to an 'Integrated Communication Approach.'
BTL is a common technique used for touch and feel
products. Those consumer items where the customer
will rely on immediate information than previously
researched items.
BTL techniques ensures recall of the brand while at
the same time highlighting the features of the
product.

Integrated Communication
Approach
Definition: A management concept
that is designed to make all aspects
of marketing communication such as
advertising, sales promotion, public
relations, and direct marketing work
together as a unified force, rather
than permitting each to work in
isolation.

Through the line-TTL

Through the line" refers to an advertising strategy
involving both above and below the line
communications in which one form of advertising
points the target to another form of advertising
thereby crossing the "line".
An example would be a TV commercial that says
'come into the store to sample XYZ product'.
In this example, the TV commercial is a form of
"above the line" advertising and once in the store,
the target customer is presented with "below the
line" promotional material such as store banners,
competition entry forms, etc

Personal selling
Personal Selling: Face to face personal
communication- Eureka Forbes
In person selling, tele-marketing
Advertising- Mass communication efforts
through media
Sales Promotion- Communication through
contests, OOH, trade shows, free samples,
yellow pages, call helplines

Personal Selling
Personal Selling

Discount coupons
Discount coupons

Promotion-2
Publicity- Communicating with an
audience by personal or nonpersonal media that are not paid for
delivering the message
Print media news, broadcast media
news-UTI,PTI, Reuters, annual
reports, speeches by employees

Branding
Signages

Known companies
Recognizable companies

Nokia
Nokia

Messages
Fly High

Examples-Lux
Same theme over the years

Chips
Competition

Celebrity endorsement
Using famous people to attract target
segment

ICICI Bank- Print Ad

Brand Ambassador
Star Power

TV
Channels

More than just news

Entertaining information to add spice

Print- Newspapers & Magazines

Radio
Growing radio stations in India

Radio Stations
Numerous- FM

Videos can be uploaded

Companies upload their corporate
films
www.youtube.com

Sales Staff & PR

Sales staff often plays an important
role in word of mouth and Public
Relations

Public Relations
Public relations are where the
communication is not directly paid for and
includes press releases, sponsorship deals,
exhibitions, conferences, seminars or trade
fairs and events.
Word of mouth is any apparently informal
communication about the product by
ordinary individuals, satisfied customers or
people specifically engaged to create word
of mouth momentum.

Press Release
Press Release

Public Relations
Press Conferences

Media Entertainment

PR Material
Press kit to be given to press with all
info.

Press Conference
Spokesperson of the company talks
to the press

Client Meetings
Word of mouth publicity

Word of mouth
publicity
Word of mouth
is a reference to the passing of information from
person to person. Originally the term referred specifically to oral
communication but now includes any type of human
communication, such as face to face, telephone, email, and text
messaging

Salespersons

At meetings

Competitors
Responding to competitor activity &
messages
You may have seen similar activity in
cola ad wars

Reports in media
Cola war shifts to a new turf
The famous cola wars have found a new
battleground the Indian fields.
The worlds largest beverage company
Coca-Cola, like its rival PepsiCo, is
finalising plans for sourcing fruit from India
for its juice brands.

OOH
Cola vans act as OOH

OOH
Pepsi van

OOH
Cola signages

Vending Machines
Vending machine- Note both brands

Recognizable logos
Coke vs Pepsi

Sales Promotion
Yeh Dil Maange More!!!

Point of Sales
Point of sales (POS) or checkout refers to both
a checkout counter in a shop, and the location
where a transaction occurs

POS Display

Cola Ads-Promotion
Cola drinks- Thums Up, Coca Cola

Vodafone vs Airtel

Airtel

Telecom Ad- Messages

Airtel- Now Airtel removes
distances across India.
Vodafone- Happy to Help
Spice- Faltoo callers ki No Entry

Vodafone vs Airtel Ads

Signages
Celebrity endorsement

Reliance Telecom
Reliance

Reliance Mobile- Hritik

Reliance Mobile
Hritik Roshan

What an idea, Sirji

Walk when you talk

OOH- Idea Cellular

Idea Cellular
IDEAs ad campaigns based on the
theme of Democracy; Championing
a world without caste; Championing
a world in which no one suffers from
the disability to communicate; and
Education for All, have been a huge
success amongst all categories of
audience.

Effectiveness of Campaign
The testimony of the success of the
campaign is reflected from the rapid
growth of IDEAs subscriber base in
the country.
The Aditya Birla Group company has
grown to become the 3rd largest
private GSM operator with over 43
million subscribers across 16 service
areas, nationally.

Bus shelters
Same message across all media

Outdoor
Hoarding/Billboard

OOH
Signages & Gates

Brands using OOH

Amul

Mobile truck- OOH

Outdoor trucks with billboard

Trade Shows & Events

Trade Shows
Events

Wall paintings- Shutters

Websites

Airline Ad Wars
Marketers should be ready to face
communication challenges
Jet Airways- Weve Changed
Kingfisher- We made them change
Go Air- Weve not changed; we are
still the smartest way to fly

Ad wars
In Mumbai- Same
location on
Nariman Point

Viral Marketing- Word of

mouth
Viral marketing depends on a high passalong rate from person to person.
If a large percentage of recipients
forward something to a large number of
friends, the overall growth snowballs
very quickly.
If the pass-along numbers get too low,
the overall growth quickly fizzles.

On the internet
On the Internet, viral marketing is
any marketing technique that
induces Web sites or users to pass on
a marketing message to other sites
or users, creating a potentially
exponential growth in the message's
visibility and effect.

Hotmail- Viral Marketing

In 1996, Hotmail was a particularly unique email
service in that it was free, could be accessed
anywhere, and would allow the user to have multiple
accounts.
One of the interesting things Hotmail did was it would
attach the message "Get your free email at Hotmail" at
the bottom of every email sent by a Hotmail user.
Once the receiving user clicked on the word "Hotmail"
they were taken to Hotmail's homepage where the free
email service was further explained.
The plan, original at the time, worked. By 1998,
Hotmail had accumulated 12 million subscribers.
Hotmail eventually sold to Microsoft for a cool $400
million.

Definition- Viral Marketing

The buzzwords viral marketing and viral
advertising refer to marketing techniques that use
pre-existing social networks to produce increases in
brand awareness or to achieve other marketing
objectives (such as product sales) through selfreplicating viral processes, analogous to the spread
of pathological and computer viruses.
It can be word-of-mouth delivered or enhanced by
the network effects of the Internet.
Viral promotions may take the form of video clips,
interactive Flash games, advergames, ebooks,
brandable software, images, or even text messages.
The basic form of viral marketing is not infinitely
sustainable.

Going Viral

Funny
Helpful & Unique
Controversial
Amazing &
Spectacular

Schematic

Close to 35 million internet

users in India
According to Internet market research firm
comScore Inc. India had 34.6 million
Internet users (who access the Web from
their homes/offices) in June, of which at
least 65%, or 22.61 million, accessed
social networking sites.
These figures have meant that people
have kept launching new social sites in
India fuelled by the hype but success is
still far for them.

TShirts
T-Shirts
with company & Logo message
Inflated
Balloons
Scooter covers

MARKETING
Marketing is a process that
depends on customers needs &
demands. And needs & demands
are dynamic that changes time
to time so marketing definition
change according to time period.

Marketing definition
1 According to my opinion the best definition
of marketing.
Marketing is a process of identifying,
satisfying and retaining customers
profitably
2 According to American Marketing
Association new definition of marketing.
Marketing is the activity, set of
institutions, and
processes for creating,
communicating, delivering, and exchanging
offerings that have value for customers,
clients, partners, and society at large.

Marketing definition contd.

American marketing association old definition
for marketing.
Marketing is an organizational function and a
set of processes for creating, communicating,
and delivering value to customers and for
managing customer relationships in ways that
benefit the organization and its stakeholders.
Another definitionThe process of planning and executing the
conception, pricing, and distribution of ideas,
goods, and services to create exchanges that
satisfy individual and organizational
objectives.

ABOUT MARKETING
* The marketing process is central to the
business performance of companies, large
and small, because it addresses the most
important aspects of the competitive
marketplace.
* Its a bit of a mouthful, but it highlights that
the customer is at the heart of marketing,
and businesses ignore this at their peril.
* In essence, the marketing function is the
study of market forces and factors and the
development of a companys position to
optimise its benefits from them.

ABOUT MARKETING
It is all about getting the right product
or services to the customer at right
price, in the place, at the right time.
Both business history and current
practice remind us that without proper
marketing, companies cannot get
close to customers and satisfy their
needs. And if they dont, a competitor
surely will.

ABOUT MARKETING
successful marketing depends up on
addressing a number of key issues. These
include: What a company is going to produce
How much it is going to charge;
How it is going to deliver its products or
services to the customer;
How it is going to tell its customers about its
products and services.
These consideration is known as 7 ps of
marketing and it is also known as marketing
mix

ABOUT MARKETING
Marketing constitutes just one of the functions
available to every business. Along with
research, production, finance, accounting, and
a myriad of other functions, marketing
contributes to the ability of a business to
succeed.
There is a long-standing myth that marketing
is easy. But after knowing the concept of
marketing , you may conclude that marketing
is interesting, fun challengingeven vague-but
it is not easy.

About marketing

Marketing is most successful when the philosophy,

tasks, and manner of implementing available
technology are coordinated and complementary.
Find & keep customer is the main motive of
marketing.

Types Of Marketing
Different author divides marketing in
different way and here we are giving
details about in two way.
According to Tangibility, standardization,
storage, production, involvement.
1.Goods marketing ex- manufacturing
comapny
2.Services marketing- ex banking sector

Types Of
Marketing
According to nature
of
contact,
information, process
for purchasing
&
delivery.
Mass marketing exsony
Direct marketing-exmagazine
Internet marketingex- flipkart.com

According to
geographic area,
extent of
distribution, network,
marketing variation
commitment to
country.
1. Local marketing
2.Regional marketing
3.National marketing
4.International

Details About Types Of

Mass Marketing- Marketing
Mass marketing is distinguished from direct

marketing in terms of the distance between the

manufacturer and the ultimate user of the product. Mass
marketing is characterized as having wide separation and
indirect communication. A mass marketer, such as Nike, has
very little direct contact with its customers and must
distribute its product through various retail outlets alongside
its competitors. Communication is impersonal, as evidenced
by its national television and print advertising campaigns,
couponing, and point-of-purchase displays. The success of
mass marketing is contingent on the probability that within
the huge audience exposed to the marketing strategy.. there
exist sufficient potential customers interested in the product
to make the strategy worthwhile.

Details About Types Of

Marketing
Direct Marketing- Direct marketing establishes

a
somewhat personal relationship with the
customer by first allowing the customer to
purchase the product directly from the
manufacturer and then communicating with the
customer on a first-name basis. This type of
marketing is experiencing tremendous growth.
Apparently, marketers have tired of the waste
associated with mass marketing and customers
want more personal attention. Also, modem
mechanisms for collecting and processing
accurate mailing lists have greatly increased the
effectiveness of direct marketing.

Details About Types Of

Marketing
Internet Marketing - Internet marketing is
a type of direct marketing, it has evolved
so quickly and demanded the attention of
so many companies that a separate
section here is warranted. Essentially,
Internet technology (which changes by
the moment) has created a new way of
doing
business.
Flipkart.com,
Watchkart.com is the best example of ebusiness.

Marketing Mix & 4 ps

It is the same with
the marketing mix.
The offer you make to
your customer can be
altered by varying the
mix elements.
So for a high profile
brand, increase the
focus on promotion
and desensitize the
weight given to price

Marketing Mix
Customizing your offer to your customer
by varying the mix elements.
The Marketing Mix is like the artist's
palette.
The marketer mixes the prime colors
(mix elements) in different quantities to
deliver a particular final color.
Every hand painted picture is original in
some way, as is every marketing mix.

Extended Marketing Mix

Booms and Bitner
included three
additional 'Ps' to
accommodate trends
towards a service or
knowledge based
economy:
People
Process
Physical Evidence

The Marketing Mix

7Ps & 7Cs

The 7 Ps
Organisation
Facing

The 7 Cs
Customer Facing

Product = Customer/ Consumer

Price = Cost
Place = Convenience
Promotion = Communication
People = Caring
Processes = Co-ordinated
Physical Evidence = Confirmation

The Marketing Mix

The tools available to a business to gain
the reaction it is seeking from its target
market in relation to its marketing
objectives
7Ps Price, Product, Promotion, Place,
People, Process, Physical Environment
Traditional 4Ps extended to encompass
growth of service industry

PRICE

PRICE

A product is only worth what customers are prepared to

pay for it. The price also needs to be competitive, but
this does not necessarily mean the cheapest; the small
business may be able to compete with larger rivals by
adding extra services or details that will offer customers
better value for money. Your pricing must also provide
a profit. It is the only element of the marketing mix
that generate revenue, everything else represents a
cost.
Thinking of price as cost to the customer helps to
underscore why it is so important.
Price positions you in the market place the more you
charge, the more value or quality your customers will
expect for their money.
Existing customers are generally less sensitive about
price than new customers, a good reason for looking

Different parts of Pricing

Price Skimming An approach

under which a producer sets a
high price for a new high-end
product (such as an expensive
perfumes)
or
a
uniquely
differentiated technical product.
Its objective is to obtain maximum
revenue from the market before
substitutes products appear. After
that is accomplished, the producer
can lower the price drastically to
capture the low-end buyers and to
thwart the copycat competitors.

Penetration pricing - A
marketing strategy used by
firms to attract customers
to a new product or
service. Penetration pricing
is the practice of offering a
low price for a new product
or service during its initial
offering in order to attract
customers
away
from
competitors. The reasoning
behind
this
marketing
strategy is that customers
will buy and become aware
of the new product due to
its lower price in the

Different parts of
Pric pricing- Setting prices according
Psychological
to the psychographics of the aimed-at market
segment.
Cost-plus pricing- One method used by
businesses to determine how to price goods
and services. This type of pricing includes the
variables costs associated with the goods, as
well as a portion of the fixed costs of operating
the business.

Pricing Strategy
Importance of:
knowing the market
elasticity
keeping an eye
on rivals

PRODUCT

Promotion

PROMOTION

Way a company communicates what it does & what it

can offer customers.
It includes activities such as branding, advertising , PR,
corporate identity, sales management, special offers and
exhibitions.
Promotion must gain attention, be appealing, tell a
consistent message and above all else give the customer
a reason to choose your product rather than someone
elses.

Good promotion is not one-way communication, It

paves the way for dialogue with customers.
Promotion should communicate the benefits that a
customer obtains from a product, and not just the
feature of that product.
Whether your promotional material is a single sheet or
a complex brochure, folder or catalogue, it must grab

PROMOTIO
N- The activity or profession of producing
Advertising

information for promoting the sale of commercial

products or services.
Branding - An identifying symbol, words, or mark that
distinguishes a product or company from its
competitors. Usually brands are registered
(trademarked) with a regulatory authority & so cannot
be used freely by other parties. For many products and
companies, branding is an essential part of marketing.
Endorsement - A written or public statement by a
celebrity, business or professional group extolling the
virtues of a product and recommending the use of the
product to the public. A product endorsement from an
authoritative figure is a key element in business
advertising and marketing campaigns.
Competitive advantage promotion differentiate your

PROMOTIONS
A brochure isnt necessarily the best way of promoting
your business, the problem being that once a brochure
has been printed, the information is fixed. You cant
change or remove anything should the need arise. A more
cost effective and flexible option might be a folder with a
professionally designed sheet inside, over a series of your
own information sheets can be customized by varying
them to suit the target customers and/or changing them
as required.

Promotion does not just mean

communicating to your customers. It is just
as important to ensure your internal
stakeholder are aware of the value and
attributes of your products. This mean

PLACE

PLACE

The place where customers buy a product, and the

means of distributing your product to that place, must
be appropriate and convenient for the customer. The
product must be available in the right place, at the right
time and in the right quantity, while keeping storage,
inventory and distribution costs to an acceptable level.
Customer
surveys
have
shown
that
delivery
performance is one of the most important criteria
when choosing a supplier.

The means by which products and

services get from producer to consumer
and where they can be accessed by the
consumer

PLACE

Retail - A business or person that sells goods to the

consumer, as opposed to a wholesaler or supplier, who
normally sell their goods to another business. Or we can
say that selling directly to consumers.
Wholesaler - Person or firm that buys large quantity of
goods from various producers or vendors, warehouses
them, and resells to retailers. Wholesalers who carry only
non-competing goods or lines are called distributors.

Direct selling - Face to face presentation, demonstration,

and sale of products or services, usually at the home or
office of a prospect by the independent direct sales
representatives. Employed by firms such as Avon, Mary
Kay, & Tupperware, direct selling differs from network
marketing in that it offers little or no incentives for
recruiting ever increasing number of sales
representatives.

PEOPLE

PEOPLE
People represent the business
The image they present can be important
First contact often human what is the lasting
image they provide to the customer?
Extent of training and knowledge
of the product/service concerned
Mission statement how relevant?
Do staff represent the desired culture
of the business?

PROCESS

PROCESS
How do people consume services?
What processes do they have to go
through to acquire the services?
Where do they find the availability
of the service?

Contact
Reminders
Registration
Subscription
Form filling
Degree of technology

PHYSICAL EVIDENCE

PHYSICAL EVIDENCE
The ambience, mood or physical
presentation of the environment

Smart/shabby?
Trendy/retro/modern/old fashioned?
Light/dark/bright/subdued?
Romantic/chic/loud?
Clean/dirty/unkempt/neat?
Music?
Smell?

THE MARKETING MIX

Blend of the mix depends upon:

Marketing objectives
Type of product
Target market
Market structure
Rivals behaviour
Global issues culture/religion, etc.
Marketing position
Product portfolio
Product lifecycle
Boston Matrix

MARKET RESEARCH:
To determine:
Target Market
Market needs
Positioning and
strategy
New product
strengths and
weaknesses
Company strengths
and weaknesses
Packaging/ pricing

Focus Group M
To distill prod
Key promotio
Anticipate pr
resistances
Know strong
competition
Unfulfilled ne

PRELAUNCH:

Marketing Plan

Anticipated date of registration

approval
Update of SWOT analysis

Preparation of training materials

Field Force
Clinical trials or seeding trials
Materials t
Organization of scientific meetings
launch
Participation at regional
With self-te
congresses
Selection o
Final marketing plan
Hospital m
MD targeti

Incentive
Press Confe
plan
Final Launch Plan

LAUNCH:

Formulary kit
Launch letters to MDs,
Product monograph
pharmacists, et al.
Collection of key clin
Press relations
studies
Symposia
Seeding trials expan
Video news releases

Profiling target MDs

Press kit
Action plans per terr

DURING THE LAUNCH

PROGRAM:
Focus on Selling Skills
MD selection
Pre-call planning
Probing for needs
Features and benefits
Clinical studies
The effective use of the monograph

FOCUS ON SELLING SKILLS TO

SELL NEW PRODUCT:

Cost effectiveness
Handling objections
Handling competition
Ensuring that first trials are
successful
Group presentations

How to put the new product into the

hospital formulary
Doing a Hospital Action Plan
Presentations to nurses, pharmacists
Sampling allocation and plan

LAUNCH:
Medical Education Program
Patient Education Program
Gimmicks, posters, etc.

POST
LAUNCH:
Handling MD resistance

Post launch bulletin

Producing the Audio Cassette Training Program, Post
Launch Feedback
Revising plans
Celebrating successes
Selling tips
New ideas to reinforce messages
Analyze effec
Interviewing happy users of new product
How to respond to Reps questions
effectiveness

Analyze comp
Market and p
Handling MD

NEW PRODUCT LAUNCH

(Tactics)
The success of a new product launch
depends largely on the planning and
preparation you invest in the launch of
your new product.
Proper planning, preparation and
practice
prevent poor performance.
- Perri

Drug Discovery &

Development
Process




.

J.S.K. NAGARAJAN

Pharmacy
pharmacy/(fahrmahse):
Branchofthehealthsciencesdealing
withthepreparation,dispensing,&pr
operutilizationofdrugs.

DRUG

J.S.K. NAGARAJAN

Drug Discovery & Development

Process
Drug:

Substance used in the

diagnosis, treatment, or
prevention of a disease or

J.S.K. NAGARAJAN

as a component of a
medication
Any chemical or biological
substance,
synthetic
or
non-synthetic

Drug Discovery & Development

Process
Why are new drugs needed?
Unmet Medical Need;

New Diseases (H1N1; AIDS, Alzheimers; obesity);

Low efficacy (dementia, cancer);
Side effects (antidepressants, antipsychotics)

Downstream health costs: Alzheimers; spinal

injury.

Cost of therapy; (Viagra, Interleukins).

Costs to individual/country: (depression).
Sustain industrial activity: pharma. industry
employs thousands and makes a massive
contribution to overseas earnings); patent

Drug Discovery & Development

Process

Lessons & development

Refine parts of treatment giving problems: (dose
interval? side effects? effective? niche market?)
Extend Usage : eg. PROPRANOLOL (beta adrenoceptor
blocker)
Antidysrhythmic >>> antianginal >>> antihypertensive
>>> relieve hyperthyroid symptoms >>>
antihypertensive with diuretic >>> prolonged release
formulation precipitate asthma attack > beta1 selective
-- ATENOLOL
J.S.K. NAGARAJAN

Drug Discovery & Development

Process
Approaches to drug discovery
Historical: Cinchona

(quinine) & willow barks (aspirin).

Study disease process;

Study

breast cancer (tamoxifen); Parkinsons disease

(L-dopa)
.
biochem/physiological pathway; renin/angiotensin

Develop SAR to natural compound;

beta-adrenoceptors

(propranolol), H2-receptors (cimetidine)

Design to fit known structurally identified biological site:

angiotensin-converting enzyme inhibitors

By chance (serendipidy):Random screening (HTS):

penicillin;
dimenhydramate; pethidine

Genomics;
materials;

identification of receptors; gene therapy; recombinant

DRIVER IS UNMET MEDICAL NEED IN A VIABLE MARKET

Drug Discovery & Development

Process

The changed context of drug discovery and developm

1800s

1990s

Natural Sources

Synthetic Souce

Limited possibilities

Unlimited Possibilities

Prepared by individuals

Prepared by Companies

Small Scale

Massive scale

Not purified, Standardised/ Tested

Highly Purified, standardised &

Tested

Limited Administration

World wide admin

No Control

Tight legislative Control

No idea of mechnism

Partly Mechanism understood

Drug Discovery & Development

Process

J.S.K. NAGARAJAN

Drug Discovery & Development

Process
Sources of drugs
Animal

insulin (pig, cow)

growth hormone (man) (Creutzfeldt-Jakob)

Plant

digitalis (digitalis purpurea - foxglove)

morphine (papaver somniferum)

Inorganic

arsenic mercury
lithium

Synthetic

chemical (propranolol)
biological (penicillin)
biotechnology (human insulin)

J.S.K. NAGARAJAN

Drug Discovery & Development

Process
Choosing a

Disease

Pharma. companies are commercial enterprises

Pharma. companies avoid products with small
market (i.e. a disease which only affects small
subset of population)
Pharma. companies -also avoid products that
would be consumed by individuals of lower
economic status (i.e. a disease which only affects
third world countries)
Most research is carried out on diseases which
afflict first world countries: (e.g. cancer,
cardiovascular diseases, depression, diabetes,
flu, migraine, obesity).

What costs what in Leeds? (GPs; 98/99)

Omeprazole (anti-gastric acid)

3.5m
Simvastatin (cholesterol lowering) 2.4m
Beclomethasone (asthma)
1.8m
Fluoxetine (antidepressant)
1.5m
Lansoprazole (anti-gastric acid)
1.4m
Ranitidine (anti-gastric acid)
1.3m
Paroxetine (antidepressant)
1.2m
TOP 7 TOTAL
>13m
Total GP drugs for Leeds
>67m

J.S.K. NAGARAJAN

Finding the Lead

Lead compound = structure that has some activity
against the chosen target, but not yet good enough to be
the drug itself.
If not known, determine the structure of lead compound
Screening synthetic banks
Pharma. companies have prepared thousands of compounds.
Stored , cataloged & screened on new targets as these new
targets are identified
Using Someone Elses Lead
Design structure which is similar to existing lead, but different
enough to avoid patent restrictions.
Sometimes this can lead to dramatic improvements in biological
activity and pharmacokinetic profile. (e.g. modern penicillins are
much better drugs than original discovery).
O
H2N

Enhance a side effect

NH2

sulphanilamide
(anantibacterialwiththesideeffectof
loweringglucoselevelsinthebloodandalso
diureticactivity)

Cl
S

NH

NH

tolbutamide
(acompoundwhichhasbeenoptimizedtoonly
lowerbloodglucoselevels.Usefulinthetreatment
ofTypeIIdiabetes.)

O
H2N

NH

S
O

Chlorothiazide
(acompoundwhichhasbeenoptimizedtoonlydisplaydiuretic
activity.)

Use structural similarity to a natural ligand

NH2

HO

N(CH3)2

H3C
N
H

5Hydroxytryptamine(5HT)
Serotonin(anaturalneurotransmitter
synthesizedincertainneuronsintheCNS)

J.S.K. NAGARAJAN

H
N

S
O O

N
H

Sumatriptan(Imitrex)
Usedtotreatmigrainheadaches
knowntobea5HT1agonist

Finding a Lead
(cont.)

Sildenafil (compound UK-92,480) - synthesized at Pfizer's Sandwich,

Kent, UK.
Initially studied for use in hypertension (high BP) & Angina Pectoris .
Phase I clinical trials under the direction of Ian Osterloh suggested
that the drug had little effect on angina, but that it could induce
marked penile erections.
Pfizer therefore decided to market it for erectile dysfunction, rather
than for angina.
Patented in 1996, approved for use in erectile dysfunction by FDA on
March 27, 1998, becoming the first pill approved to treat erectile
dysfunction in the US, & offered for sale in the US later that year.
Great success: annual sales of Viagra from 19992001 exceeded $1
billion.
O
N

N
NH

S
O

J.S.K. NAGARAJAN

viagra
(Sildenafil)

Determine toxicity and efficacy in

animal models.

Determine PD & PK of the drug.

Pharmacodynamics - drug does to the body
Pharmacokinetics -body does to the drug.
J.S.K. NAGARAJAN

 Patent the drug

Continue to study drug metabolism
Continue to test for toxicity
J.S.K. NAGARAJAN

 Design a manufacturing process

Carry out clinical trials
Market the drug

Under this law, companies who

develop such a drug are entitled
to market it without competition
for seven years.
This is considered a significant
benefit, since the standards for
patent protection are much more

Identifying a Drug Target

Drug Target = specific macromolecule, or biological
system, which the drug will interact with
Sometimes this can happen through incidental
observation

Eg:Toinhibittheuptakeofnoradrenaline,theoldertricyclic
antidepressantswereobservedtoincidentallyinhibitserotonin
uptake.
Thus,itwasdecidedtopreparemoleculeswhichcouldspecifically
inhibitserotoninuptake.Itwasntclearthatthiswouldwork,butit
eventuallyresultedintheproductionoffluoxetine.
HO

NH2

CH3

H3C

Imipramine
(aclassicaltricyclicantidepressant)

J.S.K. NAGARAJAN

N
H

serotonin

F3C

HN
O

prozac

Simultaneously, Chemistry is Improving!

Plants & natural sources not provides the cures to all diseases.
Combinatorial Chemistry large numbers of compounds can
be prepared at one time.
Efficiency of synthetic chemical transformations is improving.

Selectivity is Important!
e.g. targeting a bacterial enzyme, which is not present in
mammals, or which has significant structural differences from
the corresponding enzyme in mammals

Standards are Being Raised

More is known about the biological chemistry of living systems

For example: Targeting one subtype of receptor may enable
the pharmaceutical chemist to avoid potentially troublesome
side effects.

Problems can arise

Eg: The chosen target, may over time, lose its sensitivity to the drug
Eg: Penicillin-binding-protein (PBP) known to the the primary target of
penicillin in the bacterial species Staphylococcus aureus has evolved a
mutant form that no longer recognizes penicillin

Computer-Assisted Drug Design

If one knows the precise molecular structure of the target
(enzyme or receptor), then one can use a computer to
design a perfectly-fitting ligand.
Drawbacks: Most commercially available programs do not
allow conformational movement in the target (as the ligand
is being designed and/or docked into the active site).
Serendipity: a chance occurrence

Must be accompanied by an experimentalist who

understands the big picture (and is not solely focused on
his/her immediate research goal), who has an open mind
toward unexpected results, and who has the ability to use
deductive logic in the explanation of such results.
Example: Penicillin discovery
Example: development of Viagra to treat erectile dysfunction

SAR
Once a lead has been discovered, it is important to
understand precisely which structural features are
responsible for its biological activity (i.e. to identify
the pharmacophore)
This may enable one to prepare a more active molecule
This may allow the elimination of excessive
functionality, thus reducing the toxicity and cost of
production of the active material
This can be done through synthetic modifications
Example: R-OH can be converted to R-OCH3 to see if
O-H is involved in an important interaction
Example: R-NH2 can be converted to R-NH-COR to see
if interaction with positive charge on protonated amine
is an important interaction

J.S.K. NAGARAJAN

Next step: Improve PK

Properties

Improve pharmacokinetic properties.

pharmacokinetic = The study of absorption, distribution,
metabolism and excretion of a drug (ADME).
exercise=MedicationDistribution&title=Medication
%20Absorption,%20Distribution,%20Metabolism%20and
%20Excretion%20Animation&publication_ID=2450

Metabolism of
The body regards
drugs as foreign substances, not
Drugs
produced naturally -referred to as xenobiotics
Body has goal of removing such xenobiotics from system
by excretion in the urine
The kidney is set up to allow polar substances to escape in
the urine, so the body tries to chemically transform the drugs
into more polar structures.
Phase 1 Metabolism involves the conversion of nonpolar
bonds (eg C-H bonds) to more polar bonds (eg C-OH
bonds).
Key enzyme is the cytochrome P450 system, which
catalyzes this reaction:
RH + O2 + 2H+ + 2e ROH + H2O

Phase I metabolism may

either detoxify or toxify.

Phase I reactions produce a more polar molecule that is

easier to eliminate.
Phase I reactions can sometimes result in a substance
more toxic than the originally ingested substance.
Eg: Phase I metabolism of acetonitrile

The Liver

Oral administration frequently brings the

drugs (via the portal system) to the liver

Metabolism of Drugs
(cont.)
Phase II metabolism links the drug to still more polar

molecules to render them even more easy to excrete

UDPGlucuronicAcid

O
HO

O
O

HO

HO

GlucuronicAcid

O
P

O
NH

HO
HO

glucuronosyltransferase
enzyme

Drug

HO

OH

OH

HO

OH
OH

OH

MoreeasilyexcretedthanROHitself
R

OH

Drug

Another Phase II reaction is sulfation (shown below)

NH2
O
O
R

OH

S
O-

O
O

O-

N
N

SO3
R

Drug
O
O

OH
O-

O-

3'Phosphoadenosine5'phosphosulfate

SulfatedDrug
(moreeasilyexcreted)

Phase II
Metabolism

Phase II reactions most commonly detoxify

Phase II reactions usually occur at polar sites,
like COOH, OH, etc.

Manufacture of Drugs

Pharmaceutical companies must make a profit to continue to

exist
Therefore, drugs must be sold at a profit
One must have readily available, inexpensive starting materials
One must have an efficient synthetic route to the compound
As few steps as possible
Inexpensive reagents

 The route must be suitable to the

scale up needed for the
production of at least tens of
kilograms of final product
This may limit the structural
complexity and/or ultimate size (i.e.
mw) of the final product
In some cases, it may be useful to
design microbial processes which
produce highly functional,
advanced intermediates. This type
of process usually is more efficient
than trying to prepare the same
intermediate using synthetic
methodology.

Toxicity
Toxicity standards are continually becoming
tougher
Must use in vivo (i.e. animal) testing to
screen for toxicity
Each animal is slightly different, with different
metabolic systems, etc.
Thus a drug may be toxic to one species and not
to another

Example: Thalidomide
Thalidomide was developed by German pharmaceutical
company Grnenthal. It was sold from 1957 to 1961 in
almost 50 countries under at least 40 names.
Thalidomide was chiefly sold and prescribed during the
late 1950s and early 1960s to pregnant women, as an
antiemetic to combat morning sickness and as an aid to
help them sleep. Before its release, inadequate tests were
performed to assess the drug's safety, with catastrophic
results for the children of women who had taken
thalidomide during their pregnancies.

Antiemetic = a medication that helps prevent

and control nausea and vomiting

Birth defects caused by use of

thalidomide
1956 to 62 - 10,000 children born with severe malformities, including
phocomelia, because their mothers had taken thalidomide during
pregnancy.
In 1962, in reaction to the tragedy, the US Congress enacted laws
requiring tests for safety during pregnancy before aO drug can receive
approval for sale
in the U.S.
Researchers,
however,
continued to work with the drug. Soon after
N

NH
its banishment, an Israeli doctor discovered anti-inflammatory
O
effects of thalidomide and began to look for usesO of the medication
Thalidomide
despite its teratogenic effects.

He found that patients with erythema nodosum leprosum, a painful

Phocomelia presents at birth very short or absent long bones and
skin
condition
associated
with leprosy,
experienced
flipper-like
appearance
of hands
and sometimes
feet. relief of their
pain by taking thalidomide.
Teratogenic = Causing malformations in a fetus
Further work conducted in 1991 by Dr. Gilla Kaplan at Rockefeller
University in New York City showed that thalidomide worked in
leprosy by inhibiting tumor necrosis factor alpha. Kaplan partnered
with Celgene Corporation to further develop the potential for
thalidomide.
Subsequent research has shown that it is effective in multiple

Clinical
testing

{Phase 0 (non-clinical)}
Phase 1 (volunteers)
Phase 2 (patients)
Phase 3 (large scale multi-centre)
Phase 4 (post registration monitoring)

Clinical Trials- Phase I

Drug is tested on healthy volunteers to determine toxicity
relative to dose and to screen for unexpected side effects..
Small group of people (20-80)
HEALTHY VOLUNTEERS
INFORMED CONSENT
EVALUATE ITS SAFETY
COMMON SIDE EFFECTS
Fatigue, nausea, hair loss,
vomiting
IDENTIFY SIDE EFFFECTS
Determine safe dosage range
0.5-1.5 YEARS
ETHICAL APPROVAL
SINGLE & REPEAT DOSE
Full Rescussitation + Medical Backup + Monitor

Volunteer studies (phase I trials)

OBJECTIVES
metabolic and excretory pathways
(impinges on toxicity testing in animals)
variability between individuals; effect of
route; bioavailability
tolerated dose range
indication of therapeutic effects
indication of side effects

Clinical
trials

Drug action depends on:

pharmacodynamics
pharmacokinetics and dose regimen
drug interactions
receptor sensitivity of patient
mood/personality of patient & doctor
patients expectations and past experience
social environment of patient
clinical state of patient
Clinical trial controls these variables and examines
action of drug in defined set of circumstances

Clinical trials
controlled or uncontrolled
open or blind
parallel
sequential
crossover

A
B
A

A
B

A
B

others:-- matched pairs; combinations; ++

Pharmacokinetics
How drug is:
Absorbed
Metabolized
Excreted
Duration of action

Clinical Trials- Phase

II small group of patients to see if drug has any
Drug is tested on
beneficial effect and to determine the dose level needed for
this effect.

Larger Group of People (100300)

PATIENTS

INFORMED CONSENT

EFFECTIVENESS

EVALUATE ITS SAFETY

MAXIMUM MONITORING

DOSAGE

FULL RESCUSSITATION

TYPE OF PATIENT

INDICATION FOR USE

SEVERITY OF DISEASE

DOSE RANGE

PK STUDIES IN ILL PEOPLE

SCHEDULE & INCREMENT

NATURE OF SIDE EFFECTS & SEVERITY; EFFECTS IN SPECIAL GRUOPS

Clinical Trials- Phase III

Drug is tested on much larger group of patients and compared
with existing treatments and with a placebo
1500-3500 Patients
Multicentre
More certain data for the
objectives of phase 2
Interactions
between drugs
studies
start to become measurable
in the larger population
sub-groups start to be
established
special features and
problems show up
Monitor side effects
Confirm its effectiveness
Drug Vs Placebo

Placebo effect: measur

patients dont know if o
Patient feels better eve
Often seen with anti
antianxiety meds

Launch Drug after PIII

Clinical
Trials
Phase
IV: Drug is placed on the market and
patients are monitored for side effects

Refinement of
compounds
Can it be improved? selectivity; duration;
route of administration; stability, isomers,
ease of preparation.
Can it be patented? costs 250m; takes 814 years; high risk business.

USE iterative approach

Cause

Cause

Cause

Cause

Cause

Drug Development
Process

Discovery Process
Pre-Clinical

Search Public Genome Databases for similar (homologous)

sequences to original ACE gene

Take these snippets and hybridize with genetic material from different tissues
Matches LIGHT up.
Clone the genes that light up

Find chemical which inhibits this enzyme

DRUG CANDIDATE

Animal Studies
(preclinical studies)

Some considerations

Look at safety in animals large doses and

long term
Chronic long term- asthma, hypertension
(need to take drug for life)
Acute short term for short term illness
(e.g., bacterial infection, take antibiotic for
10 days)

Animal Models
Knockout Mice
disrupt gene by deliberate mutation gene blocked at embryo stage
Problems Animals may not get disease we get (HIV)
Model does not mimic human condition (good model athero and pigs)
PETA people for the ethical treatment of animals

Clinical Trials
IND components Goes into effect after 30 days if FDA says
nothing
Previous experiments
Chemical structure
Toxicity in animals

Purpose

Is drug SAFE AND EFFECTIVE???

Predict Toxic Effects
Determine Safe Dosage
Determine efficacy (effectiveness)

Participant in trial

Entry criteria age, sex, smoking status, other meds

Big cities
Sign a consent form
Voluntary can withdraw anytime
Confidentiality
Often paid

Phase IV
after the drug or treatment has been marketed
collect information about their effect in various populations
side effects associated with long-term use.
New indications: impt for company to extend its patent protection.
Eg. Prozac antianxiety, approved recently for PMDD (premenstrual dysorphic
disorder)

Issues

Pharmacokinetics
how quickly drug is absorbed
eliminated from body (clearance)
Delivery Problem injection vs. oral delivery
Do patients develop tolerance?
Pharmacogenetics
Interfere with meds for other diseases eg. Lower bp
but interfere with med for type II diabetes

Placebo

Discovery:
GLP
When dont you use a placebo?
Development:
Drug available already to treat diseaseGMP
SOP
Unethical to use placebo
Documentation,

Drug discovery/development
process
discovery; refinement; chemical &
biological
characterisation
safety & toxicity in animals; formulation development

volunteer studies; patient studies

lessons
&
development

post registration
monitoring

regulatory process
marketing

Discovery=find new active structure : Development=convert it to a useful drug

Refinement of compounds
Can it be improved? selectivity; duration;
route of administration; stability, isomers,
ease of preparation.
Can it be patented? costs 250m; takes 814 years; high risk business.

USE iterative approach

Levels of testing
DRUG + receptor + transduction
system (second
BINDING
functional
messenger; enzyme)
whole or
BIOCHEMICAL TESTING
part organs

ISOLATED TISSUE EXPERIMENTS

Anaesthetised or
conscious animals

WHOLE ANIMAL EXPERIMENTS

Animal models of
efficacy
Existing normal behaviours/effects (anaesthesia;
contraception; paralysis)
Create behaviours (fat rats; hypertensive rats; anxious
rats; epileptic rats)
Find unrelated behaviour affected by existing drugs
(Straub tail for narcotic analgesics; learned helplessness
for antidepressants)
How predictive is the model?
exact replica = 100% predictor
mechanism same = good predictor
mechanisms different = poor predictor

Animal models
predictive for efficacy AND toxicity?
expensive; time consuming; variable; uncertain; troublesome;
ethical questions; skilled workers
legislative control
Animal (Scientific Procedures) Act (1986)
PERSONAL LICENCE - competent, trained, procedures
specified
PROJECT LICENCE - allows a personal licence holder to carry
out specified procedures for a specified project that cannot be
done without animals and where severity justifies likely gain.

GET INTO MAN EARLY

RRR

Reducing animal
usage
About 2.6m animals/y used in procedures in UK (11.6m in Europe)
Likely to increase; more research, more targets, genetic capability

3Rs -- 3Rs -- 3Rs

REPLACEMENT: use non-animal tests if possible (cheaper, less
trouble, less variable but not possible for everything at this time)
REDUCTION: get the statistics right, dont replicate work
unnecessarily, dont overbreed
REFINEMENT: reduce suffering and severity of procedure, pay
attention to housing, stress, husbandry and rich environments,
proper analgesia and pre- and post- operative care

Chemical and
biological
characterisation
CHEMICAL; structure, synthesis, purity,
isomers, pKa, stability, solubility, salts, assay
BIOLOGICAL; acute pharmacological profile LD50, ED50, binding data for many receptors,
dose-effect relationships, open field tests,
particular tests for different activities (e.g.
CVS, CNS, GI tract)
Both positive and negative information is useful.

Safety & toxicity in

animals
Acute toxicity profile
Chronic toxicity profile
-- 14 day toxicity test in one rodent and one non-rodent
species before use in man.
-- 3 month study read out at 28 days
-- longer studies (12 & 24 month)
Three dose levels (below, about, well above human dose).
It is insufficient to to use doses which are not toxic; the
doses producing toxic effects and the nature of these
effects MUST be established.

Formulation studies
DRUG +
Additive: filler, lubricant, coating, stabiliser,
colour, binder, disintegrator
Dosage form: capsule, tablet, injection, other?
Manipulate duration/profile: e.g. sustained
release
Bioequivalence
Bioavailability
Ease of use

The Regulatory process

differs from country to country

demands safety and quality of product
encourages efficacy and need for product
grants clinical trials certificate if volunteer and animal data OK
approves protocols and examines data
50-400 volumes (30,000-150,000 pages)
original data available
two way process; authority and company trying to produce a
safe effective product
release for a specific purpose and use

Marketing
getting the product right (packaging;
formulation)
right therapeutic slot
information on new drug
information for honest comparison
reporting problems
reporting new indications
therapeutic trends

Post-registration monitoring
YELLOW CARD SYSTEM: voluntary reporting of
adverse effects by GP to Committee on Safety
of Medicines; easy; effective?
INTENSIVE MONITORING OF DEFINED GROUP:
first 10,000; administrative nightmare as
patients move/die; costly; time-consuming.
RESTRICTED RELEASE: only available to small
group of GPs; monitor their patients; elitist
MONITOR INCIDENCE OF DISEASE PROBLEM:
difficult to identify cause of change .

No medicine is necessary for him who eats after assuring (himself)

that what he has (already) eaten has been digested..

. , , J.S.S. ,

Thank Y
ou