This document provides a confidential local brand plan for Zelmac in the Middle East region for 2004. It includes a market analysis, SWOT analysis, segmentation of consumer and physician targets, competitive analysis, and patient flow summary. The brand strategy aims to rapidly penetrate and expand several IBS markets in the region through a symptom-based approach and investments in patient education and public relations to increase disease awareness. Key activities for 2004/05 include launching to primary care physicians in all markets and building a key opinion leader base.
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2
Zelnorm C4 Brand Plan – Executive Summary
• Vision
• Establish, grow and sustain market leadership in GI disorders including IBS,
CC, Dyspepsia and GERD* (combination treatment)
• Positioning
In IBS-C, Zelmac is the most effective first line Rx treatment for
abdominal pain, bloating, constipation (ABCs) because it is the only
drug that regulates motility, visceral sensitivity, and intestinal
secretion throughout the GI tract
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Zelnorm C4 Brand Plan – Executive Summary
• Brand Strategy
• Symptom based approach to rapidly penetrate & expand several IBS markets in the ME region
• Ensure a positive re-enforcement by GI segment
• Expand to “potential “ PCP and help diagnose
• Invest in patient education and utilize PR to familiarize public with the condition and
availability of new treatment
• Top activities in 04/05
• Launch to PCP audience in all ME markets
• Build KOL base by involving them in PCP education and PR activities
• Ensure an disease education and PR coverage on brand create a call for action at
patient level
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Private Market IBS: Total ME Value 26.086 (000) USD Growth:
+10.2%
0
2,000
4,000
6,000
8,000
10,000
12,000
14,000
2002 2003 2004(est.)
KSA
UAE
Leb
Jor
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Market Overview
rom limited market research in the area and focus groups conducted in 2003/2004
We are aware that:
BS is the number #1 condition for visits at the GI clinic
octors do not consider the syndrome as “serious”
diagnosis of exclusion is used in most cases rather than positive diagnosis
atients indulge in “doctor shopping” to solve their problems
evel of satisfaction with traditional therapy is relatively high in some markets -
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Consumer Segmentation & Targets
Extremely Bothered &
Dissatisfied
Socially Inhibited/
Low Esteem
Open & Pro-ActivePositive Natural
Treater
Dr./Rx Avoider
Live With It
Source: adapted from global WW Plan
•Target Segments
• Women/ men age 30-50
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Physician Segmentation & Targets
Frustrated &
Dissatisfied
22%
Empathetic
18%
Lifestyle Treater
23%
Live With It
18%
Out Of Touch
19%
Source: Lieberman Research Inc., August 2000
•Target Segments
• GI segment is the primary
target
•PCP is the secondary and
includes IM/ FM , GP and
GYN
Zelmac/Zelnorm Global IBS Brand Book: Feb 04
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Drivers of Prescribing Behavior
• GE specialists are the driving force behind prescription*
• Self medication is generally high§
• Inclusion in Social Security/ insurance affects physicians choices
• Level of satisfaction with fibers and antispasmodics is generally high – this is
linked to a high loss of patients to follow up, they do not get feedback when
treatment fails
• Traditional therapies are used as first line treatment in most cases this is
because they are ingrained in physicians’ mind as the standard of care,
perceived as safe, and inexpensive
• Pharmacists dispense cheap brands OTC and influence patients of lower
socio-economic class who seek their advise
*Pharmacy feedback and load estimates
§Market research – IPSOS Lebanon
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Key Planning Assumptions: KSA
• Positive uptake from GI segment/ support and buy-in
• No exclusion from the National Insurance List due to relative price
• PR creates public demand – patients gain awareness on availability of new
drug on the market
• Introduction in Governmental sector in 2005
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Key Planning Assumptions: Levant
• Positive uptake from GI segment/ support and buy-in
• Inclusion in Social Security in Lebanon
• Improved Zelmac’s value proposition (Exp. From Global data)/ cost
effectiveness data
• PR creates public demand – patients gain awareness on availability of new
drug on the market
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Market share (%)
0
2
4
6
8
10
12
14
Duphalac 10.9 12 11
Duspatalin 12.2 9 9
B uscopan 9.6 7 7
Dulcolax 6.6 6 7
Zelmac 0 0 3
Mat June 02 Mat June 03 Mat June 04
Market Share & Share of Voice: Lebanon
SOV( %)
0
0.05
0.1
0.15
0.2
0.25
0.3
0.35
Dulcolax 19.3% 19.6%
Dusptalin 25.0% 33.0%
Duphalac 17.0% 17.0%
B uscopan 8.0% 9%
Zelmac 0.0% 22.00%
MAT/June 03 MAT June 04
•Solvay is by far the most established in the Market with two brands they hold position 1 and 2
•Highly fragmented market and most drugs are OTC /used in other indications
•SSRI are widely promoted in IBS- not considered in the Market Place
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19Source of Business
From Where Do We Gain & to Whom Do We Lose Patients
• Main Business today comes from GI specialists – decision is made based on disease severity and sensitivity to price
• The main reason for loss of Rx is price followed by the natural tendency of IBS patients to stop medications (waxing and waning nature)
• We loose patients either to no therapy or cheaper alternatives ( Duspatalin , Librax, etc) that are given off the counter-
• Source: local panel as available
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Competitor Analysis Summary
Products
Key Messages
Antipsamodics:Dicetel/Duspatalin
Laxatives:non-soluble
DigestiveEnzymes
TricyclicAntidepressants
SSRI:Cipram
Prozac
Laxatives
Effective on all the pain and bloating
Effective on BM’s and consistency
Safe and tolerable
Convenient NA
Improves overall well- being
Compelling
and extensive
evidence
Clear
and extensive
evidence
Clear but
non extensive
evidence
Negative
evidence
Weak
or fragmented
evidence
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Perceived Differential Advantage Analysis
Product Differential
advantage
Current gap/ perception Ability to Influence
Works on all three
symptoms (ABC)
A large proportion of MD’s feel
that they have to focus on the
most annoying symptom and
treat, most int. guidelines
support the approach
Medium
Works on the underlying
reason for the condition
Support for effect on pain is
weak and complicated
Medium
Safe Last FDA update has caused
some doubts on safety
High
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ME – Patient Flow Summary (Part I)
80,000 IBS80,000 IBS
C-IBSC-IBS
80,000 IBS80,000 IBS
C-IBSC-IBS
50,000 pts50,000 pts
D-IBSD-IBS
50,000 pts50,000 pts
D-IBSD-IBS
175,000175,000
Seek medicalSeek medical
HealthHealth
175,000175,000
Seek medicalSeek medical
HealthHealth
525,000525,000
Do not seekDo not seek
MedicalMedical
healthhealth
525,000525,000
Do not seekDo not seek
MedicalMedical
healthhealth
150,000 pts150,000 pts
AlternativeAlternative
MedicineMedicine
150,000 pts150,000 pts
AlternativeAlternative
MedicineMedicine
150,000150,000
ConsultConsult
pharmacypharmacy
150,000150,000
ConsultConsult
pharmacypharmacy
700,000700,000
patientspatients
Aware of IBSAware of IBS
700,000700,000
patientspatients
Aware of IBSAware of IBS
700,000700,000
PatientsPatients
unawareunaware
700,000700,000
PatientsPatients
unawareunaware
1.4 mio1.4 mio
Potential FPotential F
patientspatients
1.4 mio1.4 mio
Potential FPotential F
patientspatients
9.37 mio9.37 mio
FemalesFemales
9.37 mio9.37 mio
FemalesFemales
11.9 mio11.9 mio
MaleMale
11.9 mio11.9 mio
MaleMale
IBS proneIBS prone
PopulationPopulation
In MEIn ME
(adult(adult
population)population)
IBS proneIBS prone
PopulationPopulation
In MEIn ME
(adult(adult
population)population)
600,000600,000
potential ptspotential pts
600,000600,000
potential ptspotential pts
21.1 mio
Adults
45,000 pts45,000 pts
A-IBSA-IBS
45,000 pts45,000 pts
A-IBSA-IBS
GE
GP
FM/ IM
225,000225,000
Suffer inSuffer in
SilenceSilence
225,000225,000
Suffer inSuffer in
SilenceSilence
120,000120,000
DrugDrug
TreatedTreated
120,000120,000
DrugDrug
TreatedTreated
30,00030,000
ReferredReferred
To DocsTo Docs
30,00030,000
ReferredReferred
To DocsTo Docs
All CPO’s major countries included:
KSA,UAE,Lebanon, Jordan, Kuwait
Key GO
Secondary GO
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80,000 IBS80,000 IBS
C-IBSC-IBS
80,000 IBS80,000 IBS
C-IBSC-IBS
50,000 pts50,000 pts
D-IBSD-IBS
50,000 pts50,000 pts
D-IBSD-IBS
45,000 pts45,000 pts
A-IBSA-IBS
45,000 pts45,000 pts
A-IBSA-IBS
50,00050,000
DiagnosedDiagnosed
50,00050,000
DiagnosedDiagnosed
30,00030,000
Mis-Mis-
diagnoseddiagnosed
30,00030,000
Mis-Mis-
diagnoseddiagnosed
40,000 Drug40,000 Drug
TreatedTreated
40,000 Drug40,000 Drug
TreatedTreated
10,000 No10,000 No
DrugDrug
ManagementManagement
10,000 No10,000 No
DrugDrug
ManagementManagement
15,00015,000
satisfiedsatisfied
With currentWith current
MedicationMedication
15,00015,000
satisfiedsatisfied
With currentWith current
MedicationMedication
25,000 dis25,000 dis
Satisfied dueSatisfied due
To efficacyTo efficacy
Or tolerabilityOr tolerability
25,000 dis25,000 dis
Satisfied dueSatisfied due
To efficacyTo efficacy
Or tolerabilityOr tolerability
Antispamodics
Laxatives
Antiflatulents
SSRI/ TCA
4,000 Seek4,000 Seek
Other medicalOther medical
OpinionOpinion
4,000 Seek4,000 Seek
Other medicalOther medical
OpinionOpinion
4,0004,000
Do not seekDo not seek
OtherOther
opinionopinion
4,0004,000
Do not seekDo not seek
OtherOther
opinionopinion
ME – Patient Flow Summary (Part II)
15,000 seek15,000 seek
OtherOther
MedicalMedical
opinionopinion
15,000 seek15,000 seek
OtherOther
MedicalMedical
opinionopinion
10,000 do10,000 do
No SeekNo Seek
Other medicalOther medical
OpinionOpinion
10,000 do10,000 do
No SeekNo Seek
Other medicalOther medical
OpinionOpinion
6,0006,000
CompliantCompliant
6,0006,000
CompliantCompliant
9,0009,000
Non-Non-
compliantcompliant
9,0009,000
Non-Non-
compliantcompliant
10,000 pts10,000 pts
Re-seekRe-seek
MedicalMedical
opinionopinion
10,000 pts10,000 pts
Re-seekRe-seek
MedicalMedical
opinionopinion
20,000 pts20,000 pts
Do notDo not
re-seekre-seek
MedicalMedical
opinionopinion
20,000 pts20,000 pts
Do notDo not
re-seekre-seek
MedicalMedical
opinionopinion
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SWOT Analysis
Strengths
• Evidence of efficacy on multiple symptom relief – 3
symptoms / 1 drug for the treatment of IBS
• Only product to demonstrate some evidence for effects on
bloating
• Rapid onset of effect
• MoA linked to pathophysiology of IBS
• Partial agonist – reduces risk of extreme SE
• High level of patient satisfaction once treated
• Good safety and tolerability profile lack of SAEs
• safety in D-IBS demonstrated
Weaknesses
• Perceived safety concerns related to delay in FDA approval
• Weak evidence to link MoA to pathophysiologyy of IBS
• Weak evidence in abdominal pain and bloating
• High placebo response rates in studies
• Marginal efficacy delta from placebo
• perceived poor risk/benefit
• Limited evidence in males and IBS-A
• Limited evidence in alternators
• Lack of active comparator data
Opportunities
• Large patient pool with high level of unmet clinical needs
• Large non presenting patient pool
• First in market. Entry advantage can shape the category by
establishing symptom based approach
• Lack of ownership of science of IBS
• IBS patients are currently poorly managed
• Unexplored potential for suppressive therapy in IBS
Threats
IBS is viewed as a non-serious condition thus ‘costly”
treatment is avoided
Insurance companies will most likely try to reduce/control
prescription
Treatment period- remains unclear or inreasonable
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Physician & Patient Key Insights – IBS-C: Summary
Patients: Want to feel better but are frustrated
• IBS has a negative impact on patients’ quality of life
• Existing treatments do not provide satisfactory relief because they may only address one symptom, may worsen
others
• Patients are frustrated with their IBS because doctors do not take them seriously
• Physicians do not perceive IBS as a serious condition
• Due to their lack of understanding of IBS, physicians are uneasy identifying and diagnosing. This can be time-consuming
• Combinations of existing treatments are generally ineffective and this causes patients to repeatedly visit their physician
• Physicians feel they are unable to provide IBS-C patients with satisfactory relief
Physicians: Frustrated when diagnosing and treating IBS
• Reinforce that IBS is a “serious” condition that has a significant impact (IMPACT MEDIUM TO HIGH)
• Facilitate open communication between patient and physician to develop common/comfortable language that enables
diagnosis through education (IMPACT LOW)
• Differentiate on multi-symptom relief (ABCs and MOA)
• Continue to emphasize the superiority of Zelnorm in providing satisfactory relief
• Mitigate stigma associated with IBS and reinforce that IBS is a “real” condition that has a significant impact
• Continue to emphasize the superiority of Zelnorm and drive additional patient demand via DTC/DTP
• Facilitate open communication between patient and physician
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From local insights
• Specialists satisfaction with Traditional Rx is high due to loss to follow up
• Combination therapy is a common choice for GE specialists
• Patients rely heavily on self medication (see back up slide)
• Doctors do not initially believe that IBS affects the quality of life of patients
suffering from IBS
• Doctors tend to place patients in mild- moderate or severe IBS based on the
patient’s perception of his/ her condition
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Growth Opportunities & Key Issues
Growth opp. Issue Priority
1. Increase Z use in
presenting patients
by reinforcing
product safety (IBS-
C, and CC, off-label
use in males)
A. Zelmac differentiation vs. competition and strength of the value proposition 1
B. Poor adherence to dosing and dosing regimen (strengthening product efficacy on
ABCs), mainly driven by the price of the drug and nature of the condition
C. physician recognition and diagnosis of IBS patients (MoA, Safety, Efficacy).
D. IBS is not recognised as a legitimate condition. Willingness to prescribe an “expensive”
brand
E. Recognition of appropriate Z patients
F. CC Label not to be extended to CH
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Growth Opportunities & Key Issues
Growth opp. Issue Priority
2. Geographic
expansion: maximise
opportunity in KSA,
Kuwait, Jordan and
rest of Pharma
Services
Optimization of current Field Force structures to allow for launch 2
Price sensitivity in smaller markets/ limits prescription
3. Increase volume
patients via DTP-DTC/
Rely on PR
A. Understanding key triggers for the DTC, ( PCP& GI must be 80% on board to be able to
recommend/prescribe Zelmac for appropriate sufferers)
3
B. Low IBS and Z awareness among sufferers, low motivation to consult specialists
c. Limited Reach of PR and heavy investment needed for DTC
4. Expand
CC/FD/GERD
A. Consolidate in lower GI by launching Z into chronic constipation. CC not seen as an
FGD
4
B. Prepare the upper GI market for future indications in FD, GERD and diabetic
gastropathy. High barriers to entry and well entrenched competitors
C. Functional dyspepsia currently managed and diagnosed as GERD patients
Future GO’s based on Indications
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Growth Opportunities: Top Line Maximization
Growth Opportunity Potential Marketing Mix elements
Patients presenting at GI
level
High GI QOL study
Pan Arab Congress
Stand Alone/ UEGW?
FF visits
Patients presenting at PCP
level
Medium Educational series
ME Workshop
FF visits
Patients unaware of
condition or new treatments
High PR Campaign
Off- label use in CC and
other indications
Medium NA – Limited
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Goal:1st line Rx Treatment for IBS-C
Symptom based approach to rapidly penetrate & expand toSymptom based approach to rapidly penetrate & expand to
several GI markets (IBS, CC, Dyspepsia, GERD)several GI markets (IBS, CC, Dyspepsia, GERD)
Where We Are Today:
The latest advancement in
IBS-C
Where We Want to Be:
The 1st
Line Rx treatment for
functional GI disorders
Differentiate Z
as first line Rx
treatment vs.
competition
Increase
awareness on
disease area
and know –how
at PCP level
Swiss
approval in
CC for ability
to push
indication
Successful
launch in KSA
In IBS-C, Zelmac is the most effective first line Rx
treatment for IBS-C abdominal pain, bloating,
constipation (ABCs) because it is the only drug that
regulates motility, visceral sensitivity, and intestinal
secretion throughout the GI tract
Strengthen
Z’s value
proposition
Establish
KOL base
Governmental
introduction
and inclusion
in major LPO
LN Social
Security
inclusion
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A-to-B Shift Strategy: IBS (MDs)
Physician does not
recognize IBS
Physician does not
proactively diagnose IBS-C
Physician diagnoses IBS-C and
treats with diet/lifestyle and
single-symptom therapies
Physician uses Zelmac first-line
for all appropriate patients
STEP # 1
STEP # 2
STEP # 3
STEP # 4
Physician uses Zelmac in some,
not all, appropriate patients
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A BSuggested location in the
Zelmac Global A-B
Marketing Mix by target segment in the Global A-B
These doctors are sceptical of this syndrome and consider it as
psychosomatic condition
Call Objective Profiling patients and diagnosis tools- link to the impact on QOL and supporting data
Patient profiles
Step 1 - Patient profile needs to be linked to Disease Diagnosis- Outline
Step 2 - those whose quality of life has been impacted and need medical care
This disorder really impacts ME people and
affects their QOL
SI 4QOL Epidemiological Study
Learning the Art of dealing with this group of
patients- Diet and lifestyle and patient care
SI1Educational Series
Real medical disorder, prevalent, associated with
ABC, serotonin implicated, burden on sufferers
and society
SI 1ME IBS Workshop
MessageLink to SIActivity*
Target segment description: Physician does not
recognise IBS
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A BSuggested location in the
Zelmac Global A-B
Marketing Mix by target Segment in the Global A-B
Physician refers ‘query-IBS-C’ patients to a specialist; worries they will misdiagnose
organic disease; only gives a diagnosis of IBS-C after ruling out all other diseases
Call Objective Positive Diagnosis is possible
Patient profiles IBS-C patients
Rome II criteria, case studiesIncrease awareness on
disease area
Dinner meetings/ Local
events
Rome II criteria , a course in GIT to help deal
with IBS in the end of the day
Increase awareness on
disease area
Educational Series
Safe, confident, positive diagnosis possible
through Identify, probe, eliminate
ME IBS Workshop
MessageLink to SIActivity*
Target segment description: Physician does not proactively diagnose
IBS-C
Increase awareness on disease
area and know –how at
PCP level
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A BSuggested location in the
Zelmac Global A-B
Marketing Mix by target Segment in the Global A-B
Physician diagnoses IBS-C and treats with diet/lifestyle and
single-symptom therapies
Call Objective
Persuade the doctor that although diet/lifestyle changes are important many patients still rely on
medication for global symptom relief
Patient profiles IBS-C patients
No single agent can relieve the overall symptoms
except Zelmac that can manage the ABC
S 1& 3Dinner meetings/ Local
events
Learning the Art of dealing with this group
of patients
S1 & S5Educational Series
Patients need Diet/life style changes in
addition to medical treatment in most
SI 4FF Calls- Pt. Educational
materials
MessageLink to SIActivity*
Target segment description: Physician does not proactively diagnose
IBS-C
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A BSuggested location in the
Zelmac Global A-B
Marketing Mix by target Segment in the Global A-B
Physicians prescribe for some but not all appropriate
patients
Call Objective
Understand the reasons behind not prescribing Zelmac for all patients: three likely options are
price, disease severity, or side effect profile / safety (less likely)
Patient profiles IBS-C patients
The value added by 5HT4 partial agonists
extended to all patients
SI 5ME WS / Pan Arab
Samples help start more patients on a good drug
and give them a chance for improvementSI 4Sampling
Patients need Diet/life style changesSI 4FF Calls- cost effectiveness
date
MessageLink to SIActivity*
Target segment description: Physician does not proactively diagnose
IBS-C
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Calendarized Plan of Personal Promotion Program: Jordan
# Universe 1063 including GI, GPs, Ims & FMs
# Target Doctors 80 04,05
Current Y - # details to target doctors Budget - # details to target doctors
Q1/T1 Q2/T2 Q3/T3 Q4 Q1/T1 Q2/T2 Q3/T3 Q4
P1 66 108 315 315 315 290
P2
P1 Eq.
SOV %
Totals
2003 2004 2005
P1 174 1235
P2
P1 Eq.
SOV %
Field Force Productive Frequency
Universe Tiers Tier Productive 2004 2005
Definition Size Frequency %attainment
Goal MAT Goal
GE 36 Tier 1 15 26 7% 95%
Tier 2 21 12 3% 90%
Tier 3
PCP Tier 1 10 24 95%
Tier 2 34 12 90%
Tier 3
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Calendarized Plan of Promotion Programs
YEAR: 2005
Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec
ME Workshop • 15 docs Levant ,32 KSA, 10 Ro Gulf
Pan Arab- Lebanon • 150 docs Levant , 25 KSA, 10 Ro Gulf
PMS Study/ QOL study
Stand Alone meeting
PR Activity • Patient education and coverage
Cancelled
PMS in KSA
QOL study in Levant and Ro Gulf
Editor's Notes
The long-term brand vision describes what position Novartis believes it can achieve in the marketplace within 5-10 years.
This vision is based on Novartis’ knowledge of several marketplace components, including the unmet patient/customer need which your brand can serve best, where the science is evolving, competitive product offerings, and what Novartis can do to differentiate its brand through development and marketing strategies.
The Global Brand Team (GBT) in collaboration with the top 10 CPOs, identified and agreed common growth opportunities that form the global brand strategy. Local vision and objectives should be consistent with this strategy. Clarify which growth opportunities are local.
This slide should present a ‘patient flow’ - showing the points at which Novartis can intervene to change prescribing decisions. This information will enable you to identify or validate your assumptions for your growth opportunities over the planning period.
The first step is to construct a qualitative patient flow, which identifies all the routes the patient could follow regarding diagnosis and treatment of the particular disease. It shows the points where patients and healthcare providers make decisions.
For the second step you quantify the patient flow to identify the under-exploited patient segments and assess their potential value. (For each segment, you should have researched patient profiles, unmet needs, customer/consumer attitudes and behaviours, and the barriers that may prevent Novartis to realise the corresponding growth opportunity to its full potential.)
Use as many sources as possible, such as global market research, contract market research companies, medical/pharmaceutical databases, government and interest group publications. Also conduct stakeholder interviews and analyse analogous data-rich markets.
For more details, go to the ‘how to do guide’ on the MPH website (accessible through the OneStopShop website).
UAE and Lebanon Flow charts are available
Ensure that your brand strategy and positioning are aligned with the global strategic plan.
A strategic imperative is a key accomplishment that is mandatory to realise a growth opportunity and subsequent business objective.
Do not list actions at this stage, since the focus here is on what needs to be done, not how to do it.