How early is too early charles view 5jun2017

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How Early is Too Early…
for Pharmaceutical Market Insights
and Product Forecasts
Stephen Murdock, Principal
CharlesView Solutions
Focused on New Product Market Insights & Forecasting
Phone: +1 508-417-7576 | Mobile: +1 508-326-1968
E-mail: stephen.murdock@charlesview.solutions
Website: www.charlesview.solutions
“Lunch &
Learn” with
CharlesView
© CharlesView Solutions, LLC, 2017

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About the Presenter
Stephen Murdock is the Principal and Founder of CharlesView Solutions, LLC. The
company focuses on qualitative market research and forecasting. It is affiliated with
innovative agency partners to also offer seamless, high quality, quantitative research,
epidemiology, and market tracking.
With over 20 years of relevant experience, Steve has held progressive positions in Market
Insights and Forecasting with Ipsen Pharmaceuticals, Pfizer (Warner-Lambert), and
Novartis (Sandoz). More recently Steve was the Senior Director, Global Strategic Market
insights for Takeda Oncology. As part of this role, he personally provided insights
covering the in-licensing and launch of new products and evolved his department’s
focus from a US-only to a global one.
Steve gained much of his qualitative research, moderating, and forecasting experience
through countless projects in oncology, hematology, and other specialty areas. His
qualitative research and interviewing expertise covers market understanding,
promotional research, and forecast-related analyses. He is equally comfortable obtaining
insights from KOL’s, community practitioners, patients, and caregivers.
While pursuing a BSc degree in Chemistry, Steve worked in the laboratory of Nobel
Laureate Dr. Richard Heck. Afterwards, Steve obtained an M.B.A. degree with
concentration in Market Research and Operations Management from Drexel’s LeBow
College. He is a past President of the Pharmaceutical Business Information & Research
Group (PBIRG).

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Contents
• Market Insights and Forecasting Research by Product Development
Phase and Project Type
• Market Insights
• Early Development: Market Characterization
• Treatment Approach
• New Product Landscape
• Target Product Profile
• Phase II/III: Opportunity Assessment
• Product Forecasts
• Market Potential Analysis
• Epidemiology Input
• Early Development: Product Forecast
• Phase II/III: Product Forecast Model

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Market Insights and Forecasting Research by
Product Development Phase and Project Type
Pre-Clinical / Phase I Phase II
• Market Characterization
• Unmet Medical Needs
• Opportunity Assessment
• Unmet Medical Needs
• Market Barriers
• Patient Journey
• Prescriber Segmentation
• Patient Segmentation
• Channel Optimization
• Attribute / Perceptual Mapping
• Prescriber Choice (Heuristics)
• Pricing, Payer, Access
• Attribute/ Perceptual Mapping
• Pricing, Payer, Access
• Strategic Market Issues
• Tactical Decision Support
• Brand Name Research
• Unbranded Message Testing/
Message Flow
• Brand Logo and Color Testing
• Package Testing
• Branded Message Testing
• White Paper Testing
• Ad/Concept Testing
• Patient/Nurse/Pharmacy Materials
Testing
• Sales Aid Testing
• Internet Site Testing
• Ad/Concept Testing
• Patient/Nurse/Pharmacy Materials
Testing
• Sales Aid Testing
• Internet Site Testing
• Competitive Response
• Impact Assessments: Pre & Post
Medical Meetings, Label changes
• Product Potential
• Revenue Forecast: Peak by US,
Global, or Region
• Revenue Forecast: Yearly by Region • Retreatment, Cannibalization
• Peak Share Research
• Abandonment, Compliance,
Persistence
• Duration of Therapy
• Epidemiology Inform Research/Model
• Revenue Forecast:
Monthly/Quarterly/Yearly by Country
• Peak Share Research
• Abandonment, Compliance,
Persistence
• Duration of Therapy
• Epidemiology Inform Research/Model
• Revenue Forecast:
Monthly/Quarterly/Yearly by Country
• KOL Influence Mapping
• Awareness, Trial, Usage (ATU)
• Chart-pull Research
• Share of Promotional Voice
• Awareness, Trial, Usage (ATU)
• Chart-pull Research
• Share of Promotional Voice
Market
Understanding
Promotional
Forecast-Related
Tracking
Qualifiers:
Preliminary / For Discussion
DIffers by Company

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PHARMACEUTICAL MARKET INSIGHTS

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Early Development: Market Characterization
Current
Market-
place
Future
Market-
place
Phase I
Insights
• Treatment by line?
• Diagnosis? Guidelines/Protocols?
• What are prescriber's treatment goals? How well do
current products support these?
Research Objectives:
• To gain an initial understanding of the current marketplace and what is required to make an impact
within the potential product indication(s)
• To develop KOL relationships for future advisory boards, clinical trials, and developmental support
• What advice/ tips do KOLs have regarding
developmental and Phase I plans?
• What specific target product profile parameters and
values do KOLs achieve/require in the indication(s)?
• Possible combinations?
• What exciting pipeline products are KOL’s aware of
and how do they perceive them?
• How will these newer agents change the treatment
landscape and impact efficacy hurdles for regulatory
approvals?
• What are the realistic unmet needs for a new agent?
Business Questions:
Early Market
Research

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8
Sample
US Only or per Region:
 5 targeted KOLs
‒ With product MOA
developmental
experience per
indication
Early Development: Market Characterization

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Early Development: TreatmentApproach
KOLrespondents’drug-treatment algorithm
Maintenance
1. Observation
2. Novel agent
Neo-adjuvant
1. Regimen A
2. Regimen B
Adjuvant
1. Regimen A
2. Regimen C
3. Regimen D
First-line
1. Regimen A
2. Single agents
Adjuvant
1. Regimen A
2. Regimen C
3. Regimen D
Surgery
1st Line
Maintenance
• Observation
• Product A
• Product B
2nd Line
Group B
1. Regimen F
2. Regimen G
Group A
1. Regimen E
2. Regimen F
~50%
~35%
15%
Maintenance
• (Observation
• Product B
• Product C
3rd+Line
Group B
1. Regimen I
2. Regimen G
Group A
1. Regimen H
2. Regimen F
Surgery
~50%
~50%
~25%
~50%
~75%
~75%
CONFIDENTIAL 9
Key Results

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Early Research: New Product Landscape
KOLs identified 10 agents with noteworthy
potential in the target indication
KOLs identified US pipeline
agents they are most excited
about in the near-term. Included,
in order of interest, were:
• MOA #1: Activity, Products
Comments:
10
Sources: clinicaltrials.gov and associated websites
Generic
(BRANDNAME)
Company
Sub-Indication
Generic
(BRANDNAME)
Company
Sub-Indication
Generic
(BRANDNAME)
Company
Sub-Indication
Generic
(BRANDNAME)
Company
Sub-Indication
Generic
(BRANDNAME)
Company
Sub-Indication
Generic
(BRANDNAME)
Company
Sub-Indication
Generic
(BRANDNAME)
Company
Sub-Indication
MOA #4
MOA #3
MOA #2
MOA #1
Generic
(BRANDNAME)
Company
Sub-Indication
Generic
(BRANDNAME)
Company
Sub-Indication
Generic
(BRANDNAME)
Company
Sub-Indication
Phase II Phase III Marketed

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Description
MOA including
Sci. Rationale
Product X is a [drug class] that acts by [mode]. Along with Product Y, which…
Dosing
Regimen
Regimen X: Product X is administered as an [oral, IV, subcutaneous] agent every [frequency] until [duration] along with…
Target Profile
Indication Regimen X is FDA-approved for the treatment of [indication, line, other qualifiers]
Primary
Efficacy
Endpoint(s)
Currently Achieved:
a.
b.
Acceptable Target:
a.
b.
Secondary
Efficacy
Endpoints
Currently Achieved:
a.
b.
c.
Acceptable Target:
a.
b.
c.
Safety
Concerns
(Grade 3-4 AEs)
Currently Achieved:
a.
b.
c.
Acceptable Target:
a.
b.
c.
Early Development: Target Product Profile
(KOLs’Perspectives after Product X Developmental Presentation)

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Phase II/III: OpportunityAssessment
Product
X Input
Future
Market-
place
Phase
III
Insights
• What exciting pipeline products are prescribers aware
of and how do they perceive them? How might they
change the current treatment paradigm?
• How has the treatment algorithm changed in the last
few years? How will it change in the next few years?
Research Objectives:
• To gain an understanding of what is required to optimize the opportunity for Product X
• What parameters, endpoints, & other considerations
are important in a phase III clinical study of ProductX
• What levels of usage would various efficacy/safety
results capture?
• What are the likes, dislikes, strengths, limitations of
ProductX?
• Where in the treatment continuum would
prescribers use Product X?
• What patient characteristics would prescribers
consider when using Product X for their patients?
• What will it take for ProductX to become the gold
standard?
• What can motivate prescribers to use ProductX for
patients who previously would have not been
treated?
Business Questions:
Extension of Early
Market Characterization

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13
Sample
Per Country:
 5 KOLs
 25 community
practitioners
◦ With minimum
prescribing criteria
Phase II/III: OpportunityAssessment

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Description
MOA including
Sci. Rationale
Product X is a [drug class] that acts by [mode]. Along with Product Y, which…
Dosing
Regimen
Regimen X: Product X is administered as an [oral, IV, subcutaneous] agent every [frequency] until [duration]
starting at ## and increasing to ## over [timeframe] along with…
Target Profile
Indication Regimen X is FDA-approved for the treatment of [Indication, line, other qualifiers]
Phase III
Trial Design
Efficacy
Regimen X
• OS = ##%
• ORR = ##%
• mPFS = ## months
Comparitor
• OS = ##%
• ORR = ##%
• mPFS = ## months
Safety (Grade
3-4 AEs)
Regimen X
• Hemorrhage: ##%
• Neutropenia: ##%
• Anemia: ##%
Comparitor
• Hemorrhage: ##%
• Neutropenia: ##%
• Anemia: ##%
## mg ## mg
## mgWeek 1
Week 2
Week 3 through ##
RANDOMIZATION
Indication
(Phase 3, n=500)
Regimen X for [duration]
Comparitor for [duration]
Product X
[duration]
Phase II/III: Target Product Profile
(For Prescribers’Reactions)
Contrast with Early
Opportunity
Assessment

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PHARMACEUTICAL PRODUCT FORECASTS
CONFIDENTIAL

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Market Potential Analysis
Product X in IndicationY
Unit
Scale definition
21 43
$MM
# of treated
patients
<$250
< 10,000
$250 to $499
10,000 to
49,000 50,000 – 99,000 > 100,000
% (yrly ave market
vol. growth)
-5% to -1% 0% to 9% 10% to 14% > 15%
-
Standard of
care strongly
served
SubOpt SOC +
Strong
competition
(>5 key players)
No SOC +
Moderate
competition
(2-5 key players)
No SOC + No
or little
competition
$000 (Annual
cost per patient)
> $100$50 to $99$10 to $49< $10
Unmet
Partially
satisfied
Well satisfied
with branded
agents
Well satisfied
with generics
Criteria
weight
-
$500 to $999 > $1,000
Points (PhIII=1,
PhII=0.5)
<5 points 5 to 9 points 10-19 points >20 points-
Endpoint / trial
size
OS
(> 800 pts)
PFS
(400-799 pts)
ORR or PFS
(100-399 pts)
CR
(<100 pts)
Criteria
Value of market /
segment
Growth rate of market /
segment
Competitive pressure
Cost of SOC
Level of unmet medical
need (e.g., safety and/or
efficacy)
Clinical trial density
Required clinical trial
investment

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Epidemiology Input
Incidence /
Prevalence
Prod. Appr.
Inc/ Prev
Country Population
Drug-treated
Appropriate Pts
X % with
Disease
X % Appro-
priate
X % Drug
Treated
X %Yearly
Change
• Early development
• Quick turn-around
• Due diligence
• Phase II / III
• Competitive Analysis
Cannibalization
Retreatment

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Early Development: Product Forecast
ProductX inIndicationY
If globally launched, Product X can achieve peak sales ranging from $## to $## million in [indication]
■Upside Potential:
Use/approval in additional indications (e.g.,)
Strong market growth/usage, particularly in Japan


■Downside Risks:
Development and adaption of [competitive MOA]
Entrenchment of [formulations, generics]


TOTAL US Europe Japan Other Assumptions
Epidemiology (2020):
Population (000) 1,851,636 334,503 749,607 125,507 642,018 (1)
% Diagnosed Prevalence 0.03% 0.02% 0.04% 0.02% 0.01% (2)
Indication Prevalence (000) 473 62 300 28 83 Calculation
% Drug Treated 39434% 66% 34% 75% 26% (3)
Drug-treated Patients 186,709 41,156 102,898 21,009 21,646 Calculation
Peak Share:
Premium Case 47% 47% 26% 9% (4)
Medium Estimate 24% 24% 13% 4% (5)
Low Case 8% 8% 4% 1% (6)
Cost:
Price per Day $43.40 $12.98 $30.38 $15.86 (7)
Persistence/Compliance/Fulfillment 63% 63% 63% 63% (8)
Average therapy days per Year 230 230 230 230 (9)
Annual Cost $9,980 $2,985 $6,986 $3,647 Calculation
Sales Forecast: (2020 $Mil)
Premium Case $383 $193 $144 $38 $7 Calculation
Medium Estimate $195 $99 $74 $19 $3 Calculation
Low Case $64 $33 $25 $6 $1 Calculation

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Phase II/III: Product Forecast Model
1. Forecast Parameters - the specification of
countries or regions and indications
2. Market sizing – the annual number of drug-
treated patients who are appropriate and have
access
3. Market share - the peak share of Product X
and each of its competitors
4. Uptake – the monthly, quarterly, or yearly
curve representing time to peak share as well
as the shape of the curve
5. Market events - the impact of any external
events that will increase or decrease Product
X’s peak share
6. Patient consumption - the annual Product X
volume per patient as well as compliance and
persistence
7. Pricing - the gross price of Product X by unit
and inflation/deflation
Forecast
Parameters
Market
Sizing
Product
Uptake
Market
Share
Market
Events
Patient
Consumptio
n
Pricing
40%
3%
12%
40%
56%
47%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
MarketShare
Patient Share Evolution
2020 2021 2022 2023 2024 2025 2026 2027 2028 2029
Contrast with Early
Product Forecast

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END –
How Early is Too Early…for Pharmaceutical
Market Insights and Product Forecasts
For Questions, Comments, or Inquiries, Please contact:
Stephen Murdock, Principal
CharlesView Solutions, LLC
Focused on New Product Market Insights & Forecasting
Phone: +1 508-417-7576 | Mobile: +1 508-326-1968
E-mail: stephen.murdock@charlesview.solutions
Website: www.charlesviewsolutions.com

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