Pharmaceutical New Product Planning Excellence:

Best Practices, LLC Strategic Benchmarking Research & Analysis for CSL Behring

Structure & Activities that Drive Profitability & Growth

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Table of Contents

Executive Summary pgs. 3-11

Research Overview pg. 3

Participating Companies pg. 4

Segmentation & Definition pg. 5

High-Level Recommendations pg. 6

Key Findings pgs. 7-11

The State of New Product Planning pgs. 12-16

New Product Planning Structure pgs. 17-33

Roles, Responsibilities, Interaction & Influence pgs. 34-44

New Product Planning Activities: Key Patterns And Activities pgs. 45-51

New Product Planning Activities: Marketing Planning pgs. 52-65

New Product Planning Activities: Market Research pgs. 66-81

New Product Planning Activities: Medical Affairs pgs. 82-95

New Product Planning Activities: Brand Strategy pgs. 96-103

New Product Planning Resources pgs. 104-115

New Product Planning Value And Impact pgs. 116-125

Study Participant Demographics pgs. 126-131

About Best Practices, LLC pgs. 132-133

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Field Research & Insight Development:

Best Practices, LLC engaged 19 biotech and pharma

leaders at 15 companies through a benchmarking

survey instrument.

Research participants worked in functions such as

marketing, and product strategy.

• Identify Timing of Key New

Product Planning Activities in

Launch & Pre-Launch

• Assess Impact of Timing Certain

Activities in Launch & Pre-

Launch

• Highlight Areas for Success in

New Product Planning

Research Objectives & Methodology

Research Objectives:

The objective of this benchmarking study is to help biopharma leaders determine how the structure,

resources and activities of NPP groups impact product commercialization efforts.

This data will serve as a reference point for executives as they determine number of employees,

budget and timing of key activities for the NPP group.

Business Objective:

Pharmaceutical and biotech companies are increasingly under pressure to deliver effective new products in

shorter time frames while minimizing development costs. This study seeks to examine the role and impact of

NPP on product commercialization.

Timing for conducting 50+ activities

FTEs allocated to global and U.S.

divisions

Anticipated future of NPP function

Top 3 most valuable activities

Segmented by structure to better understand results

Structure and organization of NPP within the

company

Percentage of budget allocated to specific pre-launch

activities

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Universe of Learning: 15 Companies Participated in the Study

This research engaged 19 marketing & commercial leaders from 15 leading pharmaceutical, biotech, and

life sciences companies.

Benchmark Class:

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Study Analyzes Two Main Segments

% Respondents

Benchmark Class

Regional

Segments NPP structure

Global Regional

Centralized Decentralized Hybrid

N=9

N=5

N=19

N=10

N=6 N=8

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High-Level Key Findings High-Level Key Recommendations

Add Role

Clarity to

Regional &

Global Teams

• The Commercial aspects of global and regional teams differ. Additionally, global

NPP teams are decision makers for portfolio strategies while regional teams

majorly play a consulting role. Adding clarity in roles will help companies to

optimize NPP decisions.

Start Regional

Involvement as

Early as the End

of Phase II

• Get regional teams' involvement in phase II for market planning. At the start of

phase III, increase regional teams' participation in market research, medical

affairs and branding activities.

Global Teams

Must Start Early

• Global teams must get a head start on most of the activities across market

research, market planning, medical affairs and branding activities. Start

market planning and market research activities during phase I, while medical

affairs and branding can be undertaken during phase II and phase III.

Align Structure

to Suit NPP

Teams

Responsibility

• Responsibilities of NPP teams differ as per their scope. Structure regional and

global NPP teams to best optimize the processes and ease decision making.

Accordingly, also re-align their functional and reporting structure.

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Key Findings:

Few of the key findings and insights that emerged from this study:

Responsibility of NPP Team Impacts Commercial Aspect: Commercial aspect of global and regional

NPP teams varies. For 56% of global teams, transition from NPP to inline marketing starts at the onset

or before submission for approval during phase III. In contrast, half of regional teams’ transition happen

at the end of phase III.

Branding Activities for Global & Regional Teams Start in Phase II and Phase III Respectively:

More than 67% of global teams start trade packaging, generic naming and positioning in phase II, while

close to 88% of global companies start brand development and trade naming in phase III. More than 75%

of regional teams start all but generic naming in phase III.

Global Teams Value Segmentation; Regional Teams Value Market Research: More than 70% of

global teams highly value segmentation and positioning, while 89% of regional teams value market

research activities. Other activities valued by global teams are TPP (57%) and market assessment

(57%) while segmentation (56%) and TPP (33%) are the activities valued by regional teams.

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The central challenge is to ensure that the right new products get developed efficiently—with minimum risk and maximum value—to allow senior management to make smart decisions confidently.

New Product Planning Bridging the Gap Between R&D and Commercial Interests

R&D COMMERCIAL pipeline marketing clinical patent brands molecules market competition phase I me-too lifecycle commercial pre-clinical co-promotion FDA submission

pharmaceutical New Product physicians

medical affairs Planning disease state

compounds phase II sales development research forecast biotech blockbuster therapeutic area phase III drug

“…with pressure on all stakeholders in the pharma industry and the few new drugs that came to the market in recent years, NPP should take on more and more importance in driving what projects to dedicate resources to…”

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Centralized, 10%

Decentralized, 30% Hybrid, 60%

Centralized, 44%

Decentralized, 33%

Hybrid, 22%

3) New Product Planning Structure: How is your company's New Product Planning function organized?

NPP Function Organization

Global and regional level New Product Planning groups have different structures. Forty-four percent of

the global groups are centrally organized while 60% of regional New Product Planning groups have a

hybrid structure.

Global Groups are Centralized; Regional Groups are Hybrid

% respondents

N=9 N=10

Global Regional

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1) When does the transition from NPP to inline (brand) marketing at your company occur?

Commercial Aspect of New Product Planning

Transition from New Product Planning to Inline Brands at Global & Regional Teams Begins at Different Stages

% respondents

Global teams are a bit ahead of regional teams in the commercialization process. While 56% of global

teams transition from NPP to inline marketing occurring during start or submission at phase III, at 50% of

regional teams, it starts at the end of phase III.

N=9 N=10

11%

22% 22%

33%

11%

20%

10%

50%

0%

20%

During Phase 2b At the beginning ofPhase 3

At the end of Phase 3 Before submission todrug approval agency

Other

Global Regional

*Others: I work in devices so that groupings above are not applicable. Launch

Readiness - after submission, Entry in development, ~3 years prior to launch

*

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14) New Product Planning Activities –Brand Strategy: For questions 11-14, please check all phases for which your

NPP group is involved in each activity.

Timing of Brand Strategy Activities: Global

More than 67% of global teams start trade packaging, generic naming and positioning during phase II,

while more than 88% start brand development and trade naming in phase III.

Global Groups Start 3 out of 5 Branding Activities in Phase II

Medical

Affairs

15%

Market

Research

33%

N-Global=8-9 Pre-clinical Phase I Phase II Phase III Launch

Development of brand

Trade naming

Trade packaging/formulations

Generic naming

Positioning

33.4-66.6% of participants performing function

1-33.3% of participants performing function

66.7-100% of participants performing function

No participants performing function

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Director/Global Director, 33%

Head, 33%

Manager, 11%

Sr. Director/Assistant

Director, 11%

Lead, 11%

1) Please provide the following information, which will be used for classification purposes and to ensure that you

receive a copy of the full study deliverable.

Participant’s Job Title:

More than half of the participants in the survey are at the Director level and above.

High-Level Executives Participated in the Survey

% respondents N= 9

Global

VP 10%

Director/Global Director

40%

Sr. Director/ Assistant Director

20%

Head 10%

Manager 20%

Regional

N= 10

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