In highly competitive markets pharmaceutical and biotech companies are constantly faced with the challenge of delivering innovative new products at lower development costs. The New Product Planning team is responsible for a host of development activities designed to seed commercial insights into the development process and prepare/educate the marketplace prior to launch. This study reviews the role of New Product Planning in the development process and examines the timing and value of key Medical Affairs activities such as advisory boards and managing thought leaders.

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Pharmaceutical New Product Planning
Role and Activities for Medical Affairs
Report Summary
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Key Study Objectives
 Assess current state of New Product
Planning in pharma
 Provide overview of New Product
Planning activities and timing during
development process
 Review the main Medical Affairs activities
carried out during the development
process and drill down on their timing,
intended outcomes, and value for the
organization
Study Objective & Methodology
This benchmarking study examines the role
and impact of NPP groups on product
commercialization efforts in pharmaceutical
and biotech companies. It provides reliable
benchmarks, observations, and best practice
insights to inform and shape executive
thinking around the challenges of new
product development in Medical Affairs
Data was collected using an online survey
instrument covering topics related to roles,
activities and value. More than a dozen in-
depth interviews were conducted with
participants to gather more detailed
information pertinent to this study.
Data for this study was collected utilizing an online survey instrument and over a dozen
in-depth qualitative interviews. Twenty-five organizations participated in this study.
Research Objective and Methodology

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Benchmark Class
Data for this study was collected utilizing an online survey instrument and over a dozen
in-depth qualitative interviews: 27 participants from 25 organizations participated in this
study.
Abbott EMD Serono
Actelion Human Genome Sciences
Alcon Merck
Allergan Novartis
Almirall Ortho Biotech, a JNJ Company
Altus Sanofi-Aventis
Amgen Stiefel Laboratories
Astellas Takeda
Auxilium Theravance
Bayer Healthcare UCB
BiogenIdec Victory
Daiichi Sankyo Wyeth
Eli Lilly

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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 COMMERCIALpipeline 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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Key Findings
Key Activities and Patterns
NPP activities generally follow established patterns of drug development. Market
planning and research must support meeting development milestones, although the
focus of NPP activity must be geared to align development with market potential, not
just getting past regulatory hurdles.
 More activities are starting early in the process, even in Pre-Clinical stages
To ensure that later (costlier) development efforts are devoted to the right
commercial targets
To enforce the market perspective and marketing discipline as early as possible
 Variations in the performance or timing of particular activities usually
depend on attributes of the particular drug or therapeutic area
Drugs with novel mechanisms of action, for instance, regularly triggered earlier
use of KOLs and ad boards, if only to seed the discussion among thought
leaders

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NPP activities adhere to a fairly common schedule. Some are started in the early stages
and continuously refined throughout the development process; others do not start until
Phase III. NPP plays only a minor role at some of the benchmarked companies after P3.
NPP Shapes Development Activity
NPP’s Role Adheres to Common Development Milestones and Guidelines
• Identify Unmet
Medical Need
• Disease State
Evaluation
• Preliminary
Market and
Competitive
Assessment
• Target Product
Profile
• Disease State
Opportunity
• Competitive
Assessment
• Market
Assessment
• Generic Naming
• Draft Launch Label
• Epidemiology
• Lifecycle Planning
• Managed Care
Research
• Patient Flow
• Ad Boards
• KOL ID & Mgmt.
• Med. Meeting Plan.
• Publication Planning
• Prelim. Positioning
• Core Message
Development
• Labeling
• Healthcare Prof.
Segmentation
• Patient Segmentation
• Positioning & Pricing
• Publications
• Dev. of Brand
• Trade Naming &
Packaging
Preliminary Forecast
of Market
TPP with Financial
Forecasts and
Competitive Profile
Indication
Prioritization
Disease Models
Branding, Positioning
& Publication Docs
Pricing Schedules
Phase II Phase IIIPhase IPre-Clinical

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Key Findings
Medical Affairs Activities
Medical Affairs should begin with understanding how best to reach the medical community, and this
involves identifying KOLs. You must plan well in advance to have a consistent message about your
product, and to generate buzz early on based upon what you seek to accomplish. Early Medical
Affairs must focus on the theoretical aspects of the drug and engaging with the medical community.
Once clinical data is available, Medical Affairs can shift to presenting the facts.
 Identify KOLs as early as possible, preferably in Pre-Clinical
To gain a deeper understanding of the medical need
To provide insight into how the new drug can fit into the market and what it must accomplish to
be considered effective
To provide insights on lifecycle management issues as indications become clearer
In Phase 1, use input from KOLs to guide clinical trials and establish market-driven endpoints
In Phase 2, set up Ad Boards to help guide positioning and messaging to doctors and to provide
insight for conducting Phase 3 trials
In Phase 3, KOLs should be heavily influencing the clinical trial processes
 Manage KOLs in two groups: one to guide the development process and provide insight
as data comes back, the other to work more closely with publications and messaging
 Branding of the Science, like all marketing activities, must be updated regularly
As data comes back about the drug at each phase, focus on positive effects
Carefully avoid messages that, with the benefit of new data, could cause a lack of trust among
doctors or regulatory agencies

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Small Company NPP Groups Often Use Ad Boards Early
50%
10%
50%
38%
11%
44%
89%
0%
20%
80%
60%
75%
13%
63%
56%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Pre-Clinical Phase 1 Phase 2 Phase 3 Launch
Half of the Small Pharma Segment NPP groups get involved with advisory boards in Pre-Clinical,
while Large Pharma Segment NPP groups get involved more in Phase 1. Smaller companies have a
greater need to reach out for support for their development, and this is the primary reason for starting
earlier. Many Regional NPP groups however don’t get involved until Phase 3, and there is the
possibility that this may impact the effectiveness of reaching advisory boards early on.
Advisory Boards
Global NPP-SPS
Regional NPP-LPS
Global NPP-LPS n=10
n=8
n=9
Percentage of each segment
performing activity at each phase

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KOL Management Insight
 Pre-Clinical:
 Use KOL’s to Fill in Expertise Gaps: “We’re a biotech company and so we don’t have
expertise in every single disease. So very early on, if we have a discovery, we will bring in
experts to tell us where we might want to go if we have a discovery or a product with a
mechanism of action. So let’s say we have a mechanism of action against a certain target. Our
scientists say this could apply to all kinds of autoimmune diseases or whatever. We’ll bring in
experts before we even go forward and get their input on where they think the science will lead
us, and sometimes they’ll want to do some studies or they’ll look at our pre-clinical data or
they’ll make some suggestions and they’ll help guide us toward what could be our first
indications with the product.”
• Information Shared: “We’ll share all of our pre-clinical data, and whether that’s test
tube data...for some indication we have a lot of different kinds of in vitro data, but then
any kind of animal data as well.”
 Phase 1:
 Employ KOL’s to Lead Phase 1 Studies: “Quite often those people (KOL’s) also are people
that do some of the Phase 1 studies. Not always, but they can help guide on how we’d want to
go that direction.”
 Phase 2 & 3:
 Change Roles for Current KOL’s and Add KOL’s as Development Proceeds to Meet
Needs: “Some of our KOLs stay with us through the entire process, but their role changes.
Then when you get more in the clinic, you try to bring in KOLs that are more savvy on the
clinical part of it, and then eventually you want people that are more savvy on the commercial
end. We continue to work within our scientific KOLs to say what other indications should we be
considering? What investigator-initiated trials, where should we try to take this product, what
do you think about a second-generation product, what kinds of things should we be doing to
make sure we don’t have any safety issues down the road?”

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Best Practices, LLC is a research and consulting firm that
conducts work based on the simple yet profound principle that
organizations can chart a course to superior economic
performance by studying the best business practices, operating
tactics and winning strategies of world-class companies.
Best Practices, LLC
6350 Quadrangle Drive, Suite 200
Chapel Hill, NC 27517
(919) 403-0251
bestpractices@best-in-class.com
www.best-in-class.com
About Best Practices, LLC
Link for Report: Pharmaceutical New Product Planning