Report Summary--Pharmaceutical New Product Planning: Roles and Activities for Medical Affairs. Contact me to view the full report.

1. Pharmaceutical New Product Planning
Role and Activities for Medical Affairs
Report Summary
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2. Research Objective and Methodology
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.
Study Objective & Methodology
Study Objective & Methodology Key Study Objectives
Key Study Objectives
This benchmarking study examines the role
This benchmarking study examines the role Assess current state of New Product
Assess current state of New Product
and impact of NPP groups on product
and impact of NPP groups on product Planning in pharma
Planning in pharma
commercialization efforts in pharmaceutical
commercialization efforts in pharmaceutical
and biotech companies. ItItprovides reliable
and biotech companies. provides reliable Provide overview of New Product
Provide overview of New Product
benchmarks, observations, and best practice
benchmarks, observations, and best practice Planning activities and timing during
Planning activities and timing during
insights to inform and shape executive
insights to inform and shape executive development process
development process
thinking around the challenges of new
thinking around the challenges of new
product development in Medical Affairs
product development in Medical Affairs Review the main Medical Affairs activities
Review the main Medical Affairs activities
carried out during the development
carried out during the development
Data was collected using an online survey
Data was collected using an online survey process and drill down on their timing,
process and drill down on their timing,
instrument covering topics related to roles,
instrument covering topics related to roles, intended outcomes, and value for the
intended outcomes, and value for the
activities and value. More than aadozen in-
activities and value. More than dozen in- organization
organization
depth interviews were conducted with
depth interviews were conducted with
participants to gather more detailed
participants to gather more detailed
information pertinent to this study.
information pertinent to this study.
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3. 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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4. New Product Planning
Bridging the Gap Between R&D and Commercial Interests
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.
R&D pipeline marketing clinical patent COMMERCIAL
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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5. 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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6. NPP Shapes Development Activity
NPP’s Role Adheres to Common Development Milestones and Guidelines
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.
Pre-Clinical Phase I Phase II Phase III
• Identify Unmet • Target Product • Draft Launch Label • Core Message
Medical Need Profile • Epidemiology Development
• Disease State • Disease State • Lifecycle Planning • Labeling
Evaluation Opportunity • Managed Care • Healthcare Prof.
• Preliminary • Competitive Research Segmentation
Market and Assessment • Patient Flow • Patient Segmentation
Competitive • Market • Positioning & Pricing
Assessment • Ad Boards
Assessment • Publications
• KOL ID & Mgmt.
• Generic Naming • Dev. of Brand
• Med. Meeting Plan.
• Publication Planning • Trade Naming &
• Prelim. Positioning Packaging
Preliminary Forecast TPP with Financial Indication Branding, Positioning
of Market Forecasts and Prioritization & Publication Docs
Competitive Profile Disease Models Pricing Schedules
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7. 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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8. Small Company NPP Groups Often Use Ad Boards Early
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
100%
90% 80% 89%
80%
70% 63%
56% 75%
60%
50% 50% 50% 60%
44%
40% 38%
30% 20%
20% 13%
10% 11% 10%
0% 0%
Pre-Clinical Phase 1 Phase 2 Phase 3 Launch
Global NPP-LPS n=10
Global NPP-SPS n=8 Percentage of each segment
performing activity at each phase
Regional NPP-LPS n=9
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9. 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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10. About Best Practices, LLC
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
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