Pharmaceutical and biotech companies realize the importance of educating the payer sector to improve the likelihood of a successful launch of their new products. As payers’ influence in the marketplace has grown, so has the importance of effective payer education tactics- no more so than in the diabetes therapeutic area where competition is fierce for prime formulary positioning. This Best Practices®, LLC benchmarking study provides benchmarks around timing of payer-oriented market education and effective education tactics for payers.

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Educating the Marketplace to
Support Successful Diabetes
Product Launches

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Key Study Objectives
Research Objective and Methodology
Study Objective & Methodology
This field research and benchmarking
study probed the broad array of medical
education and marketing practices
conducted two to three years prior to
launch that best inform and shape the
marketplace.
A quantitative survey harvested current
best practices and emerging trends in
educating the marketplace to support
successful product launches. In addition,
deep-dive executive interviews were
conducted with selected participants to
provide qualitative insights and emerging
trends.
•Identify key education tactics for
thought leaders, physicians, patients,
and payers
•Assess key market-education
practices, including thought leader
services, MedEd, scientific
publications, patient advocacy &
education, clinical trials & payer
education
•Identify key timing factors &
education mix
•Describe critical market entry pitfalls
and future trends
This study explores best practices in educating, informing and preparing the
marketplace for new products – through Physician, Patient, and Payer education,
publications, advocacy and communication strategies.

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10 Steps To Excellence: Key Themes from Market Education Research
Brand, medical and market education leaders describe various best practices for
educating and shaping the market for new bio-pharma products. These practices can be
distilled into 10 key areas that articulate a blueprint for market education excellence.
MARKETMARKET
EDUCATIONEDUCATION
EXCELLENCEEXCELLENCE
1. Develop
Integrated
Continuous
Thought Leader
Strategies
2. Manage
Clinical Trials To
Win Highly
Regarded
Investigators &
TLs
3. Data Disclosures
Inform Medical
Community of Your
Progress &
Commitment
7. Start Payer
Education Early;
Focus On Cost
& Health
Outcomes
4. Communicate
Clinical Science
Thru Journals &
Congresses5. Use Multi-
Channel Med.
Ed. To Inform
Health Care
Providers
8. Use PR & New
Technologies For
Leveraged Reach to
Patients, Physicians,
& Payers
10. Allocate
Market Ed Mix To
Reflect T.A. &
Competitive
Landscape
6. Inform
Patients Thru
Education &
Advocacy Group
Collaborations
9. Orchestrate
Med Ed Timing
To Reach Right
Constituencies
At Right Times
“I think it's going to
boil down to being
able to actually identify
by individual customer
what channel they
want information from
and how you're going
to reach them most
efficiently, and almost
going through a
decision tree that
looks at effectiveness
and cost . . ..”
-Senior Vice President, Marketing
“I think it's going to
boil down to being
able to actually identify
by individual customer
what channel they
want information from
and how you're going
to reach them most
efficiently, and almost
going through a
decision tree that
looks at effectiveness
and cost . . ..”
-Senior Vice President, Marketing

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Universe of Learning: 26 Companies Engaged
Research participants included 34 executives and managers from 26 leading
pharmaceutical, biotech and medical device companies.
Participating Companies

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Universe of Learning: Job Titles and Executive Interviews
Interview Class
• Executive Director,
Global Marketing
• Associate Brand
Director
• Senior Manager,
New Product
Commercialization
• National Sales
Manager
• Manager, Clinical
Research
• Senior Product
Manager/Payer
Marketing
• Senior Manager,
Health Care
Solutions
• Medical Adviser
• Senior VP, Commercial
Operations
• Senior VP, Marketing
• Executive Director,
Commercial Operations
• Head Clinical & Medical
Services
• Vice President, Marketing
• Senior Director,
• Director, Commercial
Analysis
• Senior Manager, Marketing
• Manager, Market Research
• Senior Director, Diabetes
• Group Sales & Brand
Manager
• Senior Manager,
Commercial Development
Job Titles
Research participants’ roles ranged from senior leaders of commercial operations to
managers of Diabetes brand teams and therapeutic franchise groups. “Lessons learned”
executive interviews were conducted with select companies.

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Diabetes/Cardiovascular Segment: 11 Participants Engaged
Diabetes/Cardiovascular research participants included 11 executives/managers at 8
companies. Three cardiovascular respondents were integrated with 8 Diabetes
respondents because of similar structural therapeutic area requirements for market
entry and common safety factors now under review by the FDA.
Benchmark Partners –
Diabetes/Cardiovascular
Participant Titles –
Diabetes/Cardiovascular
• Senior VP, Commercial Operations
• VP, Marketing
• Executive Director, Global Marketing
• Associate Brand Director
• Senior Manager, New Product
Commercialization
• National Sales Manager
• Manager, Clinical Research
• Senior Product Manager/Payer Marketing
• Senior Manager, Health Care Solutions
• Medical Adviser
• Group Sales & Brand Manager

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Diabetes Thought Leader Education Mirrors Benchmark
(n=11)
Developing Diabetes Thought Leaders: Please check when you should start each activity for
educating thought leaders.
Diabetes
Developing
Integrated
Thought Leader
Strategies
Conducting
Advisory Boards
Providing
Medical
Science
Liaison
Services
Engaging
Thought
Leaders &
Key
Investigators
in Clinical
Trial Protocol
Development
Communicating
Critical
Information and
Sharing Research
Insights
Pre-Clinical 9% 0% 0% 18% 9%
Phase I 9% 18% 18% 18% 0%
Phase II 55% 36% 9% 36% 36%
Phase III-3 Years 18% 18% 18% 9% 18%
Phase III-2 Years 9% 0% 9% 9% 18%
Phase III-1 Year 0% 18% 36% 0% 9%
NDA thru Launch Year 0% 9% 9% 9% 9%
The Diabetes marketplace is well developed and populated with many well-established products. This
perhaps explains why the Diabetes product teams seem to closely reflect the multi-therapeutic areas
benchmarks. Most thought leader services commence in Phase II. Medical Science Liaison services
usually commence in Phase III about one year prior to launch.

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Get KOLs In at Phase II to Create Ownership
“You have to let them think they're designing
the development program. So you involve
them from Phase II onward and they help you
write the protocols, and by the time they've
gone through that, it's their baby just as much as
it is yours” – Global Head of Clinical and Medical
Services
“You have to let them think they're designing
the development program. So you involve
them from Phase II onward and they help you
write the protocols, and by the time they've
gone through that, it's their baby just as much as
it is yours” – Global Head of Clinical and Medical
Services
If your compound doesn’t have a novel Method of Action or it’s not a first-in-class, it can be difficult to bring
KOLs into your development program. One approach is to get the KOL involved in the planning of the
development program so that they develop a feeling of ownership.
“We’d let doctors have raw substance samples so that they could get their Ph.D. students
playing with it and some of the pre-clinical publications would come out from their own labs.
We control that quite tightly, but other companies I worked with used to use that as a way of
engaging key opinion leaders and generating extra useful data. It really got the guys
involved. They could play with it in their own hands and do what they want with it and design
some of their own studies. That really gave them a feeling of ownership. ”
– Global Head of Clinical and Medical Services
“We’d let doctors have raw substance samples so that they could get their Ph.D. students
playing with it and some of the pre-clinical publications would come out from their own labs.
We control that quite tightly, but other companies I worked with used to use that as a way of
engaging key opinion leaders and generating extra useful data. It really got the guys
involved. They could play with it in their own hands and do what they want with it and design
some of their own studies. That really gave them a feeling of ownership. ”
– Global Head of Clinical and Medical Services

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Investigator Segmentation Systems Help Tailor Outreach
Segment investigators to understand their motivations and objectives and to fine-tune
your recruitment and relationship plan to reflect investigator motivation profile.
Drug
Develop-
ers
Business
Minded
Career
Climbers
Publishers
Thought
Leaders
Science
Motivated
Healers
““It’s not clear that each investigatorIt’s not clear that each investigator
is just one segment. There is ais just one segment. There is a
predominant motivation and apredominant motivation and a
second and third motivation.second and third motivation.
Money is not usually the primaryMoney is not usually the primary
driver. They don’t want to godriver. They don’t want to go
bankrupt. When you ask them, theybankrupt. When you ask them, they
tell you money is third or fourthtell you money is third or fourth
level of importance.”level of importance.”
-- Senior Director, Clinical Operations,-- Senior Director, Clinical Operations,
Pharmaceutical CompanyPharmaceutical Company
Physician Motivation SegmentsPhysician Motivation Segments

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Diabetes IISs Occur – But Later in Phase III or Post-Launch
Clinical Trial Tactics: Please check all stages during which you conduct investigator-initiated
studies (non-registration studies)
Total Benchmark Class
83%
53%
57%
43%
17%
17%
0% 20% 40% 60% 80% 100%
Post Launch
Launch
1 year pre-launch (Ph III)
2 years pre-launch (Ph III)
3 years pre-launch (Ph III)
Phase II
Diabetes Segment
88%
38%
63%
25%
13%
0%
0% 20% 40% 60% 80% 100%
Post Launch
Launch
1 year pre-launch (Ph III)
2 years pre-launch (Ph III)
3 years pre-launch (Ph III)
Phase II
(n=30) (n=8)
The Diabetes segment uses Investigator-Initiated Clinical Studies (IISs) more cautiously than the larger
benchmark class. Early-stage IISs are less frequent than in the overall benchmark class. New safety
concerns regarding cardiovascular risk and anti-diabetes medicines may prompt companies to be more
cautious before granting requests to stage small clinical trials exploring an investigator treatment idea.

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Early Access Programs Common in Diabetes
“I think in all specialty areas the
level of experimentation is high. …
They will put every patient into some
kind of study, because drugs tend to
come to market very quickly with the
new drugs, which means that all the
details are not worked out. It will
have been tested in one population,
but maybe the doctor thinks it could
be of benefit in another population
or a slightly different way of use or
whatever.” – Global Head of Clinical
and Medical Services
Early Access Programs can benefit patients who are looking for solutions for life-
threatening and non-life-threatening conditions. EAPs can provide insights early on for
potential new therapies.
Benefits of EAPs
 Provide potentially life-saving therapies
to patients not participating in pivotal
trials
 Provide physicians with direct positive
experience of their patients who benefit
from therapy
 Provide physicians with additional
experience with different patients who
differ from overall trial group
 Provide insights that may reveal
additional marketplace potential for
therapy
Benefits of EAPs
 Provide potentially life-saving therapies
to patients not participating in pivotal
trials
 Provide physicians with direct positive
experience of their patients who benefit
from therapy
 Provide physicians with additional
experience with different patients who
differ from overall trial group
 Provide insights that may reveal
additional marketplace potential for
therapy

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Diabetes TA Employs Primary & Secondary Journals and Congresses
(n=31)
Please rate the importance of publishing your clinical results in various channels:
Total Benchmark Class
4%
10%
17%
83%
83%
25%
72%
47%
17%
13%
4%
3%
79%
17%Internet Self-publication
Minor Congresses or Events (Regional
/Local)
Alternative Media
Secondary Journals
Online Scientific Publications
Primary Journal
Major Congresses or Events (Int'l/Nat'l)
Highly Important Important
Diabetes Segement
13%
22%
33%
89%
89%
50%
56%
56%
25%
25%Internet Self-publication
Alternative Media
Minor Congresses or Events (Regional
/Local)
Online Scientific Publications
Secondary Journals
Primary Journal
Major Congresses or Events (Int'l/Nat'l)
Highly Important Important
(n=8)
The Diabetes therapeutic segment places highest importance on publishing clinical
research in primary journals and secondary journals, along with presenting clinical
research at national and regional congresses. Similar to the multi-therapeutic area
benchmark class, online publications can also be important.

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Diabetes Publication Productivity Lags The Benchmark Class
(n=6)
Publication Productivity: Please estimate the number of publications (by type) you would expect to issue
during the Phase III to Launch period to adequately prepare the market for your product's entry:
Total Benchmark Class
25th
Percentile
Mean Median
75th
Percentile
Abstracts 7 15 10 19
Peer-reviewed Manuscripts/Papers 4 7 5 8
Non-peer Reviewed Papers 2 7 7 10
Presentations by Investigators 5 12 10 14
Poster Sessions 6 15 10 19(n=26)
Diabetes
25th
Percentile
Mean Median
75th
Percentile
Abstracts 5 13 8 10
Peer-reviewed Manuscripts/Papers 4 9 5 9
Non-peer Reviewed Papers 1 4 3 8
Presentations by Investigators 5 11 8 10
Poster Sessions 6 14 9 18
The Diabetes segment trails the total benchmark class’ productivity levels – measured
in terms of abstracts, non-peer-reviewed manuscripts, and presentations. Yet, it leads
in terms of peer-reviewed papers – suggesting this is essential in the competitive
Diabetes landscape. Top quartile productivity leaders in the benchmark class out-
produce diabetes abstracts & presentations by 30-50 percent.
Green = productivity leader Red = productivity laggard
Note: Therapeutic segment is compared to benchmark. Significant variation between TA and benchmark is noted with green spotlighting high productivity and red spotlighting low
productivity.

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In Diabetes Arena, Don’t Ignore Blogs
“In diabetes they are very active in
chat rooms and blogs and online.
For example, each region tends to
have a diabetes expert that
everyone looks to for his or her
blog, and they often critique on the
latest and greatest. They critique
what each company is doing. We
have found them to be quite
powerful in their opinion. So in my
previous company people in those
positions, they would call in to get a
response, and we would answer
them. We would talk with them.”
– National Sales Manager,
Managed Care
Diabetes is one of the therapeutic areas where blogs are an important information
source for patients and savvy pharmaceutical organizations are plugged into that
domain. While interactions need to be tempered with caution, they can be useful for both
the company and patients.
http://www.battlediabetes.com/fake-lifescan-test-strips/

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Integrate PR and Advocacy with Right Message
“Typically it's integrated from a PR
perspective and an advocacy
perspective, so you're going to work
with the right type of patient
advocacy groups and your public
relations campaign to build the right
type of messages and disseminate
them.” – Senior Vice President,
Commercial
“Typically it's integrated from a PR
perspective and an advocacy
perspective, so you're going to work
with the right type of patient
advocacy groups and your public
relations campaign to build the right
type of messages and disseminate
them.” – Senior Vice President,
Commercial
While it makes strategic sense to marry a public relations campaign with collaborative
work you’re doing with an advocacy group, it needs to be done carefully. Steer clear of
branded messages and focus on a therapeutic area and disease state information.
“You have to focus on the level of
unmet need, and then building off of
the unmet need then you talk about
emerging areas or targets or programs
that are addressing that and it's done
in a balanced but strategic manner.” –
Senior Vice President,
Commercial
“You have to focus on the level of
unmet need, and then building off of
the unmet need then you talk about
emerging areas or targets or programs
that are addressing that and it's done
in a balanced but strategic manner.” –
Senior Vice President,
Commercial
Tactics Strategy

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Build Payer Perspectives into Negotiations
When negotiating with payers, use clinical data that shows what’s in it for them – how
your product’s value can help them gain market share on their competition. If it’s a blood
pressure product, show 90 percent of their patients will be controlled and thus there are
fewer strokes/heart attacks.
“The other thing was to think
about what's in it for them. So if
you're selling to an HMO, how
can your product help that HMO
meet its targets? Not just what
does your product do for the
patients, but what does your
product do for the HMO, how
can it help them reduce costs,
how can it help it attract patients
better than other HMOs?”
– Global Head of Clinical and
Medical Services
“The other thing was to think
about what's in it for them. So if
you're selling to an HMO, how
can your product help that HMO
meet its targets? Not just what
does your product do for the
patients, but what does your
product do for the HMO, how
can it help them reduce costs,
how can it help it attract patients
better than other HMOs?”
– Global Head of Clinical and
Medical Services
April 23, 2009 Link to story

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Diabetes Targets PCPs & Nurses Earlier
Targeting the Right Groups for Education at the Right Time: Please note when you begin to
educate different target audiences in your overall efforts to educate the market.
(n=24) (n=8)
The Diabetes segment follows the Specialist → Primary Care Physician → Nurse Practitioner cascade.
However, it introduces targeting to Primary Care Physicians and Nurse Practitioners somewhat earlier – at
two year pre-launch – than the overall benchmark. It also more actively ramps up specialist targeting in
early Phase III. This likely reflects the importance of PCPs and Nurses in diabetes treatment.
Specialist Physicians Primary Care Physicians Nurse Practitioners
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
3 Years 2 Years 1 Year Launch Post
Before Before Before Year Launch
Launch Launch Launch Year
Total Benchmark Class Diabetes Segment
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
3 Years
Before
Launch
2 Years
Before
Launch
1 Year
Before
Launch
Launch
Year

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Best Practices & Lessons Learned: KOLs & Timing
Benchmark partners shared their best practices and key lessons learned regarding
market education for successful new product launches. Beginning education early and
involving Key Opinion Leaders (KOLs) are top practice areas.
Use KOLS Wisely & Often
 “KOL development, support and integration are key.”
 “Have the KOLs 'own' the content.”
 “Use KOLs where possible.”
 “KOL management and thought leader engagement needs to be
early – to partner through the highs and lows of development.”
Begin Early . . .
 “Obtain early input from all parties, including payers and patients,
not just investigators and prescribers.”
 “You can NEVER start too early.”
 “Engage payers early.”
 “Educate early; at least one year prior to launch.”
 . . . However
 “Have a detailed plan and be cautious spending too much money too soon.”