Educating KOLs, Physicians, Patients and Payers to Support Successful Product Launches Report Summary

Educating KOLs, Physicians, Patients
and Payers to Support
Successful Product Launches

Strategic Benchmarking Research, Analysis and Recommendations

BEST PRACTICES,
1 ®
Copyright © Best Practices®, LLC LLC

Table of Contents
Background
Summary of Key Insights, Findings and Lessons Learned p.4-7
Universe of Learning: Research Participants, Launch Experience, and Therapeutic
Area Demographics p.8-13
Market Entry Success Drivers
1.1 Develop Integrated Continuous Thought Leader Strategies p.14-16
1.2 Thought Leader Targeting p.17-21
1.3 Thought Leader Relationship & Value Management p.22-29
2.1 Manage Clinical Trials To Win Highly Regarded Thought Leaders &
Investigators Into Your Clinical Trials p.30-38
2.2 Managing Investigator-Initiated Studies p.39-47
2.3 Early Access Programs: Helping Patients & Expanding Physicians Experience
p.48-50
2.4 Post-Approval Early Access Programs: Helping Patients, Physicians &
Marketplace Buzz p.51-54
3.1 - Data Disclosures: Inform Medical Community of Your Progress &
Commitment p.55-60
4.1 Communicate Clinical Science Through Journals & Congresses p.61-67
4.2 - Using Scientific Publications: Marrying Productivity and Insights p.68-74
5.1 - Use Multi-Channel Medical Education To Inform Health Care Providers p.75-77
5.2 - Medical Education: Balancing the Mix of CME, Grants & Tools p.78-81

BEST PRACTICES,
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Table of Contents
6.1 - Inform Patients Through Education & Advocacy Group Collaborations p.82-90
7.1 - Payer Education Starts Early; Focus On Cost and Outcomes p.91-101
8.1 Use PR & New Technologies For Leveraged Reach to Patients, Physicians, &
Payers p.102-118
8.2 Use New Technologies For Educating & Informing Patients p.119-121
9.1 - Orchestrate Medical Education Timing To Reach Right Constituencies At the
Right Times (placeholder slide) p.122
10.1 - Allocate Market Education Mix To Reflect Therapeutic Area Needs & the
Competitive Landscape p.123-125
Lessons Learned
Voices From the Field: Best Practices, Lessons Learned & Pitfalls To Consider
p.126-129
Future Trends & Issues p.130-133
Appendix I - Orchestrate Medical Education Timing To Reach Right Constituencies
At the Right Times p.134-138
About Best Practices

BEST PRACTICES,
3 ®

Research Objective and Methodology
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.

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

BEST PRACTICES,
4 ®

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.

10. Allocate 1. Develop
Market Ed Mix To Integrated
“I think it's going to
“I think it's going to
Reflect T.A. & Continuous boil down to being
boil down to being
Competitive Thought Leader 2. Manage able to actually
9. Orchestrate able to actually
Med Ed Timing Landscape Strategies Clinical Trials To
Win Highly identify by individual
identify by individual
To Reach Right
Constituencies Regarded customer what
Investigators &
customer what
At Right Times channel they want
TLs channel they want
8. Use PR & New
MARKET information from and
3. Data Disclosures information from and
Technologies For EDUCATION Inform Medical how you're going to
Leveraged Reach to Community of Your
how you're going to
Patients, Physicians, EXCELLENCE Progress & reach them most
reach them most
& Payers Commitment efficiently, and almost
efficiently, and almost
7. Start Payer 4. Communicate going through aa
going through
Education Early; Clinical Science decision tree that
Focus On Cost
decision tree that
Thru Journals & looks at effectiveness
& Health 6. Inform 5. Use Multi- Congresses looks at effectiveness
Outcomes Patients Thru Channel Med. and cost . .. ...”
and cost ..”
Education & Ed. To Inform -Senior Vice President, Marketing
Advocacy Group Health Care -Senior Vice President, Marketing
Collaborations Providers

BEST PRACTICES,
5 ®

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

Participating Companies

BEST PRACTICES,
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Universe of Learning: Job Titles and Executive Interviews
Research participants’ roles ranged from senior leaders of commercial operations to managers of
brand teams and therapeutic franchise groups. “Lessons learned” executive interviews were
conducted across nine select companies.

Job Titles Interview Class
• Senior VP, Commercial • Executive Director,
Operations Global Marketing
• Senior VP, Marketing • Associate Brand
• Executive Director, Director
Commercial Operations • Senior Manager,
• Head Clinical & Medical New Product
Services Commercialization
• Vice President, Marketing • National Sales
• Senior Director, Oncology Manager
• Director, Oncology • Manager, Clinical
Commercial Analysis Research
• Senior Manager, Marketing • Senior Product
• Manager, Oncology Market Manager/Payer
Research Marketing
• Senior Director, Diabetes • Senior Manager,
• Group Sales & Brand Health Care
Manager Solutions
• Senior Manager, • Medical Adviser
Commercial Development

BEST PRACTICES,
7 ®

A Third of Participants Have Launched more than Five Drugs

Research participants were veterans of product launches, with 36 percent taking part
in more than five launches.

Q3. Number of New Product Launches Worked On: How many new product launches have you
participated in during your career?

Total Benchmark Class

More than Ten,
12%

Six to Ten, 24%

Less than Five,
65%

(n=34)

BEST PRACTICES,
8 ®

1.1 Develop Integrated
Continuous Thought Leader
Strategies:

Throughout Development and Market
Entry, Thought Leaders Are A
Compass Guiding Market Insights and
Education

BEST PRACTICES,
9 ®

Start Early With Thought Leader Education & Services
Thought leaders are the bellwethers of market direction. They help companies understand where
therapeutic guidelines and practices are headed; they influence how practicing physicians respond to
new therapies. Not surprisingly, the largest response groups signaled Phase II as the kickoff to most
thought leader services. Some companies with robust pipelines and deep-standing commitment to their
therapeutic areas start thought leader services as early as pre-clinical research phases.
Q6. Developing Thought Leaders: Please check when you should start each activity for
educating thought leaders.

Total Benchmark
Class
Engaging
Thought
Providing Communicating
Developing Leaders &
Medical Critical
Integrated Conducting Key
Science Information and
Thought Leader Advisory Boards Investigators
Liaison Sharing Research
Strategies in Clinical
Services Insights
Trial Protocol
Development
Pre-Clinical 6% 18% 3% 18% 12%
Phase I 15% 12% 12% 24% 9%
Phase II 41% 26% 6% 47% 29%
Phase III-3 Years 21% 24% 15% 6% 26%
Phase III-2 Years 15% 6% 21% 3% 12%
Phase III-1 Year 3% 12% 32% 0% 6%
NDA thru Launch Year 0% 3% 12% 3% 6%

(n=34)

BEST PRACTICES,
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Market Entry Teams “Seed & Grow” MSL Pre-Launch Coverage
The overall benchmark class seeds Medical Science Liaisons (MSLs) at the start of Phase III clinical trials with
typically three liaisons to serve national thought leaders and clinical investigators. As Phase III trials
progress, this number of MSLs nearly doubles or triples each subsequent year. By launch year, the average
number of MSL has reached 26. This MSL seeding and growth pattern can be observed across most
therapeutic areas – although the staffing intensity varies somewhat across individual specialty areas.
Q24. MSL Coverage: Estimate how many field-based medical science specialists or liaisons
(MSLs) you assign during each year of the Phase III pre-launch period to a new product in a
new therapeutic area?

26
# MSLs Assigned

15

8

3

Phase III-3 Phase III-2 Phase III-1 Launch
Years Years Year Year
(n=19)

BEST PRACTICES,
11 ®

2.2 Managing Investigator-
Initiated Studies:
Engaging Key Investigators in Developing
Your Product’s Full Potential

BEST PRACTICES,
12 ®

Oncology TA Tolerates Earlier Risk for IISs
Some organizations – particularly those working in Oncology, do investigator-initiated trials both early and
late in the development cycle. In Oncology, the life-threatening condition of many patients inspires
oncologists to conceive investigator initiated trials examining many tumor types and patient populations
that lie outside the first pivotal trials.
“Once you have confidence that
you've determined what your safety
profile is, you can act strategically
and build the right type of Phase
One-type programs from an IIT
perspective that'll allow you to
understand how you perform in other
diseases or in combination with other
agents. I guess if I was developing
an allergy medicine, that would be
one thing. But I think in cancer it's
very different. I think most oncology
organizations are willing to take a
calculated risk in some of these
areas.”
- Senior Vice President, Commercial
http://deainfo.nci.nih.gov/advisory/bsa/bsa030
8/presentations/Monday/1110am_Dorowshow1
.ppt

BEST PRACTICES,
13 ®

4.1 Communicate
Clinical Science Through
Journals & Congresses

BEST PRACTICES,
14 ®

Primary Journals and Congresses Drive Publication Strategies
Benchmark partners place highest importance on publishing clinical research in primary journals and
secondary journals – along with presenting clinical research at both national and regional congresses,
and to a lesser degree on some online scientific publications. Online publications can also be important.
Some therapeutic areas place relatively greater importance on publishing in alternative channels.

Q15. Please rate the importance of publishing your clinical results in various channels:

Scientific Publishing Channel Impact Map

Highly Important Important
Major Congresses or Events (Int'l/Nat'l) 83% 13%

Primary Journal 83% 17%

Online Scientific Publications 17% 47%

Secondary Journals 10% 72%

Alternative Media 4% 25%

Minor Congresses or Events 79%
4%
(Regional /Local)

Internet Self-publication 3% 17%
(n=31)

BEST PRACTICES,
15 ®

4.2 - Using Scientific
Publications: Marrying
Productivity and Insights

BEST PRACTICES,
16 ®

Lower Wall Between Medical and Marketing
As the wall between Medical and Marketing has gotten higher, marketing groups no
longer understand the importance of scientific communication and how to work with
Medical to get that information published. Each group must have its autonomy – but
they must work together for the company’s benefit.

“If you separate Medical and Marketing, then who's
going to be the one basically saying whether or not
you're getting what you need out of Medical? The
reporting chain that goes all the way up through
Medical doesn't look at things that way. We went in
and Marketing did a gap analysis. They had one
primary care study publication in the three years
since launch. And they're saying, ‘Oh, we got this in
JAMA.’ And we're like, great, isn't this a primary care
drug? Yeah, well, how many primary care
publications did you….one. Well, holy cow, guys. I
think if you don't have that commercial lens…you
need Commercial and Medical looking at it from
different perspectives, and you need both. .” –
Senior VP Commercial

BEST PRACTICES,
17 ®

7.1 - Payer Education
Starts Early; Focus On
Cost And Outcomes

BEST PRACTICES,
18 ®

Engage Payers Early & Maintain Relations Through Launch
The overall benchmark class reflects early and continuous involvement with payers and government
agencies: They engage payers through clinical trial protocol design and needs assessment in Phase II.
Commence outcome studies in early Phase III. Then conduct Ad Boards, agency meetings and payer
pricing sensitivity in mid-Phase III. Payer education activities then accelerate late in Phase III.

Q12.Educating Payers & Government Agencies: Please check when you should start each activity for educating
payers & government agencies (Medicare/Medicaid).

Phase Phase NDA thru
Total Benchmark Class Pre- Phase Phase III-
Phase I III-2 III-1 Launch
Clinical II 3 Years
Years Year Year
Conducting Advisory Boards with Payers / agencies 3% 0% 27% 15% 33% 18% 3%
Conducting Clinical Meetings / Discussions with Payers /
0% 6% 21% 9% 30% 24% 9%
Agencies
Payer and Government Needs 0% 3% 36% 12% 24% 18% 6%
Conducting Early Payer Education Activities 0% 3% 21% 15% 9% 45% 6%
Engaging Payers in Clinical Trial Protocol Development 6% 3% 38% 25% 16% 9% 3%
Conducting Health Outcomes Studies 3% 9% 27% 33% 21% 6% 0%
Assessing Payers Efficacy / Safety / Pricing Sensitivity 0% 9% 18% 18% 33% 15% 6%
Announcing Trade/Brand Name 0% 10% 6% 3% 13% 32% 35%
Announcing Generic Name 6% 13% 13% 16% 23% 19% 10%

(n=34)

BEST PRACTICES,
19 ®

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
www.best-in-class.com
Telephone: 919-403-0251

BEST PRACTICES,
20 ®

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