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

BEST PRACTICES,®

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Copyright © Best Practices®, LLC

Strategic Benchmarking Research, Analysis and Recommendations

Educating KOLs, Physicians, Patients and Payers to Support

Successful Product Launches

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Table of ContentsTable of ContentsBackground

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 Drivers1.1 Develop Integrated Continuous Thought Leader Strategies p.14-161.2 Thought Leader Targeting p.17-211.3 Thought Leader Relationship & Value Management p.22-292.1 Manage Clinical Trials To Win Highly Regarded Thought Leaders & Investigators Into Your Clinical Trials p.30-382.2 Managing Investigator-Initiated Studies p.39-472.3 Early Access Programs: Helping Patients & Expanding Physicians Experience p.48-502.4 Post-Approval Early Access Programs: Helping Patients, Physicians & Marketplace Buzz p.51-543.1 - Data Disclosures: Inform Medical Community of Your Progress & Commitment p.55-604.1 Communicate Clinical Science Through Journals & Congresses p.61-674.2 - Using Scientific Publications: Marrying Productivity and Insights p.68-745.1 - Use Multi-Channel Medical Education To Inform Health Care Providers p.75-775.2 - Medical Education: Balancing the Mix of CME, Grants & Tools p.78-81

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Table of ContentsTable 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

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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 ResearchBrand, 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.

MARKET MARKET EDUCATION EDUCATION

EXCELLENCEEXCELLENCE

1. Develop Integrated Continuous Thought Leader Strategies

2. ManageClinical Trials To

Win Highly Regarded

Investigators & TLs

3. Data Disclosures Inform Medical

Community of Your Progress &

Commitment7. 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 EngagedResearch 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, Oncology• Director, Oncology

Commercial Analysis• Senior Manager, Marketing• Manager, Oncology 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 brand teams and therapeutic franchise groups. “Lessons learned” executive interviews were conducted across nine select companies.

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Total Benchmark Class

Six to Ten, 24%

More than Ten, 12%

Less than Five, 65%

A Third of Participants Have Launched more than Five Drugs

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

(n=34)

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

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1.1 Develop Integrated Continuous Thought Leader

Strategies:

Throughout Development and Market Entry, Thought Leaders Are A

Compass Guiding Market Insights and Education

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Start Early With Thought Leader Education & Services

(n=34)

Q6. Developing Thought Leaders: Please check when you should start each activity for educating thought leaders.

Total Benchmark Class

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 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%

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.

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Market Entry Teams “Seed & Grow” MSL Pre-Launch Coverage

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?

(n=19)

3

8

15

26

Phase III-3Years

Phase III-2Years

Phase III-1Year

LaunchYear

# M

SLs

Ass

igne

d

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.

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2.2 Managing Investigator- Initiated Studies:

Engaging Key Investigators in Developing Your Product’s Full Potential

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Oncology TA Tolerates Earlier Risk for IISs

“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

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.

http://deainfo.nci.nih.gov/advisory/bsa/bsa030 8/presentations/Monday/1110am_Dorowshow1 .ppt

http://deainfo.nci.nih.gov/advisory/bsa/bsa0308/presentations/Monday/1110am_Dorowshow1.ppt



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4.1 Communicate Clinical Science Through Journals & Congresses

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Primary Journals and Congresses Drive Publication Strategies

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

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.

(n=31)

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

Scientific Publishing Channel Impact Map

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4.2 - Using Scientific Publications: Marrying

Productivity and Insights

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Lower Wall Between Medical and Marketing

“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

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.

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7.1 - Payer Education Starts Early; Focus On

Cost And Outcomes

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Engage Payers Early & Maintain Relations Through Launch

(n=34)

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

Total Benchmark Class Pre- Clinical Phase I Phase

IIPhase III- 3 Years

Phase III-2

Years

Phase III-1 Year

NDA thru Launch

Year

Conducting Advisory Boards with Payers / agencies 3% 0% 27% 15% 33% 18% 3%

Conducting Clinical Meetings / Discussions with Payers / Agencies 0% 6% 21% 9% 30% 24% 9%

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%

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.

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Best Practices, LLC6350 Quadrangle Drive, Suite 200,

Chapel Hill, NC 27517www.best-in-class.com

Telephone: 919-403-0251

About Best Practices, LLCBest 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.

http://www.best-in-class.com/

Date post:	17-Dec-2014
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Educating KOLs, Physicians, Patients and Payers to Support Successful Product Launches Report...

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