Shaping the Marketplace to Support Successful Oncology Product Launches Tactics for Educating KOLs,...

BEST PRACTICES,®

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Strategic Benchmarking Research, Analysis & Recommendations

Shaping the Marketplace to Support Successful Oncology Product Launches:

Tactics for Educating KOLs, Physicians, Patients and Payers

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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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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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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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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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 MOA 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 for the program.

“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.

DrugDevelop-

ersBusinessMinded

CareerClimbers

Publishers

ThoughtLeaders

ScienceMotivated

Healers

““ItIt’’s not clear that each investigator s not clear that each investigator is just one segment. There is a is just one segment. There is a predominant motivation and a predominant motivation and a second and third motivation. second and third motivation. Money is not usually the primary Money is not usually the primary driver. They dondriver. They don’’t want to go t want to go bankrupt. When you ask them, they bankrupt. When you ask them, they tell you money is third or fourth tell 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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Early Access Programs Common in Oncology

“I think in all specialty areas the level of experimentation is high, but in oncology it's taken to a much higher level. 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. There's a huge amount of patients in the oncology area that are in some kind of clinical trial or another.” – Global Head of Clinical and Medical Services

One Top 10 pharma company said it only provides Early Access Programs (EAP) for life- threatening conditions, which leads to EAPs mostly in oncology.

Benefits of EAPsProvide potentially life-saving

therapies to patients not participating in pivotal trialsProvide physicians with direct positive experience of their patients who benefit from therapyProvide physicians with additional experience with different patients who differ from overall trial groupProvide insights that may reveal additional marketplace potential for therapy

Benefits of EAPsProvide potentially life-saving

therapies to patients not participating in pivotal trialsProvide physicians with direct positive experience of their patients who benefit from therapyProvide physicians with additional experience with different patients who differ from overall trial groupProvide insights that may reveal additional marketplace potential for therapy

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Oncology Publishing Strategies Rely on Key Congresses & Journals

(n=31)

Q15. 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 ImportantOncology Segment

10%

10%

20%

70%

80%

10%

30%

30%

30%

20%

0%

0%

89%

90%Secondary Journals

Minor Congresses or Events (Regional/Local)

Internet Self-publication

Alternative Media

Online Scientific Publications

Major Congresses or Events(Intâ€™l/Natâ€™l)

Primary Journal

Highly Important Important

(n=11)

The Oncology segment places highest importance on publishing clinical research in primary journals, appearing at critical congresses and to a lesser degree on some online scientific publications. Similar to the multi-therapeutic area benchmark class, secondary journals and events are important.

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One Study = Five Publications

“So I have always used as a rule of thumb that an expectation that I have is I want five publications from each study at a minimum, and that's primary, secondary, different data sets, subpopulations. For the [a diabetes blockbuster] program we were able to do seven for each study. They typically look at the secondary data and things as, ‘Oh, that's not interesting, it's not exciting.’ But it's the bread and butter because that's what's going to keep feeding the promotional machine.”

– Senior VP Commercial With Diabetes Franchise

Publish multiple articles from one study to give marketing multiple presentation points and to inform healthcare professionals across a broad spectrum. Field research reveals publishing productivity improvements exist across therapeutic areas – including Diabetes and Oncology.

Link to studies

Erbitux Explores Multiple Factors in Its Clinical Trials – Resulting in Many Publishing Opportunities.

http://www.asco.org/portal/site/ascov2/gsasearch?src=abstracts&return_page=menuitem.a1c60e38cd6d5b9f01ae0094ef37a01d&return_channel=874911ff7fefd110VgnVCM100000ed730ad1RCRD&q=noQstring&search_mode=adv&the_meeting_ids=65%2C64%2C63%2C60%2C58%2C55%2C54%2C53%252

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Benchmark Start Periods: MedEd Ramps Up in Phase II & Latter Phase III

(n=34)

Q8. Educating Physicians: Please check when you should start each activity for educating physicians.

Total Benchmark ClassPre-

Clinica l

Phase I Phase IIPhase III-3

Years

Phase III-2

Years

Phase III- 1 Year

NDA thru Launch

Year

Presentations at Medical Congresses 3% 12% 41% 21% 9% 15% 0%

Employing Integrated Publishing Strategies 6% 18% 24% 32% 12% 9% 0%

Communicating & Disseminating Clinical Trial Results 0% 15% 33% 21% 15% 12% 3%

Conducting Clinical Trials 9% 29% 32% 18% 0% 9% 3%

Conducting Investigator Initiated Trials 0% 6% 13% 19% 6% 23% 32%

Utilizing New Technologies/Social Media for Physicians Education 0% 0% 6% 18% 12% 42% 21%

Using Pre-Launch Public Relations Campaigns to Communicate Clinical Trials Info 0% 3% 21% 6% 30% 21% 18%

Utilizing Speaker Programs & Training 0% 3% 6% 12% 6% 29% 44%

Developing Internet-Based Education Strategies 0% 0% 12% 9% 15% 39% 24%

Sponsoring CME Grants to Educate Physicians 0% 0% 6% 18% 18% 32% 26%

Conducting Quality/Economics Studies Meeting 0% 9% 9% 36% 21% 12% 12%

Announcing Trade/Brand Name 0% 6% 6% 12% 12% 21% 42%

Announcing Generic Name 3% 27% 27% 15% 15% 6% 6%

Across the multi-therapeutic area benchmark class, critical market educating activities usually start between Phase II and early Phase III. Some companies start notably earlier than others. The “start periods” most frequently noted are circled in red for each market education activity.

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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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Meet Payers Early to Educate and Win Acceptance

“You've got to get out in the marketplace and let your retail pharmacies know, your health plans know that this is coming. You don't want to surprise them, and you want to work with them to make sure it's included in either tier one or tier two on their formulary. And if it is a tier three, it's a tier three at a reasonable co-pay.” – Executive Director, Commercial

“You've got to get out in the marketplace and let your retail pharmacies know, your health plans know that this is coming. You don't want to surprise them, and you want to work with them to make sure it's included in either tier one or tier two on their formulary. And if it is a tier three, it's a tier three at a reasonable co-pay.”– Executive Director, Commercial

Meet with all the marketplace players well in advance of a product launch to educate and to map out the landscape you’ll have to traverse in order to get to the most appropriate tier in the managed markets.

www.ehcca.com/presentations/medicarecongress3/precon_2c.ppt

http://www.ehcca.com/presentations/medicarecongress3/precon_2c.ppt

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Best Practices & Lessons Learned: KOLs & TimingBenchmark 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.”

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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:	20-Aug-2015
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Shaping the Marketplace to Support Successful Oncology Product Launches Tactics for Educating KOLs,...

Health & Medicine