Download - Educating the Marketplace to Support Successful Diabetes Product Launches Report Summary

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Copyright © Best Practices, LLC

Educating the Marketplace to Support Successful Diabetes

Product Launches

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 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.

MARKET MARKET EDUCATION EDUCATION

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 EngagedDiabetes/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. ”


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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

““It’s not clear that each investigator It’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 don’t want to go driver. They don’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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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)


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)



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 Class25th

PercentileMean 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 Median75th

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?”


“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?”


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.”

Download - Educating the Marketplace to Support Successful Diabetes Product Launches Report Summary

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