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Success Factors and Failure Points in Metabolic Product Launches Report Summary

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Biopharmaceutical companies invest large amount of resources to develop and launch new products for metabolic therapeutic areas. However, the complexity of a new metabolic product launch is compounded by the many pitfalls that are part of the market-entry landscape.
Best Practices
®, LLC undertook this research to showcase current and future risk levels for various pitfalls across critical launch fronts that can derail a new metabolic product. Pharmaceutical launch executives can use this study to better understand the potential pitfalls and stumbling blocks that they'll have to navigate as part of a new metabolic product entering the market.
Study Overview–-
This study explores the executive insights, best practices and lessons learned to avoid common pitfalls while launching a new metabolic product into market.
About the Benchmark Class -
Forty four executives from 38 leading companies including Abbott, Amgen, Baxter, Bayer, Eisai, GlaxoSmithKline, Merck, Novartis, and Roche participated in this study. Majority of the respondents were at vice president or director level.
Section 1: Study Background --
Reviews the study background, the research approach, methodology, participant demographics, the benchmark class and key findings.
Section 2: Topical chapters --
Outlines valuable insights and findings from the study that includes pitfalls & stumbling blocks, lessons learned and best practices and future changes. Pitfalls chapter reviews current and future risk levels for these metabolic launch factors: product shaping, market shaping, physician, patient, payer, internal and regulatory.

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Success Factors and Failure Points in Metabolic Product Launches Report Summary

  1. 1. BEST PRACTIC1Copyright © Best Practices , LLC%Success Factors and Failure Points inMetabolic Product LaunchesStrategic Benchmarking Research, Analysis & Recommendations
  2. 2. BEST PRACTIC2Copyright © Best Practices , LLCTable of ContentsBackground Summary of Business Issue, Key Insights, Findings and Lessons Learned p.4-18 Universe of Learning: Research Participants, Launch Experience, Cardiology,Metabolics & Other Therapeutic Area Demographics p.19-26Main Deck Winning on Differentiated Product Positioning p.27-36 Winning a Physician’s Initial Trial of a New Product p.37-39 Articulating Benefits that Shape Positive Market Perception p.40-44 New Product Pricing Strategy p.45-56 Thought Leader Engagement p. 57-65 Early Physician Education p.66-76 Payer Education p. 77-81 Patient Advocacy and Education p.82-86 Preparing Market Constituents p.87-91 Access Insights & Success Factors p.92-100 Winning Hospital Formulary Access p.101-103 Resource Allocation for Key Stakeholders in the Current & Future Marketplacesp. 104-106 Investment Requirements, Resource Allocation & Timing p.107-117
  3. 3. BEST PRACTIC3Copyright © Best Practices , LLCTable of Contents Internal Launch Readiness p.118-131 New Technologies for Informing Patients & Physicians p.132-137 Pitfalls & Stumbling Blocks p.138-159 Demonstrating Efficacy p.160-168 Rating Different Safety Dimensions p.169-178 Lessons Learned, Best Practices & Future Changes p.179-181 About Best Practices, LLC p.182
  4. 4. BEST PRACTIC4Copyright © Best Practices , LLCFramework for Presenting Insights, Practices & PitfallsThe performance benchmark and field research have harvested scores of insights andobservations. They have been organized into the following summary framework fordiscussion and planning purposes.Insights,Best Practices,Pitfalls 3. Invest in Launch &Support4. EngageThought Leaders5. Educate KeyStakeholders: (Physicians,Patients, & Payers)6. DemonstrateValue AcrossMultiple Fronts2. Clearly Define TargetPatient Population7. Utilize NewTechnologies To Inform1. Differentiate Your Product8. Avoid Pitfalls &Stumbling Blocks
  5. 5. BEST PRACTIC5Copyright © Best Practices , LLC Differentiating Your Product - Secondary Benefits Can Be Win Themes:Differentiated positioning begins on factors established in clinical trials – such asefficacy, unmet needs, safety and target patient population. Secondary positioningfactors have less overall impact – but can be useful in a crowded market – and areoften more directly influenced through Marketing. Using secondary benefits can be aneffective strategy for positioning a product in a highly competitive market. As one executive observed during interviews: “You like to go to market with an efficacymessage, that’s what you want.. If you can’t do efficacy, fall back to safety. If you can’tdo safety, you fall back to convenience. If you can’t do convenience, you fall back topricing.” Secondary or even tertiary positioning factors have been win themes. Qualityof life, ease of use, cost effectiveness, patient compliance, or even a celebrityspokesperson are examples. Use of secondary factors varies considerably across TAs.In Diabetes, preventive benefits, unmet need, weight control, health outcome arerated as most effective1. Differentiate Your Product In A Crowded MarketDifferentiation is a key factor in a new product’s launch success. While efficacy andsafety are considered the best ways to differentiate a new product, new therapies inDiabetes also can use secondary benefits to gain traction at launch.
  6. 6. BEST PRACTIC6Copyright © Best Practices , LLCUniverse of Learning: 38 Companies EngagedParticipating CompaniesResearch participants included 44 executives and managers from 38 leadingpharmaceutical, biotech and medical device companies.Laboratorios Dermatologicos DarierTGC MedTech
  7. 7. BEST PRACTIC7Copyright © Best Practices , LLCDiabetes research participants included nine executives and managers at seven industryleading companies.Participant Titles• Business Manager• Marketing Manager• Marketing Manager• Senior Training Manager• Senior Brand Manager• Marketing Director• Global Marketing Director• Director, Strategic Planning• Former Senior Vice PresidentDiabetes Segment: 9 Participants EngagedLevothyroxineTaspoglutideDiabetes ProductsBenchmark Partners
  8. 8. BEST PRACTIC8Copyright © Best Practices , LLCEfficacy, Unmet Need Offer Best Positioning ToolsQ5. Winning On Differentiated Product Positioning: Differentiated product positioning is critical tomarket entry success. Rate the effectiveness of different positioning strategies and tactics forwinning in the marketplace.n = Total Benchmark Class NotUsedHighlyIneffectiveSomewhatIneffectiveSomewhatEffectiveHighlyEffectiveTotalEffective43 Efficacy Profile 2% 0% 2% 35% 60% 95%44 Unmet medical need 2% 2% 2% 14% 80% 93%43 Clearly Defined Patient Population/ Sub-population5% 2% 5% 51% 37% 88%44 Differences from current therapies 2% 5% 7% 32% 55% 86%44 Safety Profile 5% 0% 14% 52% 30% 82%44 Health Outcomes 7% 2% 16% 48% 27% 75%44 Tolerability 2% 2% 23% 45% 27% 73%44 Ease-of -use/ patient compliance 11% 9% 9% 48% 23% 70%44 Dosing 11% 7% 14% 43% 25% 68%44 Cost Effectiveness 14% 2% 18% 36% 30% 66%For respondents as a whole, efficacy and unmet need remain the most attractivepositioning tools for differentiating. But participants indicated that an effective use of atight target patient population/sub-population presents an opportunity where efficacy andunmet need may not be differentiating options for a new product’s launch.
  9. 9. BEST PRACTIC9Copyright © Best Practices , LLCThe fact that the BMS/AZ Diabetes product Onglyza had a safety and efficacy profile verysimilar to market leader Januvia created problems across a number of critical fronts:Payers, KOLs, Prescribers and Patients. The result - a disappointing launch.Lack of Differentiation Creates Domino Effect“I think they didn’t have a greatdifferentiation strategy. Theirefficacy was undifferentiated. Ifyou’re the same efficacy-wise, youhave to have some other goodcompelling reason, or interestingreason or a promotional reason toconsider it. I never got the sense ofwhat that really was.”– Januvia Marketing Leader“There isn’t anything good to say because there’s no mention of why is thisbetter or why this is different.” – Januvia Marketing LeaderPitfalls Created by Onglyza’sLack of DifferentiationInsurers reluctant to add toformulary at same tier as like-priced Januvia.No good reason for prescribers toshift from tried-and-true Januvia.KOLs unlikely to advocate changein prescribing habits.
  10. 10. BEST PRACTIC10Copyright © Best Practices , LLCUnmet Need, Clear Patient Group Best Diabetes PositionersQ5. Winning On Differentiated Product Positioning: Differentiated product positioning is critical tomarket entry success. Rate the effectiveness of different positioning strategies and tactics forwinning in the marketplace.n = Diabetes NotUsedHighlyIneffectiveSomewhatIneffectiveSomewhatEffectiveHighlyEffectiveTotalEffective9 Unmet medical need 0% 0% 0% 11% 89% 100%9 Clearly Defined Patient Population/ Sub-population0% 0% 0% 44% 56% 100%9 Efficacy Profile 0% 0% 11% 22% 67% 89%9 Differences from current therapies 11% 0% 0% 22% 67% 89%9 Dosing 0% 11% 0% 44% 44% 89%9 Health Outcomes 0% 0% 11% 56% 33% 89%9 Tolerability 0% 0% 11% 67% 22% 89%9 Safety Profile 11% 0% 11% 78% 0% 78%9 Patient Quality of Life 0% 0% 22% 33% 44% 78%For the Diabetes segment, meeting an unmet need and having a clearly defined patientpopulation were seen as the best positioning tools for differentiation. Interestingly, theywere followed by five positioning tools that were seen as almost equally effective,indicating they are important strategies in the Diabetes area.
  11. 11. BEST PRACTIC11Copyright © Best Practices , LLCAd Boards & Trial Involvement Effective TL StrategiesQ22. Thought Leader Engagement: Rate the effectiveness of various thought leader engagementstrategies for creating an informed and receptive marketplace at launch for your new product.n = Total Benchmark Class NotUsedHighlyIneffectiveSomewhatIneffectiveSomewhatEffectiveHighlyEffectiveTotalEffective34 Advisory boards: Using TLs fromtherapeutic areas to understand whataspects of the drug to focus on forinteractions with the physiciancommunity0% 0% 0% 24% 76% 100%34 Clinical trial involvement: Working withthought leaders to gain their involvementin investigators in clinical trials.0% 0% 0% 44% 56% 100%34 Protocol Design: Engage key thoughtleaders to help design Phase III andPhase IV clinical trial protocols0% 0% 3% 35% 62% 97%34 Scientific Publications: Engage in writingscientific publications0% 0% 3% 44% 53% 97%33 Medical Science Liaisons: Using MSLs toeducate thought leaders about benefitsof new drug compared with competitors.3% 0% 6% 39% 52% 91%To engage thought leaders, overall participants rate advisory boards and clinical trialinvolvement as effective strategies for creating an informed, receptive marketplace atlaunch. Asking key thought leaders to help design Phase III and IV clinical trial protocolsand to contribute to scientific publications are also effective engagement strategies.
  12. 12. BEST PRACTIC12Copyright © Best Practices , LLCKOLs Should Span Across Various Levels of Influence“Well, I’d say you have to have enough on sortof every different level. You’ve got maybe thetop 50 or 100 national thought leaders andthose are obviously the same within atherapeutic category. The second level is onethat is probably where there is a significantamount of real influence like regional academicmedical centers. It’s in the regional KOLswithin certain hospital or academic systemsthat may not have the publication power, butget them involved and in on publications andsecond author - stuff like that.”– Marketing Manager, Top 10 PharmaThe size of the KOL group needed to create market acceptance should be spread acrossdifferent levels of the KOL landscape – national, regional, academic and local. Look forthe influencers in your particular therapeutic area who may fall under the industry’s radaror who may be shadow thought leaders in a related therapeutic area.Source: http://pharmexec.findpharma.com/pharmexec/article/articleDetail.jsp?id=197784
  13. 13. BEST PRACTIC13Copyright © Best Practices , LLCMSLs and Ad Boards Highly Effective for DiabetesQ22. Thought Leader Engagement: Rate the effectiveness of various thought leader engagementstrategies for creating an informed and receptive marketplace at launch for your new product.n = Diabetes NotUsedHighlyIneffectiveSomewhatIneffectiveSomewhatEffectiveHighlyEffectiveTotalEffective4 Advisory boards: Using TLs fromtherapeutic areas to understand whatdrug aspects to focus on for interactionswith the physician community.0% 0% 0% 0% 100% 100%3 Medical Science Liaisons: Using MSLs toeducate thought leaders about benefitsof new drug compared with competitors.0% 0% 0% 0% 100% 100%4 Clinical trial involvement: Working withthought leaders to gain their involvementin investigators in clinical trials.0% 0% 0% 25% 75% 100%4 Consulting: Hiring thought leaders toprovide insights into the besteducational approaches to convincephysicians to try a new therapy.0% 0% 0% 50% 50% 100%4 Protocol Design: Engage key thoughtleaders to help design Phase III andPhase IV clinical trial protocols0% 0% 0% 50% 50% 100%Diabetes area participants agree that harnessing insights from advisory boards andusing MSLs to educate thought leaders about new drug benefits are “Highly Effective”strategies to engage thought leaders at launch. Other effective strategies in Diabetesinclude: trial involvement, consulting, protocol design, and scientific publication writing.
  14. 14. BEST PRACTIC14Copyright © Best Practices , LLCEnter Market: Diabetes Area Focuses on Payersn = TBC No Low High36 KOLs 0% 3% 97%34 Payers 0% 18% 82%33 Specialists 3% 15% 82%35 Policymakers /Government6% 31% 63%33 Patients / PatientAdvocacy Groups12% 36% 52%31 Primary CarePhysicians26% 68% 6%Q19. Preparing Market Constituents: Rate the importance of educating and winning support fromeach market constituency in order to (1) Enter market, (2) Win Share, and (3) Grow Market.n = Diabetes No Low High5 KOLs 0% 0% 100%4 Payers 0% 0% 100%4 Specialists 0% 25% 75%4 Patients / PatientAdvocacy Groups25% 0% 75%5 Policymakers /Government0% 40% 60%3 Primary CarePhysicians0% 100% 0%Enter MarketAlthough KOLs are important to have supporting the new product, Diabetes areaparticipants also focus early education efforts on payers, specialists and patients/ patientadvocacy groups. At this stage, educating primary care physicians receives the lowestimportance ranking.
  15. 15. BEST PRACTIC15Copyright © Best Practices , LLCWin Share: Diabetes See KOL Support as Still Necessaryn = TBC No Low High35 Specialists 0% 20% 80%33 KOLs 0% 24% 76%31 Payers 10% 35% 55%33 Primary CarePhysicians15% 36% 48%32 Patients / PatientAdvocacy Groups13% 50% 38%32 Policymakers /Government13% 53% 34%Q19. Preparing Market Constituents: Rate the importance of educating and winning support fromeach market constituency in order to (1) Enter market, (2) Win Share, and (3) Grow Market.n = Diabetes No Low High4 KOLs 0% 0% 100%4 Primary CarePhysicians0% 25% 75%3 Payers 33% 0% 67%4 Specialists 0% 50% 50%4 Policymakers /Government25% 50% 25%2 Patients / PatientAdvocacy Groups0% 100% 0%Win ShareAs with market entry, Diabetes area participants still rate KOLs as the most importantmarket constituent to educate and win support from while trying to gain share. However,75% say primary care physicians are also of high importance to win share, unlike theirlow importance rating when entering the market.
  16. 16. BEST PRACTIC16Copyright © Best Practices , LLCGrow Market: Support from PCPs Important for Diabetesn = TBC No Low High33 Specialists 0% 30% 70%34 KOLs 6% 29% 65%34 Primary CarePhysicians18% 18% 65%35 Patients / PatientAdvocacy Groups6% 31% 63%30 Payers 7% 33% 60%33 Policymakers /Government15% 42% 42%Q19. Preparing Market Constituents: Rate the importance of educating and winning support fromeach market constituency in order to (1) Enter market, (2) Win Share, and (3) Grow Market.n = Diabetes No Low High5 Primary CarePhysicians0% 0% 100%3 Payers 0% 33% 67%5 Patients / PatientAdvocacy Groups0% 40% 60%4 Specialists 0% 50% 50%4 KOLs 0% 75% 25%4 Policymakers /Government25% 50% 25%Grow MarketTo grow the market, all participants in the Diabetes area place the highest importance oneducating and gaining support from primary care physicians. Support from specialistsand KOLs, the top two placeholders in the benchmark class, fall below PCPs, payers andpatients/ patient advocacy groups for Diabetes participants.
  17. 17. BEST PRACTIC17Copyright © Best Practices , LLCManaged Care Coverage Altering Launch Approach“The most critical success factor ismanaged care. Everybody launchesa brand differently – if you want tolaunch the moment it’s approved,then the challenge with that isyou’re introducing a drug todoctors that is not going to getcovered, no matter what your pricepoint is. Some do prolong theirlaunch until they actually havesome coverage – so they’ll get theapproval, get coverage and thenlaunch but not everybody wants todo that because they want to get itout there.” – Senior Brand ManagerWinning payer coverage is challenging many organizations and changing their launchapproach. While some therapeutic areas, like Diabetes, usually get immediate coverage –albeit at a Tier 3 level until a review is complete – other TAs will not get coverage until areview. Some still believe in launching as soon as an approval hits, while others prefer anapproach of approval, coverage, launch. There are pros and cons to both approaches.Source: http://www.atkearney.com/index.php/Publications/pharmaceutical-markets-the-new-price-of-admission-eaxii-2.html
  18. 18. BEST PRACTIC18Copyright © Best Practices , LLCBest Practices, LLC6350 Quadrangle Drive, Suite 200,Chapel Hill, NC 27517www.best-in-class.comTelephone: 919-403-0251About Best Practices, LLCBest Practices, LLC is a research and consulting firm that conducts work based on thesimple yet profound principle that organizations can chart a course to superioreconomic performance by studying the best business practices, operating tactics andwinning strategies of world-class companies.Link for Report: Metabolic Product Launches Success Factors

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