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Success Factors and Failure Points in Biopharmaceutical Product Launches: An Updated Road Map for Strong Market Entry

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*Oncology, Metabolic, and Cardiovascular segmentations are available. The summaries can be found under the "New Product Planning and Launch" portion of our SlideShare channel.

*Oncology, Metabolic, and Cardiovascular segmentations are available. The summaries can be found under the "New Product Planning and Launch" portion of our SlideShare channel.

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  • 1. BEST PRACTIC1Copyright © Best Practices , LLC%Success Factors and Failure Points inBiopharmaceutical Product Launches: AnUpdated Road Map for Strong Market EntryStrategic Benchmarking Research, Analysis & Recommendations
  • 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.19-25Main Deck Winning on Differentiated Product Positioning p.26-33 Winning a Physician’s Initial Trial of a New Product p.34-35 Articulating Benefits that Shape Positive Market Perception p.36-38 New Product Pricing Strategy p.39-49 Thought Leader Engagement p. 50-55 Early Physician Education p.56-64 Payer Education p. 65-67 Patient Advocacy and Education p.68-70 Preparing Market Constituents p.71-75 Access Insights & Success Factors p.76-83 Winning Hospital Formulary Access p.84-85 Resource Allocation for Key Stakeholders in the Current & Future Marketplacesp. 86-88 Investment Requirements, Resource Allocation & Timing p.89-99
  • 3. BEST PRACTIC3Copyright © Best Practices , LLCTable of Contents Internal Launch Readiness p.100-111 New Technologies for Informing Patients & Physicians p.112-115 Pitfalls & Stumbling Blocks p.116-130 Demonstrating Efficacy p.131-137 Rating Different Safety Dimensions p.138-144 Lessons Learned, Best Practices & Future Changes p.145-147 About Best Practices, LLC p.148
  • 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. 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.1. 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 alsocan use secondary benefits to gain traction at launch.
  • 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. BEST PRACTIC7Copyright © Best Practices , LLCExecutive Interviews and Field InsightsExecutive InterviewsLaboratorios Dermatologicos DarierMore than six hours of executive interviews, in addition to field commentaries andinsights from 17 executives, shed light on the market entry success and failure factors.Perspectives range from frontline prescriber to veteran pharma executive with decades ofsuccessful launch experiences.Executive Field Insights
  • 8. BEST PRACTIC8Copyright © Best Practices , LLCSample Participant TitlesVice President/Director Largest Respondent GroupNearly 40 leaders in biotechnology and pharmaceutical product launches participated inthis research project. A majority of respondents were either at the vice president ordirector levels.Other:• Founder and President• Principal• Partner• Coordinator, Marketing• Product Physician• Senior ConsultantAssistant/AssociateDirector, 5%Other, 15%Manager, 26%SeniorManager, 8%Director, 26%Senior VicePresident, 8%Senior/ExecutiveDirector, 8%Vice President,5%(n=39)• Senior Vice President, CommercialStrategy• Senior Vice President, Marketing &Sales• Vice President, Marketing• Director, Health Outcomes• Director, Marketing• Director, Medical• Director, Strategic Planning• Associate Director, Managed CareMarketing• Senior Manager, Global Marketing• Manager, Business Intelligence• Manager, Business Unit• Manager, Category Marketing
  • 9. BEST PRACTIC9Copyright © Best Practices , LLC• Metabolics• Cardiology• Central Nervous System• Oncology• Neurology• Pulmonary• Immunology• Gastro-enterology• Musculoskeletal• Hormonal Systems• HIV Infections• Medical Nutrition• UrologyParticipants Reflected on Wide Range of TherapiesResearch participants reflected on almost 30 products, ranging from blockbusters likeJanuvia and Rituxan to new products like Onglyza and Victoza. The broad spectrum ofproducts launch experiences informed the benchmark class’ understanding of criticalsuccess factors, stumbling blocks and failure points.(n=33)BelataceptCladribine(Movectro)ClivarineEnteral feeding productsLevothyroxineMAb for Asthma/COPDNaproxcinodNew CTCAdvance catheterTaspoglutideTherapeutic Areas Products Represented by ParticipantsEndothelin Receptor Antagonist
  • 10. BEST PRACTIC10Copyright © 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.
  • 11. BEST PRACTIC11Copyright © 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.
  • 12. BEST PRACTIC12Copyright © Best Practices , LLCEase-of-Use Seen as Secondary Benefits DifferentiatorQ7. Articulating Benefits That Shape Positive Market Perception: Once youve established yourefficacy and safety profile, rate the effectiveness of various product benefits that can differentiateones market entry positioning to enable rapid launch uptake.n = Total Benchmark Class NotUsedHighlyIneffectiveSomewhatIneffectiveSomewhatEffectiveHighlyEffectiveTotalEffective41 Ease-of-use 5% 2% 7% 44% 41% 85%42 Unmet Medical Need 7% 2% 7% 12% 71% 83%43 Reduced side effects 9% 2% 7% 60% 21% 81%42 Health Outcomes 12% 0% 10% 48% 31% 79%44 Health benefit (eg. Prevents strokeor seizures)20% 0% 2% 30% 48% 77%43 Cost Effectiveness 14% 2% 12% 42% 30% 72%43 Superior speed of action 21% 2% 7% 42% 28% 70%Following efficacy and safety, launch leaders see ease-of-use and unmet need as theproduct benefits that should be used to differentiate a new product at market entry. Notethat unmet medical need won the largest “Highly Effective” rating.
  • 13. BEST PRACTIC13Copyright © Best Practices , LLCNew Product Needs 11-30% Higher Efficacy for Charge More0%2%2%0%0%5%15%32%34%10%1-10%better(i.e.more11-20%better21-30%better31-40%better41-50%better51-60%better61-70%better71-80%better81-90%better91-100%betterQ10. Efficacy & Pricing: Estimate whats the minimum level of superior efficacy required to chargemore than a branded competitor product in a crowded marketplace.Total Benchmark Class(n=41)Two thirds of the overall Benchmark Class indicated a new product requires at least 11%to 30% superior efficacy in order to win a higher price in a competitive market.
  • 14. BEST PRACTIC14Copyright © 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.
  • 15. BEST PRACTIC15Copyright © 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:
  • 16. BEST PRACTIC16Copyright © Best Practices , LLCPrice, Reimbursement Discussions Effective for PayersQ25. Payer Education: Rate the effectiveness of early payer education and engagement activitiesthat prove most critical to market entry and success.n = Total Benchmark Class NotUsedHighlyIneffectiveSomewhatIneffectiveSomewhatEffectiveHighlyEffectiveTotalEffective30 Price Parameters: Get guidance onacceptable parameters for label7% 0% 7% 37% 50% 87%30 Unmet Needs: Understand ManagedMarkets view of unmet medical needs10% 0% 3% 50% 37% 87%30 Reimbursement Prospects: Gaininsight on reimbursement prospects incontext of competitive landscape17% 0% 0% 23% 60% 83%30 Health Outcomes: Get reaction tohealth outcomes/ economics data17% 0% 3% 37% 43% 80%29 Advisory Boards: Payer advisoryboards to hear payer perspectives17% 0% 3% 17% 62% 79%30 Improving Position: Understand howto Improve formulary positioning17% 0% 7% 43% 33% 77%30 Efficacy & Safety: Learn minimumrequirements to enter market13% 0% 13% 27% 47% 73%Discussions around pricing, comparative effectiveness and reimbursement are effectiveearly payer education tactics, participants said. In interviews, executives said thesediscussions need to be approached in a collaborative manner so that payers are learningabout your perspective while you are learning about their wants and needs as well.
  • 17. BEST PRACTIC17Copyright © Best Practices , LLCWin Share: Focus Shifts to Specialistsn = 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.Win ShareFor winning share in the marketplace, 80% of participants place high importance oneducating and winning support from specialists. Also note at this stage educationincreases for primary care physicians (from 6% at Enter Market to 48% at Win Sharestage).
  • 18. BEST PRACTIC18Copyright © Best Practices , LLCDTC Campaigns Used to Push Patients to DoctorsA majority of participants see the value in DTC campaigns as a way to educate on thedisease and spur patients to engage with physicians about their ailments and speak totheir doctors about the new therapy they saw on TV. Will it work for them?Q29. DTC Value Drivers: Note all factors that informed your rationale for employing DTCcampaigns after launch.35%45%50%60%30%30%Not applicable/ NoneCommunicate product benefitsEducate on symptomidentificationProvide disease stateinformationReach large patientpopulationsEncourage patients to speak todoctorsTotal Benchmark Class(n=20)
  • 19. BEST PRACTIC19Copyright © Best Practices , LLCQ44. Launch Risk & Market Change: Please estimate the risk level of each physician pitfall that canderail a new product coming into a crowded market. First assess each pitfall in terms of its currentimportance / risk level observed during the past two years. Then estimate the risk-level / prioritychange you anticipate for the next two to three years for this risk or failure point.Total BenchmarkClass(n=24)Out of Step WithThought LeaderPerspectives: Newproducts clinical trialslag thought leaderviews or evolvingguidelines; productclaims are misalignedwith thought leaderperspectives.Missed CriticalSpecialists: Newproduct fails towin criticalspecialists or KeyOpinion Leaders -who oppose newproduct becauseof unaddressedconcerns.Failed PhysicianSegmentation: Newproduct fails tosegment market in away that allows it toaddress specificphysician segmentneeds; marketexecution fails to reachcritical segments.New ScienceEducation Missteps:New method-of-actionproducts changetreatment paradigmsbut fail to informphysicians on biology/new science tosupport paradigm shift.Access Barriers:New productsstumble or failbecause of limitedaccess to healthcare providers,managed care andinstitutions.Past 24 Months To PresentRed Alert- High Risk 71% 70% 52% 39% 58%Yellow Alert- Medium Risk 25% 30% 39% 52% 33%Green Alert- Low Risk 4% 0% 9% 9% 8%Next 24-36 Months- Anticipated ChangesDecreasing Risk or Priority 10% 14% 5% 0% 14%No Risk Change 90% 86% 95% 100% 86%Increasing Risk or Priority 0% 0% 0% 0% 0%Physician Pitfalls At Launch Across The Benchmark ClassThought leaders and specialists are the highest risk physician stumbling blocks that cantrip up a new product upon market entry. Poor physician segmentation and weak accessalso emerge as critical physician pitfalls. During the next 36 months, most of these riskfactors are expected to stay the same in terms of risk and priority at launch.
  • 20. BEST PRACTIC20Copyright © Best Practices , LLCBest Practices, LLC6350 Quadrangle Drive, Suite 200,Chapel Hill, NC 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: Biopharmaceutical Product Launches Success Factors