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Product Launch Failure & Success Report Summary
 

Product Launch Failure & Success Report Summary

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Report Summary--Success Factors and Failure Points in Biopharmaceutical Product Launches: An Updated Road Map for Strong Market Entry. Contact me to view the full report.

Report Summary--Success Factors and Failure Points in Biopharmaceutical Product Launches: An Updated Road Map for Strong Market Entry. Contact me to view the full report.

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    Product Launch Failure & Success Report Summary Product Launch Failure & Success Report Summary Presentation Transcript

    • Success Factors and Failure Points inBiopharmaceutical Product Launches: AnUpdated Road Map for Strong Market Entry % Strategic Benchmarking Research, Analysis & Recommendations BEST PRACTICES, 1 ® Copyright © Best Practices®, LLC LLC
    • Table 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 Marketplaces p. 86-88 Investment Requirements, Resource Allocation & Timing p.89-99 BEST PRACTICES, 2 ® Copyright © Best Practices®, LLC LLC
    • Table of ContentsInternal Launch Readiness p.100-111New Technologies for Informing Patients & Physicians p.112-115Pitfalls & Stumbling Blocks p.116-130Demonstrating Efficacy p.131-137Rating Different Safety Dimensions p.138-144Lessons Learned, Best Practices & Future Changes p.145-147About Best Practices, LLC p.148 BEST PRACTICES, 3 ® Copyright © Best Practices®, LLC LLC
    • Framework 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. 8. Avoid Pitfalls & 1. Differentiate Your Product Stumbling Blocks 7. Utilize New 2. Clearly Define Target Technologies To Inform Insights, Patient Population Best Practices, 6. Demonstrate Pitfalls 3. Invest in Launch & Value Across Support Multiple Fronts 5. Educate Key 4. Engage Stakeholders: (Physicians, Patients, & Payers) Thought Leaders BEST PRACTICES, 4 ® Copyright © Best Practices®, LLC LLC
    • 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. Differentiating Your Product - -Secondary Benefits Can Be Win Themes: Differentiating Your Product Secondary Benefits Can Be Win Themes: Differentiated positioning begins on factors established in clinical trials ––such as Differentiated positioning begins on factors established in clinical trials such as efficacy, unmet needs, safety and target patient population. Secondary positioning efficacy, unmet needs, safety and target patient population. Secondary positioning factors have less overall impact ––but can be useful in aacrowded market ––and are factors have less overall impact but can be useful in crowded market and are often more directly influenced through Marketing. Using secondary benefits can be an often more directly influenced through Marketing. Using secondary benefits can be an effective strategy for positioning aaproduct in aahighly competitive market. effective strategy for positioning product in highly competitive market. As one executive observed during interviews: “You like to go to market with an efficacy As one executive observed during interviews: “You like to go to market with an efficacy message, that’s what you want.. IfIfyou can’t do efficacy, fall back to safety. IfIfyou can’t message, that’s what you want.. you can’t do efficacy, fall back to safety. you can’t do safety, you fall back to convenience. IfIfyou can’t do convenience, you fall back to do safety, you fall back to convenience. you can’t do convenience, you fall back to pricing.” Secondary or even tertiary positioning factors have been win themes. Quality pricing.” Secondary or even tertiary positioning factors have been win themes. Quality of life, ease of use, cost effectiveness, patient compliance, or even aacelebrity of life, ease of use, cost effectiveness, patient compliance, or even celebrity spokesperson are examples. Use of secondary factors varies considerably across TAs. spokesperson are examples. Use of secondary factors varies considerably across TAs. BEST PRACTICES, 5 ® Copyright © Best Practices®, LLC LLC
    • Universe of Learning: 38 Companies EngagedResearch participants included 44 executives and managers from 38 leadingpharmaceutical, biotech and medical device companies. Participating Companies TGC MedTech Laboratorios Dermatologicos Darier BEST PRACTICES, 6 ® Copyright © Best Practices®, LLC LLC
    • Executive Interviews and Field InsightsMore 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 Interviews Executive Field Insights Laboratorios Dermatologicos Darier BEST PRACTICES, 7 ® Copyright © Best Practices®, LLC LLC
    • Vice President/Director Largest Respondent Group Nearly 40 leaders in biotechnology and pharmaceutical product launches participated in this research project. A majority of respondents were either at the vice president or director levels. Senior Vice Sample Participant Titles President, 8% • Senior Vice President, Commercial Other, 15% Vice President, 5% Strategy Senior/ • Senior Vice President, Marketing & Executive Sales Director, 8% • Vice President, Marketing • Director, Health OutcomesManager, 26% • Director, Marketing • Director, Medical Director, 26% • Director, Strategic Planning • Associate Director, Managed Care Senior Other: Marketing Assistant/ • Founder and President • Senior Manager, Global Marketing Manager, 8% Associate • Principal Director, 5% • Manager, Business Intelligence • Partner • Coordinator, Marketing • Manager, Business Unit(n=39) • Product Physician • Manager, Category Marketing • Senior Consultant BEST PRACTICES, 8 ® Copyright © Best Practices®, LLC LLC
    • Participants 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. Therapeutic Areas Products Represented by Participants • Metabolics Belatacept • Cardiology • Central Nervous System Clivarine Cladribine (Movectro) • Oncology Enteral feeding products • Neurology • Pulmonary Endothelin Receptor Antagonist • Immunology • Gastro-enterology Levothyroxine • Musculoskeletal MAb for Asthma/COPD Naproxcinod • Hormonal Systems New CTC Advance catheter • HIV Infections • Medical Nutrition • Urology (n=33) Taspoglutide BEST PRACTICES, 9 ® Copyright © Best Practices®, LLC LLC
    • Efficacy, Unmet Need Offer Best Positioning ToolsFor 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. Q5. Winning On Differentiated Product Positioning: Differentiated product positioning is critical to market entry success. Rate the effectiveness of different positioning strategies and tactics for winning in the marketplace. n= Total Benchmark Class Not Highly Somewhat Somewhat Highly Total Used Ineffective Ineffective Effective Effective Effective 43 Efficacy Profile 2% 0% 2% 35% 60% 95% 44 Unmet medical need 2% 2% 2% 14% 80% 93% 43 Clearly Defined Patient Population 5% 2% 5% 51% 37% 88% / Sub-population 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% BEST PRACTICES, 10 ® Copyright © Best Practices®, LLC LLC
    • Lack of Differentiation Creates Domino EffectThe 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. Pitfalls Created by Onglyza’s “I think they didn’t have a great Lack of Differentiation differentiation strategy. Their efficacy was undifferentiated. If Insurers reluctant to add to formulary at same tier as like- you’re the same efficacy-wise, you priced Januvia. have to have some other good compelling reason, or interesting No good reason for prescribers to reason or a promotional reason to shift from tried-and-true Januvia. consider it. I never got the sense of KOLs unlikely to advocate change what that really was.” in prescribing habits. – Januvia Marketing Leader “There isn’t anything good to say because there’s no mention of why is this better or why this is different.” – Januvia Marketing Leader BEST PRACTICES, 11 ® Copyright © Best Practices®, LLC LLC
    • Ease-of-Use Seen as Secondary Benefits DifferentiatorFollowing 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. Q7. Articulating Benefits That Shape Positive Market Perception: Once youve established your efficacy and safety profile, rate the effectiveness of various product benefits that can differentiate ones market entry positioning to enable rapid launch uptake.n= Total Benchmark Class Not Highly Somewhat Somewhat Highly Total Used Ineffective Ineffective Effective Effective Effective41 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 stroke 20% 0% 2% 30% 48% 77% or seizures)43 Cost Effectiveness 14% 2% 12% 42% 30% 72%43 Superior speed of action 21% 2% 7% 42% 28% 70% BEST PRACTICES, 12 ® Copyright © Best Practices®, LLC LLC
    • New Product Needs 11-30% Higher Efficacy for Charge MoreTwo 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. Q10. Efficacy & Pricing: Estimate whats the minimum level of superior efficacy required to charge more than a branded competitor product in a crowded marketplace. Total Benchmark Class 34% 32% 15% 10% 5% 2% 0% 0% 2% 0% 11-20% 21-30% 31-40% 41-50% 51-60% 61-70% 71-80% 81-90% 91-100% (i.e. more better better better better better better better better better 1-10% better (n=41) BEST PRACTICES, 13 ® Copyright © Best Practices®, LLC LLC
    • Ad Boards & Trial Involvement Effective TL StrategiesTo 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. Q22. Thought Leader Engagement: Rate the effectiveness of various thought leader engagement strategies for creating an informed and receptive marketplace at launch for your new product.n= Total Benchmark Class Not Highly Somewhat Somewhat Highly Total Used Ineffective Ineffective Effective Effective Effective34 Advisory boards: Using TLs from 0% 0% 0% 24% 76% 100% therapeutic areas to understand what aspects of the drug to focus on for interactions with the physician community34 Clinical trial involvement: Working with 0% 0% 0% 44% 56% 100% thought leaders to gain their involvement in investigators in clinical trials.34 Protocol Design: Engage key thought 0% 0% 3% 35% 62% 97% leaders to help design Phase III and Phase IV clinical trial protocols34 Scientific Publications: Engage in writing 0% 0% 3% 44% 53% 97% scientific publications33 Medical Science Liaisons: Using MSLs to 3% 0% 6% 39% 52% 91% educate thought leaders about benefits of new drug compared with competitors. BEST PRACTICES, 14 ® Copyright © Best Practices®, LLC LLC
    • KOLs Should Span Across Various Levels of InfluenceThe 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. “Well, I’d say you have to have enough on sort of every different level. You’ve got maybe the top 50 or 100 national thought leaders and those are obviously the same within a therapeutic category. The second level is one that is probably where there is a significant amount of real influence like regional academic medical centers. It’s in the regional KOLs within certain hospital or academic systems that may not have the publication power, but get them involved and in on publications and second author - stuff like that.” – Marketing Manager, Top 10 Pharma Source: http://pharmexec.findpharma.com/pharmexec/ article/articleDetail.jsp?id=197784 BEST PRACTICES, 15 ® Copyright © Best Practices®, LLC LLC
    • Price, Reimbursement Discussions Effective for Payers Discussions around pricing, comparative effectiveness and reimbursement are effective early payer education tactics, participants said. In interviews, executives said these discussions need to be approached in a collaborative manner so that payers are learning about your perspective while you are learning about their wants and needs as well. Q25. Payer Education: Rate the effectiveness of early payer education and engagement activities that prove most critical to market entry and success.n= Total Benchmark Class Not Highly Somewhat Somewhat Highly Total Used Ineffective Ineffective Effective Effective Effective30 Price Parameters: Get guidance on 7% 0% 7% 37% 50% 87% acceptable parameters for label30 Unmet Needs: Understand Managed 10% 0% 3% 50% 37% 87% Markets view of unmet medical needs30 Reimbursement Prospects: Gain 17% 0% 0% 23% 60% 83% insight on reimbursement prospects in context of competitive landscape30 Health Outcomes: Get reaction to 17% 0% 3% 37% 43% 80% health outcomes/ economics data29 Advisory Boards: Payer advisory 17% 0% 3% 17% 62% 79% boards to hear payer perspectives30 Improving Position: Understand how 17% 0% 7% 43% 33% 77% to Improve formulary positioning30 Efficacy & Safety: Learn minimum 13% 0% 13% 27% 47% 73% requirements to enter market BEST PRACTICES, 16 ® Copyright © Best Practices®, LLC LLC
    • Win Share: Focus Shifts to SpecialistsFor 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). Q19. Preparing Market Constituents: Rate the importance of educating and winning support from each market constituency in order to (1) Enter market, (2) Win Share, and (3) Grow Market. Win Share n= TBC No Low High 35 Specialists 0% 20% 80% 33 KOLs 0% 24% 76% 31 Payers 10% 35% 55% 33 Primary Care 15% 36% 48% Physicians 32 Patients / Patient 13% 50% 38% Advocacy Groups 32 Policymakers / 13% 53% 34% Government BEST PRACTICES, 17 ® Copyright © Best Practices®, LLC LLC
    • DTC 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 DTC campaigns after launch. Total Benchmark Class Encourage patients to speak to 60% doctors Reach large patient 50% populations Provide disease state 45% information Educate on symptom 35% identification Communicate product benefits 30% Not applicable/ None 30% (n=20) BEST PRACTICES, 18 ® Copyright © Best Practices®, LLC LLC
    • Physician Pitfalls At Launch Across The Benchmark Class Thought leaders and specialists are the highest risk physician stumbling blocks that can trip up a new product upon market entry. Poor physician segmentation and weak access also emerge as critical physician pitfalls. During the next 36 months, most of these risk factors are expected to stay the same in terms of risk and priority at launch. Q44. Launch Risk & Market Change: Please estimate the risk level of each physician pitfall that can derail a new product coming into a crowded market. First assess each pitfall in terms of its current importance / risk level observed during the past two years. Then estimate the risk-level / priority change you anticipate for the next two to three years for this risk or failure point. Out of Step With Missed Critical Failed Physician New Science Thought Leader Specialists: New Segmentation: New Access Barriers: Education Missteps: Perspectives: New product fails to product fails to New products New method-of-actionTotal Benchmark products clinical trials win critical segment market in a products change stumble or fail lag thought leader specialists or Key way that allows it to because of limitedClass views or evolving Opinion Leaders - address specific treatment paradigms access to health but fail to inform guidelines; product who oppose new physician segment care providers, physicians on biology claims are misaligned product because needs; market managed care and /new science to with thought leader of unaddressed execution fails to reach institutions. support paradigm shift.(n=24) perspectives. concerns. critical segments.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% BEST PRACTICES, 19 ® Copyright © Best Practices®, LLC LLC
    • About Best Practices, LLC Best 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. Best Practices, LLC 6350 Quadrangle Drive, Suite 200, Chapel Hill, NC 27517 www.best-in-class.com Telephone: 919-403-0251 BEST PRACTICES, 20 ® Copyright © Best Practices®, LLC LLC