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Success Factors and Failure Points in Oncology Product Launches Report Summary

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Biopharmaceutical companies invest large amount of resources to develop and launch new products for oncology therapeutic areas. However, the complexity of a new oncology 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 oncology 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 oncology 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 oncology 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 oncology launch factors: product shaping, market shaping, physician, patient, payer, internal and regulatory.

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Success Factors and Failure Points in Oncology Product Launches Report Summary

  1. 1. Success Factors and Failure Points in Oncology Product Launches % Strategic Benchmarking Research, Analysis & Recommendations BEST PRACTICES, 1 ® Copyright © Best Practices®, LLC LLC
  2. 2. Table of ContentsBackground Summary of Business Issue, Key Insights, Findings and Lessons Learned p. 4-17 Universe of Learning: Research Participants, Launch Experience, Oncology & Other Therapeutic Area Demographics p. 18-24Main Deck Winning on Differentiated Product Positioning p. 25-32 Winning a Physician’s Initial Trial of a New Product p. 33-35 Articulating Benefits that Shape Positive Market Perception p. 36-40 New Product Pricing Strategy p. 41-51 Thought Leader Engagement p. 52-59 Early Physician Education p. 60-70 Payer Education p. 71-75 Patient Advocacy and Education p. 76-80 BEST PRACTICES, 2 ® Copyright © Best Practices®, LLC LLC
  3. 3. Table of ContentsMain Deck (cont.) Preparing Market Constituents p. 81-85 Access Insights & Success Factors p. 86-93 Winning Hospital Formulary Access p. 94-96 Resource Allocation for Key Stakeholders in the Current & Future Marketplaces p. 97-99 Investment Requirements, Resource Allocation & Timing p. 100-110 Internal Launch Readiness p. 111-124 New Technologies for Informing Patients & Physicians p. 125-130 Pitfalls & Stumbling Blocks p. 131-150 Demonstrating Efficacy p. 151-159 Rating Different Safety Dimensions p. 160-169 Lessons Learned, Best Practices & Future Changes p. 170-172 About Best Practices, LLC p. 173 BEST PRACTICES, 3 ® Copyright © Best Practices®, LLC LLC
  4. 4. Summary of Key Insights, Operational Pitfalls & Lessons Learned BEST PRACTICES, 4 ® Copyright © Best Practices®, LLC LLC
  5. 5. 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, 5 ® Copyright © Best Practices®, LLC LLC
  6. 6. 1. Differentiate Your Product In A Crowded MarketDifferentiation is a key factor in a new product’s launch success. While efficacy andsafety are usually considered the best ways to differentiate a new product, newtherapies in Oncology also can 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, safety and target patient population. Secondary positioning factors have less efficacy, safety and target patient population. Secondary positioning factors have less overall impact ––but can be useful in aacrowded market ––and are often more directly overall impact but can be useful in crowded market and are often more directly influenced through Marketing. Using secondary benefits can be an effective strategy influenced through Marketing. Using secondary benefits can be an effective strategy for positioning aaproduct in aahighly competitive market. 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 spokesperson are examples. Use of secondary factors varies considerably across TAs. TAs. For Oncology products, several factors were cited as being effective for For Oncology products, several factors were cited as being effective for differentiation including: efficacy, target population, health outcomes, differentiation including: efficacy, target population, health outcomes, unmet needs and dosage. It is important to contrast these differences unmet needs and dosage. It is important to contrast these differences against other current therapies. against other current therapies. BEST PRACTICES, 6 ® Copyright © Best Practices®, LLC LLC
  7. 7. Universe of Learning: Research Participants, Launch Experience,Oncology & Other Therapeutic Areas Demographics BEST PRACTICES, 7 ® Copyright © Best Practices®, LLC LLC
  8. 8. 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, 8 ® Copyright © Best Practices®, LLC LLC
  9. 9. Oncology Segment: 7 Participants EngagedOncology research in survey participants included seven executives andmanagers at six different companies. Benchmark Partners Oncology Products Participant Titles • SVP CCO • Senior Consultant • Director • Global Sr. Marketing Mgr • Project Manager • Disease Area Head - Immunology • Associate Director - Managed Care Marketing BEST PRACTICES, 9 ® Copyright © Best Practices®, LLC LLC
  10. 10. Winning On Differentiated Product Positioning: Differentiated product positioning is critical to market entry success. Ratingthe effectiveness of different positioning strategies and tactics for winning in the marketplace. BEST PRACTICES, 10 ® Copyright © Best Practices®, LLC LLC
  11. 11. 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 efficacyand unmet 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. Not Highly Somewhat Somewhat Highly Total n= Total Benchmark Class 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% Clearly Defined Patient Population 43 / Sub-population 5% 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% BEST PRACTICES, 11 ® Copyright © Best Practices®, LLC LLC
  12. 12. Positioning Planning Needed for Launch Success Positioning a new product correctly in the competitive landscape is frequently cited as a critical success factor. Work starts a year before launch and it take can take a year after launch to set. Don’t underestimate its importance. “If you don’t establish positioning, they will do it themselves and it might not be an area you want it to be,” said a brand leader. “Generally speaking for all brands, a critical success factor is solidifying positioning. So pre-launch, usually a year or year and a half prior to approval, try to develop how you want the drug to be positioned within the minds of your customers. Then you use that to campaign and message – so your critical success factor is to get that positioning accomplished as soon as possible after launch. Sometimes it can be pretty quick and sometimes it can take years.” – Senior Brand ManagerSource: http://www.mmm-online.com/10-steps-to-product-positioning/article/24881/ BEST PRACTICES, 12 ® Copyright © Best Practices®, LLC LLC
  13. 13. Unmet Medical Need Most Effective in Oncology Product PositioningMost oncology heads agree that filling an unmet medical need is most advantageous toproduct positioning to ensure market entry success. Efficacy profile and differencesfrom other current therapies were also seen as effective strategies. 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. Highly Somewhat Somewhat Highly Total n= Oncology Not Used Ineffective Ineffective Effective Effective Effective 7 Differences from current therapies 0% 0% 0% 57% 43% 100% 6 Efficacy Profile 0% 0% 0% 50% 50% 100% Clearly Defined Patient Population 7 / Sub-population 0% 0% 14% 43% 43% 86% 7 Health Outcomes 0% 14% 0% 43% 43% 86% 7 Unmet medical need 0% 14% 0% 14% 72% 86% 7 Dosing 0% 0% 14% 72% 14% 86% 7 Cost Effectiveness 0% 0% 29% 29% 42% 71% 7 Safety Profile 0% 0% 29% 29% 42% 71% 7 Better Delivery mechanism 0% 0% 29% 71% 0% 71% BEST PRACTICES, 13 ® Copyright © Best Practices®, LLC LLC
  14. 14. Early Physician Education:Rating the effectiveness of early physicianeducation and engagement activities that prove most helpful to market entry and success in a competitive marketplace. BEST PRACTICES, 14 ® Copyright © Best Practices®, LLC LLC
  15. 15. Educate Docs via KOL Development and Ad BoardsDeveloping relationships with KOLs and conducting ad boards are the two most effectiveearly education methods for physicians, launch leaders agreed. Despite the industry’smove away from speaker programs, participants indicated they still felt in-personprograms provided valuable education opportunities. Q24. Physician Education: Rate the effectiveness of early physician education and engagement activities that prove most helpful to market entry and success in a competitive marketplace. Not Highly Somewhat Somewhat Highly Totaln= Total Benchmark Class Used Ineffective Ineffective Effective Effective Effective33 KOL Development 0% 0% 0% 21% 79% 100%34 Advisory Boards 3% 0% 0% 29% 68% 97% Communicating & Disseminating Clinical34 Trial Results 0% 0% 12% 21% 68% 88%34 Speaker Programs - in person 0% 3% 9% 44% 44% 88% Clinical Papers - engaging thought leaders33 as authors 0% 0% 12% 45% 42% 88% Medical Journals Publishing - publishing34 company research in peer reviewed journals 0% 0% 15% 35% 50% 85% Phase IIIB/IV Studies engaging specialists /34 KOLs 6% 0% 9% 41% 44% 85% Health Outcomes/Quality/Economics studies34 engaging specialists / KOLs 6% 0% 12% 47% 35% 82% Meetings, Congresses & Symposia34 Presentations 0% 3% 18% 35% 44% 79% BEST PRACTICES, 15 ® Copyright © Best Practices®, LLC LLC
  16. 16. KOL Development Key for Oncology Physician EducationAlthough KOL development was identified as the most effective early physician educationstrategy, half of Oncology respondents also consider speaker programs, health studies,medical publishing, sharing trial results, and phase IIIB/IV studies to be “highly effective.” Q24. Physician Education: Rate the effectiveness of early physician education and engagement activities that prove most helpful to market entry and success in a competitive marketplace. Not Highly Somewhat Somewhat Highly Total n= Oncology Used Ineffective Ineffective Effective Effective Effective 6 KOL Development 0% 0% 0% 33% 67% 100% 6 Speaker Programs - in person 0% 0% 0% 50% 50% 100% Health Outcomes/Quality/Economics 6 studies engaging specialists / KOLs 0% 0% 0% 50% 50% 100% Accredited CME grants through third 6 parties 0% 0% 17% 66% 17% 83% 6 Advisory Boards 17% 0% 0% 50% 33% 83% Medical Journals Publishing – 6 company research 0% 0% 17% 33% 50% 83% Communicating & Disseminating 6 Clinical Trial Results 0% 0% 17% 33% 50% 83% Meetings, Congresses & Symposia 6 Presentations 0% 0% 17% 50% 33% 83% Phase IIIB/IV Studies engaging 6 specialists / KOLs 0% 0% 17% 33% 50% 83% BEST PRACTICES, 16 ® Copyright © Best Practices®, LLC LLC
  17. 17. Payer Education: Rating the effectiveness of early payereducation and engagement activities that prove most critical to market entry and success. BEST PRACTICES, 17 ® Copyright © Best Practices®, LLC LLC
  18. 18. Ad Boards and Reimbursement Effective Payer Education Tools for OncologySimilar to the Benchmark Class, Oncology participants considered advisory boards andreimbursement prospects to be highly effective payer education tools critical to marketentry and success. Q25. Payer Education: Rate the effectiveness of early payer education and engagement activities that prove most critical to market entry and success. Not Highly Somewhat Somewhat Highly Totaln= Oncology Used Ineffective Ineffective Effective Effective Effective Advisory Boards: Payer advisory boards to5 understand payer perspectives 0% 0% 0% 20% 80% 100% Reimbursement Prospects: Gain insight on5 reimbursement prospects in context of 0% 0% 0% 20% 80% 100% competitive landscape Discount Expectations: Understand discount5 & margin requirements for managed care 0% 0% 0% 40% 60% 100% Unmet Needs: Understand Managed Markets5 view of unmet medical needs 0% 0% 0% 80% 20% 100% Health Outcomes: Get reaction to health5 outcomes/ health economics data 0% 0% 0% 80% 20% 100% Price Parameters: Get guidance on5 acceptable price parameters for target label 0% 0% 0% 40% 60% 100% Peer Meetings with Managed Markets:4 Team approach to critical acct meetings 0% 0% 0% 50% 50% 100% BEST PRACTICES, 18 ® Copyright © Best Practices®, LLC LLC
  19. 19. Pitfalls & Stumbling Blocks:Estimating current and future risklevels for various product pitfalls that can derail a new product coming into a crowded market. BEST PRACTICES, 19 ® Copyright © Best Practices®, LLC LLC
  20. 20. Under-spending for Launches a Common PitfallThe high price tag that comes with a new product launch is a tempting target forexecutives looking to cut costs. Not spending enough to support a launch can end upcosting an organization in the long run. “The biggest pitfall is that companies think that they can get away with under-spending on their launches because they have such a great drug that people are just going to go ahead and buy it without putting in the time, the effort and the investment to make it a success.” – Vice President, Medical Source: http://pharmexec.findpharma.com/pharmexec/Marketing/Launch-on-a- Budget/ArticleStandard/Article/detail/378000 BEST PRACTICES, 20 ® Copyright © Best Practices®, LLC LLC
  21. 21. Safety and Lifecycle Planning Key Positioning Pitfalls The biggest product shaping hurdles come from the potential high risk pitfalls of not addressing safety signals, lifecycle planning missteps, and competitive positioning errors. All three were rated as high risk by more than 50% of the benchmark class. Failures to address these issues will severely impact product differentiation and market performance. Q42. Launch Risk & Market Change: Please estimate the risk level of each product shaping 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. Competitive Indication / Lifecycle Unclear Target Patient Sub- Positioning Errors: Total Benchmark Safety & Side Effects Planning Pitfalls: Lifecycle Population: Unclear target Aggressive competitors Pitfalls: Failure to address planning missteps lead new patient population makes blunt new products Class safety signals, side effect market entry difficult against product to enter market w/ market entry or damage concerns, clinical trial size, wrong indication, suboptimal entrenched competitors - its perceived efficacy, trial duration, and other FDA dose or delivery-delaying confusing physicians when to safety or differentiation - (n=26) or physician concerns. market uptake & tarnishing use new drug. and new product never image. recovers. Past 24 Months To Present Red Alert- High Risk 88% 44% 60% 54% Yellow Alert- Medium Risk 12% 44% 36% 46% Green Alert- Low Risk 0% 12% 4% 0% Next 24-36 Months- Anticipated Changes Decreasing Risk or Priority 23% 18% 18% 14% No Risk Change 36% 45% 55% 36% Increasing Risk or Priority 41% 36% 27% 50% BEST PRACTICES, 21 ® Copyright © Best Practices®, LLC LLC
  22. 22. Safety & Side Effects, Lifecycle Planning High Risk Pitfalls for Oncology Along with the Benchmark Class, the Oncology segment chose Safety & Side Effects and Indication/Lifecycle Planning Pitfalls as their highest risk when putting a new product on the market. Q42. Launch Risk & Market Change: Please estimate the risk level of each product shaping 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. Safety & Side Effects Indication / Lifecycle Unclear Target Patient Competitive Positioning Pitfalls: Failure to Planning Pitfalls: Lifecycle Sub-Population: Unclear Errors: Aggressive address safety planning missteps lead target patient population competitors blunt new signals, side effect new product to enter makes market entry products market entry Oncology concerns, clinical difficult against market with wrong or damage its perceived trial size, trial indication, suboptimal entrenched competitors - efficacy, safety or duration, and other dose or delivery -- confusing physicians differentiation - and new FDA or physician delaying market uptake when to use new drug. product never recovers. (n=4) concerns. and tarnishing image. Past 24 Months To Present Red Alert- High Risk 75% 50% 75% 25% Yellow Alert- Medium Risk 25% 25% 25% 75% Green Alert- Low Risk 0% 25% 0% 0% Next 24-36 Months- Anticipated Changes Decreasing Risk or Priority 25% 25% 25% 25% No Risk Change 25% 50% 50% 0% Increasing Risk or Priority 50% 25% 25% 75% BEST PRACTICES, 22 ® Copyright © Best Practices®, LLC LLC
  23. 23. About 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. Best Practices, LLC 6350 Quadrangle Drive, Suite 200, Chapel Hill, NC 27517 www.best-in-class.com Telephone: 919-403-0251 BEST PRACTICES, 23 ® Copyright © Best Practices®, LLC LLC

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