Educating KOLs, Physicians, Patients and Payers to Support Successful Product Launches Report Summary


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Report Summary--Educating KOLs, Physicians, Patients and Payers to Support Successful Product Launches. Contact me to view the full report.

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Educating KOLs, Physicians, Patients and Payers to Support Successful Product Launches Report Summary

  1. 1. Educating KOLs, Physicians, Patients and Payers to Support Successful Product LaunchesStrategic Benchmarking Research, Analysis and Recommendations BEST PRACTICES, 1 ® Copyright © Best Practices®, LLC LLC
  2. 2. Table of ContentsBackground Summary of Key Insights, Findings and Lessons Learned p.4-7 Universe of Learning: Research Participants, Launch Experience, and Therapeutic Area Demographics p.8-13Market Entry Success Drivers 1.1 Develop Integrated Continuous Thought Leader Strategies p.14-16 1.2 Thought Leader Targeting p.17-21 1.3 Thought Leader Relationship & Value Management p.22-29 2.1 Manage Clinical Trials To Win Highly Regarded Thought Leaders & Investigators Into Your Clinical Trials p.30-38 2.2 Managing Investigator-Initiated Studies p.39-47 2.3 Early Access Programs: Helping Patients & Expanding Physicians Experience p.48-50 2.4 Post-Approval Early Access Programs: Helping Patients, Physicians & Marketplace Buzz p.51-54 3.1 - Data Disclosures: Inform Medical Community of Your Progress & Commitment p.55-60 4.1 Communicate Clinical Science Through Journals & Congresses p.61-67 4.2 - Using Scientific Publications: Marrying Productivity and Insights p.68-74 5.1 - Use Multi-Channel Medical Education To Inform Health Care Providers p.75-77 5.2 - Medical Education: Balancing the Mix of CME, Grants & Tools p.78-81 BEST PRACTICES, 2 ® Copyright © Best Practices®, LLC LLC
  3. 3. Table of Contents 6.1 - Inform Patients Through Education & Advocacy Group Collaborations p.82-90 7.1 - Payer Education Starts Early; Focus On Cost and Outcomes p.91-101 8.1 Use PR & New Technologies For Leveraged Reach to Patients, Physicians, & Payers p.102-118 8.2 Use New Technologies For Educating & Informing Patients p.119-121 9.1 - Orchestrate Medical Education Timing To Reach Right Constituencies At the Right Times (placeholder slide) p.122 10.1 - Allocate Market Education Mix To Reflect Therapeutic Area Needs & the Competitive Landscape p.123-125Lessons Learned Voices From the Field: Best Practices, Lessons Learned & Pitfalls To Consider p.126-129 Future Trends & Issues p.130-133 Appendix I - Orchestrate Medical Education Timing To Reach Right Constituencies At the Right Times p.134-138About Best Practices BEST PRACTICES, 3 ® Copyright © Best Practices®, LLC LLC
  4. 4. Research Objective and MethodologyThis study explores best practices in educating, informing and preparing themarketplace for new products – through Physician, Patient, and Payer education,publications, advocacy and communication strategies. Study Objective & Methodology Key Study Objectives This field research and benchmarking •Identify key education tactics for study probed the broad array of medical thought leaders, physicians, patients, education and marketing practices and payers conducted two to three years prior to •Assess key market-education launch that best inform and shape the practices, including thought leader marketplace. services, MedEd, scientific A quantitative survey harvested current publications, patient advocacy & education, clinical trials & payer best practices and emerging trends in education educating the marketplace to support successful product launches. In addition, •Identify key timing factors & deep-dive executive interviews were education mix conducted with selected participants to provide qualitative insights and emerging •Describe critical market entry pitfalls trends. and future trends BEST PRACTICES, 4 ® Copyright © Best Practices®, LLC LLC
  5. 5. 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. 10. Allocate 1. Develop Market Ed Mix To Integrated “I think its going to “I think its going to Reflect T.A. & Continuous boil down to being boil down to being Competitive Thought Leader 2. Manage able to actually 9. Orchestrate able to actually Med Ed Timing Landscape Strategies Clinical Trials To Win Highly identify by individual identify by individual To Reach Right Constituencies Regarded customer what Investigators & customer what At Right Times channel they want TLs channel they want 8. Use PR & New MARKET information from and 3. Data Disclosures information from and Technologies For EDUCATION Inform Medical how youre going to Leveraged Reach to Community of Your how youre going to Patients, Physicians, EXCELLENCE Progress & reach them most reach them most & Payers Commitment efficiently, and almost efficiently, and almost 7. Start Payer 4. Communicate going through aa going through Education Early; Clinical Science decision tree that Focus On Cost decision tree that Thru Journals & looks at effectiveness & Health 6. Inform 5. Use Multi- Congresses looks at effectiveness Outcomes Patients Thru Channel Med. and cost . .. ...” and cost ..” Education & Ed. To Inform -Senior Vice President, Marketing Advocacy Group Health Care -Senior Vice President, Marketing Collaborations Providers BEST PRACTICES, 5 ® Copyright © Best Practices®, LLC LLC
  6. 6. Universe of Learning: 26 Companies Engaged Research participants included 34 executives and managers from 26 leading pharmaceutical, biotech and medical device companies. Participating Companies BEST PRACTICES, 6 ® Copyright © Best Practices®, LLC LLC
  7. 7. Universe of Learning: Job Titles and Executive InterviewsResearch participants’ roles ranged from senior leaders of commercial operations to managers ofbrand teams and therapeutic franchise groups. “Lessons learned” executive interviews wereconducted across nine select companies. Job Titles Interview Class • Senior VP, Commercial • Executive Director, Operations Global Marketing • Senior VP, Marketing • Associate Brand • Executive Director, Director Commercial Operations • Senior Manager, • Head Clinical & Medical New Product Services Commercialization • Vice President, Marketing • National Sales • Senior Director, Oncology Manager • Director, Oncology • Manager, Clinical Commercial Analysis Research • Senior Manager, Marketing • Senior Product • Manager, Oncology Market Manager/Payer Research Marketing • Senior Director, Diabetes • Senior Manager, • Group Sales & Brand Health Care Manager Solutions • Senior Manager, • Medical Adviser Commercial Development BEST PRACTICES, 7 ® Copyright © Best Practices®, LLC LLC
  8. 8. A Third of Participants Have Launched more than Five Drugs Research participants were veterans of product launches, with 36 percent taking part in more than five launches. Q3. Number of New Product Launches Worked On: How many new product launches have you participated in during your career? Total Benchmark Class More than Ten, 12% Six to Ten, 24% Less than Five, 65% (n=34) BEST PRACTICES, 8 ® Copyright © Best Practices®, LLC LLC
  9. 9. 1.1 Develop IntegratedContinuous Thought Leader Strategies:Throughout Development and Market Entry, Thought Leaders Are ACompass Guiding Market Insights and Education BEST PRACTICES, 9 ® Copyright © Best Practices®, LLC LLC
  10. 10. Start Early With Thought Leader Education & ServicesThought leaders are the bellwethers of market direction. They help companies understand wheretherapeutic guidelines and practices are headed; they influence how practicing physicians respond tonew therapies. Not surprisingly, the largest response groups signaled Phase II as the kickoff to mostthought leader services. Some companies with robust pipelines and deep-standing commitment to theirtherapeutic areas start thought leader services as early as pre-clinical research phases. Q6. Developing Thought Leaders: Please check when you should start each activity for educating thought leaders. Total Benchmark Class Engaging Thought Providing Communicating Developing Leaders & Medical Critical Integrated Conducting Key Science Information and Thought Leader Advisory Boards Investigators Liaison Sharing Research Strategies in Clinical Services Insights Trial Protocol Development Pre-Clinical 6% 18% 3% 18% 12% Phase I 15% 12% 12% 24% 9% Phase II 41% 26% 6% 47% 29% Phase III-3 Years 21% 24% 15% 6% 26% Phase III-2 Years 15% 6% 21% 3% 12% Phase III-1 Year 3% 12% 32% 0% 6% NDA thru Launch Year 0% 3% 12% 3% 6%(n=34) BEST PRACTICES, 10 ® Copyright © Best Practices®, LLC LLC
  11. 11. Market Entry Teams “Seed & Grow” MSL Pre-Launch CoverageThe overall benchmark class seeds Medical Science Liaisons (MSLs) at the start of Phase III clinical trials withtypically three liaisons to serve national thought leaders and clinical investigators. As Phase III trialsprogress, this number of MSLs nearly doubles or triples each subsequent year. By launch year, the averagenumber of MSL has reached 26. This MSL seeding and growth pattern can be observed across mosttherapeutic areas – although the staffing intensity varies somewhat across individual specialty areas. Q24. MSL Coverage: Estimate how many field-based medical science specialists or liaisons (MSLs) you assign during each year of the Phase III pre-launch period to a new product in a new therapeutic area? 26 # MSLs Assigned 15 8 3 Phase III-3 Phase III-2 Phase III-1 Launch Years Years Year Year (n=19) BEST PRACTICES, 11 ® Copyright © Best Practices®, LLC LLC
  12. 12. 2.2 Managing Investigator- Initiated Studies:Engaging Key Investigators in Developing Your Product’s Full Potential BEST PRACTICES, 12 ® Copyright © Best Practices®, LLC LLC
  13. 13. Oncology TA Tolerates Earlier Risk for IISsSome organizations – particularly those working in Oncology, do investigator-initiated trials both early andlate in the development cycle. In Oncology, the life-threatening condition of many patients inspiresoncologists to conceive investigator initiated trials examining many tumor types and patient populationsthat lie outside the first pivotal trials. “Once you have confidence that youve determined what your safety profile is, you can act strategically and build the right type of Phase One-type programs from an IIT perspective thatll allow you to understand how you perform in other diseases or in combination with other agents. I guess if I was developing an allergy medicine, that would be one thing. But I think in cancer its very different. I think most oncology organizations are willing to take a calculated risk in some of these areas.” - Senior Vice President, Commercial 8/presentations/Monday/1110am_Dorowshow1 .ppt BEST PRACTICES, 13 ® Copyright © Best Practices®, LLC LLC
  14. 14. 4.1 CommunicateClinical Science Through Journals & Congresses BEST PRACTICES, 14 ® Copyright © Best Practices®, LLC LLC
  15. 15. Primary Journals and Congresses Drive Publication StrategiesBenchmark partners place highest importance on publishing clinical research in primary journals andsecondary journals – along with presenting clinical research at both national and regional congresses,and to a lesser degree on some online scientific publications. Online publications can also be important.Some therapeutic areas place relatively greater importance on publishing in alternative channels. Q15. Please rate the importance of publishing your clinical results in various channels: Scientific Publishing Channel Impact Map Highly Important Important Major Congresses or Events (Intl/Natl) 83% 13% Primary Journal 83% 17% Online Scientific Publications 17% 47% Secondary Journals 10% 72% Alternative Media 4% 25% Minor Congresses or Events 79% 4% (Regional /Local) Internet Self-publication 3% 17% (n=31) BEST PRACTICES, 15 ® Copyright © Best Practices®, LLC LLC
  16. 16. 4.2 - Using Scientific Publications: MarryingProductivity and Insights BEST PRACTICES, 16 ® Copyright © Best Practices®, LLC LLC
  17. 17. Lower Wall Between Medical and MarketingAs the wall between Medical and Marketing has gotten higher, marketing groups nolonger understand the importance of scientific communication and how to work withMedical to get that information published. Each group must have its autonomy – butthey must work together for the company’s benefit. “If you separate Medical and Marketing, then whos going to be the one basically saying whether or not youre getting what you need out of Medical? The reporting chain that goes all the way up through Medical doesnt look at things that way. We went in and Marketing did a gap analysis. They had one primary care study publication in the three years since launch. And theyre saying, ‘Oh, we got this in JAMA.’ And were like, great, isnt this a primary care drug? Yeah, well, how many primary care publications did you….one. Well, holy cow, guys. I think if you dont have that commercial lens…you need Commercial and Medical looking at it from different perspectives, and you need both. .” – Senior VP Commercial BEST PRACTICES, 17 ® Copyright © Best Practices®, LLC LLC
  18. 18. 7.1 - Payer EducationStarts Early; Focus On Cost And Outcomes BEST PRACTICES, 18 ® Copyright © Best Practices®, LLC LLC
  19. 19. Engage Payers Early & Maintain Relations Through Launch The overall benchmark class reflects early and continuous involvement with payers and government agencies: They engage payers through clinical trial protocol design and needs assessment in Phase II. Commence outcome studies in early Phase III. Then conduct Ad Boards, agency meetings and payer pricing sensitivity in mid-Phase III. Payer education activities then accelerate late in Phase III.Q12.Educating Payers & Government Agencies: Please check when you should start each activity for educating payers & government agencies (Medicare/Medicaid). Phase Phase NDA thru Total Benchmark Class Pre- Phase Phase III- Phase I III-2 III-1 Launch Clinical II 3 Years Years Year Year Conducting Advisory Boards with Payers / agencies 3% 0% 27% 15% 33% 18% 3% Conducting Clinical Meetings / Discussions with Payers / 0% 6% 21% 9% 30% 24% 9% Agencies Payer and Government Needs 0% 3% 36% 12% 24% 18% 6% Conducting Early Payer Education Activities 0% 3% 21% 15% 9% 45% 6% Engaging Payers in Clinical Trial Protocol Development 6% 3% 38% 25% 16% 9% 3% Conducting Health Outcomes Studies 3% 9% 27% 33% 21% 6% 0% Assessing Payers Efficacy / Safety / Pricing Sensitivity 0% 9% 18% 18% 33% 15% 6% Announcing Trade/Brand Name 0% 10% 6% 3% 13% 32% 35% Announcing Generic Name 6% 13% 13% 16% 23% 19% 10% (n=34) BEST PRACTICES, 19 ® Copyright © Best Practices®, LLC LLC
  20. 20. 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 Telephone: 919-403-0251 BEST PRACTICES, 20 ® Copyright © Best Practices®, LLC LLC