Educating KOLs, Physicians, Patients, and Payers to support successful product launches
Strategic Benchmarking Research, Analysis and Recommendations Educating KOLs, Physicians, Patients and Payers to Support Successful Product Launches
Table of Contents <ul><li>Background </li></ul><ul><ul><li>Summary of Key Insights, Findings and Lessons Learned p.4-7 </li></ul></ul><ul><ul><li>Universe of Learning: Research Participants, Launch Experience, and Therapeutic Area Demographics p.8-13 </li></ul></ul><ul><li>Market Entry Success Drivers </li></ul><ul><ul><li>1.1 Develop Integrated Continuous Thought Leader Strategies p.14-16 </li></ul></ul><ul><ul><li>1.2 Thought Leader Targeting p.17-21 </li></ul></ul><ul><ul><li>1.3 Thought Leader Relationship & Value Management p.22-29 </li></ul></ul><ul><ul><li>2.1 Manage Clinical Trials To Win Highly Regarded Thought Leaders & Investigators Into Your Clinical Trials p.30-38 </li></ul></ul><ul><ul><li>2.2 Managing Investigator-Initiated Studies p.39-47 </li></ul></ul><ul><ul><li>2.3 Early Access Programs: Helping Patients & Expanding Physicians Experience p.48-50 </li></ul></ul><ul><ul><li>2.4 Post-Approval Early Access Programs: Helping Patients, Physicians & Marketplace Buzz p.51-54 </li></ul></ul><ul><ul><li>3.1 - Data Disclosures: Inform Medical Community of Your Progress & Commitment p.55-60 </li></ul></ul><ul><ul><li>4.1 Communicate Clinical Science Through Journals & Congresses p.61-67 </li></ul></ul><ul><ul><li>4.2 - Using Scientific Publications: Marrying Productivity and Insights p.68-74 </li></ul></ul><ul><ul><li>5.1 - Use Multi-Channel Medical Education To Inform Health Care Providers p.75-77 </li></ul></ul><ul><ul><li>5.2 - Medical Education: Balancing the Mix of CME, Grants & Tools p.78-81 </li></ul></ul>
Table of Contents <ul><ul><li>6.1 - Inform Patients Through Education & Advocacy Group Collaborations p.82-90 </li></ul></ul><ul><ul><li>7.1 - Payer Education Starts Early; Focus On Cost and Outcomes p.91-101 </li></ul></ul><ul><ul><li>8.1 Use PR & New Technologies For Leveraged Reach to Patients, Physicians, & Payers p.102-118 </li></ul></ul><ul><ul><li>8.2 Use New Technologies For Educating & Informing Patients p.119-121 </li></ul></ul><ul><ul><li>9.1 - Orchestrate Medical Education Timing To Reach Right Constituencies At the Right Times (placeholder slide) p.122 </li></ul></ul><ul><ul><li>10.1 - Allocate Market Education Mix To Reflect Therapeutic Area Needs & the Competitive Landscape p.123-125 </li></ul></ul><ul><li>Lessons Learned </li></ul><ul><ul><li>Voices From the Field: Best Practices, Lessons Learned & Pitfalls To Consider p.126-129 </li></ul></ul><ul><ul><li>Future Trends & Issues p.130-133 </li></ul></ul><ul><ul><li>Appendix I - Orchestrate Medical Education Timing To Reach Right Constituencies At the Right Times p.134-138 </li></ul></ul><ul><li>About Best Practices </li></ul>
Research Objective and Methodology Key Study Objectives Study Objective & Methodology This field research and benchmarking study probed the broad array of medical education and marketing practices conducted two to three years prior to launch that best inform and shape the marketplace. A quantitative survey harvested current best practices and emerging trends in educating the marketplace to support successful product launches. In addition, deep-dive executive interviews were conducted with selected participants to provide qualitative insights and emerging trends. <ul><li>Identify key education tactics for thought leaders, physicians, patients, and payers </li></ul><ul><li>Assess key market-education practices, including thought leader services, MedEd, scientific publications, patient advocacy & education, clinical trials & payer education </li></ul><ul><li>Identify key timing factors & education mix </li></ul><ul><li>Describe critical market entry pitfalls and future trends </li></ul>This study explores best practices in educating, informing and preparing the marketplace for new products – through Physician, Patient, and Payer education, publications, advocacy and communication strategies.
10 Steps To Excellence: Key Themes from Market Education Research <ul><li>“ I think it's going to boil down to being able to actually identify by individual customer what channel they want information from and how you're going to reach them most efficiently, and almost going through a decision tree that looks at effectiveness and cost . . ..” </li></ul><ul><li>-Senior Vice President, Marketing </li></ul>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. MARKET EDUCATION EXCELLENCE 1. Develop Integrated Continuous Thought Leader Strategies 2. Manage Clinical Trials To Win Highly Regarded Investigators & TLs 3. Data Disclosures Inform Medical Community of Your Progress & Commitment 7. Start Payer Education Early; Focus On Cost & Health Outcomes 4. Communicate Clinical Science Thru Journals & Congresses 5. Use Multi-Channel Med. Ed. To Inform Health Care Providers 8. Use PR & New Technologies For Leveraged Reach to Patients, Physicians, & Payers 10. Allocate Market Ed Mix To Reflect T.A. & Competitive Landscape 6. Inform Patients Thru Education & Advocacy Group Collaborations 9. Orchestrate Med Ed Timing To Reach Right Constituencies At Right Times
Universe of Learning: 26 Companies Engaged Research participants included 34 executives and managers from 26 leading pharmaceutical, biotech and medical device companies. Participating Companies
Universe of Learning: Job Titles and Executive Interviews Interview Class <ul><li>Executive Director, Global Marketing </li></ul><ul><li>Associate Brand Director </li></ul><ul><li>Senior Manager, New Product Commercialization </li></ul><ul><li>National Sales Manager </li></ul><ul><li>Manager, Clinical Research </li></ul><ul><li>Senior Product Manager/Payer Marketing </li></ul><ul><li>Senior Manager, Health Care Solutions </li></ul><ul><li>Medical Adviser </li></ul><ul><li>Senior VP, Commercial Operations </li></ul><ul><li>Senior VP, Marketing </li></ul><ul><li>Executive Director, Commercial Operations </li></ul><ul><li>Head Clinical & Medical Services </li></ul><ul><li>Vice President, Marketing </li></ul><ul><li>Senior Director, Oncology </li></ul><ul><li>Director, Oncology Commercial Analysis </li></ul><ul><li>Senior Manager, Marketing </li></ul><ul><li>Manager, Oncology Market Research </li></ul><ul><li>Senior Director, Diabetes </li></ul><ul><li>Group Sales & Brand Manager </li></ul><ul><li>Senior Manager, Commercial Development </li></ul>Job Titles Research participants’ roles ranged from senior leaders of commercial operations to managers of brand teams and therapeutic franchise groups. “Lessons learned” executive interviews were conducted across nine select companies.
A Third of Participants Have Launched more than Five Drugs Q3. Number of New Product Launches Worked On: How many new product launches have you participated in during your career? (n=34) Research participants were veterans of product launches, with 36 percent taking part in more than five launches.
1.1 Develop Integrated Continuous Thought Leader Strategies: Throughout Development and Market Entry, Thought Leaders Are A Compass Guiding Market Insights and Education
Start Early With Thought Leader Education & Services (n=34) Q6. Developing Thought Leaders : Please check when you should start each activity for educating thought leaders. Thought leaders are the bellwethers of market direction. They help companies understand where therapeutic guidelines and practices are headed; they influence how practicing physicians respond to new therapies. Not surprisingly, the largest response groups signaled Phase II as the kickoff to most thought leader services. Some companies with robust pipelines and deep-standing commitment to their therapeutic areas start thought leader services as early as pre-clinical research phases. 6% 3% 12% 3% 0% NDA thru Launch Year 6% 0% 32% 12% 3% Phase III-1 Year 12% 3% 21% 6% 15% Phase III-2 Years 26% 6% 15% 24% 21% Phase III-3 Years 29% 47% 6% 26% 41% Phase II 9% 24% 12% 12% 15% Phase I 12% 18% 3% 18% 6% Pre-Clinical Communicating Critical Information and Sharing Research Insights Engaging Thought Leaders & Key Investigators in Clinical Trial Protocol Development Providing Medical Science Liaison Services Conducting Advisory Boards Developing Integrated Thought Leader Strategies Total Benchmark Class
Market Entry Teams “Seed & Grow” MSL Pre-Launch Coverage 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? (n=19) # MSLs Assigned The overall benchmark class seeds Medical Science Liaisons (MSLs) at the start of Phase III clinical trials with typically three liaisons to serve national thought leaders and clinical investigators. As Phase III trials progress, this number of MSLs nearly doubles or triples each subsequent year. By launch year, the average number of MSL has reached 26. This MSL seeding and growth pattern can be observed across most therapeutic areas – although the staffing intensity varies somewhat across individual specialty areas.
2.2 Managing Investigator-Initiated Studies : Engaging Key Investigators in Developing Your Product’s Full Potential
Oncology TA Tolerates Earlier Risk for IISs “ Once you have confidence that you've determined what your safety profile is, you can act strategically and build the right type of Phase One-type programs from an IIT perspective that'll 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 it's very different. I think most oncology organizations are willing to take a calculated risk in some of these areas.” - Senior Vice President, Commercial Some organizations – particularly those working in Oncology, do investigator-initiated trials both early and late in the development cycle. In Oncology, the life-threatening condition of many patients inspires oncologists to conceive investigator initiated trials examining many tumor types and patient populations that lie outside the first pivotal trials. http://deainfo.nci.nih.gov/advisory/bsa/bsa0308/presentations/Monday/1110am_Dorowshow1.ppt
4.1 Communicate Clinical Science Through Journals & Congresses
Primary Journals and Congresses Drive Publication Strategies Q15. Please rate the importance of publishing your clinical results in various channels: Benchmark partners place highest importance on publishing clinical research in primary journals and secondary 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. (n=31) 4 % 10% 17% 83% 83% 25% 72% 47% 17% 13% 4 % 3% 79% 17% Internet Self-publication Minor Congresses or Events (Regional /Local) Alternative Media Secondary Journals Online Scientific Publications Primary Journal Major Congresses or Events (Int'l/Nat'l) Highly Important Important Scientific Publishing Channel Impact Map
4.2 - Using Scientific Publications: Marrying Productivity and Insights
Lower Wall Between Medical and Marketing “ If you separate Medical and Marketing, then who's going to be the one basically saying whether or not you're getting what you need out of Medical? The reporting chain that goes all the way up through Medical doesn't 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 they're saying, ‘Oh, we got this in JAMA.’ And we're like, great, isn't this a primary care drug? Yeah, well, how many primary care publications did you….one. Well, holy cow, guys. I think if you don't have that commercial lens…you need Commercial and Medical looking at it from different perspectives, and you need both. .” – Senior VP Commercial As the wall between Medical and Marketing has gotten higher, marketing groups no longer understand the importance of scientific communication and how to work with Medical to get that information published. Each group must have its autonomy – but they must work together for the company’s benefit.
7.1 - Payer Education Starts Early; Focus On Cost And Outcomes
Engage Payers Early & Maintain Relations Through Launch (n=34) Q12.Educating Payers & Government Agencies: Please check when you should start each activity for educating payers & government agencies (Medicare/Medicaid). 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. 10% 19% 23% 16% 13% 13% 6% Announcing Generic Name 35% 32% 13% 3% 6% 10% 0% Announcing Trade/Brand Name 6% 15% 33% 18% 18% 9% 0% Assessing Payers Efficacy / Safety / Pricing Sensitivity 0% 6% 21% 33% 27% 9% 3% Conducting Health Outcomes Studies 3% 9% 16% 25% 38% 3% 6% Engaging Payers in Clinical Trial Protocol Development 6% 45% 9% 15% 21% 3% 0% Conducting Early Payer Education Activities 6% 18% 24% 12% 36% 3% 0% Payer and Government Needs 9% 24% 30% 9% 21% 6% 0% Conducting Clinical Meetings / Discussions with Payers / Agencies 3% 18% 33% 15% 27% 0% 3% Conducting Advisory Boards with Payers / agencies NDA thru Launch Year Phase III-1 Year Phase III-2 Years Phase III-3 Years Phase II Phase I Pre-Clinical Total Benchmark Class
About Best Practices, LLC Best Practices, LLC 6350 Quadrangle Drive, Suite 200, Chapel Hill, NC 27517 www.best-in-class.com Telephone: 919-403-0251 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.