1. Strategic Benchmarking Research, Analysis and Recommendations Educating KOLs, Physicians, Patients and Payers to Support Successful Product Launches

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

8. 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.

9. 1.1 Develop Integrated Continuous Thought Leader Strategies: Throughout Development and Market Entry, Thought Leaders Are A Compass Guiding Market Insights and Education

10. 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

11. 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.

12. 2.2 Managing Investigator-Initiated Studies : Engaging Key Investigators in Developing Your Product’s Full Potential

13. 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

14. 4.1 Communicate Clinical Science Through Journals & Congresses

15. 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

16. 4.2 - Using Scientific Publications: Marrying Productivity and Insights

17. 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.

18. 7.1 - Payer Education Starts Early; Focus On Cost And Outcomes

19. 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

20. 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.