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Medical Affairs Consortium

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This presentation gives an insight into the membership benefits of Best Practices, LLC’s Medical Affairs Consortium. It also highlights some of the key benchmarks and best practices that emerged from Medical Affairs Consortium.

The Medical Affairs Consortium at Best Practices, LLC provides a dedicated platform to Medical Affairs Leaders to discuss top challenges, develop action oriented solutions, share best practices & lessons learned and explore current and future trends with regards to the Medical Affairs function and its interactions with other critical functions.

Topics for the Medical Affairs Consortium are usually determined by member requests. The Medical Affairs Consortium addresses three key areas:

• Building Strong Medical Affairs Capabilities
• Medical Affairs Launch Support Excellence
• Medical Affairs’ Critical Role in Health Economics & Outcomes Research

Published in: Health & Medicine
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Medical Affairs Consortium

  1. 1. Medical Affairs Consortium 2015 Building Strong Medical Affairs Capabilities
  2. 2. Table of Contents  Medical Affairs Consortium Information Pgs. 3-9  Developing Top-Tier Medical Affairs Capabilities Pgs. 10-13  Medical Affairs Launch Support Excellence Pgs. 14-17  Medical Affairs’ Critical Role in HEOR Pgs. 18-22  About Best Practices, LLC Pgs. 23-24  Abbreviations & Definitions Pgs. 25-26
  3. 3. Medical Affairs Consortium Information
  4. 4. 6 The Medical Affairs Consortium is a unique opportunity for Medical Affairs leaders to discuss key challenges, share best practices, develop action- oriented solutions and explore current and future trends in regards to the Medical Affairs function and its interactions with other critical functions. What is the Medical Affairs Consortium (MAC)?
  5. 5. 6 Participants Found the MAC to be a Valuable Service 4.6 4.4 4.2 4.3 Quality of the survey results deliverable Value of the survey results deliverable to you Quality of the roundtable discussion Value of the roundtable discussion Q. Please rate each of the following areas on the 1-5 scale. Note: Excellent = 5 // Good = 4 // Fair = 3 // Needs Improvement = 2 // Poor = 1 N=10 Q. Would you repurchase the consortium and roundtable discussions next year? 100% Replied Yes Q. Would you recommend the consortium and roundtable discussions to other Medical Affairs colleagues outside your company? 100% Replied Yes All the clients mentioned that they are willing to repurchase the consortium service as well as recommend it to their MA peers. Client Satisfaction Survey Outcomes
  6. 6. Benefits of Becoming a MAC Member 6 Live Discussions With Other Leaders About Medical Affairs Issues Access To The Best Practices’ Medical Affairs Database Quarterly Live Webinars By Best Practices’ Advisors Three Part Reports and Customized “Health” Check Access To Best Practices’ Research Advisors Research Updates Providing The Latest Trends MEDICAL AFFAIRS CONSORTIUM Live Discussions With Other Leaders About Medical Affairs Issues Access To The Best Practices’ Medical Affairs Database Quarterly Live Webinars By Best Practices’ Advisors Three Part Reports and Customized “Health” Check Access To Best Practices’ Research Advisors Research Updates Providing The Latest Trends MEDICAL AFFAIRS CONSORTIUM
  7. 7. 6 Medical Affairs Consortium Timeline Month-I Month-II Month-III Month-IV Month-V Month-VI Month-VII Month-VIII Month-IX Month-X Month-XI Month-XII 30-45 days Survey Creation and Launch 75-90 days Data Analysis, Secondary Research & 1st Roundtable Client Deliverable 1st RT* 30 days 1st Roundtable Summary Deliverable 45-60 days Data Analysis, Secondary Research & 2nd Roundtable Client Deliverable 2nd RT* 30 days 2nd Roundtable Summary Deliverable 3rd RT* 45-60 days Data Analysis, Secondary Research & 3rd Roundtable Client Deliverable 30 days 3rd Roundtable Summary Deliverable * Note: RT= Roundtable The roundtable times are open to change (15-day range) for adjustment to members’ schedules.
  8. 8. A Majority of Survey Participants were from Mature Markets Seventy-seven top biopharmaceutical executives responded to the three-part Medical Affairs Consortium survey during the 2014-2015 fiscal year. We created several segments based on location and company size through the responses that we got. Color Code: Lower Number Higher Number
  9. 9. Universe of Learning: Research Participants from 2014 - 2015 Study We created several different segments through the responses that we gathered. You can see an example of company size based segmentation below. Benchmark Class 4 Large Companies (Revenue > $10 Billion US in 2013)  Mid‐Cap Companies ($1‐10 Billion US in 2013) Small‐Cap Companies  (< $1 Billion US in 2013) Company Size Based Segments
  10. 10. 6 Medical Affairs Consortium is A Three-Part Annual Project We create a different set of research every year after conversations with members. Member requests determine the Medical Affairs Consortium topics. The 2015 Medical Affairs Consortium was composed of the following three topical areas: Developing Top-Tier Medical Affairs Capabilities • Effective Metrics for Medical Affairs Activities to Show Success to Stakeholders • Communicating the Value of Medical Affairs • Coordinating the Global Medical Affairs Function • Managing Compliance and Information Exchange Topics Research Areas Medical Affairs Launch Support Excellence • Important Medical Affairs’ Activities that Support Launch • Thought Leader Tiering • Thought Leader Targeting and MSL Coverage • Launch Investment Level • Medical Affairs Launch Budget Allocation Medical Affairs’ Critical Role in Health Economics & Outcomes Research • Longevity of Health Outcomes (HO) Groups • HO Group Leadership and Reporting Structure • HO Group Staff Levels • Medical Affairs’ Role in HO Activities • Medical Affairs Activities to Lead HO Data Collection and Utilization • Impact of HO Data on Important Medical Affairs Decisions 2015 MAC Research Parts
  11. 11. Copyright ©  Best Practices, LLC 11 Developing Top-Tier Medical Affairs Capabilities
  12. 12. Importance of Activities Changes According To Company Size Company Size Influences Activities That Are Given Priority 38 Activity Benchmark Class Large Companies Mid-Size Companies Small Companies Medical publications and com. Thought Leader Management Field-based medical team activities HEOR Alignment of company strategies with MA practices Medical/Clinical operations Continuing MedEd Medical call centers Internal training for commercial Highest Importance Lowest Importance N= 28 While all of the large and mid-size companies segment think that field-based medical team operations and outcomes data utilization are very important or important for their senior management team, only three-fourths of the small company segment associates similar importance with these activities N=11 N=10 N=7 Relevance to Senior Management: Please rank the relative importance of the following Medical Affairs activities to your senior leadership.
  13. 13. Page 13 asd asd Indirect Reporting Channels (e-mail, online reports) Medical Call Centers MedCom TLM Clinical Operations MedEd Internal Training MSL Teams HEOR Alignment of Activities High Importance to Senior Management Low Importance to Senior Management Direct F-to-F Reporting Channels (Meeting, Presentations, Briefings) N=28 Savvy MA Leaders Align Topic Importance with Communication Channel High External Focus Both Internal and External Focus High Internal Focus Medical Affairs Topic/Channel Impact Map Note: Size of the circles represents reporting level. Activities with high internal focus: Majority of the work is processed internally. Activities with high external focus: Majority of the work is related to external stakeholders (Ex:Payers, Providers, Patients, etc…) More than 90% of the benchmark class believes that their senior management finds three Medical Affairs areas highly important or important: Field-based medical teams operations, medical publications and communications and thought leader management. Relevance to Senior Management: Please rank the relative importance of the following Medical Affairs activities to your senior leadership
  14. 14. Formal or Informal Meetings Are the Leading Communication Channel for Sharing Compliance Sharing Compliance Challenges and Best Practices: How do you share compliance challenges and best practices across global and regional level? Nearly 70% percent of the benchmark class prefers formal regional and global meetings to share compliance challenges and best practices. In addition, half of the participants also arrange informal / ad-hoc meetings and 25% use a company-wide software to communicate compliance information. 69% 50% 44% 25% 12% Formal Regional and Global Meetings Informal / Ad‐hoc regional and global meetings Online updates (Ex: e‐mail, website, etc.) Company‐wide software Do not share compliance related information Sharing Compliance Challenges and Best Practices N=15 % Respondents 47
  15. 15. Copyright ©  Best Practices, LLC 15 Medical Affairs Launch Support Excellence
  16. 16. MA leads two launch activities for 93% of the benchmark class: Scientific Publications and MSL Activities. In addition, the MA function is either leading or supporting Advisory Boards, TL Activities and Investigator & Site Identification in all participant companies. N=27 Medical Affairs' Role: Please identify Medical Affairs’ role in each of the following activities that take place during launch and pre-launch phases. 93% 93% 86% 86% 61% 57% 41% 39% 37% 26% 22% 7% 14% 14% 21% 21% 59% 57% 44% 63% 59% 7% 7% 7% 4% 4% 4% 11% 14% 4% 15% 7% 15% Scientific publications MSL activites Advisory boards TL identification & development Continuing medical educaion Real world data generation & analysis Investigator and site identification Speaker training Protocol design Study/Site support & trouble shooting Clinical research conduct MA's Role in Launch Activities – Total Benchmark Class (TBC) Lead Support Plan to Participate in the Next 12 Months None % Respondents 16 Majority Say MA Leads 6 out of 11 Launch Activities
  17. 17. At the earlier stage of pre-launch, companies focus on TL related factors such as TL’s patient demographics, Influence Network and Expertise. At the later stage of pre-launch, companies focus on a mix of factors, such as Product Qualifications, Therapeutic Area, Regional Diversity, Company’s Relationship with the TL. TL’s Patient Demographic TL’s Expertise TL’s Influence Network Therapeutic Area Product Qualifications TL’s Scientific Publications Regional Diversity Behavioral Segmentation Pre-Launch Post-Launch TL’s Experience Company’s Relationship with the TL “Creating a cross-functional plan for TL development before launch is a role that Medical Affairs can play successfully. TL management planning has to start way in advance because Medical Affairs needs time to prepare the market for disease awareness, understand key decision makers’ needs and create a value-based launch strategy for products.” - Interviewed VP, Medical Affairs (Company B) Timing of Strategies Used for Thought-Leader (TL) Tiering TL Segmentation Starts Early In the Pre-Launch Stage 17 Note: Pre-Launch captures 12-18 months before launch. Post-launch captures 12-18 months after launch. Launch
  18. 18. MA Presents Higher Percentage of Total Investment after Launch Medical Affairs’ share in total launch investment increased from 18% to 20% during pre- and post-launch periods. N=6‐9 $16,508,000 $19,080,000 $3,006,250 $3,757,143 Launch Investment Average Launch Investment Average MA Launch Investment 18% 20% 18 Launch Investment: Please indicate the total and global MA launch investment for the product you supported during each time period. Note: Pre-Launch captures 12-18 months before launch. Post-launch captures 12-18 months after launch. Pre-Launch Post-Launch
  19. 19. Copyright ©  Best Practices, LLC 19 Medical Affairs’ Critical Role in Health Economics & Outcomes Research
  20. 20. 20 Health Outcomes Shifts to Whom It Reports in Last 4 Years 45% 39% 52% 11% 11% 17% 27% 4% 2009 (N=33) 2011 (N=18) 2015 (N=23) Change in Reporting Structure Medical Affairs Clinical Affairs Sales and Marketing “I think if you have somebody with the right vision, it doesn't necessarily matter where the HO department is sitting, but I believe you have higher chances to find somebody with a right vision in Medical Affairs. The commercial function might not have as much understanding of what health outcomes really entails to. As a result, commercial may see this critical function as a very narrow role.” - VP, Medical Affairs – Company B Reporting Structure: To whom does the Health Outcomes group(s) report? While 52% of the HO groups report to Medical Affairs within the benchmark class, a quarter of the companies’ HO groups do not report to clinical affairs, medical affairs or commercial. Since HO is a recent trend, some companies still haven’t clarified the reporting structure for these groups.
  21. 21. Type of Health Outcomes Data Used Changes with the Audience N=18 Utilizing the Health Outcomes Data: Choose the top three type of Health Outcomes data that you use with the following stakeholders: Use of HO Data to Inform Different Stakeholders Patients Providers Increasing Use IncreasingUse Workplace productivity Analysis of safety Resource use Cost Analysis Analysis of efficacy Economic analysis Quality of life Burden of illness Type of HO Data Mostly Used with Payers and Patients Type of HO Data Mostly Used with Payers and Providers Type of HO Data Mostly Used with Providers Payers While payers are interested in learning about cost analysis and overall economic impact of a certain product, patients need to understand the impact of the product on quality of life and providers want to know about disease management aspect and safety profile of the products.
  22. 22. Health Outcomes Data Utilized for Research Decisions in Young Groups, for Market Access Decisions in Older Groups 22 N=18 Company Size MaturityofHOGroup HO Program ≥ 4Yrs. HO Program < 4Yrs. Medium & Small Companies. Large Companies Effect of HO Data on Critical Decisions Identifying future Health Outcomes research areas Generating market access strategies Creating scientific publication strategies Reimbursement strategies Creating drug formulary inclusion tactics Generating supportive materials for marketing Clinical trials and development Supporting price forecast Mature HO Groups Young HO Groups Mature HO groups know how to utilize HO Data for reimbursement and market access Young HO groups utilize HO Data mostly to create clinical and scientific research strategies While HO data heavily informs scientific research decisions in companies with young HO groups, this type of data is used more for Market Access purpose in companies with mature HO groups. Informing Decisions: How effective is the Health Outcomes data to inform following decisions within the Medical Affairs function?
  23. 23. Generalist Model Provides A Better Fit for HO Data Communication Generalist vs. Specialist Models Inquiry Resolved Inquiry Resolved Customer Customer Specialist HOLs Generalist HOL • Interviewed executives tend to favor a generalist model, with HOLs typically covering all major products for an assigned region. • The preference for generalization over specialization by product or therapeutic area is customer driven, with customers favoring “one stop shopping” and a single point of contact. • To ensure that “generalists” have deep as well as broad knowledge, companies provide high volumes of training. Biopharmaceutical companies are favoring a generalist model for their field-based HO staff.
  24. 24. About Best Practices, LLC 24
  25. 25. Best Practices®, LLC is an internationally recognized thought leader in the field of best practice benchmarking®. We are a research, consulting, benchmark database, publishing and advisory firm that conducts work based on the simple yet profound principle that organizations can chart a course to superior economic performance by leveraging the best business practices, operating tactics and winning strategies of world-class companies. 6350 Quadrangle Drive, Suite 200 Chapel Hill, NC 27517 (Phone): 919-403-0251 www.best-in-class.com Learn More About Our Company: 25
  26. 26. Abbreviations & Definitions 26
  27. 27. BEST PRACTICES, ® LLCCopyright © Abbreviations & Definitions 6 • MAC: Medical Affairs Consortium • MA: Medical Affairs • HO: Health Outcomes • HEOR: Health Economics and Outcomes Research • RT: Roundtable • MSL: Medical Science Liaison • TL: Thought Leader • TLM: Thought Leader Management • LCS: Large Companies Segment • MCS: Medium-Size Companies Segment • SCS: Small Companies Segment

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