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Medical Affairs Excellence Services Summary

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An overview of some of our best work in Medical Affairs. Reports are available individually or as bundles. All of our Excellence Services come with a membership to our Best Practice Database. …

An overview of some of our best work in Medical Affairs. Reports are available individually or as bundles. All of our Excellence Services come with a membership to our Best Practice Database. Contact me for details.

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  • 1. Medical Affairs Excellence Services: Research Excerpt (OPS-1A)Medical Affairs Overview This Medical Affairs Excellence Services provides executives with strategic insightExcellence Services and successful approaches competitive performance in the medical for affairs function. It focuses on many areasPROJECT BACKGROUND including utilizing health outcomes, scientific publications strategy, educating physicians, key opinion leaders, patient advocacy and clinical developments.The dynamic bio-pharmaceutical and medical devicecompanies are accelerating their medical affairs function Sample Featured Organizationsscope beyond a traditional support function. The • Abbott Laboratoriesfunction manages strategic responsibilities bridging • AstraZeneca research as well as clinical • Bayer Special Features • Bristol-Myers Squibb development, its scientific Annual Membership to the • Boehringer Ingelheim publications strategy and Best Practice Database • Cardiac Science Corp utilizes health outcomes, • Eli Lilly provides unlimited access to biostatistics, necessary • GlaxoSmithKline a $35-million growing body • Genentech medical education and of proprietary research and other medical services. • Innovex • Johnson & Johnson forward-looking analysis The medical affairs • Novartisfunction enhances a company’s scientific reputation and • Pfizer Inc.complements the work of Research & Development. It • Proctor & Gamble • Sanofi-Aventisalso provides physicians, key opinion leaders (KOLs), • Schering Ploughlegal-regulatory agencies, professional groups and • TEVAhealthcare professionals with medical and scientific Information Typesinformation and education on the value and proper use • 140+ Data Graphicsof a company’s products, therapies, devices, technology • 180+ Information Graphicsand diagnostics. • 260+ Metrics • 60+ Narratives • 50+ Best PracticesDuring several years of benchmarking world-classpharmaceutical and life science organizations, Best Questions?Practices, LLC has provided valuable information to For more information, please contactpharmaceutical companies to improve their medical Best Practices LLC at (919) 403-0251 or bestpractices@best-in-class.comaffairs capabilities.Through the Medical Affairs Excellence Services, Best Practices provides our clients with theCopyright Best Practices, LLC (919) 403-0251 1
  • 2. Medical Affairs Excellence Services: Research Excerpt (OPS-1A)insights, expertise and intelligence needed to increase the impact of Medical Affairs functionin the areas of: • Medical Affairs structuring and funding • Post-marketing surveillance for adverse events • Thought leaders relationships • Pharmaceutical speaker programs - training and development • Scientific Publications strategy • Medical Science Liaisons • Key Opinion Leader Relationships • Collaborating with patient advocacy groups • New Product Planning • Webinars for enhancing key opinion leader relationships • Educating the marketplace for new Product launches – oncologyINCLUDED RESEARCHBest Practices can tailor a service offering to meet your needs from our following productsand research. Contact us to discuss our services and pricing options for our research andservices which include:1. Budget and Staffing Excellence: Benchmarking the Resources Required to Drive Productivity and Growth (OP-97): The study examines how the most successful pharmaceutical companies structure, align staff and fund medical affairs capabilities. Executives and managers can benchmark against these companies’ staffing and spend levels; your company will gain the necessary information to conduct a performance gap analysis using the following key metrics: • FTEs by capability • Imputed FTEs Per Dedicated MA Capability • FTEs per compound • FTEs per therapy area • FTEs per $100 Million in US Sales • Total Outsourcing by Company • Outsourcing by Capability • External Spend by Capability • External Spend per CompoundCopyright Best Practices, LLC (919) 403-0251 2
  • 3. Medical Affairs Excellence Services: Research Excerpt (OPS-1A) • Effectiveness by rating2. Medical Affairs Resources, Structures & Trends (POP-228): This benchmarking study explores how U.S. and global biopharmaceutical companies are structuring and managing their Medical Affairs organizations today. The study also examines recent trends in budget and staffing resources, key challenges and top success factors for the function. Specifically, the report highlights the following areas of medical affairs: • Organizational Structure • Reporting Relationship • Job Level of Group Leader • Geographic Span • Budget Allocation by Medical Affairs Function • Percent of Budget Allocated for Outsourcing • Recent and Anticipated Changes in Resource Levels • Impact of Medical Affairs Functions on Company Success • Key Success Factors for Medical Affairs • Key Challenges for Medical Affairs3. Best Practices for Post-Marketing Surveillance of Adverse Events within the U.S. (POP-230): This benchmarking study examines the best practices for post-marketing surveillance within the United States, as well as the processes for assessing reports of adverse events, follow-up activities and compliance training. Key elements of the report include: • Staffing and Workflow • Drug Safety Processes and Reporting Sources • Approach to AE Reports from Non-Traditional Sources • Approach to AE Reports on Another Manufacturer’s Product • Drug Safety Compliance Training • Marketing Program Involvement • Drug Safety ChallengesCopyright Best Practices, LLC (919) 403-0251 3
  • 4. Medical Affairs Excellence Services: Research Excerpt (OPS-1A)4. Thought Leader Relationships: Building the Business (SM-129): This study has captured the techniques that top pharmaceutical companies use to build and manage thought leader relationships: • Aligning Field-Based Medical with Overall Objective • Managing Performance • Providing Support and Communication • Setting and Measuring Clear Goals5. Pharmaceutical Speaker Programs: Building the Business (SM-130): This Speaker Program Administration study identifies the top practices shared by benchmark partners. Your company can use consolidated insights and best practices of the benchmark class to guide thinking about your own physician relationship management process. The following include specific topics of concentration: • Selecting System Logistics • Using Vendors to Improve Performance • The Internet • Managing a World-Class System • Implementation in the Field • Budgeting • Using Speaker Programs to Build Doctor Relationships • Maximizing Influence in the Marketplace • Creating Long-Term Benefits • Ensuring Doctor Delight • Training Reps, Speakers and Coordinators • Setting Goals and Measuring Impact • Doctor Response Matrix • Reimbursement • Communication • Logistics • RelationshipsCopyright Best Practices, LLC (919) 403-0251 4
  • 5. Medical Affairs Excellence Services: Research Excerpt (OPS-1A)6. Best Practices in Speaker Training and Development: Driving Pharmaceutical Brand Growth (SM-158): This report focuses primarily on speaker training and development, a crucial link of the entire speaker management process. Report owners will learn how top pharmaceutical and biotech companies ensure the physicians that speak on their behalf are top-notch communicators of product benefits. This study highlights speaker training program logistics as well as the infrastructures companies have in place to develop physicians into effective speakers. • Training Program Design and Implementation • Speaker Identification and Utilization • Performance Measurement • Governance Structure • Resource Support7. Educating the Market: Creating Value Through Support of Continuing Medical Education (SM-180): This study, based on benchmark survey data and executive interviews of participants from several leading pharmaceutical, biotechnology and medical education companies, was conducted to identify the salient trends and likely directions of Continuing Medical Educations (CME) in the North American and European marketplaces. This report provides benchmarks, insights and best practices in such key areas as: • Geographic Delivery of CME • Structural Management of CME • CME Investment Budgets for North America & Europe • Planned versus Spontaneous CME investment • Functional Responsibility for CME • CME Delivery in North America (Company-directed versus 3rd party, etc.) • CME Delivery in Europe • Background & Experience of CME Employees • Tenure of CME Employees • Use of E-CME in North America & Europe • Effectiveness Ratings for CME Delivery Activities in North America & EuropeCopyright Best Practices, LLC (919) 403-0251 5
  • 6. Medical Affairs Excellence Services: Research Excerpt (OPS-1A)The study also incorporates third-party input from seven CME vendors and eight medicalassociations and teaching hospitals.8. Scientific Publications Strategy: Managing Reputation, Clinical Trial Results and Commercial Relevance (PSM-220): This research was launched to determine how leading pharmaceutical and biotechnology companies are shaping their global publications strategies and plans in order to maintain scientific credibility while also delivering commercially relevant publications that drive brand success. Benchmark participants from 14 leading pharmaceutical companies provided their insights and metrics to identify industry trends and performance standards: Key topics covered in the research: • Global Publications Structure and Functional Home (Medical vs. Marketing) • Key Contributors and Stakeholders in Strategy Development and Plan Delivery • Effective Publications Vehicles, Content and Audiences • Using Alternative Media • Planning for Neutral/Negative Results • Changes in Resources and Outsourcing • Measuring Performance • Strategic Next Steps9. Medical Science Liaisons: Gaining Access and Forging Relationships with Key Opinion Leaders (PSM-234): As companies compete for the attention of physicians, key opinion leaders (KOLs) and thought leaders, they increasingly use medical science liaisons (MSLs) to build and strengthen KOL relationships. This research uncovers the optimal size, mix and service frequencies of these elite medical specialist groups in an effort to build strong, productive relationships. Key topics covered in the research: • Pre-Launch Service Activities • Post-Launch Service Activities • Drivers of Group Size & FocusCopyright Best Practices, LLC (919) 403-0251 6
  • 7. Medical Affairs Excellence Services: Research Excerpt (OPS-1A) • Structuring & Aligning Field-Based Liaisons With Sales Organizations • Optimal Call Frequencies and Service Levels with Thought Leaders • Managing, Shifting & Forecasting Resources10.Optimizing Key Opinion Leader Relationships: Best Practices in KOL Management (PSM-235): This report identifies the organizational structures, management strategies and tactics, and critical success factors associated with KOL management excellence. Pharma executives can use this benchmarking research to learn best practices in KOL management and discover how they can maximize KOL relationships to benefit their own products and therapies. Included in the toolkit are the following research documents: • KOL Segmentation and Behavior Drivers • KOL Roles Over Product Lifecycle • KOL Management Models • Role of Medical Science Liaisons (MSLs) in Managing KOLs • Emerging Trends in KOL Management • Innovative Practices in KOL Management • Critical Success Factors in KOL Management • Most Difficult Challenges in KOL Management11.Best Practices in Utilizing Health Outcomes Data for Promotional/ Commercial Efforts (PSM-236): This study aims to discover and collect best practices in how companies use and review the use of Health Outcomes data in promotional/commercial settings. There is a focus upon on-label, off-label and in-label promotions. Included in the toolkit are the following research documents: • Structure and Reporting Lines of Authority • Health Outcomes Decisions • Use of Health Outcomes Data Proactively and Retrospectively • Who and How is Health Outcomes Data Utilized with Different Groups • Health Outcomes Review Process and StructureCopyright Best Practices, LLC (919) 403-0251 7
  • 8. Medical Affairs Excellence Services: Research Excerpt (OPS-1A)12.Collaborating with Patient Advocacy Groups to Educate the Marketplace (PSM- 242): This comprehensive study analyzes the best practices from leading companies, narrates their findings, details valuable statistics and, examines ideal structures and skill sets for Pharma groups that deal with advocacy groups and emerging trends and challenges in patient advocacy. Included in the toolkit are the following research documents: • Understanding the “advocacy” landscape • Effective practices for working with potentially hostile patient advocacy groups • Advocacy structures that work best • Advocacy tools • Critical competencies of Advocacy professionals • Advocacy Lessons learned from socially sensitive or stigmatized disease areas • Profiling Advocacy Group experience & expertise13.New Product Planning for Medical Marketing Structure and Activities to Drive Growth & Profitability (PSM-249): This study examines the role and impact of New Product Planning (NPP) groups on product commercialization efforts in pharmaceutical and biotech companies. It provides reliable benchmarks, observations, and best practice insights to inform and shape executive thinking around the challenges of new product development in medical marketing. Included in the toolkit are the following research documents: • NPP group structures, roles and responsibilities • Interactions and optimal working relationships between Regional and Global NPP groups • Examining the full set of activities NPP groups perform, their timing, intended outcomes, and value for the organization • The future of the NPP functionCopyright Best Practices, LLC (919) 403-0251 8
  • 9. Medical Affairs Excellence Services: Research Excerpt (OPS-1A)14.Webinar: Gaining Access & Forging Relationships with Key Opinion Leaders (WEB-16): Best Practices presented a webinar on "Gaining Access & Forging Relationships with Key Opinion Leaders" – that showcased how top performing companies manage their Medical Science Liaison function effectively and productively. Cameron Tew, an expert research lead on this study, presented quantitative and qualitative data from our newly released report.15.Shaping the Marketplace to Support Successful Oncology Product Launches: Tactics for Educating KOLs, Physicians, Patients and Payers (PSM-243): This research informs launch leaders on the most effective physician, payer and patient education practices conducted from clinical development through launch. Metrics address KOL development tactics and timing, including MSL staff numbers and calls; Physician education by publication type and timing and CME by type and timing; Patient and Advocacy Group education by timing and type and Payer education by timing and type. Included in the toolkit are the following research documents: • Identification of Key Education Tactics for Thought Leaders, Physicians, Patients, and Payers • Identification of Key Timing for Educational Activities for KOLs, Physicians, Patients and Payers • Assessment of Key Market Education Practices, including Thought Leader Activities, CME, Scientific Publication Strategy and Tactics, Patients and Patient Advocacy Education, Clinical Trials & Payer Education • Description of Critical Market Education Pitfalls and Future TrendsWHO CAN BENEFIT FROM THESE SERVICES?These services provide valuable material for executives of the pharmaceutical organizationto ensure superior execution and implementation of medical affairs strategy and driveoperational efficiency. Executives will find numerous resource-related issues addressed,Copyright Best Practices, LLC (919) 403-0251 9
  • 10. Medical Affairs Excellence Services: Research Excerpt (OPS-1A)while the execution level managers will be able to create roadmaps and plans foraccomplishing their objectives in key areas.SAMPLE FINDINGS• Medical Affairs Capabilities engagement One medical affairs executive observed that companies do tend to “swing in a pendulum” between positioning medical affairs under research and development and under sales and marketing over time. Pros and cons exist for these affiliations. When the medical affairs function is too closely nested in research and development it tends to lose its focus on business goals and objectives. On the other hand, if the medical affairs function is too closely aligned with sales and marketing, scientific rigor is perceived as being lackluster - perhaps acting as a disincentive for top medical talent.• Spend allocation - Bulk of Medical Affairs Spending Goes to Clinical Functions On average, more than a third of Medical Affairs spending goes to Medical/ Clinical Research Operations. Benchmark participants spend as much as 98% of budgets on this function.Copyright Best Practices, LLC (919) 403-0251 10
  • 11. Medical Affairs Excellence Services: Research Excerpt (OPS-1A)• Reports of adverse events Typically, reports of adverse events are driven by a company’s portfolio. Established large companies with many products generated more than 1,000 reports a month while smaller companies with fewer products reported less than 1,000 adverse events reports a month.• Field-Based Medical Management Process Map Companies that have successfully implemented field-based medical management describe a set of key benefits: faster sales uptake and better launch results, reduced clinical trials costs and more useful results from trials, faster product development and prolonged value from mature products through additional indications.Copyright Best Practices, LLC (919) 403-0251 11
  • 12. Medical Affairs Excellence Services: Research Excerpt (OPS-1A)• Speaker Program Administration System Process Map Companies that have successfully improved speaker program administration systems describe a set of key benefits: higher speaker satisfaction, deeper relationships with key speakers, reduced administrative costs, increased value for the larger sales and drug development efforts and easier market education for new products.Copyright Best Practices, LLC (919) 403-0251 12
  • 13. Medical Affairs Excellence Services: Research Excerpt (OPS-1A)• Maximizing the Use of Trained Speakers Organizations that increase each trained speaker’s usage maximize investment, reduce stale programs and avoid wasting resources training physicians that never deliver presentations. Additionally, increased usage of all speakers raises the overall speaker pool competency. The competency develops because each speaking engagement advances a physician’s presentation capabilities. By requiring reps to schedule lesser- used speakers for events, companies increase credibility, capitalize on training investments and develop a deep pool of skilled speakers.Copyright Best Practices, LLC (919) 403-0251 13
  • 14. Medical Affairs Excellence Services: Research Excerpt (OPS-1A)• Using Opportunities to Get the Funding for CME ProgramsThe amount of money required to fund CME programs can prove overwhelming for CMEorganizations with small staffs. However, half of the surveyed participants from associationsand teaching hospitals reported that they received nearly all of the necessary money forcarrying out their programs.Copyright Best Practices, LLC (919) 403-0251 14
  • 15. Medical Affairs Excellence Services: Research Excerpt (OPS-1A)• Key Contributors to Global Publications Strategy & PlanEvery company in the benchmark class turns to a medical director for strategy input. Mostcompanies also look to global brand directors and global publications directors. Overall,responsibility for publications strategy is shifting from marketing brand leaders to globalpublication, medical directors, or ‘neutral’-cross-functional teams.Copyright Best Practices, LLC (919) 403-0251 15
  • 16. Medical Affairs Excellence Services: Research Excerpt (OPS-1A)• Pre-and Post-Launch ActivitiesWhile the majority of companies involve their MSLs in most pre-launch activities, somechoose to forego activities such as clinical protocol development, assisting with sales andmarketing plans and moderating advisory boards. Thought leaders are the compass tocompetitor activities, market changes and early reactions to commercial products. Mostcompanies focus their medical specialists on developing KOLs to guide these post-launchactivities, as well as gathering competitive intelligence.Copyright Best Practices, LLC (919) 403-0251 16
  • 17. Medical Affairs Excellence Services: Research Excerpt (OPS-1A)• Utilizing Health Outcomes Data for Promotional/ Commercial EffortsSome Health Outcomes groups decide other points such as pricing and market accessstrategies. However, these occur less frequently and seem to be activities that would beundertaken by cross-functional groups or other areas within companies.Copyright Best Practices, LLC (919) 403-0251 17
  • 18. Medical Affairs Excellence Services: Research Excerpt (OPS-1A)• Collaborating with Patient Advocacy Groups to Educate the MarketplaceUnder-treated but recognized diseases may highlight public health issues. This can createfunding and collaboration opportunities for Pharma, Government and Patient AdvocacyGroups. In the case of PAD (Peripheral Arterial Disease), government funding underwrotethe creation of educational materials distributed by Pharma and advocacy groups.Copyright Best Practices, LLC (919) 403-0251 18
  • 19. Medical Affairs Excellence Services: Research Excerpt (OPS-1A)• Shaping the Marketplace to Support Successful Oncology Product Launches: Tactics for Educating Key Opinion Leaders (KOLs), Physicians, Patients and PayersThis study explores best practices in educating, informing and preparing the marketplace fornew products –through Physician, Patient, and Payer education, publications, advocacy andcommunication strategies.Copyright Best Practices, LLC (919) 403-0251 19
  • 20. Medical Affairs Excellence Services: Research Excerpt (OPS-1A)Copyright Best Practices, LLC (919) 403-0251 20
  • 21. Medical Affairs Excellence Services: Research Excerpt (OPS-1A)BEST PRACTICE DATABASE Why Best Practices, LLC’sA research, analysis and decision-support service for Best Practice Database?professionals working across functions such as • The company we keep. With overcommercial operations, HR, R&D and customer service in 44,000 benchmark partners, wemajor industries including healthcare (Pharma, biotech, work with a virtual Who’s Who list ofmed device, etc.), finance, manufacturing, technology companies in dozens of industries. This allows us to get the informationand communications. This insight-and-advisory service you need, when you need itdelivers on-demand access to valuable performance • We get our information frombenchmarks and best practice research findings from the source; recognized industryleading global companies. Membership in the Best experts. It’s not just theory, thePractice Database provides unlimited access to a $40- best practices you will find are inmillion growing body of proprietary research and forward- use today by leading companieslooking analysis on topics such as: • Membership is constantly • Sales force effectiveness increasing in value as more • Marketing performance research is added each month. • New product launch • Clinical operations • Quality initiatives Why Best Practices, LLC’s • Leadership development Best Practice Database? • The company we keep. With moreHow can a membership benefit you? than 44,000 benchmark partners,Designed especially for business professionals like we work with a virtual Who’s Whoyourself, Best Practice Database membership allows list of companies in dozens ofyou full access to $35 million in benchmarking research. industries. This allows us to get the information you need, when youMembership allows members to support daily, process, need itproductivity, and strategic decisions to optimize their • We get our information fromstructure, build a business case for change, identify the source; recognized industryperformance gaps, and leverage executive insights to: experts. It’s not just theory, the best practices you will find are in • Increase top-line revenue use today by leading companies • Enhance productivity and decrease costs • Identify and retain key customers • Membership is constantly increasing in value as more research is added each month.Copyright Best Practices, LLC (919) 403-0251 21
  • 22. Medical Affairs Excellence Services: Research Excerpt (OPS-1A)Moreover, multi-seat “Star Access” (group membership) agreements (5, 10 or more seats)can ensure that all your improvement staff can use a common platform for supporting largeinitiatives and give you the flexibility of rotating users while offering attractive rates foraccess to all our research.For more details on the specific benefits of the Best Practice Database, go towww.bestpracticedatabase.com/testimonials to learn how others use their Database accessto answer business questions, support a business case or serve internal clients.ABOUT BEST PRACTICES, LLCBest Practices, LLC is a recognized leader in the field of best practice performanceimprovement. Our suite of customized Research and Consulting services can assist inimproving your companys performance by analyzing the winning practices of leadingcorporations and institutions.Copyright Best Practices, LLC (919) 403-0251 22