Medical Affairs Excellence Services Summary


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Medical Affairs Excellence Services Summary

  1. 1. Special FeaturesAnnual Membership to theBest Practice Databaseprovides unlimited access toa $35-million growingbody of proprietary researchand forward-lookinganalysisQuestions?For more information, please contactBest Practices LLC at (919) 403-0251 orbestpractices@best-in-class.comMedical Affairs Excellence Services: Research Excerpt (OPS-1A)Medical AffairsExcellenceServicesPROJECT BACKGROUNDThe dynamic bio-pharmaceutical and medical devicecompanies are accelerating their medical affairs functionscope beyond a traditional support function. Thefunction manages strategic responsibilities bridgingresearch as well as clinicaldevelopment, its scientificpublications strategy andutilizes health outcomes,biostatistics, necessarymedical education andother medical services.The medical affairsfunction enhances a company’s scientific reputation andcomplements the work of Research & Development. Italso provides physicians, key opinion leaders (KOLs),legal-regulatory agencies, professional groups andhealthcare professionals with medical and scientificinformation and education on the value and proper useof a company’s products, therapies, devices, technologyand diagnostics.During several years of benchmarking world-classpharmaceutical and life science organizations, BestPractices, LLC has provided valuable information topharmaceutical companies to improve their medicalaffairs capabilities.Copyright Best Practices, LLC (919) 403-0251 1OverviewThis Medical Affairs Excellence Servicesprovides executives with strategic insightand successful approaches for competitiveperformance in the medical affairs function. Itfocuses on many areas including utilizinghealth outcomes, scientific publicationsstrategy, educating physicians, key opinionleaders, patient advocacy and clinicaldevelopments.Sample Featured Organizations• Abbott Laboratories• AstraZeneca• Bayer• Bristol-Myers Squibb• Boehringer Ingelheim• Cardiac Science Corp• Eli Lilly• GlaxoSmithKline• Genentech• Innovex• Johnson & Johnson• Novartis• Pfizer Inc.• Proctor & Gamble• Sanofi-Aventis• Schering Plough• TEVAInformation Types• 140+ Data Graphics• 180+ Information Graphics• 260+ Metrics• 60+ Narratives• 50+ Best Practices
  2. 2. Medical Affairs Excellence Services: Research Excerpt (OPS-1A)Through the Medical Affairs Excellence Services, Best Practices provides our clients with theinsights, 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 DriveProductivity and Growth (OP-97):The study examines how the most successful pharmaceutical companies structure, alignstaff and fund medical affairs capabilities.Executives and managers can benchmark against these companies’ staffing and spendlevels; your company will gain the necessary information to conduct a performance gapanalysis 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 CapabilityCopyright Best Practices, LLC (919) 403-0251 2
  3. 3. Medical Affairs Excellence Services: Research Excerpt (OPS-1A)• External Spend per Compound• Effectiveness by rating2. Medical Affairs Resources, Structures & Trends (POP-228):This benchmarking study explores how U.S. and global biopharmaceutical companies arestructuring and managing their Medical Affairs organizations today. The study alsoexamines recent trends in budget and staffing resources, key challenges and top successfactors 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 theU.S. (POP-230):This benchmarking study examines the best practices for post-marketing surveillancewithin the United States, as well as the processes for assessing reports of adverseevents, 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 InvolvementCopyright Best Practices, LLC (919) 403-0251 3
  4. 4. Medical Affairs Excellence Services: Research Excerpt (OPS-1A)• Drug Safety Challenges4. Thought Leader Relationships: Building the Business (SM-129):This study has captured the techniques that top pharmaceutical companies use to buildand 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 bybenchmark partners. Your company can use consolidated insights and best practices ofthe benchmark class to guide thinking about your own physician relationshipmanagement 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• CommunicationCopyright Best Practices, LLC (919) 403-0251 4
  5. 5. Medical Affairs Excellence Services: Research Excerpt (OPS-1A)• Logistics• Relationships6. Best Practices in Speaker Training and Development: Driving PharmaceuticalBrand Growth (SM-158):This report focuses primarily on speaker training and development, a crucial link of theentire speaker management process. Report owners will learn how top pharmaceuticaland biotech companies ensure the physicians that speak on their behalf are top-notchcommunicators of product benefits. This study highlights speaker training programlogistics as well as the infrastructures companies have in place to develop physiciansinto 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 MedicalEducation (SM-180):This study, based on benchmark survey data and executive interviews of participantsfrom several leading pharmaceutical, biotechnology and medical education companies,was conducted to identify the salient trends and likely directions of Continuing MedicalEducations (CME) in the North American and European marketplaces. This reportprovides 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 CMECopyright Best Practices, LLC (919) 403-0251 5
  6. 6. Medical Affairs Excellence Services: Research Excerpt (OPS-1A)• 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 & EuropeThe 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 andCommercial Relevance (PSM-220):This research was launched to determine how leading pharmaceutical and biotechnologycompanies are shaping their global publications strategies and plans in order to maintainscientific credibility while also delivering commercially relevant publications that drivebrand success. Benchmark participants from 14 leading pharmaceutical companiesprovided their insights and metrics to identify industry trends and performancestandards: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 KeyOpinion Leaders (PSM-234):Copyright Best Practices, LLC (919) 403-0251 6
  7. 7. Medical Affairs Excellence Services: Research Excerpt (OPS-1A)As companies compete for the attention of physicians, key opinion leaders (KOLs) andthought leaders, they increasingly use medical science liaisons (MSLs) to build andstrengthen KOL relationships. This research uncovers the optimal size, mix and servicefrequencies 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 & Focus• 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 KOLManagement (PSM-235):This report identifies the organizational structures, management strategies and tactics,and critical success factors associated with KOL management excellence. Pharmaexecutives can use this benchmarking research to learn best practices in KOLmanagement and discover how they can maximize KOL relationships to benefit their ownproducts 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/ CommercialEfforts (PSM-236):Copyright Best Practices, LLC (919) 403-0251 7
  8. 8. Medical Affairs Excellence Services: Research Excerpt (OPS-1A)This study aims to discover and collect best practices in how companies use and reviewthe use of Health Outcomes data in promotional/commercial settings. There is a focusupon 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 Structure12.Collaborating with Patient Advocacy Groups to Educate the Marketplace (PSM-242):This comprehensive study analyzes the best practices from leading companies, narratestheir findings, details valuable statistics and, examines ideal structures and skill sets forPharma groups that deal with advocacy groups and emerging trends and challenges inpatient 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 DriveGrowth & Profitability (PSM-249):This study examines the role and impact of New Product Planning (NPP) groups onproduct commercialization efforts in pharmaceutical and biotech companies. It providesreliable benchmarks, observations, and best practice insights to inform and shapeexecutive thinking around the challenges of new product development in medicalmarketing.Copyright Best Practices, LLC (919) 403-0251 8
  9. 9. Medical Affairs Excellence Services: Research Excerpt (OPS-1A)Included in the toolkit are the following research documents:• NPP group structures, roles and responsibilities• Interactions and optimal working relationships between Regional and Global NPPgroups• Examining the full set of activities NPP groups perform, their timing, intendedoutcomes, and value for the organization• The future of the NPP function14.Webinar: Gaining Access & Forging Relationships with Key Opinion Leaders(WEB-16):Best Practices presented a webinar on "Gaining Access & Forging Relationships with KeyOpinion Leaders" – that showcased how top performing companies manage their MedicalScience Liaison function effectively and productively. Cameron Tew, an expert researchlead on this study, presented quantitative and qualitative data from our newly releasedreport.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 patienteducation practices conducted from clinical development through launch. Metrics addressKOL development tactics and timing, including MSL staff numbers and calls; Physicianeducation by publication type and timing and CME by type and timing; Patient andAdvocacy 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 PayersCopyright Best Practices, LLC (919) 403-0251 9
  10. 10. Medical Affairs Excellence Services: Research Excerpt (OPS-1A)• Assessment of Key Market Education Practices, including Thought LeaderActivities, CME, Scientific Publication Strategy and Tactics, Patients and PatientAdvocacy 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,while the execution level managers will be able to create roadmaps and plans foraccomplishing their objectives in key areas.SAMPLE FINDINGS• Medical Affairs Capabilities engagementOne medical affairs executive observed that companies do tend to “swing in apendulum” between positioning medical affairs under research and development andunder sales and marketing over time.Pros and cons exist for these affiliations. When the medical affairs function is too closelynested in research and development it tends to lose its focus on business goals andobjectives. On the other hand, if the medical affairs function is too closely aligned withsales and marketing, scientific rigor is perceived as being lackluster - perhaps acting asa disincentive for top medical talent.• Spend allocation - Bulk of Medical Affairs Spending Goes to Clinical FunctionsOn average, more than a third of Medical Affairs spending goes to Medical/ ClinicalResearch Operations. Benchmark participants spend as much as 98% of budgets on thisfunction.Copyright Best Practices, LLC (919) 403-0251 10
  11. 11. Medical Affairs Excellence Services: Research Excerpt (OPS-1A)• Reports of adverse eventsTypically, reports of adverse events are driven by a company’s portfolio. Establishedlarge companies with many products generated more than 1,000 reports a month whilesmaller companies with fewer products reported less than 1,000 adverse events reportsa month.• Field-Based Medical Management Process MapCompanies that have successfully implemented field-based medical managementdescribe a set of key benefits: faster sales uptake and better launch results, reducedclinical trials costs and more useful results from trials, faster product development andprolonged value from mature products through additional indications.Copyright Best Practices, LLC (919) 403-0251 11
  12. 12. Medical Affairs Excellence Services: Research Excerpt (OPS-1A)• Speaker Program Administration System Process MapCompanies that have successfully improved speaker program administration systemsdescribe a set of key benefits: higher speaker satisfaction, deeper relationships with keyCopyright Best Practices, LLC (919) 403-0251 12
  13. 13. Medical Affairs Excellence Services: Research Excerpt (OPS-1A)speakers, reduced administrative costs, increased value for the larger sales and drugdevelopment efforts and easier market education for new products.• Maximizing the Use of Trained SpeakersOrganizations that increase each trained speaker’s usage maximize investment, reducestale programs and avoid wasting resources training physicians that never deliverpresentations. Additionally, increased usage of all speakers raises the overall speakerpool competency. The competency develops because each speaking engagementadvances a physician’s presentation capabilities. By requiring reps to schedule lesser-used speakers for events, companies increase credibility, capitalize on traininginvestments and develop a deep pool of skilled speakers.Copyright Best Practices, LLC (919) 403-0251 13
  14. 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.• 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 14
  15. 15. 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.• 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 15
  16. 16. 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 16
  17. 17. 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 andPayersThis 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 17
  18. 18. Why Best Practices, LLC’sBest Practice Database?• The company we keep. With over44,000 benchmark partners, wework with a virtual Who’s Who list ofcompanies in dozens of industries.This allows us to get the informationyou need, when you need it• We get our information fromthe source; recognized industryexperts. It’s not just theory, thebest practices you will find are inuse today by leading companies• Membership is constantlyincreasing in value as moreresearch is added each month.Why Best Practices, LLC’sBest Practice Database?• The company we keep. With morethan 44,000 benchmark partners,we work with a virtual Who’s Wholist of companies in dozens ofindustries. This allows us to get theinformation you need, when youneed it• We get our information fromthe source; recognized industryexperts. It’s not just theory, thebest practices you will find are inuse today by leading companies• Membership is constantlyincreasing in value as moreresearch is added each month.Medical Affairs Excellence Services: Research Excerpt (OPS-1A)BEST PRACTICE DATABASEA research, analysis and decision-support service forprofessionals working across functions such ascommercial operations, HR, R&D and customer service inmajor industries including healthcare (Pharma, biotech,med device, etc.), finance, manufacturing, technologyand communications. This insight-and-advisory servicedelivers on-demand access to valuable performancebenchmarks and best practice research findings fromleading global companies. Membership in the BestPractice Database provides unlimited access to a $40-million growing body of proprietary research and forward-looking analysis on topics such as:• Sales force effectiveness• Marketing performance• New product launch• Clinical operations• Quality initiatives• Leadership developmentHow can a membership benefit you?Designed especially for business professionals likeyourself, Best Practice Database membershipallows you full access to $35 million in benchmarkingresearch.Membership allows members to support daily,process, productivity, and strategic decisions toCopyright Best Practices, LLC (919) 403-0251 18
  19. 19. Medical Affairs Excellence Services: Research Excerpt (OPS-1A)optimize their structure, build a business case for change, identify performance gaps,and leverage executive insights to:• Increase top-line revenue• Enhance productivity and decrease costs• Identify and retain key customersMoreover, 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 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 19