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
Medical Affairs, as a function, sits at a crossroads in the pharmaceutical industry. The department is expected to act as a bridge between the commercial and scientific arms of an organization. Medical Affairs is further tasked with being the conduit of information between the company and external stakeholders, bringing efficacy and safety data to the medical community as well as gathering insights from the medical community to share internally. All responsibilities must be undertaken while keeping in mind strict regulatory controls and ensuring that medical data are interpreted appropriately.
ISR has designed this report to be used as a benchmarking tool for companies to compare their Medical Affairs functions to those of Top 50 pharmaceutical organizations.
See more: http://bit.ly/medaffairs
Medical Affairs Resources, Structures, and Trends (UPDATE) - Report SummaryBest Practices
The Update to the wildly popular Medical Affairs Resources, Structures, and Trends research from 2009 is ready! Contains linear data and new segmentation for emerging markets.
Charged with building and maintaining physician relationships, pharmaceutical Medical Affairs organizations typically oversee several important functions -- including publications, KOL programs, grants and medical education (CME) -- that have been impacted in recent years by a call for increased transparency. As such, forward-looking biopharmaceutical executives are beginning to evaluate Medical Affairs operations to ensure that the vital organization is appropriately structured and resourced to operate effectively in the current environment.
This Best Practices, LLC 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.
The report is based on the insights of 68 Medical Affairs executives and managers at 50 leading global companies. The benchmark class in this study consists of a Mature Markets and Emerging Markets Segment. The Mature Market Segment includes 41 participants from pharma and 12 device respondents. The Emerging Markets Segment consists of 15 participants working in India, China, Brazil, and Turkey.
The best Medical Affairs organizations are evolving from a support-only function to a strategic partner of the business. Explore a common set of Medical Affairs challenges with other leaders from Pharma, Biotech, and Medical Device companies.
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.
Medical Affairs, as a function, sits at a crossroads in the pharmaceutical industry. The department is expected to act as a bridge between the commercial and scientific arms of an organization. Medical Affairs is further tasked with being the conduit of information between the company and external stakeholders, bringing efficacy and safety data to the medical community as well as gathering insights from the medical community to share internally. All responsibilities must be undertaken while keeping in mind strict regulatory controls and ensuring that medical data are interpreted appropriately.
ISR has designed this report to be used as a benchmarking tool for companies to compare their Medical Affairs functions to those of Top 50 pharmaceutical organizations.
See more: http://bit.ly/medaffairs
Medical Affairs Resources, Structures, and Trends (UPDATE) - Report SummaryBest Practices
The Update to the wildly popular Medical Affairs Resources, Structures, and Trends research from 2009 is ready! Contains linear data and new segmentation for emerging markets.
Charged with building and maintaining physician relationships, pharmaceutical Medical Affairs organizations typically oversee several important functions -- including publications, KOL programs, grants and medical education (CME) -- that have been impacted in recent years by a call for increased transparency. As such, forward-looking biopharmaceutical executives are beginning to evaluate Medical Affairs operations to ensure that the vital organization is appropriately structured and resourced to operate effectively in the current environment.
This Best Practices, LLC 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.
The report is based on the insights of 68 Medical Affairs executives and managers at 50 leading global companies. The benchmark class in this study consists of a Mature Markets and Emerging Markets Segment. The Mature Market Segment includes 41 participants from pharma and 12 device respondents. The Emerging Markets Segment consists of 15 participants working in India, China, Brazil, and Turkey.
The best Medical Affairs organizations are evolving from a support-only function to a strategic partner of the business. Explore a common set of Medical Affairs challenges with other leaders from Pharma, Biotech, and Medical Device companies.
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.
Successful market / customer access is a primary objective in healthcare marketing. This presentation provides the insight to successfully position, price and promote your pharmaceutical, medical device or clinical service in leading healthcare market segments.
This presentation is from www.healthcaremedicalpharmaceuticaldirectory.com, no subscription is required. Please visit us to see more presentations about the latest marketing trends in the healthcare industry.
John Baresky Healthcare Marketing Leader, Pharmaceutical Marketing, Digital Marketing Strategy, Content Marketing Strategy, Market Access Strategy, Healthcare RPA Software Marketing Strategy
www.healthcaremedicalpharmaceuticaldirectory.com
John G. Baresky
https://www.linkedin.com/in/johngbaresky
#baresky
MedDRA - the Medical Dictionary for Regulatory Activities - is a medical terminology used to classify adverse event information associated with the use of biopharmaceuticals and other medical products (e.g., medical devices and vaccines). Coding these data to a standard set of MedDRA terms allows health authorities and the biopharmaceutical industry to more readily exchange and analyze data related to the safe use of medical products.
Introduction to Regulatory Affairs - Pauwels Consulting AcademyPauwels Consulting
On Tuesday, June 14, our colleagues Fiorenzo Savoretti, Senior Regulatory and Quality Consultant at Pfizer and Nick Deschacht, Senior RA Consultant at GSK, gave an interesting “Introduction to Regulatory Affairs”.
Fiorenzo and Nick talked about RA and their projects, each from their unique angle. They delivered their presentations for ## attendees at our Brussels office at the Lambroekstraat 5a in Diegem.
Project Work Scienziati in Azienda: Market accessFree Your Talent
«Market Access»: Ridurre il time to market, creando, incrementando e sostenendo il valore del farmaco.
A cura di Annarita Formicola, Antonio Marsico, Arianna Bianchi, Carmen Iodice, Davide Cocca e Guglielmo Cocozza, Programma Scienziati in Azienda ISTUD 2014-2015
Pharmacovigilance in USA and Europe_Katalyst HLSKatalyst HLS
Introduction to Drug Safety & Pharmacovigilance in USA and Europe for Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Budget Allocation for a Successful Bio-Pharma Product LaunchBest Practices
Bio-Pharma companies can no longer afford to rely solely on past experiences when budgeting for a new product launch in today's fast-changing, highly competitive market. This comprehensive benchmark study by Best Practices, LLC investigates current costs as well as budget and staffing allocations required for a successful drug launch.
This study can help bio-pharma leaders to develop competitive launch and pre-launch activity budgets to ensure successful U.S. market entry for new products.
Download Full Report: http://bit.ly/2aMYron
The basics of launching a pharmaceutical drug-
Based on studies done on the practices of 13 top pharmaceutical companies in the world.
For more, write to info@markivmedical.com
Description of the Brand Booster Program which includes three innovative marketing approaches: the Brand Preference Mix to increase market share - the Behavioral Prescriber Segmentation to increase the efficiency of field forces and the Individual Prescriber Plan to fine tune the marketing mix
The Healthcare CEO gets a New Job – Accenture Strategyaccenture
In a healthcare industry undergoing foundational transformation, healthcare provider CEOs and leadership teams are being challenged to adapt.
CEOs must expand their leadership teams with skills not historically found in healthcare organizations. To make transformation to an agile patient-centric model stick, retooling the bench for digital and consumer skills is key.
View questions every healthcare provider CEO should ask to test their organizations readiness for change.
Successful market / customer access is a primary objective in healthcare marketing. This presentation provides the insight to successfully position, price and promote your pharmaceutical, medical device or clinical service in leading healthcare market segments.
This presentation is from www.healthcaremedicalpharmaceuticaldirectory.com, no subscription is required. Please visit us to see more presentations about the latest marketing trends in the healthcare industry.
John Baresky Healthcare Marketing Leader, Pharmaceutical Marketing, Digital Marketing Strategy, Content Marketing Strategy, Market Access Strategy, Healthcare RPA Software Marketing Strategy
www.healthcaremedicalpharmaceuticaldirectory.com
John G. Baresky
https://www.linkedin.com/in/johngbaresky
#baresky
MedDRA - the Medical Dictionary for Regulatory Activities - is a medical terminology used to classify adverse event information associated with the use of biopharmaceuticals and other medical products (e.g., medical devices and vaccines). Coding these data to a standard set of MedDRA terms allows health authorities and the biopharmaceutical industry to more readily exchange and analyze data related to the safe use of medical products.
Introduction to Regulatory Affairs - Pauwels Consulting AcademyPauwels Consulting
On Tuesday, June 14, our colleagues Fiorenzo Savoretti, Senior Regulatory and Quality Consultant at Pfizer and Nick Deschacht, Senior RA Consultant at GSK, gave an interesting “Introduction to Regulatory Affairs”.
Fiorenzo and Nick talked about RA and their projects, each from their unique angle. They delivered their presentations for ## attendees at our Brussels office at the Lambroekstraat 5a in Diegem.
Project Work Scienziati in Azienda: Market accessFree Your Talent
«Market Access»: Ridurre il time to market, creando, incrementando e sostenendo il valore del farmaco.
A cura di Annarita Formicola, Antonio Marsico, Arianna Bianchi, Carmen Iodice, Davide Cocca e Guglielmo Cocozza, Programma Scienziati in Azienda ISTUD 2014-2015
Pharmacovigilance in USA and Europe_Katalyst HLSKatalyst HLS
Introduction to Drug Safety & Pharmacovigilance in USA and Europe for Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Budget Allocation for a Successful Bio-Pharma Product LaunchBest Practices
Bio-Pharma companies can no longer afford to rely solely on past experiences when budgeting for a new product launch in today's fast-changing, highly competitive market. This comprehensive benchmark study by Best Practices, LLC investigates current costs as well as budget and staffing allocations required for a successful drug launch.
This study can help bio-pharma leaders to develop competitive launch and pre-launch activity budgets to ensure successful U.S. market entry for new products.
Download Full Report: http://bit.ly/2aMYron
The basics of launching a pharmaceutical drug-
Based on studies done on the practices of 13 top pharmaceutical companies in the world.
For more, write to info@markivmedical.com
Description of the Brand Booster Program which includes three innovative marketing approaches: the Brand Preference Mix to increase market share - the Behavioral Prescriber Segmentation to increase the efficiency of field forces and the Individual Prescriber Plan to fine tune the marketing mix
The Healthcare CEO gets a New Job – Accenture Strategyaccenture
In a healthcare industry undergoing foundational transformation, healthcare provider CEOs and leadership teams are being challenged to adapt.
CEOs must expand their leadership teams with skills not historically found in healthcare organizations. To make transformation to an agile patient-centric model stick, retooling the bench for digital and consumer skills is key.
View questions every healthcare provider CEO should ask to test their organizations readiness for change.
A new and improved edition of our introductory services for law firms. The Benchmark Report is our basic site audit and competitive analysis and provides the client with a comprehensive strategy to improve your online legal marketing.
A few practice areas where we have helped attorneys grow their business include:
-Corporate Litigation
-Real Estate
-Energy
-Finance
-Patent Law
-Regulatory
-Class Action
-Immigration
*Members of the Southern California and New York City chapters of the Legal Marketing Association. We are invited to speak at conferences like the LMA because of our excellent reputation for online legal marketing.
Optimize the Role of Medical Affairs in Health Economics & Outcomes Research ...Best Practices
The Medical Affairs function plays an important role in health outcomes (HO) information exchange between bio-pharmaceutical organizations and key external stakeholders.
Development of robust health outcomes capabilities within Medical Affairs function requires an increase in the function’s involvement with health outcomes groups, development of field-based health outcomes capabilities, customization of health outcomes data as per stakeholders’ needs, and building real world data capabilities to generate and utilize health outcomes information.
This benchmarking research from Best Practices, LLC is designed to assist companies focused on oncology therapies find better ways to develop effective health outcomes groups. It provides current data and best practices from Medical Affairs leaders with an oncology focus at leading bio-pharmaceutical companies.
Download Full Report: http://bit.ly/2e3sl9Q
Strategies to Increase Medical Affairs' Role in Health Outcomes Data Generati...Best Practices
With the shift toward evidence-based medicine and value-based pricing, many bio-pharmaceutical companies are transitioning their Health Economics and Outcomes Research (HEOR) function away from the Commercial organization to Medical Affairs. This has some major implications towards the interactions with key stakeholders, the way interactions are documented and the skill sets & activities that may be required. Development of strong health outcomes capabilities within Medical Affairs organizations requires an increase in that function’s involvement with health outcomes groups, development of field-based health outcomes capabilities, customization of health outcomes data by stakeholders and building real world data capabilities to generate and utilize health outcomes information.
Best Practices, LLC undertook this study to identify strategies to increase MA’s role in Health Outcomes data generation and utilization. Specifically, the study highlights the role of Medical Affairs function in HO activities, industry drivers and resource levels for HO groups, challenges of MA’s involvement in HO activities and strategies for effective HO data communication and utilization.
Download Full Report: http://bit.ly/2dGFAbz
Measuring the return from pharmaceutical innovation 2016Deloitte UK
The seventh annual pharmaceutical innovation study by the Deloitte UK Centre for Health Solutions looks at the challenges the industry faces in generating returns from its R&D investments while highlighting the key strategies to help increase pipeline value while reduce R&D costs to generate sustainable R&D returns.
Ten Distinguishing Ideas for Health Communication in the 21st Century renataschiavo
This presentation draws upon my book, Health Communication: From Theory to Practice, Second Edition, San Francisco: Jossey-Bass, an imprint of Wiley, 2013. It was given as part of a Sept. 10, 2014 Author's Night at the New York Academy of Medicine.
Benchmarking Advisory Board Management at Mid-Sized Pharmaceutical & Medical ...Best Practices
Biopharmaceutical and medical device companies rely on advisory board for strategic inputs and guidance on various business aspects. However, successful advisory board management requires optimum investment in resources and operations. It is also important that the biopharmaceutical and medical device executives ensure quality of meetings and dialogue with advisory boards is excellent for maximum ROI.
This research from Best Practices, LLC showcase the best practices in advisory board management at mid-sized biopharmaceutical and medical device companies. It also highlights the top challenges, winning strategies and best practices for conducting advisory boards.
Best-in-Class Strategies to Develop Effective Medical Information GroupsBest Practices
Medical information groups within bio-pharmaceutical companies play a vital role in the management of publications and product inquiries during the commercialization of drugs.
However, recent regulatory changes in the industry have made it imperative for the Medical Affairs function to align its medical information activities with compliance requirements.
This Best Practices, LLC report establishes benchmarks on the critical requirements to create strong medical information groups. In particular, this report identifies best practices in internal collaboration, alignment of information activities with compliance requirements and the structure, leadership and resource levels required to develop best-in-class medical information groups.
Download Full Report: http://bit.ly/2ewac07
Middleville Regional Health Care is one (1) of three (3) hospitaEvonCanales257
Middleville Regional Health Care is one (1) of three (3) hospitals serving a community of 350,000 people. Summary statistics on Middleville and its competitors, from the
AHA Guide
, are shown below in Table 1. All three organizations are
not-for-profit
.
Table 1: Middleville, Brierfield, and Greystone Health Care Systems
Name
Beds
Admissions
Census
OP Visits
Births
Expenses (000)
Personnel
Middleville
575
13,000
350
221,000
2,300
$125,000
2,000
Brierfield
380
17,000
260
175,000
1,200
$130,000
1,875
Greystone
350
10,000
180
40,000
900
$80,000
1,200
The governing board of Middleville hired a consulting company to evaluate its strategic performance, specifically in the areas of Human Resources, Information Technology, Financing, and Marketing. As part of the consultant’s evaluation, several leaders of Middleville’s units were asked their perspective of the organization’s performance.
You are working for the consultant
. Your job is to identify the issues from the response that should be considered further by the consultant team and possibly discussed with the governing board and the CEO. The firm has a rule, “Never offer a criticism or negative finding without suggesting how the client organization can correct it,” so you must indicate what sort of
correction you would recommend as part of your list. Because you know there were about two (2) dozen other interviews, you decide you should rank your issues in importance, to make sure the most critical are discussed.
Write a
six to eight (6-8) page paper
in which you:
Explain the governing board’s role in these strategic initiatives, determining its responsibility and involvement.
Evidence-based management means that operational and strategic decisions are made based upon the evidence that goals and objectives are actually being met. Quantitative measurements must be identified and measured. This data is then used to evaluate the HCO’s performance. Name three (3) performances Middleville can use to measure its success in providing quality healthcare to the community, and identify quantifiable, measureable indicators that can be used to do so. Explain the importance of each performance measurement.
Given the statistics of Middleville and its two (2) competitors provided in Table 1, recommend to the HCO what areas it should focus on to maintain its competitive market share as well as continue to provide healthcare to the community in the 21st century.
Some of Middleville’s Board members are very interested in pursuing advanced technology systems over the next five (5) years, while others are concerned about the enormous expense and need assurance that the investment in technology will be worthwhile. In both monetary and process terms, describe the
costs and benefits
associated with implementing ...
Emerging Medical Education Trends in the Medical Device Industry: Benchmarks ...Best Practices
Medical education programs play an important role in informing health care professionals about the safe and effective use of medical devices.
To probe emerging medical education trends in the device sector, Best Practices, LLC undertook benchmarking research. In particular, this study provides benchmarks on the proper size, structure, funding channels, staffing and investment for medical education groups.
Download Full Report: http://bit.ly/2bY2NZ8
Benchmarking Advisory Board Management At Large Pharmaceutical And Medical De...Best Practices
Pharmaceutical advisory boards provide strategic inputs and guidance to organizations on various business aspects. However, successful advisory board management requires optimum investment in resources and operations. To maximize the return on investment it is important for pharmaceutical and medical device professionals to ensure that the quality of meetings and dialogue with advisory boards is excellent.
This research from Best Practices, LLC is designed for pharmaceutical and biotech executives seeking ways to best utilize the knowledge of advisory boards. Research findings provide benchmarks on the appropriate structure for various types of advisory boards, selection of advisory board participants, advisory board operational and resource benchmarks.
Developing High-Impact Communication Forms to Brief Senior Leaders: Optimizin...Best Practices
Competitive Assessments and Clinical Landscape Assessments are crucial to the success of new products in the pharmaceutical industry. In order to inform busy executives quickly and effectively, market intelligence and analytics leaders must develop briefing templates that are clear, concise, and impactful.
This study identifies winning strategies for effectively informing senior leaders through Competitive Landscape Summaries and Clinical Development Profile Maps. The research will help executives to understand what the important elements to include are, and what are the best formats for two critical healthcare briefing templates: : 1) the Competitive Landscape Summary Map and 2) the Development Landscape Profile Map (often described as the Data Disclosure or Clinical Trials Progress Summary).
Read more at: http://www.best-in-class.com/bestp/domrep.nsf/products/developing-high-impact-communication-forms-to-brief-senior-leaders-optimizing-competitive-assessment-data-disclosure-summaries?OpenDocument
Benchmarking Professional Medical Education Excellence StructuresBest Practices
Continuing Medical Education (CME) programs serve to maintain, develop or enhance the skills, knowledge and professional performance & relationships that a physician uses to provide services to patients, public and the profession. However, recent compliance and transparency rules have tempered the sponsorship of some medical education programs by bio-pharmaceutical companies as well as some third-party providers of such services. Critics such as Morris and Taitsman also prefer that the medical profession eliminate commercial support for CME.
Best Practices, LLC conducted this study to inform those who lead medical education programs at large bio-pharmaceutical companies about the proper size, resourcing and structure for the medical education function. The study looks into emerging Medical Education trends at medical device and pharmaceutical organizations regarding funding and program types.
Download Full Report: http://bit.ly/2bAUm6U
Drive Growth and Profitability Through Strategic Pharmaceutical New Product P...Kuheli Roy
The new product planning function within bio-pharmaceutical companies is tasked with the challenging role of delivering potential new products in shorter time frames and minimum development costs.
This Best Practices, LLC benchmarking report examines the role and impact of new product planning function on product commercialization. In particular, it examines the impact of structure, resources and activities of new product planning groups on product commercialization.
Download Full Report: http://bit.ly/2e8ErMD
Drive Growth and Profitability Through Strategic Pharmaceutical New Product P...Best Practices
The new product planning function within bio-pharmaceutical companies is tasked with the challenging role of delivering potential new products in shorter time frames and minimum development costs.
This Best Practices, LLC benchmarking report examines the role and impact of new product planning function on product commercialization. In particular, it examines the impact of structure, resources and activities of new product planning groups on product commercialization.
Download Full Report: http://bit.ly/2e8ErMD
Elevating Medical Management Services to Meet Member ExpectationsCognizant
Healthcare payer organizations can lower the cost of commoditized medical management functions via better and different processes, and invest the savings in member-centric care management services.
Highlights from three different speakers on the actual use of dashboards for decisionmaking.
MEASURE Evaluation shares the results of a landscape analysis looking for specific examples of dashboards prompting action. BroadReach shares an example of how their Vantage platform is making HIV data accessible in South Africa. JSI shares an example of low-tech but high-impact dashboard development and coaching that has transformed districts in Zimbabwe.
Growing Bio-pharma Digital Marketing Impact by Digitizing Launch, Developing ...Best Practices
It has become quite crucial to identify the drivers of digital marketing performance excellence in the health care industry which will enable companies to gain valuable customer insights, build effective relationships, leverage online media, and maximize revenue.
Best Practices, LLC undertook this benchmarking research to provide critical insights into how savvy bio-pharma digital marketers are enhancing the medical and commercial potential of new products, improving alignment with brand teams, acquiring and training new digital marketers, managing service delivery for key programs and optimizing insource vs. outsource mix.
Download Full Report: http://bit.ly/2gnXrIu
Best Practices in Patient Advocacy Groups Collaboration and Relationship Mana...Best Practices
The current structure of medical education emphasizes pedagogy related to the physician-patient relationship, and thus advocacy opportunities at this level. Patient and professional Advocacy Groups are important to the process of educating the marketplace on new therapies. Strong relationships with advocacy groups are important for educating the public on socially-sensitive conditions and treatment options.
Best Practices, LLC's study identifies effective practices in patient advocacy group collaboration and relationship management. This study also examines ideal structures and skill sets for pharma groups that deal with advocacy groups and emerging trends and challenges in patient advocacy.
Download Full Report: http://bit.ly/2evZ0AE
Benchmarking Bio-Pharmaceutical Medical Education Programs: Structures, Resou...Best Practices
Bio-pharmaceutical organizations have long relied on medical education programs to provide latest medical knowledge to physicians and other health care professionals. However, recent compliance rules and regulations have tempered the sponsorship of some medical education programs by bio-pharmaceutical companies, as well as some third-party providers of such services.
Best Practices, LLC, undertook benchmarking research to probe emerging medical education trends at top bio-pharmaceutical companies. In particular, this research provides benchmarks on the proper size, structure, activities performed, staffing, and investment for the Medical Education function.
Download Full Report: http://bit.ly/2cf5PYb
Delays in the launch and execution of critical market research projects can slow down the decision-making process, resulting in missed opportunities and increased costs. Therefore, it is absolutely critical for bio-pharmaceutical companies to develop a tactical approach to expedite the market research approval process for quicker and more meaningful insights.
According to recent research by Best Practices, LLC, nearly three-quarters of the benchmarked study participants use review cycle time as a metric for determining if the market research approval process is functioning at an acceptable level. One tip that participants gave on how to control processes and to ensure high performance is to create checklists. Begin with checklists in pinch points that are most problematic, and then extend to entire process and operations. This report will help leaders to gain critical insights they need to compete successfully in a fast-changing market.
Download Full Report: http://bit.ly/2bfAhOc
Given the stringent regulatory requirements in the health care industry, it is important for bio-pharmal companies to develop innovative Risk Evaluation and Mitigation Strategies (REMS) plans during the commercialization of certain products to ensure an acceptable risk-to-benefit ratio.
This benchmark study published by Best Practices, LLC examines how companies develop and execute successful Risk Evaluation and Mitigation Strategies (REMS) plans for newly-approved drugs in the U.S. market. This study can help bio-pharma companies in creating successful REMS programs.
Download Full Report: http://bit.ly/2aOt5Id
Driving Performance Excellence in the Regulatory Affairs Function at Medical ...Best Practices
Optimizing the resource and staffing levels at medical device companies enables Regulatory Affairs leaders to prioritize roles and responsibilities, thereby driving organizational growth.
Research & Consulting leader, Best Practices, LLC engaged Regulatory Affairs leaders at 32 leading medical device companies through a benchmarking survey to capture insights regarding current and future trends shaping the Regulatory Affairs function. This study delivers benchmarks around the critical drivers of regulatory performance excellence at medical device companies.
Download Full Report: http://bit.ly/2asHvQh
Disease Awareness Program Excellence: Structure, Timing, Activities & Investm...Best Practices
Bio-pharmaceutical companies use disease state awareness campaigns to disseminate unbranded information to external stakeholders such as physicians, patients and payers.
Best Practices, LLC undertook research to deliver benchmarks around the structure, timing, investment and activities for disease awareness programs.
Download Full Report: http://bit.ly/2a7CnUS
Library Services Benchmarks - Using Corporate Library Services in PharmaBest Practices
Libraries are custodians of invaluable information. The study - Library Services Benchmarks 2016: Corporate Library Services in the Pharmaceutical Industry published by Best Practices, LLC examines the trends and staffing benchmarks such as library staff per potential and actual users across companies providing access to library services across the bio-pharmaceutical space.
This study looks into staff with formal education level and the number of staff inside and outside the library who provide library services. This study can be used by bio-pharmaceutical companies to improve upon existing library services and staffing.
Download Full Report: http://bit.ly/29QZcbM
Effective Launch Training Practices for District Sales Managers: Optimize Per...Best Practices
Rising competition and access restrictions in the bio-pharmaceutical industry have made it critical for companies to prepare and measure the performance of their District Sales Managers (DMs) who oversee launch-related activities in the field.
Best Practices, LLC engaged 20 sales leaders from bio-pharmaceutical companies to establish benchmarks around the training and accountability of District Sales Managers at launch. Insights from this study will serve as a reference point for companies to evaluate their launch training programs for the sales force against industry benchmarks.
Download Full Report: http://bit.ly/29Gq68L
Best Practices in Creating Global Brand for New Products and Ensuring Alignme...Best Practices
In order to develop an effective global branding program for new bio-pharmaceutical products, it is important to ensure brand consistency across all functions and geographies.
Best Practices, LLC undertook research to gather benchmarks on key aspects of the global branding process, including activities, timing, positioning, key message development, regional alignment, agency utilization & cost and the tradename process.
Download Full Report: http://bit.ly/2a1XqUV
Optimizing the Managed Markets Function: Roles, Structures, Resources and Act...Best Practices
Managed Market’s role within the pharmaceutical industry has increased as the influence of payers is simultaneously increasing. Organizations are now being forced to reassess managed markets resources and market markets structures to optimize these groups and to encourage overall organizational success.
Best Practices, LLC designed this benchmarking study to assess managed markets role within small and mid-cap pharmaceutical companies. The overall goal of this project was to illustrate how to have the most impact within the organization while continuing to operate on lean resource levels.
Read more at: http://www.best-in-class.com/bestp/domrep.nsf/products/optimizing-managed-markets-function-roles-structures-resources-activities?OpenDocument
Optimizing Global Brand Website Launches (Pharma)Best Practices
The global launch of a brand website represents a critical point in a new product's entry into the marketplace. Brand websites provide an important information portal for healthcare professionals, payers, patients, and advocacy groups.
Creating and launching a website that fulfills the diverse needs of key stakeholders while being mindful of regional differences in regulations and cultures are factors that can heavily influence how a new drug performs at launch.
This benchmark study probes current and evolving approaches for site development and optimization for brand websites as part of a global launch. The study also provides evidence-based benchmarks on what critical success factors are important for understanding and engaging key stakeholders, particularly physicians.
Clinical Affairs Excellence: Benchmarking Clinical Trial Strategies for Pharm...Best Practices
In the face of cost and regulatory pressures, clinical programs at pharmaceutical organizations have looked to less expensive and regulated areas of the world to perform clinical trial activities. Emerging markets are also fast-growing regions that present future growth opportunities for organizations that have seen sales growth slow in mature markets.
However, there are still questions around the cost, acceptability, quality and pitfalls of conducting clinical trials in emerging regions.
Best Practices®, LLC conducted primary research to inform clinical affairs leaders at pharmaceutical companies on emerging approaches to staffing, outsourcing and managing clinical trials outside of the European and U.S. regions.
Critical outsourcing questions addressed in this survey include:
-What are the regions where pharmaceutical companies are conducting clinical trials and the percent of patients recruited annually from these regions?
-Which clinical trial activities are best suited for outsourcing?
-What is the appropriate staffing mix (in-house and outsourced) for clinical trials?
-What are the most important competencies for clinical research associates, managers, and directors?
This report will inform Clinical Affairs leaders on these questions and others regarding staffing, outsourcing and managing clinical trials outside of the U.S.
Clinical Affairs Excellence: Benchmarking Clinical Trial Strategies To Ensure...Best Practices
In the face of cost and regulatory pressures, clinical programs at medical device organizations have looked to less expensive and regulated areas of the world to perform clinical trial activities. Emerging markets are also fast-growing regions that present future growth opportunities for organizations that have seen sales growth slow in mature markets. However, there are still questions around the cost, acceptability, quality and pitfalls of conducting clinical trials in emerging regions.
Best Practices®, LLC conducted primary research to inform clinical affairs leaders at medical device companies on emerging approaches to staffing, outsourcing and managing clinical trials outside of the European and U.S. regions.
Critical outsourcing questions addressed in this survey include:
-What are the regions where medical device companies are conducting clinical trials and the percent of patients recruited annually from these regions?
-Which clinical trial activities are best suited for outsourcing?
-What is the appropriate staffing mix (in-house and outsourced) for clinical trials?
-What are the most important competencies for clinical research associates, managers, and directors?
This report will inform Clinical Affairs leaders on these questions and others regarding staffing, outsourcing and managing clinical trials outside of the U.S.
Anti ulcer drugs and their Advance pharmacology ||
Anti-ulcer drugs are medications used to prevent and treat ulcers in the stomach and upper part of the small intestine (duodenal ulcers). These ulcers are often caused by an imbalance between stomach acid and the mucosal lining, which protects the stomach lining.
||Scope: Overview of various classes of anti-ulcer drugs, their mechanisms of action, indications, side effects, and clinical considerations.
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
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i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
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The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
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Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
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It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
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Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
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Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
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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
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. 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. 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. 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. 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. 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. 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
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. 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. 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
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. 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. 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
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. 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. 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. 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.
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