Medical Affairs Excellence Services Summary

Medical Affairs Excellence Services: Research Excerpt (OPS-1A)

Medical Affairs
Overview
This Medical Affairs Excellence Services
provides executives with strategic insight

Excellence Services and successful approaches
competitive performance in the medical
for

affairs function. It focuses on many areas

PROJECT BACKGROUND including utilizing health outcomes,
scientific publications strategy, educating
physicians, key opinion leaders, patient
advocacy and clinical developments.
The dynamic bio-pharmaceutical and medical device
companies are accelerating their medical affairs function Sample Featured Organizations
scope beyond a traditional support function. The • Abbott Laboratories
function 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 • Novartis
function enhances a company’s scientific reputation and • Pfizer Inc.
complements the work of Research & Development. It • Proctor & Gamble
• Sanofi-Aventis
also provides physicians, key opinion leaders (KOLs),
• Schering Plough
legal-regulatory agencies, professional groups and • TEVA

healthcare professionals with medical and scientific
Information Types
information and education on the value and proper use
• 140+ Data Graphics
of a company’s products, therapies, devices, technology • 180+ Information Graphics
and diagnostics. • 260+ Metrics
• 60+ Narratives
• 50+ Best Practices
During several years of benchmarking world-class
pharmaceutical and life science organizations, Best Questions?
Practices, LLC has provided valuable information to For more information, please contact
pharmaceutical companies to improve their medical Best Practices LLC at (919) 403-0251 or
bestpractices@best-in-class.com
affairs capabilities.

Through the Medical Affairs Excellence Services, Best Practices provides our clients with the

Copyright Best Practices, LLC (919) 403-0251 1


insights, expertise and intelligence needed to increase the impact of Medical Affairs function
in 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 – oncology

INCLUDED RESEARCH
Best Practices can tailor a service offering to meet your needs from our following products
and research. Contact us to discuss our services and pricing options for our research and
services 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 Compound



• Effectiveness by rating

2. 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 Affairs

3. 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 Challenges



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 Goals

5. 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
• Relationships



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 Support

7. 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
Education's (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 & Europe



The study also incorporates third-party input from seven CME vendors and eight medical
associations 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 Steps

9. 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 & Focus



• Structuring & Aligning Field-Based Liaisons With Sales Organizations
• Optimal Call Frequencies and Service Levels with Thought Leaders
• Managing, Shifting & Forecasting Resources

10.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 Management

11.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.

• 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 Structure



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.


• 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 & expertise

13.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.


• 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 function



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.


• 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 Trends

WHO CAN BENEFIT FROM THESE SERVICES?

These services provide valuable material for executives of the pharmaceutical organization
to ensure superior execution and implementation of medical affairs strategy and drive
operational efficiency. Executives will find numerous resource-related issues addressed,



while the execution level managers will be able to create roadmaps and plans for
accomplishing 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.



• 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.



• 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.



• 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.



• Using Opportunities to Get the Funding for CME Programs
The amount of money required to fund CME programs can prove overwhelming for CME
organizations with small staffs. However, half of the surveyed participants from associations
and teaching hospitals reported that they received nearly all of the necessary money for
carrying out their programs.



• Key Contributors to Global Publications Strategy & Plan
Every company in the benchmark class turns to a medical director for strategy input. Most
companies also look to global brand directors and global publications directors. Overall,
responsibility for publications strategy is shifting from marketing brand leaders to global
publication, medical directors, or ‘neutral’-cross-functional teams.



• Pre-and Post-Launch Activities
While the majority of companies involve their MSLs in most pre-launch activities, some
choose to forego activities such as clinical protocol development, assisting with sales and
marketing plans and moderating advisory boards. Thought leaders are the compass to
competitor activities, market changes and early reactions to commercial products. Most
companies focus their medical specialists on developing KOLs to guide these post-launch
activities, as well as gathering competitive intelligence.



• Utilizing Health Outcomes Data for Promotional/ Commercial Efforts
Some Health Outcomes groups decide other points such as pricing and market access
strategies. However, these occur less frequently and seem to be activities that would be
undertaken by cross-functional groups or other areas within companies.



• Collaborating with Patient Advocacy Groups to Educate the Marketplace

Under-treated but recognized diseases may highlight public health issues. This can create
funding and collaboration opportunities for Pharma, Government and Patient Advocacy
Groups. In the case of PAD (Peripheral Arterial Disease), government funding underwrote
the creation of educational materials distributed by Pharma and advocacy groups.



• Shaping the Marketplace to Support Successful Oncology Product Launches:
Tactics for Educating Key Opinion Leaders (KOLs), Physicians, Patients and
Payers

This study explores best practices in educating, informing and preparing the marketplace for
new products –through Physician, Patient, and Payer education, publications, advocacy and
communication strategies.



BEST PRACTICE DATABASE Why Best Practices, LLC’s
A research, analysis and decision-support service for Best Practice Database?
professionals working across functions such as
• The company we keep. With over
commercial operations, HR, R&D and customer service in 44,000 benchmark partners, we
major industries including healthcare (Pharma, biotech, work with a virtual Who’s Who list of

med device, etc.), finance, manufacturing, technology companies in dozens of industries.
This allows us to get the information
and communications. This insight-and-advisory service
you need, when you need it
delivers on-demand access to valuable performance
• We get our information from
benchmarks and best practice research findings from
the source; recognized industry
leading global companies. Membership in the Best
experts. It’s not just theory, the
Practice Database provides unlimited access to a $40-
best practices you will find are in
million growing body of proprietary research and forward- use today by leading companies
looking 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 more
How can a membership benefit you?
than 44,000 benchmark partners,
Designed especially for business professionals like we work with a virtual Who’s Who
yourself, Best Practice Database membership allows list of companies in dozens of
you full access to $35 million in benchmarking research. industries. This allows us to get the
information you need, when you
Membership allows members to support daily, process, need it

productivity, and strategic decisions to optimize their • We get our information from
structure, build a business case for change, identify the source; recognized industry
performance 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.



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 large
initiatives and give you the flexibility of rotating users while offering attractive rates for
access to all our research.

For more details on the specific benefits of the Best Practice Database, go to
www.bestpracticedatabase.com/testimonials to learn how others use their Database access
to answer business questions, support a business case or serve internal clients.

ABOUT BEST PRACTICES, LLC
Best Practices, LLC is a recognized leader in the field of best practice performance
improvement. Our suite of customized Research and Consulting services can assist in
improving your company's performance by analyzing the winning practices of leading
corporations and institutions.


Medical Affairs Excellence Services Summary

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