Medical Affairs Excellence Services Summary

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

Special Features Annual Membership to the

Best Practice Database

provides unlimited access to

a $35-million growing body

of proprietary research and

forward-looking analysis

Questions?

For more information, please contact Best Practices LLC at (919) 403-0251 or [email protected]

Medical Affairs Excellence Services PROJECT BACKGROUND

The dynamic bio-pharmaceutical and medical device

companies are accelerating their medical affairs function

scope beyond a traditional support function. The

function manages strategic responsibilities bridging

research as well as clinical

development, its scientific

publications strategy and

utilizes health outcomes,

biostatistics, necessary

medical education and

other medical services.

Overview This Medical Affairs Excellence Services

provides executives with strategic insight

and successful approaches for

competitive performance in the medical

affairs function. It focuses on many areas

including utilizing health outcomes,

scientific publications strategy, educating

physicians, key opinion leaders, patient

advocacy and clinical developments.

The medical affairs

function enhances a company’s scientific reputation and

complements the work of Research & Development. It

also provides physicians, key opinion leaders (KOLs),

legal-regulatory agencies, professional groups and

healthcare professionals with medical and scientific

information and education on the value and proper use

of a company’s products, therapies, devices, technology

and diagnostics.

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 • TEVA

During several years of benchmarking world-class

pharmaceutical and life science organizations, Best

Practices, LLC has provided valuable information to

pharmaceutical companies to improve their medical

affairs capabilities.

Information Types • 140+ Data Graphics • 180+ Information Graphics • 260+ Metrics • 60+ Narratives • 50+ Best Practices

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

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

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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 Best Practice Database?

• The company we keep. With over

44,000 benchmark partners, we

work with a virtual Who’s Who list of

companies in dozens of industries.

This allows us to get the information

you need, when you need it

• We get our information from the source; recognized industry

experts. It’s not just theory, the

best practices you will find are in

use today by leading companies

• Membership is constantly increasing in value as more

research is added each month.

A research, analysis and decision-support service for

professionals working across functions such as

commercial operations, HR, R&D and customer service in

major industries including healthcare (Pharma, biotech,

med device, etc.), finance, manufacturing, technology

and communications. This insight-and-advisory service

delivers on-demand access to valuable performance

benchmarks and best practice research findings from

leading global companies. Membership in the Best

Practice 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 Why Best Practices, LLC’s Best Practice Database?

• The company we keep. With more

than 44,000 benchmark partners,

we work with a virtual Who’s Who

list of companies in dozens of

industries. This allows us to get the

information you need, when you

need it

• We get our information from the source; recognized industry

experts. It’s not just theory, the

best practices you will find are in

use today by leading companies

• Membership is constantly increasing in value as more

research is added each month.

• Leadership development

How can a membership benefit you?

Designed especially for business professionals like

yourself, Best Practice Database membership allows

you full access to $35 million in benchmarking research.

Membership allows members to support daily, process,

productivity, and strategic decisions to 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 customers




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

Business

medical affairs resources

medical affairs organizations

medical affairs structuring

medical affairs functionsample

medical devicecompanies

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amedical affairs

medical affairskey challenges