Medical Affairs Consortium

Copyright © Best Practices, LLC 6350 Quadrangle Drive, Suite 200, Chapel Hill, NC 27517 Ph.: 919-403-0251 www.best-in-class.com

Our company works on the principle that organizations can chart a course to superior economic performance by studying the best business practices, operating tactics and winning strategies of world-class organizations.

Best Practices, LLC Medical Affairs – Accessing Intelligence

Medical Affairs Brand Management

Market Research

Regulatory Affairs

Competitive Intelligence

• 400,000 Business Professionals

• 86% of Fortune 100 Companies

• $40 million in proprietary

benchmarking analysis, insights

and findings


Best Practices Medical Affairs Consortium

Learn

Compare

Decide

Execute

Our business model is geared to address your critical issues. You set the research agenda. We design and deliver benchmark tools across many different companies to identify your specific performance gaps and growth opportunities.

Structure• What is the optimal structure for Medical Affairs Success?

Managing Compliance• How do you navigate across an ever‐changing regulatory landscape?

Demonstrating Value• What are the optimal mediums and metrics to demonstrate Medical Affairs Value?

How do we make the most of Medical Affairs?


Best Practices Medical Affairs ConsortiumAll consortium members participate in creating the study. Take a look at these other benefits:

Research and Insights• Customized Analysis of how these insights affect your organization moving forward

• Customized Executive summary to provide to your team or to help build the business case for change.

A deeper, richer analysis• Not only are your insights personalized, all members of the consortium will receive analysis that comprises intelligence from in depth, intensive interviews with key digital marketing executives

Theme Creation• You help create the path of the study.• Your main issues become our main issues as we look to you for guidance on how we look to find the information important to you

Advisory Support• Ongoing support from your BP Advisory Team to help you understand how to incorporate the findings.

• The ability to have our team personally advise you and your team to help develop your strategy based on your customized results.

Live and Online Learning Events• Scheduled learning sessions where you and executives can probe for further insights on the data you receive

• Conveniently scheduled so that you or a member of your team can attend

Executive Networking• Access to leading peer executives from around the world who you can share and learn best practices from


Medical Affairs Capabilities – Project Methodology

Project Shaping Benchmark Survey Lessons Learned Interviews

• Engineer key issues into operational questions

• Combine performance metrics with process

• Engage many companies

• Engineer for ease of response

• Use to screen higher performers

• Conduct interviews with high performers & with leaders of failed launches

• Probe soft factors that drive success and failure

• Process insights• What would you do

differently?• Lessons Learned

Best Practice Blueprint for Excellence

• Identify industry business Issue

• Identify industry needs & objectives

• Articulate key issues to probe in field research

• Scope and scale project

• Engage all constituents

Field Research Process

• Integrate qualitative and quantitative insights

• Conduct Analysis• Prepare key

recommendations• Integrate “best of the

best” practices• Identify key pitfalls to

avoid failure• Share lessons learned

Here’s How We Helped a Top Pharma Company:Client Issue: This research was designed for our client to probe the different ways of structuring and aligning Medical Affairs. Ultimately, the client wanted to identify how other Medical Affairs executives build their value proposition and garner additional resources.


Challenges Confronting Medical Affairs Leaders

People Development/

Retention

Organizational Value/

Measurement Issues

Impact of Regulatory Landscape

Insufficient Budget/Staff Resources

Leadership/ Management

Insufficient Internal

Alignment

Global Issues

Role/ Function Not Clearly

Define

Lack of Differentiation

Hierarchy of Impact: Identifying Challenges with Greatest ImpactM

inor

Cha

lleng

eM

ajor

Cha

lleng

e


Groups in the formative stage can learn from the less lean, more established groups in our study.

Maturation Process of Medical Affairs Function

Medical Affairs Functional Maturity

Med

ical

Affa

irs M

anag

emen

t

MA in Formative Stage: Escalating MA Capabilities: Established MA: Medical Affairs infancy Executive Committee

Reporting structure Mainly based on

Clinical Ops/ Med Ed Expanding Field groups Dependent on

Commercial Growing because of

pipeline or emergence of medical need at company or in region

Independent, but aligned with Commercial

Differentiated MSLs targeting specific groups

Strong Health Outcomes group within department

High visibility of all Medical Affairs functions

Struggling to fight for head count, usually because of maturation of products

500K – 5M spend 1-10 FTEs

5M – 75M spend 11-120 FTEs

75M+ spend 120+ FTEs

Definitive metrics for MA value proposition

Global reach, but clear compliance guidelines

Strong MSL group, increased clinical bandwidth and expanded role beyond handling off-label issues

Reports to R&D/Clinical Increase in FTEs and staffing

because of more requests

“It does matter how big of a company you are. You reach a threshold where you are having

enough success [and] all of a sudden the requests and the level that you have to satisfy

are different.” – Interviewed Senior Director


Medical Affairs Capabilities – Sample Issue

2% 2%

14% 9%

33% 44%

28%

33%

23%12%

Actual FTE # change from2011 to 2012

Estimated FTE # change from2012 to 2013

FTE Level ChangesIncrease by 1-10% Increase by >10%Stay the SameDecrease by 1-10%Decrease by >10%

(n=43)

5% 2%

14% 16%

36% 39%

20%23%

25% 20%

Actual budget change from2011 to 2012

Estimated budget changefrom 2012 to 2013

Mature Markets 2012

Budget Level Changes

(n=44)

Medical Affairs is growing as a whole, however this is largely influenced by pipeline and maturation of products.



Leadership

(n=21)(n=53)

Mature Markets Segment: Mature Markets Segment:

*Other:• Regional President

Chief Medical Officer, 19%

Senior/Executive

Vice President,

25%

Vice President,

38%

Senior/Executive

Director, 11%

Director, 8%Chief Medical Officer, 19%

Senior/Executive

Vice President, 5%

Vice President,

33%

Senior/Executive

Director, 23%

Director, 14%

Other, 5%

2012 2009

The increase in more senior leadership reflects the growing importance of the function.



Educate stakeholders via the delivery of

accurate, complete, and

unbiased information. Develop KOL

strategies associated with the company’s

business objectives.

Support clinical trials via site identification,

patient enrollment, and supervision.

Create medical information

which monitors trial data and scientific literature.

Seek feedback from KOLs to shape the company’s business strategies.

Evolving Function of

Medical Affairs

“At the highest level, Medical Affairs as a

function is rapidly evolving from serving

as a support-only function to a strategic

function, particularly in the U.S., as the

healthcare market consolidates and

evolves. As access to all of these groups

lessens, becoming that scientific partner

and being able to talk on a more

sophisticated level will be a key driver in

the company.”

- Interviewed Vice President

In order to deeply entrench your importance at your organization, you must evolve and garner more responsibilities.


Ten key themes shared by benchmark partners for developing and maintaining an effective Medical Affairs function:

Critical Success Factors for Medical Affairs Effectiveness

Critical Success

Factors for Effective

Medical Affairs

Critical Success

Factors for Effective

Medical Affairs

Adequate Resources

Support from Senior Leadership

Strategic Planning & Well‐Defined Priorities

Hiring & Retaining Top Quality Staff

Continuous People DevelopmentDeveloping Strong

Internal & External Partner Relationships

Sound Organizational Management/ Leadership

Focus on Innovation & Outcomes

Collaborating/ Communicating with Stakeholders

Demonstrating Medical Affairs

Business Value


Range and Depth of our Medical Affairs Support

Medical Affairs

Data Management

& Biostatistics

Medical Information

Scientific/ Medical Liaisons

Thought Leader Services

Scientific Publications Strategy

Medical Education & Research

Health Economics/ Outcomes


Benchmarking is #1 Most Used

Global Mgt. Tool . (Source: Bain & Co. 2011 Mgt. Tools & Trends Census)

Yet most companies fail to use

benchmarking to their full

advantage.

We have developed more than 25

types of benchmarks to help clients

look forward and build winning

strategies, tactics & plans.

Ask us what approach is right for

your competitive situation.

Best Practice Benchmarking is a powerful tool to gain competitive insight. We develop “Market Topography Maps” that use evidence-based benchmarks to analyze your competitive landscape. We spotlight your strengths and weaknesses. Then we recommend how to avoid failure points and build on your advantages!

DIFFERENT BENCHMARKS YIELD DIFFERENT INSIGHTS

• 1) STRATEGY 2) STRUCTURE 3) LEADERSHIP

• 4) COST 5) INVESTMENT 6)BUSINESS ECONOMICS

• 7) STAFFING 8) SKILLS 9) TALENT 10) SOURCING

• 11) SERVICES 12) ACTIVITIES 13) IMPACT ANALYSIS

• 14) TECHNOLOGY 15) INNOVATION 16) FUTURE TRENDS

• 17) QUALITY 18) CYCLE TIMES, 19) YIELDS, 20) PRODUCTIVITY

• 21) BEST PRACTICE INSIGHTS 22) PROCESS EXCELLENCE

• 23) ANALOGS, 24) LAUNCH PLANNING & 25) LIFECYCLE INSIGHTS

Competitive Benchmarking Helps You Mine For Your Advantage


Best Practices Medical Affairs Consortium

To learn more or to become an Early Advisor:

Or Directly Contact:

Marty DanielClient Services Manager(919) 767‐9223 direct

mdaniel@best‐in‐class.com

Click on the Yellow “ ” Envelope Below


Thank You for Viewing!We appreciate the support of our Followers and Viewers. To be notified of our new presentations via an email from SlideShare, Follow our channel here:

14


The End

15

Have a Wonderful Day!

Health & Medicine

Medical Affairs Consortium