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.

1. Best Practices, LLC Medical Affairs – Accessing Intelligence
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.
• 400,000 Business Professionals
• 86% of Fortune 100 Companies
• $40 million in proprietary
benchmarking analysis, insights
and findings
Brand Market Regulatory Competitive
Medical Affairs
Management Research Affairs Intelligence
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2. Best Practices Medical Affairs Consortium
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.
How do we make the most of Medical Affairs?
Learn
Structure Managing Demonstrating
• What is the Compliance Value Compare
optimal structure • How do you • What are the
for Medical navigate across optimal mediums
Affairs Success? an ever‐changing and metrics to
regulatory demonstrate Decide
landscape? Medical Affairs
Value?
Execute
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3. Best Practices Medical Affairs Consortium
All consortium members participate in creating the study. Take a look at these other
benefits:
Research and Insights Advisory Support
• Customized Analysis of how these insights affect • Ongoing support from your BP Advisory Team to
your organization moving forward help you understand how to incorporate the
• Customized Executive summary to provide to findings.
your team or to help build the business case for • The ability to have our team personally advise
change. you and your team to help develop your strategy
based on your customized results.
A deeper, richer analysis Live and Online Learning Events
• Not only are your insights personalized, all • Scheduled learning sessions where you and
members of the consortium will receive analysis executives can probe for further insights on the
that comprises intelligence from in depth, data you receive
intensive interviews with key digital marketing • Conveniently scheduled so that you or a member
executives of your team can attend
Theme Creation Executive Networking
• You help create the path of the study. • Access to leading peer executives from around
• Your main issues become our main issues as we the world who you can share and learn best
look to you for guidance on how we look to find practices from
the information important to you
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4. Medical Affairs Capabilities – Project Methodology
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.
Field Research Process
Best Practice
Lessons Learned
Project Shaping Benchmark Survey Blueprint for
Interviews
Excellence
• Identify industry • Engineer key issues • Conduct interviews • Integrate qualitative
business Issue into operational with high performers & and quantitative
• Identify industry needs questions with leaders of failed insights
& objectives • Combine performance launches • Conduct Analysis
metrics with process • Probe soft factors that • Prepare key
• Articulate key issues to drive success and recommendations
probe in field research • Engage many failure • Integrate “best of the
• Scope and scale companies • Process insights best” practices
project • Engineer for ease of • What would you do • Identify key pitfalls to
• Engage all constituents response differently? avoid failure
• Use to screen higher • Lessons Learned • Share lessons learned
performers
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5. Challenges Confronting Medical Affairs Leaders
Hierarchy of Impact: Identifying Challenges with Greatest Impact
Challenge
Major
People
Development/
Retention
Impact of
Regulatory
Landscape
Organizational
Insufficient
Value/
Budget/Staff
Measurement
Resources
Issues
Insufficient Role/ Function
Internal Not Clearly
Alignment Define
Challenge
Minor
Leadership/ Lack of
Global Issues
Management Differentiation
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6. Maturation Process of Medical Affairs Function
Groups in the formative stage can learn from the less lean, more established groups in
our study.
MA in Formative Stage: Escalating MA Capabilities: Established MA:
 Medical Affairs infancy  Definitive metrics for MA value  Independent, but aligned
Medical Affairs Management
 Executive Committee proposition with Commercial
Reporting structure  Global reach, but clear compliance  Differentiated MSLs
 Mainly based on guidelines targeting specific groups
Clinical Ops/ Med Ed  Strong MSL group, increased clinical  Strong Health Outcomes
 Expanding Field groups bandwidth and expanded role beyond group within department
 Dependent on handling off-label issues  High visibility of all Medical
Commercial  Reports to R&D/Clinical Affairs functions
 Growing because of  Increase in FTEs and staffing  Struggling to fight for head
pipeline or emergence because of more requests count, usually because of
of medical need at maturation of products
company or in region “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
 500K – 5M spend  5M – 75M spend  75M+ spend
 1-10 FTEs  11-120 FTEs  120+ FTEs
Medical Affairs Functional Maturity
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7. Medical Affairs Capabilities – Sample Issue
Medical Affairs is growing as a whole, however this is largely influenced by pipeline and
maturation of products.
Mature Markets 2012
Decrease by >10% Decrease by 1-10% Stay the Same Increase by 1-10% Increase by >10%
FTE Level Changes Budget Level Changes
12%
23% 20%
25%
33%
23%
28% 20%
36% 39%
33% 44%
14% 14% 16%
9%
2% 2% 5% 2%
Actual FTE # change from Estimated FTE # change from Actual budget change from Estimated budget change
2011 to 2012 2012 to 2013 2011 to 2012 from 2012 to 2013
(n=43) (n=44)
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8. Medical Affairs Capabilities – Sample Issue
The increase in more senior leadership reflects the growing importance of the function.
Leadership
Mature Markets Segment: Mature Markets Segment:
Director, 8%
Senior/ Other, 5%
Chief Medical Chief Medical
Executive Officer, 19% Director, 14% Officer, 19%
Director, 11%
Senior/
Executive
Vice
President, 5%
2012 2009
Senior/
Executive
Vice Vice
President, President, Senior/ Vice
38% 25% Executive President,
Director, 23% 33%
*Other:
• Regional President
(n=53) (n=21)
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9. Medical Affairs Capabilities – Sample Issue
In order to deeply entrench your importance at your organization, you must evolve and
garner more responsibilities.
Educate
stakeholders via
the delivery of
“At the highest level, Medical Affairs as a
accurate,
complete, and function is rapidly evolving from serving
unbiased
information. as a support-only function to a strategic
Seek feedback Develop KOL
from KOLs to strategies function, particularly in the U.S., as the
shape the associated with
company’s Evolving the company’s healthcare market consolidates and
business Function of business evolves. As access to all of these groups
strategies. objectives.
Medical
Affairs lessens, becoming that scientific partner
and being able to talk on a more
Create medical Support clinical sophisticated level will be a key driver in
information trials via site the company.”
which monitors identification,
trial data and patient - Interviewed Vice President
scientific enrollment, and
literature. supervision.
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10. Critical Success Factors for Medical Affairs Effectiveness
Ten key themes shared by benchmark partners for developing and maintaining an
effective Medical Affairs function:
Demonstrating Medical
Affairs Adequate Resources
Business Value
Collaborating/
Support from Senior
Communicating Leadership
with Stakeholders
Critical
Focus on Innovation & Success Strategic Planning &
Outcomes Well‐Defined Priorities
Factors for
Effective
Hiring & Retaining
Sound Organizational Medical Affairs Top Quality Staff
Management/ Leadership
Continuous People
Developing Strong Development
Internal & External
Partner Relationships
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11. Range and Depth of our Medical Affairs Support
Data
Management
&
Biostatistics
Health
Medical
Economics/
Information
Outcomes
Medical
Medical Affairs Scientific/
Education & Medical
Research Liaisons
Scientific Thought
Publications Leader
Strategy Services
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12. Competitive Benchmarking Helps You Mine For Your Advantage
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 Benchmarking is #1 Most Used
Global Mgt. Tool . (Source: Bain & Co.
• 1) STRATEGY 2) STRUCTURE 3) LEADERSHIP
2011 Mgt. Tools & Trends Census)
• 4) COST 5) INVESTMENT 6)BUSINESS ECONOMICS Yet most companies fail to use
benchmarking to their full
• 7) STAFFING 8) SKILLS 9) TALENT 10) SOURCING
advantage.
• 11) SERVICES 12) ACTIVITIES 13) IMPACT ANALYSIS We have developed more than 25
• 14) TECHNOLOGY 15) INNOVATION 16) FUTURE TRENDS types of benchmarks to help clients
look forward and build winning
• 17) QUALITY 18) CYCLE TIMES, 19) YIELDS, 20) PRODUCTIVITY
strategies, tactics & plans.
• 21) BEST PRACTICE INSIGHTS 22) PROCESS EXCELLENCE Ask us what approach is right for
• 23) ANALOGS, 24) LAUNCH PLANNING & 25) LIFECYCLE your competitive situation.
INSIGHTS
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13. Best Practices Medical Affairs Consortium
To learn more or to become an Early Advisor:
Click on the Yellow “ ” Envelope Below
Or Directly Contact:
Marty Daniel
Client Services Manager
(919) 767‐9223 direct
mdaniel@best‐in‐class.com
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