India and Medical Affairs: Building Best-in-Class Medical Affairs Capabilities In India – A Case...

BEST PRACTICES,

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Best Practices, LLC Strategic Benchmarking Research

Building Best-in-Class Medical Affairs

Capabilities In India – A Case Study

For High-Growth Emerging Markets

BEST PRACTICES,

®

LLC

Table of Contents

Executive Summary pp. 3-12

Research Overview pp. 3

Participating Companies pp. 4-5

Key Recommendations pp. 7-8

Maturity of Medical Affairs pp. 9

Key Findings & Insights pp. 10-12

Scope & Structure pp. 13-18

Leadership & Oversight pp. 19-25

Regulatory Landscape & Challenges pp. 26-30

Spend Allocation pp. 31-36

Staffing pp. 37-46

Functional Responsibility pp. 44-50

Budget Trends & Success Factors pp. 51-54

Participant Demographic Data pp. 55-59

About Best Practices, LLC pp. 60-61

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Field Research & Insight Development:

Surveyed 68 Medical Affairs leaders at 50 different

pharmaceutical and medical device companies

across mature Global markets.

Compared an India market class from 8 respon-

dents at 7 India companies with global benchmark.

Conducted Deep-dive interviews with Medical

Affairs veterans at seven leading companies. .

Optimize Budget Allocation

Improve Staff Management

Increase Overall Effectiveness

Research Objectives & Methodology

Research Objectives:

Illustrate how leading Global and Indian pharmaceutical and medical device companies structure and

organize their Medical Affairs functions based on industry and market changes.

Identify trends expected to impact the allocation of resources across different Medical Affairs functions.

Analyze how regulatory requirements are internalized and managed by Medical Affairs.

Describe the success factors and top current challenges regarding Global & Indian Medical Affairs.

Identify what percentage of MA budget leading companies allocate to outsourcing.

Trace how successful Medical Affairs organizations work cross-functionally to enhance effectiveness.

Business Objectives:

Across the global healthcare landscape, the Medical Affairs function is essential to meeting current

challenges in clinical development, market education, and regulatory compliance. This research – which

delivers current comparative metrics, executive insights, and best practices from Medical Affairs leaders

throughout the industry – specifically probes the state of Medical Affairs in the India marketplace.

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Universe of Learning: Participants in Benchmark Study

Benchmark Class

This study engaged 68 Medical Affairs leaders from 50 leading healthcare companies in a

benchmarking survey. Best Practices, LLC analysts also conducted deep-dive interviews with

executives at seven leading companies to harvest additional insights.

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Defining Medical Affairs and Key Functions

Best Practices, LLC conducted this benchmarking study to identify best practices and innovative

methods for developing a Medical Affairs function capable of meeting diverse goals.

Medical Affairs: Refers to all the functions dedicated to building and maintaining

relationships with physicians and the medical community, including, but not limited to, the

following:

Medical Education: Responsible for CME & educational grants.

Medical Communications & Publications: Develops or reviews scientific/medical content--including

medical journal articles--for communications to healthcare professionals, patients, consumers and

payers. Develops/ manages publication plan. Includes medical information call center.

Medical/Clinical Research Operations: Creates and guides strategy for clinical development

programs. Develops and executes investigator and company-initiated clinical studies, including cost-

marketing/ Phase IV studies. Includes Medical Directors.

Medical/Scientific Liaisons (MSLs): Non-sales field force responsible for medical relations & training.

Outcomes Research: Collects and analyzes Health Outcomes/ Economics data.

Phamacovigilance/Safety: Oversees the collection and analysis of information on adverse drug

reactions.

Thought Leader Management: Responsible for the identification, recruitment and development of

physicians who can influence the medical perspective and practice of their peers.

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Demonstrate Medical

Affairs Value to

Commercial/

Marketing

Medical Science Liaison (MSL) groups are virtually non-existent in India,

though they are rapidly growing in mature markets focused on clinical

education. The concept of clinical and off-label communication is evolving in

India. As the market becomes more research-driven, the need for MSL staff

equipped to handle diverse clinical discussions is expected to grow.

MSL Staffing

Increase Likely

Engagement with

Management and

Commercial

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High-Level Key Findings: Medical Affairs Function in India

Ensure Medical

Affairs Directive

Comes from Top

Successful Medical Affairs groups often thrive because Corporate realizes

they provide value-added services. In India, the Medical Affairs group is still

seminal, and removing ambiguity in reporting relationship and structure will

be beneficial in future.

Traditionally. the Indian Pharmaceutical industry is sales & operations

driven. Moreover, it is still rapidly evolving. The Indian Medical Affairs

function is highly focused and linked to commercial. Mature markets have

been shifting reporting away from commercial. Clear metrics highlighting

MA value is a current and future need for continued evolution in India.

India-based management teams give less importance to MA because their

primary focus is sales and commercial development. MA must show that

clinical excellence and commercial growth are married in mature markets.

India MA are starting to make the case that sound clinical practices, which

safeguard customers and the company, is also sound business practice.

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Centralized organization (serving entire

enterprise under one

administration/

budget), 22%

Decentralized by region,

22%

Decentralized by

therapeutic area, 33%

Hybrid (some

functions centralized &

others

decentralized), 22%

Medical Affairs Is Decentralized at Indian Companies

The Indian regulatory and market landscape is very different from those in mature markets. Moreover, the Indian pharmaceutical industry is highly fragmented with more revenue coming from OTC drugs. Due to this, 77% of Indian benchmark companies prefer some form of decentralization for Medical Affairs, compared with 56% of the mature markets companies.

Q. Which of the following best describes the current structure of Medical Affairs at your company?

(choose one)

Centralized organization (serving entire

enterprise under one

administration/

budget), 42%

Decentralized by region,

11%

Decentralized by

therapeutic area, 9%

Hybrid (some functions

centralized & others

decentralized), 36%

Other , 2%

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Current Structure

(n=9) (n=53)

Mature Markets Segment: India Segment:

*

*Other: • Decentralized by region and TA

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Reporting Patterns Not Clearly Set in Indian Bio-Pharma

Companies

Q. What is the job level of the person who currently heads Medical Affairs? (choose one)

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Leadership

(n=8) (n=53)

Mature Markets Segment: India Segment:

Chief Medical Officer, 19%

Senior/ Executive

Vice President,

25% Vice President,

38%

Senior/ Executive

Director, 11%

Director, 8%

Even though a dedicated Medical Affairs function exists at most of the benchmarked companies in India,

there is no clearly defined reporting relationship, indicating the group is still in its formative stages. At

33% of companies Medical Affairs reports into a Director, while 34% report into a VP. On the other hand,

63% of mature market companies report to the Vice President level or above.

Chief Medical Officer

11%

Vice President

34% Senior/Execut

ive Director 22%

Director 33%

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4%

2%

2%

2%

2%

10%

4%

4%

6%

2%

4%

44%

46%

25%

33%

25%

19%

31%

23%

26%

44%

25%

40%

40%

23%

19%

24%

25%

33%

33%

34%

44%

Medical Education

Pharmacovigilance/Safety

Thought Leader Management

Medical/Clinical Research Operations

Medical Communications &Publications

Medical/Scientific Liaisons

Outcomes Research

Much Less Important Somewhat Less Important No Change Somewhat More Important Much More Important

In India, Outcomes Research & MSLs Are Rapidly Gaining In Importance for Medical Affairs Although spend and resource allocations favor Medical/Clinical operations, 67% of benchmark

participants in India consider Outcomes Research as gaining in importance for a company’s future

success, while 74% spotlight MSLs as gaining importance. This trend is similar to the mature market

benchmark class.

Q. In your recent experience, have the following Medical Affairs functions become more or less

important to the overall success of your company? (choose one response for each functional area)

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India Segment: Importance of Medical Affairs Functions

(n=8)

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About Best Practices, LLC

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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.

Learn More About Our Company:

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India and Medical Affairs: Building Best-in-Class Medical Affairs Capabilities In India – A Case...

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Transcript of India and Medical Affairs: Building Best-in-Class Medical Affairs Capabilities In India – A Case...