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Building Best-in-Class Medical Affairs Capabilities In India – A Case Study For High-Growth Emerging Markets

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Pages: 61

Published: Pre-2014

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STUDY OVERVIEW
BENCHMARK CLASS
STUDY SNAPSHOT
KEY FINDINGS
VIEW TOC AND LIST OF EXHIBITS

Medical Affairs function at bio-pharmaceutical companies plays a vital role in bridging the gap between commercial and R&D operations. Evidently, across the global healthcare landscape, the Medical Affairs function is essential to meeting current challenges in clinical development, market education, and regulatory compliance.

In� India, the Medical Affairs function is still developing, following a similar path to maturity as that traveled by MA groups in Mature Markets. Medical Affairs groups in India need to establish a clear value proposition in order to evolve beyond their traditional roles.

Best Practices, LLC's recent case study illustrates how mature and Indian biopharmaceutical companies include Abbott, Alkem Laboratories, AstraZeneca, Biocon, MSD Pharma, Ranbaxy, Sanofi & Astellas Pharma 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 particularly for Indian organizations.

Industries Profiled:
Pharmaceutical; Biotech; Health Care; Biopharmaceutical; Diagnostic; Laboratories; Chemical; Technology; Medical Device; Manufacturing; Financial Services; Consumer Products

Companies Profiled:
Pfizer; LifeCell; Biocon; Biogen Idec; Alkem; AstraZeneca; Ipsen; Esteve; Guerbet; Endo Pharmaceuticals; Allergan; BD; Methapharm; GlaxoSmithKline ; Gilead Sciences; Ethicon; Johnson & Johnson; Mylan; Forest Laboratories; MedImmune; Upsher-Smith; Grunenthal; Phillips; Sandoz; Baxter International; ONYX; Xanodyne Pharmaceuticals; ViroPharma; Ranbaxy; Bristol-Myers Squibb; Novartis; Medtronic; Astellas; GE Healthcare; Eisai; Roche; Teva Pharmaceutical Industries Ltd; MSD; Bayer; Boehringer Ingelheim; Shire; Novo Nordisk; Sanofi Pasteur; Genentech; Cubist Pharmaceuticals; UCB Pharma; Sunovion; Valeant

Study Snapshot

This study engaged executives from 50 leading healthcare companies. Segmentation analysis was key to examining trends and effective practices. Within the Mature Markets Segment, 41 participants make up the Pharmaceutical Segment, while the Medical Device Segment consists of 12 participants. The India Segment consists of 8 companies working actively in the India market.

Key topics include:

Medical Affairs: Scope & Structure
Medical Affairs: Leadership & Oversight
Medical Affairs: Regulatory Landscape & Challenges
Medical Affairs: Spend Allocations & Investment Benchmarks
Medical Affairs: Staffing Benchmarks
Medical Affairs: Functional Responsibility & Service Benchmarks
Medical Affairs: Budget Trends & Success Factor Benchmarks
Participant Demographic Data

Sample Key Findings

Global Scope of Medical Affairs: All Mature Market participants have a group dedicated to Medical Affairs. Among companies in India, 89% have a fully dedicated Medical Affairs group based in India, illustrating how Medical Affairs has grown into a global function with emerging market MA groups now a normal practice.

Mature Market Medical Affairs Reporting into R&D, Becoming Own Entity; India Medical Affairs Reporting to Commercial: Four out of 10 mature market groups in the benchmark class report to R&D. As a function, Medical Affairs tends to more aligned with R&D, reflecting a common drive to differentiate itself from the commercial side of the organization. However, half of India segment participants report into Commercial/Marketing highlighting the fact that MA in India is still in formative stages.

Table of Contents

Executive Summary

Research Overview
Participating Companies
Key Recommendations
Maturity of Medical Affairs
Key Findings & Insights

Scope & Structure
Leadership & Oversight
Regulatory Landscape & Challenges
Spend Allocation
Staffing
Functional Responsibility
Budget Trends & Success Factors
Participant Demographics

Sample List of Charts & Exhibits

Medical Affairs group dedication

Departmental reporting relationships
Job level or Medical Affairs head
Geographic span of organization
Percentage of spending per Medical Affairs function
Directional trends in Medical Affairs funding levels
Directional trends in staffing levels
Reasons cited for budget/staff increases
Reasons cited for budget/staff decreases
Relative importance of seven different Medical Affairs functions
Reasons cited for increased importance
Reasons cited for decreased importance
Percentage of budget allocated for outsourcing
Percent of companies impacted by FDA Revitalization Act
Top three success factors for developing and maintaining effective Medical Affairs group
Top three challenges for developing and maintaining effective Medical Affairs group