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


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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 …

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.

Published in: Health & Medicine, Business

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  • 1. BEST PRACTICES, ® LLC Best Practices, LLC Strategic Benchmarking Research Building Best-in-Class Medical Affairs Capabilities In India – A Case Study For High-Growth Emerging Markets
  • 2. 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 2 Copyright © Best Practices, LLC
  • 3. BEST PRACTICES, ® LLC 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. 3 Copyright © Best Practices, LLC
  • 4. BEST PRACTICES, ® LLC 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. 4 Copyright © Best Practices, LLC
  • 5. BEST PRACTICES, ® LLC 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. 5 Copyright © Best Practices, LLC
  • 6. BEST PRACTICES, ® LLC 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 6 Copyright © Best Practices, LLC 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.
  • 7. BEST PRACTICES, ® LLC 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% 7 Copyright © Best Practices, LLC Current Structure (n=9)(n=53) Mature Markets Segment: India Segment: * *Other: • Decentralized by region and TA
  • 8. BEST PRACTICES, ® LLC 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) 8 Copyright © Best Practices, LLC 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%
  • 9. BEST PRACTICES, ® LLC 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) 9 Copyright © Best Practices, LLC India Segment: Importance of Medical Affairs Functions (n=8)
  • 10. BEST PRACTICES, ® LLC 10 Copyright © Best Practices, LLC About Best Practices, LLC
  • 11. BEST PRACTICES, ® LLC 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: 11 Copyright © Best Practices, LLC 6350 Quadrangle Drive, Suite 200 Chapel Hill, NC 27517 (Phone): 919-403-0251 D410, Neelkanth Business Park, Behind Bus Depot, Vidyavihar West, Mumbai 400086 India (Phone): 022-2515 1836