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This book explores the evolving and strategic leadership role of Medical Affairs within the pharmaceutical industry-an area uniquely positioned at the intersection of clinical science, product development, and stakeholder engagement.Spanning all phases of the medicinal product lifecycle, Medical Affairs functions as a critical bridge between industry and the broader medical community. Success in this role demands a robust, interdisciplinary skill set encompassing scientific, clinical, regulatory, and strategic competencies. The accelerating pace of technological advancement, digital transformation, and integration of artificial intelligence is reshaping the landscape of healthcare and Medical Affairs alike.
Simultaneously, healthcare systems face increasing resource constraints, while the burden of chronic disease rises and treatment options expand. In this complex environment, the success of innovative medicinal products depends not only on clinical efficacy but also on demonstrating economic value to a broad array of stakeholders, including patients, healthcare professionals, payers, regulators, and medical societies. Products that integrate the needs of these stakeholders early in development and commercialization are positioned to deliver the highest value.
The book is structured in three parts:
Part I outlines the mission, values, and overarching objectives of Medical Affairs. Part II delivers practical, in-depth guidance on the foundational principles and essential functions of Medical Affairs, with dedicated chapters on key activities. Part III addresses current challenges and innovations, including ethical considerations and compliance in industry-healthcare professional interactions.
Throughout, real-world examples and applied insights illustrate core concepts, making the content highly relevant for professionals across experience levels. Whether a medical or science student exploring career opportunities in industry, or a healthcare professional seeking to broaden their strategic impact, this book serves as a comprehensive, practice-oriented guide to the future of Medical Affairs.
Dr. Andriy Krendyukov, MD, MBA, is a seasoned physician-scientist and pharmaceutical executive with nearly two decades of experience in the development, launch, and commercialization of innovative therapies across oncology, cardiology, endocrinology, neuroscience, and dermatology.
A graduate of the Medical University, Dr. Krendyukov completed his medical training and specialization in 1997, followed by an MBA from the ESSEC & Mannheim Business School in 2013. His early career in Health Care included clinical and research roles at a University Clinic and within emergency medical services.
Driven by a passion for advancing patient care through innovation, Dr. Krendyukov transitioned to the pharmaceutical industry, where he has contributed at both regional and global levels. He frequently lectures on strategy development and pharmaceutical innovation, including engagements at Mannheim Business School's Consulting Club and major international oncology forums such as ESMO, ESMO Asia.
In recent years, his research has focused on key topics including adaptive trial designs (on-going postdoctoral research at University of Mannheim), strategic frameworks for innovative therapies, healthcare communication pathways, and early access programs. His work has been presented at major scientific conferences and published in peer-reviewed journals.
Preface.- Part I Chapter 1 Medical Affairs: What It Is and What It Isn't.- Chapter 2 Navigating an Evolving Landscape in the Pharmaceutical Industry.- Chapter 3 Medical Affairs key activities.- Part II Chapter 4 Modern Concepts and Strategy Development.- Chapter 5 Scientific Communication in Pharma.- Chapter 6 Clinical study.- Chapter 7 Education and Training in Pharmaceutical Companies with a Focus on Medical Affairs.- Chapter 8 External Experts Development and Management, Interaction and Collaboration with Key Medical Societies.- Part III.- Chapter 9 Medical Affairs enabling activities.- Chapter 10 Safety and Pharmacovigilance in the Lifecycle of Medicinal Products.- Chapter 11 Medical Affairs and Real-World Evidence.- Chapter 12 Ethics and Compliance: The Leading Role of Medical Affairs.- Chapter 13 The Role of Artificial Intelligence in Healthcare and the Pharmaceutical Industry.
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