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OverviewFull Product DetailsAuthor: Dylan LeePublisher: IGI Global Imprint: Business Science Reference ISBN: 9798337374796Pages: 300 Publication Date: 11 March 2026 Audience: College/higher education , Professional and scholarly , Tertiary & Higher Education , Professional & Vocational Format: Paperback Publisher's Status: Active Availability: In Print This item will be ordered in for you from one of our suppliers. Upon receipt, we will promptly dispatch it out to you. For in store availability, please contact us. Table of ContentsReviewsAuthor InformationDr. Dylan Lee is a physician-scientist and healthcare executive whose work sits at the intersection of medical innovation, regulatory governance, and global health markets. He holds an MD from a leading medical university, a PhD in Strategic Leadership from a U.S. research university, and an MBA from an accredited U.S. program. This training reflects a deliberate integration of clinical medicine, institutional strategy, and economic decision making. In industry, Dr. Lee has served as a senior corporate officer at a global biopharmaceutical company with direct responsibility for clinical development strategy and multi region regulatory execution across the United States, Europe, and Asia. His leadership spans the full translational and industrial lifecycle of healthcare innovation, from preclinical rationale and mechanism based prioritization to first in human studies, late phase trials, and regulatory submissions. He has led IND and CTA authoring under FDA, EMA, and Asian regulatory frameworks and established cross functional governance structures integrating medical affairs, regulatory science, pharmacovigilance, biostatistics, and quality systems under GxP standards. Crucially, Dr. Lee’s industry work has been shaped not only by scientific feasibility but also by political and economic constraints, including payer expectations, intellectual property regimes, pricing and reimbursement logic, and the realities of cross border market access. He has overseen global, multi site clinical programs using risk based monitoring and evidence standards aligned with regulatory and reimbursement requirements. He has also participated in portfolio strategy, indication selection, and capital allocation decisions where scientific value, regulatory risk, and commercial sustainability intersect. His experience includes managing cross border partnerships, technical and regulatory diligence, and post transaction integration in multinational healthcare settings. Alongside his executive responsibilities, Dr. Lee maintains an active academic profile with formal appointments in molecular medicine and immunology, graduate level teaching in research design and clinical methodology, supervision of trainees, and sustained contributions to peer reviewed scholarship. His service as a reviewer and editorial contributor reinforces a commitment to methodological rigor, transparent reporting, and evidence synthesis. These principles inform both his academic and industry leadership. This combined trajectory of clinical training, academic rigor, and operational execution underpins Dr. Lee’s perspective in this volume. It allows him to approach healthcare not simply as a scientific or ethical endeavor but as a governed industry shaped by state authority, market structures, and power relations. His work reflects a practical understanding of how biomedical innovation is translated into regulated products, priced within political systems, and ultimately embedded within national and global health economies. Tab Content 6Author Website:Countries AvailableAll regions |
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