A comprehensive overview of the new business context for biopharma companies, featuring numerous case studies and state-of-the-art marketing models Biotechnology has developed into a key innovation driver especially in the field of human healthcare. But as the biopharma industry continues to grow and expand its reach, development costs are colliding with aging demographics and cost-containment policies of private and public payers. Concurrently, the development and increased affordability of sophisticated digital technologies has fundamentally altered many industries including healthcare. The arrival of new information technology (infotech) companies on the healthcare scene presents both opportunities and challenges for the biopharma business model. To capitalize on new digital technologies from R&D through commercialization requires industry leaders to adopt new business models, develop new digital and data capabilities, and partner with innovators and payers worldwide. Written by two experts, both of whom have had decades of experience in the field, this book provides a comprehensive overview of the new business context and marketing models for biotech companies. Informed by extensive input by senior biotech executives and leading consultancies serving the industry, it analyzes the strategies and key success factors for the financing, development, and commercialization of novel therapeutic products, including strategies for engagement with patients, physicians and healthcare payers. Throughout case studies provide researchers, corporate marketers, senior managers, consultants, financial analysts, and other professionals involved in the biotech sector with insights, ideas, and models. JACQUALYN FOUSE, PhD, RETIRED PRESIDENT AND CHIEF OPERATING OFFICER, CELGENE “Biotech companies have long been innovators, using the latest technologies to enable cutting edge science to help patients with serious diseases. This book is essential to help biotech firms understand how they can–and must–apply the newest technologies including disruptive ones, alongside science, to innovate and bring new value to the healthcare system.” BRUCE DARROW, MD, PhD, CHIEF MEDICAL INFORMATION OFFICER, MOUNT SINAI HEALTH SYSTEM “Simon and Giovannetti have written an essential user’s manual explaining the complicated interplay of the patients who deserve cutting-edge medical care, the biotechnology companies (big and small) creating the breakthroughs, and the healthcare organizations and clinicians who bridge those worlds.” EMMANUEL BLIN, FORMER CHIEF STRATEGY OFFICER AND SENIOR VICE PRESIDENT, BRISTOL-MYERS SQUIBB “If you want to know where biopharma is going, read this book! Our industry is facing unprecedented opportunities driven by major scientific breakthroughs, while transforming itself to address accelerated landscape changes driven by digital revolutions and the emergence of value-based healthcare worldwide. In this ever-changing context, we all need to focus everything we do on the patients. They are why we exist as an industry, and this is ultimately what this insightful essay is really about.” JOHN MARAGANORE, PRESIDENT AND CHIEF EXECUTIVE OFFICER, ALNYLAM PHARMACEUTICALS “Since the mapping of the human genome was completed nearly 15 years ago, the biotechnology industry has led the rapid translation of raw science to today’s innovative medicines. However, the work does not stop in the lab. Delivering these novel medicines to patients is a complex and multifaceted process, which is elegantly described in this new book.”

As an authoritative guide to biotechnology enterprise and entrepreneurship, Biotechnology Entrepreneurship and Management supports the international community in training the biotechnology leaders of tomorrow. Outlining fundamental concepts vital to graduate students and practitioners entering the biotech industry in management or in any entrepreneurial capacity, Biotechnology Entrepreneurship and Management provides tested strategies and hard-won lessons from a leading board of educators and practitioners. It provides a 'how-to' for individuals training at any level for the biotech industry, from macro to micro. Coverage ranges from the initial challenge of translating a technology idea into a working business case, through securing angel investment, and in managing all aspects of the result: business valuation, business development, partnering, biological manufacturing, FDA approvals and regulatory requirements. An engaging and user-friendly style is complemented by diverse diagrams, graphics and business flow charts with decision trees to support effective management and decision making. - Provides tested strategies and lessons in an engaging and user-friendly style supplemented by tailored pedagogy, training tips and overview sidebars - Case studies are interspersed throughout each chapter to support key concepts and best practices. - Enhanced by use of numerous detailed graphics, tables and flow charts

A biotech manager's handbook lays out - in a simple, straightforward manner - for the manager or would-be entrepreneur the basic principles of running a biotech company. Most managers in biotechnology companies are working in their first company or in their first managerial role. Their expertise and experience in the scientific part of the work can be taken as a given but there is a whole range of other skills to be learned and areas of expertise to come to terms with. Small companies do not have big budgets to hire people or time to become an expert in so many areas. The book starts by outlining the state of the biopharmaceutical industry and goes on to explain the importance of planning (no matter what the size of the company). Succeeding chapters deal with the basics of intellectual property, perspectives from a university technology transfer office and how to raise some initial funding from an investor and entrepreneur. - No other 'how to' manual exists for this sector - Written by a range of expert professionals in each area, all in one book - Is the only 'bench to bedside' book covering the whole spectrum of development

Building Biotechnology helps readers start and manage biotechnology companies and understand the business of biotechnology. This acclaimed book describes the convergence of scientific, political, regulatory, and commercial factors that drive the biotechnology industry: * Cultivate a career in biotechnology, with or without an MBA or Ph.D. * Fund and assemble a company * Manage research and development, alliances, and funding * Understand the diverse factors defining the biotechnology industry * Invest intelligently in biotechnology This second edition significantly expands upon the foundation laid by the first, updating recent developments and adding significantly more case studies, informative figures and tables.

A comprehensive overview of the new business context for biopharma companies, featuring numerous case studies and state-of-the-art marketing models Biotechnology has developed into a key innovation driver especially in the field of human healthcare. But as the biopharma industry continues to grow and expand its reach, development costs are colliding with aging demographics and cost-containment policies of private and public payers. Concurrently, the development and increased affordability of sophisticated digital technologies has fundamentally altered many industries including healthcare. The arrival of new information technology (infotech) companies on the healthcare scene presents both opportunities and challenges for the biopharma business model. To capitalize on new digital technologies from R&D through commercialization requires industry leaders to adopt new business models, develop new digital and data capabilities, and partner with innovators and payers worldwide. Written by two experts, both of whom have had decades of experience in the field, this book provides a comprehensive overview of the new business context and marketing models for biotech companies. Informed by extensive input by senior biotech executives and leading consultancies serving the industry, it analyzes the strategies and key success factors for the financing, development, and commercialization of novel therapeutic products, including strategies for engagement with patients, physicians and healthcare payers. Throughout case studies provide researchers, corporate marketers, senior managers, consultants, financial analysts, and other professionals involved in the biotech sector with insights, ideas, and models. JACQUALYN FOUSE, PhD, RETIRED PRESIDENT AND CHIEF OPERATING OFFICER, CELGENE “Biotech companies have long been innovators, using the latest technologies to enable cutting edge science to help patients with serious diseases. This book is essential to help biotech firms understand how they can–and must–apply the newest technologies including disruptive ones, alongside science, to innovate and bring new value to the healthcare system.” BRUCE DARROW, MD, PhD, CHIEF MEDICAL INFORMATION OFFICER, MOUNT SINAI HEALTH SYSTEM “Simon and Giovannetti have written an essential user’s manual explaining the complicated interplay of the patients who deserve cutting-edge medical care, the biotechnology companies (big and small) creating the breakthroughs, and the healthcare organizations and clinicians who bridge those worlds.” EMMANUEL BLIN, FORMER CHIEF STRATEGY OFFICER AND SENIOR VICE PRESIDENT, BRISTOL-MYERS SQUIBB “If you want to know where biopharma is going, read this book! Our industry is facing unprecedented opportunities driven by major scientific breakthroughs, while transforming itself to address accelerated landscape changes driven by digital revolutions and the emergence of value-based healthcare worldwide. In this ever-changing context, we all need to focus everything we do on the patients. They are why we exist as an industry, and this is ultimately what this insightful essay is really about.” JOHN MARAGANORE, PRESIDENT AND CHIEF EXECUTIVE OFFICER, ALNYLAM PHARMACEUTICALS “Since the mapping of the human genome was completed nearly 15 years ago, the biotechnology industry has led the rapid translation of raw science to today’s innovative medicines. However, the work does not stop in the lab. Delivering these novel medicines to patients is a complex and multifaceted process, which is elegantly described in this new book.”

Under Gordon Binder's leadership, Amgen became the world's largest and most successful biotech company in the world. This text describes what it really takes to manage risk, financing, creative employees, and intellectual property on the international stage.

This book describes the way that pharmaceutical projects and programs are currently managed, and offers views from many highly experienced practitioners from within the industry on future directions for drug program management. The book integrates portfolio, program, and project management processes as fundamental for effective and efficient drug product development. Contributing expert authors provide their view of how the projectization approach can be taken forward by the drug industry over the coming years.