This comparative study looks at the early development of biotechnology in the US and Japan. Drawing on primary and secondary sources it traces the historical roots of recombinant DNA technology, discusses the tensions between regulation and promotional policies and identifies the major actors and strategies that launched biotechnology in both countries. Developing several strands of theory in economic history, science and technology policy, the book proposes a simple model that relates the differences in the two countries' responses to variations in the availability of institutional, financial and organizational resources needed to commercialize the new technology.

This comparative study looks at the early development of biotechnology in the US and Japan. Drawing on primary and secondary sources it traces the historical roots of recombinant DNA technology, discusses the tensions between regulation and promotional policies and identifies the major actors and strategies that launched biotechnology in both countries. Developing several strands of theory in economic history, science and technology policy, the book proposes a simple model that relates the differences in the two countries' responses to variations in the availability of institutional, financia.

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

The Business of Biotechnology: From the Bench to the Street thoroughly examines the existing and future business challenges for biotechnology, providing a unique insight into the intricate web of critical factors with which biotechnology entrepreneurs must come to terms if they wish to be successful. The book begins with discussions of the evolution of biotechnology; entrepreneurship in the biotechnology industry; university-industry technology transfer process; and the life cycle of a biotechnology company. It considers the prospects for biotechnology, from the perspective of a venture capitalist and human resource practitioner. There are separate chapters that deal with the cloning and expression of recombinant gene products; developing strategies to reduce the cost-to-produce (CTP) therapeutic proteins; intellectual property protection; and the regulation of commercial biotechnology. The final chapters cover the marketing of biotechnology companies and products; the performance of biotechnology stocks; mergers and acquisitions in the biotechnology industry, and prospects for the Japanese and European biotechnology industry.