Healthcare Biotechnology

Book excerpt: Foreseeing and planning for all of the possibilities and pitfalls involved in bringing a biotechnology innovation from inception to widespread therapeutic use takes strong managerial skills and a solid grounding in biopharmaceutical research and development procedures. Unfortunately there has been a dearth of resources for this aspect of the field. Until now. Focusing on the management of healthcare-related biotech, from conception through the product’s regulatory approval and entire life cycle, Healthcare Biotechnology: A Practical Guide provides a practical, applicable resource to assist all health-care related biotech professionals in their day-to-day activities from the lab to the boardroom. Divided into six sections, the book begins with current systems and recent progress and controversy, major players and products, and a comparison with the pharmaceutical industry. It covers intellectual property protection and management, the innovation cycle, patent application, commercialization, and competition. Coverage includes funding, partnering, cash-intensive activities, financing alternatives, and the complexities of alliance implementation and management. It highlights research, development, and biomanufacturing; and examines clinical trial design and regulations; "fast-track" approvals; and patient recruitment as well as production platforms and processes, costs, strategies, and timelines. It investigates marketing including planning, promotion, pricing, supply chain management, and bio-brand lifecycle management. It concludes with tips on running the business, offering diverse biobusiness models and reasonable expectations from inception through maturity and decline. An indispensible guide, this book offers more than 40 figures, 220 tables, and 180 references as well as a list of abbreviations and a business plan outline. Each chapter contains 10 questions to reinforce the material covered and 10 exercises to challenge the reader and inspire critical thinking. Ancillary materials including solutions manual and over 1000 PowerPoint slides available for qualifying course adoption.