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
Table of Contents
The Healthcare Biotechnology Industry: Bioeconomy. Intellectual Property: Intellectual Property Management. Biolicensing. Funding: Biofinance. Biopartnering. New Product Development: Biodrug Research. Biomanufacturing. Marketing: Biomarketing planning. Biopromotion. Biopricing. Biosupply Chain. Product Life Cycle Management. Running the Business: Biobusiness models. Biosimilars Model. Biocompany Life Cycle.
Dr. Dimitris Dogramatzis was born in Greece in 1962. After earning a Bachelor's diploma in Pharmacy from the University of Patras in Greece, he spent the next seven years in Texas studying and working for the University of Texas system. During this period, he completed his Ph.D. in Pharmacology and Toxicology at the University of Texas Medical Branch at Galveston. Later he went on to complete two successive postdoctoral trainings at the University of Texas Medical Branch at Galveston, as well as at the M.D. Anderson Cancer Center at Houston, Texas. He is currently the owner of a retail pharmacy in Athens, a business consultant, and a writer.