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
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